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February 2025
The global biologics CDMO market size is calculated at USD 22 billion in 2024, grew to USD 25.41 billion in 2025, and is projected to reach around USD 92.79 billion by 2034. The market is expanding at a CAGR of 15.48% between 2025 and 2034. The growing demand for biologics, increasing investments, and growing research and development activities drive the market.
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A contract drug manufacturing organization (CDMO) is a company that provides drug development and manufacturing services to pharmaceutical and biotechnology companies. It offers a diverse range of services, including drug development, scale-up, quality control, manufacturing, inventory management, regulatory compliance, packaging, and distribution. CDMOs provide companies with relevant expertise and infrastructure facilities, enabling them to save costs. They can accelerate the time to market a biological product by optimizing processes and streamlining development, manufacturing, and approval timelines. Additionally, CDMOs offer scalable solutions, allowing companies to easily scale up or down based on demand.
The rising incidences and prevalence of chronic disorders necessitate research and development activities to find cutting-edge solutions. The growing demand for biologics such as regenerative medicines, monoclonal antibodies, and vaccines potentiates the demand for CDMO services. The stringent regulatory compliance and new product launches facilitate CDMO services as they provide relevant expertise. The increasing number of clinical trials also favors market growth. Moreover, favorable government policies and increasing investments augment the market. The advent of advanced technologies also promotes the market.
Artificial intelligence (AI) and machine learning (ML) algorithms have become an indispensable part of the healthcare sector, driving the latest innovations. AI and ML also play a crucial role in CDMOs. However, the integration of AI and ML is still in its infancy. However, they have the potential to revolutionize CDMO services in the near future. Some companies have already integrated AI and ML into their workflows, introducing automation. AI and ML lead to process optimization in manufacturing and drug development. AI-enabled predictive analytics detect errors, enabling manufacturers to make timely decisions. AI and ML can enhance the speed of research processes, allowing researchers to make more efficient products in a short time. Furthermore, the supply chain can also be automated through AI and ML, catering to the huge demand for biologicals.
Growing Number of Start-ups
The major growth factor of the biologics CDMO market is the growing number of pharmaceutical and biotechnology start-ups. The increasing demand for biologicals due to the rising prevalence of chronic disorders and new product launches facilitate start-ups to outsource their services. Biologics are more complex and expensive to manufacture and sell. However, they have the potential to cure untreatable or difficult-to-treat diseases, enhancing their demand. Start-ups lack the resources and expertise to develop and manufacture such biologicals in-house. Many companies are now developing biosimilars, a generic alternative to biologicals, providing cost-effective products. Hence, they prefer CDMOs to navigate through regulatory requirements and accelerate time to market. The dependence on CDMOs enables pharma and biotech start-ups to stay competitive in the market and enhance their brand value.
High Installation Cost
The major challenge faced by the market is the high installation cost of a biologics CDMO facility. The cost of the facility depends on the size, location, and complexity of the production process. The average cost for a biologics CDMO facility is around several million dollars to $100 million. This limits the affordability of many CDMO organizations in low- and middle-income countries, hindering market growth.
Environmental Sustainability
The future of the biologics CDMO market is promising, driven by the burgeoning need for environmental sustainability. Pharmaceutical companies negatively impact the environment through flushing or other means. Numerous government organizations and regulatory agencies have raised concerns about enhancing environmental sustainability in pharma and biotech processes. It is estimated that pharmaceutical manufacturing contributes approximately a quarter of all greenhouse gas emissions in the U.S., making it the third largest contributor. Numerous CDMOs are integrating green technologies into their processes to reduce carbon footprints. Additionally, the pharmaceutical supply chain accounts for 90% of the energy consumption. Hence, CDMOs are upgrading their infrastructure and supporting more eco-friendly practices. Focus is also increasing on innovative, eco-friendly packaging solutions to maintain the integrity of sensitive biologics.
By type, the mammalian segment held a dominant presence in the biologics CDMO market in 2024. Mammalian cell lines are the most dominant platform for recombinant protein and viral-based vector and vaccine production purposes. The growing demand for vaccines and monoclonal antibodies boosts the segment’s growth. Mammalian cell lines enable in vitro production of viruses to develop vaccines. They are widely preferred as they mimic human physiological conditions, enabling researchers to study complex cellular functions. They are also essential to evaluate drug efficacy and toxicity more accurately compared to bacterial cell culture.
By type, the microbial segment is projected to expand rapidly in the market in the coming years. Microbial systems such as E.coli and Saccharomyces cerevisiae are used to produce hormones, cytokines, enzymes, and some monoclonal antibodies. It is estimated that around 48% of biologics approved are developed from microbial systems. These cell lines offer high scalability and achieve high protein yields, leading to shorter process times. They are in high demand due to affordability and easy availability of microbes.
By molecule, the monoclonal antibodies segment led the global biologics CDMO market in 2024. Monoclonal antibodies are lab-made proteins that bind to only one antigen. They have widespread applications in clinical fields such as diagnostic testing, radioimmunotherapy, and therapeutics for several chronic disorders, including cancer, autoimmune disorders, and inflammatory conditions. They also modulate the immune response to activate immune cells to fight against any disease. Favorable regulatory frameworks and new product launches augment the segment’s growth. The advent of antibody-drug conjugates potentiates the demand for monoclonal antibodies.
By molecule, the recombinant proteins segment is anticipated to grow with the highest CAGR in the market during the studied years. Recombinant proteins are proteins that are produced through genetic engineering techniques like recombinant DNA technology. They are predominantly used as therapeutics such as human insulin, human growth factors, clotting factors, and monoclonal antibodies. The major advantage of using recombinant protein is it can be modified based on disease requirements, enabling researchers to produce personalized therapies. Additionally, the demand for safe and highly pure biological fuels the segment’s growth.
By product, the biologics segment held the largest share of the biologics CDMO market in 2024. Some common examples of biologics include gene therapies, transplant tissue, recombinant proteins, and stem cell therapies. Biologics are in high demand as they are comparatively safe and can cure numerous chronic disorders. They provide targeted therapeutic effects, reducing systemic side effects. They are also less likely to interact with other drugs, reducing the risk of drug-drug interactions. The increasing investments and new product launches encourage manufacturers to produce biologics.
By indication, the oncology segment registered its dominance over the global biologics CDMO market in 2024. The rising prevalence of cancer and its complexity increases the need for biologics for effective treatment and diagnosis. The American Cancer Society estimates more than 2 million cancer cases in the U.S. in 2025. Biologics have revolutionized the treatment of cancer by specifically targeting cancerous cells, reducing the effect on normal tissues. They also help the immune system to stop the growth of cancer cells and destroy them. In the second quarter of 2024, the U.S. Food and Drug Administration approved 17 new biologicals for the treatment of cancer.
By indication, the auto-immune diseases segment is predicted to witness significant growth in the market over the forecast period. Biologicals have been developed for treating auto-immune disorders such as rheumatoid arthritis, psoriasis, ankylosing spondylitis, inflammatory bowel disease, and systemic lupus erythematosus. Biologics are more effective compared to small molecules in treating these diseases, owing to their target-specific therapeutic actions. The increasing prevalence of auto-immune disorders and the inability of small molecules to treat these diseases propel the segment’s growth.
North America dominated the global biologics CDMO market share by 37% in 2024. The presence of key players and technological advancements drive the market. Key players such as Alcami Corporation, MilliporeSigma, and Thermo Fisher Scientific hold a major share of the North American market. The state-of-the-art research and development facilities and new product launches increase the demand for biologics CDMO. The increasing number of clinical trials also boosts the market. Approximately 9,959 Phase I-III clinical trials were performed in the U.S. in 2024, an increase of 9.4% from 2023. In addition, the increasing investments, collaborations, investments, and mergers & acquisitions help CDMOs to adopt advanced technologies and increase the accessibility of biologics among a large number of patients.
Asia-Pacific is anticipated to grow at the fastest rate in the market during the forecast period. The rising prevalence of chronic disorders and suitable manufacturing infrastructure drive the market. The increasing number of pharma and biotech start-ups contribute to the market. There were a total of 2,127 pharma start-ups in India as of June 2024, according to the Department for Promotion of Industry and Internal Trade (DPIIT). The increasing investments and favorable government policies augment the market. The total funding provided to healthcare start-ups in China is around $538 million in 2024. The rising healthcare expenditure promotes the development of biosimilars, especially in developing countries of Asia-Pacific, potentiating the demand for biologics CDMO. The growing research and development and increasing number of patents also propel the market.
Bill Humphries, CEO of Alcami Corporation, commented on the collaboration with Tanvex CDMO that both companies are committed to helping clients overcome development and manufacturing obstacles during unprecedented demand for complex biologics and specialized therapeutics. He also said that the collaboration will leverage 60 years of combined expertise and close working relationships and expedite the delivery of sterile injectables.
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February 2025
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