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-wide 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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93 pages

Publication Date : February 2008