Biosimilars Market: Patent Expiry of Major Biologics to Accelerate Market Growth

Biosimilars Market: Introduction

Biosimilars can be defined as a biologic medical product, which is considered to be similar to already approved biologic. These biosimilars are approved based on their efficacy, quality, safety, and the same standards of pharmaceutical quality that apply to all biologic medicines. Chronic disease prevalence has been increasing significantly at the global level. This necessitates the need for affordable treatment, contributing to the growth of the biosimilars market.

Europe dominated the biosimilars market in 2018 and the trend is anticipated to continue during the forecast period. The strong growth of the market in the region can be attributed to increase in approvals of biosimilars in Europe. For instance, in 2018, over 16 biosimilars were approved in the region for various indications, including oncology, chronic diseases, and autoimmune diseases.

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Patent Expiry of Major Biologics to Accelerate Market Growth

Patent expiries of major biologics are expected to contribute to the growth of the biosimilars market.

  • For instance, the U.S. patent of MabThera/Rituxan (rituximab), a biologic manufactured by Roche, expired in 2016. This provides ample growth opportunities to manufacturers of rituximab biosimilar, such as Amgen, Boehringer Ingelheim, and Pfizer. In addition, a range of top selling brands including Herceptin, Enbrel, Humalog, and Aranesp are anticipated to lose patents during the forecast period.

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Increase in Approvals of Biosimilars to Drive Global Market

The U.S. has witnessed a wave of biosimilar approvals in 2019. According to the Antibody Society in the U.S., over 16 antibody biosimilar therapeutics were approved  from 2015 to 2019. Drugs approved in 2019 include Trazimera, Kanjinti, and Ruxience.

As per the FDA’s Biosimilars Action Plan, new policies are being made to make the development of biosimilars more efficient and provide significant opportunities to biosimilar manufacturers. This is anticipated to propel the rate of biosimilar approvals in the U.S., contributing to the growth of the biosimilars market. 

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High Demand for Recombinant Non-glycosylated Protein Biosimilars

In terms of product, the recombinant non-glycosylated proteins segment is likely to account for a major share of the global biosimilars market. Moreover, the insulin sub-segment of the recombinant non-glycosylated proteins segment dominated the market in 2018. It is likely to grow at a high CAGR during the forecast period, due to increase in prevalence of diabetes globally. According to the International Diabetes Federation, over 463 million adults aged between 20 years and 79 years lived with diabetes in 2019.

Biosimilars for Oncology Indication to Dominate Global Market

In terms of indication, the global biosimilars market has been divided into chronic diseases, oncology, autoimmune diseases, infectious diseases, blood disorders, growth hormone deficiency, and others. The oncology segment held the largest market share in 2018 and the trend is anticipated to continue during the forecast period. The robust growth of the segment can be attributed to rise in prevalence of cancer cases globally. According to the World Cancer Research fund, over 18 million cancer cases were reported in 2018. In addition, the patent expiration of a range of cancer biologic drugs, leading to the growing usage of biosimilars, owing to their lower costs contributes to the growth of the segment in the forecast period.

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Biosimilars Market: Key Strategies

  • The global biosimilars market is consolidated in terms of number of players. Key players operating in the global biosimilars market include Pfizer, Inc., Intas Pharmaceuticals Ltd., Biocon, Dr. Reddy’s Laboratories Ltd., Teva Pharmaceutical Industries Ltd., Sandoz International GmbH (A Novartis Division), Celltrion Inc., Amgen, Inc., STADA Arzneimittel AG, and Apotex Inc. (Apobiologix).
  • These players have adopted various strategies such as product portfolio expansion, investment in research & development, collaborations, and product launches to establish a strong geographic presence. For instance, in November 2019, Pfizer received the U.S. FDA approval for its ABRILADA, a biosimilar to Humira, for the treatment of patients with rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult Crohn's disease, ulcerative colitis, and plaque psoriasis.

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