Biosimilars Market By Products (Non-glycosylated Proteins, Recombinant Glycosylated Proteins, Others) By Diseases (Oncology, Chronic Diseases, Others) By Type of Manufacturing (In-house/Contract Manufacturing, Others) Regional Analysis & Forecast - 2026

Biosimilars are referred as biological medicines that contain a highly similar version of the active substance of an already approved biologic reference product. A biosimilar is going to use the same mechanism of action as the reference biologic, and its condition of use is the same as the approved indication, although extrapolation is permitted across indications under regulatory guidance. A biosimilar should have a similar route of administration, dosage, and strength as the reference biologic. Biosimilars are synthesized by using biologic components that include monoclonal antibodies, proteins, hormones, nucleic acids, colony stimulating factors, interleukins, and enzymes.

Market Overview

The Global Biosimilar market was expected to be valued at USD xx million in 2018 and is expected to register a CAGR of xx% during the forecast period of 2018-2023. With some of the world’s best-known biologics continuing to face patent expiration forthcoming, the biosimilars market is placed for continued growth. The comparatively easy manufacturing of biosimilars and the license provided to manufacture biosimilars after the expiration of original reference biologic is acting in favor of the global biosimilars market. For instance, Roche’s MabThera/Rituxan (rituximab), a monoclonal antibody 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 drug of rituximab.

In the recent past, numerous blockbuster biologic drugs of major pharmaceuticals companies, including Remicade, Rituxan, Herceptin, Enbrel, Lantus, and others expired. In the coming years, there would be a rise in the patent expiration of many existing biological drugs, including Erbitux, Avastin, Orencia, and others that would provide an opportunity for many innovator companies and generic manufacturers to offer services, specially tailored toward biosimilars.

Market growth is driven by factors that include an increase in demand for biosimilar drugs due to their cost-effectiveness, an increase in incidences of chronic diseases, and strategic collaborations resulting in enhanced productivity and clinical trial activities. Further, the market growth is limited by the high cost of reference products that increases the financial burden on patients and reimbursement service providers. The factor that results in these high costs is the lack in economies of scale due to lower demand. Further, the growth of the biosimilars market is hampered due to the lack of regulatory guidelines, consumer’s brand preferences, the reluctance of physicians to prescribed biosimilars and the high capital required for research and development.

Key Developments

• In May 2018, the FDA approved a biosimilar version of epoetin alfa (Epogen/Procrit), called Retacrit (epoetin alfa-epbx), for treatment of chemotherapy- and kidney disease-associated anemia, as well as for anemia resulting from zidovudine among HIV-positive patients.


• Sandoz’s biosimilar adalimumab, Hyrimoz (adalimumab-adaz) injection was approved in October 2018, and Celltrion’s Truxima (rituximab-abbs), the first biosimilar to be approved in the U.S. for non-Hodgkin lymphoma and the first approved biosimilar to Rituxan, was approved in November 2018.


• January 2019, Ontruzant biosimilar of trastuzumab by Samsum Bioepis which was approved by EMA in 2017 is now approved by the FDA.

Segmentation

The global biosimilars market is segmented based on the product, type of manufacturing, disease, and region.

Products: Non-glycosylated proteins, recombinant glycosylated proteins, and recombinant peptides. The non-glycosylated proteins segment is expected to account for the largest market share, however, recombinant glycosylated proteins hold the largest share of the market during the forecast period.

Type of manufacturing: In-house manufacturing and contract manufacturing. The in-house manufacturing segment was accounting for the largest share. Several players in the biosimilars market prefer the in-house method of manufacturing as they can develop biosimilars in their own laboratories and thus eliminates shipping and delivery costs.

Diseases: Oncology, chronic diseases, blood disorders, growth hormone deficiency, autoimmune diseases, infectious diseases, and other diseases. The blood disorder segment is accounting for the largest share of the market.

Geography: North America, Europe, Asia-Pacific, Middle East & Africa, and South America. The market was dominated by Europe. Europe is also expected for the largest share of the global market during the forecast period. Despite, Asia is expected to witness the highest CAGR from 2018 to 2023.

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.