(MENAFN- GlobeNewsWire - Nasdaq) The U.S. cell and gene therapy CDMO market is primed for rapid expansion due to increased R&D investments, rising approvals of innovative therapies, and the soaring demand for specialized manufacturing. Key partnerships with CDMOs address production bottlenecks and highlight growth opportunities in oncology and rare diseases.

Dublin, Nov. 21, 2025 (GLOBE NEWSWIRE) -- The "U.S. Cell and Gene Therapy CDMO Market Size, Share & Trends Analysis Report by Phase (Pre-clinical, Clinical), Product (Gene Therapy, Cell Therapy, Gene-Modified Cell Therapy), Indication (Oncology, Infectious Diseases), and Growth Forecasts, 2025-2033" report has been added to ResearchAndMarkets's offering.
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 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.

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

Key Attributes:

Report Attribute	Details
No. of Pages	150
Forecast Period	2025 - 2033
Estimated Market Value (USD) in 2025	$1.94 Billion
Forecasted Market Value (USD) by 2033	$10.34 Billion
Compound Annual Growth Rate	23.2%
Regions Covered	United States

Key Topics Covered:
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
2.1. Market Outlook
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. U.S. Cell and Gene Therapy CDMO Market: Variables, Trends, & Scope
3.1. Market Lineage Outlook
3.1.1. Parent Market Outlook
3.1.2. Ancillary Market Outlook
3.2. U.S. Cell and Gene Therapy CDMO Market Dynamics
3.2.1. Market Driver Impact Analysis
3.2.2. Market Restraint Analysis
3.3. Technological Landscape
3.4. Pricing Model Analysis
3.5. U.S. Cell and Gene Therapy CDMO Market: Analysis Tools
3.5.1. Porter's Five Forces Analysis
3.5.2. PESTEL Analysis
Chapter 4. U.S. Cell and Gene Therapy CDMO Market: Service Estimates & Trend Analysis
4.1. Segment Dashboard
4.2. U.S. Cell and Gene Therapy CDMO Market Phase Movement Analysis
4.3. U.S. Cell and Gene Therapy CDMO Market Size & Trend Analysis, by Phase, 2021 to 2033 (USD Million)
4.4. Pre-clinical
4.5. Clinical
Chapter 5. U.S. Cell and Gene Therapy CDMO Market: Product Estimates & Trend Analysis
5.1. Segment Dashboard
5.2. U.S. Cell and Gene Therapy CDMO Market Product Movement Analysis
5.3. U.S. Cell and Gene Therapy CDMO Market Size & Trend Analysis, by Product, 2021 to 2033 (USD Million)
5.4. Gene Therapy
5.4.1. Gene Therapy Market Estimates and Forecasts, 2021-2033 (USD Million)
5.4.2. Ex-vivo
5.4.3. In-vivo
5.5. Gene-Modified Cell Therapy
5.5.1. Gene-Modified Cell Therapy Market Estimates and Forecasts, 2021-2033 (USD Million)
5.5.2. CAR T-cell therapies
5.5.3. CAR-NK cell therapy
5.5.4. TCR-T cell therapy
5.5.5. Other
5.6. Cell Therapy
Chapter 6. U.S. Cell and Gene Therapy CDMO Market: Indication Estimates & Trend Analysis
6.1. Segment Dashboard
6.2. U.S. Cell and Gene Therapy CDMO Market Indication Movement Analysis
6.3. U.S. Cell and Gene Therapy CDMO Market Size & Trend Analysis, by Indication, 2021 to 2033 (USD Million)
6.4. Oncology
6.5. Infectious Diseases
6.6. Neurological disorders
6.7. Rare Diseases
6.8. Others
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.2. U.S. Cell and Gene Therapy CDMO Market Share Analysis, 2024
7.3. Company Profiles

• Lonza
• Catalent, Inc
• Cytiva
• Samsung Biologics
• Thermo Fisher Scientific Inc.
• Novartis AG
• WuXi AppTec
• AGC Biologics
• OmniaBio
• Rentschler Biopharma SE
• Charles River Laboratories

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• U.S. Cell and Gene Therapy CDMO Market

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