Global Biologics Contract Development And Manufacturing Organization (CDMO) Market Size, Share, and Trends Analysis Report – Industry Overview and Forecast to 2032

Biologics Contract Development and Manufacturing Organization (CDMO) Market Size

• The global biologics contract development and manufacturing organization (CDMO) market size was valued at USD 16.61 billion in 2024 and is expected to reach USD 38.27 billion by 2032, at a CAGR of 11.00% during the forecast period
• The market growth is largely fueled by the growing adoption and technological progress within biologic therapies and advanced manufacturing technologies, leading to increased outsourcing by pharmaceutical and biotechnology companies to specialized Biologics Contract Development and Manufacturing Organizations (CDMOs). The complexity of biologics production, including monoclonal antibodies, recombinant proteins, and cell and gene therapies, has driven demand for CDMOs with deep technical expertise and regulatory compliance capabilities
• Furthermore, rising demand for cost-effective, scalable, and flexible manufacturing solutions is establishing CDMOs as strategic partners of choice for both large pharma and emerging biotech firms. These converging factors are accelerating the uptake of Biologics CDMO solutions, thereby significantly boosting the industry's growth. CDMOs offering integrated services—from early-stage development and process optimization to clinical and commercial-scale manufacturing—are particularly well-positioned to benefit from the growing biologics pipeline across therapeutic areas such as oncology, autoimmune diseases, and rare disorders

Biologics Contract Development and Manufacturing Organization (CDMO) Market Analysis

• Biologics contract development and manufacturing organizations (CDMOs), providing outsourced services for the development and production of biologic drugs, are becoming increasingly critical to the pharmaceutical industry due to rising biologics demand, cost pressures, and the need for specialized expertise in complex manufacturing
• The growing pipeline of monoclonal antibodies, cell and gene therapies, and other biologic modalities is driving pharmaceutical companies to rely more heavily on CDMOs for flexible, scalable, and compliant manufacturing support
• North America dominated the biologics contract development and manufacturing organization (CDMO) market with the largest revenue share of 40.9% in 2024, supported by a well-established biopharmaceutical industry, advanced infrastructure, and a concentration of major CDMO providers such as Thermo Fisher Scientific and Catalent
• Asia-Pacific is expected to be the fastest growing region in the biologics contract development and manufacturing organization (CDMO) market during the forecast period, projected to expand at a CAGR of 13.1% from 2025 to 2032, due to lower production costs, rising investment in biologics manufacturing in countries like China, India, and South Korea, and favorable regulatory reforms promoting outsourcing
• The manufacturing segment dominated the biologics contract development and manufacturing organization (CDMO) market with a market revenue share of 48.9% in 2024, due to the increasing outsourcing of commercial-scale production and the complexity of biologics requiring specialized infrastructure. CDMOs with advanced biomanufacturing capabilities are increasingly being relied upon by pharmaceutical companies to handle large-scale, GMP-compliant production, driving segment growth

Report Scope and Biologics Contract Development and Manufacturing Organization (CDMO) Market Segmentation         

Biologics Contract Development and Manufacturing Organization (CDMO) Market Trends

“Increasing Integration of Advanced Technologies Such As Artificial Intelligence (AI), Machine Learning, and Automation Into Biologics Development”

• A significant and accelerating trend in the global biologics contract development and manufacturing organization (CDMO) market is the increasing integration of advanced technologies such as artificial intelligence (AI), machine learning, and automation into biologics development and manufacturing workflows. These innovations are enhancing process efficiency, optimizing biologics production, and improving decision-making in real-time
  • For instance, AI-driven platforms are now being employed to streamline early-stage drug discovery, design more efficient manufacturing processes, and predict optimal conditions for cell line development and protein expression. This not only shortens development timelines but also reduces costs and improves yield consistency
• Automation technologies, including robotic systems for high-throughput screening and digitally controlled bioreactors, are being widely adopted to reduce human error, ensure regulatory compliance, and facilitate scalable biologics production. Companies leveraging digital twins and data analytics are gaining a competitive edge in offering highly customized CDMO solutions
• Moreover, CDMOs are increasingly offering cloud-based platforms and client portals to enhance transparency and communication throughout the product lifecycle. These digital tools allow clients to track project milestones, review batch data, and manage documentation efficiently
• This trend toward greater technological sophistication and customer-centric functionality is fundamentally reshaping the biologics CDMO landscape. Companies that invest in integrated tech infrastructures and prioritize user-friendly, flexible solutions are poised to attract a broader clientele, particularly biotech startups and mid-sized pharmaceutical firms looking for end-to-end services

Biologics Contract Development and Manufacturing Organization (CDMO) Market Dynamics

Driver

“Growing Need Due to Increasing Biologic Drug Demand and Outsourcing Trends”

• The growing prevalence of chronic diseases, complex biologics, and personalized medicine is driving increased demand for biologics manufacturing, significantly accelerating the growth of the Biologics Contract Development and Manufacturing Organization (CDMO) market
  • For instance, in April 2024, WuXi Biologics announced the expansion of its drug substance manufacturing facility in Worcester, Massachusetts, enhancing its global biologics production capacity. Such strategic investments by key players are expected to boost the Biologics CDMO market during the forecast period
• As pharmaceutical and biotechnology companies look to optimize costs, reduce time-to-market, and access specialized expertise, there is a growing preference for outsourcing drug development and manufacturing services to CDMOs
• Furthermore, the complexity of biologics such as monoclonal antibodies, gene therapies, and cell therapies has intensified the reliance on CDMOs with advanced technological capabilities, robust compliance frameworks, and global manufacturing networks
• The rising number of pipeline biologics, regulatory support for biosimilars, and growing partnerships between biotech innovators and CDMOs are also strengthening the market outlook. Biologics CDMOs that offer end-to-end solutions—from cell line development to commercial-scale production—are particularly favored

Restraint/Challenge

“High Operational Costs and Regulatory Complexities”

• The Biologics CDMO market faces challenges due to the high capital investment required for building and maintaining GMP-compliant manufacturing facilities equipped for biologics
  • For instance, small and mid-sized CDMOs may struggle with the upfront costs of establishing cutting-edge facilities, including those needed for cell and gene therapy manufacturing, which demand specialized infrastructure and rigorous quality systems
• Furthermore, biologics development is subject to stringent regulatory scrutiny across multiple regions. Ensuring compliance with varying standards such as FDA, EMA, and PMDA adds complexity and cost for CDMOs, especially those operating globally
• Intellectual property concerns, limited standardization in biologics manufacturing, and fluctuating client demands can also hinder scalability and resource planning
• Overcoming these barriers requires sustained investment in advanced bioprocessing technologies, workforce training, and regulatory alignment. CDMOs that can offer flexible, high-quality, and cost-effective services will be best positioned to capture emerging growth opportunities

Biologics Contract Development and Manufacturing Organization (CDMO) Market Scope

The market is segmented on the basis of product type, service type, and end-users.

• By Product Type

On the basis of product type, the biologics contract development and manufacturing organization (CDMO) market is segmented into gene products, vaccines, stem cells, monoclonal antibodies, and others. The monoclonal antibodies segment dominated the largest market revenue share of 41.6% in 2024, driven by their widespread use in oncology, autoimmune diseases, and infectious disorders. The increasing approvals of monoclonal antibody therapies and the rising number of pipeline candidates are significantly driving this segment.

The gene products segment is projected to witness the fastest CAGR of 18.2% from 2025 to 2032, attributed to growing demand for gene therapies in rare and genetic diseases and advancements in vector-based delivery platforms.

• By Service Type

On the basis of service type, the biologics contract development and manufacturing organization (CDMO) market is segmented into manufacturing, research and development, clinical trials, and others. The manufacturing segment held the largest market revenue share of 48.9% in 2024, due to the increasing outsourcing of commercial-scale production and the complexity of biologics requiring specialized infrastructure.

The clinical trials segment is expected to witness the fastest growth rate of 16.5% from 2025 to 2032, driven by the rising number of biologic drug candidates entering clinical evaluation and the need for end-to-end CDMO support services.

• By End-Users

On the basis of end-users, the biologics contract development and manufacturing organization (CDMO) market is segmented into biotechnology companies, biopharmaceutical companies, and others. The biopharmaceutical companies segment accounted for the largest market share of 55.3% in 2024, driven by increasing partnerships and long-term outsourcing agreements with CDMOs to accelerate biologics development pipelines.

The biotechnology companies segment is expected to register the fastest CAGR of 17.4% during the forecast period, owing to the surge in startup activity, venture capital funding, and demand for cost-effective external development capabilities.

Biologics Contract Development and Manufacturing Organization (CDMO) Market Regional Analysis

• North America dominated the biologics contract development and manufacturing organization (CDMO) market with the largest revenue share of 40.9% in 2024, driven by a strong biotechnology ecosystem, extensive R&D investments, and the presence of major biopharmaceutical players such as Lonza, Catalent, and Thermo Fisher Scientific
• The U.S. is the primary contributor to regional dominance, attributed to its advanced regulatory framework, robust funding for biologics development, and ongoing clinical trials focused on monoclonal antibodies, cell therapies, and vaccines
• Furthermore, growing collaborations between CDMOs and academic research institutes, along with the rise of personalized medicine and biosimilars, continue to accelerate market expansion across the region

U.S. Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The U.S. biologics contract development and manufacturing organization (CDMO) market captured 61% of North America’s share in 2024. This dominance is fueled by increased demand for outsourcing across biologic pipelines, supported by FDA fast-track approvals and a strong presence of biologics manufacturing infrastructure. The growing trend toward specialized CDMOs offering end-to-end services is further boosting the market.

Europe Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The Europe biologics contract development and manufacturing organization (CDMO) market is anticipated to grow at a substantial CAGR during the forecast period, driven by expanding biologics research, increasing biosimilar production, and support from EU-funded life sciences projects. Countries such as Germany and Switzerland are leading in biologics manufacturing due to strong academic-industry partnerships and innovations in single-use bioprocessing technologies.

U.K. Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The U.K. biologics contract development and manufacturing organization (CDMO) market is expected to grow steadily due to government initiatives like the Medicines and Healthcare products Regulatory Agency (MHRA) modernization and increased investments in cell and gene therapy manufacturing hubs. A robust clinical trial infrastructure and the presence of major pharma outsourcing players continue to support market expansion.

Germany Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The Germany biologics contract development and manufacturing organization (CDMO) market is a leading CDMO hub in Europe with strong capabilities in upstream and downstream processing. The country benefits from a skilled workforce, automation adoption, and a supportive regulatory environment. Increased demand for biosimilars and complex biologics such as ADCs (antibody-drug conjugates) is driving further growth.

Asia-Pacific Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The Asia-Pacific biologics contract development and manufacturing organization (CDMO) market is projected to witness the fastest CAGR of 13.1% from 2025 to 2032, owing to low manufacturing costs, expanding healthcare access, and the rise of biologics-focused biotech companies in China, India, South Korea, and Japan. Government initiatives promoting domestic manufacturing and regulatory harmonization (e.g., China’s MAH reforms) are accelerating CDMO partnerships.

Japan Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The Japan biologics contract development and manufacturing organization (CDMO) market is expanding due to increased demand for regenerative medicine and cell-based therapies. Regulatory support from the PMDA, an aging population, and strategic collaborations between pharma and biotech firms are propelling growth in this high-potential market.

China Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight

The China biologics contract development and manufacturing organization (CDMO) market led the Asia-Pacific CDMO market in revenue share in 2024, bolstered by strong government investment in biotech innovation zones, favorable policy reforms, and rising biologics consumption. Domestic players are expanding their capabilities in biosimilars and mAb production, while foreign CDMOs are forming joint ventures to enter the market.

Biologics Contract Development and Manufacturing Organization (CDMO) Market Share

The biologics contract development and manufacturing organization (CDMO) industry is primarily led by well-established companies, including:

• Boehringer Ingelheim Group (Germany)
• Wuxi Biologics (China)
• Samsung Biologics (South Korea)
• Lonza Group (Switzerland)
• Fujifilm Diosynth Biotechnologies USA Inc. (U.S.)
• Toyobo Co. Limited (Japan)
• Parexel International Corporation (U.S.)
• Icon PLC (Ireland)
• Binex Co. Limited (South Korea)
• JRS Pharma (Germany)
• Rentschler Biotechnologies (Germany)
• AGC Biologics (U.S.)
• Catalent Inc. (U.S.)

Latest Developments in Global Biologics Contract Development and Manufacturing Organization (CDMO) Market

• In July 2025, Thermo Fisher Scientific announced the acquisition of Sanofi’s biologics fill–finish facility in Ridgefield, New Jersey, aimed at expanding its biologics manufacturing capabilities in the U.S. This acquisition strengthens Thermo Fisher’s long-term partnership with Sanofi and increases capacity to meet rising demand in biologics development and production
• In March 2025, Zydus Lifesciences entered the U.S. biologics CDMO market through the acquisition of two manufacturing facilities in California (Emeryville & Berkeley) from a global biotech firm. The USD 75 million deal marks a significant strategic expansion, allowing Zydus to scale its biologics and biosimilars portfolio in North America
• In March 2025, Syngene International acquired its first U.S.-based biologics manufacturing facility in Baltimore from Emergent BioSolutions for USD 36.5 million. The acquisition is expected to boost Syngene’s biologics capacity and support clients seeking commercial manufacturing for complex biologics and injectables
• In February 2025, Lonza Group finalized the acquisition of Roche’s large-scale biologics manufacturing site in Vacaville, California, for USD 1.2 billion. The deal adds 330,000 liters of capacity and will be followed by a CHF 500 million investment to upgrade and expand the facility to meet future commercial demand
• In January 2025, Bora Biologics announced the expansion of its San Diego biologics CDMO facility. The company is adding GMP suites and over 8,000 square feet of cleanroom space to support upstream and downstream biologics processing. This move aligns with growing client demand for full-service biologics development

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