The global biosimilar contract manufacturing market accounted for USD 7.48 billion in 2023 and is expected to reach at USD 48.67 billion by 2034 with a CAGR of 18.56% during the forecast period 2024-2034. The rise in the popularity of biosimilars for treating various diseases such as cancer & autoimmune disorders, the lower cost of biosimilar compared to biologics, increasing adoption of biosimilars, expiration of patents for major biologics, escalating need for affordable yet potent medications, growing demand for cost-effective & highly efficient therapeutics, surge in biosimilar pipeline, rising regulatory approvals, and increasing novel biosimilar development efforts by industry players are some of the key factors boosting the market growth.
Increasing novel biosimilar development efforts by industry players is predicted to boost the market growth during the forecast period. The Biosimilar Contract Manufacturing Market entails the delegation of biosimilar pharmaceutical product manufacturing tasks to specialized contract manufacturing organizations (CMOs). Biosimilars are biological products that closely resemble approved reference biologics without any clinically significant variances. Contract manufacturing enables companies to utilize the proficiency, resources, and production capacity of CMOs to produce biosimilars in a cost-efficient, streamlined, and regulatory-compliant manner. For instance, in January 2023, AMJEVITA (adalimumab-atto), a biosimilar of Humira (adalimumab), was introduced by Amgen Inc. in the US.
By products, recombinant non-glycosylated proteins was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the increase in diabetes cases has led to the availability of biosimilars at lower prices compared to branded insulins. Recombinant non-glycosylated proteins encompass Granulocyte Colony-Stimulating Factors (G-CSFs), insulin, interferon, and human growth hormone. G-CSF, a naturally occurring growth factor targeting hematopoietic cells, is administered to patients following myelosuppressive chemotherapy, with its utilization notably enhancing among cancer patients undergoing chemotherapy. Insulin stands as another prevalent recombinant non-glycosylated protein in widespread use. Additionally, recombinant glycosylated proteins is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for monoclonal antibodies, increase in cancer diagnoses, and growing trend of collaborations among industry stakeholders. Biosimilars of recombinant glycosylated proteins are employed in the treatment of blood disorders, cancers, and infectious diseases. For instance, in November 2023, SwiftPharma, a biotechnology company specializing in plant molecular farming based in Belgium, has entered into a contract manufacturing agreement with PlantForm Corporation, a Canadian biopharmaceutical company. SwiftPharma will provide proteins and antibodies for PlantForm's product pipeline as per this agreement.
By production technology, mammalian was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the utilizing mammalian cells for protein expression offers a significant advantage such as the production of mammalian proteins with accurate post-translational modifications, ensuring a native structure. Additionally, non-mammalian is predicted to grow at the fastest CAGR during the forecast period owing to the increase in partnerships between industry participants. Non-mammalian products encompass biotherapeutics derived from microbial sources. Microbial systems are frequently employed for the production of recombinant protein therapeutics. Moreover, microbial products play a role in producing cytokines, hormones, enzymes, and monoclonal antibodies (MABs). For instance, in October 2022, Biocon and Yoshindo Inc. have formed a partnership to commercialize Biocon's pipeline products ustekinumab and bDenosumab in Japan.
By application, oncology was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the significant occurrence of cancer, including liver, stomach, breast, colorectal, lung, & blood cancers, rising need for cost-effective therapeutic medications that deliver high efficacy, and increasing number of approvals by regulatory agencies. For instance, in August 2022, The FDA in the United States granted approval to Coherus' medication Cimerli as an interchangeable biosimilar for Lucentis. Additionally, chronic & autoimmune disorders is predicted to grow at the fastest CAGR during the forecast period owing to the increasing incidence of chronic and autoimmune conditions. Among the most prevalent autoimmune disorders treatable with biosimilars are polyarticular spondylitis, plaque psoriasis, Crohn’s disease, and arthritis.
North America region is anticipated for the highest revenue share during the forecast period owing to the rise in the use of biosimilars, coupled with substantial biopharmaceutical contract development & manufacturing capabilities, a robust healthcare infrastructure, rise in product releases, advancements in biosimilar production technology, and the expanding range of advanced services offered by industry participants. For instance, in October 2023, Tanvex Biopharma Inc., a company specializing in the development and production of biopharmaceuticals, has introduced Tanvex CDMO. This new entity aims to deliver extensive contract development and manufacturing services for biologics, leveraging its knowledge and proficiency to support the biopharmaceutical sector. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increase in the authorization of biosimilar medications, rising need for more affordable therapeutic options, growing prevalence of chronic & non-communicable diseases, heightened demand for cost-effective treatments and the expansion efforts of market participants. For instance, in June 2023, Enzene Biosciences unveiled its latest cutting-edge manufacturing facility in Pune, India, with the objective of enhancing its drug development and manufacturing capacities.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Increasing novel biosimilar development efforts by industry players is predicted to boost the market growth during the forecast period. The Biosimilar Contract Manufacturing Market entails the delegation of biosimilar pharmaceutical product manufacturing tasks to specialized contract manufacturing organizations (CMOs). Biosimilars are biological products that closely resemble approved reference biologics without any clinically significant variances. Contract manufacturing enables companies to utilize the proficiency, resources, and production capacity of CMOs to produce biosimilars in a cost-efficient, streamlined, and regulatory-compliant manner. For instance, in January 2023, AMJEVITA (adalimumab-atto), a biosimilar of Humira (adalimumab), was introduced by Amgen Inc. in the US.
By products, recombinant non-glycosylated proteins was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the increase in diabetes cases has led to the availability of biosimilars at lower prices compared to branded insulins. Recombinant non-glycosylated proteins encompass Granulocyte Colony-Stimulating Factors (G-CSFs), insulin, interferon, and human growth hormone. G-CSF, a naturally occurring growth factor targeting hematopoietic cells, is administered to patients following myelosuppressive chemotherapy, with its utilization notably enhancing among cancer patients undergoing chemotherapy. Insulin stands as another prevalent recombinant non-glycosylated protein in widespread use. Additionally, recombinant glycosylated proteins is predicted to grow at the fastest CAGR during the forecast period owing to the rising demand for monoclonal antibodies, increase in cancer diagnoses, and growing trend of collaborations among industry stakeholders. Biosimilars of recombinant glycosylated proteins are employed in the treatment of blood disorders, cancers, and infectious diseases. For instance, in November 2023, SwiftPharma, a biotechnology company specializing in plant molecular farming based in Belgium, has entered into a contract manufacturing agreement with PlantForm Corporation, a Canadian biopharmaceutical company. SwiftPharma will provide proteins and antibodies for PlantForm's product pipeline as per this agreement.
By production technology, mammalian was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the utilizing mammalian cells for protein expression offers a significant advantage such as the production of mammalian proteins with accurate post-translational modifications, ensuring a native structure. Additionally, non-mammalian is predicted to grow at the fastest CAGR during the forecast period owing to the increase in partnerships between industry participants. Non-mammalian products encompass biotherapeutics derived from microbial sources. Microbial systems are frequently employed for the production of recombinant protein therapeutics. Moreover, microbial products play a role in producing cytokines, hormones, enzymes, and monoclonal antibodies (MABs). For instance, in October 2022, Biocon and Yoshindo Inc. have formed a partnership to commercialize Biocon's pipeline products ustekinumab and bDenosumab in Japan.
By application, oncology was the highest revenue-grossing segment in the global biosimilar contract manufacturing market in 2023 owing to the significant occurrence of cancer, including liver, stomach, breast, colorectal, lung, & blood cancers, rising need for cost-effective therapeutic medications that deliver high efficacy, and increasing number of approvals by regulatory agencies. For instance, in August 2022, The FDA in the United States granted approval to Coherus' medication Cimerli as an interchangeable biosimilar for Lucentis. Additionally, chronic & autoimmune disorders is predicted to grow at the fastest CAGR during the forecast period owing to the increasing incidence of chronic and autoimmune conditions. Among the most prevalent autoimmune disorders treatable with biosimilars are polyarticular spondylitis, plaque psoriasis, Crohn’s disease, and arthritis.
North America region is anticipated for the highest revenue share during the forecast period owing to the rise in the use of biosimilars, coupled with substantial biopharmaceutical contract development & manufacturing capabilities, a robust healthcare infrastructure, rise in product releases, advancements in biosimilar production technology, and the expanding range of advanced services offered by industry participants. For instance, in October 2023, Tanvex Biopharma Inc., a company specializing in the development and production of biopharmaceuticals, has introduced Tanvex CDMO. This new entity aims to deliver extensive contract development and manufacturing services for biologics, leveraging its knowledge and proficiency to support the biopharmaceutical sector. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the increase in the authorization of biosimilar medications, rising need for more affordable therapeutic options, growing prevalence of chronic & non-communicable diseases, heightened demand for cost-effective treatments and the expansion efforts of market participants. For instance, in June 2023, Enzene Biosciences unveiled its latest cutting-edge manufacturing facility in Pune, India, with the objective of enhancing its drug development and manufacturing capacities.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Product, Production Technology, and Application
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of Top 10+ Major Market Players
Segmentation: Biosimilar Contract Manufacturing Market Report 2023 - 2034
Biosimilar Contract Manufacturing Market Analysis & Forecast by Product 2023 - 2034 (Revenue USD Bn)
- Recombinant Glycosylated Proteins
- Recombinant Non-glycosylated Proteins
Biosimilar Contract Manufacturing Market Analysis & Forecast by Production Technology 2023 - 2034 (Revenue USD Bn)
- Non-Mammalian
- Mammalian
Biosimilar Contract Manufacturing Market Analysis & Forecast by Application 2023 - 2034 (Revenue USD Bn)
- Chronic & Autoimmune Disorders
- Growth Hormonal Deficiency
- Rheumatoid Arthritis
- Blood Disorders
- Oncology
- Others
Biosimilar Contract Manufacturing Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Biosimilar Contract Manufacturing Market: Product Estimates & Trend Analysis
8. Biosimilar Contract Manufacturing Market: Production Technology Estimates & Trend Analysis
9. Biosimilar Contract Manufacturing Market: Application Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Biosimilar Contract Manufacturing Market
12. Europe Global Biosimilar Contract Manufacturing Market
13. Asia Pacific Global Biosimilar Contract Manufacturing Market
14. Latin America Global Biosimilar Contract Manufacturing Market
15. MEA Global Biosimilar Contract Manufacturing Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Boehringer Ingelheim Biopharmaceuticals GmbH
- Fujifilm Kyowa Kirin Biologics Co. Ltd.
- Element Materials Technology
- Thermo Fisher Scientific Inc.
- Rentschler Biopharma SE
- Alcami Corporation Inc.
- Avid Bioservices Inc.
- Samsung Biologics
- WuXi Biologics
- AGC Biologics
- Almac Group
- Catalent Inc.
- IQVIA Inc.
- Biocon
- Lonza
