Biosimilars to account for 2.6% of biological market by 2016
US regulatory resistance holding market back, says Urch report
Biosimilars will account for 2.6% of the biological market by 2016, forecasts a new report from URCH Publishing. However, this assumes that biosimilars will be permitted under US law by 2012.
Biosimilars: A Growing Market – An overview of developments, companies & commercial opportunities says the biosimilars market is poorly developed but is widely expected to become significant over the next few years, capturing a healthy percentage share of the biologicals market. Few companies apart from Novartis have yet clearly developed strategies to compete in the biosimilars market, the report finds.
Assuming a US regulatory pathway is approved by 2012, the value of the biosimilars market will continue to be dominated by European sales, and this is likely to account for about 0.6% of the fast-growing market.
By 2016 this share should have grown to 2.6%, with the US overtaking Europe as the leading source of revenues from such products. The greater opportunities after 2016 should see substantial increases in the sales of biosimilars and by 2020 the segment may command a 10% share of the total value of the biologicals market.
However, the report’s author Dr Peter Norman warns against over-confidence about this new market. ‘Many forecasts relating to the development of the biosimilars market seem over-optimistic, and appear to assume a rapid resolution of the legislative impasse in the US with respect to the approval of biosimilars, and overlook the strength of Amgen’s patent position with respect to epoetin alfa,’ he said.
The expiration of patents on key products from 2010–2020 should provide major commercial opportunities for companies that successfully develop biosimilars of these products, the report says.