Press release
Cell & Gene Therapy CRO Market to Reach USD 9.82 Billion by 2034 Amid Rising Outsourcing of Advanced Therapies
Cell & Gene Therapy CRO Market
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Market Summary
The Cell & Gene Therapy CRO Market is witnessing exceptional growth driven by rising demand for complex clinical trial management, specialized analytical services, viral vector expertise, and regulatory navigation required for advanced therapies.
With more than 2,000+ ongoing CGT trials globally, sponsors are depending heavily on CROs to accelerate timelines, manage global studies, and address scientific, logistic, and compliance challenges. Growth is further supported by increasing FDA/EMA approvals, rapid expansion of personalized therapies, and rising investments in CAR-T, AAV, lentiviral, and gene-editing technologies. North America leads the market, while Asia-Pacific is the fastest-growing region due to lower clinical trial costs, expanding GMP facilities, and strong government support for biotech innovation.
Key Takeaways
• 2024 Market Value: USD 3.42 Billion
• 2034 Forecast: USD 9.82 Billion
• CAGR (2025-2034): 10.9%
• Increased outsourcing for CGT clinical trials, analytics, and regulatory services
• CROs offering viral vector testing and gene-editing expertise gaining traction
• Asia-Pacific emerging as a major CGT outsourcing hub
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Market Drivers
• Explosive growth in cell & gene therapy clinical pipelines
• Need for specialized testing (potency, vector analytics, immunogenicity)
• Regulatory complexity requiring expert CRO partners
• Rising demand for decentralized and adaptive trial models
• Increasing biotech partnerships and funding inflows
Segmentation Snapshot
By Therapy Type
• Cell Therapy
• Gene Therapy
• Gene-Modified Cell Therapy (CAR-T, TCR)
By Service Type
• Clinical Trial Management
• Analytical Testing Services
• Regulatory & Compliance Services
• Manufacturing Support / CDMO Coordination
By Phase
• Preclinical
• Phase I
• Phase II
• Phase III
By End-User
• Biopharmaceutical Companies
• Biotechnology Startups
• Research Institutes
By Region
• North America (Largest Share)
• Europe
• Asia-Pacific (Fastest Growing)
• Latin America
• Middle East & Africa
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Recent Developments
• CROs expanding CGT-specific labs for viral vector testing and potency assays.
• Partnerships between CROs and CDMOs for integrated development-to-manufacturing workflows.
• Increased investment in AI-enabled trial monitoring for CGT programs.
Expert Quote - Irfan Tamboli, Business Development Executive
"Cell and gene therapies demand highly specialized development workflows. CROs with deep scientific expertise, advanced analytics, and global trial capabilities are becoming indispensable partners for biotech innovators."
Conclusion
The Cell & Gene Therapy CRO Market is set for strong double-digit growth through 2034 as CGT innovations accelerate worldwide. CROs offering end-to-end, technologically advanced, and regulatory-ready solutions will be critical in supporting next-generation therapeutic breakthroughs.
This report is also available in the following languages : Japanese (細胞・遺伝子治療CRO市場), Korean (세포 및 유전자 치료 CRO 시장), Chinese (细胞和基因治疗CRO市场), French (Marché des CRO en thérapie cellulaire et génique), German (Markt für Auftragsforschungsinstitute (CROs) im Bereich Zell- und Gentherapie), and Italian (Mercato CRO per la terapia cellulare e genica), etc.
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Connect Us:
Irfan Tamboli
PHONE NUMBER +1 (704) 266-3234
EMAIL ADDRESS: sales@exactitudeconsultancy.com
About Us
Exactitude Consultancy is a market research & consulting services firm which helps its client to address their most pressing strategic and business challenges. Our market research helps clients to address critical business challenges and also helps make optimized business decisions with our fact-based research insights, market intelligence, and accurate data.
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