Global Biosimilars Market (Follow-on-Biologics) by Types (Human growth hormone, Erythropoietin, Monoclonal antibodies, Insulin, Interferon, Granulocyte-Colony Stimulating Factor, Peptide), Application (Blood disorders, Oncology diseases, Growth hormone deficiencies) is projected to grow at a CAGR of 49.1% from 2015 to 2020, according to new research published by Allied Market Research.
Portland, OR -- (SBWIRE) -- 07/06/2017 -- Biosimilars or follow-on-biologics are the "copied" and licensed versions of those reference biologics that have undergone patent expiration. Biosimilars development and validation with reference biologics is a crucial aspect of the overall development process. Regulations for biosimilars play a vital role in maintaining the viability and balance between original and biosimilars products. Various regulatory authorities such as EMA and FDA actively regulate the biosimilars commercialization and development.
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Recent approval of Zarxio (filgrastim-sndz) as first biosimilar by U.S. FDA has opened new opportunities for biosimilar manufactures. Patents for 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 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 crucial role in commercial growth of 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 Global Biosimilars Market:
1. The biosimilar applications in blood disorders and oncology collectively evaluated at 61% in 2014
2. Interferon is fastest growing biosimilar, expected to grow at a CAGR of 51.1% during the forecast period
3. U.S. would find space in biosimilar market with single-digit revenue share of overall biosimilar market by 2020
European region is the leading beneficiary of biosimilars market and is attracting investors, interested in 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 into 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 United States, the investors are now focusing on this region to boost their prospects.