Global Generics Industry Report

Summary

The global generics market has grown at a rate of 20% in 2005; which is four times that of patented drugs and over three times that of pharmaceutical market. It is estimated to grow at a CAGR of 13.62% during the five-year period 2006-10. The market growth has been triggered by the rising number of patent expiries of blockbuster drugs and increasing healthcare expenditure. The US has the largest generics market and account to 44% of the global generics market. Teva Pharmaceuticals, based in Israel is the market leader in this industry followed by Sandoz

Scope Of The Report

This report discusses in detail about the major generic markets while giving information on their market size, recent trends, major players (15 major generic companies have been profiled with information on their business and financial profile, key strategies, R&D pipeline and outlook for the company.), generics pricing and outlook for the market. The report also analyses the factors that drive the growth of the generics industry, Overview of the generics industry in terms of size, geographical and therapeutic segmentation., Top 10 products in world's largest generics market, Issues & Challenges, Critical success factors, Growth Drivers, Mergers & Acquisitions, Major Markets( North America, Europe and Asia Pacific), Emergence of India as an important player in global generics industry, Amount & Area of R&D spend of major generic companies, Regulations governing generics, key patent expiries in the future, Outlook for the global generics industry for the next five years, FOR WHOM - , Lifesciences companies (Bulk drugs, Formulations and Biopharma), Govt departments & agencies working in Pharma, Consultants, Associations & Consortia of the industry, Research Institutions, Education Institutes, No of Pages : 127, List of Tables : 14, List of Figures : 32

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 Therapeutic segmentation
  • 3.5 Ethical vs. OTC generics
  • 3.6 Top 10 products in world's largest generics market
  • 3.7 Major generic companies
• 4. Industry Trend
  • 4.1 Mergers and Acquisitions
  • 4.2 Patent challenges
  • 4.3 Regulatory changes
• 5. Major Markets
  • 5.1 North America
  • 5.2 Europe
  • 5.3 Asia Pacific
• 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
• 8. Research And Development
  • 8.1 R&D spend of 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
• 10. Major Players
  • 10.1 Teva Pharmaceutical Industries
  • 10.2 Sandoz
  • 10.3 Merck KgaA
  • 10.4 Ratiopharm
  • 10.5 Watson Pharmaceuticals
  • 10.6 Mylan Laboratories Inc
  • 10.7 STADA Pharmaceuticals
  • 10.8 Pliva
  • 10.9 Ranbaxy Laboratories
  • 10.10 Barr Pharmaceuticals Inc
  • 10.11 Andrx Corporation
  • 10.12 Hexal AG
  • 10.13 Cipla
  • 10.14 Actavis
  • 10.15 Dr. Reddy's Laboratories Limited
• 11. Critical Success Factor
  • 11.1 Biogenerics
  • 11.2 Outsourcing
  • 11.3 Venturing into "difficult to make" generics
  • 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 Expiries - 2006-09
• 13. Outlook
• Annexure I
• Annexure Ii
• List Of Figures
  • Figure 3.1: Global generics market - 2001-05 (USD bn)
  • Figure 3.2: Pharmaceutical market vs Generics and Patented drugs growth rate - (2003-05)
  • Figure 3.3: Geographical segmentation of global generics market - 2005
  • Figure 3.4: Therapeutic segmentation of global generics market 2005
  • Figure 3.5: Ethical vs. OTC generics - 2005
  • Figure 3.6: Top 10 generic drugs in the US by value - 2005
  • Figure 3.7: Top 10 generic players by revenue- 2005 (USD bn)
  • Figure 4.1: M&A in global generics market - 2004-06 (USD bn)
  • Figure 4.2: Number of Para IV filings in USFDA - 2004-06
  • Figure 5.1: US generics market - 2001-05 (USD bn)
  • Figure 5.2: Canada generics market - 2001-05 (USD bn)
  • Figure 5.3: Germany generics market - 2001-05 (USD bn)
  • Figure 5.4: UK generics market - 2001-05 (USD bn)
  • Figure 5.5: France generics market - 2001-05 (USD bn)
  • Figure 5.6: Italy generics market - 2001-05 (USD m)
  • Figure 5.7: Spain generics market - 2001-05 (USD m)
  • Figure 5.8: Japan generics market - 2001-05 (USD bn)
  • Figure 5.9: China generics market - 2001-05 (USD bn)
  • Figure 5.10: India generics market - 2001-05 (USD bn)
  • Figure 5.11: Indian DMF submissions in the US - 2001-05
  • Figure 5.12: Indian ANDA approvals - 2001-05
  • Figure 6.1: Patent expiries by value - (2005-10) (USD bn)
  • Figure 6.2: Healthcare expenditure as a % of GDP
  • 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 (2000-2025)
  • Figure 7.1: Generics pricing - The market scenario
  • Figure 7.2: Generics competition and drug prices
  • Figure 8.1: Top generic players by R&D spend- 2005 (USDm)
  • 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 spend as a percentage of sales of major generic players - 2005
  • Figure 13.1: Global generics market - 2006-10 (USD bn)
• List Of Tables
  • Table 4.1: Key M&A in global generics industry - 2004
  • Table 4.2: Key M&A in global generics industry - 2005
  • Table 4.3: Key M&A in global generics industry - 2006 (Jan-Jun'06)
  • Table 5.1: Top 5 generic companies in the US (MAT June 2006)
  • Table 5.2: Key M&A by Indian companies in the recent past
  • Table 5.3: Major players in India
  • Table 6.1: Cost comparison - Branded vs. Generic drugs
  • Table 7.1 List of authorized generics launched in the past
  • Table 7.2: Companies that used 6 months paediatric exclusivity in the past
  • Table 11.1: Key biopharmaceutical patent expiries - 2006
  • Table 12.1: Key Patent expiries 2006
  • Table 12.2: Key Patent expiries 2007
  • Table 12.3: Key Patent expiries 2008
  • Table 12.4: Key Patent expiries 2009