GENERIC DRUGS MARKET ANALYSIS

Market Challenges And Opportunities

Patent expiry of branded drugs is a factor expected to boost growth of the global generic drugs market

Manufacturers of generic drugs are focusing on development and introduction of various innovative medication and formulation such as biosimilars. According to IMS Health data, generic drugs accounted for over 80% of the prescriptions dispensed in the U.S. in 2013. The number of patents expiring in the near future serves to be a major driver for growth of generic drugs market. For instance, Cetuximab (Erbitux) is an epidermal growth factor receptor inhibitor that is indicated in the treatment of metastatic colorectal cancer and head and neck cancer. It is manufactured under the patent by Bristol-Myers Squibb and Eli Lily Company in Europe. The drug’s patent expires in 2018 and thus, is expected to provide opportunity for a large number of market players to manufacture its generic version. Furthermore, supportive initiative by FDA to promote development of biosimilars is encouraging manufacturers to focus towards its development. For instance, the Biologics Price Competition and Innovation Act in the U.S. grants 12 months patent exclusivity with higher profit margins to the first manufacturer than the conventional generic manufacturers bringing the drugs in market later. Various other factors contributing to growth of generic drugs market include rampant growth in incidence of chronic diseases. However, shortage of active pharmaceutical ingredients leading to unavailability of generics in the market and increasing FDA pressure on manufacturers regarding manufacturing quality of these drugs are hindering the market growth.