US and European Prescription Generic Markets: An Examination of Commercial and Regulatory Contrasts


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Publication Date: July 2005

Pages: 196

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The US generics market was estimated at US$18.1 billion in 2004; the leading European generics markets together totalled between US$10-US$11 billion for the same period. This new report asks why there is such a difference in value?

Contrasts in regulatory systems, legislative background and market characteristics increase the difficulties for companies from one area who are trying to enter another market. US and European Prescription Generic Markets reviews these divergent characteristics and also looks at those areas where the two sides are moving closer together.

One major finding that emerges from this analysis is the surprising absence of the majority of US domestic generic companies from overseas markets. The report contrasts this with the increasing presence of foreign generic companies in the US, looks at where these new competitors have come from and assesses how much of a threat they represent to the major US companies.

US and European Prescription Generic Markets provides an in-depth examination of:

  • Successful generic growth strategies and how they vary
  • Defensive tactics of the multinationals
  • Generic industry growth prospects and possible threats
  • A history of the generic markets
  • The legislative and regulatory background
  • How differences between the US and European markets have developed
  • Who are the major players and how they rose to the top

 

Table of Contents

 

Foreword
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
1 Sandoz
2 Teva
3 Merck Generics
4 IVAX
5 Watson
6 Ratiopharm
7 Mylan
8 Alpharma
9 Barr
10 Ranbaxy

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

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