Cell and Gene Therapy Clinical Trials Market Size Grows at a Staggering CAGR of 15.37%

Introduction

Straits Research released its highly anticipated report, “Cell and Gene Therapy Clinical Trials Market Size & Outlook, 2026-2034.” According to the study, the global cell and gene therapy clinical trials market size is valued at USD 13.93 billion in 2025 and is projected to expand to USD 50.27 billion by 2034, registering a compound annual growth rate (CAGR) of 15.37%.

Market Dynamics

The growth of the cell and gene therapy clinical trials market is primarily driven by the increasing prevalence of genetic and rare diseases, coupled with advancements in gene editing technologies such as CRISPR and CAR-T that enable precise and personalized treatment approaches. However, the market faces a significant restraint due to the high cost and complexity of conducting these trials, including challenges in manufacturing, logistics, and regulatory compliance, which limit accessibility for smaller biotech firms. Despite this, a major opportunity lies in the rising government and private sector investments aimed at expanding clinical research infrastructure and accelerating regulatory approvals, particularly in emerging regions, fostering innovation and wider adoption of advanced therapies.

Market Highlights

• Phase: The Phase III segment dominated the market in 2025, with a revenue share of 59.28%.
• Indication: The Hematology segment is expected to witness the highest CAGR (16.12%) during the forecast period, fuelled by the growing prevalence of blood-related disorders such as leukaemia, lymphoma, and sickle cell anaemia, along with increasing research on gene-modified cell therapies targeting hematologic malignancies.
• Regional Insights: North America dominates the market with a 43.17% share, driven by the strong presence of leading biotechnology and pharmaceutical companies, potent clinical research infrastructure, and favourable regulatory support for advanced therapy development.

Competitive Players

1. Novartis AG
2. Gilead Sciences, Inc. 
3. CRISPR Therapeutics
4. Intellia Therapeutics, Inc.
5. Editas Medicine
6. bluebird bio, Inc.
7. Sarepta Therapeutics, Inc.
8. ALLOGENE THERAPEUTICS
9. Adaptimmune
10. Beam Therapeutics
11. Orchard Therapeutics plc
12. REGENXBIO Inc.
13. uniQure NV.
14. Rocket Pharmaceuticals
15. Abeona Therapeutics Inc.
16. Krystal Biotech, Inc.
17. MeiraGTx Limited.
18. Bristol-Myers Squibb Company
19. Pfizer Inc.
20. Takeda Pharmaceutical Company Limited
21. Others

Recent Developments

Segmentation

1. By Phase (2026-2034)
   1. Phase I
   2. Phase II
   3. Phase III
   4. Phase IV
2. By Indication (2026-2034)
   1. Oncology
   2. Cardiology
   3. Musculoskeletal
   4. Infectious Diseases
   5. Dermatology
   6. Immunology & Inflammation
   7. Opthalmology
   8. Hematology
   9. Gastroenterology
   10. Others