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The Global Biosimilars Market is projected to reach USD 44.7 billion by 2026 from USD 15.6 billion in 2021, at a CAGR of 23.5% during the forecast period of 2021 to 2026. Market growth is largely driven by the rising incidence of chronic diseases and increasing demand of biosimilars for their cost-effectiveness. Regulatory approvals and other regulations favouring biosimilars adoption in different countries is also a major driving factor in the biosimilars market. However, the complexities in the development and manufacturing of biosimilars and resistance from reference biologic manufacturers is expected to restrain the growth of this market during the forecast period.

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Key Market Players:

Novartis AG (Switzerland), Pfizer, Inc. (US), Dr. Reddy’s Laboratories Ltd. (India), Amgen, Inc. (US), Eli Lilly and Company (US), Teva Pharmaceutical Industries Ltd. (Israel), Fresenius SE & Co. KGaA (Germany), STADA Arzneimittel AG (Germany), Boehringer Ingelheim (Germany)

COVID-19 impact on the Biosimilars Market

Coronavirus disease 2019 (COVID‐19) is an acute respiratory infectious disease caused by severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2). Largely unknown before the outbreak began in Wuhan (China) in December 2019, COVID-19 has moved from a regional crisis to a global pandemic in just a few weeks. The World Health Organization (WHO) declared COVID-19 as a pandemic on March 11, 2020. There has been a tremendous amount of effort put into developing new treatments and vaccines to cure the infection. Within a few weeks of research, companies started coming up with drugs and treatments to treat the infection. 

Global Biosimilars Market Dynamics

According to American Journal of Managed Care, biosimilars are priced around 20–30% lower than their parent/branded counterparts. This results in both cost-savings and access to highly effective treatments for patients. Biosimilars have lower R&D costs as compared to innovator biologics. Lower R&D costs lower the cost for biosimilars. Lower-priced biosimilars also tend to have a downward effect on the prices of reference biologics through price competition among manufacturers. This significant cost-to-benefit ratio offered by biosimilar drugs is expected to increase their demand in the coming years.

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The Oncology segment dominated the biosimilars market in 2020:

Based on the indication, the biosimilars market is segmented into oncology, inflammatory and autoimmune diseases,  chronic diseases, blood disorders, growth hormone deficiency, infectious diseases, and other indications (infertility, hypoglycemia, myocardial infarction, postmenopausal osteoporosis, chronic kidney failure, and ophthalmic diseases). Oncology is the largest segment in this market owing to the availability of biosimilars at a lower price than innovative biologics and a large number of cancer patients. The availability of biosimilars in the field of oncology has lowered prices and made cancer treatment more affordable and accessible.  Also, due to the high incidence and prevalence of cancer, healthcare systems across the globe are focusing on reducing the burden of cancer by adopting cost effective treatment options. In this scenario, biosimilar drugs might witness widespread adoption in major markets such as the US, Europe, and the Asia Pacific. Considering these factors and the upending competition from biosimilars, many major biologic pharmaceutical companies are making significant investments in the development and approval of biosimilar drugs.

The monoclonal antibodies segment accounted for the largest share in 2020

Based on the product, the biosimilars market is segmented into monoclonal antibodies; insulin; Granulocyte Colony-Stimulating Factor; Erythropoietin; Recombinant Human Growth Hormone; Etanercept; Follitropin; Teriparatide; Interferons; Enoxaparin Sodium; Glucagon and Calcitonin. Monoclonal antibodies accounted for a share of around 27%. Monoclonal antibodies and Insulin are seen to be the leading segments with respect to the growth rate during the forecast period as a result of wide applications of monoclonal antibodies in the treatment of cancer, autoimmune disorders and osteoporosis, and rising incidents of insulin dependent diabetes globally and increasing demand for cost-effective treatment options.

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Recent Developments

·         In July 2021, Biocon Ltd (Biocon Biologics) in partnership with Viatris, Inc. received FDA approval for the first interchangeable biosimilar SEMGLEE (insulin glargine-yfgn injection) for the treatment of diabetes.

·         In April 2021, Novartis AG (Sandoz) signed an agreement with Bio-Thera Solutions (China) to commercialize BAT1706 (proposed bevacizumab biosimilar by Bio-Thera Solutions) in the US, Europe, Canada, and other international markets.

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