Biologics Contract Manufacturing Market

Biologics Contract Manufacturing Market by Type of Biologics Manufactured (Cell-Based Biologics, Gene-Based Biologics, Monoclonal Antibodies, Vaccines, Recombinant Protiens, and Others), Type of Expression System (Microbial, Mammalian, and Others), Application (Oncology, Immunology, Cardiology, Neurological, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of chronic diseases, robust pipeline of biologics, increase in advancements in biotechnology and biomedical science techniques, and growing product development activities across the globe.

The global biologics contract manufacturing market was valued at USD 23,240.99 million in 2024, growing at a CAGR of 9.39% during the forecast period from 2025 to 2032 to reach USD 47,494.63 million by 2032. The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is fueling the demand for biologics, leading pharmaceutical companies to increase outsourcing to contract manufacturers for large-scale production. Simultaneously, a robust pipeline of biologics, including monoclonal antibodies, vaccines, and biosimilars, requires flexible manufacturing solutions to meet growing market needs efficiently. Advancements in biotechnology and biomedical science techniques such as recombinant DNA technology and improved expression systems are enabling faster development cycles, making contract manufacturing a preferred choice for scalability. Furthermore, growing product development activities globally, driven by small and mid-sized biotech firms and major pharmaceutical players, are enhancing collaborations with CMOs and CDMOs to accelerate time-to-market while maintaining cost efficiency. Together, these factors are propelling the biologics contract manufacturing market forward, addressing the need for high-quality, large-scale production with enhanced flexibility and expertise during the forecast period from 2025 to 2032.

Biologics Contract Manufacturing Market Dynamics:

As per the recent data and stats provided by the International Agency for Research on Cancer (2024), in 2022, the estimated new cases of cancer across the globe was 20 million and the projections are indicated to increase by 32.6 million by 2045. The increase in cancer cases is significantly boosting the biologics contract manufacturing market, as biologics such as monoclonal antibodies, cell therapies, and cancer vaccines play a critical role in oncology treatments. The rising incidence of cancers, including breast, lung, and colorectal cancers, has driven pharmaceutical companies to expand their biologics portfolios. For instance, as per the data provided by the International Agency for Research on Cancer (2024), in 2022, the estimated new cases of breast cancer was 2.30 million, and colorectal cancer was 1.93 million and the projections were indicated to increase by 3.36 million and 3.29 million respectively by 2045. This, in turn, increases the demand for contract manufacturing organizations (CMOs) that offer specialized facilities, scalable production, and regulatory expertise.

Additionally, the biologics pipeline consists of products like monoclonal antibodies (mAbs), vaccines, recombinant proteins, and gene therapies. Increasing investments in research and development (R&D) and the need for treatments for chronic diseases, cancer, and infectious diseases are driving this growth. As more biologics progress through clinical trials toward commercialization, demand for contract manufacturing services rises. Biopharmaceutical companies often outsource production to CMOs due to the lack of in-house capacity and infrastructure for complex biologics, which require specialized techniques such as cell culture and purification processes. For instance, in March 2025, India's Syngene International acquired its first U.S. biologics facility from Emergent BioSolutions for $36.5 million. Located in Baltimore, the facility will enhance Syngene's large molecule discovery, development, and manufacturing services, increasing its bioreactor capacity from 20,000 to 50,000 liters. Thereby, escalating the overall market of biologic contract manufacturing across the globe.

Furthermore, the ongoing development activities among the key market players are further bolstering the overall market of biologics contract manufacturers. For instance, in August 2024, AGC Biologics partnered with NEC Bio Therapeutics to advance the production of NECVAX-NEO1, an orally delivered, bacteria-based DNA vaccine targeting patient-specific tumor neoantigens. NEC Bio integrates AI and machine learning with traditional biologics to enhance personalized care solutions.

Thus, the factors mentioned above are expected to boost the overall market of biologics contract manufacturing across the globe during the forecast period from 2025 to 2032.

However, limited production capacity and supply chain issues along with strict regulatory guidelines (like cGMP) from agencies such as the FDA and EMA may result in slight obstacles to the growth of the biologics contract manufacturing market.

Biologics Contract Manufacturing Market Segment Analysis:

Biologics Contract Manufacturing Market by Type of Biologics Manufactured (Cell-Based Biologics, Gene-Based Biologics, Monoclonal Antibodies, Vaccines, Recombinant Protiens, and Others), Type of Expression System (Microbial, Mammalian, and Others), Application (Oncology, Immunology, Cardiology, Neurological, and Others), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) 

In the type of biologics manufactured segment of the biologics contract manufacturing market, monoclonal antibodies are estimated to have a significant revenue share in the biologics contract manufacturing market in 2024. Monoclonal antibodies (mAbs) have become a cornerstone of modern medicine, significantly boosting the biologics contract manufacturing market. Their unique ability to target specific antigens makes them invaluable in treating various diseases, particularly cancers and autoimmune disorders. Monoclonal antibodies are designed to bind to specific targets on cancer cells or pathogens, enhancing the precision of therapeutic interventions. This targeted approach has led to improved patient outcomes and fewer side effects compared to traditional therapies.

The demand for targeted therapies is driving biopharmaceutical companies to invest in mAb development, subsequently increasing the need for contract manufacturing services that can efficiently produce these complex biologics.

Additionally, the monoclonal antibodies pipeline is expanding rapidly, in various stages of clinical trials. According to the FDA (2024), over 100 monoclonal antibodies have been approved by the FDA, with many more under development. This growing pipeline necessitates reliable contract manufacturing organizations (CMOs) capable of scaling production to meet clinical and commercial demands.

With more companies focusing on personalized medicine, such as antibody-drug conjugates (ADCs) and immune checkpoint inhibitors, the demand for biologics contract manufacturing continues to rise. Overall, monoclonal antibodies are playing a pivotal role in shaping the growth trajectory of the biologics manufacturing market. For instance, in December 2024, Eurofins CDMO Alphora Inc. announced the construction of a GMP biologics manufacturing facility in Mississauga, Ontario. This 112,000 sq ft facility is designed to produce monoclonal antibodies and protein therapies for clinical and commercial applications, with completion expected by 2026.

Thus, the factors mentioned above are expected to boost the segment thereby boosting the overall market of biologics contract manufacturing across the globe.

North America is expected to dominate the overall biologics contract manufacturing market:

North America is expected to hold the largest share of the biologic contract manufacturing organization market in 2024, driven by several key factors. North America is expected to dominate the biologics contract manufacturing market due to the rising prevalence of chronic diseases such as cancer, autoimmune disorders, and cardiovascular conditions, which drive demand for biologics. The region is home to several leading biopharmaceutical companies and CMOs with advanced manufacturing facilities, offering expertise in cell culture, fermentation, and downstream processes. Additionally, increased investments in research and development (R&D), favorable regulatory frameworks, and government initiatives supporting biotechnology innovation further strengthen market growth. Furthermore, the presence of key players, a robust pipeline of biologics, and growing outsourcing trends among pharmaceutical companies are also contributing factors to North America's leadership in this market.

As per the recent data provided by GLOBOCAN (2024), in 2022, the estimated new cases of cancer in North America was 2.67 million and the projections were estimated to increase by 3.83 million by 2045. As pharmaceutical and biotech companies develop a growing pipeline of biologics for oncology, many are outsourcing production to Contract Manufacturing Organizations (CMOs). These organizations offer specialized capabilities, such as large-scale cell culture, fermentation technologies, and aseptic manufacturing, required for complex biologics production. Furthermore, the rising number of clinical trials for biologics of cancer treatment adds to the demand for contract manufacturing services to meet production scalability and commercialization needs.

Additionally, advancements in biotechnology and biomedical science are significantly boosting the biologics contract manufacturing market by enabling more efficient, precise, and scalable production processes. As new technologies emerge such as CRISPR-based gene editing, advanced fermentation methods, and cutting-edge cell culture systems biopharmaceutical companies are developing increasingly complex biologics, including monoclonal antibodies (mAbs), recombinant proteins, and cell and gene therapies. These advanced techniques allow for faster R&D and improved yields during manufacturing. However, many biopharma companies lack the infrastructure and expertise required to handle these novel production technologies, leading them to rely on specialized Contract Manufacturing Organizations (CMOs). For example, Samsung Biologics offers large-scale production of biologics using advanced single-use systems to meet the growing demand for mAbs and vaccines. Similarly, Lonza Group leverages cutting-edge technologies in cell and gene therapy manufacturing, offering flexible solutions that support the production of next-generation therapies.

Additionally, the increase in product development activities across the region is also boosting the overall market of biologics contract manufacturing. For instance, in August 2024, Novartis Pharma AG and biotech Lindy Biosciences agreed to collaborate to advance subcutaneous biologic injectables.

Thus, the above-mentioned factors are expected to escalate the market of biologics contract manufacturing in the region.

Biologics Contract Manufacturing Market Key Players:

Some of the key market players operating in the biologics contract manufacturing market include AGC Biologics, Boehringer Ingelheim, Catalent, Cell Therapies, Charles River Laboratories, FUJIFILM Diosynth Biotechnologies, KBI Biopharma, Kemwell Biopharma, Lonza, Miltenyi Biotec, Minaris Regenerative Medicine, Samsung Biologics, Sandoz, Vetter Pharma, WuXi Biologics, Sanofi, Kymab, Novartis Pharma AG, Lindy Biosciences, Siegfried AG, and others.

Recent Developmental Activities in the Biologics Contract Manufacturing Market:

• In October 2024, Enzene Biosciences launched EnzeneX™ 2.0 the next generation of its fully-connected continuous manufacturing™ (FCCM™) technology for biologics at CPHI Milan 2024.
• In August 2024, NEC Bio Therapeutics and AGC Biologics announced a collaboration to manufacture personalized cancer vaccines.

Key Takeaways From the Biologics Contract Manufacturing Market Report Study

• Market size analysis for current biologics contract manufacturing size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the biologics contract manufacturing market.
• Various opportunities available for the other competitors in the biologics contract manufacturing market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current biologics contract manufacturing market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for biologics contract manufacturing market growth in the coming future?

Target Audience Who Can be Benefited From This Biologics Contract Manufacturing Market Report Study

• Biologics contract manufacturing product providers
• Research organizations and consulting companies
• Biologics contract manufacturing-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in biologics contract manufacturing
• Various end-users who want to know more about the biologics contract manufacturing market and the latest technological developments in the biologics contract manufacturing market. 

Frequently Asked Questions for the Biologics Contract Manufacturing Market:

1. What are biologics contract manufacturing?

• Biologics contract manufacturing involves outsourcing the production of complex biological products such as monoclonal antibodies, vaccines, recombinant proteins, and cell or gene therapies to specialized companies. These Contract Manufacturing Organizations (CMOs) provide the infrastructure, expertise, and technology required for large-scale biologics production, allowing biopharma companies to focus on research and innovation while meeting regulatory and market demands efficiently.

2. What is the market for biologics contract manufacturing?

• The global biologics contract manufacturing market was valued at USD 23,240.99 million in 2024, growing at a CAGR of 9.39% during the forecast period from 2025 to 2032 to reach USD 47,494.63 million by 2032.

3. What are the drivers for the global biologics contract manufacturing market?

• The rising prevalence of chronic diseases such as cancer, diabetes, and autoimmune disorders is fueling the demand for biologics, leading pharmaceutical companies to increase outsourcing to contract manufacturers for large-scale production. Simultaneously, a robust pipeline of biologics, including monoclonal antibodies, vaccines, and biosimilars, requires flexible manufacturing solutions to meet growing market needs efficiently. Advancements in biotechnology and biomedical science techniques such as recombinant DNA technology and improved expression systems are enabling faster development cycles, making contract manufacturing a preferred choice for scalability. Furthermore, growing product development activities globally, driven by small and mid-sized biotech firms and major pharmaceutical players, are enhancing collaborations with CMOs and CDMOs to accelerate time-to-market while maintaining cost efficiency. Together, these factors are propelling the biologics contract manufacturing market forward, addressing the need for high-quality, large-scale production with enhanced flexibility and expertise during the forecast period from 2025 to 2032.

4. Who are the key players operating in the global biologics contract manufacturing market?

• Some of the key market players operating in the biologics contract manufacturing are AGC Biologics, Boehringer Ingelheim, Catalent, Cell Therapies, Charles River Laboratories, FUJIFILM Diosynth Biotechnologies, KBI Biopharma, Kemwell Biopharma, Lonza, Miltenyi Biotec, Minaris Regenerative Medicine, Samsung Biologics, Sandoz, Vetter Pharma, WuXi Biologics, Sanofi, Kymab, Novartis Pharma AG, Lindy Biosciences, Siegfried AG, and others.

5. Which region has the highest share in the global biologics contract manufacturing market?

• North America is expected to dominate the biologics contract manufacturing market due to the rising prevalence of chronic diseases such as cancer, autoimmune disorders, and cardiovascular conditions, which drive demand for biologics. The region is home to several leading biopharmaceutical companies and CMOs with advanced manufacturing facilities, offering expertise in cell culture, fermentation, and downstream processes. Additionally, increased investments in research and development (R&D), favorable regulatory frameworks, and government initiatives supporting biotechnology innovation further strengthen market growth. Furthermore, the presence of key players, a robust pipeline of biologics, and growing outsourcing trends among pharmaceutical companies are also contributing factors to North America leadership in this market.