Biosimilars Market

Report Overview

The global biosimilars market was pegged at US$ 15.1 billion in 2021 and is expected to witness a CAGR of 21.5% during the forecast period.

Market Fundamentals 

Biosimilar products are used for treatment, cure, prevention, or diagnosis of several conditions such as diabetes, kidney diseases, autoimmune disorders, and various types of cancers. These are derived from living organisms, such as plant cells, animal cells, and microorganisms. Biosimilars are identical in terms of potency, purity, and safety. The minor difference between the reference product and biosimilar is the clinically inactive compounds used in the making of biosimilars whereas the active compound (API) remains the same. Major approved biosimilars include monoclonal antibodies, vaccines, and therapeutic proteins. The prices of biosimilars are decreasing by each year owning to market competition. 

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Market Dynamics

The global biosimilars market is mainly driven by their cost-effectiveness and rising prevalence of chronic diseases such as cancer, diabetes, and rheumatoid arthritis. Also, globally increasing geriatric population also fueling the market growth. An increasing number of pipeline products are playing a pivotal role in contributing to the market growth globally. Biosimilars are a generic versions of biological products. Although they have same potency and effectiveness as biological products take usually a longer time for Research and development as compared to other conventional products. The longer time required for development, complex manufacturing process, higher cost development, and stringent government regulations for biosimilars production are some of the factors hindering the market growth. 

Market Ecosystem

The global biosimilars market has been analyzed from four perspectives: Products, Disease Indication, Manufacturing Type, and Region. 

Biosimilars Market by Product

Based on the product, the biosimilars market has been segmented into recombinant glycosylated proteins (monoclonal antibodies, follitropin, and erythropoietin), recombinant peptides (calcitonin and glucagon), and recombinant non-glycosylated proteins (human growth hormone, insulin, interferons, and granulocyte colony-stimulating factor). The recombinant non-glycosylated proteins segment is segmented into human growth hormone, insulin, interferons, and granulocyte colony-stimulating factor. The recombinant non-glycosylated proteins segment is anticipated to hold the largest market share owing to high patient pool of chronic diseases, continuous introduction of new biosimilars and current trend for alternative medicine. For instance, in May 2022 US FDA-approved new biosimilars like Fylnetra (pegfilgrastim-pbbk), Alymsys (bevacizumab-maly) and Releuko (filgrastim-ayow) and many biosimilars that can be used to treat stomach cancer, breast cancer, colorectal cancer, and other diseases that can be used as novel treatment. 

Biosimilars Market by Disease Indication

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Based on disease indication, the market has been segmented into infectious diseases, oncology, autoimmune diseases, growth hormone deficiency blood disorders, and others. The oncology segment held the largest market share owing to increasing prevalence of cancers, increasing R&D activities for cancer drugs and need for low-cost treatment for cancers. Also, regulatory authority for use of biosimilars for cancer treatment pushes the biosimilars market growth.  The cost of cancer treatment is not affordable for everyone and rapidly becoming challenging. Oncology biosimilars are helping minimize the economic burden associated with cancer treatment.

Biosimilars Market by Manufacturing Type

Based on manufacturing type, the market has been segmented into in-house manufacturing and contract manufacturing. In-house manufacturing segment held the largest market share owing to factors such as involvement of lower manufacturing costs, and increasing preference for in-house production to ensure product quality and confidentiality of the manufacturing process. 

Biosimilars Market by Region

Based on the region, the global biosimilars market has been segmented into North America, Europe, Asia Pacific, and the Rest of the World (RoW). Europe dominated the biosimilars market followed by Asia Pacific. The large share of Europe in the global market can be attributed to several factors such as rising incidence of infectious diseases, rising geriatric population, and the presence of prominent players in this region. The presence of biosimilars in European market has been stronger giving early bird advantage to the region. Also, it is reported that over the past decade, Europe has witnessed the highest number of biosimilar commercialization. 

Competitive Landscape

Some of the prominent players operating in the global biosimilars market are Pfizer Inc., Sandoz International GmbH, Amgen Inc., Samsung Biologics., Biocon, Teva Pharmaceutical Industries Ltd., Eli Lilly and Company, Celltrion Healthcare Co., Ltd., Mylan N.V., and STADA Arzneimittel AG among others.

Strategic Developments

• In June 2022, Biogen Inc.  and Samsung Bioepis Co., Ltd. launched BYOOVIZ™ (ranibizumab-nuna) biosimilar referencing LUCENTIS® (ranibizumab) which is 40% lower than the current list price of LUCENTIS
• In May 2022, Sandoz (Novartis) launched a new global initiative called ‘Act4Biosimilars’ to help address health inequity and inequality worldwide. Act4biosmilars aims to increase patient acceptability, affordability, and accessibility to biosimilars.
• In May 2019, STADA Arzneimittel AG and Xbrane Biopharma AB expanded their strategic biosimilar development partnership. Through this partnership, both companies can evaluate potential development, commercialization, and collaborations around Xbrane's Xdivane and Xcimzane, preclinical biosimilars, and also for additional biosimilars that are deemed fit in their biosimilar portfolios.
• In December 2019, Mylan N.V. and Biocon Ltd. launched Ogivri (trastuzumab-dkst), a biosimilar to Herceptin (trastuzumab) in the U.S. Ogivri can be used in the treatment of HER2-positive breast and gastric cancer patients

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