The global biosimilars market size is expected to reach a value of USD 61.47 billion by 2025, according to a new report by Grand View Research, Inc. It is expected to expand at a CAGR of 34.2% over the forecast period. Major biological drugs are approaching the patent cliff. This is the most significant driving factor for the market. For instance, Roche’s MabThera/Rituxan (rituximab), a monoclonal antibody biologics was approved by the U.S. Food and Drug Administration (FDA) in November 1997 and its U.S. patent expired in September 2016. Several companies such as Amgen, Boehringer Ingelheim, and Pfizer are focusing on the development of biosimilar drugs of rituximab.
Furthermore, the lower cost of biosimilars compared to patented biologics and positive outcomes in clinical trials are expected to boost market growth. For instance, in July 2016; Allergan plc and Amgen stated results from a Phase 3 clinical study of ABP 980 compared with trastuzumab, a recombinant DNA-derived humanized monoclonal antibody. This drug was approved for early and metastatic breast cancer and metastatic gastric cancer in many regions. Currently, there is a boom in the pharmaceutical industry for the development of biosimilar drugs, which is a cost-saving alternative to biologic drugs. Amgen Inc.; Sandoz International GmbH; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Biocon; Samsung Bioepis; and Mylan N.V are some of the companies focusing on the development and production of biosimilars.
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Further key findings from the report suggest:
In 2016, the recombinant non-glycosylated protein was the largest revenue-grossing segment in the biosimilars market owing to the prevalence of growth hormone deficiency and diabetes and other chronic diseases
Recombinant glycosylated protein segment is expected to grow at a significant rate during the forecast period owing to demand erythropoietin and monoclonal antibodies for the treatment of cancer and anemia
Oncology accounted for the largest share in the application segment in 2016 due to increasing adoption of low-cost biosimilar drugs for cancer treatment
Europe was the leading regional segment in terms of revenue share in 2016 owing to favorable regulatory policies
North America is expected to witness the highest CAGR during the forecast period owing to the high prevalence of chronic diseases and a rising number of drug approvals
Some of the major players are Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; and Mylan N.V.
Grand View Research has segmented the global biosimilars market on the basis of product, application, and region:
Biosimilars Product Outlook (Revenue, USD Million, 2014 - 2025)
Recombinant Non-glycosylated Proteins
Human Growth Hormones
Granulocyte Colony-stimulating Factor (G-CSF)
Recombinant Glycosylated Proteins
Biosimilars Application Outlook (Revenue, USD Million, 2014 - 2025)
Growth Hormonal Deficiency
Chronic and Autoimmune Disorders
Biosimilars Regional Outlook (Revenue, USD Million, 2014 - 2025)
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