DUBLIN--(BUSINESS WIRE)--The "Cell and Gene Therapy CRO Market: Industry Trends and Global Forecasts, Till 2035 - Distribution by Type of Cell Therapy, Type of Genetic Modification, Stage of Development, Therapeutic Area, End-users and Key Geographical Regions" report has been added to ResearchAndMarkets.com's offering.
The global cell and gene therapy CRO market is estimated to grow from $1.65 billion in 2024 to $3.51 billion by 2035, representing a CAGR of 7.1% during the forecast period 2024-2035.
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.
Competitive Landscape of Cell and Gene Therapy Contract Research Organizations
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.
Clinical Trials Analysis: Over 3,500 Trials are Evaluating Cell and Gene Therapies to Treat Myriad of Disease Indications
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.
Cell and Gene Therapy CRO Market Share Insights
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 below:
- Historical Trend: 2018-2023
- Base Year: 2023
- Forecast Period: 2024-2035
- Market Size Value in 2024: $1.65 Billion
- Growth Rate: CAGR of 7.1% from 2024 to 2035
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Type of Cell Therapy
- CAR-NK
- CAR-T
- TCR-T
- Others
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Type of Genetic Modification
- Ex vivo
- In vivo
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Stage of Development
- Discovery
- Preclinical
- Clinical
-
Therapeutic Area
- Blood Disorders
- Cardiovascular Disorders
- Dermatological Disorders
- Immunological Disorders
- Infectious Diseases
- Metabolic Disorders
- Musculoskeletal Disorders
- Neurological Disorders
- Oncological Disorders
- Rare Diseases
- Other Disorders
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End Users
- Industry Players
- Non-Industry Players
-
Key Geographical Regions
- North America
- Europe
- Asia-Pacific
- Rest of the World
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Leading Market Players
- Altasciences
- Allucent
- CMIC
- Labcorp
- Linical
- Medpace
- PPD
- Precision for Medicine
- QPS
- Syneos Health
- CMED
- ICON
- Pharmalex
- Novotech
- PowerPoint Presentation (Complimentary)
- Customization Scope: 15% Free Customization
-
Excel Data Packs (Complimentary)
- Market Landscape Analysis
- Benchmark Analysis
- Partnerships and Collaborations
- Mergers and Acquisitions
- Key Acquisition Targets
- Clinical Trial Analysis (Cell Therapy)
- Clinical Trial Analysis (Gene Therapy)
- Total Cost of Ownership
- Market Sizing and Opportunity Analysis
For more information about this report visit https://www.researchandmarkets.com/r/6n6imn
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