Biosimilars Market To Reach A Valuation Of ~US$ 61.1 Bn By 2027: TMR

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.

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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