In 2009, the combined biosimilars market size for the US and five major European markets was a mere US$150 million. The positive forecast by Datamonitor for 2015 is mainly based on the fact that between 2011 and 2015 more than 30 branded biologicals with sales of US$51 billion will lose their patent exclusivity.

The market analyst company believes that ‘due to their complexity, cost, and development risks’ biosimilar production will be limited to ‘only a handful of pharma companies, all of which are established generics players’. Although electronics giant, Samsung, has perhaps not listened to this advice—with their biosimilars deal with Quintiles announced on 28 February 2011.

Drivers for growth in the biosimilars market include the growing use of biologicals, and the need for more cost-effective treatments. However, there remain a large number of barriers, not least of which is the lack of guidance for the implementation of the biosimilars pathway in the US.

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