Biosimilars could account for 2.6% of biological market by 2016, forecasts URCH

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 US law by 2012, notes the market strategy report 'Biosimilars: A Growing Market - An overview of developments, companies and commercial opportunities.'

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. A separate report form Frost & Sullivan has estimated that biosimilars markets in Europe and the USA have the potential to generate sales of $16.4 billion by 2011. Today, branded biopharmaceuticals account for between 10% and 15% of the world pharmaceutical market, with sales in the USA alone now reaching around $60 billion

Of the developed regions, only Europe has an established regulatory approval system for biosimilars. In Japan, draft guidelines were published in September 2008. In November of that year, Kissei Pharmaceutical filed an application for an erythropoietin product as Japan's first biosimilar. An approval pathway for biosimilars is still under discussion in the USA, but this is one of the elements of the country's just passed health care reform, and contains provisions for a 12-year exclusivity that has been won by the biotechnology industry (The Pharma Letters passim),