Biologics Contract Manufacturing Market Driven by Rising Biopharma Outsourcing and Demand for Scalable Production | Wuxi Biologics, AGC Biologics, Lonza, FUJIFILM Diosynth Biotechnologies

Biologics contract manufacturing outsourced production of biologics like mAbs, vaccines, cell and gene therapies has become indispensable to biopharma innovation. Based on DataM Intelligence analysis, the global market was valued at USD 26.03 billion in 2024 and is expected to reach USD 83.47 billion by 2033, growing at a 14.0% CAGR from 2025 to 2033.

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Biologics Contract Manufacturing Market Segments

By Product Type:

Monoclonal antibodies (mAbs) held the largest share in 2024, underpinned by their widespread therapeutic use (~52%). Vaccines and cell & gene therapies are experiencing the fastest growth, fuelled by emerging mRNA platforms and personalized medicine demand.

By Application:

Oncology indications lead market share (~36%) given high volumes of antibody and CAR-T therapies; autoimmune and rare diseases are fastest-growing areas as investment accelerates in targeted biologic treatments.

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Key Players in Biologics Contract Manufacturing Market

Major biologics CDMOs and service providers include:

• WuXi Biologics via its expansive Shanghai/Wuxi facilities and Western acquisitions
• Fujifilm Diosynth Biotechnologies with multi-site cell culture operations including North Carolina and California
• Lonza Group booming CDMO performance and strong U.S. growth in Vacaville, CA

Samsung Biologics, AGC Biologics, Catalent, Thermo Fisher, KBI Biopharma and Recipharm, Vetter Pharma, Recipharm AB., Abzena Ltd, Samsung Biologics, Eurofins CDMO, Boehringer Ingelheim International GmbH, among others all key collaborators in global biologics supply chains.

Biologics Contract Manufacturing Market Regional Insights

North America
North America leads the market, accounting for over 34-35% share in 2024, powered by strong local CDMO offerings, early biologics adoption, and long-term partnerships with major pharma players.

Asia-Pacific
Asia-Pacific is the fastest-growing region, with rising biologics infrastructure in China, India, and South Korea. Japan's biologics CDMO sector is gaining traction through AGC Biologics' strategic partnership with BioConnection and new regulatory support for scalable domestic manufacturing.

Recent Investments & Strategic Partnerships in Biologics Contract Manufacturing Market

United States
• Regeneron-Fujifilm Diosynth 10 Year Deal: Valued at over USD 3 billion, this partnership expands U.S. manufacturing capacity to support Regeneron's biologics pipeline via Fujifilm's North Carolina facility, set to be operational in late 2025.
• Johnson & Johnson Investment: Over USD 56 billion planned within four years to expand U.S. biologics manufacturing, including a new facility in North Carolina targeting oncology and immunology biologics.
• AstraZeneca U.S. Expansion: A USD 50 billion investment program includes new biologics and cell therapy sites in Virginia, Maryland, Texas and beyond to ensure domestic production resilience.
Japan
• AGC Biologics-BioConnection Partnership (May 2024): Aimed at strengthening Japan's CDMO capabilities for cell and gene therapies and biologics development services.
• Zydus Acquisition (June 2025): Zydus Lifesciences acquired Agenus Inc.'s biologics manufacturing assets in California, marking entry into global CDMO services with implications for future Japan-U.S. collaboration.

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Innovation & Drivers

• Technological Advancements: Adoption of continuous bioreactor systems, single-use platforms, and automation improves capacity and flexibility.
• Integrated Service Providers: Demand is rising for CDMOs offering end-to-end process development, analytical testing, fill-finish, and regulatory support.
• Outsourcing Trend: Biopharma firms increasingly favor CDMOs to reduce capital burden and accelerate time-to-market amidst complex biologics pipelines.

Policy & Market Influences
• U.S. Supply Chain Realignment: Tariff risks and federal scrutiny of Chinese CDMOs (e.g., WuXi AppTec) are driving investment in domestic capacity and alternative contract partners like Fujifilm and Lonza.
• Japanese Biotech Reforms: PMDA regulatory reforms and public-private initiatives are enhancing Japan's attractiveness for biologics CDMO investments.

Challenges & Future Outlook

Challenges:

• High Entry Costs: Biologics manufacturing infrastructure demands huge capital and regulatory compliance investments.
• Complex IP & Quality Assurance: Maintaining data security across outsourced manufacturing and globally dispersed quality systems adds operational complexity.

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