Cell and Gene Therapy CRO Market Leaders
- Charles River Laboratories
- Labcorp / Covance
- ICON plc
- IQVIA
- Parexel
- Syneos Health
- Medpace
- PPD
- Novotech
- Precision for Medicine
- QPS
- CMIC Group
- Altasciences
- Aixial
- WuXi AppTec
- Catalent
- Thermo Fisher Scientific / Patheon
- Cryoport / Clinical logistics specialists
- TrakCel / Vineti
- Specialist boutique CROs
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.
Cell and Gene Therapy CRO Market Trends
Increasing government programmes that support to design of cell-based therapies to treat human disease and for the repair of damaged or destroyed tissues.
For instance,
- In July 2025, CMS announced that 33 states, along with the District of Columbia and Puerto Rico, will be participating in the CGT Access Model. Of these, seven states and the District of Columbia have applied for and been awarded Cooperative Agreement funding. The Cell and Gene Therapy (CGT) Access Model aims to improve the lives of people living with rare and severe diseases by increasing access to potentially transformative treatments.
Increasing demand for medical disposables due to increasing healthcare demands, improving hygiene, lowering infection challenges, and enhancing efficiency drives the growth of the market.
For Instance,
- In April 2025, AGC biologics launched a novel dedicated cell and gene business division. The new Cell and Gene Technologies Division will focus on elevating existing AGC Biologics capabilities and supporting developers in need of capacity, scientific capabilities, and technically qualified cell and gene CDMO operators
Cell and Gene Therapy CRO Market – Value Chain Analysis
R&D
R&D of cell and gene therapies involves many steps, including cell harvesting, transportation, expansion, gene transduction, and infusion into the patient, each of which demands to be reliable and reproducible.
Key Players: uniQure and Oxford Biomedica
Clinical Trials
Clinical trials of gene and cell therapy are often organised as a phase I / II study, where a small group of participants with the disease are registered and both efficacy and safety tests are conducted. Significant activities involve gene introduction or cell reprogramming, vector manufacturing and testing, cell extension and quality control, and delivery to patients, and rigorous monitoring.
Key Players: Novartis and Sarepta Therapeutics, Beam Therapeutics, and Intellia Therapeutics
Patient Support and Services
Cell and gene therapies support the patient by involving the transfer of cells with the appropriate function to the patient. Approximately protocols use both gene therapy and cell therapy. The patient journey includes some steps, from early diagnosis and pre-treatment testing to the actual administration and succeeding monitoring.
Key Players: Biostate.ai and Kite Pharma
Latest Announcements by Industry Leaders
In April 2025, Artis CEO Brian Neel stated, “Advanced therapies continue to be a driving force of invention in the biopharma ecosystem, and we believe the industry is at an inflection point in advancing and developing the significant processes and the manufacturing of these therapies.”
Recent Developments in the Cell and Gene Therapy CRO Market
- In July 2025, Genethon, a worldwide pioneer and leader in research and development in gene therapy for rare genetic diseases, received approvals from regulatory authorities, MHRA and EMA, to begin pivotal Phase 3 clinical trials in France and the UK of its gene therapy, GNT0004, for Duchenne muscular dystrophy (DMD).
- In April 2025, Gene therapy CDMO Artis BioSolutions launched with the acquisition of Landmark Bio. Novel CDMO Artis BioSolutions has decloaked on a mission to tackle the tricky production process for advanced therapeutics.
- In April 2025, INmune Bio Inc., a clinical-stage biotechnology company targeting inflammation and immunology through the innate immune system, partnered with the Cell and Gene Therapy Catapult to establish large-scale, commercial-ready manufacturing for its cell therapy platforms. CGT Catapult is an independent technology and innovation organization specializing in the advancement of the cell and gene therapy industry. It was established by and works in partnership with Innovate UK.
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