US and European Prescription Generic Markets

Content

• a. Major International Generics Companies
• b. Multinational R&D Companies' Generic Involvement
• c. Similarities and Contrasts - US and Europe
• 1 Overview of US Generics Industry
  • 1.1 A Brief History
  • 1.2 Market Size and Growth Drivers
    • 1.2.1 Impact of Generic Growth on Branded Companies
    • 1.2.2 Criteria Required for Development of a Generic Market
  • 1.3 Factors That Influence Pricing
  • 1.4 Growth Opportunities and Possible Threats for the Whole Industry
    • 1.4.1 Opportunities - Patent Expiries
    • 1.4.2 Opportunities - Prescription Growth
    • 1.4.3 Threats - Indian Competition
    • 1.4.4 Threats - Reference Pricing
  • 1.5 Growth Strategies and Possible Threats for Individual Companies
    • 1.5.1 Growth Strategies - Moves Upstream - Added Value Products
    • 1.5.2 Growth Strategies - Acquisitions
    • 1.5.3 Growth Strategies - Biogenerics
  • 1.6 Leading Companies
    • 1.6.1 Overseas Presence in the US
      • 1.6.1.1 Overseas Presence - European Companies
      • 1.6.1.2 Overseas Presence - Indian Companies
  • 1.7 Legislative Background
    • 1.7.1 Legislation - Hatch-Waxman
    • 1.7.2 Legislation - Gregg-Schumer
• 2 European Overview - Major Generics Markets
  • 2.1 Origins - Why is the Market so Fragmented?
    • 2.1.1 Historical Background
    • 2.1.2 Requirements for a Healthy Generic Market - European Perspective
  • 2.2 Probable Future Trends
  • 2.3 Major Mature Generic Markets
    • 2.3.1 Germany
      • 2.3.1.1 Market Size and Growth Drivers
      • 2.3.1.2 Factors that Influence Pricing
      • 2.3.1.3 Growth Prospects and Possible Threats
      • 2.3.1.4 Leading Companies
    • 2.3.2 United Kingdom
      • 2.3.2.1 Market Size and Growth Prospects
      • 2.3.2.2 Factors That Influence Pricing
      • 2.3.2.3 Growth Prospects and Possible Threats
      • 2.3.2.4 Leading Companies
    • 2.3.3 Netherlands
      • 2.3.3.1 Market Size and Growth Prospects
      • 2.3.3.2 Factors that Influence Pricing
      • 2.3.3.3 Growth Prospects and Possible Threats
      • 2.3.3.4 Leading Companies
• 3 European Overview - Smaller Generics Markets
  • 3.1 France
    • 3.1.1 Market Size and Growth Drivers
      • 3.1.1.1 Growth History
      • 3.1.1.2 Government Attitudes
      • 3.1.1.3 Future Growth Drivers
    • 3.1.2 Unlocking the Market Potential
      • 3.1.2.1 Changes in Legislation
      • 3.1.2.2 Incentives to Doctors
      • 3.1.2.3 Outcome of Measures to Promote Generics
    • 3.1.3 Factors that Influence Pricing
      • 3.1.3.1 Pricing and Reimbursement System
      • 3.1.3.2 Reference Prices
      • 3.1.3.3 Changes in Distribution Patterns
    • 3.1.4 Growth Prospects and Possible Threats
      • 3.1.4.1 Industry Perspective
      • 3.1.4.2 Possible Concerns
    • 3.1.5 Leading Companies
  • 3.2 Italy
    • 3.2.1 Market Size and Growth Drivers
      • 3.2.1.1 Current Situation
      • 3.2.1.2 Historical Aspects
    • 3.2.2 Unlocking the Market Potential
      • 3.2.2.1 Lack of Generic Incentives
      • 3.2.2.2 Changes in Legislation
    • 3.2.3 Growth Prospects and Possible Threats
      • 3.2.3.1 Co-payment Changes
      • 3.2.3.2 Regional Differences
      • 3.2.3.3 Patent Life Extensions
    • 3.2.4 Leading Companies
  • 3.3 Spain
    • 3.3.1 Market Size and Growth Drivers
      • 3.3.1.1 Current Situation
      • 3.3.1.2 Historical Aspects
    • 3.3.2 Unlocking the Market Potential
      • 3.3.2.1 Lack of Generic Incentives
      • 3.3.2.2 Changes in Legislation
    • 3.3.3 Growth Prospects and Possible Threats
    • 3.3.4 Leading Companies
  • 3.4 Greece, Ireland, Portugal
    • 3.4.1 Market Sizes and Growth Drivers
      • 3.4.1.1 Pharmaceutical Production
      • 3.4.1.2 Total Pharmaceutical Market
      • 3.4.1.3 Generic Markets
      • 3.4.1.4 Growth Drivers
    • 3.4.2 Unlocking the Market Potential
      • 3.4.2.1 Greece
      • 3.4.2.2 Portugal
    • 3.4.3 Leading Companies
      • 3.4.3.1 Portugal
      • 3.4.3.2 Greece
      • 3.4.3.3 Ireland
  • 3.5 Scandinavia
    • 3.5.1 Denmark
      • 3.5.1.1 Market
      • 3.5.1.2 Generic Measures
      • 3.5.1.3 Potential Savings
      • 3.5.1.4 Companies
    • 3.5.2 Finland
      • 3.5.2.1 Market Trends
      • 3.5.2.2 Disputes Over Substitution
    • 3.5.3 Norway
      • 3.5.3.1 Market
      • 3.5.3.2 Companies
      • 3.5.3.3 Pricing
    • 3.5.4 Sweden
      • 3.5.4.1 Generic Market
      • 3.5.4.2 Pricing
    • 3.5.5 Scandinavian Comparison
  • 3.6 US Presence in Europe
• 4 European Legislative Background
  • 4.1 Directive 2001/83/EC
  • 4.2 Directive 2004/27/EC
    • 4.2.1 Legal Definition of a Generic
    • 4.2.2 Prevention of Product Withdrawal
    • 4.2.3 Smoothing Out of Data Exclusivity Periods
    • 4.2.4 New "Bolar" Clause
    • 4.2.5 Mutual Recognition Procedure Difficulties
    • 4.2.6 Overview of Benefits
• 5 US-European Contrasts
  • 5.1 Market Sizes and Fragmentation
    • 5.1.1 US - European Market Size Contrasts
  • 5.2 Price Controls
    • 5.2.1 UK Price Comparisons
  • 5.3 Major Competitors
  • 5.4 Patents and Intellectual Property
    • 5.4.1 Patents
      • 5.4.1.1 European Situation
      • 5.4.1.2 US Situation
    • 5.4.2 Exclusivity - Data or Marketing?
  • 5.5 Regulatory Process
    • 5.5.1 European Difficulties and Solutions
  • 5.6 Parallel Imports
• 6 Generic Strategies and Defences
  • 6.1 What Has Worked in the USA?
    • 6.1.1 Commodities - Distribution
    • 6.1.2 Commodities - Manufacture
    • 6.1.3 Patent Challenges
    • 6.1.4 Speciality and Added Value Products
    • 6.1.5 Expansion Through Acquisition
  • 6.2 What has Worked in Europe?
    • 6.2.1 Commodities
    • 6.2.2 Patent Challenges
    • 6.2.3 First to Launch - the European Way
    • 6.2.4 Speciality and Added Value Products, Biogenerics
  • 6.3 How Multinationals Fight Back - Defensive Tactics
    • 6.3.1 Legal Tactics - US-European Contrasts
    • 6.3.2 Defensive Patent Clusters
    • 6.3.3 API Tactics
    • 6.3.4 Formulation Tactics
    • 6.3.5 OTC Switching
    • 6.3.6 Multinational Involvement in Generics - Authorised Generics
• 7 Summary and Conclusions
  • 7.1 Future trends - Opportunities and Threats
    • 7.1.1 Opportunity - Future Patent Expiries
      • 7.1.1.1 Transatlantic Contradictions
    • 7.1.2 Threat - Market Saturation
  • 7.2 Harmonisation or Divergence?
    • 7.2.1 Are Europe and the US Moving Together or Apart?
    • 7.2.2 Is European Harmonisation Working?
  • 7.3 The Challenge from the East
  • 7.4 Tomorrow's Generic Champions - Who Will They Be?
• 8 Key Company Profiles
  • 8.1 Sandoz
  • 8.2 Teva
  • 8.3 Merck Generics
  • 8.4 IVAX
  • 8.5 Watson
  • 8.6 Ratiopharm
  • 8.7 Mylan
  • 8.8 Alpharma
  • 8.9 Barr
  • 8.10 Ranbaxy
• List of Tables
  • Table 1.1 Key Requirements for a Strong Generic Market
  • Table 1.2 Lipitor Worldwide Prices Comparison
  • Table 1.3 Patent Expiry Dates for Major Products
  • Table 1.4 Dependence of Leading Companies on US Sales
  • Table 1.5 Defects Addressed by Gregg-Schumer Act
  • Table 2.1 Comparison of European Market Environments
  • Table 2.2 Per Capita Pharmaceutical Consumption
  • Table 2.3 Comparison of Generic Market Prospects
  • Table 2.4 German Generic Market Split
  • Table 2.5 European Patent Expiry Dates
  • Table 2.6 Leading German Generic Companies
  • Table 2.7 Leading UK Generic Firms 2004
  • Table 2.8 Leading Dutch Generic Firms 2004
  • Table 3.1 Generic Market Share in French Multi-source Market
  • Table 3.2 Changes in French Distribution Channels
  • Table 3.3 Leading French Generic Firms
  • Table 3.4 Italian Generic Market Share Compared to Other EU Markets
  • Table 3.5 Status of Prerequisites for a Strong Generic Market in Italy
  • Table 3.6 Italian Patent Expiry Dates Compared to the Rest of the EU
  • Table 3.7 Leading Italian Generic Companies 2004
  • Table 3.8 European Pharmaceutical Distribution Channels
  • Table 3.9 Per Capita Consumption - Greece, Ireland, Portugal
  • Table 3.10 Leading Portuguese Generic Companies
  • Table 3.11 Scandinavian Market Sizes
  • Table 3.12 Generic Companies in Norway
  • Table 4.1 Data Exclusivity Period Variations Across Europe
  • Table 5.1 US Market Compared to European Top Five
  • Table 5.2 German prices 1991
  • Table 5.3 UK 5-year Price Comparison 2003
  • Table 5.4 Leading World Generic Firms 2004
  • Table 6.1 Summary of Generic Strategies USA - Advantages and Disadvantages
  • Table 7.1 US-EU Generic Market Contrasts
  • Table 7.2 US-EU Generic Market Similarities
  • Table 7.3 Patent Expiry Dates for Leading World Products 2004
  • Table 7.4 Tomorrow's Generic Champions
• List of Graphs
  • Graph 1.1 Generic Versus Branded Market Share - US
  • Graph 1.2 Annual Value of Major Patent Expiries
  • Graph 2.1 Major European Pharmaceutical Markets 2004
  • Graph 2.2 German Generic Market Split
  • Graph 2.3 International Price Comparison 2003
  • Graph 2.4 Comparison of German and UK Generic Prices
  • Graph 2.5 UK Generic Prescribing Rates 1987-2003
  • Graph 2.6 Dutch Generic Prescribing Rate 2004
  • Graph 3.1 Comparison of Generic Markets Shares 2004 - Southern Europe
  • Graph 5.1 Comparison of Generic Market Shares - US and Europe
  • Graph 5.2 US Market Compared to European Top Five
  • Graph 5.3 Parallel import Market Shares
  • Graph 6.1 NCE Launches 1990 -2003