Sales of biologicals have almost doubled from US$63.8 billion in 2006 to US$124.6 billion in 2012.
During this time period, the best selling therapeutic classes have also changed. Back in 2006, erythropoietin biologicals were at the top of the sales league with sales of US$11.9 billion. While in 2012 erythropoietins have dropped to sixth position, with sales of US$7.2 billion, and therapeutic antibodies have taken prime position on the sales leader board. Sales of antibody biologicals accounted for 51.8% of total biologicals sales in 2012 compared to only 34.5% in 2006.
The number of blockbuster biologicals, i.e. products with sales of more than US$1 billion per year, has also increased since 2006. In 2006, there were just 20 blockbuster biologicals, whereas in 2012 this number has increased to 33.
Seven of the top 10 blockbuster biologicals are antibodies, the top selling therapeutic proteins are insulin glargine and pegfilgrastim. The anti-TNF antibody Humira (adalimumab) is the top selling single brand of a recombinant biological; with 2012 sales of US$9.5 billion, see Table 1.
Table 1: Top 10 blockbuster biologicals 2012
The patents on almost all of these biological blockbusters will be expired by 2020, apart from Enbrel (etanercept) where the US patent has been extended to 2028 [2]. Considering just these 10 biologicals, this will open up around US$63 billion in sales to competition from biosimilars. The biosimilars market earned revenue of approximately US$172 million in 2010 and with global sales of biologicals on the rise, this can only increase.
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