Global Biosimilars/Follow-on-Biologics Market would reach $35 billion by 2020 from the estimated $1.3 billion in 2013, according to new research published by Allied Market Research.Deeper penetration with clearer regulatory pathways in developed markets and higher efficacy & safety in emerging markets will back the market growth during the forecast period.
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Over 10 blockbuster biologics with annual sales of $60 billion are facing patent expires 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 a 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.
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.
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.
Multi-class combination drugs segment had accounted for more than one-third revenue of the overall HIV drug market in 2015, owing to increase in adoption of combination drugs from this medication class due to their better results in the control of HIV & related coinfections and their ease in consumption & adherence. Increase in the number of HIV infected patients across the globe increases the need for effective treatment for HIV related diseases. Use of Multi-class combination products is an efficient way of treating HIV. Atripla and Prezista are among the blockbuster combination drugs used in the HIV treatment.
North America was the highest revenue contributor in 2015; this is attributed to the awareness about healthcare in the region, higher HIV diagnosis & treatment rate, ample healthcare expenditure, well-established healthcare system, and proactive government initiatives to control the spread of HIV in the North American countries. Gilead, GlaxoSmithKline, Novartis, and Merck & Co. are some of the key players in the North American HIV drugs market. However, Asia-Pacific region is projected to grow with the highest CAGR of 6.3% during the analysis period, due to the presence large HIV patient pool and ample growth opportunities in terms of unmet medical needs for management of HIV in the region. Moreover, increase in focus & investment from leading players in the region support the growth of the HIV drugs market in the Asia-Pacific region.
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