The global cell and gene therapy clinical trials market accounted for USD 9.45 billion in 2023 and is expected to reach at USD 43.17 billion by 2034 with a CAGR of 14.81% during the forecast period 2024-2034. Rise in funding for research & development, heightened patient interest in new treatments, particularly in the realm of cell & gene therapies for cancer, favorable regulatory conditions, increasing prevalence of chronic diseases & rare genetic conditions, surge in both the approval of innovative therapies, and growing number of clinical trials in this field are some of the key factors boosting the market growth.
Growing number of clinical trials in this field is predicted to boost the market growth during the forecast period. Cell and gene therapies (CGTs) represent the forefront of therapeutic innovation, yielding promising treatments globally. While some initial therapies have received marketing approval, there are countless other promising therapies undergoing development worldwide. For instance, in June 2023, Vertex Pharmaceuticals and CRISPR Therapeutics have collaborated on exa-cel, a treatment targeting sickle cell disease, while Sarepta Therapeutics has developed SRP-9001, the first gene therapy for Duchenne muscular dystrophy (DMD). SRP-9001 has the potential to be the second gene therapy to be approved through the accelerated approval pathway.
By therapy type, cell therapy was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the rising advancements in cell therapy methods, significant investments from key industry players & successful outcomes observed in clinical trials. Additionally, gene therapy is predicted to grow at the fastest CAGR during the forecast period owing to the growing prevalence of chronic diseases and increasing approvals of novel therapies. For instance, in December 2023, The FDA granted approval for two groundbreaking treatments, Casgevy and Lyfgenia, marking the first instances of cell-based gene therapies authorized for sickle cell disease (SCD) treatment in patients aged twelve and above.
By phase, phase II was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the increased spending on research & development, along with the intricacies involved in conducting phase II clinical trials, rise in the number of such trials. For instance, in October 2022, Moderna announced that Merck (MSD) has opted to activate its $250 million option to jointly develop and market PCV mRNA-4157/V940. This vaccine is currently undergoing phase II clinical trials as an adjuvant treatment for high-risk melanoma patients, alongside pembrolizumab, Merck's PD-1 antibody. Additionally, phase 1 is predicted to grow at the fastest CAGR during the forecast period owing to the progression of drugs from preclinical stages to First-in-Human clinical trials has been successful. While phase I and phase II trials continue to dominate in the realm of cell and gene therapy, there is a slight uptick in the proportion of trials now entering phase III and phase IV.
By indication, oncology was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the growing occurrence of cancer, heightened investments in cancer research, and surge in collaborations among industry stakeholders. For instance, in April 2022, Labcorp and Xcell Biosciences have formed a partnership aimed at assisting Xcell Biosciences in developing cell and gene therapies (CGTs) for treating cancer, Parkinson's disease, and other uncommon conditions. Additionally, cardiology is predicted to grow at the fastest CAGR during the forecast period owing to the surge in prevalence of cardiovascular diseases and rising development of novel therapies.
North America region is anticipated for the highest revenue share during the forecast period owing to the supportive legal environment, increase in the quantity of research institutions, robust regulatory structure for executing clinical trials, and rising number of innovative therapies being introduced. For instance, in October 2022, Allogene Therapeutics, Inc., a biotechnology company in the clinical stage, introduced CAR T Together, a pioneering initiative involving prominent clinical trial researchers dedicated to advancing the development of "off-the-shelf" chimeric antigen receptor (CAR) T products. The aim is to enhance the scalability and accessibility of CAR T therapy for specific cancer patients. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rise in clinical studies involving cell & gene therapy (CGT), a large patient pool, increasing number of centers focused on cell research & therapy, growing presence of biotechnology companies, and surge in regulatory approvals. For instance, in October 2023, India's regulatory body akin to the US FDA, the Central Drugs Standard Control Organization, authorized NexCAR19 as India's inaugural CAR-T cell therapy. Approval was granted following the outcomes of two minor clinical studies conducted in India, encompassing 64 individuals with advanced lymphoma or leukemia.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Growing number of clinical trials in this field is predicted to boost the market growth during the forecast period. Cell and gene therapies (CGTs) represent the forefront of therapeutic innovation, yielding promising treatments globally. While some initial therapies have received marketing approval, there are countless other promising therapies undergoing development worldwide. For instance, in June 2023, Vertex Pharmaceuticals and CRISPR Therapeutics have collaborated on exa-cel, a treatment targeting sickle cell disease, while Sarepta Therapeutics has developed SRP-9001, the first gene therapy for Duchenne muscular dystrophy (DMD). SRP-9001 has the potential to be the second gene therapy to be approved through the accelerated approval pathway.
By therapy type, cell therapy was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the rising advancements in cell therapy methods, significant investments from key industry players & successful outcomes observed in clinical trials. Additionally, gene therapy is predicted to grow at the fastest CAGR during the forecast period owing to the growing prevalence of chronic diseases and increasing approvals of novel therapies. For instance, in December 2023, The FDA granted approval for two groundbreaking treatments, Casgevy and Lyfgenia, marking the first instances of cell-based gene therapies authorized for sickle cell disease (SCD) treatment in patients aged twelve and above.
By phase, phase II was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the increased spending on research & development, along with the intricacies involved in conducting phase II clinical trials, rise in the number of such trials. For instance, in October 2022, Moderna announced that Merck (MSD) has opted to activate its $250 million option to jointly develop and market PCV mRNA-4157/V940. This vaccine is currently undergoing phase II clinical trials as an adjuvant treatment for high-risk melanoma patients, alongside pembrolizumab, Merck's PD-1 antibody. Additionally, phase 1 is predicted to grow at the fastest CAGR during the forecast period owing to the progression of drugs from preclinical stages to First-in-Human clinical trials has been successful. While phase I and phase II trials continue to dominate in the realm of cell and gene therapy, there is a slight uptick in the proportion of trials now entering phase III and phase IV.
By indication, oncology was the highest revenue-grossing segment in the global cell and gene therapy clinical trials market in 2023 owing to the growing occurrence of cancer, heightened investments in cancer research, and surge in collaborations among industry stakeholders. For instance, in April 2022, Labcorp and Xcell Biosciences have formed a partnership aimed at assisting Xcell Biosciences in developing cell and gene therapies (CGTs) for treating cancer, Parkinson's disease, and other uncommon conditions. Additionally, cardiology is predicted to grow at the fastest CAGR during the forecast period owing to the surge in prevalence of cardiovascular diseases and rising development of novel therapies.
North America region is anticipated for the highest revenue share during the forecast period owing to the supportive legal environment, increase in the quantity of research institutions, robust regulatory structure for executing clinical trials, and rising number of innovative therapies being introduced. For instance, in October 2022, Allogene Therapeutics, Inc., a biotechnology company in the clinical stage, introduced CAR T Together, a pioneering initiative involving prominent clinical trial researchers dedicated to advancing the development of "off-the-shelf" chimeric antigen receptor (CAR) T products. The aim is to enhance the scalability and accessibility of CAR T therapy for specific cancer patients. Additionally, Asia Pacific region is predicted to grow at fastest CAGR during the forecast period owing to the rise in clinical studies involving cell & gene therapy (CGT), a large patient pool, increasing number of centers focused on cell research & therapy, growing presence of biotechnology companies, and surge in regulatory approvals. For instance, in October 2023, India's regulatory body akin to the US FDA, the Central Drugs Standard Control Organization, authorized NexCAR19 as India's inaugural CAR-T cell therapy. Approval was granted following the outcomes of two minor clinical studies conducted in India, encompassing 64 individuals with advanced lymphoma or leukemia.
This comprehensive research report focuses on the global and regional market size and forecasts from 2023 to 2034.
Report Scope:
- Base Year: 2023
- Forecast Period: 2024-2034
- Study Coverage
- Market Forecast by Therapy Type, Phase, and Indication
- Market Forecast for 5 Regions and 17+ Countries
- North America (U.S. and Canada)
- Europe (Germany, France, UK, Spain, Italy, Russia, Rest of Europe)
- Asia Pacific (China, Japan, India, Australia, South Korea, Rest of APAC)
- Latin America (Brazil, Mexico, Argentina, Rest of LATAM)
- MEA (South Africa, GCC, Rest of MEA)
- Exhaustive Company Profiles of Top 10+ Major Market Players
Segmentation: Cell And Gene Therapy Clinical Trials Market Report 2023 - 2034
Cell And Gene Therapy Clinical Trials Market Analysis & Forecast by Therapy Type 2023 - 2034 (Revenue USD Bn)
- Gene Therapy
- Cell Therapy
Cell And Gene Therapy Clinical Trials Market Analysis & Forecast by Phase 2023 - 2034 (Revenue USD Bn)
- Phase I
- Phase II
- Phase III
- Phase IV
Cell And Gene Therapy Clinical Trials Market Analysis & Forecast by Indication 2023 - 2034 (Revenue USD Bn)
- CNS
- Oncology
- Cardiology
- Hematology
- Dermatology
- Ophthalmology
- Musculoskeletal
- Gastroenterology
- Infectious Diseases
- Immunology & Inflammation
- Endocrine, Metabolic, Genetic
- Others
Cell And Gene Therapy Clinical Trials Market Analysis & Forecast by Region 2023 - 2034 (Revenue USD Bn)
- North America
- U.S.
- Canada
- Europe
- Germany
- France
- UK
- Spain
- Italy
- Rest of Europe
- Asia Pacific
- China
- Japan
- India
- Australia
- South Korea
- Rest of APAC
- Latin America
- Brazil
- Mexico
- Argentina
- Rest of LATAM
- Middle East & Africa
- South Africa
- GCC
- Rest of MEA
Table of Contents
1. Research Methodology
2. Introduction
4. Market Environment Analysis
5. Market Dynamics
7. Cell And Gene Therapy Clinical Trials Market: Therapy Type Estimates & Trend Analysis
8. Cell And Gene Therapy Clinical Trials Market: Phase Estimates & Trend Analysis
9. Cell And Gene Therapy Clinical Trials Market: Indication Estimates & Trend Analysis
10. Regional Market Analysis
11. North America Cell And Gene Therapy Clinical Trials Market
12. Europe Global Cell And Gene Therapy Clinical Trials Market
13. Asia Pacific Global Cell And Gene Therapy Clinical Trials Market
14. Latin America Global Cell And Gene Therapy Clinical Trials Market
15. MEA Global Cell And Gene Therapy Clinical Trials Market
16. Competitor Analysis
17. Company Profiles
Companies Mentioned
- Charles River Laboratories International Inc.
- Laboratory Corporation of America Holdings
- PAREXEL International Corp.
- Medpace Holdings Inc.
- Syneos Health
- Veristat LLC
- Novotech
- ICON Plc
- PPD Inc.
- IQVIA
