Cell & Gene Therapy Clinical Trials Market - Global Forecast 2025-2032

The cell and gene therapy clinical trials market is evolving rapidly, providing new avenues to advance precision medicine through innovative biological techniques and integrated research platforms. Senior decision-makers in biopharma, healthcare investment, and clinical development will find critical insights here to inform strategic priorities and investments.

Market Snapshot: Cell & Gene Therapy Clinical Trials Market

The cell and gene therapy clinical trials market grew from USD 10.48 billion in 2024 to USD 12.08 billion in 2025. It is expected to continue expanding with a CAGR of 15.14%, reaching USD 32.38 billion by 2032. Growing alignment among academic, industry, and regulatory bodies is accelerating the development of advanced therapies, with clinical trial activity broadening across a spectrum of indications and modalities.

Scope & Segmentation

• Therapy Type: CAR T cell therapies, dendritic cell therapies, NK cell therapies, stem cell therapies, non-viral gene therapies (electroporation, lipid nanoparticles, naked DNA/RNA), viral vector gene therapies (adeno-associated virus, adenoviral, retroviral), and tissue engineered products
• Vector Type: Non-viral vectors including electroporation, lipid nanoparticles, and naked DNA/RNA; viral vectors such as adeno-associated virus, adenoviral, and retroviral systems
• Cell Type: Dendritic cells, NK cells, hematopoietic stem cells, mesenchymal stem cells, CAR T cells, and TCR-engineered T cells
• Indication Areas: Neurology (Alzheimer disease, Parkinson disease), oncology (hematologic cancers including leukemia and lymphoma, solid tumors including breast cancer and melanoma), rare genetic disorders (cystic fibrosis, hemophilia), metabolic disorders
• Clinical Trial Phases: Phases I through III, ranging from initial safety and proof-of-concept to large-scale efficacy trials
• Geographic Coverage: Americas (North America—United States, Canada, Mexico; Latin America—Brazil, Argentina, Chile, Colombia, Peru); Europe, Middle East & Africa (United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland; UAE, Saudi Arabia, Qatar, Turkey, Israel; South Africa, Nigeria, Egypt, Kenya); Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan)
• Featured Companies: Novartis AG, Gilead Sciences, Spark Therapeutics, bluebird bio, Sangamo Therapeutics, CRISPR Therapeutics, Editas Medicine, Fate Therapeutics, Orchard Therapeutics, uniQure NV

Key Takeaways for Senior Decision-Makers

• Diversification of therapy and vector platforms results in tailored development pathways, requiring strategies that consider both technical and regulatory requirements.
• Adoption of modular manufacturing and digital analytics is reducing operational complexity while supporting scale-up and ensuring therapy quality.
• Collaborative networks, including alliances between biotech firms, pharmaceutical companies, contract manufacturers, and academic centers, are accelerating trial progress and facilitating resource pooling.
• Personalized medicine is advancing as trials increasingly address difficult-to-treat oncologic, neurologic, and rare genetic diseases.
• Emerging regional hubs and proactive policies are shaping the pace and breadth of clinical research globally.

Tariff Impact on Supply Chain Resilience

New United States tariff measures implemented in 2025 have led to increased costs across the clinical supply chain, including raw materials such as vector plasmids and single-use consumables. Sponsors are exploring domestic sourcing and nearshoring to counteract elevated expenses. Logistics solutions, updated warehousing strategies, and buffer inventories are helping ensure uninterrupted trial operations. Stakeholders are working through added documentation and customs hurdles, with some viewing these challenges as a potential catalyst for long-term domestic manufacturing investment and supply chain resilience.

Methodology & Data Sources

This research employs a blend of secondary and primary data, including in-depth expert interviews, regulatory filings, patent analysis, and clinical trial registry data. Insights and segmentation frameworks were rigorously validated through consultations with clinical, regulatory, and manufacturing professionals to ensure accuracy and industry relevance.

Why This Report Matters

• Builds actionable strategies for optimizing cell and gene therapy development, clinical trial execution, and investment allocation.
• Clarifies critical segmentation and regional trends, enabling leaders to benchmark position and plan market entry or expansion.
• Delivers an up-to-date perspective on regulatory, technological, and supply chain dynamics shaping the future of precision medicine.

Conclusion

The cell and gene therapy clinical trials market is undergoing significant transformation, powered by regulatory, technological, and collaborative advancements. Senior leaders equipped with this focused intelligence will be positioned to drive value, foster innovation, and advance new therapies globally.

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