The U.S. cell and gene therapy CDMO market size was estimated at USD 1.94 Billion in 2025 and is projected to reach USD 10.34 billion by 2033, growing at a CAGR of 23.26% from 2025 to 2033. The market is driven by rising investments in advanced therapeutic modalities, increasing approvals of gene and CAR-T therapies, and the growing need for specialized manufacturing capacity. Pharmaceutical and biotech companies are increasingly partnering with CDMOs to overcome bottlenecks in viral vector production, cell expansion, and GMP-compliant facilities, as internal capabilities often cannot keep pace with the rapid innovation in this sector.
The market is primarily driven by the biotechnology and pharmaceutical industries' increased R&D funding and investments in cell and gene therapeutics (CGT). Cell and gene therapies hold significant potential in treating a wide range of diseases, including cancer, genetic disorders, and certain infectious diseases. Hence, owing to the great potential of these therapeutics, there has been a considerable increase in interest from both private and public sectors in the development and discovery of innovative cell and gene therapies. Most big pharmaceutical companies are now investing in CGT to create a strong position in the market. There has been a considerable increase in venture capital investments, especially in the life sciences sector.
Furthermore, an increased clinical pipeline and persistent reliance on outsourcing due to the specialized expertise and infrastructure required for production drive market growth. According to the data published by clinicaltrials.org, there are currently over 2,000 ongoing clinical trials in cell and gene therapies progressing through development stages, and each transition from early to late phase amplifies the demand for viral vectors, plasmids, and clinical-grade cell processing. FDA approvals of novel treatments such as Casgevy for sickle cell disease and Elevidys for Duchenne muscular dystrophy in 2023-24, alongside EMA’s approval of Roctavian for hemophilia A, highlight the growing momentum of advanced therapies entering the commercial stage.
Most small and mid-sized biotech firms pioneering these innovations lack large-scale GMP facilities, making partnerships with CDMOs essential to reach patients. To meet this surge, leading players like Lonza, Catalent, WuXi Advanced Therapies, and Thermo Fisher have invested heavily in expanding viral vector and cell therapy capacity, indicating strong confidence in sustained outsourcing demand. Together, these drivers position the market for sustained high growth as approvals accelerate, pipelines deepen, and manufacturing needs outpace in-house capabilities.
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The market is primarily driven by the biotechnology and pharmaceutical industries' increased R&D funding and investments in cell and gene therapeutics (CGT). Cell and gene therapies hold significant potential in treating a wide range of diseases, including cancer, genetic disorders, and certain infectious diseases. Hence, owing to the great potential of these therapeutics, there has been a considerable increase in interest from both private and public sectors in the development and discovery of innovative cell and gene therapies. Most big pharmaceutical companies are now investing in CGT to create a strong position in the market. There has been a considerable increase in venture capital investments, especially in the life sciences sector.
Furthermore, an increased clinical pipeline and persistent reliance on outsourcing due to the specialized expertise and infrastructure required for production drive market growth. According to the data published by clinicaltrials.org, there are currently over 2,000 ongoing clinical trials in cell and gene therapies progressing through development stages, and each transition from early to late phase amplifies the demand for viral vectors, plasmids, and clinical-grade cell processing. FDA approvals of novel treatments such as Casgevy for sickle cell disease and Elevidys for Duchenne muscular dystrophy in 2023-24, alongside EMA’s approval of Roctavian for hemophilia A, highlight the growing momentum of advanced therapies entering the commercial stage.
Most small and mid-sized biotech firms pioneering these innovations lack large-scale GMP facilities, making partnerships with CDMOs essential to reach patients. To meet this surge, leading players like Lonza, Catalent, WuXi Advanced Therapies, and Thermo Fisher have invested heavily in expanding viral vector and cell therapy capacity, indicating strong confidence in sustained outsourcing demand. Together, these drivers position the market for sustained high growth as approvals accelerate, pipelines deepen, and manufacturing needs outpace in-house capabilities.
U.S. Cell And Gene Therapy 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. cell and gene therapy CDMO market report based on phase, product, and indication.Phase Outlook (Revenue, USD Million, 2021-2033)
- Pre-clinical
- Clinical
Product Outlook (Revenue, USD Million, 2021-2033)
- Gene Therapy
- Gene-Modified Cell Therapy
- Cell Therapy
Indication Outlook (Revenue, USD Million, 2021-2033)
- Oncology
- Infectious Diseases
- Neurological disorders
- Rare Diseases
- 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. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Cell and Gene Therapy CDMO Market: Variables, Trends, & Scope
Chapter 4. U.S. Cell and Gene Therapy CDMO Market: Service Estimates & Trend Analysis
Chapter 5. U.S. Cell and Gene Therapy CDMO Market: Product Estimates & Trend Analysis
Chapter 6. U.S. Cell and Gene Therapy CDMO Market: Indication Estimates & Trend Analysis
Chapter 7. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The leading players profiled in this U.S. Cell and Gene Therapy CDMO market report include:- onza
- atalent, Inc
- ytiva
- amsung Biologics
- hermo Fisher Scientific Inc.
- ovartis AG
- uXi AppTec
- GC Biologics
- mniaBio
- entschler Biopharma SE
- harles River Laboratories
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | September 2025 |
| Forecast Period | 2025 - 2033 |
| Estimated Market Value ( USD | $ 1.94 Billion |
| Forecasted Market Value ( USD | $ 10.34 Billion |
| Compound Annual Growth Rate | 23.2% |
| Regions Covered | United States |
| No. of Companies Mentioned | 12 |
