GVR Report cover Biosimilars Market Size, Share & Trends Report

Biosimilars Market Size, Share & Trends Analysis Report By Product, By Application (Oncology, Growth Hormone, Blood Disorders, Chronic & Autoimmune Disorders), By Region, And Segment Forecasts, 2018 - 2025

  • Published Date: Jul, 2018
  • Base Year for Estimate: 2015
  • Report ID: 978-1-68038-916-6
  • Format: Electronic (PDF)
  • Historical Data: 2014 - 2015
  • Number of Pages: 70

Report Overview

The global biosimilars market size was valued at USD 4.36 billion in 2016. It is anticipated to exhibit a CAGR of 34.2% during the forecast period. The cost-effectiveness of biosimilar drugs and the high prevalence of chronic disorders globally are some major factors contributing to market growth.

Germany biosimilars market

Biosimilar drugs are highly identical to approved biologic drugs. They possess similar medical properties in terms of potency, safety, and efficacy to original biologic products. High prevalence of chronic diseases such as diabetes, cancer, growth hormone deficiency, and anemia is expected to further fuel market expansion in the near future.

As stated by the National Cancer Institute (NCI), an estimated 1,735,350 new cases of cancer are likely to be diagnosed in the U.S. in 2018, and 609,640 people will die from the disease. In 2012, there were around 14 million new cancer cases and about 8.2 million cancer-related deaths worldwide. Thus, there is a high demand for cost-effective biosimilars for the treatment of such chronic disorders, which, in turn, is expected to boost the market growth.

Total healthcare costs have increased due to high-prices patented pharmaceutical drugs, especially biologics. Governments of several countries are emphasizing on cost-effective drug synthesis. The U.S. is known as the country with the highest health expenditure. It has recently put emphasis on cutting healthcare expenditures. Similarly, price regulation in Japan and reduced health budget in India, have raised cost containment demands. This brings into the light the need for developing new, improved, efficient, and affordable therapeutics. Thus, efforts to bring down healthcare expenditures are projected to boost the market for biosimilars.

Stringent government regulations for the development and production of biosimilars could hinder biosimilars market growth. Specific guidelines are provided by various regulatory authorities to maintain the safety profile and effectiveness of proposed drugs. Different regulatory bodies including European Medicines Agency, U.S. Food and Drug Administration (FDA), and China Food and Drug Administration have diverse regulations for drug approvals. The presence of different regulations make biosimilar drug approval process highly tedious and time-consuming.

Product Insights

Recombinant non-glycosylated proteins include human growth hormone, granulocyte colony-stimulating factor, interferons, and insulin. In 2016, recombinant non-glycosylated proteins was the largest revenue-generating segment due to increased regulatory approvals. For instance, in November 2016, the European Medicines Agency approved three drugs: Lusduna (insulin glargine biosimilar) and Movymia and Terrosa (teriparatide biosimilar).

In addition, increasing incidence of chronic diseases such as diabetes, cancer, arthritis, Alzheimer’s disease, chronic kidney disease, and chronic pain is expected to boost the market growth. According to the Centers for Disease Control and Prevention (CDC), in 2016, around 29.0 million individuals in the U.S. were suffering from diabetes. As stated by the Canadian Diabetes Association, the prevalence of diabetes is growing in Canada and it is projected to reach around 5.0 million by 2025.

The recombinant glycosylated proteins segment is expected to witness lucrative CAGR during the study period. Patent cliff of biologics products including erythropoietin and monoclonal antibodies is anticipated to propel this growth. For instance, Roche’s Actemra/RoActemra (tocilizumab) was approved by the European Medicines Agency in January 2009 and by the U.S. FDA in January 2010. Patents of these drugs expired in the U.S. in December 2015 and it will expire in Europe in April 2017.

European countries including Germany, U.K., and France have the most favorable market conditions for biosimilars. Demand for biosimilars is high in European countries as compared to other regions owing to the availability of a well-developed regulatory framework coupled with the presence of a large number of biopharmaceutical companies. These companies focus on price competition and innovative product development to command market dominance.

Application Insights

The oncology segment dominated the global market for biosimilars in terms of revenue in 2016. This is due to the high prevalence of cancer including lung, liver, colorectal, stomach, breast, and blood cancer. According to the World Health Organization (WHO), cancer is the second leading cause of deaths around the world. It was accountable for around 8.8 million deaths in 2015.

The death rate due to cancer is high in low- and middle-income countries with about 70% deaths caused by cancer. The high cost of cancer drugs and treatment and the unavailability of advanced healthcare facilities are some of the major factors responsible for the high mortality rate. Therefore, there is an increasing demand for low-cost therapeutic drugs that are highly effective and less expensive.

China biosimilars market

The blood disorders segment is projected to grow at a lucrative rate during the forecast period. Factors such as the positive outcome of the ongoing biosimilars clinical trials and prevalence of anemia, hemophilia, and blood clots among other blood disorders are expected to propel growth in the near future. Thus, there is a rising demand for innovative therapeutic products at low cost which is expected to drive growth.

Germany, U.K., China, and India are projected to account for the largest share in the market for biosimilars. The favorable regulatory environment, government support, and increasing prominence to cut down healthcare expenditures in these countries are some of the key reasons for high product adoption in these regions. In addition, biopharmaceutical companies are focusing on new product development and its launch to cater to the unmet needs of patients, which is expected to positively impact market growth.

Regional Insights

Europe has held the largest market share in terms of revenue due to the presence of a well-defined regulatory framework for biosimilars and major biopharmaceutical companies such as Johnson & Johnson, Novartis, AstraZeneca, Pfizer, Merck, Sanofi, and GlaxoSmithKline. Furthermore, well-developed healthcare infrastructure and a growing number of product launches have fueled the regional market growth.

Europe was followed by Asia Pacific, which accounted for a major market share in 2016. Growing demand for less expensive therapeutic products and a high prevalence of chronic diseases in Asia Pacific are contributing to the regional market growth. Increasing focus on product developments in countries including China, India, and South Korea is another major factor market drivers.

North America is projected to exhibit high CAGR during the forecast period, due to rising efforts from manufacturers to tap growth opportunities in the U.S. and Canada. The U.S. biosimilar regulatory pathway was established in March 2009, and since then the region has gained significant momentum, presenting new opportunities and challenges. U.S. FDA approved the first biosimilar product, Zarxio (filgrastim-sndz), in March 2015.

Key Companies & Market Share Insights

The market is fragmented with the presence of many medium- and large-scale manufacturers. Several big companies in the sector include Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; and Mylan N.V.

Leading players are involved in collaborations, new drug developments, mergers and acquisitions, and regional expansions to strengthen their market positions. New drug launches and collaborations help companies to gain maximum revenue share and expand regional presence and existing product portfolio. For instance, in October 2016, Teva Pharmaceutical Industries Ltd. and Celltrion Healthcare entered into a strategic partnership to commercialize CT-P10 and CT-P6 (Celltrion’s monoclonal antibodies biosimilar candidates) in U.S. and Canada.

Biosimilars Market Report Scope

Report Attribute


Market size value in 2020

USD 13.2 billion

Revenue forecast in 2025

USD 61.47 billion

Growth Rate

CAGR of 34.2% from 2016 to 2025

Base year for estimation


Historical data

2014 - 2015

Forecast period

2016 - 2025

Quantitative units

Revenue in USD million and CAGR from 2016 to 2025

Report coverage

Revenue forecast, company share, competitive landscape, growth factors and trends

Segments covered

Technology, application, end-use, region

Regional scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country scope

The U.S.; Canada; The U.K.; Germany; India; China

Key companies profiled

Amgen Inc.; F. Hoffmann-La Roche Ltd.; Sandoz International GmbH; Dr. Reddy’s Laboratories Ltd.; Teva Pharmaceutical Industries Ltd.; Pfizer Inc.; Samsung Bioepis; Biocon; Mylan N.V.

Customization scope

Free report customization (equivalent up to 8 analysts working days) with purchase. Addition or alteration to country, regional & segment scope.

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Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global biosimilars market report on the basis of product, application, and region:

  • Product Outlook (Revenue, USD Million, 2014 - 2025)

    • Recombinant Non-Glycosylated Proteins

      • Human Growth Hormones

      • Granulocyte Colony-Stimulating Factor (G-CSF)

      • Interferons

      • Insulin

    • Recombinant Glycosylated Proteins

      • Erythropoietin

      • Monoclonal Antibodies

      • Follitropin

  • Application Outlook (Revenue, USD Million, 2014 - 2025)

    • Oncology

    • Blood Disorders

    • Growth Hormonal Deficiency

    • Chronic and Autoimmune Disorders

    • Others

  • Regional Outlook (Revenue, USD Million, 2014 - 2025)

    • North America

      • The U.S.

      • Canada

    • Europe

      • Germany

      • The U.K.

    • Asia Pacific

      • China

      • India

    • RoW

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