For the complete report, get in touch with us at : info@netscribes.com The Indian clinical trials market is growing at an excellent rate and currently witnessing a large number of global pharmaceutical companies outsourcing trials to contract research organizations (CROs) in India. This is largely due to the country’s lower costs and various other advantages. Moreover, many domestic pharmaceutical companies as well have increased their R&D spending for new drug development and are outsourcing clinical trials to various CROs. With this rapid increase in clinical trials outsourcing, the market is set to exhibit steady growth in future, thus providing players the opportunity to increase profitability. The report provides a snapshot of the clinical trials market. It begins with an introduction section which briefly discusses the various stages in clinical trials. This section also discusses the various services provided by contract research organizations. This is followed by the market overview section which provides an insight into the market and highlights the market size and growth of clinical trials in the country. India’s current and projected share in the global clinical trials market has also been provided. The section also analyses the number of new trials registered in the country each year and segmentation of trials on the basis of the therapeutic area. The distribution of trials currently under progress, on the basis of the phase in which they are in, is also provided. Moreover the segmentation of trials on the basis of the sponsors has also been included in this section. The major pharmaceutical companies that are sponsoring trials in India have also been mentioned. This is followed by an analysis of the drivers leading to growth in the market. This includes cost competitiveness, vast patient population with diverse number of diseases, increasing R&D expenditure by pharmaceutical companies, friendly regulatory environment, sound medical infrastructure and international quality standards. The main challenges to the market include shortage of research professionals, delays in trial approval, lack of data exclusivity and challenges of unethical trials. A section on government regulations in the industry has also been included. It covers the various government regulations outlining the legal and regulatory framework for conducting clinical trials in India. The competition section provides an overview of the competitive landscape in the industry and includes a detailed profile of the major players in the market. The Porter’s Five Forces analysis for the clinical trials market is provided in this section. A summary of the major players operating in the market has also been provided in the form of a bubble chart. It also includes the list of products and services, key people, financial snapshot, key ratios and key recent developments for the major players.

1. Clinical Trials Market – India
April 2012

2. Executive Summary
 Clinical trials market in India was valued at INR b bn in 2011 and is estimated to reach INR f bn by
2015, growing at a CAGR of x%
Market  India is the ‘y’ largest clinical trials market in Region 1, following Country 2
 India’s share in the global clinical trials market was u% in 2011 and will grow to v% by 2015
Drivers: Challenges:
– Cost competitiveness – Shortage of research professionals
– Vast patient population with diverse – Delays in trial approval
Drivers & number of diseases – Lack of data exclusivity
– Increasing R&D expenditure by – Challenges of unethical trials
Challenges pharmaceutical companies
– Friendly regulatory environment
– Sound medical infrastructure
– International quality standards
 Clinical trial can be initiated only after approval from Association 1 and are governed by
Government Scheduled ‘XX’ of Act 1
Regulations  Registration of trials involving humans has been made mandatory starting in June 2009 on the
Clinical Trials Registry‐India (CTRI) website
Major Domestic Players Major Foreign Players
Company 1 Company 3 Company 5 Company 7
Competition
Company 2 Company 4 Company 6 Company 8
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 2

3. •Introduction
•Market Overview
•Drivers & Challenges
•Government Regulations
•Competition
•Clinical Research Institutes
•Key Developments
•Strategic Recommendations
•Appendix
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 3

4. India is emerging as a preferred destination for clinical trials
and the market is expected to show steady growth
Market Overview Market Size and Growth (Value‐wise)
• Clinical trials market in India is growing at a very fast INR bn
pace and is expected to be more than double in 2015
50 f
from its size in 2011
40 x% e
• India is the ‘y’ largest clinical trials market in Region 1
d
following Country 1 30 c
• Major sponsors for clinical trials are international b
a
pharmaceuticals companies with huge R&D spending 20
• Many Indian and foreign pharmaceutical companies 10
have tied up with other specialist research
0
companies for development of new drugs
2010 2011 2012e 2013e 2014e 2015e
• Pharma companies are leaning towards outsourcing
and concentrating on marketing without spending
time for drug discovery and manufacturing Global Pharma Companies
• Internationally certified central laboratories and
research institutes also take part in clinical trials in
Outsource
India
Drug Discovery Clinical Trials
India’s share in the global clinical trials
market is expected to increase from u% in Research Contract Research
2011 to v% in 2015 Institutions Organizations
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 4

5. Although the number of new trials registered in India in
2011 declined, the market will continue to grow steadily
New Trials Registered Number of Trials Registered Each Year
•Total number of trials registered in India till 400 D
date is 1875 B C
•Number of new trials registered in India in 300
A E
2011 had sharply declined from the number of
200
trials registered in 2010
•However, the market is not expected to be 100
negatively impacted by the lower number of
new trials registered in 2011 0
2007 2011 2009 2010 2011
 At present 513 clinical trial studies are being
conducted in India which is far greater than the
331 studies being conducted in 2010 and 181 Trials According to Therapeutic Areas
studies being conducted in 2009
Cancer
 Since trials for a single drug itself may take several A%
years, the market will continue to exhibit steady F% CNS
growth even if the number of new trials Infectious Diseases
registered declines in a particular year B% Diabetes
CVD
E% Others
Cancer, CNS and infectious diseases are the
most popular therapeutic areas for clinical C%
trials, followed by diabetes and CVD
D%
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 5

6. Majority of the trials conducted in India are Phase III trials
and are sponsored by large pharmaceutical companies
Distribution of trials on basis of Phase Major Pharma Companies Sponsoring trials
D% C% Company No. of Trials
Phase I
Phase II A 86
B%
Phase III B 74
Phase IV
C 73
Distribution has been done on the basis of D 71
A% ongoing trials. However, some trials have not
been taken into account as information E 64
regarding their phase is not available
F 61
G 56
Segmentation of trials on basis of Sponsors
H 49
I 42
A% A J 32
B
K 31
L 27
B% M 26
N 23
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 6

7. Drivers & Challenges – Summary
Drivers Challenges
Cost competitiveness Shortage of research professionals
Vast patient population with diverse Delays in trial approval
number of diseases
Increasing R&D expenditure by Lack of data exclusivity
pharmaceutical companies
Friendly regulatory environment Challenges of unethical trials
Sound medical infrastructure
International quality standards
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 7

8. Major Private Companies – Summary
Net Profit Size of the Bubble represents Total Assets in INR mn
140
130
120
g
110
100
90
h
80
f
70
60
50
40
d
30
e
20 c
10 b
a
0
‐10 Revenue
0 50 100 150 200 250 300 350 400 450 500 550 600 650 700 750 800 850
Company 1 Company 2 Company 3 Company 4 Company 5 Company 6 Company 7 Company 8
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 8

9. Private: Domestic Company – Company 1
(1/3)
Company Information Offices and Centres – India
Corporate Address
Tel No.
Fax No.
Website
Year of Incorporation
Products and Services
Head Office
Products/Services Regional Offices
Offers services such as Service 1, Service 2, Service 3, Service 4, Key People
Service 5, Service 6
Name Designation
Person 1 Director
Person 2 Director
Person 3 Director
Person 4 Director
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 9

10. Private: Domestic Company – Company 1
(2/3)
Financial Snapshot Key Ratios
y‐o‐y change
Total Income Net Profit / Loss Particulars 2011 2010 2009 2008
(2011‐10)
INR mn INR mn Profitability Ratios
Operating Margin
300 x y 50
v Net Margin
250 0 Profit Before Tax Margin
200 ‐50 Return on Equity
u
150 ‐100 Return on Capital Employed
b
100 ‐150 Return on Working Capital
a Return on Assets
50 ‐200
Return on Fixed Assets
0 c d ‐250
Cost Ratios
2008 2009 2010 2011 Operating costs (% of Sales)
Administration costs (% of
Financial Summary Sales)
Interest costs (% of Sales)
• Company incurred a net profit of INR X mn in FY 2011, as Liquidity Ratios
compared to net profit of INR Y mn in FY 2010 Current Ratio
Cash Ratio
• It reported total Income of INR XX mn in FY 2011, Leverage Ratios
registering a decrease of X per cent over FY 2010 Debt to Equity Ratio
Debt to Capital Ratio
• Earned an operating margin of X.X per cent in FY 2011, an Interest Coverage Ratio
increase of X.X percentage points over FY 2010 Efficiency Ratios
• The company reported debt to equity ratio of X.XX in FY Fixed Asset Turnover
2011, a decrease of X.X per cent over FY 2010 Asset Turnover
Current Asset Turnover
Working Capital Turnover
Capital Employed Turnover
Improved Decline
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 10

11. Private: Domestic Company – Company 1
(3/3)
Business Highlights
Description News
• It provides clinical research services to Type 1, Type 2 and Type 3 companies
• It also provides Type 1, Type 2, Type 3, Type 4, Type 5, Type 6, Type 7, Type 8 and Type 9
services
• It offers clinical trial services in Therapeutic Area 1, Therapeutic Area 2, Therapeutic Area
Overview 3, Therapeutic Area 4, Therapeutic Area 5, Therapeutic Area 6, Therapeutic Area 7,
Therapeutic Area 8, Therapeutic Area 9, Therapeutic Area 10, Therapeutic Area 11,
Therapeutic Area 12, Therapeutic Area 13 and Therapeutic Area 14
• Its Category 1 laboratory is accredited by the Institution 1 and its Category 2 laboratory is
accredited by the Institution 1 and Institution 2
Share Holding Pattern • Company 1 is a division of Company 2
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 11

12. Clinical Research Institutes (x/y)
Institute Location Areas of Research
• At present comprises of the basic and clinical research wings and a 50‐
Institution 1 City 1 bed hospital
• Conducts research and development on cancer
• Design and development of drugs, diagnostics/vaccines right from the
synthesis of compounds upto regulatory studies and clinical trials
• Undertakes contractual research work
• Research activities are broadly divided into three subgroups:
Institution 2 City 2  Drug discovery & development
 Regulatory studies
 Infrastructural support groups
• Developed a new drug to control and cure depression, the new drug
has been found to be safer that the existing anti‐depression drugs
• Promotes research in the field of cancers
Institution 3 City 3 • Institute undertakes multidisciplinary studies in order to understand
the natural history, biological behavior and mechanisms of
carcinogenesis
CLINICAL TRIALS MARKET IN INDIA 2012.PPT 12

13. Thank you for the attention
The Clinical Trials Market – India report is part of Research on India’s Healthcare Industry
Series.
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