The U.S. large molecule drug substance CDMO market size was estimated at USD 13.08 Billion in 2025 and is projected to reach USD 22.56 billion by 2033, growing at a CAGR of 7.06% from 2025 to 2033. This market is experiencing significant growth due to the growing prevalence of chronic diseases, further driving the demand for biologics such as monoclonal antibodies, cell therapies, and gene therapies. Moreover, increasing outsourcing trends by pharmaceutical and biotech companies to reduce costs, access specialized expertise, and accelerate commercialization are also some of the factors contributing to the market growth.
The market is driven by the growing demand for biologics to meet the growing demand for effective therapeutic options for chronic and complex diseases. The increasing prevalence of cancer, autoimmune disorders, and metabolic diseases globally is leading to the growing demand for more advanced therapies. Biologics such as monoclonal antibodies, recombinant proteins, cell therapies, and gene therapies have emerged as prominent solutions, but their development and manufacturing processes are comparatively complex and require advanced infrastructure. Therefore, several pharmaceutical and biotechnology companies increasingly turn to contract development and manufacturing organizations to streamline operations and address the growing complexity of large molecule drug development. Thus, these factors would help companies to reduce the burden of high capital investments, avoid lengthy facility set-ups, and gain faster access to specialized expertise that ensures regulatory compliance and high-quality production.
Furthermore, growing innovation and regulatory support to create a favorable environment for CDMOs in the U.S. is also contributing to the market growth. Continuous advancements in bioprocessing technologies, such as the shift towards single-use systems and the adoption of continuous manufacturing, are making biologics production more efficient, flexible, and cost-effective. These improvements not only help manufacturers meet the rising global demand but also enable CDMOs to handle more complex pipelines, including biosimilars that are rapidly emerging as patents for blockbuster biologics expire.
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The market is driven by the growing demand for biologics to meet the growing demand for effective therapeutic options for chronic and complex diseases. The increasing prevalence of cancer, autoimmune disorders, and metabolic diseases globally is leading to the growing demand for more advanced therapies. Biologics such as monoclonal antibodies, recombinant proteins, cell therapies, and gene therapies have emerged as prominent solutions, but their development and manufacturing processes are comparatively complex and require advanced infrastructure. Therefore, several pharmaceutical and biotechnology companies increasingly turn to contract development and manufacturing organizations to streamline operations and address the growing complexity of large molecule drug development. Thus, these factors would help companies to reduce the burden of high capital investments, avoid lengthy facility set-ups, and gain faster access to specialized expertise that ensures regulatory compliance and high-quality production.
Furthermore, growing innovation and regulatory support to create a favorable environment for CDMOs in the U.S. is also contributing to the market growth. Continuous advancements in bioprocessing technologies, such as the shift towards single-use systems and the adoption of continuous manufacturing, are making biologics production more efficient, flexible, and cost-effective. These improvements not only help manufacturers meet the rising global demand but also enable CDMOs to handle more complex pipelines, including biosimilars that are rapidly emerging as patents for blockbuster biologics expire.
U.S. Large Molecule Drug Substance CDMO Market Report Segmentation
This report forecasts revenue growth at country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, the analyst has segmented the U.S. large molecule drug substance CDMO market report based on product, service, source, and end use.Product Outlook (Revenue, USD Million, 2021-2033)
- Biologics
- Biosimilar
Service Outlook (Revenue, USD Million, 2021-2033)
- Contract Manufacturing
- Contract Development
Source Outlook (Revenue, USD Million, 2021-2033)
- Mammalian
- Microbial
- Others
End Use Outlook (Revenue, USD Million, 2021-2033)
- Biotech Companies
- CRO
- Others
Why should you buy this report?
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segmental and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Research Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Large Molecule Drug Substance CDMO Market Variables, Trends & Scope
Chapter 4. U.S. Large Molecule Drug Substance CDMO Market: Product Estimates & Trend Analysis
Chapter 5. U.S. Large Molecule Drug Substance CDMO Market: Service Estimates & Trend Analysis
Chapter 6. U.S. Large Molecule Drug Substance CDMO Market: Source Estimates & Trend Analysis
Chapter 7. U.S. Large Molecule Drug Substance CDMO Market: End Use Estimates & Trend Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this U.S. Large Molecule Drug Substance CDMO market report include:- urofins Scientific
- uXi Biologics
- amsung Biologics
- atalent, Inc.
- entschler Biopharma SE
- GC Biologics
- ecipharm AB
- iegfried Holding AG
- oehringer Ingelheim
- UJIFILM Diosynth Biotechnologies
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 120 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 13.08 Billion |
| Forecasted Market Value ( USD | $ 22.56 Billion |
| Compound Annual Growth Rate | 7.0% |
| Regions Covered | United States |
| No. of Companies Mentioned | 11 |
