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Biosimilars Market – Insights

Biosimilar products are suspected to continue to have a significant impact on the pharmaceutical industry. Many regulatory bodies have established clinical guidelines to support the development of biosimilars, laying down the requirements for demonstrating comparable pharmacokinetics, pharmacodynamics, safety and efficacy from Phase I on to controlled, randomized Phase III trials.

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.

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).

Global Biosimilars Market Share (%) Analysis, By Product Type, 2017

Source: Coherent Market Insights Analysis (2019)

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. For instance, since 2015, the U.S. FDA has approved 16 biosimilars and the number is expected to increase over the forecast period. Several other government agencies are also following similar trends for product approvals. For instance, in November 2017, Samsung Bioepis received two approval for its adalimumab biosimilar, Hadlima (SB5) and for its trastuzumab biosimilar, Samfenet (SB3), from the Korean Ministry of Food and Drug Safety (South Korea).

Biosimilars Market – Restraints

Stringent regulatory guidelines for development and manufacturing of biosimilars in the U.S. is expected to restrain growth of the global biosimilars market. For instance, the U.S. FDA rejected four biosimilar applications during 2018. In April 2018, the U.S. FDA rejected Pfizer’s candidate trastuzumab biosimilar and Sandoz’s candidate rituximab biosimilar in May 2018.

Moreover, several manufacturing challenges for biosimilars that primarily arise due to biologics being far more structurally complex and more difficult to characterize, produce, and reproduce than most small-molecule drugs are also expected to restrain the market growth. A small variations in the manufacturing process can potentially alter the medicine’s safety and efficacy.

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.

Global Biosimilars Market Value (US$ Bn) & Y-o-Y Growth (%), 2016-2026

Source: Coherent Market Insights Analysis (2019)

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.