Global Biosimilars Market Projected To Expand At A CAGR Of 43.8% During The Forecast Period 2018 – 2023
Biosimilars Market Overview
The global biosimilar market has been estimated at USD 3474.01 million in 2017. The market is expected to register a CAGR of 43.8% during the forecast period, 2018 to 2023. North America accounted for the largest market share, accounting for approximately 30% of the global market share in 2017, while Asia-Pacific region was estimated to register the fastest CAGR through the forecast period, 2018-2023.
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Upcoming Decade to Witness Patent Expiration of Several Biopharmaceuticals
In recent past, several blockbuster biologic drugs of major pharmaceuticals companies expired such as remicade, rituxan, herceptin, Enbrel, lantus and others. In the coming decade, there would be rise in the patent expiration of several existing biological drugs such as Erbitux, Avastin, Orencia and others, which would invite many innovator companies as well as generic manufacturers to offer services specially tailored towards biosimilar. In addition, factors such as cost effectiveness nature of biosimilar, rising acceptance and adoption by various stakeholders with need of diversification in technology and business models drive the global biosimilar market.
Key Developments in the Market
• December 2017: Pfizer received US FDA approval for infliximab biosimilar for all eligible indications
• December 2017: Mylan received US FDA approval for Ogivri, first biosimilar for trastuzumab; co-developed with Biocon
• November 2017: Samsung Bioepis Co Ltd received European Commission marketing approval for Ontruzant, biosimilar for trastuzumab, for the treatment of breast cancer
• November 2017: Samsung Bioepis Co Ltd received approval for Samfenet, a biosimilar for Herceptin to be sold in South Korea
Major Players:
PFIZER inc, ELI LILLY AND COMPANY, CELLTRION HEALTHCARE, MYLAN nv, NOVARTIS AG, SAMSUNG BIOEPIS CO ltd, STADA ARZNEIMITTEL ag, TEVA PHARMACEUTICAL INDUSTRIES ltd, INTAS PHARMACEUTICALS ltd AND LG LIFE SCIENCES
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High Investments and Longer Timelines are needed
Development and manufacture of biosimilar are more complex compared to generics. A biosimilar takes around 7 to 8 years for its development with high financial investments between USD 100 million and USD 300 million which considerably much higher than the USD 1 million to USD 5 million for generic production. In addition, the manufacturing complexity in each step involves a high degree of variability and hundreds of controlling input parameters for safety and efficacy. At the same time, factors such as lack of definitive standards for approval and adequate profitability given the greater risk with concerns regarding substitutability and interchangeability, many companies are discouraged in investing in this market which impedes the growth of biosimilar market.
North America to Dominate the Market Growth
The global biosimilar market is segmented by products class and geography. By geography, it is segmented into North America, Europe, Asia-Pacific, the Middle East and Africa and South America.
North America accounted for the largest market share, accounting for approximately 30% of the global market share in 2017. The market for North America is highly driven by the presence of many large research laboratories such as Sandoz, Amgen, Teva Pharmaceutical and others. According to a recent report, more than 40 biosimilars are under development, including approximately 20 biosimilars ready to be released into the market, and a large number of biosimilar are in pipeline. Asia Pacific is also expected to grow quickly owing to the immense economic developments and rising biotechnology companies in this region.
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