Fifty-eight biopharmaceuticals were approved by the US and the EU from January 2006 to June 2010. These include 30 hormones, growth factors and other regulatory molecules; 13 mAb-based products; four blood-related proteins; two subunit vaccines; and nine other biopharmaceuticals, including fusion proteins and therapeutic enzymes. Twenty-five of these products were new biopharmaceuticals, as opposed to biosimilars or products that had been previously approved elsewhere in another region. Just 21% of new approvals in the US and 18% of new approvals in the EU were genuinely new. The number of new biological entities (NBEs) that have been approved over the past few years is significantly lower than previous times. Few of those that were approved are likely to be blockbusters, as many are for rare or orphan indications. The most common blockbusters are mAb-based products for treating cancer and anti-tumor necrosis factor alpha antibodies, which each produced $18 billion in sales in 2009. The next-largest product group, insulin and insulin analogs, together had $13.3 billion in sales. EPO-based products accounted for $9.5 billion in sales. The 2009 global pharmaceuticals market was $99 billion.

Source: Nature Biotechnology