Lowest Price Guaranteed
Pages
343
Last Updated
April 2026
View Count
22513
The global cell and gene therapy CRO market, valued at USD 1.7 billion in 2024, is estimated to reach USD 1.9 billion in 2025 and USD 3.5 billion by 2035, representing a CAGR of 6.3% during the forecast period.
 |
To learn more about this report, request a free sample copy
The new research study consists of industry trends, detailed cell and gene therapy CRO market analysis, key market insights, market impact analysis, market forecast and opportunity analysis. The rise in the opportunity for contract research organizations over the next decade is likely to be the result of the anticipated rise in the demand for cell and gene therapies.
Cell and gene therapy candidates have demonstrated the potential to treat rare and complex diseases, including indications, for which no effective treatment is currently available. It is important to mention that, in case of cell therapy, human cells are transplanted to repair or replace the damaged cells / tissues, thereby enabling their treatment through alteration or restoration of certain set of cells; the cells may originate from the patient (autologous cells) or a donor (allogeneic cells). On the other hand, gene therapy aims to correct the underlying genetic problem to ensure the treatment, as well as prevention of diseases, by replacing, inactivating or introducing genes into cells, either inside or outside of the body. It is worth highlighting that some therapeutic interventions can be considered both cell and gene therapies. The mechanism of action of such therapies usually involves alteration of genes in specific types of cells and subsequently, their insertion into the patient body.
Presently, over 90 cell and gene therapies have been approved globally. Notable examples of recently approved therapies include (in reverse chronological order of year of approval) Fucaso (2023; developed by IASO Bio) for the treatment of multiple myeloma, Elvediys, (2023; developed by Sarepta Therapeutics) for the treatment of duchenne muscular dystrophy and Vyjuvek (2023; developed by Krystal Biotech) for the treatment of dystrophic epidermolysis bullosa. Additionally, more than to 3,500 clinical studies are currently evaluating cell and gene therapies across 16 therapeutic areas.
In addition to the biotechnology companies developing cell and gene therapies, there are several stakeholders in the market that are defining the success of these immunotherapies. In addition to the CROs, there are companies that are providing suitable clinical trial software solutions for clinical trial management. These platform providers are also working on exploring novel platforms that can allow decentralized / virtual clinical trials for cell and gene therapies. One such company is the US based Jeeva Clinical Trials, which is developing a SaaS platform aimed at reducing the travel burden for participants. In addition, there are companies developing cell and gene therapy supply chain software to allow the drug developers and CROs to manage the supply chains.
With rapidly evolving cell and gene therapy landscape, CROs bring expertise in navigating complex regulatory frameworks, optimizing study designs, and supporting seamless transition from preclinical to clinical success. The aforementioned factors are likely to present lucrative market growth opportunities for contract service providers during the forecast period.
 |
 |
 |
The market research report presents an in-depth analysis of the various firms / organizations in the cell and gene therapy CRO market, across different segments, as defined in the table below:
| Key Report Attribute | Details | |
| Historical Trend | Since 2018 | |
| Forecast Period | 10+ Years | |
| Market Size 2025 | $1.9 Billion | |
| Market Size 2035 | $3.5 Billion | |
| CAGR (Till 2035) | 6.3% | |
| Type of Cell Therapy |
|
|
| Type of Genetic Modification |
|
|
| Stage of Development |
|
|
| Therapeutic Area |
|
|
| End Users |
|
|
| Key Geographical Regions |
|
|
| Leading Market Players |
|
|
| PowerPoint Presentation (Complimentary) |
Available | |
| Customization Scope | 15% Free Customization | |
| Excel Data Packs (Complimentary) |
|
|
 |
 |
 |
One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential for the contract research organizations serving the cell and gene therapy industry, over the forecast period. Based on multiple parameters, likely adoption trends and through primary validations, we have provided an informed estimate on the market evolution during the forecast period till 2035.
The market report also features the likely distribution of the current and forecasted opportunity within the cell and gene therapy CRO market across various segments, such as type of cell therapy (CAR-NK, CAR-T, TCR-T, and others), type of genetic modification (ex vivo and in vivo), stage of development (discovery, preclinical, and clinical), therapeutic area (blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders), end-users (industry players and non-industry players) and key geographical regions (North America, Europe, Asia-Pacific, and Rest of the World).
In order to account for future uncertainties and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.
The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders in the cell and gene therapy CRO market. In addition, the research report features detailed transcripts of interviews held with the following industry stakeholders (arranged on the basis of designation):
Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.
The overall cell therapy market is segmented into CAR-NK, CAR-T, TCR-T, and others. The CAR-T cell therapy market segment currently occupies the highest share and is expected to remain dominant during the forecast period. This can be attributed to the fact that CAR-T cell therapies have resulted in profound clinical responses in the treatment of various disease indications, such as CD19-positive haematological malignancies, acute lymphoblastic leukemia and multiple myeloma.
This section highlights the overall gene therapy CRO market across ex vivo and in vivo. The ex vivo segment currently occupies the highest share and is expected to dominate during the forecast period. This can be primarily attributed to the fact that ex vivo techniques involve the use of viral vectors, which are effective in delivering and integrating modified genetic material into cells.
This section segments the cell and gene therapies on the basis of their stage of development (discovery, preclinical and clinical) in the cell and gene therapy CRO market. The clinical segment currently occupies the highest share and is expected to be dominant during the forecast period. This can be attributed to the fact that the therapies undergo rigorous clinical testing to meet regulatory standards before reaching the market. Further, majority (47%) of the trials evaluating cell and gene therapies are currently in phase II.
This section segments the global cell and gene therapy CRO market based on therapeutic area into blood disorders, cardiovascular disorders, dermatological disorders, immunological disorders, infectious diseases, metabolic disorders, musculoskeletal disorders, neurological disorders, oncological disorders, rare diseases, and other disorders. The oncological disorders segment occupies the highest share and this trend (in terms of market share) is likely to remain same during the forecast period. In addition, the favorable clinical outcomes for oncological-based studies has contributed to the increase in the development of cell and gene therapies, thereby leading to a higher market share as compared to other therapeutic areas.
Based on end-users, the global cell and gene therapy CRO market is segmented into industry and non-industry players. Presently industry players generate the maximum revenues, thereby capturing majority of the market share in this domain and this trend (in terms of market share) is likely to remain same during the forecast period.
This segment highlights the distribution of cell and gene therapy CRO market across various geographies, namely North America, Europe, Asia-Pacific and Rest of the World. According to our 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. It is worth highlighting that the market in Asia-Pacific is expected to grow at a relatively healthy CAGR (8.1%), during the period till 2035.
The Cell and Gene Therapy CRO Market (4th Edition): Industry Trends and Global Forecasts, Till 2035 market report features an extensive study of the current market landscape, market size, market share, market analysis, market forecast and future opportunities for the cell and gene therapy CROs. Key takeaways of the market report are briefly discussed below:
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.
It is worth highlighting that, in recent years, ATMPs have emerged as one of the potential therapeutic modalities that are likely to change the standardized management in order to control the onset of chronic diseases. Thus, the growing demand for novel cell and gene therapies, approvals from various regulatory bodies and technological advancements in order to streamline the drug discovery and clinical research processes, are expected to drive the cell and gene therapy CRO market growth during the forecast period.
Over the years, cell and gene therapy contract research organizations have made significant efforts to conduct clinical trials for evaluating the efficacy of these therapies for targeting various disorders, including oncological disorders, neurological disorders, and cardiovascular disorders. Majority (49%) of these trials were registered in North America. Further, the maximum number of patients (110,585) have been enrolled in clinical trials conducted in North America, which account for 32% of the overall patient enrollment. It is worth mentioning that Chongqing Precision Biotech is conducting the maximum number of trials in this industry for various therapeutic areas, including oncological disorders, autoimmune / inflammatory disorders and liver disorders. This is followed by Chia Tai Tianqing Pharmaceutical with majority of its therapy candidates in the phase II clinical trials.
Several stakeholders have been forging alliances with other industry / non-industry players in the cell and gene therapy CRO industry. It is worth highlighting that, since 2015, over 65 strategic partnerships have been established in this domain. Interestingly, most of the agreements signed between the stakeholders were instances of acquisitions. This can be attributed to the fact that the rapid advancements in the cell and gene therapy market has created a competitive landscape, thereby leading to acquisitions of specialized firms by leading players in order to enhance their capabilities and stay at the forefront of innovation. For instance, in October 2023, QHP Capital acquired Applied Stem Cell, a US based company. The primary purpose of this acquisition was to utilize Applied Stem Cell’s technology and capabilities combined with QHP’s strategic network and deep industry knowledge in order to accelerate the development of regenerative medicines.
This is followed by clinical trial agreements and service alliances signed between various stakeholders in this domain. Notable examples of players that have adopted the service alliance partnership model (in reverse chronological order) include Obio Technology and Tofflon, Parexel and Partex, Labcorp and Forge Biologics and Syneos Health and Cryoport.
It is a well-known fact that the development and clinical evaluation of cell and gene therapies is both challenging and cost intensive, and only a few therapeutic developers have the required technical expertise to carry out in-house clinical research. This can be attributed to the peculiar requirements associated with acquiring the necessary infrastructure and capabilities to carry out research, along with advanced product development expertise. The aforementioned challenges are believed to be the key factors for driving the outsourcing of research operations to a cell and gene therapy CRO.
CROs play a pivotal role in advancing healthcare innovations through preclinical and clinical development stages. For instance, in the preclinical phase, CROs aid in conducting rigorous assessments of potential therapies in laboratory settings, evaluating safety, and refining protocols before human trials.
Further in the clinical stage, CROs facilitate the execution of trials, ensure adherence to regulatory standards, effective monitoring and management of clinical trial-related patient data.
The global cell and gene therapy CRO market is estimated to be worth $1.9 billion in 2024. Driven by the increase in potential of these therapies to treat myriad of disease indications, the market is anticipated to grow at a CAGR of 6.3% during the forecast period. Specifically, in terms of type of cell therapy, majority of the market share is anticipated to be captured by CAR-T cell therapy segment.
Further, by 2035, in terms of stage of development, majority of the market share is anticipated to be captured by the clinical segment.
Majority of the cell and gene therapy CRO are headquartered in North America, followed by companies based in Europe. Currently, North America and Europe capture over 80% of the market share of the overall cell and gene therapy CRO market.
In recent years, demand for cell and gene therapies in the North America region has witnessed a tremendous increase owing to increasing R&D investments and number of clinical studies pertaining to the development of cell and gene therapy-based products. However, in the coming years, Asia-Pacific region is likely to grow at a much faster rate as compared to other geographies.
Examples of key cell and gene therapy CRO (which have also been profiled in this market report; the complete list of companies is available in the full report) include Altasciences, Allucent, CMIC, Labcorp, Linical, Medpace, PPD, Precision for Medicine, QPS, Syneos Health, CMED, ICON, Pharmalex and Novotech. This global cell and gene therapy CRO market research report includes an easily searchable excel database of all the companies that offer contract research services for cell and gene therapy worldwide.
The market report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this industry, across different geographies. Amongst other elements, the market report includes:
 |
 |
 |
Several recent developments have taken place in the field of cell and gene therapy CRO. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.