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Global Generic Pharmaceuticals Market –
         Brighter Times Ahead

 Analyzing the Global Business Prospects for Generic Drug
  Manufacturers in the Developed and Emerging Markets



       Aiswariya Chidambaram, Research Analyst
                      Healthcare
                       9.2.2012
Aiswariya Chidambaram

                       Functional Expertise
                           Particular expertise in:
                             - Analyzing regional sales performance, identifying performance gaps and providing relevant solutions to
                            stakeholders for the growth and development of regional business.
                             - Designing and roll out of appropriate training modules, conducting workshops on selling skills excellence and
                            working on development of Business executives at professional and personal levels.
                             - Conducting induction training to new recruits and field coaching on marketing projects to ensure smooth
                            implementation.
                             - Recruiting candidates and identifying talents at regional level by appropriate means of performance analysis and
                            competency mapping. Special projects implementation on a regional scale
                       Industry Expertise
                           Expertise in diverse therapeutic segments and product portfolios which include
                             - Diabetology – Oral Anti Diabetics
                             - Cardiovascular Diseases – Anti-hypertensives.
Aiswariya                    - General Medicine – Antibiotics, Anti-fungals, and Health supplements.
Chidambaram                  - Women’s Healthcare – Oral Contraceptives
                       What I bring to the Team
Research Analyst,          In depth knowledge of four specific Therapeutic segments.
                           Expertise in tracking Industry trends and events as part of Market Vigilance.
Healthcare Practice,       Reasoning based recommendation for improved efficiency.
Frost & Sullivan           Excellent communication and presentation skills.
Global,                Career Highlights
Chennai,                   Have successfully completed a NIH project on Filariasis at the Tuberculosis Research Centre (Chennai).
India                      Completed internship projects on Industrial Microbiology, Cytogenetics and Karyotyping, and a course on “Tools in
                            Bio-informatics and Vector Designing.”
                           Worked as a Performance Consultant for South India (covering four states – Tamil Nadu, Andhra Pradesh, Kerala and
                            Karnataka) with a leading Multinational firm, Bayer Healthcare.
                           Worked on market research projects such as the “Global Generics Pharmaceutical Market”, “European Pharmaceutical
                            and Biotech Contract Manufacturing Markets” and so on with Frost & Sullivan.
                       Education
                           Bachelors in Technology, specialization in Biotechnology, from Anna University, Chennai, India.
Focus Points

        Generics Lead the Way Ahead

               Key Therapeutic Areas Overview

                    Key Therapeutic Areas – Growth Analysis

                       Key Patent Expiries Between 2010 and 2017

                         Global Hot Spots – Generic Pharmaceuticals Market

                          Key Market Drivers and Restraints Summary
Focus Points               Mergers and Acquisitions Outlook

                          Key Mergers and Acquisitions in 2010

                        Competitive Landscape Analysis

                     Future Trends and Directions

                   Strategic Recommendations for Success

            Conclusions and Implications
Generics Lead the Way Ahead


  The global generic pharmaceuticals market was
 valued at $123.85 billion in 2010, growing at 11.0%

                                                                                       Blockbuster
                                                                                    drugs worth $150
    U.S is the world’s largest                                                       billion are set to
  generics market constituting                                                          lose patent
               45%.                                 Emerging markets such                protection
                                                     as Brazil, Russia, India,      between 2010 and
                                                        China, Turkey and                   2017
                                                      South Korea present
                                                    growth opportunities of
                                                        15 % to 20% while
India and China are huge generic                      matured markets are
  markets in terms of production                    likely to grow between 6
                                                                                 The top eight global
             volume.                                                             markets – the United
                                                     % to 10 % over the next
                                                                                   States, Germany,
                                                             five years           France, the United
                                                                                  Kingdom, Canada,
                                                                                    Italy, Spain and
                                                                                 Japan – account for
                                                                                    80% of the total
                                                                                      generic sales
 The top ten global generic companies constitute a share of 47% of
                     the total generics market.


                                                                                             Source: Frost and Sullivan
Key Therapeutic Areas Overview

        Generic Pharmaceuticals Market: Percent Revenue Contribution of Therapeutic Segments (Global),
                                                    2010




                                                                      Note: All figures are rounded; the base year is 2010. Source: Frost & Sullivan


                               Others include Gastro-intestinal, HIV, Immunology and so on.



 Cardiovascular and CNS are the two largest market segments, constituting nearly 38 per cent of the global
generic pharmaceuticals market together.
 However, therapeutic segments such as Respiratory, CNS and Oncology are likely to witness significantly high
growth rates, attracting the attention of market participants.
 On the contrary, segments such as Diabetes and Genitourinary/ hormonal drugs are expected to decline by the
2017.
Key Therapeutic Areas – Growth Analysis

    20%               The patent expiry of several key
                      antipsychotics and anti-depressants                                   The reason behind such
                      contribute to the rapid growth of CNS                                 enormous growth is the
                      drugs market between 2010 and 2017.                                   massive number of
    14%                                                                                     patent expiries. Almost
                                                                       Development/         half of the global asthma
                                                                       Fast Growing         and COPD market drugs
                                                                                            are set to lose patent
    12%                                                                                     protection by 2016.           Relatively     lesser
                                                                                                                          number of drugs are
                                                                                                                          subjected to generic
                                 Fast                                                                                     exposure during the
    10%                        Growing                                                                                    forecast period and
C
                                        Development/                                                                      hence the decline in
A                                                                                                                         growth.
                                        Fast Growing
G    8%           Fast
R               Growing                                   Growing                                            Growing
                                     One of the promising
     6%                              segments for generic                                    Declining                   Declining        Stable
                                     participants to venture
                                                                                      Intense competition,
                                     between 2010 and
                                                                                      promotion of branded
                                     2015 is oncology as
     4%                              drugs worth $10 b are
                                                                                      drugs      and      new
                                                                                      innovative
                                     set to lose patent
                                                                                      formulations such as
                                     protection by 2015
                                                                                      inhalable insulin are all
     2%                                                                               likely to deter the
                                                                                      growth of generics.


              Cardiovascular   CNS      Oncology        Rheumatology    Respiratory         Diabetes        Dermatology Genitourinary    Others

    Bubble size represents market value                                                                           Source: Frost & Sullivan analysis.
Key Patent Expiries Between 2010 and 2016

 Expiry in 2010
• Advair/Seretide by GSK            Expected expiry in 2012                        Expected expiry in 2014
• Aricept by Pfizer, Eisai          • Avandia by GSK                               •   Actonel by Warner Chilcott
• Arimidex by Astra Zeneca          • Avapro by Sanofi Aventis, BMS                •   Celebrex by Pfizer
• Cozaar by Merck                   • Detrusitol by Pfizer,                        •   Copaxone by Teva
• Effexor by Pfizer                   Pharmacia-Upjohn                             •   Cymbalta by Eli Lilly
• Flomax by Boehringer, Astellas    • Diovan by Novartis                           •   Micardis by Boehringer
• Gemzar by Eli Lilly               • Evista by Eli Lilly                          •   Nexium by Astra Zeneca
• Hycamptin by GSK, Pfizer,         • Lexapro by Forest                            • Spiriva by Boehringer Ingelheim
  Protonix                          • Seroquel by Astra Zeneca
• Levaquin by J&J                   • Singulair by Merck
                                                                                   Expected expiry in 2015
• Taxotere by Sanofi Aventis        • Symbicort by Astra Zeneca
                                                                                   • Abilify by Otsuka
                                    • Viagra by Pfizer
Expiry in 2011                                                                     • Enablex by Novartis
                                    • Viramune by Boehringer
• Actos by Takeda                                                                  • Neulasta by Amgen
                                    • Zeldox/Geodon by Pfizer
• Alimta by Eli Lilly                                                              • Tracleer by Actelion
                                    • Zometa by Novartis
•   Atacand by Astra Zeneca
•   Femara by Novartis              Expected expiry in 2013
                                    • Epogen by Amgen                               Expected expiry in 2016
•   Lipitor by Pfizer
                                    • Pariet by Eisai                               • Cialis by Eli Lilly
•   Oxycontin by Purdue
                                    • Procrit by Amgen                              • Crestor by Astra Zeneca
•   Plavix by BMS, Sanofi Aventis
•   Zyprexa by Eli Lilly
                                             Source: Generic Pharmaceutical Association, CPA Global, Frost & Sullivan analysis.
Global Hot Spots – Generic Pharmaceuticals Market

                                                                                      Key
                                                                                                   Mature
                                Germany
                                Size : $8.80 billion
                                                             India                                 Emerging
                                                             Size:$10.00 billion
                                                                                                   Growing


                           United Kingdom
                           Size : $5.40 billion



              United States                                Italy
              Size:$55.78 billion                          Size:$1.09 billion      China
                                                                                   Size:$26.45 billion

  Note
                                                         France
   India and China are studied as two separate
 generic pharmaceuticals market owing to the             Size:$4.20 billion
  lack of implementation of patent protection
laws up to 2005. Hence, domestic players were
 free to produce generic versions of molecules         Spain
  under patent protection in these markets by          Size:$2.20 billion
          means of reverse engineering.
                                                                                       Source: Frost & Sullivan analysis.
Key Market Drivers and Restraints Summary
 Generic Pharmaceuticals Market: Key Drivers and Restraints Summary (Global), 2011-2017

                    Blockbuster drugs                        Key Drivers
                    worth $150 billion
                      are due to lose
                     patent protection             New provisions
                    between 2010 and                introduced by                       Changing population
                           2017                    governments to                        demographics and
                                                      encourage                           lifestyle patterns
                                                  generic utilisation




                                           Increasingly
         Gaining access to                                         Threat of introduction
                                             stringent
         emerging markets                                          of authorised generics
                                         regulations and
        and niche therapeutic                                            by branded
                                           price control
              segments                                                   companies
                                            measures


                                                                         Parallel trading
                                                                        and counterfeiting
                                                                         of generics from
                                                                        low cost markets

Key Restraints/Challenges                                                                    Source: Frost & Sullivan analysis
Mergers & Acquisitions Outlook

  Generic Pharmaceuticals Market: Number of Deals and Amount Spent on Mergers & Acquisitions (Global), 2000 - 2009




The number of deals and the total expenditure on mergers and acquisitions have been increasing steadily over the
years since 2000. There was a peak in M&A activity in 2005 and 2008. The trend is likely to continue with all the key
generic participants increasing their dependence on strategic alliances to conquer market shares.
                                                                                                  Source: Frost & Sullivan analysis.
Key Mergers & Acquisitions in 2010



       Abbott -                Abbott – Piramal                  Teva –                     Mylan –
       Solvay                    Healthcare                    Ratiopharm               Bioniche Pharma




                            Value: $3.72 billion
Value: $6.20 billion        Key Reason:                  Value: $5.00 billion       Value: $550.0 million
Key Reason:                 • Abbott, by acquiring the   Key Reason:                Key Reason:
• This acquisition will     entire solutions business    • Ratiopharm, the          •. Bioniche Pharma has
enable Abbott to attain     of a leading company in      second largest generic     more than 30 products in
leadership in emerging      the branded Indian           company in Germany         the market, 15 ANDAs
markets where there is      generic pharmaceuticals      and the sixth largest      pending for approval at
significant opportunity     market such as Piramal       worldwide, will position   the United States FDA
for branded generics        Healthcare, has the          Teva as the leading        and 25 products in
and in specialty markets    rights to gain access to     generic pharmaceutical     developmental stages.
like cardiovascular,        350 brands and               company in Europe,         This will help drive both
neuroscience and            trademarks. These            particularly in Germany    top and bottom line
gastroenterology. It is     include market- leading      as well as in emerging     growth for Mylan and
expected to add another     brands in multiple           markets like Spain,        facilitate direct entry into
$2.90 billion to Abbott’s   therapeutic areas such       Italy, France, and the     the North American
2010 sales.                 as respiratory and           Netherlands.               injectables market.
                            antibiotics..
                                                                                        Source : Frost & Sullivan analysis.
Competitive Landscape Analysis

       Generic Pharmaceuticals Market: Top Five Companies by Market Share (Global), 2010


                                                 The top five generic pharmaceutical companies
Rank                  Company                     accounted for 39 per cent of the share in the global
                                                  generic pharmaceuticals market in 2010.

                                                 The top three companies namely Teva, Sandoz
                                                  and Mylan registered significant growth rates of
 1                                                16, 14 and 11 per cent respectively in 2010.

                                                 Most of the big companies prefer mergers and
 2                                                acquisitions to organic growth as a faster means to
                                                  consolidate and expand their market shares.

 3                     Mylan

 4

 5
                                                                        Source: Frost and Sullivan analysis
Future Trends and Directions

                Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed markets to
                      emerging markets owing to immense market opportunities and untapped market potentials.


                          Consolidation is expected to remain the key factor for growth and sustenance of generic
                            companies. Partnerships, mergers, acquisitions and strategic alliances will help both
                          branded and generic companies to expand their global footprint and gain market shares.



                                    Large generic companies seek to establish their own R&D entity and hence are
Key Trends                             likely to increase their investments in R&D activities for long-term growth
                                                      and sustenance in the pharmaceutical industry.

          Technology
 Development of Transgenic technologies
                                  Generic consumption is likely to be favoured in a big way by the government, payers,
         Stem cell technologies
          Cloning technologies
                                   policy-makers and physicians owing to the huge cost-saving benefits to the patients
                                                       and curtail healthcare expenditure.


                Generic manufacturers tend to increasingly focus on higher value biological therapies, biosimilars,
                 controlled release products, sterile formulations and niche therapeutic segments, which are less
                                              competitive yet commercially attractive.
                                                                                     Source: Frost and Sullivan analysis
Strategic Recommendations for Success

Strategy is a style of thinking, a conscious and deliberate process, an intensive implementation system, the science
                                       of insuring future success – Pete Johnson


    Differentiated Approach       Explore New Avenues           Instill Competitive      Plan Ahead for the Future
                                                                    Capabilities




   Big multinational generic
   firms require to focus on     Analyze prospects for
                                                              Invest in R&D.                  Research customer
    Products with                market globalization
                                                                                                needs, preferences,
      technologically           - Strategic alliances
                                                              Improve product line.            expectations.
      challenging                 between multinational
      formulations.               generic firms and
                                                              Defend company’s                Monitor new
    Products which require       domestic participants
                                                               position in the market.          technological
      significant regulatory      with locally restricted
                                                                                                developments to face
      support.                    operations.
                                                              Strike a balance                 the change.
    Products with limited                                     between supply and
      availability of APIs.      Strengthen distribution.
                                                               demand side.                    Target therapeutic
                                                                                                areas with high levels
   Medium-sized generic firms                                 Pioneer new and better           of unmet clinical
   require to focus on                                         technologies.                    needs.
    Products with relatively
      higher profit margins.
    Appropriate time of
      entry into the right
      market.
                                                                                         Source: Frost and Sullivan analysis
Conclusions and Implications

 The global generic pharmaceuticals market is expected to peak in 2012, owing
to the patent expiry of several leading brands such as Seroquel, Viagra, Lexapro to
name a few.
 Regulations favoring generics, wider health insurance coverage by Government
and private bodies, and better co-operation from physicians and pharmacists are
expected to boost generic consumption.
 The consolidation wave is likely to rise high in the global generic pharmaceuticals
market.
 CNS and Cardiovascular are expected to be the therapeutic areas of interest for
generic drug manufacturers.
 However, market participants are likely to face challenges due to increasing
pricing pressure, price-cuts and regulatory barriers.




                                                                  Source: Frost and Sullivan analysis
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Global generic pharmaceuticals market – brighter times ahead

  • 1. Global Generic Pharmaceuticals Market – Brighter Times Ahead Analyzing the Global Business Prospects for Generic Drug Manufacturers in the Developed and Emerging Markets Aiswariya Chidambaram, Research Analyst Healthcare 9.2.2012
  • 2. Aiswariya Chidambaram Functional Expertise  Particular expertise in: - Analyzing regional sales performance, identifying performance gaps and providing relevant solutions to stakeholders for the growth and development of regional business. - Designing and roll out of appropriate training modules, conducting workshops on selling skills excellence and working on development of Business executives at professional and personal levels. - Conducting induction training to new recruits and field coaching on marketing projects to ensure smooth implementation. - Recruiting candidates and identifying talents at regional level by appropriate means of performance analysis and competency mapping. Special projects implementation on a regional scale Industry Expertise  Expertise in diverse therapeutic segments and product portfolios which include - Diabetology – Oral Anti Diabetics - Cardiovascular Diseases – Anti-hypertensives. Aiswariya - General Medicine – Antibiotics, Anti-fungals, and Health supplements. Chidambaram - Women’s Healthcare – Oral Contraceptives What I bring to the Team Research Analyst,  In depth knowledge of four specific Therapeutic segments.  Expertise in tracking Industry trends and events as part of Market Vigilance. Healthcare Practice,  Reasoning based recommendation for improved efficiency. Frost & Sullivan  Excellent communication and presentation skills. Global, Career Highlights Chennai,  Have successfully completed a NIH project on Filariasis at the Tuberculosis Research Centre (Chennai). India  Completed internship projects on Industrial Microbiology, Cytogenetics and Karyotyping, and a course on “Tools in Bio-informatics and Vector Designing.”  Worked as a Performance Consultant for South India (covering four states – Tamil Nadu, Andhra Pradesh, Kerala and Karnataka) with a leading Multinational firm, Bayer Healthcare.  Worked on market research projects such as the “Global Generics Pharmaceutical Market”, “European Pharmaceutical and Biotech Contract Manufacturing Markets” and so on with Frost & Sullivan. Education  Bachelors in Technology, specialization in Biotechnology, from Anna University, Chennai, India.
  • 3. Focus Points Generics Lead the Way Ahead Key Therapeutic Areas Overview Key Therapeutic Areas – Growth Analysis Key Patent Expiries Between 2010 and 2017 Global Hot Spots – Generic Pharmaceuticals Market Key Market Drivers and Restraints Summary Focus Points Mergers and Acquisitions Outlook Key Mergers and Acquisitions in 2010 Competitive Landscape Analysis Future Trends and Directions Strategic Recommendations for Success Conclusions and Implications
  • 4. Generics Lead the Way Ahead The global generic pharmaceuticals market was valued at $123.85 billion in 2010, growing at 11.0% Blockbuster drugs worth $150 U.S is the world’s largest billion are set to generics market constituting lose patent 45%. Emerging markets such protection as Brazil, Russia, India, between 2010 and China, Turkey and 2017 South Korea present growth opportunities of 15 % to 20% while India and China are huge generic matured markets are markets in terms of production likely to grow between 6 The top eight global volume. markets – the United % to 10 % over the next States, Germany, five years France, the United Kingdom, Canada, Italy, Spain and Japan – account for 80% of the total generic sales The top ten global generic companies constitute a share of 47% of the total generics market. Source: Frost and Sullivan
  • 5. Key Therapeutic Areas Overview Generic Pharmaceuticals Market: Percent Revenue Contribution of Therapeutic Segments (Global), 2010 Note: All figures are rounded; the base year is 2010. Source: Frost & Sullivan Others include Gastro-intestinal, HIV, Immunology and so on.  Cardiovascular and CNS are the two largest market segments, constituting nearly 38 per cent of the global generic pharmaceuticals market together.  However, therapeutic segments such as Respiratory, CNS and Oncology are likely to witness significantly high growth rates, attracting the attention of market participants.  On the contrary, segments such as Diabetes and Genitourinary/ hormonal drugs are expected to decline by the 2017.
  • 6. Key Therapeutic Areas – Growth Analysis 20% The patent expiry of several key antipsychotics and anti-depressants The reason behind such contribute to the rapid growth of CNS enormous growth is the drugs market between 2010 and 2017. massive number of 14% patent expiries. Almost Development/ half of the global asthma Fast Growing and COPD market drugs are set to lose patent 12% protection by 2016. Relatively lesser number of drugs are subjected to generic Fast exposure during the 10% Growing forecast period and C Development/ hence the decline in A growth. Fast Growing G 8% Fast R Growing Growing Growing One of the promising 6% segments for generic Declining Declining Stable participants to venture Intense competition, between 2010 and promotion of branded 2015 is oncology as 4% drugs worth $10 b are drugs and new innovative set to lose patent formulations such as protection by 2015 inhalable insulin are all 2% likely to deter the growth of generics. Cardiovascular CNS Oncology Rheumatology Respiratory Diabetes Dermatology Genitourinary Others Bubble size represents market value Source: Frost & Sullivan analysis.
  • 7. Key Patent Expiries Between 2010 and 2016 Expiry in 2010 • Advair/Seretide by GSK Expected expiry in 2012 Expected expiry in 2014 • Aricept by Pfizer, Eisai • Avandia by GSK • Actonel by Warner Chilcott • Arimidex by Astra Zeneca • Avapro by Sanofi Aventis, BMS • Celebrex by Pfizer • Cozaar by Merck • Detrusitol by Pfizer, • Copaxone by Teva • Effexor by Pfizer Pharmacia-Upjohn • Cymbalta by Eli Lilly • Flomax by Boehringer, Astellas • Diovan by Novartis • Micardis by Boehringer • Gemzar by Eli Lilly • Evista by Eli Lilly • Nexium by Astra Zeneca • Hycamptin by GSK, Pfizer, • Lexapro by Forest • Spiriva by Boehringer Ingelheim Protonix • Seroquel by Astra Zeneca • Levaquin by J&J • Singulair by Merck Expected expiry in 2015 • Taxotere by Sanofi Aventis • Symbicort by Astra Zeneca • Abilify by Otsuka • Viagra by Pfizer Expiry in 2011 • Enablex by Novartis • Viramune by Boehringer • Actos by Takeda • Neulasta by Amgen • Zeldox/Geodon by Pfizer • Alimta by Eli Lilly • Tracleer by Actelion • Zometa by Novartis • Atacand by Astra Zeneca • Femara by Novartis Expected expiry in 2013 • Epogen by Amgen Expected expiry in 2016 • Lipitor by Pfizer • Pariet by Eisai • Cialis by Eli Lilly • Oxycontin by Purdue • Procrit by Amgen • Crestor by Astra Zeneca • Plavix by BMS, Sanofi Aventis • Zyprexa by Eli Lilly Source: Generic Pharmaceutical Association, CPA Global, Frost & Sullivan analysis.
  • 8. Global Hot Spots – Generic Pharmaceuticals Market Key Mature Germany Size : $8.80 billion India Emerging Size:$10.00 billion Growing United Kingdom Size : $5.40 billion United States Italy Size:$55.78 billion Size:$1.09 billion China Size:$26.45 billion Note France India and China are studied as two separate generic pharmaceuticals market owing to the Size:$4.20 billion lack of implementation of patent protection laws up to 2005. Hence, domestic players were free to produce generic versions of molecules Spain under patent protection in these markets by Size:$2.20 billion means of reverse engineering. Source: Frost & Sullivan analysis.
  • 9. Key Market Drivers and Restraints Summary Generic Pharmaceuticals Market: Key Drivers and Restraints Summary (Global), 2011-2017 Blockbuster drugs Key Drivers worth $150 billion are due to lose patent protection New provisions between 2010 and introduced by Changing population 2017 governments to demographics and encourage lifestyle patterns generic utilisation Increasingly Gaining access to Threat of introduction stringent emerging markets of authorised generics regulations and and niche therapeutic by branded price control segments companies measures Parallel trading and counterfeiting of generics from low cost markets Key Restraints/Challenges Source: Frost & Sullivan analysis
  • 10. Mergers & Acquisitions Outlook Generic Pharmaceuticals Market: Number of Deals and Amount Spent on Mergers & Acquisitions (Global), 2000 - 2009 The number of deals and the total expenditure on mergers and acquisitions have been increasing steadily over the years since 2000. There was a peak in M&A activity in 2005 and 2008. The trend is likely to continue with all the key generic participants increasing their dependence on strategic alliances to conquer market shares. Source: Frost & Sullivan analysis.
  • 11. Key Mergers & Acquisitions in 2010 Abbott - Abbott – Piramal Teva – Mylan – Solvay Healthcare Ratiopharm Bioniche Pharma Value: $3.72 billion Value: $6.20 billion Key Reason: Value: $5.00 billion Value: $550.0 million Key Reason: • Abbott, by acquiring the Key Reason: Key Reason: • This acquisition will entire solutions business • Ratiopharm, the •. Bioniche Pharma has enable Abbott to attain of a leading company in second largest generic more than 30 products in leadership in emerging the branded Indian company in Germany the market, 15 ANDAs markets where there is generic pharmaceuticals and the sixth largest pending for approval at significant opportunity market such as Piramal worldwide, will position the United States FDA for branded generics Healthcare, has the Teva as the leading and 25 products in and in specialty markets rights to gain access to generic pharmaceutical developmental stages. like cardiovascular, 350 brands and company in Europe, This will help drive both neuroscience and trademarks. These particularly in Germany top and bottom line gastroenterology. It is include market- leading as well as in emerging growth for Mylan and expected to add another brands in multiple markets like Spain, facilitate direct entry into $2.90 billion to Abbott’s therapeutic areas such Italy, France, and the the North American 2010 sales. as respiratory and Netherlands. injectables market. antibiotics.. Source : Frost & Sullivan analysis.
  • 12. Competitive Landscape Analysis Generic Pharmaceuticals Market: Top Five Companies by Market Share (Global), 2010  The top five generic pharmaceutical companies Rank Company accounted for 39 per cent of the share in the global generic pharmaceuticals market in 2010.  The top three companies namely Teva, Sandoz and Mylan registered significant growth rates of 1 16, 14 and 11 per cent respectively in 2010.  Most of the big companies prefer mergers and 2 acquisitions to organic growth as a faster means to consolidate and expand their market shares. 3 Mylan 4 5 Source: Frost and Sullivan analysis
  • 13. Future Trends and Directions Balance in terms of healthcare expenditure and sales revenue is likely to shift from developed markets to emerging markets owing to immense market opportunities and untapped market potentials. Consolidation is expected to remain the key factor for growth and sustenance of generic companies. Partnerships, mergers, acquisitions and strategic alliances will help both branded and generic companies to expand their global footprint and gain market shares. Large generic companies seek to establish their own R&D entity and hence are Key Trends likely to increase their investments in R&D activities for long-term growth and sustenance in the pharmaceutical industry. Technology Development of Transgenic technologies Generic consumption is likely to be favoured in a big way by the government, payers, Stem cell technologies Cloning technologies policy-makers and physicians owing to the huge cost-saving benefits to the patients and curtail healthcare expenditure. Generic manufacturers tend to increasingly focus on higher value biological therapies, biosimilars, controlled release products, sterile formulations and niche therapeutic segments, which are less competitive yet commercially attractive. Source: Frost and Sullivan analysis
  • 14. Strategic Recommendations for Success Strategy is a style of thinking, a conscious and deliberate process, an intensive implementation system, the science of insuring future success – Pete Johnson Differentiated Approach Explore New Avenues Instill Competitive Plan Ahead for the Future Capabilities Big multinational generic firms require to focus on  Analyze prospects for  Invest in R&D.  Research customer  Products with market globalization needs, preferences, technologically - Strategic alliances  Improve product line. expectations. challenging between multinational formulations. generic firms and  Defend company’s  Monitor new  Products which require domestic participants position in the market. technological significant regulatory with locally restricted developments to face support. operations.  Strike a balance the change.  Products with limited between supply and availability of APIs.  Strengthen distribution. demand side.  Target therapeutic areas with high levels Medium-sized generic firms  Pioneer new and better of unmet clinical require to focus on technologies. needs.  Products with relatively higher profit margins.  Appropriate time of entry into the right market. Source: Frost and Sullivan analysis
  • 15. Conclusions and Implications  The global generic pharmaceuticals market is expected to peak in 2012, owing to the patent expiry of several leading brands such as Seroquel, Viagra, Lexapro to name a few.  Regulations favoring generics, wider health insurance coverage by Government and private bodies, and better co-operation from physicians and pharmacists are expected to boost generic consumption.  The consolidation wave is likely to rise high in the global generic pharmaceuticals market.  CNS and Cardiovascular are expected to be the therapeutic areas of interest for generic drug manufacturers.  However, market participants are likely to face challenges due to increasing pricing pressure, price-cuts and regulatory barriers. Source: Frost and Sullivan analysis
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