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

The Cell & Gene Therapy Clinical Trials Market is undergoing rapid transformation, driven by scientific advances and evolving regulatory environments. This growth is catalyzing innovation, expanding access, and redefining standards in modern healthcare development.

Market Snapshot: Cell & Gene Therapy Clinical Trials Market

The Cell & Gene Therapy Clinical Trials Market grew from USD 10.48 billion in 2024 to USD 12.08 billion in 2025. It is projected to maintain a strong compounded annual growth rate (CAGR) of 15.14%, reaching USD 32.38 billion by 2032.

Scope & Segmentation

This report delivers a comprehensive breakdown across critical clinical trial segments and geographic regions to support investment and operational decisions:

• Therapy Type: Cell therapy (CAR T, dendritic cell therapy, NK cell therapy, stem cell therapy), gene therapy (non-viral vector: electroporation, lipid nanoparticle, naked DNA/RNA; viral vector: adeno-associated virus, adenoviral, retroviral), tissue engineered products
• Vector Type: Non-viral vector (electroporation, lipid nanoparticle, naked DNA/RNA), viral vector (adeno-associated virus, adenoviral, retroviral)
• Cell Type: Dendritic cell, NK cell, stem cell (hematopoietic, mesenchymal), T cell (CAR T, TCR)
• Indication: Neurology (Alzheimer's, Parkinson's), oncology (hematologic cancer: leukemia, lymphoma; solid tumor: breast cancer, melanoma), rare disease (genetic disorder: cystic fibrosis, hemophilia; metabolic disorder)
• Trial Phase: Phase I, Phase II, Phase III
• Regions: Americas (North America: United States, Canada, Mexico; Latin America: Brazil, Argentina, Chile, Colombia, Peru), Europe, Middle East & Africa (Europe: United Kingdom, Germany, France, Russia, Italy, Spain, Netherlands, Sweden, Poland, Switzerland; Middle East: United Arab Emirates, Saudi Arabia, Qatar, Turkey, Israel; Africa: South Africa, Nigeria, Egypt, Kenya), Asia-Pacific (China, India, Japan, Australia, South Korea, Indonesia, Thailand, Malaysia, Singapore, Taiwan)
• Leading Companies: Novartis AG, Gilead Sciences, Inc., Spark Therapeutics, Inc., bluebird bio, Inc., Sangamo Therapeutics, Inc., CRISPR Therapeutics AG, Editas Medicine, Inc., Fate Therapeutics, Inc., Orchard Therapeutics Ltd, uniQure N.V.

Key Takeaways for Senior Decision-Makers

• Recent breakthroughs in adoptive cell therapy and non-viral gene delivery have broadened trial applications, accelerating both immuno-oncology and regenerative medicine strategies.
• Advanced vector platforms and closed-system bioreactors are redefining trial scalability and reliability, with digital twins and AI-powered analytics supporting process optimization.
• Regulatory agencies in North America, Europe, and Asia-Pacific have issued harmonized technical guidance and expedited approval pathways, encouraging the entry of both established pharmaceutical leaders and agile biotech startups.
• Diverse trial sites and strong public-private partnerships support regional resilience, while operational complexities—including workforce competition and balancing quality frameworks—demand careful navigation.
• Segmentation shows increasing traction for niche modalities, such as natural killer cell therapies and decentralized trial approaches, particularly in hard-to-enroll patient groups.

Tariff Impact on Clinical Trial Supply Chains

The 2025 introduction of new United States tariffs has imposed cost pressures across the cell and gene therapy supply chain, particularly affecting critical materials such as viral vector plasmids, growth media, and single-use consumables. Sponsors have adapted procurement and engagement strategies to consider nearshoring and domestic manufacturing in order to offset these challenges. Enhanced warehousing requirements, supply chain buffer strategies, and evolving customs documentation add operational complexity, but are also fostering regional resilience and encouraging public-private infrastructure projects.

Methodology & Data Sources

This report integrates secondary research, including scientific literature, regulatory filings, and patent databases, with primary interviews from clinical, manufacturing, and regulatory stakeholders. Expert consultations validated data, while extensive triangulation and analysis across multiple registries and independent sources ensured thoroughness and reliability of insights.

Cell & Gene Therapy Clinical Trials Market: Why This Report Matters

• Provides a robust framework for benchmarking market opportunities and identifying competitive dynamics within therapy, vector, and indication segments.
• Delivers actionable intelligence on supply chain, regulatory, and manufacturing trends, empowering strategic planning and resource allocation.
• Supports senior leaders in safeguarding project continuity and assessing risk under shifting policy or tariff conditions.

Conclusion

Senior decision-makers gain the strategic visibility needed to seize emerging opportunities in the evolving cell and gene therapy clinical trial ecosystem. This report equips stakeholders to drive progress, optimize investment, and anchor resilient operations in a dynamic industry landscape.

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