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Generic Drugs

Global. Generics

 

Publication Date April 2009
Publisher Cygnus
Product Type Report
Pages 129
ISBN Number not applicable
Product Code CYG00085

Price

£800.00
approximately: $1,211 | €893

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Summary

Global generics market was valued at US$106.12 billion in 2008, registering a growth of 12.56% over the previous year, which is five times that of patented drugs. Cygnus estimates that the global generics market will sustain a CAGR of 14% during the period, 2008-12. Patent expiries of blockbuster drugs and increasing healthcare expenditure will continue to drive the growth of the industry. The major generic firms will become more dominant with further acquisitions in future.

Scope of the Report:

  • i. Global generics market overview with various patent challenges, mergers and acquisitions and regional market overview (North America, Europe and Asia Pacific) along with growth drivers of the industry are discussed to provide a broad global scenario of the market.
  • ii. The industry faces several challenges, which are discussed in Issues and Challenges chapter.
  • iii. The R&D expenditure of global generics companies has been discussed separately, followed by regulations of the industry.
  • iv. Ten leading industry players are discussed in Major Players chapter discussing their Business Profile, Financial Profile, Key Strategies, Outlook followed by critical success factors.
  • v. Another important topic i.e. key patent expiries during 2008-12 has been discussed along with the future outlook of the industry.

Reasons to Buy

  • Provides insight into the key concepts of Global Generics in a comprehensive manner
  • Useful to pharma industry experts, global investors and generics companies.
  • Prepares students of Pharma Courses to face the industry confidently
  • Can assess the industry status broadly by Financial institutes, offering term loans to generic pharma companies

Contents

  • 1.Executive Summary

  • 2. Highlights

  • 3. Market Overview

    • 3.1 Global generics market
    • 3.2 Growth rate comparison
    • 3.3 Geographical segmentation
    • 3.4 Ethical Vs. OTC generics
    • 3.5 Top 20 products in the US
    • 3.6 Major generic companies

  • 4. Industry Trend

    • 4.1 Mergers and Acquisitions
    • 4.2 Patent challenges
    • 4.3 Regulatory changes
    • 4.4 New Distribution Models
    • 4.5 Centralised contracting and increasing role of payers

  • 5. Major Markets

    • 5.1 North America
      • 5.1.1 The US
      • 5.1.2 Canada
    • 5.2 Europe
      • 5.2.1 Germany
      • 5.2.2 The UK
      • 5.2.5 Italy
    • 5.3 Asia Pacific
      • 5.3.1 Japan
      • 5.3.2 China
      • 5.3.3 India

  • 6. Growth Drivers

    • 6.1 Cost advantage
    • 6.2 Increasing patent expiries
    • 6.3 Rising healthcare expenditure
    • 6.4 Greater M&A activities
    • 6.5 Shifting disease pattern
    • 6.6 Changing age structure of the global population

  • 7. Issues and Challenges

    • 7.1 Authorized generics
    • 7.2 Patent extension strategies
    • 7.3 Price erosion leads to intense competition
    • 7.4 Litigation and legal aspects
    • 7.5 Competition from low cost manufacturers
    • 7.6 More branded companies in generic competition

  • 8. Research and Development

    • 8.1 R&D spending by major generic companies
    • 8.2 Areas of R&D spend

  • 9. Regulations

    • 9.1 Regulatory aspects in the US
    • 9.2 Regulatory aspects in Europe
    • 9.3 Regulatory aspects in Japan
    • 9.4 International agreements on IPR protection
      • 9.4.1 General Agreement on Tariffs and Trade, (GATT)
      • 9.4.2 Trade Related Aspects of Intellectual Property Rights (TRIPS)
      • 9.4.3 The Paris Convention for the Protection of Industrial Property (PCPIP)
      • 9.4.4 The Patent Co-operation Treaty (PCT)

  • 10. Major Players

    • 10.1 Teva Pharmaceutical Industries Ltd.
      • 10.1.1 Business Profile
      • 10.1.2 Financial Profile
      • 10.1.3 Key Strategies
      • 10.1.4 Outlook
    • 10.2 Sandoz
      • 10.2.1 Business profile
      • 10.2.2 Financial Profile
      • 10.2.3 Key Strategy
      • 10.2.4 Outlook
    • 10.3 Watson Pharmaceuticals
      • 10.3.1 Business profile
      • 10.3.2 Financial Profile
      • 10.3.3 Key Strategy
      • 10.3.4 Outlook
    • 10.4 Mylan Inc.
      • 10.4.1 Business profile
      • 10.4.2 Financial Profile
      • 10.4.3 Key Strategy
      • 10.4.4 Outlook
    • 10.5 STADA
      • 10.5.1 Business profile
      • 10.5.2 Financial Profile
      • 10.5.3 Key Strategy
      • 10.5.4 Outlook
    • 10.6 Pliva
      • 10.6.1 Business profile
      • 10.6.2 Financial Profile
      • 10.6.3 Key Strategy
      • 10.6.4 Outlook
    • 10.7 Daiichi Sankyo
      • 10.7.1 Business Profile
      • 10.7.2 Financial Profile
      • 10.7.3 Key Strategy
      • 10.7.4 Outlook
    • 10.8 Cipla Ltd.
      • 10.8.1 Business profile
      • 10.8.2 Financial Profile
      • 10.8.3 Key Strategy
      • 10.8.4 Outlook
    • 10.9 Actavis
      • 10.9.1 Business Profile
      • 10.9.2 Financial Profile
      • 10.9.3 Key Strategy
      • 10.9.4 Outlook
    • 10.10 Dr. Reddy''s Laboratories Ltd.
      • 10.10.1 Business profile
      • 10.10.2 Financial Profile
      • 10.10.3 Key Strategy
      • 10.10.4 Outlook

  • 11. Critical Success Factors

    • 11.1 Biogenerics
    • 11.2 Outsourcing
    • 11.3 Venturing into ifficult to makegenerics
    • 11.4 Mergers and Acquisitions
    • 11.5 Investments in R&D
    • 11.6 Identifying the right patents to challenge
    • 11.7 Striking alliances

  • 12. Key Patent Expires 2008-12

  • 13. Outlook

  • Annexure I

  • Annexure II

  • Annexure III

  • Annexure IV

  • List of Figures

    • Figure 3.1: Global generics market - 2004-08 (US$bn)
    • Figure 3.2: Pharmaceutical market vs Generics (2006-08)
    • Figure 3.3: Geographical representation of global generics market - 2008
    • Figure 3.4: Ethical vs. OTC generics - 2008
    • Figure 3.5: Top generic players by revenue- 2008 (US$ bn)
    • Figure 4.1: M&A in global generics market - 2006-08 (US$ bn)
    • Figure 4.2: Number of Para IV filings (2006-08)
    • Figure 5.1: US generics market (2004-08)
    • Figure 5.2: Growth of Generic prescriptions (2002-07)
    • Figure 5.3: Canada generics market (2004-08)
    • Figure 5.4: Germany generics market (2004-08)
    • Figure 5.5: UK generics market (2004-08)
    • Figure 5.6: France generics market (2004-08)
    • Figure 5.7: Spain generics market (2004-08)
    • Figure 5.8: Italy generics market (2004-08)
    • Figure 5.9: Japan generics market (2004-08)
    • Figure 5.10: China generics market (2004-08)
    • Figure 5.11: India generics market (2004-08)
    • Figure 5.12: DMF filings (global vs India)
    • Figure 5.13: Country wise DMF filings (2000-08)
    • Figure 5.14: Indian ANDA approvals % of total Approvals (2001- 08)
    • Figure 5.15: ANDA approvals received by Indian Players (2001-08)
    • Figure 6.1: Patent expiries by value (2008-12)
    • Figure 6.2: Healthcare expenditure as a % of GDP (2002-06)
    • Figure 6.3: Global DALYs by disease - (2000-30)
    • Figure 6.4: Percentage of population aged 55 & above as a percentage to the total population (2008-2025)
    • Figure 7.1: Authorized generic launches (1999-02 to 2008)
    • Figure 7.2: Generics pricing - The market scenario
    • Figure 8.1: Top generic players by R&D spend- 2008
    • Figure 8.2: Areas of R&D spend by generic firms
    • Figure 9.1: Generic drug approval procedure in the US
    • Figure 11.1: R&D expenditure as a percentage of sales - 2008
    • Figure 13.1: Global generics market (2008-12)

  • List of Tables

    • Table 3.1: Top 20 products in world''s largest generics market by prescription
    • Table 4.1: Key M&A in global generics industry - 2008
    • Table 4.2: Key M&A in global generics industry - 2007
    • Table 4.3: Key M&A in global generics industry - 2006
    • Table 5.1: Top generic companies in the US based on generation of prescriptions during 2005-07(in million)
    • Table 5.2: Top 10 generic companies as per retail prescriptions (MAT June 2008)
    • Table 5.3: Key M&A by Indian Players in Generics
    • Table 5.4: Top 5 players in India (MAT November''08)
    • Table 6.1: Cost Comparison of 20 Branded Drugs and their Generic Counterparts
    • Table 6.2: Drug Patent Expiries (2008-09)
    • Table 7.1 List of authorized generics launched in the past
    • Table 7.2: Companies extending patent exclusivity
    • Table 11.1: Patent expiration of biological products in US Market
    • Table 11.2: Top 10 companies by number of patent challenges
    • Table 12.1: Drug Patent Expiries (2008)
    • Table 12.2: Drug Patent Expiries-2009
    • Table 12.3: Drug Patent Expiries-2010
    • Table 12.4: Drug Patent Expiries-2011
    • Table 12.5: Drug Patent Expiries-2012