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Biosimilars Market Poised to Take Off by 2026

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 d
Biosimilars Market: Moving Towards a Brighter
Future 2018-2026
Biosimilars Market, by Drug Class (Recombinant Human Growth Hormone,
Granulocyte Colony-Stimulating Factor, Insulin, Anticoagulants, Fusion Proteins,
Erythropoietin, Monoclonal Antibodies, Follitropin, and Others), by Therapy
Type (Oncology, Immunology, Hematology, Hormone Therapy, Metabolic
Disorders, and Others), by Distribution Channel (Hospital Pharmacies, Retail
Pharmacies, and Specialty Pharmacies), and by Region (North America, Latin
America, Europe, Asia Pacific, Middle East, and Africa) - Size, Share, Outlook,
and Opportunity Analysis, 2018-2026
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
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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.
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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