United States Biologics Contract Manufacturing Market Accelerates with Growing Biopharma Outsourcing and Need for Scalable Production | Key Players: Wuxi Biologics, AGC Biologics, Lonza, FUJIFILM Diosynth Biotechnologies

Outsourced biologics manufacturing including monoclonal antibodies (mAbs), vaccines, and advanced therapies such as cell and gene treatments has become essential to driving biopharma innovation. According to DataM Intelligence, the global biologics contract manufacturing market was valued at USD 26.03 billion in 2024 and is projected to reach USD 83.47 billion by 2033, expanding at a CAGR of 14.0% between 2025 and 2033.

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Biologics Contract Manufacturing Market Segments

By Product Type:

Monoclonal antibodies (mAbs) dominated the market in 2024, accounting for around 52% of revenue due to their broad therapeutic applications. Meanwhile, vaccines and cell & gene therapies are witnessing the fastest growth, driven by the rise of mRNA platforms and increasing demand for personalized medicine.

By Application:

Oncology remained the leading application segment, representing about 36% of the market, supported by strong uptake of antibody-based and CAR-T therapies. Autoimmune and rare diseases are emerging as the fastest-growing areas, fueled by rising investment in targeted biologic treatments.

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Key Players in the Biologics Contract Manufacturing Market
Leading CDMOs and service providers shaping the global biologics landscape include:

• WuXi Biologics - leveraging its large-scale Shanghai/WuXi facilities and strategic Western acquisitions.
• Fujifilm Diosynth Biotechnologies - operating multi-site cell culture facilities across North Carolina and California.
• Lonza Group - demonstrating strong CDMO growth with expanding U.S. operations in Vacaville, CA.

Other major players contributing to global biologics supply chains include Samsung Biologics, AGC Biologics, Catalent, Thermo Fisher, KBI Biopharma, Recipharm, Vetter Pharma, Abzena Ltd, Eurofins CDMO, and Boehringer Ingelheim International GmbH, among others.

Biologics Contract Manufacturing Market Regional Insights

Regional Insights

North America

North America dominated the biologics contract manufacturing market in 2024, accounting for ~34-35% share. Growth is underpinned by robust CDMO capabilities, early adoption of biologics, and long-standing collaborations with major pharmaceutical companies.

Asia-Pacific (Focus on Japan)

Asia-Pacific is the fastest-growing region, supported by expanding biologics infrastructure in China, India, and South Korea. In Japan, the CDMO sector is gaining momentum, driven by AGC Biologics' partnership with BioConnection and supportive regulatory frameworks encouraging domestic, scalable biologics manufacturing.

Recent Investments & Strategic Partnerships

United States

• Regeneron-Fujifilm Diosynth (2024): A USD 3+ billion, 10-year collaboration to expand biologics production at Fujifilm's North Carolina site, operational by late 2025.
• Johnson & Johnson (2025): Committed USD 56 billion over four years to boost biologics capacity, including a new North Carolina facility focused on oncology and immunology.
• AstraZeneca (2025): Launched a USD 50 billion expansion program with new biologics and cell therapy sites across Virginia, Maryland, and Texas, strengthening U.S. production resilience.

Japan
• AGC Biologics-BioConnection (May 2024): Partnership aimed at enhancing Japan's CDMO capacity in biologics and cell & gene therapies.
• Zydus Lifesciences (June 2025): Acquired Agenus Inc.'s biologics manufacturing assets in California, marking its entry into global CDMO services with implications for Japan-U.S. collaboration.

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Innovation & Key Market Drivers

• Technological Advancements: Continuous bioreactor systems, single-use platforms, and automation are transforming biologics production, enabling greater scalability, efficiency, and flexibility.
• Integrated Service Models: Demand is rising for CDMOs that provide end-to-end solutions-from process development and analytical testing to fill-finish services and regulatory support.
• Outsourcing Momentum: Biopharma companies are increasingly outsourcing to CDMOs to reduce capital expenditure, manage complex biologics pipelines, and accelerate time-to-market.

Policy & Market Influences

• U.S. Supply Chain Realignment: Tariff risks and heightened federal scrutiny of Chinese CDMOs (e.g., WuXi AppTec) are prompting stronger investment in domestic capacity and partnerships with players such as Fujifilm and Lonza.
• Japanese Biotech Reforms: Regulatory changes from the PMDA and public-private initiatives are positioning Japan as an attractive hub for biologics CDMO investments.

Challenges & Future Outlook
• High Entry Barriers: Significant capital investment and strict compliance requirements remain obstacles to new entrants in biologics manufacturing.
• Complex IP & Quality Assurance: Ensuring data security, safeguarding intellectual property, and maintaining consistent quality across global, outsourced production networks remain critical challenges.

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