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India Pharma
Inc.: Capitalising
on India’s
Growth Potential
Foreword


                                                                          Sujay Shetty                 Jai Hiremath
                                                                              Director                    Chairman,
                                                                     India Pharmaceuticals &     CII Pharma Summit 2010 &
                                                                     Life sciences leader, PwC   Vice Chairman & Managing
                                                                                                      Director, Hikal Ltd.


The global Pharma industry is under serious pressure from a large number of innovator molecules facing patent expiration,
a thin pipeline of new drugs, regulatory challenges and pricing pressures. This has led to a directional shift towards the
emerging markets of Asia, Australia, Africa and Latin America, which are growing three times faster than the current
growth rates experienced in the industry’s leading markets of North America, Japan and Europe. We expect over 40% of
the global Pharma industry’s incremental growth over the next decade to come from the emerging markets.
The Indian Pharma industry is on the threshold of becoming a major global market by 2020. Many experts believe that
the Industry has the potential to grow at an accelerated 15 to 20% CAGR for the next 10 years to reach between US$49
billion to US$74 billion in 2020.
The Indian pharmaceuticals market is witnessing dynamic changing trends such as large acquisitions by multinational
companies in India, increasing investment by domestic and international players in India, deeper penetration into the rural
markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZ’s). We believe
these trends combined with increased purchasing power and access to good quality medical care will continue to propel
the domestic pharmaceutical industry to new heights.
Indian Pharma companies are already major outsourcing partners of global Pharma companies. Research & Development
in India is getting more innovative. Domestic companies have strengthened their position in the world for supplying
solutions across the pharmaceutical value chain. They are likely to become a competitor of global Pharma in the areas
of manufacturing and R&D, and a potential partner in others.
In this report, we look at developments in the branded generics market, over-the-counter products (OTC), vaccines and
rural markets, and analyse what lies ahead for the industry as it aims to capitalise on the promise of the domestic market
place. We believe that the domestic Indian pharmaceutical market has a positive growth trajectory but will also face major
transformational challenges in the next decade. We address some of these challenges and identify key imperatives to
accelerate the domestic market’s growth.
Contents




Background                                 6

The Indian Domestic Pharma Market         14

Indian Pharma Market Segments             18

Rural markets                             28

Vaccines                                  34

Changing Tax Environment                  38

Challenges                                44

The Road Ahead - Imperatives for Growth   48

Profiles                                  52

References                                60

About Confederation of Indian Industry    62

About PricewaterhouseCoopers              63

Contacts
Executive Summary

The global pharmaceutical market is          industry has a favourable macro-              Currently, around 67% of India’s
undergoing rapid transformation. As          environment to grow in. The Indian            population, or 742 million people live
blockbuster drugs come off patent, there     economy has rebounded from the global         in rural areas (6), but rural markets
are fewer new products in the pipeline to    economic downturn, with real gross            contribute to only 17% (7) of the overall
replace them. This is due to declining       domestic product (GDP) growth reaching        market’s sales. This represents a huge
R&D productivity and rising regulatory       9.66% in 2010.(4) The Indian middle           opportunity for pharmaceutical
costs. In PwC Pharma 2020 series of          class is also expanding rapidly, with         companies, as we expect these markets
reports, we have examined in detail the      affordability of medicines increasing,        to be the future growth drivers for the
challenges faced by Big Pharma in this       and an increased percentage of                industry. The rural market has several
regard. There has been a dramatic shift      disposable income being spent on              challenges, and in order to tap the full
towards emerging markets as western          healthcare. The government has made           potential of this opportunity, companies
markets slow down. Global Pharma             public healthcare one of its top priorities   should:
multinational corporations are looking       by launching policies and programmes          •	 create demand by increasing
at new growth drivers such as the Indian     that are aimed at making healthcare              awareness and education;
domestic market to capitalise on the         more affordable and accessible, especially    •	 work with the government through
growing opportunity.                         in rural markets.                                public-private partnerships (PPP),
The paradigm faced by the leading            The industry is witnessing trends                in order to improve hygiene and
economies of the US, Europe and Japan        such as acquisition activity, increasing         infrastructure conditions;
are significantly different from those in    investment, deeper penetration into           •	 mobilise primary care givers and
the emerging markets of India, China,        the tier I to tier VI and rural markets,         paramedics through health and
South America and Russia. According          growth in insurance coverage and                 diagnostic camps;
to IMS Health, the emerging markets          innovation in healthcare delivery.            •	 bring specific product solutions to
of Asia/Africa/Australia grew at a rate      Taken together, these trends are leading         the market and use local languages;
of 15.9% in 2009, as compared to much        to increased affordability of services        •	 improve accessibility of medicines
slower growth rates in North America         to patients and access to quality medical        by innovative distribution channels
(5.5%), Japan (7.6%) and Europe              care. We believe these trends, along             and
(4.8%).(1) Emerging markets will be the      with the favourable macro environment         •	 make products affordable, through
next major growth drivers for the global     will propel the industry to the next level       appropriate pricing and packaging.
Pharma industry, with more than 40%          of growth.
                                                                                           Top Indian and foreign companies will
of incremental growth of the industry        At the moment, approximately 90% of           look to increase their market share by
coming from emerging economies in            India’s pharmaceutical market is made         entering into strategic alliances,
the next decade.(2)                          up of branded generics.(5) We estimate        strengthening their sales forces and
In our report, “Capitalising on India’s      that this segment will grow at a CAGR         increasing penetration into newer
growth potential”, we analyse the            of 15% - 20% for the next five years.(5)      markets.
immense potential of India’s domestic        Generic generics’ and patented products’
                                                                                           The potential that the Indian Pharma
Pharma market, which was valued at           contributions to the market as a whole is
                                                                                           industry holds is unquestionable. India
approximately US$12 billion in 2010,         currently very low. Although this is the
                                                                                           is home to approximately 1/6th of the
and showed a strong growth of 21.3%          expected model of the future, we do not
                                                                                           world’s population, and is expected to
for the twelve months ending September       foresee a significant increase in the next
                                                                                           become the most populous nation in the
2010.(3) PwC estimates that over the next    five years; the market is expected to
                                                                                           world by 2050.(8) Demand for
10 years, the domestic market will grow      remain comprised predominantly of
                                                                                           pharmaceuticals will grow decidedly.
to US$49 billion - a compounded annual       branded generics. By 2020 though,
                                                                                           Government must continue to invest in
growth rate (CAGR) of 15%, with the          patented drug sales are expected to
                                                                                           healthcare and medical infrastructure in
potential to reach US$74 billion – a         increase, owing to an improvement in
                                                                                           rural markets, raise healthcare spending,
CAGR of 20%, if aggressive growth            the implementation of patent laws and
                                                                                           encourage innovation, contain healthcare
drivers kick in.                             spread of health insurance. We also
                                                                                           costs and work with private players to
One of the reasons behind this expected      expect the OTC segment to be a strong
                                                                                           take the market to the next level.
growth rate is that India’s pharmaceutical   growth driver for the industry.
Background
Strong macroeconomics
over the next decade




 The Growing Indian Economy

 Growing Middle Class With Higher Purchasing Power

 Changing Disease Profile

 Government Policies

 Healthcare Insurance
Large numbers of forthcoming patent
expiries, a dry pipeline of new drugs,              Figure 1: Emerging markets (Asia/Australia/Africa & Latin
regulatory challenges and pricing                   America) growing faster than developed markets
restrictions have collectively contributed
to low growth rates for prominent global                                                                                                            15.90%
pharmaceutical markets. As global                               18.00%

markets such as North America, Europe                           16.00%
and Japan continue to slow down (See                            14.00%
figure 1), pharmaceutical companies are                                                                                                                                   10.60%
                                              Growth Rate (%)




                                                                12.00%
scanning markets for new growth
opportunities to boost drug discovery                           10.00%
                                                                                                                             7.60%
potential, reduce time to market and                             8.00%
                                                                                5.50%
squeeze costs along the value chain. The                         6.00%                                   4.80%
Industry is beginning to realize that some
                                                                 4.00%
of the most promising opportunities will
                                                                 2.00%
come from emerging markets (Asia/
Australia/Africa & Latin America).                               0.00%
                                                                         North America                   Europe              Japan              Asia/Australia/            Latin
                                                                               1                     2                   3                  4                5
IMS Health and other sources suggest                                                                                                                Africa                America
that emerging markets (China, India,
Brazil, Russia, Turkey, Mexico and South     Source: IMS Health market prognosis, March 2010
Korea) will contribute to over 40% of the
incremental growth of the global
Pharmaceutical industry over the next
decade.(2) In this report, we will look at      Figure 2: Emerging markets drive industry growth
the domestic Indian Pharma market, and
the opportunities it holds.
                                             100%
The huge potential of the Indian                                                                                                7
pharmaceutical industry is impossible for    90%                                                            22                 11                  22                23
                                                                         32
global Pharma companies to ignore,           80%
                                                                                        35                                              1
given that India will be one of the top 10                                                                   9                          3           9
                                             70%                                                                                                                     9
sales markets in the world by 2020.                                      9                                  10                                      7                6
                                             60%                                         9                                                                  2                 2
Some of the largest Pharma companies in                                                          3
                                                                                                                     2
                                                                         10
the world have been in the Indian market     50%
                                                                                2                                              63
since the 1970s, and 5 out of the top 10     40%
domestic Pharma companies are already                                                   42                  44                                     48                46
                                             30%
foreign owned, with a consolidated share                                 37
of 22 – 23%.                                 20%

India’s domestic pharmaceutical market       10%
                                                                                        12                  12                 15                  11                12
                                                                         9
has recorded a CAGR of 13.5% over the             0%
past five years.(5) With considerable                                2009 (f)         2010 (f)            2011 (f)           2012 (f)            2013 (f)       2008-2013 (f)
expertise in manufacturing of generics
and vaccines, Indian companies have                             Rest of World       Emerging markets             South Korea, Canada               Japan        EU       US

now also started significant research
and development (R&D). India has the
                                               Source: IMS Health, Market Prognosis, October 2009
world’s second biggest pool of English
speakers and a strong system of higher
education, all this has well-positioned

                                                                          	                                                                                           PwC 	         7
India to become an outsourcing partner     changing disease profile. Increase in                                                     growth of the industry, such that it is on
     in manufacturing and R&D, and as a         insurance coverage, aggressive market                                                     the threshold of becoming a competitor
     location for clinical trials.              creation, growth in the income of the                                                     of global Pharma companies in some key
     The Indian economy is growing strongly     Indian population and steady                                                              areas, and a potential partner in others.
     and healthcare is expanding to meet the    government investment into medical
     needs of a growing population with a       infrastructure has further propelled the




     Macro factors pushing the industry

     The Growing Indian Economy                          Figure 3: India’s strong GDP growth rate
     The Indian economy is growing fast,                                                           12
     and is valued at US$1.430 trillion in
                                                                                                   10
     2010.(4) GDP growth, calculated on
                                                          GDP growth (%)




     a Purchasing Power Parity basis has                                                               8
     reached 9.66% in the year 2010, and
                                                                                                       6
     the International Monetary Fund (IMF)
     expects it to remain consistently above                                                           4
     8% till 2015. Furthermore, India’s share
                                                                                                       2
     in the world GDP has been steadily
     increasing, and is expected to reach                                                              0
                                                                                                             2005   2006   2007    2008   2009   2010    2011   2012    2013    2014   2015
     6.28% in 2015, up from 4.17% in 2005.(4)          GDP growth % 9.167 9.658 9.886 6.396 5.678 9.668 8.373 7.976 8.174 8.148 8.128

                                                        Source: International Monetary Fund, World Economic Outlook, (October 2010)



                                                         Figure 4: Growing global share of India’s GDP (%)

                                                                                                   7
                                                            India’s share of the World’s GDP (%)




                                                                                                                                                                               6.074
                                                                                                   6                                                        5.677
                                                                                                                                             5.276                     5.873           6.28
                                                                                                   5                        4.74                        5.486
                                                                                                               4.365
                                                                                                                                      5.051
                                                                                                   4                   4.544
                                                                                                           4.173
                                                                                                   3

                                                                                                   2

                                                                                                   1

                                                                                                   0
                                                                                                   2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015

                                                        Source: International Monetary Fund, World Economic Outlook, (October 2010)




8	     India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                                                             2010
Growing middle class with higher purchasing power
  India’s population is currently just                                                                 at 2001-02 prices), which has grown                                   is rapidly acquiring the purchasing
  over 1.1 billion and is projected to                                                                 rapidly, from 25 million people in 1996                               power necessary to afford quality
  rise to 1.6 billion by 2050 – a 45.5%                                                                to 153 million people in 2010.(11) If the                             western medicine due to an increase
  increase that will see it outstrip China                                                             economy continues to grow fast and                                    in disposable income. The Indian
  as the world’s most populous state.(9)                                                               literacy rates keep rising, around a third                            population spent 7% of its disposable
  Besides, India has a huge middle class                                                               of the population (34%) is expected                                   income on healthcare in 2005; this
  population (households with annual                                                                   to join the middle class in the near                                  number is expected to nearly double, to
  incomes of US$4762 to US$23,810                                                                      future. The middle class population                                   13%, by 2025.(12)



          Figure 5: Population growth projections                                                                                                     Figure 6: Ascent of the Indian Middle Class -
                                                                                                                                                      Percentage of the population
                                                                                                                                     1326.1

                                                                                                                                1311.6
                                                                                                                   1296.8
                                                                                                        1281.9
Million Persons




                                                                                              1266.9
                                                                 1251.7
                                                       1236.3                                                                                                                                         34%
                                             1220.8
                                                                                                                                                                                         13%
                                   1205.1                                                                                                                                                              • 2020
                        1189.2                                                                                                                                                            • 2009-10
                                                                                                                                                                                                       (Forecast)
                                                                                                                                                                         11.7%

                                                                                                                                                                             • 2007-08


                                                                                                                                                           6%
                                                                                                                                                             • 2001-02
                  2010/11


                             2011/12


                                        2012/13


                                                  2013/14


                                                            2014/15


                                                                                         2015/16


                                                                                                   2016/17


                                                                                                              2017/18


                                                                                                                           2018/19


                                                                                                                                      2019/20




 Source: ISI analytics (2010)                                                                                                                        Source: Economic Times (April 2009), PwC analysis




         Figure 7: Indian population’s expenditure break up as a % of overall disposable income

                                                                                                         4%
                                                                                         100%
                                                                                                                            7%               9%      13%
                                                                                          90%                                                               Healthcare


                                                                                                                                                            Education &
                                                                                          80%
                                                                                                                                                            Recreation
                                                                                                                                                            Communication
                                                                                          70%

                                                                                                                                                            Tranportation
                                                                      Percentage spend




                                                                                          60%
                                                                                                                                                            Personal products
                                                                                          50%                                                               and services
                                                                                                                                                            Household
                                                                                                                                                            products
                                                                                          40%
                                                                                                                                                            Housing & utilities

                                                                                          30%
                                                                                                                                                            Apparel

                                                                                          20%
                                                                                                                                                            Food, beverages
                                                                                                                                                            and tobacco
                                                                                          10%


                                                                                             0%
                                                                                                       1995             2005         2015F        2025F
                                                                                                                               Year
                                                                      Source: IDFC Institutional Securities, Indian Pharma (June 2010)

                                                                                                                                         	                                                                          PwC 	   9
Changing Disease Profile
    The Indian population is experiencing                IMS Health indicates that some of the      Along with chronic, in the last year there
    a shift in disease profiles (Figure 8).              fastest growing therapeutic segments       has been a rebound in sales in the acute
    Traditionally, the acute disease segment             in the Indian Pharma space today are       diseases segment. This trend is likely to
    held a significant share of the Indian               chronic disease-related therapeutic        continue over the next few years, as we
    pharmaceutical market. This segment                  segments. The anti-diabetic segment        see companies widening their reach into
    will continue to grow at a steady rate,              grew 29% in the 12 months ending July      newer markets, which have a relatively
    due to issues relating to public hygiene             2010. Cardio-vascular medication and       higher number of treatment naïve
    and sanitation. But, with increase in                nervous system disorder medication         patients requiring basic treatment, thus,
    affluence, rise in life expectancy and               grew at 22% for the same period of time,   creating new demand for drugs of the
    the onset of lifestyle related conditions,           indicating rapid growth.(13)               acute therapies segment.
    the disease profile is gradually shifting            The growing size of the Indian geriatric
    towards a growth in the chronic diseases             population will be a key factor in
    segment. India has the largest pool of               influencing the growth of the chronic
    diabetic patients in the world, with more            segment. By 2028, an estimated 199
    than 41 million people suffering from the            million Indians will be age 60 or older,
    disease; this is projected to reach 73.5             up from about 91 million in 2008.(9)
    million in 2025.(10)




                 Figure 8: Shift in Disease Profile toward Chronics

                         100%   1                   2
                                3
                                                    4
                                3
                                2                   5
                         90%    2
                                                    2
                                5                   2

                         80%                        6
                                11
                                                                Cancer
                         70%    5                   12
                                                                Heart disease
Disease Prevalence (%)




                                7                               Other circulatory
                         60%    2                   8
                                                                CNS Disorders
                                                                Diabetes
                         50%                        12
                                                                Asthma
                                                    2
                         40%                                    Others
                                                                Sense organs
                         30%    57                              Muscoloskeletal
                                                                Accidents
                         20%                        41
                                                                Acute Infections

                         10%


                          0%
                                     2001    2012

    Source: IDFC Institutional Securities, Indian Pharma (June 2010)
Government policies
The Indian government has been             plans to spend US$293 million on             India’s healthcare expenditure is
making efforts to improve nationwide       the promotion of healthcare through          financed out of pocket. This limits
provision of healthcare. It has launched   programmes for the prevention and            the propensity of Indians to spend on
policies that are aimed at:                cure of diseases such as cancer, diabetes,   healthcare, particularly in lower and
•	 building more hospitals,                heart ailments and stroke in 2011-12.        middle income groups which comprise
•	 boosting local access to healthcare,    Diabetes, hypertension and non-              around 95% of population.(8)
•	 improving the quality of medical        communicable disease patients will be        The small percentage of Indians who
   training,                               screened under the National Programme        do have some insurance, the main
•	 increasing public expenditure on        for Prevention and Control of Cancer,        provider is the Government-run
   healthcare to 2-3% of GDP, up from a    Diabetes, Cardiovascular Diseases and        General Insurance Company (GIC).
   current low of 1%.(14)                  Stroke (NPCDCS). The programme is            Private insurance only came into the
Some of the significant government         likely to cover more than 70 million         market post 2007, when the Insurance
allocations on healthcare spend include    adults across 100 districts in 15 states     Regulatory and Development
a five year tax break for opening          and union territories of the country.(15)    Authority (IRDA) eliminated tariffs
hospitals anywhere in India, with                                                       on general insurance. Apollo was
an added focus on tier II and tier III
                                           Healthcare Insurance                         the first private healthcare insurance
markets, both in the 2008-09 Union         India’s healthcare insurance industry        provider in the country; other private
Budget.                                    is currently very small and limited,         entrants are ICICI Lombard, Tata AIG,
                                           but is expected to grow at a CAGR of         Royal Sundaram, Star Allied Health
                                           15% till 2015. Around 80% of                 Insurance, Cholamandalam DBS and
                                                                                        Bajaj Allianz Apollo.




Going forward, the Indian government
Figure 9: Healthcare expenditure break up 2009
                                                                                                                                               Local
                                                                                                                             11%
                                                                                                                                               Social Insurance
                                                                                                                                   6%


                                                                                        State   71%                                 12%        Centre


                                                                           Government
                                                        17%

                                                                3%         Insurance


       Out of Pocket          80%




      Source: ISI Analytics, Healthcare Industry (2010)




         Figure 10: Increase in penetration of Healthcare Insurance



                90000
                                                                                        81000
                80000          Size of the Healthcare
                               Insurance Industry
                70000                                                           66000                                  70

                60000                                                                                                  60
  INR Million




                                                                                                     Million Persons




                50000                                                                                                  50

                40000                                                   32090                                          40                               No. of People
                30000                                                                                                  30                               covered by
                                                                22220                                                                                   Health Insurance
                20000                                   17320                                                          20                               (Million)
                                              13540
                                    10040
                10000       7610                                                                                       10
                   0                                                                                                   0
                            2002     2003     2004      2005    2006    2007    2008    2009                                2006        2015

      Source: ISI Analytics, Healthcare Industry (2010), General Insurance Council of India (2010)




12	             India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                                2010
“In terms of factors that could drive the market up,
                                                                 I think insurance would be a major factor. Insurance
                                                                 penetration numbers should go up dramatically,
                                                                 because out of pocket payment for medications is not a
                                                                 model anywhere in the world, as it cannot drive a large
                                                                 part of the market. A lot of countries have gone through
                                                                 this change; it is imperative to take us to the next level.”

                                                                 – Achin Gupta , Sr. V.P, Corporate Strategy, Glenmark




The government runs a programme           The government, along with many             Overall, lack of insurance coverage still
called the National Rural Health          in the industry believes that increase in   remains a challenge. Widespread use
Mission (NRHM), for the development       insurance coverage is essential             of health insurance could take many
of the poor, allocating US$2920 million   to take the market forward. But,            years, not least because insurance
in the 2008-09 budget, under the          other experts believe that the spread       companies lack the data they require
NRHM.(16) A health insurance scheme       of health insurance could lead to           to assess health risks accurately and
called Rashtriya Swasthya Bima Yojna      a market wherein there is minimal           the only products they sell work on
(RSBY) that provided US$745 worth         differentiation between branded             an indemnity basis – that is, they
of cover for every worker was also        generics. An important success factor       reimburse the patient after he or she
included. The total allocation of this    for generic makers is differentiation of    has paid the healthcare provider’s bill,
inclusion was US$51 million(17), which    their products. While increased health      making such policies
was then increased in the subsequent      insurance coverage may benefit generic      less attractive.
budgets. The latest budget, 2010-11,      drug manufacturers by increasing the
incorporated a further 20% of the         market’s affordability for medicines,
population covered under the NREGA        it may, in combination with increased
(National Rural employment Guarantee      institutional sales cause a reduction in
Act).(18)                                 prices, owing to the rising influence of
                                          insurance companies.




      Key takeaways
      1.	 The Indian economy is growing strongly, and will continue
          to provide a conducive macro-environment for the industry
          to grow in.

      2.	 The government is increasing spend on healthcare; and the
          Indian population is spending an increased amount of money
          on healthcare as a percentage of disposable income.

      3.	 The disease profile is changing with an increase in acute
          diseases along side growth of chronics.

      4.	 Health insurance is growing.




                                                             	                                                      PwC 	       13
The Indian Domestic
Pharma market
Set for robust growth




 Key Players

 Industry SWOT

 Key Recent Trends

 Investment Scenario
According to IMS Health, in               domestic market size to be US$12
September 2010, on a Moving annual        billion. We estimate that by 2020,
total (MAT) basis, the Indian Pharma      it will grow to US$49 billion - a
market grew at 21.3%, reaching            conservative CAGR of 15%, with
a size of US$10.9 billion.(3) Taking      the potential to reach US$74 billion –
into account generic medicines sold       at an aggressive CAGR of 20%, if
directly to institutions and OTC drugs    growth drivers kick in.
sold through non-pharmacy retailers,
PwC and IMS Health estimate the




Key Players

There is a high level of market                      Figure 11: India Pharma top 10 players: 12 month growth
fragmentation. As of 2009, there                     rate ending July 2010 (09/10 Revenues in US$ millions)
were more than 10,000 firms in the
market, of which, around 200 of them
collectively controlled about 70% of
                                                                  Cipla                             19% (1276.1)
the market share.(19)
Most of the top 10 players in the                          Ranbaxy                             15.5% (1125.45)

market had growth rates of over 18%                       GSK India                                 19% (445.87)
for the 12 months ending July 2010.
                                                  Piramal Healthcare                                18.6% (631.18)
Of these, Cipla continued to have the
largest market share of 5.2%, followed                  Sun Pharma                                             25.7% (600.65)
by Ranbaxy (now a subsidiary of
                                                       Zydus cadila                                         24.1% (436.40)
Daiichi-Sankyo), with a 4.7% share.(13)
                                                        Alkem Labs                                         23.3% (276.49)

                                                         Pfizer India                                       23.6% (192.59)

                                                    Mankind Pharma                                                               37.20%
                                                                                                                                (200.06)
                                                             Abbott                                           25% (189.07)



                                                    Source: Business Standard (October 2010), IMS Health, Capitaline




                                                              	                                                              PwC 	    15
Industry SWOT

       Figure 12: Indian Pharma Industry SWOT analysis


          Strengths                                                       Weaknesses
          • Higher GDP growth leading to increased disposable             • Poor all-round infrastructure is a major challenge
            income in the hands of general public and their               • Stringent price controls
            positive attitude towards spending on healthcare
                                                                          • Lack of data protection
          • Cost Competitiveness
                                                                          • Poor health insuracnce coverage
          • Low-cost, highly skilled set of English speaking
            labour force
          • Growing treatment naive patient population




          Opportunities                                                   Threats
          • Global demand for generics rising                             • Labour shortage
          • Rapid OTC and generic market growth                           • Wage inflation
          • Increased penetration in the non - metro markets              • Government expanding the umbrella of the Drugs
          • Large demand for quality diagnostic services                    Price Control Order (DPCO)
          • Increase in healthcare insurance coverage                     • Considerable counterfeiting threat
          • Significant investment from MNCs                              • Competition from other emerging economies
          • Public-Private Partnerships for strengthning
            infrastructure



      Source: PwC analysis, Industry & Company interviews




      Key Recent Trends
       Figure 13: Industry trends and implications

           Increase           Increasing
                                                    Goods &
         Investments           reach in                                Growing               Changing            Healthcare
                                                   Services Tax
            & MNC             Non-Metro                               Insurance           disease profile        innovation
                                                      (GST)
            activity           markets

       Shift towards a      Seen as the          Though            More numbers         • Shift towards       • Use of
       Networked            next volume          delayed from      of patients will       biotech &             technology &
       business model       driver, though       its April 2010    be coming in           speciality            IT for innovation
       Increasing M&A       costs of             implementation    for treatment.         therapies,            in healthcare
       and aliiances        operation is         date, GST will                         • increased             delivery
                            high due to          add significant                          investment            • e.g. Mobile
       Consolidation        poor health          efficiencies to                          in R&D and                    clinics
       in the market        infrastructure       economy and                              acute disease
                                                 lead to an                               segment will
                                                 overhaul of                              sustain strong
                                                 supply chain                             growth



      Source: PwC analysis, Industry & Company interviews


16	      India Pharma Inc.: Capitalising on India’s Growth Potential								                                                        2010
Investment Scenario

The Indian Pharma industry has                      then, there has been a trend of higher                 rapid rate in the recent past. Deals
attracted US$1707.52 million worth                  valuations of Indian Pharma companies,                 between Pfizer and Aurobindo, and
of foreign direct investment (FDI) in               culminating with a new benchmark: in                   GlaxoSmithKline and Dr. Reddy’s Labs
the period between April 2000 and                   2010, Abbott bought Piramal Healthcare                 are recent examples of out-licensing
April 2010.(20) This FDI is exclusive of            in a deal worth US$3.7 billion(22), a                  deals where generic makers are signing
investments in shares of Indian firms.              valuation that was nine times the value                distribution and marketing contracts,
Acquisitions of local players by large              of Piramal’s sales revenue.(12)                        so their products reach foreign regulated
MNCs illustrate the increasing level                                                                       and developing markets. Due to the
of interest that they have shown in                 Partnerships and                                       large number of drugs going off-patent
the Indian market.                                  Licensing deals                                        in the next few years, this trend is
MNC acquisitions in the Indian                                                                             expected to increase even further.
Pharma space took off in 2008 with                  Although long-term supply deals
the acquisition of Ranbaxy by Japanese              between innovators and generic-
drug maker, Daiichi Sankyo for US$4.6               producers have been taking place for a
billion.(21) This deal was valued at                while now, the frequency of these deals
five times Ranbaxy’s sales.(12) Since               has been growing at an increasingly




 Table 1: Key recent mergers & acquisitions

 Year   Indian Player   MNC       Nature of deal      Details
 2010   Piramal         Abbott    Sale of domestic    Abbott acquired Piramal's domestic branded
        Healthcare                branded             formulations division, along with its 350 brands,
                                  formulations        Baddi facility and about 5,200-strong sales force
                                                      for US$3.72 billion
 2010   Strides         Pfizer    Licensing           To supply 40 off patent products, mainly oncology
        Acrolabs                  and supply          ingestables that would be commercialised by Pfizer
                                  arrangement
 2009   Shantha         Sanofi-   Acquisition         Acquired for about US$820mn and got access to
        Biotech         Aventis                       Shantha's vaccines pipeline and access to emerging                  India’s domestic
                                                      markets                                                             market is poised for
 2009   Aurobindo       Pfizer    Dossier             Formulations and injectables for US,EU and ROW                      strong growth on the
                                  licensing &         markets on exclusive and co-exclusive basis                         back of increased
                                  supply contract                                                                         foreign investment
 2009   Biocon          Mylan     Development &       To develop, manufacture, supply and commercialise                   in the region, an
                                  supply contract     many high-value generic biologic compounds for the                  increased reach in
                                                      global markets.                                                     non-metro markets,
                                                                                                                          the implementation of
 2009   Dr. Reddy’s     GSK       Supply contract     To develop and market more than 100 branded
                                                                                                                          GST, growing insurance
        Labs            Pharma                        products on an exclusive basis across an extensive
                                                      number of emerging markets, excluding India.                        coverage, a change in
                                                                                                                          the population’s disease
 2008   Strides-Aspen   GSK       Upfront             To manufacture and supply branded generics to GSK                   profile and increase in
        JV              Pharma    milestone &         which would be marketed in about 80 emerging                        healthcare innovation,
                                  supply contract     markets.
                                                                                                                          in combination with
 2008   Ranbaxy         Daiichi   Acquisition         Daiichi acquired Ranbaxy and got access to Ranbaxy's                growth of key segments
                        Sankyo                        diversified product portfolio and vast geographical                 – branded generics,
                                                      presence.                                                           OTC, rural markets
                                                                                                                          and vaccines.
Source: Centrum. Pharmaceuticals update, (June 2010).


                                                                          	                                                             PwC 	        17
Indian Pharma
Market Segments
A market dominated
by branded generics




 Branded Generics

 Generic Generics

 Over-The-Counter Products

 Patented Products

 Retail vs. Institutional sales

 Road ahead
It is difficult to track and estimate the   of total sales, and represents one          products.(5) The branded generics
exact composition of India’s domestic       of the key strengths of the market,         segment is expected to grow at a CAGR
Pharma market; but industry experts         encompassing the OTC segment as             of 15% - 20% for the next decade.(5)
believe that this market is largely         well. Only about 10% of the market
dominated by branded generics.              constitutes commodity generics sold
This segment contributes around 90%         through institutional sales and innovator



 Figure 14: Indian Pharma market is predominantly a branded generics market




Other drugs: 10%
                                            10%

Branded Generics: 90%
                                                            90%

Source: Industry & Company interviews




Branded generics

In the global context, IMS Health,          made by or under license from the           an innovator product goes off-patent -
which began tracking and reporting          innovator company and sold without a        is the key driver for generics. In India,
on branded generics in 2002, defines        brand name.                                 it’s about driving a difference using
the category as including “prescription     In India, any non patented molecule         the core equity of a brand, over a
products that are either novel dosage       with a brand name other than the            competitor’s product.
forms of off-patent products produced by    innovator’s name is termed as a
a manufacturer that is not the originator   branded generic. Chemically, branded
of the molecule, or a molecule copy         generics are identical, or bioequivalent
of an off-patent product with a trade       to innovator drugs. It is the share of
name.” This definition is used by both                                                             Any non patented molecule
                                            voice the brand commands by getting                    with brand name, which is
the United States of America’s Food         repeatedly prescribed by the physicians,
and Drug Administration (FDA) and                                                                  other than the innovator’s
                                            due to some degree of recall and                       name, is termed as a
the United Kingdom’s National Health        preference over the other brands. In
Service (NHS). It does not include                                                                 branded generic.
                                            the global context, substitution – when
authorized generics, which are drugs
                                                               	                                                        PwC 	       19
“India has a very large acute
                                                                                                    segment growing at strong double
                                                                                                    digits, which is expected to
                                                                                                    continue. While the chronic market
                                                                                                    is relatively small, it is on a rapid
                                                                                                    growth path due to an ageing
                                                                                                    population and changing lifestyles.
                                                                                                    Therefore, both markets will be
                                                                                                    attractive.”
                                                                                                    - Vivek Mohan, MD, Abbott India




  Top Brands
  Table 2 gives the top 20 brands in the              The last few years has seen aggressive        increasing level of awareness is
  Indian market, as tracked by IMS Health.            new brand launches. However, not many         leading to a greater propensity to self
  The leading brand, according to                     of these have made it to the top 20           medicate, thus further increasing the
  September 2010 sales (MAT) is Corex®,               ranking, indicating that some of the older    uptake of these brands. Finally, many
  followed by Phensedyl® both of which are            brands have created a strong equity,          of the classic chronic brands are finding
  cough preparations.(23) Figure 15 shows a           enabling them to maintain market share.       a wider prescription base from general
  direct correlation between the age of a             Older brands have been creating newer         physicians.
  brand and its ranking - 19 of the top 20            opportunities in the tier II to tier VI and   An example of this is pain management
  brands are over a decade old.                       rural markets, where demand is mainly         brand Aspirin, which is over a 100
                                                      for acute therapies. In addition, an          years-old and still enjoys strong sales.



      Table 2: Top 20 Brands

       Rank     Top Brands MAT 2010            Company                Year of   Market
                                                                      launch    Share (%)
        1       COREX (CRX)                    Pfizer                  1993     0.5
        2      PHENSEDYL COUGH                 Piramal                 1996     0.4
               (PHNSL)                         Healthcare
        3       VOVERAN (VVR)                  Novartis                1986     0.4
        4       HUMAN MIXTARD (HMIX)           Abbott                  1994     0.4
        5       AUGMENTIN (AUG)                GlaxoSmithKline         1992     0.4
        6       REVITAL (REV)                  Ranbaxy                 1989     0.4
        7       ZIFI                           FDC                     1999     0.3
        8       MONOCEF (MCF)                  Aristo Pharma           2001     0.3
        9       DEXORANGE (DEX)                Franco Indian           1990     0.3
       10       TAXIM (TAX)                    Alkem                   1990     0.3
       11       BECOSULES (BEC)                Pfizer                  1989     0.3
       12       LIV-52 (LIV)                   Himalaya                1989     0.3
       13       MOX                            Ranbaxy                 1997     0.3
       14       ASTHALIN (ASN)                 Cipla                   1993     0.3
       15       BETADINE (BET)                 Win Medicare            1990     0.3
       16       TAXIM-O (TAX-O)                Alkem                   1998     0.3
       17       AZITHRAL (AZL)                 Alembic                 1994     0.2
       18       CALPOL (CAL)                   GlaxoSmithKline         1995     0.2
       19       ZINETAC (ZNC)                  GlaxoSmithKline         1986     0.2
       20       STORVAS (SVS)                  Ranbaxy-Stancare        1999     0.2


  Source: IMS Health, MAT, (August, September 2010)

20	    India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                2010
Figure 15: Older brands are higher ranked

                                     25




                                     20               SVS
                                                                                            ZNC
                                                                   CAL
                                                                        AZL
                                                          TAX-O
                                     15                                          BET
                        Brand Rank




                                                                         ASN
                                                             MOX
                                                                                   LIV
                                                                                                                       Series1
                                                                                 BEC
                                     10                                                                                Linear (Series1)
                                                                                  TAX
                                                          DEX
                                                                                 MCF
                                                   ZIFI
                                                                                   REV
                                      5                                 AUG
                                                                          HMIX
                                                                                            VVR
                                                                PHNSL
                                                                          CRX
                                      0
                                          0    5           10            15            20         25        30
                                                                   Brand Age
Source: PwC Analysis.




Brand Premium
Brands have always been synonymous            over the next-in-line brand, Moxikind-
with quality. This often makes leading        CV, and 101% over the third ranked                  “Brand premium differs from
brands command a price remium                 brand, Clavam A.K. But, in the case                 therapeutic area to therapeutic
over the next ranked brands in their          of the molecule Cefixime, the leading               area. There are instances where the
categories. This premium can be               brand, Zifi, commands a price premium               price of the brand leader is 3 times
negligible or as high as 300%.(5) For         of just 2% over the second ranked, and              the price of the cheapest brand,
example, in figure 16, the number             24% over the third-ranked brand.                    and others where there is a 30%
1 ranked brand for the molecule                                                                   increase.”
Amoxicillin clavulanate, Augmentin,
commands a premium as high as 260%                                                                – Dr. Hasit Joshipura, MD, GSK



                                                                    	                                                            PwC 	    21
Figure 16: Leading brands command a price premium



                                                    Amoxicillin clavulanate                                                                                                                                             Cefixime

                                                                                                                                                     Price of 200 mg, 10 tablets (Rs.)
                                          300
      Price of 625 mg, 10 tablets (Rs.)




                                                                                                                                                                                         120

                                          250     Rs. 241                                                                                                                                             Rs. 99        2% premium    Rs. 97
                                                                                                                                                                                         100                                                   24% premium
                                                                                                                     101%                                                                                                                                    Rs. 80
                                          200                                                                                                                                            80
                                                                                                                     premium
                                          150                           260%                                                     Rs. 119.7                                               60
                                                                        premium
                                          100                                 Rs. 67                                                                                                     40

                                          50                                                                                                                                             20

                                           0                                                                                                                                              0
                                                Augmentin (1)            Moxikind-CV (2)                                         Clavam (3)                                                           Zifi (1)                   Cefolac (2)             Mahacef (3)

                                                            Brands (2010 ranking based on revenue)                                                                                                          Brands (2010 ranking according to revenue)




                                                                                                                                        Atorvastatin
                                                                                                               100
                                                                                                                        Rs. 96       0.1% premium Rs. 95.9
                                                                            Price of 10 mg, 10 tablets (Rs.)




                                                                                                               95


                                                                                                               90
                                                                                                                                                                                               16% premium

                                                                                                               85                                                                                          Rs. 83


                                                                                                               80


                                                                                                               75
                                                                                                                       Storvas (1)                 Atorva (2)                                             Aztor (3)

                                                                                                                               Brands (2010 ranking according to revenue)




      Source: IMS Health, MAT, (August 2010)




      Premium charged by innovator brands

      Innovator brands can command high premiums over branded generics. For example, in table 3, Risperdal, an innovator
      brand, commands a 1048% premium over Risdone (generic brand).




22	                                       India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                                                                                                          2010
Table 3: Innovator brands command a large price premium

 Drug               Brand          Manufacturer                      Quantity            Price (US$)
 Risperidone        Risperdal      Johnson & Johnson (Innovator)     2 mg, 10 tablets        6.54
                    Risdone        Intas Pharma                      2 mg, 10 tablets        0.57
 Risedronate        Actonel        Sanofi Aventis (Innovator)        35 mg, 4 tablets      50.28
                    Risofos        Cipla                             35 mg, 4 tablets        2.97
 Clopidogrel        Plavix         Sanofi Aventis (Innovator)        75 mg, 10 tablets      38.45
                    Noklot         Zydus                             75 mg, 10 tablets          2
 Pregabalin         Lyrica         Pfizer (Innovator)                75 mg, 10 tablets      18.28
                    Pregabit       Intas Pharma                      75 mg, 10 tablets       1.76
 Levofloxicin       Tavanic        Sanofi Aventis (Innovator)        500 mg, 5 tablets      11.48
                    Leevoflox      Cipla                             500 mg, 5 tablets       2.07


Source: PwC Analysis, Primary Research




Brand premium is dependent on
1. First mover advantage                             representative quality by improving
First mover brands always have an                    their interpersonal skills for customer        4. Appropriate pricing strategy
advantage over late entrants. If a brand             targeting and maintaining a strong             India is a price sensitive market. Pricing
is built over 3 to 5 years before                    doctor-rep relationship,                       strategies for both the rural and tier II
competition intensifies, it can command           •	 strong life-cycle management                   to tier VI markets, should be based on
a price premium of close to 100% over                programme by launching line                    market affordability.
the later entrants.(5) Once competition              extensions,
increases, it will have to cut prices to                                                            i.	 For drugs that are not under the
                                                  •	 quality of formulation,
sustain market share.                                                                                    government’s price control
                                                  •	 attractive packaging,                               mechanism, companies can charge
2. Creating a value proposition                   •	 cost competitiveness,                               any amount as base price, and can
Creating a value proposition can help             •	 company name and reputation.                        increase it annually by up to 10%.(24)
build brand names, thus increasing the                                                              ii.	 For drugs covered by the Drugs Price
brand’s longevity. This value proposition         3. Being the innovator drug
                                                                                                         Control Order (DPCO), National
is created by:                                    Industry experts believe that if a
                                                                                                         Pharmaceutical Pricing Authority
                                                  company launches an innovator drug in
•	 offering value added services, such                                                                   (NPPA) norms must be adhered to.
                                                  the market late, it can still enjoy a price
   as backing up the brand with scientific        premium, and it will not lose out to the          iii.	Another pricing strategy is the
   data, continuous medical education             first mover brand. The reason being                    differential pricing of Merck’s
   and a strong portfolio of products,            there will always be a certain percentage              diabetes drug Januvia, which is priced
•	 doctor – representative relationship:          of the population that would be willing                at approximately US$1 per dose in
   continuous improvement in sales                to pay a premium for innovator drugs.                  India – a fifth of its price in the US.(25)




                                                                     	                                                                PwC 	      23
Maximising the focus on branded generics - For example: Abbott-
                                                                                                                 Piramal deal for branded generics
                                                                                                                 An excellent example of a deal that was carried out on the back of
                                                                                                                 the value of branded generics is the Abbott acquisition of Piramal
                                                                                                                 Healthcare. Abbott was looking to increase its stake in the Indian
                                                                                                                 branded generics sector, and agreed to pay US$3.72 billion,
                                                                                                                 a valuation that was 9-times that of Piramal’s sales. The deal
                                                                                                                 included Piramal’s domestic formulations business, including its
                                                                                                                 branded formulations business and its manufacturing facility at
                                                                                                                 Baddi. The valuation of the deal was unprecedented in the Indian
                                                                                                                 Pharma market, and is a signal of interest that large Pharma
                                                                                                                 companies have in the Indian branded generics market.




      Maximising focus on branded generics
      Both multinational companies and                                           for its strong sales force and branded                    leading pharmaceutical companies
      domestic firms are taking steps                                            generics portfolio (Refer pull out).                      adding to their sales forces by nearly
      towards maximising potential returns                                       Domestic firms are also looking to                        50% in 2010 (Figure 17).(26)
      from branded generics. For example,                                        increase their share of the branded
      Abbott acquired Piramal Healthcare                                         generics market, with some of the



                Figure 17: Leading Indian firms are ramping up sales forces

  Sales forces numbers 2010 (% increase from 2009)

                            6000                     (28.6%)
      Sales force numbers




                            5000
       Sales for numbers




                                   (17.6%)                     (60%)                                              (52%)
                            4000                                                 (22.7%)
                                                                                           (47.8%)
                                             (50%)
                            3000                                          (0%)                        (20%)               (25%)

                            2000
                            1000
                              0
                                    Cadila


                                             DRL


                                                       Cipla


                                                                Ranbaxy


                                                                          Sun


                                                                                  Lupin


                                                                                            Torrent


                                                                                                      Glenmark


                                                                                                                   Ipca


                                                                                                                          Unichem




      Source: Emkay research (August, 2010)




  Generic generics

  Currently, the market share of generic                                             (ANDA) guidelines that exist                          run ‘Jan Aushadi’. This programme
  generics is very low. We see two main                                              in the U.S.                                           provides no-name generic drugs at
  hurdles to pure genericisation of the                                          2.	 Doctor comfort derived from                           subsidized prices in 24-hour pharmacies
  Indian market:                                                                     prescribing medications on the                        that are located all over the country.
  1.	 Lack of generic generics regulations                                           basis of brand name.
      and guidelines for the establishment                                       A good example of a generic generics
      of bio-equivalence, for example the                                        programme in India is the government-
      Abbreviated New Drug Application




24	                         India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                                    2010
Over-the-counter products
The OTC segment has been identified as       grow to US$11 billion - a CAGR of 18%,         Although the phrase ‘OTC’ has no legal
one of the potential growth drivers for      with the potential to reach US$13 billion      recognition in India, all the drugs not
the Indian Pharma industry, as the sale of   – at an aggressive CAGR of 20%.                included in the list of ‘prescription-only
OTC drugs in India has been increasing       ‘OTC Drugs’ means drugs legally allowed        drugs’ are considered to be non-
over the years. The OTC market was           to be sold ‘Over The Counter’ by               prescription drugs (or OTC drugs).
worth about US$1.8 billion in 2009(27),      pharmacists, i.e. without the prescription
and PwC estimates that by 2020, it will      of a Registered Medical Practitioner.




                                                                                          “The OTC segment is going to grow
                                                                                          faster. We are looking at a growth rate
                                                                                          of around 25%, more than that of the
                                                                                          overall market growth of around 15%.”
                                                                                          – Sanjeev I. Dani, Sr. V.P.& Regional
                                                                                          Director (Asia, CIS & Africa), Ranbaxy




                                                                	                                                           PwC 	    25
Key drivers behind the growth of the OTC segment:

      Figure 18: OTC segment growth drivers



                 Wider                      Direct to                      Increased                         Low
              distribution                 consumer                        consumer                         price
                channel                  advertisements                    awareness                       controls

      Companies can sell their     The government allows           There is an increased         Other than acetylsalicylic
      products outside of          public advertising of these     reliance on self-medication   acid and ephedrine and
      pharmacies, for example in   products, giving drug           as public awareness of        its salts, very few of the
      post-offices and             makers greater freedom to       common ailments goes up.      OTC active ingredients fall
      department stores            use more creative methods                                     under the current DPCO
                                   while marketing their                                         price controls.
                                   products.
                                   Magic Remedies
                                   (Objectionable Advertise-
                                   ments) act prescribes a
                                   negative list of diseases for
                                   which medication cannot
                                   be publicly advertised.




  The above factors have meant that there            examples of Indian companies that have         Pfizer and Johnson & Johnson are
  are a large number of Indian companies             done well in the OTC segment. The              examples of MNCs that have a strong
  that manufacture and sell OTC products.            attractiveness of the Indian OTC market        presence in the Indian OTC segment.
  Cipla, Ranbaxy and Zydus Cadila are                has extended to MNCs as well. Novartis,




  Patented Products

  The market size for patented drugs                 impact on the industry. Industry               In the future, with growing
  as of today is very small. Only about              experts believe that the current size of       affordability, deepening of health
  1-2% of the market is made up of                   the patented drug market is estimated          insurance and steady improvement
  patented drugs, which are being sold               at US$120-130 million.(5)                      in Intellectual Property Rights (IPR),
  by multinational innovators. There are             Due to weak patent laws in the past,           patented product launches should
  multiple Indian companies that have                and multiple, cheap generic versions           increase.
  drugs in the pipeline, with a greater              of drugs present in the market,
  focus on R&D, but estimates suggest                multinational players were hesitant
  that it would be at least 7 to 10 years            to introduce their patented products.
  before these begin to have a serious




26	    India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                2010
Retail vs. Institutional sales

Currently, majority (91%) of drug sales     institutional sales will be marginal in     be driven by the increase in the
is through the retail markets, while        the next 5 years, and will only show        penetration of insurance, and the
institutional sales are very low (9%).(5)   significant impact between 2015 and         growing number of government and
We believe that the increase in             2020. Increased institutional sales will    private hospitals.



 Figure 19: Institutional sales increase marginally over the next 5 years




                                91%                                                 88%
                                                                                    Retail
                                Retail                                12%
                   9%                                               Institutional
                Institutional




Road ahead

The branded generics segment has            Generic generics’ and patented              affluence, decreasing generic launches,
been the key driving force behind the       products’ contributions to the              increasing number of patented product
growth of the pharmaceutical market.        market as a whole is expected to rise.      launches from foreign companies, and
In the next 5-10 years, the market          Although this is the expected model         potential releases of novel drugs will
is expected to remain comprised             of the future, we do not foresee            impact the share of branded generics
predominantly of branded generics.          a significant challenge to the              significantly.
We also expect the OTC segment              domination of branded generics in the
to be a strong volume driver for            next 5 years. By 2020, improvement
pharmaceutical companies.                   in the implementation of patent laws,
                                            spread of health insurance, rising




                                                                	                                                   PwC 	   27
Rural Markets
The next frontier




 Market Sizing

 Key Challenges

 The Government’s Role

 Pharmaceutical companies entering rural markets

 Novartis Arogya Parivar Case Study

 Road ahead
Figure 20: Geographical split of the Indian population




                                                    27 Cities
                                                     (11%)


33% of Market
(cities & towns)                                 398 Towns (9%)




                                             4,738 Periurban (13%)




                                                                                          Bottom of
                                             600,000 Villages (67%)
                                                                                          the Pyramid




Source: Novartis, Arogya Parivar: Health for the poor (April 2010)




Market Sizing

Majority of the Pharma market’s                     PwC estimates that over the next ten         in villages that require treatment, and
growth is driven by the urban markets,              years, rural markets will grow at a          quality treatment and medicines
that is, areas that are classified as               CAGR ranging from a conservative             reaching these villages. Accessibility of
metros or tier I cities (Refer figure 20).          15% to an aggressive 20%, reaching           medication in rural areas is very poor,
Tier II to tier VI is classified as peri            an expected valuation of between             with less than 20% of the population
urban, while rural is the bottom of the             US$8 billion and US$12 billion,              having access.(6) This gap represents a
pyramid, which constitutes 67% of                   depending on the implementation              huge opportunity for pharmaceutical
India’s population (600,000 villages).              of growth drivers.                           companies to expand, and we believe
As per IMS Health, peri-urban markets                                                            that these markets will be the future
account for 38% of total industry sales,            The opportunity                              volume drivers of the industry.
being valued at US$3.4 billion(28),
while, rural markets account for 17%                Around 742 million people reside in
of total industry sales, being valued at            rural areas.(6) There is a significant gap
US$2 billion, in 2010.(7)                           between the number of people residing



                                                                       	                                                      PwC 	    29
Key challenges of the market


  Low government spend on healthcare
  India has a low level of government                  significantly low levels of public            increase from US$49.7 billion to
  spending on healthcare, at 1% of                     spending to health.(14) Business              US$86.9 billion between 2009
  the GDP, putting the country in the                  Monitor International forecasts that          and 2014, a rise of 75%.(29)
  lowest 20% of those that contribute                  healthcare expenditure in India will




      Poor Infrastructure
      Healthcare infrastructure is poor,               norm].(6) Doctors are not qualified, as       counterfeiting and spurious drugs
      compared to urban areas. The doctor              most of them in villages have Bachelor of     that have been exposed. Majority of
      patient ratio in rural areas is 1:20,000,        Health Sciences (BHS) & Bachelor of           the patients earn a basic daily wage,
      versus the urban ratio of 1:2000 [India          Ayurvedic Medicine and Surgery                and affordability is very low.
      requires 600,000 doctors in order to             (BAMS) degrees. The quality and
      meet the statutory 1:250 ratio that is a         availability of medicines in rural areas is
      World Health Organisation (WHO)                  dubious, as there are many cases of




       Table 4: Healthcare penetration in rural areas is significantly lower than in urban areas


       Population                   Rural (72%) 742 Million Population             Urban (28%) 285 Million Population
       Hospital %                                 31                                                   69
       Hospital Bed %                             20                                                   80
       Doctors %                                  08                                                   92
       Doctors/100,000 people                     05                                                   50
       Spurious Pharma sales %                75-80                                                  20-25


  Source: Novartis, Arogya Parivar: Health for the poor (April 2010)




30	     India Pharma Inc.: Capitalising on India’s Growth Potential								                                                                  2010
Limited affordability
Healthcare is a low priority when it comes
to income allocation, with average consumer
expenditure on healthcare at just 7%.(6) 80%
of the rural population is on a daily wage,
income levels are as low as <US$1.78 per day.(6)


Low awareness of diseases
and possible treatment
People here have lower literacy levels and
lack awareness about various diseases &
their treatment option. They rely mainly on
alternative forms of treatment such as Ayurvedic
medicine, Unani and Acupuncture.


Poor basic hygiene and
living conditions
33% of the diseases in rural areas are related to
unsafe drinking water & poor sanitation. This is
because 80% of rural inhabitants lack adequate
sanitation, and 70% don’t have safe drinking
water.(6) This has led to a market dominated by
acute illnesses.




The Government’s role

•	 Providing universal access to              the country, especially in the 18    Standards (IPHS), integration of
   health including water, sanitation,        special focused states, which have   vertical Health & Family Welfare
   nutrition, primary education,              weak public health indicators        Programmes, optimal utilization
   communication and employment               or weak infrastructure (details      of funds and infrastructure and
   are essential to balanced                  discussed in chapter 1).             strengthening the delivery of
   development.                           •	 Further, the NRHM emphasizes          primary healthcare. It also targets
•	 Incentives for setting up hospitals       on provision of a female              to improve access of rural people,
   anywhere in India, especially in          health activist in each village,      especially poor women and
   tier II and tier III towns.               strengthening of rural hospitals      children, to equitable, affordable,
                                             for effective curative care and       accountable and effective primary
•	 The NRHM 2005 - 2012 aims                                                       healthcare.
   to provide effective healthcare           making this measurable and
   to rural population throughout            accountable to the community
                                             through Indian Public Health

                                                           	                                               PwC 	    31
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
PWC CII-pharma-summit-capitalising on indias growth potential
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PWC CII-pharma-summit-capitalising on indias growth potential

  • 2.
  • 3. Foreword Sujay Shetty Jai Hiremath Director Chairman, India Pharmaceuticals & CII Pharma Summit 2010 & Life sciences leader, PwC Vice Chairman & Managing Director, Hikal Ltd. The global Pharma industry is under serious pressure from a large number of innovator molecules facing patent expiration, a thin pipeline of new drugs, regulatory challenges and pricing pressures. This has led to a directional shift towards the emerging markets of Asia, Australia, Africa and Latin America, which are growing three times faster than the current growth rates experienced in the industry’s leading markets of North America, Japan and Europe. We expect over 40% of the global Pharma industry’s incremental growth over the next decade to come from the emerging markets. The Indian Pharma industry is on the threshold of becoming a major global market by 2020. Many experts believe that the Industry has the potential to grow at an accelerated 15 to 20% CAGR for the next 10 years to reach between US$49 billion to US$74 billion in 2020. The Indian pharmaceuticals market is witnessing dynamic changing trends such as large acquisitions by multinational companies in India, increasing investment by domestic and international players in India, deeper penetration into the rural markets, growth and availability of healthcare and incentives for setting up special economic zones (SEZ’s). We believe these trends combined with increased purchasing power and access to good quality medical care will continue to propel the domestic pharmaceutical industry to new heights. Indian Pharma companies are already major outsourcing partners of global Pharma companies. Research & Development in India is getting more innovative. Domestic companies have strengthened their position in the world for supplying solutions across the pharmaceutical value chain. They are likely to become a competitor of global Pharma in the areas of manufacturing and R&D, and a potential partner in others. In this report, we look at developments in the branded generics market, over-the-counter products (OTC), vaccines and rural markets, and analyse what lies ahead for the industry as it aims to capitalise on the promise of the domestic market place. We believe that the domestic Indian pharmaceutical market has a positive growth trajectory but will also face major transformational challenges in the next decade. We address some of these challenges and identify key imperatives to accelerate the domestic market’s growth.
  • 4. Contents Background 6 The Indian Domestic Pharma Market 14 Indian Pharma Market Segments 18 Rural markets 28 Vaccines 34 Changing Tax Environment 38 Challenges 44 The Road Ahead - Imperatives for Growth 48 Profiles 52 References 60 About Confederation of Indian Industry 62 About PricewaterhouseCoopers 63 Contacts
  • 5. Executive Summary The global pharmaceutical market is industry has a favourable macro- Currently, around 67% of India’s undergoing rapid transformation. As environment to grow in. The Indian population, or 742 million people live blockbuster drugs come off patent, there economy has rebounded from the global in rural areas (6), but rural markets are fewer new products in the pipeline to economic downturn, with real gross contribute to only 17% (7) of the overall replace them. This is due to declining domestic product (GDP) growth reaching market’s sales. This represents a huge R&D productivity and rising regulatory 9.66% in 2010.(4) The Indian middle opportunity for pharmaceutical costs. In PwC Pharma 2020 series of class is also expanding rapidly, with companies, as we expect these markets reports, we have examined in detail the affordability of medicines increasing, to be the future growth drivers for the challenges faced by Big Pharma in this and an increased percentage of industry. The rural market has several regard. There has been a dramatic shift disposable income being spent on challenges, and in order to tap the full towards emerging markets as western healthcare. The government has made potential of this opportunity, companies markets slow down. Global Pharma public healthcare one of its top priorities should: multinational corporations are looking by launching policies and programmes • create demand by increasing at new growth drivers such as the Indian that are aimed at making healthcare awareness and education; domestic market to capitalise on the more affordable and accessible, especially • work with the government through growing opportunity. in rural markets. public-private partnerships (PPP), The paradigm faced by the leading The industry is witnessing trends in order to improve hygiene and economies of the US, Europe and Japan such as acquisition activity, increasing infrastructure conditions; are significantly different from those in investment, deeper penetration into • mobilise primary care givers and the emerging markets of India, China, the tier I to tier VI and rural markets, paramedics through health and South America and Russia. According growth in insurance coverage and diagnostic camps; to IMS Health, the emerging markets innovation in healthcare delivery. • bring specific product solutions to of Asia/Africa/Australia grew at a rate Taken together, these trends are leading the market and use local languages; of 15.9% in 2009, as compared to much to increased affordability of services • improve accessibility of medicines slower growth rates in North America to patients and access to quality medical by innovative distribution channels (5.5%), Japan (7.6%) and Europe care. We believe these trends, along and (4.8%).(1) Emerging markets will be the with the favourable macro environment • make products affordable, through next major growth drivers for the global will propel the industry to the next level appropriate pricing and packaging. Pharma industry, with more than 40% of growth. Top Indian and foreign companies will of incremental growth of the industry At the moment, approximately 90% of look to increase their market share by coming from emerging economies in India’s pharmaceutical market is made entering into strategic alliances, the next decade.(2) up of branded generics.(5) We estimate strengthening their sales forces and In our report, “Capitalising on India’s that this segment will grow at a CAGR increasing penetration into newer growth potential”, we analyse the of 15% - 20% for the next five years.(5) markets. immense potential of India’s domestic Generic generics’ and patented products’ The potential that the Indian Pharma Pharma market, which was valued at contributions to the market as a whole is industry holds is unquestionable. India approximately US$12 billion in 2010, currently very low. Although this is the is home to approximately 1/6th of the and showed a strong growth of 21.3% expected model of the future, we do not world’s population, and is expected to for the twelve months ending September foresee a significant increase in the next become the most populous nation in the 2010.(3) PwC estimates that over the next five years; the market is expected to world by 2050.(8) Demand for 10 years, the domestic market will grow remain comprised predominantly of pharmaceuticals will grow decidedly. to US$49 billion - a compounded annual branded generics. By 2020 though, Government must continue to invest in growth rate (CAGR) of 15%, with the patented drug sales are expected to healthcare and medical infrastructure in potential to reach US$74 billion – a increase, owing to an improvement in rural markets, raise healthcare spending, CAGR of 20%, if aggressive growth the implementation of patent laws and encourage innovation, contain healthcare drivers kick in. spread of health insurance. We also costs and work with private players to One of the reasons behind this expected expect the OTC segment to be a strong take the market to the next level. growth rate is that India’s pharmaceutical growth driver for the industry.
  • 6. Background Strong macroeconomics over the next decade The Growing Indian Economy Growing Middle Class With Higher Purchasing Power Changing Disease Profile Government Policies Healthcare Insurance
  • 7. Large numbers of forthcoming patent expiries, a dry pipeline of new drugs, Figure 1: Emerging markets (Asia/Australia/Africa & Latin regulatory challenges and pricing America) growing faster than developed markets restrictions have collectively contributed to low growth rates for prominent global 15.90% pharmaceutical markets. As global 18.00% markets such as North America, Europe 16.00% and Japan continue to slow down (See 14.00% figure 1), pharmaceutical companies are 10.60% Growth Rate (%) 12.00% scanning markets for new growth opportunities to boost drug discovery 10.00% 7.60% potential, reduce time to market and 8.00% 5.50% squeeze costs along the value chain. The 6.00% 4.80% Industry is beginning to realize that some 4.00% of the most promising opportunities will 2.00% come from emerging markets (Asia/ Australia/Africa & Latin America). 0.00% North America Europe Japan Asia/Australia/ Latin 1 2 3 4 5 IMS Health and other sources suggest Africa America that emerging markets (China, India, Brazil, Russia, Turkey, Mexico and South Source: IMS Health market prognosis, March 2010 Korea) will contribute to over 40% of the incremental growth of the global Pharmaceutical industry over the next decade.(2) In this report, we will look at Figure 2: Emerging markets drive industry growth the domestic Indian Pharma market, and the opportunities it holds. 100% The huge potential of the Indian 7 pharmaceutical industry is impossible for 90% 22 11 22 23 32 global Pharma companies to ignore, 80% 35 1 given that India will be one of the top 10 9 3 9 70% 9 sales markets in the world by 2020. 9 10 7 6 60% 9 2 2 Some of the largest Pharma companies in 3 2 10 the world have been in the Indian market 50% 2 63 since the 1970s, and 5 out of the top 10 40% domestic Pharma companies are already 42 44 48 46 30% foreign owned, with a consolidated share 37 of 22 – 23%. 20% India’s domestic pharmaceutical market 10% 12 12 15 11 12 9 has recorded a CAGR of 13.5% over the 0% past five years.(5) With considerable 2009 (f) 2010 (f) 2011 (f) 2012 (f) 2013 (f) 2008-2013 (f) expertise in manufacturing of generics and vaccines, Indian companies have Rest of World Emerging markets South Korea, Canada Japan EU US now also started significant research and development (R&D). India has the Source: IMS Health, Market Prognosis, October 2009 world’s second biggest pool of English speakers and a strong system of higher education, all this has well-positioned PwC 7
  • 8. India to become an outsourcing partner changing disease profile. Increase in growth of the industry, such that it is on in manufacturing and R&D, and as a insurance coverage, aggressive market the threshold of becoming a competitor location for clinical trials. creation, growth in the income of the of global Pharma companies in some key The Indian economy is growing strongly Indian population and steady areas, and a potential partner in others. and healthcare is expanding to meet the government investment into medical needs of a growing population with a infrastructure has further propelled the Macro factors pushing the industry The Growing Indian Economy Figure 3: India’s strong GDP growth rate The Indian economy is growing fast, 12 and is valued at US$1.430 trillion in 10 2010.(4) GDP growth, calculated on GDP growth (%) a Purchasing Power Parity basis has 8 reached 9.66% in the year 2010, and 6 the International Monetary Fund (IMF) expects it to remain consistently above 4 8% till 2015. Furthermore, India’s share 2 in the world GDP has been steadily increasing, and is expected to reach 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 6.28% in 2015, up from 4.17% in 2005.(4) GDP growth % 9.167 9.658 9.886 6.396 5.678 9.668 8.373 7.976 8.174 8.148 8.128 Source: International Monetary Fund, World Economic Outlook, (October 2010) Figure 4: Growing global share of India’s GDP (%) 7 India’s share of the World’s GDP (%) 6.074 6 5.677 5.276 5.873 6.28 5 4.74 5.486 4.365 5.051 4 4.544 4.173 3 2 1 0 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 Source: International Monetary Fund, World Economic Outlook, (October 2010) 8 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 9. Growing middle class with higher purchasing power India’s population is currently just at 2001-02 prices), which has grown is rapidly acquiring the purchasing over 1.1 billion and is projected to rapidly, from 25 million people in 1996 power necessary to afford quality rise to 1.6 billion by 2050 – a 45.5% to 153 million people in 2010.(11) If the western medicine due to an increase increase that will see it outstrip China economy continues to grow fast and in disposable income. The Indian as the world’s most populous state.(9) literacy rates keep rising, around a third population spent 7% of its disposable Besides, India has a huge middle class of the population (34%) is expected income on healthcare in 2005; this population (households with annual to join the middle class in the near number is expected to nearly double, to incomes of US$4762 to US$23,810 future. The middle class population 13%, by 2025.(12) Figure 5: Population growth projections Figure 6: Ascent of the Indian Middle Class - Percentage of the population 1326.1 1311.6 1296.8 1281.9 Million Persons 1266.9 1251.7 1236.3 34% 1220.8 13% 1205.1 • 2020 1189.2 • 2009-10 (Forecast) 11.7% • 2007-08 6% • 2001-02 2010/11 2011/12 2012/13 2013/14 2014/15 2015/16 2016/17 2017/18 2018/19 2019/20 Source: ISI analytics (2010) Source: Economic Times (April 2009), PwC analysis Figure 7: Indian population’s expenditure break up as a % of overall disposable income 4% 100% 7% 9% 13% 90% Healthcare Education & 80% Recreation Communication 70% Tranportation Percentage spend 60% Personal products 50% and services Household products 40% Housing & utilities 30% Apparel 20% Food, beverages and tobacco 10% 0% 1995 2005 2015F 2025F Year Source: IDFC Institutional Securities, Indian Pharma (June 2010) PwC 9
  • 10. Changing Disease Profile The Indian population is experiencing IMS Health indicates that some of the Along with chronic, in the last year there a shift in disease profiles (Figure 8). fastest growing therapeutic segments has been a rebound in sales in the acute Traditionally, the acute disease segment in the Indian Pharma space today are diseases segment. This trend is likely to held a significant share of the Indian chronic disease-related therapeutic continue over the next few years, as we pharmaceutical market. This segment segments. The anti-diabetic segment see companies widening their reach into will continue to grow at a steady rate, grew 29% in the 12 months ending July newer markets, which have a relatively due to issues relating to public hygiene 2010. Cardio-vascular medication and higher number of treatment naïve and sanitation. But, with increase in nervous system disorder medication patients requiring basic treatment, thus, affluence, rise in life expectancy and grew at 22% for the same period of time, creating new demand for drugs of the the onset of lifestyle related conditions, indicating rapid growth.(13) acute therapies segment. the disease profile is gradually shifting The growing size of the Indian geriatric towards a growth in the chronic diseases population will be a key factor in segment. India has the largest pool of influencing the growth of the chronic diabetic patients in the world, with more segment. By 2028, an estimated 199 than 41 million people suffering from the million Indians will be age 60 or older, disease; this is projected to reach 73.5 up from about 91 million in 2008.(9) million in 2025.(10) Figure 8: Shift in Disease Profile toward Chronics 100% 1 2 3 4 3 2 5 90% 2 2 5 2 80% 6 11 Cancer 70% 5 12 Heart disease Disease Prevalence (%) 7 Other circulatory 60% 2 8 CNS Disorders Diabetes 50% 12 Asthma 2 40% Others Sense organs 30% 57 Muscoloskeletal Accidents 20% 41 Acute Infections 10% 0% 2001 2012 Source: IDFC Institutional Securities, Indian Pharma (June 2010)
  • 11. Government policies The Indian government has been plans to spend US$293 million on India’s healthcare expenditure is making efforts to improve nationwide the promotion of healthcare through financed out of pocket. This limits provision of healthcare. It has launched programmes for the prevention and the propensity of Indians to spend on policies that are aimed at: cure of diseases such as cancer, diabetes, healthcare, particularly in lower and • building more hospitals, heart ailments and stroke in 2011-12. middle income groups which comprise • boosting local access to healthcare, Diabetes, hypertension and non- around 95% of population.(8) • improving the quality of medical communicable disease patients will be The small percentage of Indians who training, screened under the National Programme do have some insurance, the main • increasing public expenditure on for Prevention and Control of Cancer, provider is the Government-run healthcare to 2-3% of GDP, up from a Diabetes, Cardiovascular Diseases and General Insurance Company (GIC). current low of 1%.(14) Stroke (NPCDCS). The programme is Private insurance only came into the Some of the significant government likely to cover more than 70 million market post 2007, when the Insurance allocations on healthcare spend include adults across 100 districts in 15 states Regulatory and Development a five year tax break for opening and union territories of the country.(15) Authority (IRDA) eliminated tariffs hospitals anywhere in India, with on general insurance. Apollo was an added focus on tier II and tier III Healthcare Insurance the first private healthcare insurance markets, both in the 2008-09 Union India’s healthcare insurance industry provider in the country; other private Budget. is currently very small and limited, entrants are ICICI Lombard, Tata AIG, but is expected to grow at a CAGR of Royal Sundaram, Star Allied Health 15% till 2015. Around 80% of Insurance, Cholamandalam DBS and Bajaj Allianz Apollo. Going forward, the Indian government
  • 12. Figure 9: Healthcare expenditure break up 2009 Local 11% Social Insurance 6% State 71% 12% Centre Government 17% 3% Insurance Out of Pocket 80% Source: ISI Analytics, Healthcare Industry (2010) Figure 10: Increase in penetration of Healthcare Insurance 90000 81000 80000 Size of the Healthcare Insurance Industry 70000 66000 70 60000 60 INR Million Million Persons 50000 50 40000 32090 40 No. of People 30000 30 covered by 22220 Health Insurance 20000 17320 20 (Million) 13540 10040 10000 7610 10 0 0 2002 2003 2004 2005 2006 2007 2008 2009 2006 2015 Source: ISI Analytics, Healthcare Industry (2010), General Insurance Council of India (2010) 12 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 13. “In terms of factors that could drive the market up, I think insurance would be a major factor. Insurance penetration numbers should go up dramatically, because out of pocket payment for medications is not a model anywhere in the world, as it cannot drive a large part of the market. A lot of countries have gone through this change; it is imperative to take us to the next level.” – Achin Gupta , Sr. V.P, Corporate Strategy, Glenmark The government runs a programme The government, along with many Overall, lack of insurance coverage still called the National Rural Health in the industry believes that increase in remains a challenge. Widespread use Mission (NRHM), for the development insurance coverage is essential of health insurance could take many of the poor, allocating US$2920 million to take the market forward. But, years, not least because insurance in the 2008-09 budget, under the other experts believe that the spread companies lack the data they require NRHM.(16) A health insurance scheme of health insurance could lead to to assess health risks accurately and called Rashtriya Swasthya Bima Yojna a market wherein there is minimal the only products they sell work on (RSBY) that provided US$745 worth differentiation between branded an indemnity basis – that is, they of cover for every worker was also generics. An important success factor reimburse the patient after he or she included. The total allocation of this for generic makers is differentiation of has paid the healthcare provider’s bill, inclusion was US$51 million(17), which their products. While increased health making such policies was then increased in the subsequent insurance coverage may benefit generic less attractive. budgets. The latest budget, 2010-11, drug manufacturers by increasing the incorporated a further 20% of the market’s affordability for medicines, population covered under the NREGA it may, in combination with increased (National Rural employment Guarantee institutional sales cause a reduction in Act).(18) prices, owing to the rising influence of insurance companies. Key takeaways 1. The Indian economy is growing strongly, and will continue to provide a conducive macro-environment for the industry to grow in. 2. The government is increasing spend on healthcare; and the Indian population is spending an increased amount of money on healthcare as a percentage of disposable income. 3. The disease profile is changing with an increase in acute diseases along side growth of chronics. 4. Health insurance is growing. PwC 13
  • 14. The Indian Domestic Pharma market Set for robust growth Key Players Industry SWOT Key Recent Trends Investment Scenario
  • 15. According to IMS Health, in domestic market size to be US$12 September 2010, on a Moving annual billion. We estimate that by 2020, total (MAT) basis, the Indian Pharma it will grow to US$49 billion - a market grew at 21.3%, reaching conservative CAGR of 15%, with a size of US$10.9 billion.(3) Taking the potential to reach US$74 billion – into account generic medicines sold at an aggressive CAGR of 20%, if directly to institutions and OTC drugs growth drivers kick in. sold through non-pharmacy retailers, PwC and IMS Health estimate the Key Players There is a high level of market Figure 11: India Pharma top 10 players: 12 month growth fragmentation. As of 2009, there rate ending July 2010 (09/10 Revenues in US$ millions) were more than 10,000 firms in the market, of which, around 200 of them collectively controlled about 70% of Cipla 19% (1276.1) the market share.(19) Most of the top 10 players in the Ranbaxy 15.5% (1125.45) market had growth rates of over 18% GSK India 19% (445.87) for the 12 months ending July 2010. Piramal Healthcare 18.6% (631.18) Of these, Cipla continued to have the largest market share of 5.2%, followed Sun Pharma 25.7% (600.65) by Ranbaxy (now a subsidiary of Zydus cadila 24.1% (436.40) Daiichi-Sankyo), with a 4.7% share.(13) Alkem Labs 23.3% (276.49) Pfizer India 23.6% (192.59) Mankind Pharma 37.20% (200.06) Abbott 25% (189.07) Source: Business Standard (October 2010), IMS Health, Capitaline PwC 15
  • 16. Industry SWOT Figure 12: Indian Pharma Industry SWOT analysis Strengths Weaknesses • Higher GDP growth leading to increased disposable • Poor all-round infrastructure is a major challenge income in the hands of general public and their • Stringent price controls positive attitude towards spending on healthcare • Lack of data protection • Cost Competitiveness • Poor health insuracnce coverage • Low-cost, highly skilled set of English speaking labour force • Growing treatment naive patient population Opportunities Threats • Global demand for generics rising • Labour shortage • Rapid OTC and generic market growth • Wage inflation • Increased penetration in the non - metro markets • Government expanding the umbrella of the Drugs • Large demand for quality diagnostic services Price Control Order (DPCO) • Increase in healthcare insurance coverage • Considerable counterfeiting threat • Significant investment from MNCs • Competition from other emerging economies • Public-Private Partnerships for strengthning infrastructure Source: PwC analysis, Industry & Company interviews Key Recent Trends Figure 13: Industry trends and implications Increase Increasing Goods & Investments reach in Growing Changing Healthcare Services Tax & MNC Non-Metro Insurance disease profile innovation (GST) activity markets Shift towards a Seen as the Though More numbers • Shift towards • Use of Networked next volume delayed from of patients will biotech & technology & business model driver, though its April 2010 be coming in speciality IT for innovation Increasing M&A costs of implementation for treatment. therapies, in healthcare and aliiances operation is date, GST will • increased delivery high due to add significant investment • e.g. Mobile Consolidation poor health efficiencies to in R&D and clinics in the market infrastructure economy and acute disease lead to an segment will overhaul of sustain strong supply chain growth Source: PwC analysis, Industry & Company interviews 16 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 17. Investment Scenario The Indian Pharma industry has then, there has been a trend of higher rapid rate in the recent past. Deals attracted US$1707.52 million worth valuations of Indian Pharma companies, between Pfizer and Aurobindo, and of foreign direct investment (FDI) in culminating with a new benchmark: in GlaxoSmithKline and Dr. Reddy’s Labs the period between April 2000 and 2010, Abbott bought Piramal Healthcare are recent examples of out-licensing April 2010.(20) This FDI is exclusive of in a deal worth US$3.7 billion(22), a deals where generic makers are signing investments in shares of Indian firms. valuation that was nine times the value distribution and marketing contracts, Acquisitions of local players by large of Piramal’s sales revenue.(12) so their products reach foreign regulated MNCs illustrate the increasing level and developing markets. Due to the of interest that they have shown in Partnerships and large number of drugs going off-patent the Indian market. Licensing deals in the next few years, this trend is MNC acquisitions in the Indian expected to increase even further. Pharma space took off in 2008 with Although long-term supply deals the acquisition of Ranbaxy by Japanese between innovators and generic- drug maker, Daiichi Sankyo for US$4.6 producers have been taking place for a billion.(21) This deal was valued at while now, the frequency of these deals five times Ranbaxy’s sales.(12) Since has been growing at an increasingly Table 1: Key recent mergers & acquisitions Year Indian Player MNC Nature of deal Details 2010 Piramal Abbott Sale of domestic Abbott acquired Piramal's domestic branded Healthcare branded formulations division, along with its 350 brands, formulations Baddi facility and about 5,200-strong sales force for US$3.72 billion 2010 Strides Pfizer Licensing To supply 40 off patent products, mainly oncology Acrolabs and supply ingestables that would be commercialised by Pfizer arrangement 2009 Shantha Sanofi- Acquisition Acquired for about US$820mn and got access to Biotech Aventis Shantha's vaccines pipeline and access to emerging India’s domestic markets market is poised for 2009 Aurobindo Pfizer Dossier Formulations and injectables for US,EU and ROW strong growth on the licensing & markets on exclusive and co-exclusive basis back of increased supply contract foreign investment 2009 Biocon Mylan Development & To develop, manufacture, supply and commercialise in the region, an supply contract many high-value generic biologic compounds for the increased reach in global markets. non-metro markets, the implementation of 2009 Dr. Reddy’s GSK Supply contract To develop and market more than 100 branded GST, growing insurance Labs Pharma products on an exclusive basis across an extensive number of emerging markets, excluding India. coverage, a change in the population’s disease 2008 Strides-Aspen GSK Upfront To manufacture and supply branded generics to GSK profile and increase in JV Pharma milestone & which would be marketed in about 80 emerging healthcare innovation, supply contract markets. in combination with 2008 Ranbaxy Daiichi Acquisition Daiichi acquired Ranbaxy and got access to Ranbaxy's growth of key segments Sankyo diversified product portfolio and vast geographical – branded generics, presence. OTC, rural markets and vaccines. Source: Centrum. Pharmaceuticals update, (June 2010). PwC 17
  • 18. Indian Pharma Market Segments A market dominated by branded generics Branded Generics Generic Generics Over-The-Counter Products Patented Products Retail vs. Institutional sales Road ahead
  • 19. It is difficult to track and estimate the of total sales, and represents one products.(5) The branded generics exact composition of India’s domestic of the key strengths of the market, segment is expected to grow at a CAGR Pharma market; but industry experts encompassing the OTC segment as of 15% - 20% for the next decade.(5) believe that this market is largely well. Only about 10% of the market dominated by branded generics. constitutes commodity generics sold This segment contributes around 90% through institutional sales and innovator Figure 14: Indian Pharma market is predominantly a branded generics market Other drugs: 10% 10% Branded Generics: 90% 90% Source: Industry & Company interviews Branded generics In the global context, IMS Health, made by or under license from the an innovator product goes off-patent - which began tracking and reporting innovator company and sold without a is the key driver for generics. In India, on branded generics in 2002, defines brand name. it’s about driving a difference using the category as including “prescription In India, any non patented molecule the core equity of a brand, over a products that are either novel dosage with a brand name other than the competitor’s product. forms of off-patent products produced by innovator’s name is termed as a a manufacturer that is not the originator branded generic. Chemically, branded of the molecule, or a molecule copy generics are identical, or bioequivalent of an off-patent product with a trade to innovator drugs. It is the share of name.” This definition is used by both Any non patented molecule voice the brand commands by getting with brand name, which is the United States of America’s Food repeatedly prescribed by the physicians, and Drug Administration (FDA) and other than the innovator’s due to some degree of recall and name, is termed as a the United Kingdom’s National Health preference over the other brands. In Service (NHS). It does not include branded generic. the global context, substitution – when authorized generics, which are drugs PwC 19
  • 20. “India has a very large acute segment growing at strong double digits, which is expected to continue. While the chronic market is relatively small, it is on a rapid growth path due to an ageing population and changing lifestyles. Therefore, both markets will be attractive.” - Vivek Mohan, MD, Abbott India Top Brands Table 2 gives the top 20 brands in the The last few years has seen aggressive increasing level of awareness is Indian market, as tracked by IMS Health. new brand launches. However, not many leading to a greater propensity to self The leading brand, according to of these have made it to the top 20 medicate, thus further increasing the September 2010 sales (MAT) is Corex®, ranking, indicating that some of the older uptake of these brands. Finally, many followed by Phensedyl® both of which are brands have created a strong equity, of the classic chronic brands are finding cough preparations.(23) Figure 15 shows a enabling them to maintain market share. a wider prescription base from general direct correlation between the age of a Older brands have been creating newer physicians. brand and its ranking - 19 of the top 20 opportunities in the tier II to tier VI and An example of this is pain management brands are over a decade old. rural markets, where demand is mainly brand Aspirin, which is over a 100 for acute therapies. In addition, an years-old and still enjoys strong sales. Table 2: Top 20 Brands Rank Top Brands MAT 2010 Company Year of Market launch Share (%) 1 COREX (CRX) Pfizer 1993 0.5 2 PHENSEDYL COUGH Piramal 1996 0.4 (PHNSL) Healthcare 3 VOVERAN (VVR) Novartis 1986 0.4 4 HUMAN MIXTARD (HMIX) Abbott 1994 0.4 5 AUGMENTIN (AUG) GlaxoSmithKline 1992 0.4 6 REVITAL (REV) Ranbaxy 1989 0.4 7 ZIFI FDC 1999 0.3 8 MONOCEF (MCF) Aristo Pharma 2001 0.3 9 DEXORANGE (DEX) Franco Indian 1990 0.3 10 TAXIM (TAX) Alkem 1990 0.3 11 BECOSULES (BEC) Pfizer 1989 0.3 12 LIV-52 (LIV) Himalaya 1989 0.3 13 MOX Ranbaxy 1997 0.3 14 ASTHALIN (ASN) Cipla 1993 0.3 15 BETADINE (BET) Win Medicare 1990 0.3 16 TAXIM-O (TAX-O) Alkem 1998 0.3 17 AZITHRAL (AZL) Alembic 1994 0.2 18 CALPOL (CAL) GlaxoSmithKline 1995 0.2 19 ZINETAC (ZNC) GlaxoSmithKline 1986 0.2 20 STORVAS (SVS) Ranbaxy-Stancare 1999 0.2 Source: IMS Health, MAT, (August, September 2010) 20 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 21. Figure 15: Older brands are higher ranked 25 20 SVS ZNC CAL AZL TAX-O 15 BET Brand Rank ASN MOX LIV Series1 BEC 10 Linear (Series1) TAX DEX MCF ZIFI REV 5 AUG HMIX VVR PHNSL CRX 0 0 5 10 15 20 25 30 Brand Age Source: PwC Analysis. Brand Premium Brands have always been synonymous over the next-in-line brand, Moxikind- with quality. This often makes leading CV, and 101% over the third ranked “Brand premium differs from brands command a price remium brand, Clavam A.K. But, in the case therapeutic area to therapeutic over the next ranked brands in their of the molecule Cefixime, the leading area. There are instances where the categories. This premium can be brand, Zifi, commands a price premium price of the brand leader is 3 times negligible or as high as 300%.(5) For of just 2% over the second ranked, and the price of the cheapest brand, example, in figure 16, the number 24% over the third-ranked brand. and others where there is a 30% 1 ranked brand for the molecule increase.” Amoxicillin clavulanate, Augmentin, commands a premium as high as 260% – Dr. Hasit Joshipura, MD, GSK PwC 21
  • 22. Figure 16: Leading brands command a price premium Amoxicillin clavulanate Cefixime Price of 200 mg, 10 tablets (Rs.) 300 Price of 625 mg, 10 tablets (Rs.) 120 250 Rs. 241 Rs. 99 2% premium Rs. 97 100 24% premium 101% Rs. 80 200 80 premium 150 260% Rs. 119.7 60 premium 100 Rs. 67 40 50 20 0 0 Augmentin (1) Moxikind-CV (2) Clavam (3) Zifi (1) Cefolac (2) Mahacef (3) Brands (2010 ranking based on revenue) Brands (2010 ranking according to revenue) Atorvastatin 100 Rs. 96 0.1% premium Rs. 95.9 Price of 10 mg, 10 tablets (Rs.) 95 90 16% premium 85 Rs. 83 80 75 Storvas (1) Atorva (2) Aztor (3) Brands (2010 ranking according to revenue) Source: IMS Health, MAT, (August 2010) Premium charged by innovator brands Innovator brands can command high premiums over branded generics. For example, in table 3, Risperdal, an innovator brand, commands a 1048% premium over Risdone (generic brand). 22 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 23. Table 3: Innovator brands command a large price premium Drug Brand Manufacturer Quantity Price (US$) Risperidone Risperdal Johnson & Johnson (Innovator) 2 mg, 10 tablets 6.54 Risdone Intas Pharma 2 mg, 10 tablets 0.57 Risedronate Actonel Sanofi Aventis (Innovator) 35 mg, 4 tablets 50.28 Risofos Cipla 35 mg, 4 tablets 2.97 Clopidogrel Plavix Sanofi Aventis (Innovator) 75 mg, 10 tablets 38.45 Noklot Zydus 75 mg, 10 tablets 2 Pregabalin Lyrica Pfizer (Innovator) 75 mg, 10 tablets 18.28 Pregabit Intas Pharma 75 mg, 10 tablets 1.76 Levofloxicin Tavanic Sanofi Aventis (Innovator) 500 mg, 5 tablets 11.48 Leevoflox Cipla 500 mg, 5 tablets 2.07 Source: PwC Analysis, Primary Research Brand premium is dependent on 1. First mover advantage representative quality by improving First mover brands always have an their interpersonal skills for customer 4. Appropriate pricing strategy advantage over late entrants. If a brand targeting and maintaining a strong India is a price sensitive market. Pricing is built over 3 to 5 years before doctor-rep relationship, strategies for both the rural and tier II competition intensifies, it can command • strong life-cycle management to tier VI markets, should be based on a price premium of close to 100% over programme by launching line market affordability. the later entrants.(5) Once competition extensions, increases, it will have to cut prices to i. For drugs that are not under the • quality of formulation, sustain market share. government’s price control • attractive packaging, mechanism, companies can charge 2. Creating a value proposition • cost competitiveness, any amount as base price, and can Creating a value proposition can help • company name and reputation. increase it annually by up to 10%.(24) build brand names, thus increasing the ii. For drugs covered by the Drugs Price brand’s longevity. This value proposition 3. Being the innovator drug Control Order (DPCO), National is created by: Industry experts believe that if a Pharmaceutical Pricing Authority company launches an innovator drug in • offering value added services, such (NPPA) norms must be adhered to. the market late, it can still enjoy a price as backing up the brand with scientific premium, and it will not lose out to the iii. Another pricing strategy is the data, continuous medical education first mover brand. The reason being differential pricing of Merck’s and a strong portfolio of products, there will always be a certain percentage diabetes drug Januvia, which is priced • doctor – representative relationship: of the population that would be willing at approximately US$1 per dose in continuous improvement in sales to pay a premium for innovator drugs. India – a fifth of its price in the US.(25) PwC 23
  • 24. Maximising the focus on branded generics - For example: Abbott- Piramal deal for branded generics An excellent example of a deal that was carried out on the back of the value of branded generics is the Abbott acquisition of Piramal Healthcare. Abbott was looking to increase its stake in the Indian branded generics sector, and agreed to pay US$3.72 billion, a valuation that was 9-times that of Piramal’s sales. The deal included Piramal’s domestic formulations business, including its branded formulations business and its manufacturing facility at Baddi. The valuation of the deal was unprecedented in the Indian Pharma market, and is a signal of interest that large Pharma companies have in the Indian branded generics market. Maximising focus on branded generics Both multinational companies and for its strong sales force and branded leading pharmaceutical companies domestic firms are taking steps generics portfolio (Refer pull out). adding to their sales forces by nearly towards maximising potential returns Domestic firms are also looking to 50% in 2010 (Figure 17).(26) from branded generics. For example, increase their share of the branded Abbott acquired Piramal Healthcare generics market, with some of the Figure 17: Leading Indian firms are ramping up sales forces Sales forces numbers 2010 (% increase from 2009) 6000 (28.6%) Sales force numbers 5000 Sales for numbers (17.6%) (60%) (52%) 4000 (22.7%) (47.8%) (50%) 3000 (0%) (20%) (25%) 2000 1000 0 Cadila DRL Cipla Ranbaxy Sun Lupin Torrent Glenmark Ipca Unichem Source: Emkay research (August, 2010) Generic generics Currently, the market share of generic (ANDA) guidelines that exist run ‘Jan Aushadi’. This programme generics is very low. We see two main in the U.S. provides no-name generic drugs at hurdles to pure genericisation of the 2. Doctor comfort derived from subsidized prices in 24-hour pharmacies Indian market: prescribing medications on the that are located all over the country. 1. Lack of generic generics regulations basis of brand name. and guidelines for the establishment A good example of a generic generics of bio-equivalence, for example the programme in India is the government- Abbreviated New Drug Application 24 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 25. Over-the-counter products The OTC segment has been identified as grow to US$11 billion - a CAGR of 18%, Although the phrase ‘OTC’ has no legal one of the potential growth drivers for with the potential to reach US$13 billion recognition in India, all the drugs not the Indian Pharma industry, as the sale of – at an aggressive CAGR of 20%. included in the list of ‘prescription-only OTC drugs in India has been increasing ‘OTC Drugs’ means drugs legally allowed drugs’ are considered to be non- over the years. The OTC market was to be sold ‘Over The Counter’ by prescription drugs (or OTC drugs). worth about US$1.8 billion in 2009(27), pharmacists, i.e. without the prescription and PwC estimates that by 2020, it will of a Registered Medical Practitioner. “The OTC segment is going to grow faster. We are looking at a growth rate of around 25%, more than that of the overall market growth of around 15%.” – Sanjeev I. Dani, Sr. V.P.& Regional Director (Asia, CIS & Africa), Ranbaxy PwC 25
  • 26. Key drivers behind the growth of the OTC segment: Figure 18: OTC segment growth drivers Wider Direct to Increased Low distribution consumer consumer price channel advertisements awareness controls Companies can sell their The government allows There is an increased Other than acetylsalicylic products outside of public advertising of these reliance on self-medication acid and ephedrine and pharmacies, for example in products, giving drug as public awareness of its salts, very few of the post-offices and makers greater freedom to common ailments goes up. OTC active ingredients fall department stores use more creative methods under the current DPCO while marketing their price controls. products. Magic Remedies (Objectionable Advertise- ments) act prescribes a negative list of diseases for which medication cannot be publicly advertised. The above factors have meant that there examples of Indian companies that have Pfizer and Johnson & Johnson are are a large number of Indian companies done well in the OTC segment. The examples of MNCs that have a strong that manufacture and sell OTC products. attractiveness of the Indian OTC market presence in the Indian OTC segment. Cipla, Ranbaxy and Zydus Cadila are has extended to MNCs as well. Novartis, Patented Products The market size for patented drugs impact on the industry. Industry In the future, with growing as of today is very small. Only about experts believe that the current size of affordability, deepening of health 1-2% of the market is made up of the patented drug market is estimated insurance and steady improvement patented drugs, which are being sold at US$120-130 million.(5) in Intellectual Property Rights (IPR), by multinational innovators. There are Due to weak patent laws in the past, patented product launches should multiple Indian companies that have and multiple, cheap generic versions increase. drugs in the pipeline, with a greater of drugs present in the market, focus on R&D, but estimates suggest multinational players were hesitant that it would be at least 7 to 10 years to introduce their patented products. before these begin to have a serious 26 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 27. Retail vs. Institutional sales Currently, majority (91%) of drug sales institutional sales will be marginal in be driven by the increase in the is through the retail markets, while the next 5 years, and will only show penetration of insurance, and the institutional sales are very low (9%).(5) significant impact between 2015 and growing number of government and We believe that the increase in 2020. Increased institutional sales will private hospitals. Figure 19: Institutional sales increase marginally over the next 5 years 91% 88% Retail Retail 12% 9% Institutional Institutional Road ahead The branded generics segment has Generic generics’ and patented affluence, decreasing generic launches, been the key driving force behind the products’ contributions to the increasing number of patented product growth of the pharmaceutical market. market as a whole is expected to rise. launches from foreign companies, and In the next 5-10 years, the market Although this is the expected model potential releases of novel drugs will is expected to remain comprised of the future, we do not foresee impact the share of branded generics predominantly of branded generics. a significant challenge to the significantly. We also expect the OTC segment domination of branded generics in the to be a strong volume driver for next 5 years. By 2020, improvement pharmaceutical companies. in the implementation of patent laws, spread of health insurance, rising PwC 27
  • 28. Rural Markets The next frontier Market Sizing Key Challenges The Government’s Role Pharmaceutical companies entering rural markets Novartis Arogya Parivar Case Study Road ahead
  • 29. Figure 20: Geographical split of the Indian population 27 Cities (11%) 33% of Market (cities & towns) 398 Towns (9%) 4,738 Periurban (13%) Bottom of 600,000 Villages (67%) the Pyramid Source: Novartis, Arogya Parivar: Health for the poor (April 2010) Market Sizing Majority of the Pharma market’s PwC estimates that over the next ten in villages that require treatment, and growth is driven by the urban markets, years, rural markets will grow at a quality treatment and medicines that is, areas that are classified as CAGR ranging from a conservative reaching these villages. Accessibility of metros or tier I cities (Refer figure 20). 15% to an aggressive 20%, reaching medication in rural areas is very poor, Tier II to tier VI is classified as peri an expected valuation of between with less than 20% of the population urban, while rural is the bottom of the US$8 billion and US$12 billion, having access.(6) This gap represents a pyramid, which constitutes 67% of depending on the implementation huge opportunity for pharmaceutical India’s population (600,000 villages). of growth drivers. companies to expand, and we believe As per IMS Health, peri-urban markets that these markets will be the future account for 38% of total industry sales, The opportunity volume drivers of the industry. being valued at US$3.4 billion(28), while, rural markets account for 17% Around 742 million people reside in of total industry sales, being valued at rural areas.(6) There is a significant gap US$2 billion, in 2010.(7) between the number of people residing PwC 29
  • 30. Key challenges of the market Low government spend on healthcare India has a low level of government significantly low levels of public increase from US$49.7 billion to spending on healthcare, at 1% of spending to health.(14) Business US$86.9 billion between 2009 the GDP, putting the country in the Monitor International forecasts that and 2014, a rise of 75%.(29) lowest 20% of those that contribute healthcare expenditure in India will Poor Infrastructure Healthcare infrastructure is poor, norm].(6) Doctors are not qualified, as counterfeiting and spurious drugs compared to urban areas. The doctor most of them in villages have Bachelor of that have been exposed. Majority of patient ratio in rural areas is 1:20,000, Health Sciences (BHS) & Bachelor of the patients earn a basic daily wage, versus the urban ratio of 1:2000 [India Ayurvedic Medicine and Surgery and affordability is very low. requires 600,000 doctors in order to (BAMS) degrees. The quality and meet the statutory 1:250 ratio that is a availability of medicines in rural areas is World Health Organisation (WHO) dubious, as there are many cases of Table 4: Healthcare penetration in rural areas is significantly lower than in urban areas Population Rural (72%) 742 Million Population Urban (28%) 285 Million Population Hospital % 31 69 Hospital Bed % 20 80 Doctors % 08 92 Doctors/100,000 people 05 50 Spurious Pharma sales % 75-80 20-25 Source: Novartis, Arogya Parivar: Health for the poor (April 2010) 30 India Pharma Inc.: Capitalising on India’s Growth Potential 2010
  • 31. Limited affordability Healthcare is a low priority when it comes to income allocation, with average consumer expenditure on healthcare at just 7%.(6) 80% of the rural population is on a daily wage, income levels are as low as <US$1.78 per day.(6) Low awareness of diseases and possible treatment People here have lower literacy levels and lack awareness about various diseases & their treatment option. They rely mainly on alternative forms of treatment such as Ayurvedic medicine, Unani and Acupuncture. Poor basic hygiene and living conditions 33% of the diseases in rural areas are related to unsafe drinking water & poor sanitation. This is because 80% of rural inhabitants lack adequate sanitation, and 70% don’t have safe drinking water.(6) This has led to a market dominated by acute illnesses. The Government’s role • Providing universal access to the country, especially in the 18 Standards (IPHS), integration of health including water, sanitation, special focused states, which have vertical Health & Family Welfare nutrition, primary education, weak public health indicators Programmes, optimal utilization communication and employment or weak infrastructure (details of funds and infrastructure and are essential to balanced discussed in chapter 1). strengthening the delivery of development. • Further, the NRHM emphasizes primary healthcare. It also targets • Incentives for setting up hospitals on provision of a female to improve access of rural people, anywhere in India, especially in health activist in each village, especially poor women and tier II and tier III towns. strengthening of rural hospitals children, to equitable, affordable, for effective curative care and accountable and effective primary • The NRHM 2005 - 2012 aims healthcare. to provide effective healthcare making this measurable and to rural population throughout accountable to the community through Indian Public Health PwC 31