U.S. Cell and Gene Therapy CDMO Market Driven by Advanced Therapies

Revenue, 2025

USD 3.14 Billion

Forecast, 2035

USD 37.5 Billion

CAGR, 2026-2035

28.15%

Report Coverage

Global

U.S. Cell and Gene Therapy CDMO Market Size, Key Players with Trends and Growth

The U.S. cell and gene therapy CDMO market size was estimated at USD 3.14 billion in 2025 and is predicted to increase from USD 4.02 billion in 2026 to approximately USD 37.5 billion by 2035, expanding at a CAGR of 28.15% from 2026 to 2035.

The U.S. cell and gene therapy CDMO market is growing strongly, driven by rising clinical pipelines, complex manufacturing requirements, and increased outsourcing by biotech companies. Demand is supported by advances in viral vectors, CAR-T therapies, and regenerative medicine, along with regulatory support, strong funding activity, and expanding manufacturing infrastructure across the country.

Key Takeaways

• U.S. cell and gene therapy CDMO market to crossed USD 4.02 billion by 2026.
• Market projected at USD 37.5 billion by 2035.
• CAGR of 28.15% expected in between 2026 to 2035.
• The global cell and gene therapy CDMO market is projected to grow from US$ 6.41 billion in 2024 to about US$ 75.32 billion by 2034, at a CAGR of 27.94%.
• By phase, the pre-clinical segment held the largest market share in 2025.
• By phase, the clinical segment is expected to grow at the fastest CAGR in the market during the forecast period. 
• By product, the cell therapy segment led the market in 2025.
• By product, the gene-modified cell therapy segment is expected to grow at the fastest CAGR in the market during the forecast period.
• By indication, the oncology segment dominated the U.S. cell and gene therapy CDMO market.
• By indication, the rare diseases segment is expected to grow at the fastest CAGR in the market during the forecast period.

Quick Facts Table

Powering the Next Wave of Advanced Therapies: Growth of the U.S. Cell & Gene Therapy CDMO Market

A cell and gene therapy CDMO is an outsourced partner that develops and manufactures cell-and gene-based therapies for biotech and pharmaceutical companies. The U.S. cell and gene therapy CDMO market is growing due to rising biotech R&D investments, expanding clinical pipelines, and increasing approvals of advanced therapies. Companies lack in-house manufacturing capacity for complex viral vectors and cell products, so they outsource to specialized CDMOs. Strong funding, technological innovation, and regulatory support further boost demand.

How AI Can Affect the Market?

AI is transforming the U.S. cell and gene therapy CDMO market by optimizing process development, improving vector design, and enhancing quality control through predictive analytics. AI-driven automation reduces manufacturing costs, shortens development timelines, and increases batch success rates, enabling CDMOs to scale complex therapies faster while meeting strict regulatory and commercialization requirements.

Trend and Future Outlook of the Market

Expanded Manufacturing Capacity

Growing demand for viral vectors and cell products is driving CDMOs to invest heavily in scalable facilities and advanced bioreactor systems, reducing bottlenecks and supporting commercial-scale production.

AI and Digital Integration

AI, machine learning, and automation enhance process optimization, predictive quality analytics, and supply chain efficiency, accelerating development timelines and lowering costs for complex therapy manufacturing.

Strategic Partnerships & M&A

Rising collaboration between biotech, pharma, and CDMOs, along with mergers/acquisitions, strengthens technical capabilities, broadens service offerings, and accelerates market entry for novel cell and gene therapies.

Major Investments in the U.S. Cell & Gene Therapy CDMO Market

• In 2025, disclosed investments in CDMO manufacturing reached roughly $24.86 billion, with about $18.48 billion going to U.S. facilities, including large builds like FUJIFILM’s $3.2 billion biomanufacturing site.
• In December 2023, FUJIFILM Corporation announced a USD 200 million investment in two businesses to strengthen its global cell therapy CDMO capabilities. This move aims to support the rapidly growing cell therapy sector, which is expected to expand at an annual rate exceeding 30%, driven by rising demand for advanced therapeutic manufacturing.

Segmental Insights

By Phase Insights

Why did the pre-clinical Segment Dominate in the Market in 2025?

The pre-clinical phase segment holds a strong share of the U.S. cell and gene therapy CDMO market due to a large volume of early-stage research programs and startups. Companies increasingly outsourced vector development, process optimization, and analytical testing to CDMOs to reduce costs, manage technical complexity, and accelerate progression toward clinical trials.

Clinical Phase

The clinical phase is expected to grow at the fastest CAGR as more cell and gene therapies advanced form early research into human trials. Rising numbers of phase I-III studies, complex GMO manufacturing needs, and limited in-house capabilities are driving sponsors to rely on specialized CDM for clinical-scale production, regulatory support, and quality compliance throughout trial progression.

By Product Insights

How will the Cell Therapy Segment dominate the Market in 2025?

The cell therapy segment led the U.S. cell and gene therapy CDMO market due to the strong adoption of CAR-T, stem cell, and immune cell therapies across oncology and regenerative medicine. A large number of approved products and active clinical pipelines increased demand for specialized manufacturing cell processing and quality testing services, prompting companies to outsource complex production activities to experienced CDMOs.

Gene-Modified Cell Therapy

The gene-modified cell therapy segment is expected to grow at the fastest CAGR due to increasing development of CAR-T, TCR, and other engineered cell therapies. Rising clinical trials, strong investment in gene-editing technologies, and the need for specialized manufacturing and regulatory expertise drive outsourcing to CDMOs, enabling faster scale-up, efficient production, and accelerated time-to-market for advanced gene-modifying therapies.

By Indication Insights

How Does the Oncology Segment Dominate the Market in 2025?

The oncology segment dominated the U.S. cell and gene therapy CDMO market due to the high prevalence of cancer and the growing adoption of CAG-T, TCR, and personalized cell therapies. The increasing number of clinical trials, approvals of innovative oncology treatments, and the complex manufacturing requirements for cancer-targeted therapies have led companies to outsource production and development to specialized CDMOs, driving market leadership in this indication.

Rare Disease

The rare diseases segment is expected to grow at the fastest CAGR due to the rising development of gene and cell therapies targeting genetic and orphan disorders. Limited patient populations and complex, personalized manufacturing requirements encourage biotech companies to rely on CDMOs for scalable production, regulatory compliance, and quality assurance, accelerating clinical and commercial availability of therapies for rare conditions.

Cell and Gene Therapy CDMO Market Growth

The global cell and gene therapy CDMO market size is calculated at US$ 6.41 in 2024, grew to US$ 8.2 billion in 2025, and is projected to reach around US$ 75.32 billion by 2034. The market is expanding at a CAGR of 27.94% between 2025 and 2034.

Top Vendors in the Market & Their Offerings

SWOT Analysis

Strengths

• Advanced manufacturing infrastructure and specialized facilities.
• Strong expertise in viral vectors, CAR-T, and gene therapies.
• High outsourcing demand due to complex production needs.
• Access to a skilled workforce and regulatory knowledge.

Weaknesses

• High operational and capital costs.
• Limited production scalability for certain therapies.
• Dependence on biotech and pharma outsourcing budgets.
• Complex regulatory compliance requirements.

Opportunities

• Growing clinical pipelines for cell and gene therapies.
• Increasing use of AI and automation in manufacturing.
• Expansion of strategic partnerships and collaborations.
• Rising demand for personalized and rare disease therapies.

Threats

• Intense competition among CDMOs.
• Regulatory delays or changing guidelines.
• Supply chain disruptions for raw materials.
• Rapid technological changes require continuous investment.

What are the Recent Developments in the U.S. Cell & Gene Therapy CDMO Market?

• In August 2025, Lonza partnered with Excellos and Akadeum Life Sciences to enhance upstream cell therapy manufacturing. The collaboration focuses on improving starting material quality and adopting modular, integrated workflows to increase efficiency, consistency, and reproducibility across cell and gene therapy production.
• In January 2025, Catalent formed a strategic partnership with Galapagos NV to enable decentralized production of GLPG5101, a CAR-T therapy for non-Hodgkin lymphoma. The collaboration uses local manufacturing sites to improve patient access and speed up clinical development timelines.

Segments Covered in the Report

By Phase

• Pre-clinical
• Clinical

By Product

• Gene Therapy
• Ex-vivo
• In-vivo
• Gene-Modified Cell Therapy
• CAR T-cell therapies
• CAR-NK cell therapy
• TCR-T cell therapy
• Cell Therapy

By Indication

• Oncology
• Infectious Diseases
• Neurological disorders
• Rare Diseases
• Others