New York, According to a new market research report published by Global Insight Services “Biosimilars Market” is expected to reach US$ XX bn by 2031. Report includes in-depth segmentation and market size data by categories, product types, applications, and geographies. Report also includes comprehensive analysis of key issues, trends and drivers, restraints and challenges, competitive landscape, as well as recent events such as M&A activities in the market.
Biosimilars are biological products that are approved by the FDA to be highly similar to an already-approved biological product, known as a reference product. Biosimilars are also called subsequent entry biologics (SEBs). Biosimilars can be used to treat the same conditions as the reference product.
The FDA has a pathway for approving biosimilars that meets the requirements of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The pathway includes showing that a biosimilar has the same high level of safety and effectiveness as the reference product. The FDA has approved several biosimilars, and more are in development.
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Key Trends
The biosimilars market is expected to grow significantly in the next few years. The key drivers of this growth include the expiry of patents for biologic drugs, the increasing number of biosimilar products in development, and the growing awareness of biosimilars among patients and healthcare providers.
The number of biosimilar products in development has increased significantly in recent years. In Europe, there are currently more than 100 biosimilar products in clinical development, and this number is expected to grow in the coming years. In the United States, the FDA has approved several biosimilar products, and more are in development.
Key Drivers
The key drivers of the biosimilars market are the expiry of patents for biologic drugs, the increasing prevalence of chronic diseases, and the growing demand for biologic drugs.
The expiry of patents for biologic drugs is the primary driver of the biosimilars market. Biologic drugs are large, complex molecules that are difficult to replicate. As a result, when patents for these drugs expire, there are few companies that are able to produce biosimilars. The increasing prevalence of chronic diseases is also a driver of the biosimilars market. Chronic diseases, such as cancer and diabetes, require long-term treatment with biologic drugs.
Key Market Segments
The biosimilars market bifurcated on the basis of product, application and region. On the basis of product it is segmented into insulin, granulocyte colony-stimulating factor, erythropoietin, and others. By application, it is spread across oncology, blood disorders, growth hormonal deficiency, and others. Region-wise, it is studied across North America, Europe, Asia-Pacific, and rest of the World.
Key Market Players
The biosimilars market report includes players such as Pfizer Inc., Novartis AG, Amgen Inc., Biocon, Samsung Bioepis, Mylan N.V., Viatris Inc., Dr. Reddy’s Laboratories Ltd, Biocad, and Apotex Inc.
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