United States Biologics Contract Development and Manufacturing Organization (CDMO) Market Insight
Published: 15 June 2026 | Report Format: Electronic (PDF) | Author: Sanket and Pranali
The United States Biologics Contract Development and Manufacturing Organization (CDMO) Market is projected to grow at a CAGR of around 12.6%, driven by increasing outsourcing of biologics manufacturing, rising biologic drug approvals, expanding cell and gene therapy pipelines, and growing demand for specialized development and commercial manufacturing capabilities
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market Forecasts to 2035
- The United States Biologics Contract Development and Manufacturing Organization (CDMO) Market Size Was Estimated at USD 10.82 Billion in 2025.
- The Market Size is Expected to Grow at a CAGR of around 12.6% from 2025 to 2035.
- The United States Biologics Contract Development and Manufacturing Organization (CDMO) Market Size is Expected to Reach around USD 35.36 Billion by 2035.
Notable Insights for the United States Biologics Contract Development and Manufacturing Organization (CDMO) Market
- Segmentation Based on Service Type, biologics manufacturing, process development, and analytical testing segments held a dominant position in the United States Biologics CDMO Market in 2025 with nearly 76% share, supported by increasing outsourcing across clinical and commercial production.
- Segmentation Based on Product Type, monoclonal antibodies, recombinant proteins, and vaccines collectively accounted for approximately 71% share in 2025, owing to robust biologics pipelines and expanding therapeutic applications.
- The United States Biologics CDMO Market is led by Lonza Group, Thermo Fisher Scientific, and Catalent, with combined revenues exceeding approximately USD 50.24 Billion in 2025, reflecting extensive biologics manufacturing capabilities and diversified service portfolios.
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- Samsung Biologics, Fujifilm Diosynth Biotechnologies, and WuXi Biologics collectively generated revenues of approximately USD 10.86 Billion in 2025, highlighting aggressive capacity expansion and increasing participation in outsourced biologics development programs.
Why Buy This Report
- Provides a comprehensive analysis of the impact of biologics outsourcing trends, increasing demand for flexible manufacturing capacity, cell and gene therapy commercialization, and regulatory developments on market growth.
- Offers key insights into technological advancements in single-use bioprocessing systems, continuous manufacturing technologies, high-yield cell culture platforms, and next-generation biologics production capabilities.
- Helps stakeholders evaluate competitive positioning, expansion strategies, service innovations, strategic collaborations, investment priorities, and long-term growth opportunities across the biologics CDMO value chain.
Competitive Analysis:
The report offers the appropriate analysis of the key organizations/companies involved within the United States biologics contract development and manufacturing organization (cdmo) market, along with a comparative evaluation primarily based on their product of offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborative analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.
Top Companies in United States Biologics Contract Development and Manufacturing Organization (CDMO) Market
• Lonza Group AG
• Thermo Fisher Scientific Inc.
• Catalent, Inc.
• Samsung Biologics Co., Ltd.
• Fujifilm Diosynth Biotechnologies
• WuXi Biologics
• AGC Biologics
• Boehringer Ingelheim BioXcellence
• AbbVie Contract Manufacturing
• KBI Biopharma
Recent Developments:
- In October 2025, Thermo Fisher Scientific Inc. launched expanded commercial biologics manufacturing capabilities at its U.S. facilities to support increasing customer demand for large-scale biologic drug production
- In June 2025, Fujifilm Diosynth Biotechnologies collaborated with Regeneron Pharmaceuticals to strengthen end-to-end biologics manufacturing capacity and accelerate the development of innovative therapeutic candidates.
Market Segmentation:
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market, By Service Type
• Process Development
• Analytical & QC Studies
• Biologics Manufacturing
• Fill-Finish Services
• Packaging Services
• Others
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market, By Product Type
• Monoclonal Antibodies
• Recombinant Proteins
• Vaccines
• Cell Therapies
• Gene Therapies
• Others
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market, By Expression System
• Mammalian Expression Systems
• Microbial Expression Systems
• Yeast Expression Systems
• Insect Cell Expression Systems
• Others
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market, By Scale of Operation
• Preclinical Manufacturing
• Clinical Manufacturing
• Commercial Manufacturing
United States Biologics Contract Development and Manufacturing Organization (CDMO) Market, By End User
• Biopharmaceutical Companies
• Biotechnology Companies
• Research Institutes
• Academic Organizations
• Others
Expert Views:
The United States Biologics Contract Development and Manufacturing Organization (CDMO) Market is anticipated to witness substantial growth through 2035, supported by rising biologics approvals, increasing reliance on outsourced manufacturing expertise, and expanding investments in advanced bioprocessing infrastructure. Continued capacity expansion, technological innovation, and strategic collaborations are expected to enhance operational efficiency and strengthen the market's long-term growth potential.
Author: Sanket and Pranali By Decisions Advisors and Consulting