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Europe is in an era of aging populations and rising health care costs. The use of generic medicines has allowed patients to access safe, effective, high-quality medicines at 20%-80% of the price of branded originator medicines. In this way, generic medicines are supporting the sustainability of health care provision and contribute to controlling pharmaceutical expenditure. Competition from generic medicines is also inciting originator companies to develop innovative medicines and reduce prices of off patent originator medicines, thus generating additional savings to patients.
A generic drug is a copy that is the same as a brand-name drug in dosage, safety, strength, how it is taken, quality, performance and intended use. A generic drug is marketed in compliance with international patent law. It is identified either by its internationally approved non-proprietary scientific name (INN) or by its own brand name. In most cases, generic products are not available until the patent protections afforded to the original developer have expired.
In recent years, the European generic drugs markets have experienced dramatic changes. The business environment has become significantly more complex, and generic pharmaceutical companies are becoming increasingly international. To excel, companies must seek out the best conditions for developing, manufacturing and marketing their products. And they must work with governments to create this environment.
The fragmented nature of the European generics market is partly a reflection of the geographical distinctions present within the region. However, it is also a reflection of the differences in social standards and development in Europe, which has generated a range of markets reflecting the local market drivers. While the European Union has attempted to bring a measure of consistency to the market in the form of the European pharmaceutical directive, member states have individual regimes adapted to their individual economic and healthcare needs, with a resultant complex pricing, regulation and reimbursement regime.
This report on the European Generic Drugs Market starts off with a focus on generic drugs on a broad scale – analysis in this section deals with what are generic drugs, their benefits, patents issues, etc. Moving on, we take a look at the development of the generic drugs market throughout history, leading on the analysis of the European generics market. Further, the report looks at healthcare spending in Europe, trends affecting the market such as pricing and patent issues, patient co-payment, and many others. The emergence of biosimilars of generic biologics is also discussed in the report. Regulatory policies governing the European generics market and the pharmaceutical market in Europe are also discussed, including supply side and demand side policies, along with market entry policies for generic medicines, policies governing the pricing of generic medicines, and others. Following all this is a country-wise analysis of the leading European generics markets. Profiles of the major companies actively competing in this industry are included in the report as well.
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Table of Contents
Executive Summary 5
Introduction to Generic Drugs 7
What are Generic Drugs? 7
Benefits of Low-priced Generic Drugs 7
Patent Issues facing Generic Drugs 8
Production of Generic Drugs 8
Prevention of Generic Competition 9
Exclusivity of Generic Drugs 9
Regulatory and Approval Process of Generic Drugs 10
Generics Market Evolution – A Historical View 11
Analysis of the European Market 13
Overview of the European Generics Market 13
Healthcare Spending in Europe 14
Buyers of Generics and Pricing Trends 16
Patient Co-payments and Relation to Price 17
Prescribing of Generics and Generic Substitution 18
Consolidation in the Industry 18
Emergence of Biosimilars of Generic Biologics 19
Future Outlook 20
Drivers Impacting Growth of Europe’s Generics Market 21
Strong Sector Performance 21
Increased M&A Activity 22
Upcoming Product Patent Expirations 23
Changing Demographics of the Population 24
Challenges and Risks Facing the Industry 25
Policies and Regulatory Framework 27
Overview 27
Supply Side Policies 27
Demand Side Policies 28
Market Entry Policies for Generic Medicine 28
Pricing of Generic Medicines 29
Incentive Policies for Generic Medicines 30
For Physicians 30
For Pharmacists 31
For Patients 32
Country-Wide Analysis 33
Austria 33
Belgium 34
Bulgaria 36
Denmark 38
France 39
Germany 41
Italy 44
Portugal 45
Spain 47
The Netherlands 48
Poland 50
United Kingdom 52
Major Players in the Industry 54
Actavis 54
Amgen Inc. 55
Barr Pharmaceuticals, Inc. 56
Baxter International 57
Biogen Idec 59
Eli Lilly and Company 61
Fresenius Medical Care 63
Gedeon Richter 65
Genzyme 66
Hikma Pharmaceuticals 68
Johnson & Johnson 69
Lupin Ltd 71
Merck & Co. 71
Mylan Laboratories Inc. 73
Novartis AG 74
Novo Nordisk 75
Pfizer 77
Ranbaxy Laboratories Limited 78
Roche Holding 80
Schering-Plough 82
Stada Arzneimittel 83
Sun Pharmaceuticals Industries Limited 84
Zentiva 85
Appendix and Glossary 86
List of Figures and Tables
Figure 1: Active and Inactive Citizens in Europe (in millions) 15
Figure 2: EU Healthcare Spending & Use of Medicines by Age Group 15
Figure 3: Setting Generic Price Levels in EU 17
Figure 4: European Generic Penetration by Country 21
Figure 5: Upcoming Worldwide Patent Expiries 23
Figure 6: Oil Price Expectations 25
Figure 7: Market Share of Generic Drugs in Austria 33
Figure 8: Market Share of Generic Drugs in Belgium 35
Figure 9: Market Share of Generic Drugs in Denmark 38
Figure 10: Market Share of Generic Drugs in France 40
Figure 11: Market Share of Generic Drugs in Italy 44
Figure 12: Market Share of Generic Drugs in Portugal 45
Figure 13: Market Share of Generic Drugs in Spain 47
Figure 14: Market Share of Generic Drugs in Netherlands 49
Figure 15: Market Share of Generic Drugs in Poland 51
Figure 16: Market Share of Generic Drugs in United Kingdom 52
Figure 17: Pharmaceutical Spending and Generic Share in US & Western Europe (2006) 86
Figure 18: Pharmaceutical Spending and Generic Share in Central & Eastern Europe (2006) 86
Figure 19: Pharmaceutical Spending and Generic Share in Northern Europe (2006) 87
Figure 20: Upcoming Patent Expiries in Germany, the UK, France and Italy (€ million) 87
Figure 21: Top 15 Pharmaceuticals Markets by Value (2006) 88
Table 1: European Healthcare Markets by Country in 2006 14
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