Over 10 blockbuster biologics with annual sales of $60 billion are facing patent expiries in Europe and in the U.S. during the next four years. Top pharmaceutical manufacturing brands are repositioning their strategic agendas from approvals to product launches to gain market capitalization. "Biosimilars developers have been using emerging markets with less intellectual property protection as their launch pad for established markets" say AMR analysts. "With regulatory framework maturing in established markets, it will be easier for biosimilars manufacturers to quickly enter into such markets" analysts added, citing collaboration between Mylan and Biocon to commercialize biosimilar of trastuzumab in India and the approval of first biosimilar version of monoclonal antibody drug by Hospira in Europe. Due to lower intellectual property rights protection and higher activity of regional players, the Asia Pacific region has emerged as the leader in biosimilars market.
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Biosimilars as a cost effective alternative provides room for economical biopharmaceutical medications for chronic disorders that are rampant around the globe. The widespread chronic disorders and the need for cost effective medication is driving the biosimilars commercialization. The strategic collaborations for global expansion, especially for the high potential segments such as monoclonal antibodies (mAbs) and erythropoietin will be key to the market growth; however, the strategies are persistently threatened by traditional patent-infringements. Key product segments such as follitropins, interferons, and insulin biosimilars will emerge lucrative segments in the long run. Certain therapeutic classes such as oncology and autoimmune diseases will gain importance from the biosimilars developers as these classes will have higher room for growth due to awaited patent expiries during 2014 - 2019.
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AMR analysis suggests that Erythropoietin biosimilars are the most promising products, anticipating substantial revenue generation from patented biologics. Granulocyte colony-stimulating factor biosimilars are following erythropoietin in terms of revenue generation during the forecast period. Biosimilars in oncology disorders are currently dominating the market due to high-priced patented drugs such as erythropoietin and monoclonal antibodies that are largely used in the oncology treatments. However, biosimilars for chronic and autoimmune diseases and blood disorders are the fastest growing applications and expecting a salutary growth during the analysis period.
Key biosimilars developers such as Novartis (Sandoz), Synthon Pharmaceuticals, Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen idec, Inc. and Genentech (Roche Group) have adopted approval and clinical trials as key developmental strategies to gain competitive edge in the pharmaceuticals market. These firms are also focusing on adhering to regulatory guidelines to expand in the world markets.
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