Biosimilars Market 2019 | Ongoing research and development by Players Novartis AG, Pfizer, Inc., Teva Pharmaceutical Industries Ltd., Celltrion Healthcare Co., Ltd., Biocon Limited, Amgen, Inc., Dr. Reddy's Laboratories, and Sanofi S.A

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. However, stringent regulatory guidelines for development and manufacturing of biosimilars and fragile process of biosimilars production are expected to negatively impact growth of the global biosimilars market.

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Demand for biosimilars is increasing in healthcare sectors in comparison to small molecules due to low manufacturing cost of biosimilars. Biosimilars are less expensive to produce than reference biologics. For instance, as per a National Center for Biotechnology 2017 study, biosimilars generally require 8 to 10 years to develop at a cost between US$ 100 and US$ 200 million, compared to around US$ 2.5 billion for developing a new drug. As a result, manufacturers have fewer expenses to recover, which theoretically allows for biosimilars to build upon the innovation of the reference product and have lower list prices.

Increasing number of manufacturers engaged in developing biosimilars that are similar to current analogs at more affordable prices. The low cost and effectiveness of biosimilar insulin is aiding in treatment of patients suffering from diabetes mellitus.

Major investments by regional players for research and development of biosimilar production is expected to drive growth of the market in emerging economies. For instance, in October 2016, Cipla Inc. invested US$ 8 million to set up manufacturing plant for biosimilars in South Africa. International players are collaborating with local players in emerging economies to enhance their market share. For instance, Mylan N.V. has a long-standing biosimilars partnership with India-based Biocon.

Moreover, several manufacturing companies are expected to lose patent protection for various drugs. For instance, LEVEMIR, an Insulin by Novo Nordisk is expected to lose its patent rights in 2019. Such instances are creating opportunities for pharmaceutical manufacturers to develop alternatives to the patents. Furthermore, expiry and termination of pharmaceuticals drugs such as Humira, Enbrel, and Remicade is offering significant opportunity for new players to enter in the market.

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Major 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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