The 60 page publication says that the biosimilars market segment is poorly developed.
(1888PressRelease) March 25, 2010 - The value of the biosimilars market segment will account for 2.6% of the biological market by 2016, forecasts a new report from URCH Publishing. However, this forecast assumes biosimilars become permitted under U.S. law by 2012, notes the market strategy report "Biosimilars: A Growing Market - An overview of developments, companies & commercial opportunities".
The 60 page publication says that the biosimilars market segment is poorly developed but is widely expected to become a significant commercial segment over the next few years, capturing a healthy percentage share of the biologicals market.
Assuming a passing of US legislation by 2012, the value of the biosimilars market segment will continue to be dominated by European sales revenues in 2012, and this is likely to account for about 0.6% of the fast-growing biologicals 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 this 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.
Analysis in the study shows that the key patents for most of the leading biological products will expire in the period between 2012 and 2017. In Japan the later approval dates of many leading biological products will result in much later expiration of market exclusivity then elsewhere once patent-term restoration has been applied to the key patents. The expiration of patents on key products in the period from 2010 to 2020 should provide major commercial opportunities for companies that successfully develop biosimilars of these products.
The anti-TNF segment offers the best commercial opportunity for biosimilars, with the three leading products all likely to face competition from biosimilars in Europe and/or the US by 2016, with such products emerging in 2014, says the report.
Biosimilars: A Growing Market - An overview of developments, companies & commercial opportunities is available from URCH Publishing.
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