U.S. Cell and Gene Therapy Clinical Trials Market Size, Share, and Growth Outlook to Reach USD 22.25 Billion by 2034, Expanding at 15.3% CAGR

Polaris Market Research has announced a report, namely U.S. Cell and Gene Therapy Clinical Trials Market Size, Share, Trend, Industry Analysis Report By Phase (Phase I, Phase II, Phase III, Phase IV), By Indication – Market Forecast, 2025–2034, that presents a granular analysis of current and future growth status with a detailed analysis of key growth drivers accelerating the market sales globally.

The report provides a detailed analysis of the market status, U.S. Cell and Gene Therapy Clinical Trials Market size, share, future trends, growth rate, sales channels, and export & import. The report categorizes the market by top players/brands, region, type, and end user. It provides a detailed analysis enclosing business growth opportunities, challenges, and emerging trends.

U.S. Cell and Gene Therapy Clinical Trials Market Size:

The U.S. cell and gene therapy clinical trials market is experiencing strong growth, driven by rapid advances in biotechnology, rising prevalence of genetic and chronic diseases, and increased investment in regenerative medicine. Valued at USD 5.36 billion in 2024, the market is expanding as pharmaceutical and biotech companies accelerate R&D activities and clinical trial pipelines. Supportive regulatory frameworks, growing adoption of personalized medicine, and collaborations between academic institutes and industry players are expected to propel the market at a CAGR of 15.3%, reaching an estimated USD 22.25 billion by 2034.

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Key Market Dynamics

The report deep dives into industry revenue, U.S. Cell and Gene Therapy Clinical Trials Market demand status, competitive landscape, and CAGR status across all regions. The report is served as a crucial resource for companies planning to chart their future course and establish effective strategies. The report aids companies to gain a thorough analysis of the market, identify customer needs and preferences, and better understand the overall industry.

Market Drivers:

The research offers a comprehensive analysis of trends, drivers, restraints, competitive landscape, and factors that are majorly driving the industry expansion. It elaborates on market dynamics and future trends in this industry. Also, crucial factors that will have a huge influence on the market, i.e., industry news and policies, global rise, and regional conflict, are taken into consideration. The study helps in predicting revenue-boosting prospects in the market. In addition, growth, volume trends, and opportunities in the U.S. Cell and Gene Therapy Clinical Trials Market are predicted. 

Market Restraints:

The report highlights regulatory issues and entry barriers that have a significant effect U.S. Cell and Gene Therapy Clinical Trials Market growth. It mentions constraints that can become great obstructions to the industry's progress. The report analyzes crucial strategies for seizing opportunities and mitigating risks during the forecast period. This study emphasizes prospective commercial opportunities and assists readers in making knowledgeable business decisions.

Key Benefits for Stakeholders:

• The report estimates the size of the total market opportunity of global and key countries
• Market growth potential is assessed
• The report forecasts future growth in each product and end-user market
• It analyzes competitive factors affecting the marketplace
• This report profiles key players in the market
• Segmentation analysis helps identify current opportunities in the market
• The report provides an in-depth analysis of current trends and dynamics
• The report plots revenue contribution in each geographical region

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List of Major Key Players

• Charles River Laboratories
• ICON Plc
• IQVIA
• LabCorp
• Medpace
• Novotech
• PAREXEL International Corp.
• Syneos Health
• Thermo Fisher Scientific, Inc.
• Veristat, LLC

Competitive Landscape:

For the competitive landscape, the report introduces U.S. Cell and Gene Therapy Clinical Trials Market key players along with their share, company overview, production, value, product portfolio, gross margin, key developments, and geographical presence. The key companies in this market are engaged in intense competition for a share in terms of innovation, technology, product development, and pricing. Additionally, new U.S. Cell and Gene Therapy Clinical Trials Market trends, regional conflicts, and mergers and acquisitions will all be taken into account.

Geographic Segment Covered in the Report

The report delivers country-level and regional-level data incorporating the supply and demand strengths that are enhancing the market growth. The section gives information about the market regions, subdivided into sub-regions and countries/regions. In addition, U.S. Cell and Gene Therapy Clinical Trials Market share in each country and sub-region, along with information on profit opportunities, is estimated and shared in this report.

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Objectives of the Report

• To carefully analyze and forecast the size of the market by value and volume.
• To evaluate the market shares of major segments of the market
• To explain the development of the industry in different parts of the world.
• To analyze and study micro-markets in terms of their contributions to the market, their prospects, and individual growth trends.
• To offer precise and valuable details about factors affecting the U.S. Cell and Gene Therapy Clinical Trials Market forecasts
• To provide a meticulous assessment of crucial business strategies used by leading companies.

Some of The Key Questions Answered in This Report

Q1. What is driving the growth of the U.S. cell and gene therapy clinical trials market?

Ans: The market is driven by rising investments in regenerative medicine, increasing prevalence of genetic disorders and cancer, strong R&D pipelines, and supportive regulatory initiatives accelerating clinical trial approvals.

Q2. Which therapeutic areas dominate clinical trials in this market?

Ans: Oncology, rare genetic disorders, cardiovascular diseases, and neurological conditions dominate due to high unmet medical needs and promising clinical outcomes.

Q3. How do regulatory frameworks impact market growth?

Ans: Streamlined approval pathways, orphan drug designations, and fast-track programs significantly reduce development timelines, encouraging sponsors to conduct more trials.

Q4. What role do CROs play in this market?

Ans: Contract research organizations provide end-to-end trial management, regulatory support, and patient recruitment, helping sponsors reduce costs and accelerate timelines.

Q5. How is technology influencing clinical trials?

Ans: Advanced analytics, AI-driven patient matching, and decentralized trial models improve efficiency, data accuracy, and patient retention.

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