Gene Therapy Clinical Trial Services

Global Gene Therapy Clinical Trial Services Market to Reach US$1.9 Billion by 2030

The global market for Gene Therapy Clinical Trial Services estimated at US$1.2 Billion in the year 2024, is expected to reach US$1.9 Billion by 2030, growing at a CAGR of 8.1% over the analysis period 2024-2030. Clinical Trial Design & Planning, one of the segments analyzed in the report, is expected to record a 10.2% CAGR and reach US$530.6 Million by the end of the analysis period. Growth in the Supply & Logistics Services segment is estimated at 9.3% CAGR over the analysis period.

The U.S. Market is Estimated at US$317.5 Million While China is Forecast to Grow at 12.9% CAGR

The Gene Therapy Clinical Trial Services market in the U.S. is estimated at US$317.5 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$406.3 Million by the year 2030 trailing a CAGR of 12.9% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 4.0% and 7.9% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 5.4% CAGR.

Global Gene Therapy Clinical Trial Services Market – Key Trends & Drivers Summarized

Why Are Gene Therapy Clinical Trials Expanding Rapidly?

Gene therapy clinical trials have witnessed unprecedented growth in recent years, driven by advancements in gene-editing technologies, viral vector development, and regulatory support for novel genetic treatments. As gene therapy moves from experimental research to clinical application, specialized clinical trial services are playing a crucial role in evaluating the safety, efficacy, and long-term impact of these groundbreaking therapies. Clinical trials are essential for establishing regulatory approval pathways, optimizing dosing regimens, and ensuring patient safety before commercial deployment.

The rapid development of CRISPR-based gene editing, AAV (Adeno-Associated Virus) vectors, and ex vivo gene therapy techniques has expanded the scope of clinical trials across multiple therapeutic areas. Rare genetic disorders, inherited metabolic diseases, and hematological conditions such as sickle cell disease and beta-thalassemia are among the primary targets of gene therapy trials. Additionally, oncology has emerged as a major focus area, with gene-modified cell therapies such as CAR-T (Chimeric Antigen Receptor T-cell) therapy demonstrating promising results in treating hematologic malignancies. With increasing patient enrollment and investment in gene therapy trials, the demand for specialized clinical trial services is at an all-time high.

Which Therapeutic Areas Are Driving the Growth of Gene Therapy Clinical Trials?

The field of gene therapy is expanding into multiple disease areas, each requiring rigorous clinical evaluation to ensure long-term safety and effectiveness. Rare genetic disorders remain a significant focus, with clinical trials targeting conditions such as Duchenne muscular dystrophy (DMD), spinal muscular atrophy (SMA), and lysosomal storage diseases. Many of these trials leverage viral and non-viral delivery systems to introduce functional genes that compensate for defective or missing genetic material.

In oncology, gene therapy clinical trials are advancing immunotherapy approaches that modify a patient’s immune cells to enhance cancer-fighting capabilities. CAR-T cell therapy, which involves genetically reprogramming T cells to recognize and destroy cancer cells, has led to breakthroughs in leukemia, lymphoma, and multiple myeloma treatment. Neurological disorders such as Parkinson’s disease, Alzheimer’s disease, and Huntington’s disease are also emerging as potential targets for gene therapy trials, with research focusing on neuroprotective gene modifications. As the therapeutic landscape broadens, gene therapy clinical trials are expanding into cardiovascular, ophthalmic, and autoimmune disease treatments.

What Are the Latest Innovations in Gene Therapy Clinical Trial Services?

Advancements in gene therapy trial methodologies have significantly improved trial design, patient recruitment, and regulatory compliance. One of the most important innovations is the use of AI-driven analytics to streamline patient selection, ensuring that clinical trials enroll individuals with the highest likelihood of benefiting from gene therapy. AI-powered data management platforms are also improving trial monitoring, enabling real-time tracking of patient responses and adverse events.

Additionally, the development of decentralized clinical trial models has increased patient accessibility, allowing participants to undergo certain assessments remotely through digital health platforms. The rise of biomarker-driven trials, which use genetic and molecular profiling to identify responders, has enhanced trial efficiency by reducing variability and increasing success rates. Furthermore, regulatory agencies such as the FDA and EMA have introduced accelerated approval pathways for promising gene therapies, leading to increased investment in clinical trial services. These advancements are optimizing the gene therapy trial process, accelerating the timeline from research to commercialization.

What Factors Are Fueling the Growth of the Gene Therapy Clinical Trial Services Market?

The growth in the gene therapy clinical trial services market is driven by several factors, including rising investment in gene-based treatments, regulatory support for innovative therapies, and technological advancements in clinical trial design. Pharmaceutical and biotech companies are dedicating substantial resources to gene therapy research, leading to a surge in trial activity worldwide. The success of FDA-approved gene therapies, such as Luxturna and Zolgensma, has further validated the potential of gene therapy, encouraging increased clinical trial participation.

The expansion of contract research organizations (CROs) specializing in gene therapy trials has also contributed to market growth. These organizations provide expertise in regulatory navigation, patient recruitment, and compliance with Good Manufacturing Practices (GMP) for gene-based treatments. Additionally, advancements in vector manufacturing and gene delivery systems have improved trial scalability and efficiency. With gene therapy expected to revolutionize disease treatment, the demand for specialized clinical trial services is projected to grow, shaping the future of precision medicine and genetic innovation.

SCOPE OF STUDY:

The report analyzes the Gene Therapy Clinical Trial Services market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Services (Clinical Trial Design & Planning, Supply & Logistics Services, Regulatory Services, Data Management & Biostatistics, Site Management & Monitoring, Other Gene Therapy Clinical Trial Services); Therapeutic Area (Oncology, Hematology, Endocrine / Metabolic Disorders, Musculoskeletal Diseases, Cardiovascular Diseases, Neurology Disorders, Infectious Diseases, Ophthalmology, Immunology, Other Therapeutic Areas); End-User (Pharma & Biotech Companies End-User, Contract Research Organizations End-User, Academic & Research Institutes End-User, Other End-Users)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; Spain; Russia; and Rest of Europe); Asia-Pacific (Australia; India; South Korea; and Rest of Asia-Pacific); Latin America (Argentina; Brazil; Mexico; and Rest of Latin America); Middle East (Iran; Israel; Saudi Arabia; United Arab Emirates; and Rest of Middle East); and Africa.

Select Competitors (Total 48 Featured) -

• ACM Global Laboratories
• BioAgilytix Labs
• Celerion
• Charles River Laboratories International Inc.
• Covance Inc. (Now part of Labcorp)
• Fortrea Holdings Inc.
• ICON plc
• KCR
• Laboratory Corporation of America Holdings
• Medpace Holdings Inc.
• Medpace Reference Laboratories
• Novotech
• Parexel International Corporation
• PPD Inc. (Thermo Fisher Scientific)
• PRA Health Sciences
• PSI CRO
• SGS Life Sciences
• Syneos Health Inc.
• Worldwide Clinical Trials
• WuXi AppTec

TARIFF IMPACT FACTOR

Our new release incorporates impact of tariffs on geographical markets as we predict a shift in competitiveness of companies based on HQ country, manufacturing base, exports and imports (finished goods and OEM). This intricate and multifaceted market reality will impact competitors by artificially increasing the COGS, reducing profitability, reconfiguring supply chains, amongst other micro and macro market dynamics.

We are diligently following expert opinions of leading Chief Economists (14,949), Think Tanks (62), Trade & Industry bodies (171) worldwide, as they assess impact and address new market realities for their ecosystems. Experts and economists from every major country are tracked for their opinions on tariffs and how they will impact their countries.

We expect this chaos to play out over the next 2-3 months and a new world order is established with more clarity. We are tracking these developments on a real time basis.

As we release this report, U.S. Trade Representatives are pushing their counterparts in 183 countries for an early closure to bilateral tariff negotiations. Most of the major trading partners also have initiated trade agreements with other key trading nations, outside of those in the works with the United States. We are tracking such secondary fallouts as supply chains shift.

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APRIL 2025: NEGOTIATION PHASE

Our April release addresses the impact of tariffs on the overall global market and presents market adjustments by geography. Our trajectories are based on historic data and evolving market impacting factors.

JULY 2025 FINAL TARIFF RESET

Complimentary Update: Our clients will also receive a complimentary update in July after a final reset is announced between nations. The final updated version incorporates clearly defined Tariff Impact Analyses.

Reciprocal and Bilateral Trade & Tariff Impact Analyses:

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CHINA
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EU
JAPAN
INDIA
176 OTHER COUNTRIES.

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