Market Size by Product (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins), by Application (Hematology, Oncology, Autoimmune Disease, Growth Hormone Deficiency), by Manufacturer, by Technology, Global Forecast.
Report ID: GMI3328
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Published Date: July 2023
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Report Format: PDF
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Biosimilars Market Size
Biosimilars Market size was worth more than USD 35 billion in 2022 and is poised to witness substantial growth at 13% CAGR from 2023 to 2032 driven by the high prevalence of chronic diseases globally.
The surging burden of higher obesity rates, poor diets, and persistent physical inactivities has compelled several healthcare systems to look for multiple methods to provide patients with affordable treatments. According to the WHO, 167 million adults and children will have greater health issues by 2025 as a result of being overweight or obese. In contrast to costly biologic medications used to treat diseases, including autoimmune disorders, cancer, and diabetes, biosimilars have emerged as more affordable alternatives. Additionally, organizations, such as the Canadian Diabetes Association recommend using biosimilar insulins before starting treatment, further adding to the business progress.
The high cost of pharmaceuticals, especially biologics is among the major factors restraining the market expansion. The investments needed to develop and market biosimilars is substantially more than USD 1 to $4 million. Additionally, the process of producing one biosimilar takes about 7 to 8 years, accounting for $100 million to $250 million in expenditure. Additionally, the intricacy of developing monoclonal antibodies results in substantially greater production costs than biosimilars, further slowing down the industry development.
COVID-19 Impact
The pandemic had mixed influence on market growth driven by the rising focus on healthcare and the thriving necessity for affordable treatment choices. The importance of diversified supply chains led to the need to produce crucial medications, including biosimilars on local basis. However, the pandemic raised concerns about difficulties, such as delays in clinical studies, global supply chain disruptions, and regulatory approval procedures. Additionally, the reallocation of healthcare resources towards COVID-19 management also impacted the market progress.
Biosimilars Market Trends
The major trend promoting better market accessibility and competitiveness is the rise in the number of biosimilar products receiving regulatory authority clearance. For instance, in July 2021, the U.S. FDA authorized Glenmark Pharmaceuticals' Ryaltris (olopatadine hydrochloride and mometasone furoate), a biosimilar of Dymista, for the treatment of allergic rhinitis. Similarly, in June 2021, the European Commission authorized the sale of Aybintio (bevacizumab), a biosimilar of Avastin created by Samsung Bioepis. Additionally, the market is witnessing an increase in R&D activities as businesses engage in cutting-edge manufacturing techniques and innovative analytics for the development of biosimilars, which will support industry landscape.
Biosimilars Market Analysis
The recombinant non-glycosylated proteins segment, comprising human growth hormone, granulocyte stimulating factor, insulin and interferon, in the biosimilars market is expected to grow at 12.8% CAGR from 2023-2032. These biosimilar products are largely used in the treatment of growth hormone deficiencies, infections during chemotherapy, diabetes, malignant myeloma, and renal carcinoma among others. The rising focus on treating various chronic diseases, such as blood disorders and growth hormone deficiencies as well as offering comparable safety and efficacy profiles will add to the segment expansion.
Biosimilars market size from the hematology segment is projected to generate more than USD 52 billion by 2032. The development of monoclonal antibodies for the treatment of blood diseases has provided lucrative growth prospects for the expansion of the biosimilars industry. Healthcare professionals are looking for more reasonably priced treatment alternatives to meet the demands of patients on account of the rising frequency of hematology-related disorders. The presence of supportive regulatory frameworks along with the increasing patient and physician awareness is also driving the use of biosimilars in hematology.
North America biosimilars market recorded significant growth in 2022 and is expected to reach over USD 26.5 billion by 2032. Biosimilars are gaining popularity as viable replacements for expensive biologics as the preference for cost-effective healthcare solutions is increasing across the region. Additionally, the presence of supportive regulatory frameworks such as the US Biologics Price Competition and Innovation Act, have simplified the clearance process for biosimilars, promoting market access and competition. Furthermore, the patent expiration of numerous bestselling biologics has opened opportunities for new biosimilar producers to enter the market, further augmenting the market outlook.
Biosimilars Market Share
The competitive landscape of the biosimilars market includes:
prominent enterprises
such as Dr. Reddy’s Laboratories
Sandoz
Coherus Biosciences
Viatris
Bio-Thera Solutions
Pfizer
Apobiologix
Amgen
Teva Pharmaceuticals
Fresenius Kabi
Biocon Ltd
Biocad
Reliance Life Sciences
Intas Pharma
Celltrion
Zydus Cadila
Lupin Pharma, and Samsung Bioepis.
Biosimilars Market News
In May 2023, Boehringer Ingelheim received U.S. FDA clearance for Cyltezo Pen, a novel autoinjector choice for Cyltezo (adalimumab-adbm), an FDA-approved interchangeable biosimilar to Humira.
In June 2022, Biogen Inc. partnered with Samsung Bioepis Co., Ltd. to introduce BYOOVIZ (ranibizumab-nuna), a biosimilar of LUCENTIS (ranibizumab) in the U.S.
The biosimilars market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:
Chapter 6 Biosimilars Market Size and Forecast, By Application (USD Million)
6.1 Key trends, by application
6.2 Hematology
6.2.1 Neutropenia
6.2.2 Anemia
6.2.3 Other hematology applications
6.3 Oncology
6.3.1 Lung cancer
6.3.2 Brain cancer
6.3.3 Breast cancer
6.3.4 Cervical cancer
6.3.5 Colorectal cancer
6.3.6 Leukemia
6.3.6.1 Non-Hodgkin Lymphoma (NHL)
6.3.6.2 Chronic Lymphocytic Leukemia (CLL)
6.3.6.3 Others
6.3.7 Other cancers
6.4 Autoimmune Disease
6.4.1 Arthritis
6.4.1.1 Rheumatoid arthritis
6.4.1.2 Psoriatic arthritis
6.4.1.3 Juvenile arthritis
6.4.1.4 Ankylosing spondylitis
6.4.1.5 Other arthritis
6.4.2 Inflammatory Bowel Disease (IBD)
6.4.2.1 Ulcerative Colitis
6.4.2.2 Crohn's disease
6.4.2.3 Other IBD
6.4.3 Psoriasis
6.4.4 Other autoimmune diseases
6.5 Growth hormone deficiency
6.6 Diabetes
6.7 Other applications
Chapter 7 Biosimilars Market Size and Forecast, By Manufacturer (USD Million)
7.1 Key trends, by manufacturer
7.2 Contract research and manufacturing services
7.3 In-house
Chapter 8 Biosimilars Market Size and Forecast, By Technology (USD Million)
8.1 Key trends, by technology
8.2 Recombinant DNA Technology (rDNA technology)
8.3 Monoclonal Antibodies (MAb) Technology
Chapter 9 Biosimilars Market Size and Forecast, By Region (USD Million)
9.1 Key trends, by region
9.2 North America
9.2.1 U.S.
9.2.2 Canada
9.3 Europe
9.3.1 Germany
9.3.2 UK
9.3.3 France
9.3.4 Spain
9.3.5 Italy
9.3.6 Turkey
9.3.7 Austria
9.3.8 Belgium
9.3.9 Bulgaria
9.3.10 Czech Republic
9.3.11 Denmark
9.3.12 Finland
9.3.13 Greece
9.3.14 Hungary
9.3.15 Ireland
9.3.16 Netherlands
9.3.17 Norway
9.3.18 Romania
9.3.19 Slovakia
9.3.20 Slovenia
9.3.21 Sweden
9.3.22 Switzerland
9.3.23 Rest of Europe
9.4 Asia Pacific
9.4.1 Japan
9.4.2 China
9.4.3 India
9.4.4 Australia
9.4.5 South Korea
9.4.6 New Zealand
9.4.7 Singapore
9.4.8 Malaysia
9.4.9 Rest of Asia Pacific
9.5 Latin America
9.6 Middle East & Africa
Chapter 10 Company Profiles
10.1 Biocon Ltd.
10.2 Sandoz
10.3 Viatris
10.4 Bio-Thera Solutions
10.5 Pfizer
10.6 Dr. Reddy’s Laboratories
10.7 Amgen Inc.
10.8 Teva Pharmaceuticals
10.9 Fresenius Kabi
10.10 Coherus Biosciences
10.11 Apobiologix
10.12 Biocad
10.13 Intas Pharma
10.14 Reliance Life Sciences
10.15 Celltrion
10.16 Zydus Cadila
10.17 Lupin Pharma
10.18 Samsung Bioepis
Don't see your key competitors?
The companies listed in this report are a curated selection - not the full competitive universe.
Our market revenue calculations use a bottom-up methodology that accounts for all players across all regions - including manufacturers, distributors, and specialists not individually profiled. The profiles section spotlights strategically significant players; it does not define the scope of our market sizing.
Your competitive landscape may also include
Regional or domestic-only leaders not in the global top tier
Distributors and channel partners who control market access
Emerging disruptors, startups, or adjacent-industry entrants
Niche players focused on a specific application or end-use
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Authors: Monali Tayade, Jignesh Rawal
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Premium Report Details
Base Year: 2022
Companies Profiled: 18
Tables & Figures: 1164
Countries covered: 36
Pages: 700
Download Free PDF
Premium Report Details
Base Year: 2022
Companies covered: 18
Tables & Figures: 1164
Countries covered: 36
Pages: 700
Download Free PDF
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Monali Tayade. 2023, July. Biosimilars Market - By Product (Recombinant Non-Glycosylated Proteins, Recombinant Glycosylated Proteins), By Application (Hematology, Oncology, Autoimmune Disease, Growth Hormone Deficiency), By Manufacturer, By Technology, Global Forecast, 2023-2032 (Report ID: GMI3328). Global Market Insights Inc. Retrieved May 14, 2026, from https://www.gminsights.com/toc/details/biosimilars-market
Biosimilars Market
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Biosimilars Market Size
Biosimilars Market size was worth more than USD 35 billion in 2022 and is poised to witness substantial growth at 13% CAGR from 2023 to 2032 driven by the high prevalence of chronic diseases globally.
The surging burden of higher obesity rates, poor diets, and persistent physical inactivities has compelled several healthcare systems to look for multiple methods to provide patients with affordable treatments. According to the WHO, 167 million adults and children will have greater health issues by 2025 as a result of being overweight or obese. In contrast to costly biologic medications used to treat diseases, including autoimmune disorders, cancer, and diabetes, biosimilars have emerged as more affordable alternatives. Additionally, organizations, such as the Canadian Diabetes Association recommend using biosimilar insulins before starting treatment, further adding to the business progress.
The high cost of pharmaceuticals, especially biologics is among the major factors restraining the market expansion. The investments needed to develop and market biosimilars is substantially more than USD 1 to $4 million. Additionally, the process of producing one biosimilar takes about 7 to 8 years, accounting for $100 million to $250 million in expenditure. Additionally, the intricacy of developing monoclonal antibodies results in substantially greater production costs than biosimilars, further slowing down the industry development.
COVID-19 Impact
The pandemic had mixed influence on market growth driven by the rising focus on healthcare and the thriving necessity for affordable treatment choices. The importance of diversified supply chains led to the need to produce crucial medications, including biosimilars on local basis. However, the pandemic raised concerns about difficulties, such as delays in clinical studies, global supply chain disruptions, and regulatory approval procedures. Additionally, the reallocation of healthcare resources towards COVID-19 management also impacted the market progress.
Biosimilars Market Trends
The major trend promoting better market accessibility and competitiveness is the rise in the number of biosimilar products receiving regulatory authority clearance. For instance, in July 2021, the U.S. FDA authorized Glenmark Pharmaceuticals' Ryaltris (olopatadine hydrochloride and mometasone furoate), a biosimilar of Dymista, for the treatment of allergic rhinitis. Similarly, in June 2021, the European Commission authorized the sale of Aybintio (bevacizumab), a biosimilar of Avastin created by Samsung Bioepis. Additionally, the market is witnessing an increase in R&D activities as businesses engage in cutting-edge manufacturing techniques and innovative analytics for the development of biosimilars, which will support industry landscape.
Biosimilars Market Analysis
The recombinant non-glycosylated proteins segment, comprising human growth hormone, granulocyte stimulating factor, insulin and interferon, in the biosimilars market is expected to grow at 12.8% CAGR from 2023-2032. These biosimilar products are largely used in the treatment of growth hormone deficiencies, infections during chemotherapy, diabetes, malignant myeloma, and renal carcinoma among others. The rising focus on treating various chronic diseases, such as blood disorders and growth hormone deficiencies as well as offering comparable safety and efficacy profiles will add to the segment expansion.
Biosimilars market size from the hematology segment is projected to generate more than USD 52 billion by 2032. The development of monoclonal antibodies for the treatment of blood diseases has provided lucrative growth prospects for the expansion of the biosimilars industry. Healthcare professionals are looking for more reasonably priced treatment alternatives to meet the demands of patients on account of the rising frequency of hematology-related disorders. The presence of supportive regulatory frameworks along with the increasing patient and physician awareness is also driving the use of biosimilars in hematology.
North America biosimilars market recorded significant growth in 2022 and is expected to reach over USD 26.5 billion by 2032. Biosimilars are gaining popularity as viable replacements for expensive biologics as the preference for cost-effective healthcare solutions is increasing across the region. Additionally, the presence of supportive regulatory frameworks such as the US Biologics Price Competition and Innovation Act, have simplified the clearance process for biosimilars, promoting market access and competition. Furthermore, the patent expiration of numerous bestselling biologics has opened opportunities for new biosimilar producers to enter the market, further augmenting the market outlook.
Biosimilars Market Share
The competitive landscape of the biosimilars market includes:
Biosimilars Market News
The biosimilars market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue in USD Million from 2018 to 2032 for the following segments:
By Product
By Application
By Manufacturer
By Technology
The above information is provided for the following regions and countries: