Growth of the Biosimilars Market Is Mainly Driven by Increasing Number of Approved Biosimilars

A biosimilar is a biologic medical product that is similar to another already approved biological medicine, in terms of quality, safety, and efficacy. Biosimilars are a class of therapeutic drugs that provide additional treatment options and help reduce healthcare costs. Thus, there is an increasing demand for biosimilar drugs due to increasing prevalence of autoimmune diseases, key factor driving the growth of the biosimilars market. According to the National Stem Cell Foundation (NSCF), around 4% of the world's population is affected by one of more than 80 different autoimmune diseases, the most common of which include multiple sclerosis, type 1 diabetes, scleroderma, Crohn's disease, lupus, psoriasis and. rheumatoid arthritis.

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Autoimmune diseases are a family of more than 80 chronic, often debilitating and, in some cases, life-threatening illnesses. Moreover, growth of the biosimilars market is being driven by the increasing research and development and speedy approvals of biosimilars, especially in the North America. For instance, in 2019, the United States Food and Drug Administration (FDA) approved Amgen’s AVSOLA (infliximab-axxq), for all approved indications of the reference product, Remicade (infliximab), for the treatment of rheumatoid arthritis, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis, Crohn's Disease, and chronic severe plaque psoriasis. However, stringent regulations and manufacturing complications are major factors expected to restrain the biosimilars market growth.

Furthermore, the biosimilar market, in Europe, is witnessing robust growth due to the growing adoption of biosimilars due low price and rapid entry of biosimilars in the region. For instance, in 2018, European Commission (EC) approved Sandoz’s Zessly, a biosimilar for use in Europe, confirming that Zessly matches safety, efficacy, and quality of reference medicine. Zessly is approved for the treatment of adult and pediatric Crohn's disease, adult and pediatric ulcerative colitis, rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, and plaque psoriasis. However, the adoption rate varies from country to country, always associated with regulatory and market access issues. This in turn is also expected to hamper the biosimilars market growth.

Growth of the biosimilars market can also be attributed to rich pipeline of biosimilar products and expiry/termination of existing drugs. As of June 2020, FDA has approved 27 biosimilars, plus four follow-on biologicals. The pipeline for biosimilars continues to grow, however, of the 27 approved biosimilars, only 17 have been launched so far. Biosimilars on average can cost 30% less than reference biologicals. Thus, pharmaceutical and biotechnology companies are focusing on developing safe and effective biosimilars, because a small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy.

Biosimilars Market - Competitive Landscape

Key players operating in the global biosimilars market include, Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy's Laboratories, and Sanofi S.A.

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