Cell and Gene Therapy CRO Market Size Worth over USD 3,500 Million in 2035 | Roots Analysis
The cell and gene therapy CRO market is anticipated to be worth USD 1,653 million in 2023 and this value is likely to reach over USD 3,513 million by 2035.

In the last few years, many cell and gene therapy contract research organizations (CROs) have emerged and significantly impacted the overall biopharmaceutical market. It is worth mentioning that the presence of CROs has enabled small and mid-sized companies, which lack the necessary expertise and elaborate resources, to successfully initiate R&D programs in several domains.
Additionally, outsourcing research activities allows sponsor companies to focus on other activities within their organization. An ideal CRO has a well-qualified and skilled staff and offers high-quality services that can fulfil client requirements. The aforementioned advancements are expected to enable the modern CROs to aid the biopharmaceutical industry well beyond what their traditional counterparts offered.
The cell and gene therapy CRO market is anticipated to be worth USD 1,653 million in 2023 and this value is likely to reach over USD 3,513 million by 2035, expanding at a CAGR of 7.1% according to a new report by Roots Analysis.
Key Report Takeaways
§ The current market landscape features the presence of over 105 well-established players and new entrants that claim to have the necessary capabilities to offer contract research services; majority of these firms are based in North America.
§ Contract research services are offered for cell and gene therapies across different scales of operations; further close to 20% of the players offer all types of clinical services.
§ More than 65 deals have been inked between various stakeholders involved in this domain since 2015; acquisitions emerged as the most common type of partnership model.
§ In the last few years, a number of mergers and acquisitions have been reported in this domain; 58% of such initiatives were signed to incorporate additional capabilities to their existing portfolio offerings
§ More than 3,000 clinical trials have been registered for cell therapies since 2018; over 70% of the trials initiated in 2023 are currently recruiting patients.
§ Close to 500 clinical trials (with over 48,000 enrolled patients) have been registered to investigate gene therapies, across different geographies.
§ In order to meet the rising demand for cell and gene therapies, stakeholders are striving to upgrade / expand their capabilities to enhance their respective service portfolios.
§ Our proprietary total cost of ownership model offers an informed estimate of capital and operational expenses associated with the establishment and maintenance of a contract research facility, over a span of 20 years.
§ It is worth highlighting that the CRO market in China is likely to grow at a faster pace. Further, about 25% of the market is expected to be captured by revenues generated from cell and gene therapies for oncological disorders.
§ Competitive Landscape of Cell and Gene Therapy CRO Market
The cell and gene therapy CRO market features over 105 large, mid-sized and small contract research organizations that are engaged in offering services for cell and gene therapy across preclinical, clinical, and commercial scales of operation.
Currently, 80% of the contract research organizations offer their expertise for the advancement of cell and gene therapies to drug developers in order to ensure efficiency, from initial research and development to clinical trials and regulatory approvals; notable examples (in alphabetical order) include Absorption Systems, Accelera, Advanced BioScience Laboratories, and Advanced Cell Diagnostics. In addition, majority of these companies are actively involved in offering clinical trial management services, followed by clinical research monitoring services.
Cell and Gene Therapy CRO Market Regional Outlook
Based on the key geographical regions, the cell and gene therapy CRO market can be segmented into four major regions, including North America, Europe, Asia-Pacific and Rest of the World.
According to Roots Analysis projections, North America is likely to capture majority (59%) of the cell and gene therapy CRO market share, and this trend is unlikely to change in the future. This can be attributed to the fact that prominent players such as Charles River laboratories, ICON, IQVIA, Labcorp, Syneos Health and Evotec generate substantial revenues in North America. Additionally, 111,000 patients were enrolled in clinical trials related to cell and gene therapies in North America.
Further, it is anticipated that the market in Asia-Pacific is likely to grow at a consistent rate as the research and development of cell and gene therapies in Asia-Pacific is highly favorable in terms of producing high-quality products for global markets. This can be attributed to lower costs of conducting trials conducting costs, availability of skilled workforce, growing patient population and ease of regulatory compliance in this region.
Cell and Gene Therapy CRO Market Key Players
Examples of key companies engaged in cell and gene therapy CRO market (which have also been profiled in this market report; the complete list of companies is available in the full report) include: Aixial, Altasciences, CMIC Group, ICON, Labcorp, Linical, Medpace, Novotech, PPD, Precision for Medicine, QPS, Syneos Health.
It is interesting to note that in April 2022, Labcorp entered into an agreement with Xcellbio to work on a series of projects focused on improving the safety and efficacy of cell and gene therapies, resulting in substantial market growth during the forecast period.
Cell and Gene Therapy CRO Market Segments
Based on the research, Roots Analysis has segmented the Cell and Gene Therapy CRO Market into Type of Cell therapy, Type of Genetic Modification, Stage of Development, Therapeutic Area, Type of End-users and Geography.
by Type of Cell Therapy
§ CAR-NK
§ CAR-T
§ TCR-T
§ Others
by Type of Genetic Modification
§ Ex vivo
§ In vivo
by Stage of Development
§ Clinical
§ Preclinical
§ Discovery
by Type of Therapeutic Area
§ Oncological Disorders
§ Rare Diseases
§ Neurological Disorders
§ Metabolic Disorders
§ Musculoskeletal Disorders
§ Cardiovascular Disorders
§ Immunological Disorders
§ Dermatological Disorders
§ Blood Disorders
§ Infectious Diseases
§ Other Disorders
by Type of End-user
§ Industry Players
§ Non-Industry Players
by Key Geographical Regions
§ North America
§ Europe
§ Asia Pacific
§ Rest of the Word
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