ジェネリック医薬品の将来の拡大機会

Abstract

The number of commercially lucrative drugs coming off patent has catalyzed the growth of the generics industry, creating significant profit opportunities for generics manufacturers. However, this market faces a considerable number of threats, with bulk manufacturers from developing countries becoming internationally competitive and the aggressive actions of branded pharmaceutical marketers in protecting their patent and market position resulting in ramifications for the sector as a whole. Future Growth Opportunities in Generics provides an in-depth analysis into the direction of the global generics market, evaluating competitive dynamics through a detailed review of major consolidation activity in the sector. Opportunities for future success are also explored, including the potential offered by biosimilars and the increasing focus by governments on healthcare cost containment, enabling you to determine the factors crucial to your success in the global generics market.

Table of Contents

Executive Summary

• Generics growth opportunities and branded defense strategies
• Generics market analysis by country and region
• Generics market analysis by therapeutic area
• Leading generics players
• Consolidation in the generics industry

Chapter 1 Generics growth opportunities and branded defense strategies

• Summary
• Introduction
• Key generics growth opportunities
• Availability of off-patent treatments and paragraph IV challenges
• Healthcare cost containment policies
• The biogenerics/biosimilars opportunity
• Mergers and acquisitions
• Defense strategies from branded companies
• Rx-to-OTC switching
• Defensive pricing
• Patent litigation
• Reformulation
• Authorized generics agreements and settlements
• Launching in-house generics

Chapter 2 Generics market analysis by country and region

• Summary
• Introduction
• Regional generics market analysis
• North American market
• Major markets of Latin America
• Major European markets
• Major markets of Central and Eastern Europe
• Japanese market
• Chinese market
• Selected markets in the Asia-Pacific region

Chapter 3 Generics market analysis by therapeutic area

• Summary
• Introduction
• Market breakdown by therapeutic area
• CNS disorders market analysis
• Cardiovascular diseases market analysis
• Alimentary tract and metabolism market analysis
• Cancer market analysis
• Anti-infectives market analysis
• Therapy area forecasts

Chapter 4 Leading generics players

• Summary
• Introduction
• Key players in the global generics market
• Performance of major generics companies by region
• Company portfolio analysis
• Novartis
  • Marketed product portfolio
  • Forecast sales
• Teva
  • Marketed product portfolio
  • Forecast sales
• Mylan
  • Marketed product portfolio
  • Forecast sales
• Ratiopharm
  • Marketed product portfolio
  • Forecast sales
• Watson
  • Marketed product portfolio
  • Forecast sales
• Merck KGaA
  • Marketed product portfolio
  • Forecast sales
• Ivax
  • Marketed product portfolio
  • Forecast sales
• Apotex
  • Marketed product portfolio
  • Forecast sales
• Par
  • Marketed product portfolio
  • Forecast sales
• Alpharma
  • Marketed product portfolio
  • Forecast sales

Chapter 5 Consolidation in the generics industry

• Summary
• Introduction
• Factors influencing M&A deals across markets
• Key deals in emerging markets
• Dr. Reddy' s
  • Betapharm acquisition
  • Roche' s API facility acquisition
  • Trigenesis acquisition
• Ranbaxy
  • Mundogen acquisition
  • Ethimed acquisition
  • Terapia acquisition
• Egis
  • Serdix acquisition
• Zentiva
  • Sicomed acquisition
• Key deals in Western Europe
• Sandoz/Novartis
  • Sabex acquisition
  • Hexal/Eon acquisition
• Stada Arzneimittel
  • Hemofarm acquisition
  • Nizpharm acquisition
  • Other acquisitions
• Ratiopharm
  • Magnafarma BV acquisition
  • Pulmotec acquisition
  • Ribosepharm acquisition
• Merck KGaA
  • Prasfarma acquisition
  • NM Pharma acquisition
• Actavis
  • Alpharma acquisition
  • Amide acquisition
  • Sindan acquisition
  • Keri Pharma acquisition
• Key deals in the US
• Watson
  • Amarin acquisition
  • Sekhsaria acquisition
  • Andrx acquisition
• Barr
  • Pliva acquisition
• Mylan
  • Matrix Labs acquisition
• Perrigo
  • Agis acquisition
• Other key deals
• Teva
  • Ivax acquisition
• Conclusions

Chapter 6 Appendix

• Glossary
• Index

List of Figures

• Figure 1.1: Generics company growth strategies
• Figure 1.2: Number of ANDA and first-to-file approvals, 2001-2006
• Figure 1.3: Average monthly ANDA and first-to-file approvals, 2001-2006
• Figure 1.4: Pharmaceutical cost containment policies in developed and developing markets
• Figure 2.5: Market dynamics in the global unbranded generics market by country, 2004-05
• Figure 3.6: Market breakdown of the major therapy classes in the global unbranded generics market, 2001 & 2005
• Figure 3.7: Market dynamics of the major CNS unbranded generics, 2005
• Figure 3.8: Market dynamics of the major cardiovascular unbranded generics, 2005
• Figure 3.9: Market dynamics of the major alimentary tract and metabolism generics, 2005
• Figure 3.10: Market dynamics of the leading cancer unbranded generics, 2005
• Figure 3.11: Market dynamics of the leading anti-infectives unbranded generics, 2005
• Figure 4.12: Performance of major players in the global generics market, 2001 & 2005
• Figure 5.13: Factors shaping M&A deals across the US, EU and emerging markets
• Figure 5.14: Key generics M&A by region, 2004-06
• Figure 5.15: Competitive pressures influencing generics M&A strategies, 2005-06

List of Tables

• Table 2.1: Sales of unbranded generics by country, 2004-05
• Table 2.2: Sales of unbranded generics in North America, 2004-05
• Table 2.3: Sales of unbranded generics in Latin America, 2004-05
• Table 2.4: Sales of unbranded generics in major Western European markets, 2004-05
• Table 2.5: Sales of unbranded generics in major Central and Eastern European markets, 2004-
• Table 2.6: Sales of unbranded generics in Japan, 2004-05
• Table 2.7: Sales of unbranded generics in China, 2004-05
• Table 2.8: Sales of unbranded generics in Asia-Pacific, 2001-05
• Table 3.9: Sales by major therapeutic area across the global unbranded generics market, 2004-
• Table 3.10: Sales of major molecules in the global CNS unbranded generics market, 2004-05
• Table 3.11: Sales of major molecules in the global cardiovascular unbranded generics market, 2004-05
• Table 3.12: Sales of major molecules in the alimentary tract and metabolic disorders global unbranded generics market, 2004-05
• Table 3.13: Sales of major molecules in the global cancer unbranded generics market, 2004-05
• Table 3.14: Sales of major molecules in the global anti-infectives unbranded generics market,2004-05
• Table 3.15: Forecast global unbranded generics sales by therapy area, 2005-11
• Table 4.16: Leading ten generics companies by global unbranded generics sales, 2004-05
• Table 4.17: Leading generics companies by global generics sales, 2004-05
• Table 4.18: Leading products in Novartis' generics portfolio, 2004-05
• Table 4.19: Forecast sales of Novartis' current generics portfolio, 2005-2011
• Table 4.20: Leading products in Teva' s generics portfolio, 2004-05
• Table 4.21: Forecast sales of Teva' s current generics portfolio, 2005-2011
• Table 4.22: Leading products in Mylan' s generics portfolio, 2004-05
• Table 4.23: Forecast sales of Mylan' s current generics portfolio, 2005-2011
• Table 4.24: Leading products in Ratiopharm' s generics portfolio, 2004-05
• Table 4.25: Forecast sales of Ratiopharm' s current generics portfolio, 2005-2011
• Table 4.26: Leading products in Watson' s generics portfolio, 2004-05
• Table 4.27: Forecast sales of Watson' s current generics portfolio, 2005-2011
• Table 4.28: Leading products in Merck KGaA' s generics portfolio, 2004-05
• Table 4.29: Forecast sales of Merck KGaA' s current generics portfolio, 2005-2011
• Table 4.30: Leading products in Ivax' s generics portfolio, 2004-05
• Table 4.31: Forecast sales of Ivax' s current generics portfolio, 2005-2011
• Table 4.32: Leading products in Apotex' s generics portfolio, 2004-05
• Table 4.33: Forecast sales of Apotex' s current generics portfolio, 2005-2011
• Table 4.34: Leading products in Par' s generics portfolio, 2004-05
• Table 4.35: Forecast sales of Par' s current generics portfolio, 2005-2011
• Table 4.36: Leading products in Alpharma' s generics portfolio, 2004-05
• Table 4.37: Forecast sales of Alpharma' s current generics portfolio, 2005-2011