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Biosimilars Market Size By Product (Recombinant Non-Glycosylated Proteins {Human Growth Hormone, Granulocyte Colony-Stimulating Factor, Insulin, Interferon}, Recombinant Glycosylated Proteins {Erythropoietin, Monoclonal Antibodies, Follitropin, Low Molecular Weight Heparin}), By Application (Haematology {Neutropenia, Anaemia}, Oncology {Lung Cancer, Brain Cancer, Breast Cancer, Cervical Cancer, Colorectal Cancer, Leukaemia or Blood Cancer}, Autoimmune Disease {Arthritis, Inflammatory Bowel Disease, Psoriasis}, Growth Hormone Deficiency, Diabetes), By Manufacturer (Contract Research and Manufacturing Services, In-house), By Technology (Recombinant DNA Technology, Monoclonal Antibodies Technology) Industry Analysis Report, Regional Outlook, Application Potential, Price Trends, Competitive Market Share & Forecast, 2019 – 2025

  • Report ID: GMI3328
  • Base Year: 2018
  • Report Format: PDF

Industry Trends

Biosimilars Market size was valued at USD 10 billion in 2018 and is anticipated to witness 25% CAGR from 2019 to 2025. Increase in demand for biosimilar drugs in order to reduce the healthcare cost will be one of the major factors driving the market growth.

Biosimilars Market Overview

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Growing prevalence of chronic diseases across the globe, especially in developing regions owing to rise in sedentary lifestyle and increasing habit of fast food consumption will result in increasing number of people suffering from such diseases. Hence, prevalence rate in developed as well as in certain areas in developing nations will augment the demand and adoption rate of biosimilar drugs, fueling the industry growth.

However, high development cost of the biosimilar drug will be one of the major reasons impeding the acceptance rates in under-developed and few developing countries. As per a recent research, it takes around 7 to 8 years and costs around USD 100 million to USD 250 million to develop a biosimilar. High cost related to biosimilar drugs development will continue to hinder the market expansion over the forecast timeframe.

By Product

Biosimilars Market Share

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Recombinant non-glycosylated proteins segment in the biosimilars market exceeded USD 6.73 billion in 2018. Recent technological advancements in cell technology and high-throughput analytical techniques will help enable effective production of recombinant non-glycosylated proteins resulting in enhanced sales. Also, recent launch of insulin glargine in major countries and growing demand of filgrastim will further foster the industry expansion.

Recombinant glycosylated proteins segment is estimated to grow at 28.7% growth rate through 2025. Increase in number of people suffering from autoimmune diseases, chronic kidney disease and several hematological disorders such as anemia, neutropenia, etc. will lead to growing demand and adoption rate of biosimilar drugs.

By Application

The hematology segment accounted for USD 4.55 billion in 2018. Advancements in chemotherapy and cancer treatment has helped many patients survive, but many of the patients suffer from side-effects of chemotherapy resulting in chemotherapy-induced anemia. Increase in number of people suffering from blood disorders such as, neutropenia, anemia etc. will boost the sales of biosimilars.

Oncology application segment will attain a CAGR of 37.2% by 2025. The recent approvals of biosimilar for cancer treatment and large number of oncology products in the pipeline will stimulating the market progression.

By Manufacturer

In-house manufacturing segment dominated more than 75% of the biosimilars market share and captured USD 7.84 billion in 2018. In-house manufacturing of the biosimilar products helps the companies to monitor and assess every step on the production and reduces other costs of delivery and shipping. Also, the flexibility and efficiency of the work provided by in-house manufacturing benefits the operational and financial capabilities of the company.

Contract research and manufacturing segment will showcase growth of 28.8% during the forecast period. The companies in developing regions of APAC are forming strategic alliance and partnerships with big global pharma players to manufacture the biosimilars. Currently, there are few companies that give contract manufacturing of biosimilars, but recent strategic developments of the contract manufacturers and low overhead cost of manufacturing will result in growing contract manufacturing of biosimilars.

By Technology

Recombinant DNA technology (rDNA technology) held for 80% of revenue share and crossed a valuation of USD 8.12 billion in 2018. Several biosimilar products such as human growth hormones, insulin, erythropoietin etc. are manufactured using recombinant DNA technology. The technology enhances the capability of the biosimilars to treat the disease immediately and efficiently.

Monoclonal antibodies (MAb) technology segment is poised to expand at 30% CAGR till 2025. Increase in number of monoclonal antibody application in treatment of cancer and autoimmune disease has resulted in growing monoclonal antibody technology usage, accelerating the industry value.

By Region

Biosimilars Market Size  

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U.S. biosimilars market size was over USD 655.6 million in 2018 on account of the presence of primary new technology and state-of-art facilities for biosimilar production. Also, recent biosimilar approvals by FDA in the year 2015 will result in rapid biosimilar acceptance, influencing the market value. During the forecast years, it will register significant growth attributed to relatively low addressable needs.

India market will observe 26.7% gain during 2019 to 2025 impelled by the rising prevalence of chronic diseases due to growing lifestyle-related habits and increase in trends of tobacco intake in millennials. Furthermore, expansion of new healthcare facilities, development of hospitals, and growing acceptance of private clinics have augmented the industry progression. Also, increase in R&D activities in the country by major player such as Biocon, Zydus Cadila etc. will boost the sales of biosimilars.

Competitive Market Share

Amgen, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Coherus BioSciences are some of the major companies operating in the global market. These participants are predicted to hold significant share owing to better R&D capabilities, strong financial position, finest quality products and strong product pipeline. These leaders implement several strategies in order to gain competitive advantage over its competitors. Key strategies implemented by manufacturers in the market include novel product launches, acquisition strategy, expansion strategy, etc.

Industry Background

Biosimilars market will grow at a substantial rate during the forecast timeframe led by the patent expiration of well-known and bestselling biologic drugs. Biosimilars have become common in hospitals and clinics in the developed regions of Europe. The first biosimilar was approved in Europe in the year 2006 and since then over 40 biosimilars have been approved. The Europe market is slated to show mature growth and follow similar trend whereas recent FDA approvals in the year 2015 will lead to rapid growth of market in the United States.

In the year 2017, several biosimilars were approved across the globe and since then there has been a rapid acceleration of biosimilars demand and adoption rate thereby, fueling the market revenue. Big pharmaceutical companies have made considerable investments in development of further biosimilars, and many marketing authorization applications, particularly of monoclonal antibodies, are awaiting consideration by the several regulatory authorities.

Biosimilars market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD million from 2014 to 2025, for the following segments:

Market, by Product

  • Recombinant Non-Glycosylated Proteins 
    • Human Growth Hormone
    • Granulocyte Colony-Stimulating Factor (Filgrastim)
    • Insulin
    • Interferon
      • Alfa
      • Beta
  • Recombinant Glycosylated Proteins 
    • Erythropoietin
      • Alfa
      • Zeta
    • Monoclonal Antibodies 
      • Infliximab
      • Rituximab
      • Adalimumab
      • Trastuzumab
      • Bevacizumab
      • Etanercept
    • Follitropin
      • Alpha
      • Beta
    • Low Molecular Weight Heparin

Market, by Application

  • Hematology
    • Neutropenia
    • Anemia
    • Others
  • Oncology
    • Lung Cancer
    • Brain Cancer
    • Breast Cancer
    • Cervical Cancer
    • Colorectal Cancer
    • Leukemia
      • Non-Hodgkin Lymphoma (NHL)
      • Chronic Lymphocytic Leukemia (CLL)
      • Others
    • Others
  • Autoimmune Disease
    • Arthritis
      • Rheumatoid Arthritis
      • Psoriatic Arthritis
      • Juvenile Arthritis
      • Ankylosing Spondylitis
      • Others
    • Inflammatory Bowel Disease (IBD)
      • Ulcerative Colitis
      • Crohn's Disease
      • Others
    • Psoriasis
    • Others
  • Growth Hormone Deficiency
  • Diabetes
  • Others

Market, by Manufacturer

  • Contract Research and Manufacturing Services
  • In-house

Market, by Technology

  • Recombinant DNA Technology (rDNA technology)
  • Monoclonal Antibodies (MAb) Technology

The above information is provided for the following regions/countries:

  • North America
    • U.S.
    • Canada
  • Europe
    • Germany
    • UK
    • France
    • Spain
    • Italy
    • Russia
    • Turkey
    • Austria
    • Belgium
    • Bulgaria
    • Czech Republic
    • Denmark
    • Finland
    • Greece
    • Hungary
    • Ireland
    • Netherlands
    • Norway
    • Romania
    • Slovakia
    • Slovenia
    • Sweden
    • Switzerland
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Australia
    • New Zealand
    • Singapore
    • Malaysia
    • Rest of the world


Authors: Sumant Ugalmugale, Rupali Swain

Frequently Asked Questions (FAQ) :

The market size of biosimilars surpassed USD 10 billion in 2018.

The industry share of biosimilars is expected to witness 27% CAGR from 2019 to 2025.

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Premium Report Details

  • Published Date: May 2019
  • Companies covered: 20
  • Tables & Figures: 1245
  • Countries covered: 34
  • Pages: 600

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