Biosimilars market growing rapidly with a CAGR of 49.1% by 2020 | Top 5 players are Novartis (Sandoz), Synthon Pharmaceuticals Inc., Teva Pharmaceutical Industries Ltd., LG Life Sciences
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Europe would continue to dominate the market while the Asia Pacific would emerge as the fastest growing region over the forecast period.
The recent approval of Zarxio (filgrastim-sndz) as the first biosimilar by U.S. FDA has opened new opportunities for biosimilar manufacturers. Patents for a number of blockbuster bio-pharmaceuticals have either expired or are on the verge of expiration, which is majorly driving the growth of biosimilars industry. Changes in regulatory guidelines and convenient biosimilar drug approval processes have a major impact on the commercial growth of the global biosimilars market.
However, the high investment associated with research and development, longer development processes and requirements of economies of scale for profitability largely limit the growth of biosimilars market. The integration of developmental plan with regulatory guidelines and the adoption of optimal commercial strategies would play a crucial role in the commercial growth of the biosimilars market.
Glycosylated proteins namely, erythropoietin and monoclonal antibodies are the leading biosimilar segments commercially available across the globe, together accounting for about one-third of the market revenue in 2014. This significant hold in the market is chiefly due to its large application in the treatment of chronic conditions such as blood-related disorders, cancer, among others.
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Key findings of the Global Biosimilars Market:
• The biosimilar applications in blood disorders and oncology collectively evaluated at 61% in 2014
• Interferon is fastest growing biosimilar, expected to grow at a CAGR of 51.1% during the forecast period
• The U.S. would find space in the biosimilar market with a single-digit revenue share of overall biosimilar market by 2020.
The European region is the leading beneficiary of the biosimilars market and is attracting investors, interested in the biosimilars industry. The prospects in the European region are largely supplemented by the presence of streamlined regulatory guidelines and a high level of adoption for biosimilars among physicians. The establishment of favorable regulations such as Article 10(4) of Directive 2001/83/EC by the European Medical Association (EMA) has clarified the clinical aspect of biosimilars.
This standard set by EMA has attracted investors to invest in the development of biosimilars. The Asia-Pacific region projects the fastest growth rate, supplemented by the high prevalence of chronic diseases and the growing demand for economic bio-pharmaceuticals. The commercial scenario of biosimilars in North America is bleak due to the absence of regulations for approval and commercialization. However, after the launch of the first biosimilar in the United States, the investors are now focusing on this region to boost their prospects.
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