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

Published Date: May 2019  |  Report ID: GMI3328  |  Authors: Sumant Ugalmugale, Rupali Swain

Report Format: PDF   |   Pages: 600   |   Base Year: 2018

Summary Table of Contents Industry Coverage Methodology

Industry Trends

Biosimilars Market size was valued at over USD 10 billion in 2018 and is expected to witness 27% CAGR from 2019 to 2025.

Biosimilars Market Overview

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As per a recent article, biosimilars are estimated to play a significant role in enhancing the public health issue by addressing the customer needs. The potential savings from the use of biosimilars is poised to be around over USD 100 billion by the year 2020. Increase in demand for biosimilar drugs in order to reduce the healthcare cost will be one of the major factors for the market growth.

Rising 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 growing 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.

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 during the forecast timeframe.

By Product

Biosimilars Market Size

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Recombinant non-glycosylated proteins segment in the biosimilars market accounted for around 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 fuel the industry growth.

Recombinant glycosylated proteins segment is anticipated to observe 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 exceeded 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 segment is predicted to expand at a CAGR of more than 37.2% by 2025. The recent approvals of biosimilar for cancer treatment and large number of oncology products in the pipeline will be a major market driving factor. The European Medicines Agency (EMA) approved the first oncology product in the year 2017 and number of other oncology products such as rituximab, trastuzumab and bevacizumab in the year 2018. Hence, recent oncology product approvals will stimulate the market demand during the forecast timeframe.

By Manufacturer

In-house manufacturing segment dominated more than 75% of the biosimilars market share and accounted for 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 services segment is poised to expand at 28.8% CAGR through 2025. The companies in developing regions of Asia Pacific 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) captured 80% of the biosimilars market share and exceeded 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. Hence, manufacturers use the recombinant DNA technology in order to manufacture biosimilar products.

Monoclonal antibodies (MAb) technology will register growth of 30% by 2025. Rise in number of monoclonal antibody application in treatment of cancer and autoimmune disease has resulted in growing monoclonal antibody technology usage, impelling the industry demand.

By Region

Europe Biosimilars Market  

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U.S. dominated the North America biosimilars market and accounted for over USD 655.6 million in 2018 owing to 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, augmenting the market revenue. During the forecast years, it will showcase significant growth due to relatively low addressable needs.

India market is projected to grow at a CAGR of 26.7% through 2025 led by rising prevalence of chronic diseases attributed to the 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 boosted the industry expansion. Also, increase in R&D activities in the country by major player such as Biocon, Zydus Cadila etc. will foster the sales of biosimilars.

Competitive Market Share

Amgen, Biocon, Biogen, Boehringer Ingelheim, Celltrion, Coherus BioSciences are some of the major companies operating in the market. These key market participants are set to hold significant revenue share credited 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 companies in the market include novel product launches, acquisition strategy, expansion strategy, etc.

Industry Background

Biosimilars market is slated to grow at a substantial rate during the forecast timeline driven by 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 estimated 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 value. 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. Hence, recent product approvals, low cost of the biosimilar drugs, reduction in the healthcare cost, patent expiration of the major biologics and growing R&D activities of the major pharma players will lead to propel the industry revenue.

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

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.

Premium Report Details

  • Published Date: May 2019
  • Pages: 600
  • Tables: 1236
  • Charts / Figures: 9
  • Companies covered: 20
  • Countries covered: 34

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