The Global Biosimilars Market size was valued at US$ 5.0 billion in 2017, and is expected to witness a CAGR of 35.2% over the forecast period (2018 – 2026).

Biosimilars are biopharmaceutical drugs that have active components and are similar to the drugs, which have been previously licensed. They are identical copies of the original product and can be manufactured only when the patent for the original innovator product expires. Biosimilars are majorly used in therapeutic applications for the treatment of various types of cancer and non-communicable diseases (asthma and arthritis).

Increasing prevalence of cancer is expected to boost growth of the biosimilars market. For instance, according to National Institute of Cancer Prevention and Research (NICPR), in 2018, 1,62,468 new cases and 87,090 deaths were reported due to breast cancer in India. Biosimilars are designed to be highly similar to originator biologic products, which represents an opportunity to increase access and reduce costs for patients and healthcare systems.

Market Dynamics

Increasing number of biosimilar approvals in clinical management of various diseases such as diabetes and hormonal imbalance is expected to drive growth of the biosimilars market. According to the Generics and Biosimilars Initiative (GABI) 2017 report, around 40 different biosimilars were approved in Europe, covering several different therapeutic classes: granulocyte colony-stimulating factors, and erythropoiesis-stimulating agents (ESAs), among others.

Moreover, increasing research and development in biosimilars, robust biosimilar pipeline portfolio, and support from healthcare regulatory bodies in fast lining biosimilar approvals are some of the major factors that are expected to drive growth of the market. The U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) both provide guidance for the development of biosimilar drugs.

Although biosimilars are not required to undergo intense clinical trials for their approval, the data demonstrating their similarity to an original biologic in terms of clinical efficacy and safety is required. The adoption of biosimilars varies from country to country, which is invariably linked to regulatory and market access issues. The biosimilars market is expected to witness significant growth, owing to expiry and termination of existing drugs and presence of rich pipeline of biosimilar products especially those in Phase III stage.

Increasing number of biosimilar approvals is expected to drive the growth of biosimilars market

Increase in number of approved biosimilars due to greater clarity in the U.S. Food and Drug Administration (FDA) review process other than manufacturing and development process are expected to drive biosimilars market growth. For instance, in July 2018, the U.S. FDA introduced a Biosimilars Action Plan to encourage the development of biosimilars. This approval process encourages applicants to resolve patent disputes before launch of biosimilars.

Moreover, the number of filed biosimilars applications has increased as manufacturers have become more comfortable with the complex regulatory and litigation schemes associated with filing a biosimilar application.

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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.

Biosimilars Market - Regional Insights

On the basis of region, the global biosimilars market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa. Europe is expected to be the most lucrative market for biosimilars over the forecast period. Increasing focus of regulatory bodies in development of novel biosimilars is expected to drive growth of the market in Europe. For instance, in July 2016, the European Medicines Agency (EMA) authorized the introduction and marketing of Thorinane and Inhixa, biosimilars of the Low Molecular Weight Heparin (LMWH), enoxaparin.

Asia Pacific biosimilars market size is expected to foresee a rapid growth, owing to significantly increasing number of biosimilar approvals. For instance, in 2017, Celltrion received approval from China Food and Drug Administration (CFDA) to start clinical trials for its infliximab biosimilar, Remsima (CT-P13), in China. This makes Celltrion the first foreign company to initiate clinical trials of an antibody biosimilar in China.

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