Cell and Gene Therapy Clinical Trial Services

Global Cell and Gene Therapy Clinical Trial Services Market to Reach US$28.9 Billion by 2030

The global market for Cell and Gene Therapy Clinical Trial Services estimated at US$11.7 Billion in the year 2024, is expected to reach US$28.9 Billion by 2030, growing at a CAGR of 16.3% over the analysis period 2024-2030. Phase I, one of the segments analyzed in the report, is expected to record a 17.9% CAGR and reach US$15.1 Billion by the end of the analysis period. Growth in the Phase II segment is estimated at 15.8% CAGR over the analysis period.

The U.S. Market is Estimated at US$3.1 Billion While China is Forecast to Grow at 15.3% CAGR

The Cell and Gene Therapy Clinical Trial Services market in the U.S. is estimated at US$3.1 Billion in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$4.4 Billion by the year 2030 trailing a CAGR of 15.3% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 15.2% and 13.9% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 11.8% CAGR.

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

Why Is the Demand for Cell and Gene Therapy Clinical Trial Services Increasing?

The demand for cell and gene therapy clinical trial services is increasing due to the growing number of innovative therapies entering the development pipeline, the rise of personalized medicine, and the expanding regulatory support for advanced therapeutic products. Cell and gene therapies have shown significant potential in treating previously untreatable conditions, including rare genetic disorders, cancers, and neurodegenerative diseases. As pharmaceutical and biotech companies continue investing in regenerative medicine, the need for specialized clinical trial services has grown exponentially.

Advancements in genetic engineering, CRISPR-based technologies, and autologous and allogeneic cell therapies have further accelerated research and development efforts in this field. With a rise in clinical trials targeting rare diseases and oncology, contract research organizations and specialized trial service providers are playing a critical role in ensuring regulatory compliance, patient recruitment, and trial execution. Additionally, global regulatory agencies such as the FDA and EMA are introducing streamlined approval pathways for cell and gene therapies, increasing the demand for clinical trial expertise to navigate the complex regulatory landscape.

How Are Technological Advancements Improving Cell and Gene Therapy Clinical Trials?

Technological innovations in clinical trial design, real-time monitoring, and patient data analytics are revolutionizing the execution of cell and gene therapy studies. One of the most significant advancements is the use of artificial intelligence and machine learning to optimize patient recruitment and predictive modeling for therapy outcomes. AI-driven trial design helps identify suitable candidates, improve trial efficiency, and reduce time-to-market for breakthrough therapies.

Another major breakthrough is the integration of decentralized clinical trials, which enable remote patient monitoring and reduce the logistical challenges associated with traditional study designs. Wearable biosensors, telemedicine platforms, and electronic patient-reported outcomes are making trials more patient-centric, ensuring better compliance and data collection. Additionally, advancements in cryopreservation and logistics for cell-based therapies are enhancing the ability to conduct multi-site and global trials. With increasing automation in laboratory processes and bioinformatics tools for genomic analysis, cell and gene therapy trials are becoming more precise, scalable, and efficient.

Which Market Trends Are Driving Growth in the Cell and Gene Therapy Clinical Trial Services Industry?

The increasing number of clinical trials focused on rare diseases and oncology is one of the most influential trends shaping the cell and gene therapy clinical trial services market. Many of these therapies target small patient populations, requiring specialized recruitment strategies and trial designs tailored to complex treatment protocols. The expansion of regenerative medicine and immunotherapy-based treatments has also led to a growing need for customized trial services that address the unique challenges of cell-based interventions.

Another key trend influencing market growth is the rise of global collaborations between pharmaceutical companies, research institutions, and contract research organizations. As cell and gene therapy trials require specialized facilities, skilled personnel, and advanced manufacturing capabilities, companies are increasingly outsourcing clinical trial management to experienced service providers. Additionally, regulatory harmonization across different regions is facilitating faster approvals, allowing companies to conduct multi-center trials more efficiently. The increasing role of real-world evidence in therapy assessment is also shaping clinical trial methodologies, integrating long-term patient outcomes into approval and reimbursement strategies.

What Are the Key Growth Drivers Shaping the Future of the Cell and Gene Therapy Clinical Trial Services Market?

The growth in the cell and gene therapy clinical trial services market is driven by several factors, including increased investment in regenerative medicine, the rise of advanced biomanufacturing techniques, and evolving regulatory frameworks supporting novel therapies. One of the primary growth drivers is the significant funding from both public and private sectors into cell and gene therapy research, with governments and venture capital firms heavily investing in next-generation treatments.

Another crucial driver shaping the market is the expansion of clinical trial infrastructure, including specialized research centers and manufacturing hubs dedicated to advanced therapies. As the demand for personalized treatments increases, trial service providers are focusing on adaptive trial designs and precision medicine approaches to improve therapy efficacy and patient outcomes. Additionally, the increasing acceptance of decentralized and hybrid trial models is enabling wider patient participation and reducing trial costs. As the field of cell and gene therapy continues to evolve, clinical trial services will remain essential in bringing transformative treatments to market, addressing complex diseases, and advancing the future of precision medicine.

SCOPE OF STUDY:

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

Segments:
Phase (Phase I, Phase II, Phase III, Phase IV); Indication (Oncology Indication, CNS Indication, Cardiology Indication, Ophthalmology Indication, Immunology and Inflammation Indication, Hematology Indication, Musculoskeletal Indication, Endocrine, Metabolic, Genetic Indication, Infectious Diseases Indication, Other Indications)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 34 Featured) -

• Charles River Laboratories
• Clinipace
• Covance Inc.
• ICON plc
• IQVIA Biotech
• KCR
• Labcorp Drug Development
• Linical Co., Ltd.
• Medpace
• Novotech
• Parexel International
• Pivotal Clinical Research
• PPD (Thermo Fisher Scientific)
• PRA Health Sciences
• Premier Research
• Syneos Health
• Synteract
• Veristat
• 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.

To our valued clients, we say, we have your back. We will present a simplified market reassessment by incorporating these changes!

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:

USA
CHINA
MEXICO
CANADA
EU
JAPAN
INDIA
176 OTHER COUNTRIES.

Leading Economists - Our knowledge base tracks 14,949 economists including a select group of most influential Chief Economists of nations, think tanks, trade and industry bodies, big enterprises, and domain experts who are sharing views on the fallout of this unprecedented paradigm shift in the global econometric landscape. Most of our 16,491+ reports have incorporated this two-stage release schedule based on milestones.

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