Generic biologics forecast to enter the US market by 2008
Despite inevitable legal disputes and the high cost of manufacturing, several generic biologics players are poised to enter the US marketplace, says a new report from Californian life sciences market consultancy Front Line Strategic Consulting.
Despite inevitable legal disputes and the high cost of manufacturing, several generic biologics players are poised to enter the US marketplace, says a new report from Californian life sciences market consultancy Front Line Strategic Consulting.
According to 'Generic Biologics: A Strategic Market Outlook and Business Analysis', the imminent approval of generic biologics by the FDA, along with a positive response to Sandoz's generic somatropin by the EMEA, is triggering alarm from brand innovators, such as Amgen and Genentech.
Front Line notes that a number of first-mover generic companies, such as Dragon, BioGenerix, and STADA, are planning to produce generic biologics that have large existing markets. Recombinant human insulin and erythropoietin are projected to account for 27% and 36% of the biogenerics market respectively by 2010. The least complex biologics, such as insulin and somatropin, are likely to gain generic FDA approval by 2005, encouraging some companies to prepare for this entry date, the report says.
According to Front Line's research and analysis, the value of the generic biologics market will reach an estimated US$30m (€25.6m) worldwide in 2003, and nearly $12bn (€10.3bn) in 2010, given certain assumptions regarding the development of a regulatory approval process in the US, price discounts, and market penetration.
However, growth could be hindered, by price erosion due to generic competition, complications with biologics manufacturing, and the introduction of superior, second-generation brand products.