| Study Period | 2019 - 2030 |
| Market Size (2025) | USD 11.98 Billion |
| Market Size (2030) | USD 25.16 Billion |
| CAGR (2025 - 2030) | 16.00 % |
| Fastest Growing Market | Asia Pacific |
| Largest Market | North America |
| Market Concentration | High |
Major Players
*Disclaimer: Major Players sorted in no particular order |
Biosimilar Contract Manufacturing Market Analysis
The Biosimilar Contract Manufacturing Market size is estimated at USD 11.98 billion in 2025, and is expected to reach USD 25.16 billion by 2030, at a CAGR of 16% during the forecast period (2025-2030).
Biosimilar contract manufacturing involves outsourcing the production of biosimilar drugs to specialized contract manufacturing organizations (CMOs). These drugs, while highly similar to existing biological medicines, require complex manufacturing processes. CMOs play a pivotal role in ensuring quality, scalability, and cost-effectiveness for companies in biosimilar production. Several factors, such as increasing technological advancements, growing demand for biosimilars, and strategic collaborations and partnerships, are expected to drive market growth over the forecast period.
Furthermore, there is an increasing demand for cost-effective solutions to enhance global patient access to biosimilars. Strategic collaborations among key players are playing a pivotal role in this expansion. For instance, in September 2023, Chime Biologics entered a strategic partnership with Kings Pharm. As per the terms of the agreement, Chime Biologics will utilize its extensive expertise in biosimilar projects to offer a suite of services to Kings Pharm. These services encompass cell line development, early process development, global clinical and commercial manufacturing, and registration services. Such partnerships are expected to strengthen the market's growth trajectory, ensuring the delivery of high-quality biosimilars to meet the rising global demand.
In addition, as the demand for complex biosimilars rises, the biosimilar contract manufacturing market is undergoing significant transformation. Companies are increasingly forming strategic partnerships to address global patient needs and expand access to innovative treatments. By leveraging advanced manufacturing capabilities and strengthening collaborations, these companies aim to streamline production processes and enhance patient outcomes worldwide. For instance, in March 2023, Samsung Biologics and Pfizer recently expanded their partnership. Initially, the two companies signed a manufacturing agreement for a specific Pfizer product. Under the new long-term contract, Samsung Biologics will provide additional capacity to support Pfizer’s multi-product biosimilar portfolio, which includes treatments for oncology, inflammation, and immunology. Samsung will utilize its cutting-edge Plant 4 facility for large-scale production. This growing emphasis on strategic collaborations is expected to drive the biosimilar contract manufacturing market forward, ensuring scalability and innovation in meeting global healthcare demands.
Therefore, owing to factors such as increasing technological advancements, growing demand for biosimilars, and strategic collaborations and partnerships, the biosimilar contract manufacturing market is anticipated to witness growth over the forecast period. However, the high initial investment & manufacturing costs, as well as challenges associated with biosimilar manufacturing, are expected to restrain market growth.
Biosimilar Contract Manufacturing Market Trends
The Oncology Segment is Expected to Witness Significant Growth Over the Forecast Period
The oncology segment in biosimilar contract manufacturing focuses on producing cost-effective biosimilar versions of complex cancer therapies, such as monoclonal antibodies. These alternatives aim to reduce treatment costs and improve patient access to critical oncology drugs. Moreover, the increasing prevalence of cancer, growing demand for biosimilars, increasing technological advancement, and rising focus on cost-effective therapies are expected to create substantial opportunities for market players over the forecast period.
Moreover, the increasing incidence of cancer, particularly lymphoma, is driving the demand for effective treatments. For example, the American Cancer Society estimated that approximately 89,100 new lymphoma cases were diagnosed in the United States in 2024. This high prevalence of cancer is boosting the need for targeted therapies, thereby driving the segment growth over the forecast period. In addition, companies are establishing strategic partnerships to broaden their market presence and improve access to essential medicines. For instance, in September 2023, Abbott entered a collaboration with mAbxience Holdings S.L., a prominent biotech firm based in Spain, to roll out a series of biosimilars targeting oncology, women's health, and respiratory ailments. This collaboration aims to enhance the accessibility of these vital medicines in emerging markets. The biosimilar was expected to be introduced in 2025, with subsequent launches dependent on the successful completion of clinical trials and regulatory approvals. Such partnerships underscore the growing importance of biosimilar contract manufacturing in addressing global healthcare needs.
Additionally, key market players are collaborating to establish an ideal strategic partnership model, aiming to optimize development costs, mitigate risks, and leverage extensive commercial capabilities. For instance, in April 2024, Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., partnered with mAbxience. The two companies signed a strategic licensing agreement for a biosimilar candidate under development, targeting multiple oncology indications. These biosimilars present significant potential as cost-effective alternatives to existing oncology therapies, addressing a critical need in global cancer care. Under the licensing agreement, mAbxience will utilize its expertise in biosimilar development and its state-of-the-art, cGMP-approved facilities in Spain and Argentina to develop and manufacture the biosimilar. This partnership underscores the growing importance of biosimilars in transforming oncology treatment landscapes over an anticipated period.
Furthermore, the expiration of patent exclusivity for key oncology drugs is driving growth in biosimilar contract manufacturing within the oncology segment. This trend focuses on delivering cost-effective cancer treatments. Technological advancements, including plant molecular farming and cutting-edge GMP facilities, are instrumental in enhancing the efficiency and scalability of complex biosimilar production, thereby improving global access to vital cancer therapies. For instance, in November 2023, SwiftPharma entered into a contract manufacturing agreement with Canadian biopharmaceutical firm PlantForm Corporation. Under this partnership, SwiftPharma manufactures antibodies and proteins for PlantForm’s product portfolio. The agreement also provides PlantForm with non-exclusive access to SwiftPharma's manufacturing capabilities to produce biosimilar pembrolizumab using PlantForm’s proprietary systems and materials. These advancements and collaborations underscore the oncology segment's pivotal role in shaping the biosimilar contract manufacturing market.
Hence, due to the abovementioned factors, the oncology segment is expected to witness significant growth in the upcoming years.
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North America is Expected to Dominate the Market Over the Forecast Period
North America is expected to dominate the market owing to factors such as the rising need for cost-efficient biosimilar manufacturing, growing biopharmaceutical companies, and increasing strategic collaborations aimed at enhancing the accessibility and affordability of biosimilars.
Moreover, growth in the North American biosimilar contract manufacturing market is fueled by the reliance of numerous small and mid-sized biotech companies in the United States on external manufacturing support to commercialize their novel molecules. Limited clinical phase capacity among these firms has further increased the demand for contract manufacturing services. Additionally, the rising need for cost-efficient biosimilar manufacturing is accelerating market growth. For instance, in January 2024, Enzene Biosciences revealed plans to establish its first manufacturing facility in the United States. The facility was projected to become operational by June 2024, with customers already securing capacities for continuous manufacturing and fed-batch processes. Enzene Biosciences plans to expand its operations across the five major markets for biologics and biosimilars, including Europe, the United States, Canada, Australia, and Japan, with the goal of positioning itself as a prominent biotech company serving a global clientele. These developments underscore the growing importance of contract manufacturing in meeting the evolving needs of the biosimilar industry.
Furthermore, increasing demand for cost-effective biosimilars and the rising adoption of biosimilars across diverse therapeutic areas are contributing to market growth. This growth plays a critical role in the pharmaceutical industry by enabling the large-scale production of biosimilars, which are essential for addressing the growing healthcare needs. For instance, in January 2024, the Journal of Infusion Nursing reported that the United States FDA had approved 40 biosimilars as of March 2023. These biosimilars cater to various therapeutic areas, including immunology (like rheumatoid arthritis and psoriasis), oncology (such as non-Hodgkin's lymphoma), supportive care (like neutropenia treatment), ophthalmology (for age-related macular degeneration), and diabetes management (insulin therapy). In addition, according to the United States FDA, there are 68 total approved biosimilars as of March 2025. This upward trend underscores the growing importance of biosimilars in the pharmaceutical industry and highlights the expanding opportunities within the contract manufacturing market.
Additionally, increasing strategic collaborations aimed at enhancing the accessibility and affordability of biosimilars. Such partnerships are pivotal in addressing the growing demand for high-quality biosimilars in the healthcare sector. For instance, in April 2024, Alvotech, in collaboration with Teva Pharmaceuticals, a United States affiliate of Teva Pharmaceutical Industries Ltd., inked a pivotal agreement. Under this United States partnership, Alvotech aimed to manufacture a high-concentration interchangeable biosimilar of Humira (adalimumab) specifically for Quallent Pharmaceuticals. This aligns seamlessly with Alvotech's existing United States commercialization pact with Teva. The newly developed interchangeable biosimilar is marketed under Quallent’s private label upon distribution. Alvotech's commercial partnerships in the United States market are aimed at expanding healthcare access, ensuring the timely availability of cost-effective, high-quality biologics for patients. Such collaborations underscore the importance of the biosimilar contract manufacturing market as companies strive to meet the increasing demand for cost-effective solutions, thereby driving market growth.
Therefore, owing to the factors mentioned above, such as the rising need for cost-efficient biosimilar manufacturing, growing biopharmaceutical companies, and increasing strategic collaborations aimed at enhancing the accessibility and affordability of biosimilars, the North American region is set to witness significant growth in the biosimilar contract manufacturing market.
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Biosimilar Contract Manufacturing Industry Overview
The biosimilar contract manufacturing market is consolidated due to the presence of several companies operating globally and regionally. Leading companies shaping the market include both global players and notable local firms. Key participants were Boehringer Ingelheim Biopharmaceuticals GmbH, Lonza, Catalent, Inc., Biocon, and IQVIA Inc., among others.
Biosimilar Contract Manufacturing Market Leaders
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Boehringer Ingelheim Biopharmaceuticals GmbH
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Lonza
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Catalent, Inc.
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Biocon
- *Disclaimer: Major Players sorted in no particular order
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Biosimilar Contract Manufacturing Market News
- October 2024: Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd., and mAbxience, a group majority-owned by Fresenius Kabi and partially owned by Insud Pharma, entered into a global licensing agreement for the development of an anti-PD-1 biosimilar oncology. This marks the second collaboration between the two companies, highlighting the firm foundation of their partnership, which began in April 2024.
- May 2024: Boehringer Ingelheim Biopharmaceuticals GmbH finalized an agreement with Quallent Pharmaceuticals. This strategic partnership aims to utilize Quallent's extensive network and expertise to expand the availability of Boehringer Ingelheim's biosimilar products. The collaboration aligns with Boehringer Ingelheim's broader strategy to improve healthcare affordability and increase patient access to high-quality biosimilars.
Biosimilar Contract Manufacturing Industry Segmentation
Biosimilar contract manufacturing refers to the practice of outsourcing the production of biosimilar drugs to specialized contract manufacturing organizations (CMOs). These organizations possess the expertise and infrastructure required to handle the complex and highly regulated processes involved in biosimilar production. Biosimilars are biologic medicines that are highly similar to already approved reference products, offering comparable safety, efficacy, and quality.
The biosimilar contract manufacturing market is segmented into production technology, product, application, service type, and geography. By production technology, the market is segmented into mammalian and microbial. By product, the market is segmented into recombinant non-glycosylated proteins and recombinant glycosylated proteins. By application, the market is segmented into oncology, infectious diseases, blood disorders, chronic & autoimmune diseases, growth hormonal deficiency, and others. The other applications include genetic diseases and neurological diseases, among others. By service type, the market is segmented into upstream processing, downstream processing, biosimilarity testing, bioassays, process development, and fill & finish. By geography, the market is segmented into North America, Europe, Asia-Pacific, South America, Middle East and Africa. For each segment, the market sizing and forecasts have been done based on revenue (USD).
| By Production Technology | Mammalian | ||
| Microbial | |||
| By Product | Recombinant Non-glycosylated Proteins | ||
| Recombinant Glycosylated Proteins | |||
| By Application | Oncology | ||
| Infectious Diseases | |||
| Blood Disorders | |||
| Chronic & Autoimmune Diseases | |||
| Growth Hormonal Deficiency | |||
| Others | |||
| By Service Type | Upstream Processing | ||
| Downstream Processing | |||
| Biosimilarity Testing | |||
| Bioassays | |||
| Process Development | |||
| Fill & Finish | |||
| Geography | North America | United States | |
| Canada | |||
| Mexico | |||
| Europe | Germany | ||
| United Kingdom | |||
| France | |||
| Italy | |||
| Spain | |||
| Rest of Europe | |||
| Asia Pacific | China | ||
| Japan | |||
| India | |||
| Australia | |||
| South Korea | |||
| Rest of Asia-Pacific | |||
| Middle East and Africa | GCC | ||
| South Africa | |||
| Rest of Middle East and Africa | |||
| South America | Brazil | ||
| Argentina | |||
| Rest of South America | |||
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Biosimilar Contract Manufacturing Market Research Faqs
How big is the Biosimilar Contract Manufacturing Market?
The Biosimilar Contract Manufacturing Market size is expected to reach USD 11.98 billion in 2025 and grow at a CAGR of 16% to reach USD 25.16 billion by 2030.
What is the current Biosimilar Contract Manufacturing Market size?
In 2025, the Biosimilar Contract Manufacturing Market size is expected to reach USD 11.98 billion.
Who are the key players in Biosimilar Contract Manufacturing Market?
Boehringer Ingelheim Biopharmaceuticals GmbH, Lonza, Catalent, Inc. and Biocon are the major companies operating in the Biosimilar Contract Manufacturing Market.
Which is the fastest growing region in Biosimilar Contract Manufacturing Market?
Asia Pacific is estimated to grow at the highest CAGR over the forecast period (2025-2030).
Which region has the biggest share in Biosimilar Contract Manufacturing Market?
In 2025, the North America accounts for the largest market share in Biosimilar Contract Manufacturing Market.
What years does this Biosimilar Contract Manufacturing Market cover, and what was the market size in 2024?
In 2024, the Biosimilar Contract Manufacturing Market size was estimated at USD 10.06 billion. The report covers the Biosimilar Contract Manufacturing Market historical market size for years: 2019, 2020, 2021, 2022, 2023 and 2024. The report also forecasts the Biosimilar Contract Manufacturing Market size for years: 2025, 2026, 2027, 2028, 2029 and 2030.
Biosimilar Contract Manufacturing Industry Report
Statistics for the 2025 Biosimilar Contract Manufacturing market share, size and revenue growth rate, created by Mordor Intelligence™ Industry Reports. Biosimilar Contract Manufacturing analysis includes a market forecast outlook for 2025 to 2030 and historical overview. Get a sample of this industry analysis as a free report PDF download.
