The global biologics CDMO market size was estimated at USD 22 billion in 2024 and is anticipated to reach around USD 92.79 billion by 2034, expanding at a CAGR of 15.48% from 2025 to 2034.
The growth of the biologics CDMO market is driven by the rising incidences of age-related illness and the increasing production of biologics. Furthermore, rising investments in drug discovery and development contribute to market expansion.
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Market Overview
The biopharmaceutical industry worldwide is booming, directly contributing to market's growth. With a rise in demand for biologics and novel drugs, there is a high demand for outsourced services. Biopharmaceutical companies worldwide are outsourcing the development and production of various drugs to biologics contract development and manufacturing organizations (CDMOs). Outsourcing the development and production to CDMOs helps organizations keep up with the demand.
These CDMOs have experience and expertise in handling clinical trials, pre-formulations, and commercial production that benefit biopharmaceutical companies. Outsourcing biologics manufacturing to CDMOs enables biopharmaceutical companies to focus on other core areas. This further helps accelerate drug development processes.
The biologics CDMO market is witnessing rapid growth due to the rising demand for biological therapies. These therapies can treat various illnesses, including chronic diseases, autoimmune disorders, cancer, infectious diseases, and genetic diseases. The rising collaborations between biopharmaceutical companies and CDMOs further support market expansion. Collaborating with CDMOs enables biopharmaceutical companies to accelerate the development of new biologics.
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Major Trends in the Biologics CDMO Market
Rising Demand for Biological Products:
With the growing prevalence of chronic diseases worldwide, the demand for biological products, such as drugs, vaccines, tissues, and recombinant therapeutic proteins, is rising. Biologics are more effective than small-molecule drugs, making them an ideal option to treat a range of diseases. The growing awareness among people regarding the benefits of biologics or biological therapies is a major factor boosting their demand.
However, outsourcing biologics manufacturing to CDMOs helps biopharmaceutical companies maximize the manufacturing of different biological products, further helping them to meet the growing demand. Moreover, the rising demand for targeted therapies and personalized medicine supports market expansion.
Regulatory Compliance:
Since biologics are subject to stringent regulatory requirements, the biopharmaceutical industry must meet regulations set by regulatory bodies. CDMOs have skilled experts and are often engaged with regulatory bodies, which helps them align their practices as per regulations. This further leads to the faster approval process. Therefore, outsourcing biologics manufacturing to CDMOs ensures that the final products meet stringent regulations, which benefits biopharmaceutical companies.
Technological Advancements:
Technological advancements have optimized various manufacturing processes for CDMOs, pharmaceutical, and biopharmaceutical companies. Innovations in biomanufacturing technologies help CDMOs enhance the efficacy and safety of biological products. Technologies like blockchain and RFID help optimize the supply chain and ensure proper delivery of products. With blockchain technology, labeling pharmaceuticals and maintaining their digital ledger becomes easy. It helps them keep track of products through the supply chain.
Integrating innovative technologies like automation, artificial intelligence (AI), and the Internet of Things (IoT) helps automate manufacturing processes. These technologies enhance the quality control process and help CDMOs to ensure that their manufacturing processes comply with GMP. Moreover, AI reduces human errors and detects inconsistencies or defects during the production processes. This helps streamline the manufacturing process and boost production output.
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Regional Insights
North America’s Pivotal Role in the Biologics CDMO Market
North America captured the largest share of the market in 2024. This is mainly due to its well-established healthcare industry, which offers a solid foundation for CDMO operations. There is a stronghold of biotechnology, pharmaceutical, and biopharmaceutical industries in North America. With the rising incidence of chronic diseases and growing geriatric populations, the demand for biological products has increased.
Countries like the U.S. and Canada are major contributors to the North American biologics CDMO market. These countries are home to leading pharmaceutical and biopharmaceutical companies that are seeking to accelerate and maximize the production of biological products. However, outsourcing biologics production to CDMOs enables pharmaceutical and biopharmaceutical companies to focus on other areas, leading to faster development of biological products. In addition, the rising investments in R&D further support regional market growth. The country has a skilled workforce, advanced manufacturing facilities, and support from the government, contributing to market growth.
Unleashing Asia’s Role in the Market
Asia Pacific is projected to emerge as the fastest-growing region in the market in the coming years. This is mainly due to the increasing demand for novel drugs and therapeutics. Asian countries are witnessing a rise in foreign direct investments, specifically from the biopharmaceutical sector, which will boost market growth. The increasing investment in research and development to advance manufacturing capacitates further contributes to market expansion. China is leading the Asia Pacific biologics CDMO market due to its large-scale API production and strong government support. In addition, the rising burden of chronic and genetic disorders is expected to contribute to market growth.
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Market Segmentation
Type Insights
The mammalian segment registered dominance in 2024. This is mainly due to the increased demand for mammalian cell-based biologics due to their improved efficacy. These biologics have proven to be more effective in treating severe chronic illnesses, like diabetes, cardiovascular, cancer, autoimmune disorders, and genetic disorders. They are heavily used in recombinant protein and vaccine production purposes.
On the other hand, the microbial segment is projected to grow at the fastest rate in the coming years. Microbial production systems are less expensive than mammalian cell systems. This cost advantage makes microbial-based biologics more attractive for CDMOs. In addition, microbial systems can achieve high cell yield.
Molecular Type Insights
The monoclonal antibodies segment led the market in 2024. The rise in investments in developing novel drugs and therapies is a major factor supporting segmental dominance. Monoclonal antibodies (mAbs) play a crucial role in therapeutic applications for treating a range of diseases like autoimmune disorders, infectious diseases, and cancer. However, the recombinant proteins segment is expected to expand rapidly during the forecast period. Advances in expression methods, cell-free protein synthesis, and single-use bioreactors have streamlined manufacturing recombinant proteins. These proteins are essential in developing vaccines against viruses.
Product Type Insights
The biologics segment dominated the biologics CDMO market by holding a significant share in 2024. This is mainly due to the increased demand for biological products. Biologics help treat various chronic diseases due to their high efficacy. They also play a crucial role in targeted therapies like vaccines and cell and gene therapies. The rising demand for personalized medicine further supports segmental growth.
Indication Insights
The oncology segment led the market with the largest share in 2024. This is mainly due to the increased burden of cancer worldwide. This significantly boosted the demand for novel treatments and drugs, and so did the need for biologics. However, outsourcing biologics manufacturing to CDMOs accelerates the production process of novel drugs, ensuring products reach the market as soon as possible. On the other hand, the auto-immune diseases segment is projected to grow at a notable rate throughout the studied period. With the growing number of cases of auto-immune disorders, the demand for biological products is increasing, contributing to market expansion.
Competitive Landscape & Major Breakthroughs in the Market
The biologics CDMO market is evolving rapidly. Key players operating in the market include 3P BIOPHARMACEUTICALS S.L.U, Bora Pharmaceuticals Co. Ltd, AGC Biologics, Boehringer Ingelheim International GmbH, Binex Co. Ltd., Catalent Inc. FUJIFILM Corp., Evonik Industries AG, Rentschler Biopharma SE, Samsung Electronics Co. Ltd., and others. These companies are focusing on expanding their operations to cater to customers worldwide.
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Recent Developments
• In December 2024, an established South Korean biosimilar company, Celltrion Inc., announced the launch of Celltrion BioSolutions, a new subsidiary specializes in contract development and manufacturing organization (CDMO) of biopharmaceuticals.
• In September 2024, Eurofins CDMO Alphora Inc. announced its plan for the construction of a new GMP Biologics manufacturing facility in Mississauga, Ontario, Canada. This facility will manufacture monoclonal antibodies and protein therapies.
Segments Covered in the Report
By Type
• Mammalian
• Microbial
By Molecule Type
• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Hormones
• Others
By Product Type
• Biologics
• Biosimilars
By Indication
• Oncology
• Auto-Immune Diseases
• Infectious Diseases
• Neurology
• Others
By Region
• North America
• Asia Pacific
• Latin America
• Europe
• Middle East & Africa
Discover our detailed Table of Contents (TOC) for the Biologics CDMO Market @ https://www.towardshealthcare.com/table-of-content/biologics-cdmo-market-sizing
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