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GLOBAL PHARMACEUTICAL INDUSTRY


                                  Submitted by
              -Chandan   Kumar Singh 11DCP-071


   1
CASE BACKGROUND
 The case describes how the prescription pharmaceutical
  industry has changed since its modern beginnings in the
  early 1950s.
 The various forces affecting the competitive environment
  of the industry are discussed in terms of
  origins, immediate past and immediate future (2004
  onwards).
 Provides insights into the evolution of barriers to enter
  and exit the industry for prescription pharmaceuticals
 Detailed industry note on the “ethical” pharmaceutical
  industry which provides an opportunity to analyse key
                                                            2
  success factors of major players.
CASE BACKGROUND

 Descriptive overview of the predominant issues in the
  three major Triad market areas: the US, Europe and
  Japan .
 Covers the overall industry environment with indepth
  discussion of the driving forces in the industry such as
  globalisation (in particular global regulatory
  issues, changing world demographics and worldwide
  pricing disparities).
 Development of new technology; the importance of time
  to market; and amalgamations.
 The case also examines issues around corporate social
                                                           3
  responsibility
BRIEF HISTORY
 Post WWII, the pharmaceutical industry operated within a
  quite stable & highly profitable environment as compared
  to other industries
 The industry saw the development of many new drugs
  during the 1960s due to technological success.
 However as legislation was introduced in the 70s the
  number of „generics‟ increased & consequentially time to
  market of drugs also increased
 Emergence of biotechnology firms, limited buying ability of
  consumers leading to reliance on blockbuster drugs for
  income resulted in the instability in the industry
                                                          4
Patents introduced

  BRIEF HISTORY                           60
                                          50
                                          40
o Simple infections that were easy        30                                     Patents
  drug targets had been addressed         20                                     introduce
                                          10                                     d
                                           0
o Advances over existing treatments




                                                            1999
                                                     1980


                                                                   2001
                                                                          2002
  & research for therapy of
  previously untreated diseases
  started proving expensive & risky
                                              R&D Expenditure
                                        60
o Consumers started demanding           50
  value for money products as their     40
  buying power became increasingly      30                                         R&D
                                                                                   Expendit
  limited                               20
                                        10                                         ure
                                         0                                              5
                                      In Billion $
                                                     1981            2000
ENVIRONMENT ANALYSIS




  External      Internal
                                     Scenario
Environment   Environment

                                  Favorable, moderate
  PESTEL      Five forces Model
                                    and unfavorable




                                                        6
PESTEL ANALYSIS

  Political Factors

  • Highly fragmented industry in 80‟s. Mergers
    led to concentration of jobs in select
    countries
  • More control thereby exercised by
    Governments
  • Easy Targets – To control rising healthcare
    costs when medicines amount to 15% of
    healthcare expenditure
  • Multi country pricing due to Govt regulations.
  • Patent on drugs – India patents the process
    while US and EU patent the drug                  7
PESTEL ANALYSIS

  Economic Factors

  • Demand side
    • Doctors tend to favor branded drugs which are high
      margin.
    • Globalization has made it possible for big
      companies to mass market the drugs.
  • Supply side
    • Global supply is fragmented. Pfizer has largest
      market share of 11%
    • Regional players and the generic drugs which are
      relatively cheaper are popular in developing world
    • Need for blockbuster products as R&D investments     8
      do not justify the number of new drugs
PESTEL ANALYSIS
  Social Factors –

  • Advancement in medicine has raised the life
    expectancy to 75 and aged population increases
    the consumption. This adds strain on insurance
    companies and govts
  • Socially aware and demanding consumers

  Technological and Environmental
  factors
  • Human Genome and genetics are new ways to
    discover drugs
  • Rising aged population in west and middle class in
    developing countries makes the long term             9
    prospective good.
PESTEL ANALYSIS


  Legal factors

  • Varied patent laws in different countries
  • Many best selling drugs are replicated
    as generic medicine in developing
    countries with full government backing.
  • Clinical trials have become more
    rigorous thereby testing more than
    20,000 people in the complete run of
    10-14 years
                                                10
ENVIRONMENT ANALYSIS




  External      Internal
                                     Scenario
Environment   Environment

                                  Favorable, moderate
  PESTEL      Five forces Model
                                    and unfavorable




                                                        11
Factors      Past                                     Future


 Threat of   •   The industry has already high entry •    Firms specializing       in moving
 potential       barriers which are increasing.           specific molecules along the value
 entrants    •   lead times for new drugs to be           chain could be tomorrow's main
                 marketed increasing from 3 to            competitors.
                 5years in the 1960s to 12 years by •     Emphasis on high-priced niche
                 the mid-1990s.                           drugs for high unmet need diseases
             •   Need for global return on costly R&D     likely to support market entry by bio
                 favors large firms only                  techs.




  Power      •   Governments (EU) and managed •           Controls on pricing , reimbursement
 of buyers       health organizations (US)imposing        and market access continue to
                 systems            to         control    tighten(„value for money‟ is atop
                 prices/reimbursement and demand .        concern on both sides of the
             •   Growth of parallel trade.                Atlantic).
             •   Harmonization of regulatory approval •   Growth of managed care continues
                 systems. Rising patient expectations.    deteriorating the profitability of big
                                                          pharmaceuticals regardless of the
                                                          outcome of regulation.
                                                                                       12
Factors        Past                                         Future


  Power of     •   Cheap generics.                     •        Biological generics appear.
 substitutes   •   Reduced lead times for „me-too‟ •            Diversification      into   generics
                   drugs from 6to 7 years to 18months;          protects volume share (but not the
               •   Consumer suspicion of drugs leads            profit) of      big pharmaceutical
                   to increasing use of alternative             companies.
                   remedies                            •        Functional foods preferred as
                                                                safer alternative to drugs


  Power of     •   Global sourcing leads to further •           Emergence of China and India as
  suppliers        reductions in the costs of raw               key out-sourcing locations.
                   materials.                               •   Cost of licensing deals drives
               •   Major pharma companies come                  companies        towards    more
                   increasingly to rely on in-licensing for     acquisitions
                   new products, raising prices on such
                   deals
 Competitie    •   Profitable, cash-rich industry but •         Continued industry consolidation in
   rivalry         margins declining.                           static market results in fewer larger
               •   Mergers     and     acquisitions are         global companies, focused on
                   expected to continue as they could           specific franchises , with intense
                   lead to economies of scale, global           rivalry within therapeutic franchises.
                                                                                               13
                   sales and marketing and more
                   efficient R&D efforts.
               •   Intense      rivalry within product
ENVIRONMENT ANALYSIS




  External      Internal
                                     Scenario
Environment   Environment

                                  Favorable, moderate
  PESTEL      Five forces Model
                                    and unfavorable




                                                        14
INDUSTRY TRENDS

o The pharmaceutical industry is facing a rapidly changing
    environment.
o   The need for global presence to achieve adequate return on
    escalating marketing and R&D costs
o   A strong focus on health care cost containment, such that new
    treatments must be justified on cost–benefit grounds, adding to
    development costs
o   To command price premiums, new products must offer unique
    benefits, yet information leakage means that most products are
    imitated rapidly
o   IT developments provide greater access to detailed health care
    information for both providers and patients, also pushing
    forward cost-effective treatments
o   Educated consumers demanding advances in therapy
                                                                   15
o   There are opportunities to change organizational models but
    no-one has yet found a feasible alternative
Scenario 1: Favorable
 Increased opportunities for pharmaceutical sales
  developing in emerging markets.
 Little substitution from biotech products
 No entry of new participants and a decrease in mergers
  and acquisition activity
 Time to market remains critical but genomics helps to fine-
  tune NCE selection and reduce time in clinical trials.
 Organisational changes result in a number of very
  promising “blockbuster drugs” advancing through the
  pipeline
 There will be greater harmonisation amongst international
  markets.
•
                                                           16
Scenario 2: Moderate
 Substitution from biotech products, some advances to
  reduce R&D expenditure.
 Outsourcing (i.e. licensing of products) continues to
  develop but without challenging established players.
 Entry of new participants and/or consumers opting for
  some forms of alternative medicine
 Slow but consistent steps towards greater industry
  concentration continue.
 There will be increasing sales opportunities in emerging
  and recently industrialised countries.

                                                             17
Scenario 3: Unfavorable
   Most income generation is associated to licensing agreements
    and profits will thereby get squeezed.
   There is a recruitment crisis as a whole generation of new
    scientists is lost to mid-sized players and biotechs.
   Results in dying of blockbuster drugs.
   All investments in genomics prove futile at present as it will be
    one or two more generations before any practical result is
    evident.
   Emergence of new alternative forms of non-drug-based
    therapeutic treatments and widespread adoption of alternative
    medicine practices.
   Entry of new global participants such as Japanese, Korean or
    Indian laboratories will intensify the competition.
   Increased mergers and acquisition activity puts substantial
    short-term pressure on profit margins.                           18
ETHICAL CONSIDERATION
 There are thus key issues around the
 ethical stance of pharmaceuticals, their
 stakeholders and society at large including:
     Property rights
     R&D, budget constrains and the pursuit of
      ailments in emerging markets
     Being in the public eye (as a consumer goods
      manufacturer and a provider of health products)


                                                        19
BUSINESS IMPLICATIONS-GOING FORWARD
   Innovation will be the most important thing, more
    important than the size of the organization.
   The main reason behind this is that there has to be
    points of difference with every new product so as to
    charge a premium price to it.
   With more of information leakage, most of the products
    are copied quickly.
   With more of R&D costs, it becomes extremely
    necessary to achieve adequate returns on the pipeline
    as this will pave the way for the success of
    manufacturers.
   New drugs need to be developed with respect to
    diseases which are ignored.
   A firm has to be more consistent in its approach with
    having constant innovation of new drugs.                 20
THANKS FOR YOUR TIME AND
     CONSIDERATION



                           21

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Global pharmaceuticals group3

  • 1. GLOBAL PHARMACEUTICAL INDUSTRY Submitted by -Chandan Kumar Singh 11DCP-071 1
  • 2. CASE BACKGROUND  The case describes how the prescription pharmaceutical industry has changed since its modern beginnings in the early 1950s.  The various forces affecting the competitive environment of the industry are discussed in terms of origins, immediate past and immediate future (2004 onwards).  Provides insights into the evolution of barriers to enter and exit the industry for prescription pharmaceuticals  Detailed industry note on the “ethical” pharmaceutical industry which provides an opportunity to analyse key 2 success factors of major players.
  • 3. CASE BACKGROUND  Descriptive overview of the predominant issues in the three major Triad market areas: the US, Europe and Japan .  Covers the overall industry environment with indepth discussion of the driving forces in the industry such as globalisation (in particular global regulatory issues, changing world demographics and worldwide pricing disparities).  Development of new technology; the importance of time to market; and amalgamations.  The case also examines issues around corporate social 3 responsibility
  • 4. BRIEF HISTORY  Post WWII, the pharmaceutical industry operated within a quite stable & highly profitable environment as compared to other industries  The industry saw the development of many new drugs during the 1960s due to technological success.  However as legislation was introduced in the 70s the number of „generics‟ increased & consequentially time to market of drugs also increased  Emergence of biotechnology firms, limited buying ability of consumers leading to reliance on blockbuster drugs for income resulted in the instability in the industry 4
  • 5. Patents introduced BRIEF HISTORY 60 50 40 o Simple infections that were easy 30 Patents drug targets had been addressed 20 introduce 10 d 0 o Advances over existing treatments 1999 1980 2001 2002 & research for therapy of previously untreated diseases started proving expensive & risky R&D Expenditure 60 o Consumers started demanding 50 value for money products as their 40 buying power became increasingly 30 R&D Expendit limited 20 10 ure 0 5 In Billion $ 1981 2000
  • 6. ENVIRONMENT ANALYSIS External Internal Scenario Environment Environment Favorable, moderate PESTEL Five forces Model and unfavorable 6
  • 7. PESTEL ANALYSIS Political Factors • Highly fragmented industry in 80‟s. Mergers led to concentration of jobs in select countries • More control thereby exercised by Governments • Easy Targets – To control rising healthcare costs when medicines amount to 15% of healthcare expenditure • Multi country pricing due to Govt regulations. • Patent on drugs – India patents the process while US and EU patent the drug 7
  • 8. PESTEL ANALYSIS Economic Factors • Demand side • Doctors tend to favor branded drugs which are high margin. • Globalization has made it possible for big companies to mass market the drugs. • Supply side • Global supply is fragmented. Pfizer has largest market share of 11% • Regional players and the generic drugs which are relatively cheaper are popular in developing world • Need for blockbuster products as R&D investments 8 do not justify the number of new drugs
  • 9. PESTEL ANALYSIS Social Factors – • Advancement in medicine has raised the life expectancy to 75 and aged population increases the consumption. This adds strain on insurance companies and govts • Socially aware and demanding consumers Technological and Environmental factors • Human Genome and genetics are new ways to discover drugs • Rising aged population in west and middle class in developing countries makes the long term 9 prospective good.
  • 10. PESTEL ANALYSIS Legal factors • Varied patent laws in different countries • Many best selling drugs are replicated as generic medicine in developing countries with full government backing. • Clinical trials have become more rigorous thereby testing more than 20,000 people in the complete run of 10-14 years 10
  • 11. ENVIRONMENT ANALYSIS External Internal Scenario Environment Environment Favorable, moderate PESTEL Five forces Model and unfavorable 11
  • 12. Factors Past Future Threat of • The industry has already high entry • Firms specializing in moving potential barriers which are increasing. specific molecules along the value entrants • lead times for new drugs to be chain could be tomorrow's main marketed increasing from 3 to competitors. 5years in the 1960s to 12 years by • Emphasis on high-priced niche the mid-1990s. drugs for high unmet need diseases • Need for global return on costly R&D likely to support market entry by bio favors large firms only techs. Power • Governments (EU) and managed • Controls on pricing , reimbursement of buyers health organizations (US)imposing and market access continue to systems to control tighten(„value for money‟ is atop prices/reimbursement and demand . concern on both sides of the • Growth of parallel trade. Atlantic). • Harmonization of regulatory approval • Growth of managed care continues systems. Rising patient expectations. deteriorating the profitability of big pharmaceuticals regardless of the outcome of regulation. 12
  • 13. Factors Past Future Power of • Cheap generics. • Biological generics appear. substitutes • Reduced lead times for „me-too‟ • Diversification into generics drugs from 6to 7 years to 18months; protects volume share (but not the • Consumer suspicion of drugs leads profit) of big pharmaceutical to increasing use of alternative companies. remedies • Functional foods preferred as safer alternative to drugs Power of • Global sourcing leads to further • Emergence of China and India as suppliers reductions in the costs of raw key out-sourcing locations. materials. • Cost of licensing deals drives • Major pharma companies come companies towards more increasingly to rely on in-licensing for acquisitions new products, raising prices on such deals Competitie • Profitable, cash-rich industry but • Continued industry consolidation in rivalry margins declining. static market results in fewer larger • Mergers and acquisitions are global companies, focused on expected to continue as they could specific franchises , with intense lead to economies of scale, global rivalry within therapeutic franchises. 13 sales and marketing and more efficient R&D efforts. • Intense rivalry within product
  • 14. ENVIRONMENT ANALYSIS External Internal Scenario Environment Environment Favorable, moderate PESTEL Five forces Model and unfavorable 14
  • 15. INDUSTRY TRENDS o The pharmaceutical industry is facing a rapidly changing environment. o The need for global presence to achieve adequate return on escalating marketing and R&D costs o A strong focus on health care cost containment, such that new treatments must be justified on cost–benefit grounds, adding to development costs o To command price premiums, new products must offer unique benefits, yet information leakage means that most products are imitated rapidly o IT developments provide greater access to detailed health care information for both providers and patients, also pushing forward cost-effective treatments o Educated consumers demanding advances in therapy 15 o There are opportunities to change organizational models but no-one has yet found a feasible alternative
  • 16. Scenario 1: Favorable  Increased opportunities for pharmaceutical sales developing in emerging markets.  Little substitution from biotech products  No entry of new participants and a decrease in mergers and acquisition activity  Time to market remains critical but genomics helps to fine- tune NCE selection and reduce time in clinical trials.  Organisational changes result in a number of very promising “blockbuster drugs” advancing through the pipeline  There will be greater harmonisation amongst international markets. • 16
  • 17. Scenario 2: Moderate  Substitution from biotech products, some advances to reduce R&D expenditure.  Outsourcing (i.e. licensing of products) continues to develop but without challenging established players.  Entry of new participants and/or consumers opting for some forms of alternative medicine  Slow but consistent steps towards greater industry concentration continue.  There will be increasing sales opportunities in emerging and recently industrialised countries. 17
  • 18. Scenario 3: Unfavorable  Most income generation is associated to licensing agreements and profits will thereby get squeezed.  There is a recruitment crisis as a whole generation of new scientists is lost to mid-sized players and biotechs.  Results in dying of blockbuster drugs.  All investments in genomics prove futile at present as it will be one or two more generations before any practical result is evident.  Emergence of new alternative forms of non-drug-based therapeutic treatments and widespread adoption of alternative medicine practices.  Entry of new global participants such as Japanese, Korean or Indian laboratories will intensify the competition.  Increased mergers and acquisition activity puts substantial short-term pressure on profit margins. 18
  • 19. ETHICAL CONSIDERATION  There are thus key issues around the ethical stance of pharmaceuticals, their stakeholders and society at large including:  Property rights  R&D, budget constrains and the pursuit of ailments in emerging markets  Being in the public eye (as a consumer goods manufacturer and a provider of health products) 19
  • 20. BUSINESS IMPLICATIONS-GOING FORWARD  Innovation will be the most important thing, more important than the size of the organization.  The main reason behind this is that there has to be points of difference with every new product so as to charge a premium price to it.  With more of information leakage, most of the products are copied quickly.  With more of R&D costs, it becomes extremely necessary to achieve adequate returns on the pipeline as this will pave the way for the success of manufacturers.  New drugs need to be developed with respect to diseases which are ignored.  A firm has to be more consistent in its approach with having constant innovation of new drugs. 20
  • 21. THANKS FOR YOUR TIME AND CONSIDERATION 21