U.S. Cell and Gene Therapy CRO Market AI Driven Outlook

Revenue, 2025

USD 2.33 Billion

Forecast, 2035

USD 6.02 Billion

CAGR, 2026-2035

9.95%

Report Coverage

United States

U.S. Cell and Gene Therapy CRO Market Size, Insights and Key Players with Trends

The U.S. cell and gene therapy CRO market size was estimated at USD 2.33 billion in 2025 and is predicted to increase from USD 2.56 billion in 2026 to approximately USD 6.02 billion by 2035, expanding at a CAGR of 9.95% from 2026 to 2035.

The growing incidence of various chronic diseases across the U.S. is increasing the demand for cell and gene therapies, ultimately encouraging the use of CRO services. The growing trial complexities and regulatory hurdles are also increasing their use, where AI technologies are also being utilized to support the development of cell and gene therapies. The increasing government initiatives and new launches are also promoting the market growth.

Key Takeaways

• The U.S. cell and gene therapy CRO market will likely exceed USD 2.56 billion by 2026.
• Valuation is projected to hit USD 6.02 billion by 2035.
• Estimated to grow at a CAGR of 9.95% starting from 2026 to 2035.
• The global cell and gene therapy CRO market is projected to grow from US$ 4.9 Bn 2024 to US$ 12.6 Bn by 2034, at a 9.9% CAGR.
• By service type, the clinical operations & site management segment dominated the market in 2025.
• By service type, the bioanalytics & assay development segment is expected to be the fastest growing during the forecast period.
• By therapy modality supported type, the gene-modified cell therapies segment dominated the market in 2025.
• By therapy modality supported type, the in-vivo gene therapies segment is expected to be the fastest-growing during the forecast period.
• By sponsor type/end user, the biotech & VC-backed innovators segment dominated the U.S. cell and gene therapy CRO market in 2025.
• By sponsor type/end user, the large pharma segment is expected to be the fastest growing during the forecast period.
• By trial phase/activity type, the phase I/I–II segment dominated the market in 2025.
• By trial phase/activity type, the phase II & pivotal segment is expected to be the fastest growing during the forecast period.

Executive Summary Table

What are the U.S. Cell and Gene Therapy CROs?

The U.S. cell and gene therapy CRO market is driven by the growing complexity of the therapies and the increasing volume of clinical trials. The U.S. cell and gene therapy CROs refer to the contract research organizations offering research, bioanalytical, regulatory, and clinical trial services, along with other specialized services, to support the development of cell and gene therapies across the U.S. These services help in streamlining the preclinical studies, manufacturing, and testing of the therapies, along with the management of clinical trials.

AI Technological Shifts in the Market

The use of AI in the U.S. cell and gene therapy CRO market is increasing for the discovery of drugs and their potential targets. It is also being used for the evaluation of the efficacy, safety, and adverse reactions of the products, where their integration with bioanalytical assays is also accelerating their analysis. They are also used for data management, trials, and manufacturing process optimization.

What are the Trends & Future Outlook of the Market?

Blooming Cell and Gene Therapy Pipeline

Different types of cell and gene therapies are being developed across the U.S., which is increasing the demand for CRO services, where their growing clinical trials are also increasing the use of their services.

Demand for Advanced Technologies

The U.S. CROs provide advanced technologies that attract companies, where the growing investments are also driving the development and adoption of integrated platforms.

Growth in the Demand for Skilled Workforce

The growing number of cell and gene therapy innovations across the U.S. cell and gene therapy CRO market and institutions is increasing the demand for their skilled personnel, which is increasing the collaboration with the CROs to leverage their services.

What are the New Government Initiatives in the Market?

• In January 2026, to oversee the chemistry, manufacturing, and control (CMC) requirements of cell and gene therapies (CGT), the information about a flexible approach was announced by the U.S. Food and Drug Administration. Moreover, the development strategies utilized in the preparation for a Biologics License Application (BLA) submission will also be evaluated with this approach.
• In July 2025, the participation of the 33 states, along with the District of Columbia and Puerto Rico, in the Cell and Gene Therapy (CGT) Access Model, which is an approach to offer cutting-edge treatments to patients with sickle cell disease on Medicaid, was announced by the Centers for Medicare & Medicaid Services (CMS).

Segmental Insights

By Service Type Insights

Why Did the Clinical Operations & Site Management Segment Dominate in the Market in 2025?

The clinical operations & site management segment held the dominating share in the U.S. cell and gene therapy CRO market in 2025, due to complex cell and gene therapy clinical trials. This increased their demand for regulatory compliance and management of investigational sites. Moreover, the operation efficiency and affordability also increased their use.

Bioanalytics & Assay Development

The bioanalytics & assay development segment is expected to show the highest growth during the predicted time, due to growth in the cell and gene therapy development. They are also being used to identify the potency and mechanism of action of the therapies. Additionally, they also ensure regulatory compliance, which is increasing their adoption rates.

By Therapy Modality Supported Insights

How Gene-Modified Cell Therapies Segment Dominated the Market in 2025?

The gene-modified cell therapies segment led the U.S. cell and gene therapy CRO market in 2025, driven by their wide range of applications. This increased their production rates, where their proven clinical efficacy also increased their use, increasing demand for CRO services. Additionally, the complex development also increased the collaboration with these CROs.

In-Vivo Gene Therapies

The in-vivo gene therapies segment is expected to show rapid growth during the predicted time, due to their direct delivery of therapeutic genes into the patient's body. Moreover, their broad range of targets is also increasing their R&D, which is encouraging the strategic partnerships with U.S. CROs to streamline their workflow.

By Sponsor Type/End User Insights

Which Sponsor Type/End User Type Segment Held the Dominating Share of the Market in 2025?

The biotech & VC-backed innovators segment held the dominating share in the U.S. cell and gene therapy CRO market in 2025, due to growth in the R&D activities. Additionally, the funding also accelerated the development of various cutting-edge therapies, which increased the demand for CRO expertise, along with the use of other services.

Large Pharma

The large pharma segment is expected to show the highest growth during the upcoming years, due to the growing cell and gene therapy pipeline. This is increasing the demand for technical and specialized expertise, driving collaboration with U.S. cell and gene therapy CROs. Additionally, their affordability is also attracting the companies.

By Trial Phase/Activity Insights

What Made Phase I/I–II the Dominant Segment in the Market in 2025?

The phase I/I–II segment led the U.S. cell and gene therapy CRO market in 2025, due to its focus on safety requirements. Additionally, this phase included the therapies in the early clinical development phase, where all these factors increased the reliance on the U.S. CRO services. Furthermore, the growth of outsourcing trends has also increased their demand.

Phase II & Pivotal

The phase II & pivotal segment is expected to show rapid growth during the upcoming years, due to the growing development of cell and gene therapies backed by investments. These phases also involve intensive safety and efficacy evaluation in a larger population, which increases the demand for cell and gene therapy expertise.

Regional Insights

Large Industries Propel the U.S.

The U.S. cell and gene therapy CRO market is significantly growing due to the presence of large biotechnology and pharmaceutical industries, which are increasing the development of cell and gene therapies, driving the demand for their CRO services. The growth in the R&D investments and funding is accelerating their R&D and clinical trials. Furthermore, all these factors, along with regulatory complexities, are increasing the demand for cell and gene therapy CRO services, promoting the market growth.

Cell and Gene Therapy CRO Market Growth

The global cell and gene therapy CRO market size is estimated at US$ 4.90 billion in 2024, is projected to grow to US$ 5.39 billion in 2025, and is expected to reach around US$ 12.59 billion by 2034. The market is projected to expand at a CAGR of 9.9% between 2025 and 2034.

Market Value Chain Analysis: Unlocking New Opportunities

R&D

• The R&D of cell and gene therapy in the U.S. CRO involves the bioanalytical assay development, regulatory strategy, preclinical safety assessment, and viral vector design.
• Key players: IQVIA, Charles River Laboratories, LabCorp Drug Development.

Clinical Trials and Regulatory Approvals

• Safety, efficacy, manufacturing consistency, and long-term durability are evaluated in the clinical trials and regulatory approval of the U.S. cell and gene therapy CROs.
• Key players: Medpace, Syneos Health, ICON plc.

Formulation and Final Dosage Preparation

• The formulation and final dosage preparation of the cell and gene therapies in the U.S. CRO involves the use of aseptic fill-finish to develop stable dosage forms.
• Key players: Charles River Laboratories, Thermo Fisher Scientific, Altasciences.

Packaging and Serialization

• Cryogenic-ready packaging and track-and-trace serialization are involved in the packaging and serialization of the U.S. cell and gene therapy CROs.
• Key players: Syneos Health, Charles River Laboratories, Thermo Fisher Scientific.

Distribution to Hospitals, Pharmacies

• The distribution of cell and gene therapies from U.S. CROs to the hospital and pharmacies involves the use of ultra-cold chain logistics and chain of custody tracking.
• Key players: Syneos Health, Thermo Fisher Scientific, and IQVIA.

Patient Support and Services

• Long-term follow-up monitoring, patient travel logistics, and hub services for reimbursement support are provided in the patient support and services of the U.S. cell and gene therapy CRO.
• Key players: Precision for Medicine, Syneos Health, and IQVIA.

Who are the Market Top Vendors and What are Their Offerings

SWOT Analysis

Strengths

• The U.S. cell and gene therapy CROs offer specialized and technical expertise, which helps in the development of effective therapies.
• They also offer advanced technologies along with their affordable service, which attracts companies, accelerating their development.
• Their expertise in the complex clinical trials also increased their demand to reduce the chance of product denials.
• Additionally, their experience in the trial management also helps in faster patient recruitment and retention, along with effective site management.

Weaknesses

• The shortage of trained and specialized expertise acts as the major weakness in the U.S. cell and gene therapy CRO market, as it limits their use.
• Limited scalability reduces the development of personalized cell and gene therapies, which restrains the CRO collaborations.

Opportunities

• The growing R&D of cell and gene therapies is increasing the demand for their CRO services across the U.S.
• The increasing incidence of rare and genetic diseases is also accelerating their innovation, ultimately increasing the demand for CRO services.
• The growing outsourcing trends to reduce errors and to reduce the chances of failures are also increasing the use of cell and gene therapy CROs.
• The clinical trial complexities are also increasing the demand for CROs, driving new collaborations among the companies.

Threats

• The U.S. cell and gene therapy CROs consist of a complex manufacturing process, which increases the chances of errors.
• The use of expensive reagents, technologies, and viral vectors increases the overall production cost of the therapies, limiting the use of the U.S. CRO services.

Recent Developments in the Market

• In January 2026, an expansion of the team by utilizing technical expertise and supporting the development of novel therapies was announced by Allucent, a CRO, where they will also utilize new technologies to support the clinical trials of small and mid-size biopharma companies.
• In October 2025, an expansion of the cell and gene therapy (CGT) laboratory in Madison was announced by Labcorp, where the facility will offer state-of-the-art testing capabilities, enhance preclinical research, and streamline workflow efficiency.

Segments Covered in the Report

By Service Type

• Clinical Operations & Site Management
• Preclinical GLP Toxicology & IND-enabling Studies
• Bioanalytics & Assay Development
• Translational Medicine & Biomarker Services
• Regulatory Affairs & CMC Support
• Decentralized & Patient Logistics Services
• Long-term Follow-up (LTFU) & Safety Surveillance

By Therapy Modality Supported

• Gene-modified cell therapies
• In-vivo gene therapies

By Sponsor Type/End User

• Biotech & VC-backed innovators
• Large Pharma
• Academic consortia/foundations

By Trial Phase/Activity

• Phase I/I–II
• Phase II & Pivotal