Cost cutting measures and patent expirations to propel the European generics and biogenerics market

The upcoming spate of patent expirations bodes well for the European generics market. The growing loss of patent protection on blockbuster brands over the next few years, coupled with the rising need to contain spiralling healthcare costs, is set to provide a fillip to market expansion.

Recent analysis by Frost & Sullivan shows that the European generics and biogenerics market is estimated to grow from US$ 10.9 billion in 2003 to US$ 21.2 billion in 2010.

As most European governments strive to reimburse part or all of the cost of prescription medicines, price controls have become integral to containing excess spending. It is estimated that the use of generic products in Europe has yielded an annual cost savings of nearly US$ 25 billion over branded medications in 2003.

The Netherlands and the UK have well-established markets for drugs sold under their generic names. In France, generics have begun to take a firmer hold on the pharmaceuticals market, while in Italy, the development of the market is progressing more slowly.

However, even while the generics and biogenerics market demonstrates great potential, unclear regulatory processes and patent issues are likely to pose a major challenge. This difficulty is likely to be more prevalent in the case of biogenerics that are much more complex formulations compared to the generics.

EU legislation expected to come to force in 2005 is also likely to provide a boost to generic drug production. It is likely that regulatory procedures will be streamlined to speed up the process of approving new generics.

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