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Growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
The global biosimilars market is expected to reach $35 billion by 2020 from the estimated $1.3 billion in 2013, according to a new report by Allied Market Research titled, Global biosimilars/follow-on-biologics market (types, applications and geography)-Size, Share, Global Trends, Company Profiles, Demand, Insights, Analysis, Research, Report, Opportunities, Segmentation and Forecast, 2013–2020. This growth is said to be driven by the deeper penetration of biosimilars in developed and emerging markets as a result of clearer regulatory pathways.
The next four years will see more than 10 blockbuster biologic drugs with annual sales of $60 billion facing patent expiries in Europe and the United States. Biosimilars offer a cost effective alternative for the treatment of chronic disorders. Top pharmaceutical manufacturing brands are repositioning their strategic agendas from approvals to product launches to gain market capitalization.
AMR analysts noted that biosimilars developers have been using emerging markets with less intellectual property protection as their launch pad for established markets. With regulatory framework maturing in established markets, it will be easier for biosimilars manufacturers to quickly enter into such markets, said the analysts, 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. Asia Pacific has emerged as the leader in biosimilars market because of the lower intellectual property rights protection in the region, hence, attracting key players.
According to the report, 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. Nonetheless, companies must constantly watch out for traditional patent infringements that could threaten their business strategies. The follitropins, interferons, and insulin biosimilars are thought to be lucrative segments in the long run. Therapeutic classes such as oncology and autoimmune diseases will gain importance from the biosimilars developers because these products have higher room for growth due to awaited patent expiries during 2014–2019.
The report highlighted Novartis (Sandoz), Synthon Pharmaceuticals, Teva, LG Life Sciences, Celltrion, Biocon, Hospira, Merck Serono (Merck Group), Biogen Idec, and Genentech (Roche Group) as key players that have put developmental strategies in place to gain a competitive edge in the market. These companies are looking to expand in the world markets by focusing on adhering to regulatory guidelines.
Source: Allied Market Research