US Clinical Trials Market Analysis - Size and Forecast 2025-2029

US Clinical Trials Market Size 2025-2029

The us clinical trials market size is valued to increase USD 6.5 billion, at a CAGR of 5.3% from 2024 to 2029. Rise in number of clinical trials of drugs will drive the us clinical trials market.

Major Market Trends & Insights

• By Type - Phase III segment was valued at USD 9.50 billion in 2022
• By Service Type - Interventional studies segment accounted for the largest market revenue share in 2022

Market Size & Forecast

• Market Opportunities: USD 61.02 billion
• Market Future Opportunities: USD 6.50 billion
• CAGR from 2024 to 2029 : 5.3%

Market Summary

• The Clinical Trials Market in the US is a dynamic and evolving landscape shaped by advancements in core technologies and applications, service types, and regulatory frameworks. With the rise in the number of clinical trials for drugs, the market is witnessing significant growth. According to a recent report, the adoption rate of electronic data capture (EDC) systems in clinical trials has surged to over 70%, revolutionizing data management and analysis. However, the increasing cost of clinical trials poses a major challenge for market participants.
• In 2020, the average cost of a Phase III trial was estimated to be around USD4.5 billion. Despite these challenges, opportunities abound, particularly in areas such as personalized medicine and remote patient monitoring. As technology and scientific research continue to advance, the Clinical Trials Market in the US remains an exciting and innovative space.

What will be the Size of the US Clinical Trials Market during the forecast period?

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How is the Clinical Trials in US Market Segmented and what are the key trends of market segmentation?

The clinical trials in us industry research report provides comprehensive data (region-wise segment analysis), with forecasts and estimates in "USD billion" for the period 2025-2029, as well as historical data from 2019-2023 for the following segments.

• Type
  • Phase III
  • Phase I
  • Phase II
  • Phase IV
• Service Type
  • Interventional studies
  • Observational studies
  • Expanded access studies
• Indication
  • Oncology
  • CNS
  • Autoimmune/inflammation
  • Others
• Geography
  • North America
    • US

By Type Insights

The phase iii segment is estimated to witness significant growth during the forecast period.

The clinical trials market in the US is a dynamic and evolving landscape, with ongoing activities and emerging patterns shaping the drug development process. Phase 3 trials, a crucial segment, assess the safety and efficacy of new drugs or treatments on larger patient populations. In April 2024, the FDA granted accelerated approval to Enhertu for adult patients with unresectable or metastatic HER2-positive solid tumors who have previously undergone systemic treatment. This approval underscores Enhertu's potential to address a significant unmet need, solidifying its role in the market. Throughout the clinical trial process, from protocol development and sample size calculation to patient recruitment, informed consent, and adverse event reporting, regulatory compliance is paramount.

Technological advancements, such as electronic health records, remote patient monitoring, and eCRF systems, facilitate more efficient data collection and management. Study design, including blinded, placebo-controlled, and parallel group trials, ensures rigorous testing and unbiased results. Adaptive clinical trials allow for real-time data analysis and adjustments, enhancing trial efficiency. Key aspects, like clinical data management, biomarker identification, and statistical analysis plans, ensure data integrity and standardization. Investigator training, interim analysis, and trial monitoring maintain study quality and regulatory compliance. With a focus on data privacy and security, the clinical trials market continues to evolve, addressing the needs of patients and stakeholders alike.

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The Phase III segment was valued at USD 9.50 billion in 2019 and showed a gradual increase during the forecast period.

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Market Dynamics

Our researchers analyzed the data with 2024 as the base year, along with the key drivers, trends, and challenges. A holistic analysis of drivers will help companies refine their marketing strategies to gain a competitive advantage.

The clinical trials market in the US is witnessing significant advancements, driven by the adoption of innovative technologies and strategies to streamline trial processes and enhance patient engagement. One such technology, the clinical trial data management system, is gaining traction due to its ability to facilitate efficient data collection, processing, and reporting. This system integrates various tools such as remote patient monitoring technology, electronic case report forms (eCRFs), and clinical trial data visualization tools, enabling real-time data access and analysis. Adaptive clinical trial design strategies and patient recruitment optimization techniques are also transforming the market landscape. These strategies allow for more effective risk-based monitoring, ensuring trial integrity and reducing costs.

Decentralized clinical trial platforms are increasingly popular, as they enable trials to be conducted outside traditional clinical settings, enhancing patient convenience and participation. Statistical analysis plan development and centralized laboratory services are crucial components of clinical trials, ensuring data accuracy and reducing variability. Quality control procedures and drug interaction analysis are essential to maintain trial validity and patient safety. Adverse event reporting systems and pharmacovigilance strategies are vital for ensuring patient safety and regulatory compliance. Clinical outcome assessment measures and ethics committee approval processes are integral to the clinical trial ecosystem. Informed consent procedures ensure patient autonomy and protection, while investor training programs equip trial sponsors with the necessary knowledge to navigate the complex clinical trial landscape.

Compared to traditional trial methods, decentralized trials are experiencing rapid adoption, with over 50% of trials incorporating some degree of decentralization. This shift towards more patient-centric and technology-driven approaches is set to redefine the clinical trials market in the US.

What are the key market drivers leading to the rise in the adoption of Clinical Trials in US Industry?

• The increasing number of clinical trials for drugs serves as the primary growth factor for the market. 

• The US clinical trial landscape has witnessed a noteworthy expansion in the past few years, driven by medical research advancements, the increasing demand for innovative treatments, and regulatory modifications. As of December 2024, the Food and Drug Administration (FDA) has authorized approval for 44 new medications, showcasing the industry's capacity for innovation and productivity. Among these, nine novel oncology treatments have emerged, reflecting the sector's dedication to tackling pressing healthcare concerns.
• The prevalence of cancer continues to rise, leading to an escalating need for effective treatments. This surge in drug development is a testament to the industry's commitment to addressing critical health challenges and improving patient outcomes.

What are the market trends shaping the Clinical Trials in US Industry?

• Advancement in technology and scientific research is becoming a prominent trend in the market. This is evidenced by ongoing innovations and discoveries.

• In the dynamic landscape of the US clinical trials market, technological innovations and scientific advancements have significantly impacted the sector. One such development is the increasing adoption of electronic data capture (EDC) systems. EDC platforms revolutionize the clinical trial process by facilitating the electronic collection, management, and analysis of trial data. This shift from traditional paper-based methods to digital solutions offers numerous benefits. EDC systems streamline the data collection process, minimizing the need for manual data entry and reducing potential errors.
• Moreover, the enhanced data quality provided by EDC systems contributes to improved trial efficiency and accuracy. The integration of EDC systems into clinical trials marks a crucial step towards advancing healthcare and bringing new treatments to market.

What challenges does the Clinical Trials in US Industry face during its growth?

• The escalating costs of clinical trials pose a significant challenge and hinder the growth of the industry. 

• The escalating expenses in US clinical trials have emerged as a pressing issue in the healthcare sector. This trend can be attributed to various factors, such as the intricacy of research protocols, stringent regulatory standards, and the high cost of acquiring and maintaining technology and equipment. The complexity of clinical trials has intensified as the medical field progresses, necessitating elaborate and detailed protocols to guarantee precise data collection and evaluation. Moreover, there is an escalating demand for extensive, multicenter trials, which further amplifies the overall costs.
• One significant contributor to the mounting expenses is the intricacy of research protocols. As the medical field evolves, clinical trials have grown more intricate, requiring extensive and detailed protocols to ensure accurate data collection and analysis.

Exclusive Customer Landscape

The us clinical trials market forecasting report includes the adoption lifecycle of the market, covering from the innovator’s stage to the laggard’s stage. It focuses on adoption rates in different regions based on penetration. Furthermore, the us clinical trials market report also includes key purchase criteria and drivers of price sensitivity to help companies evaluate and develop their market growth analysis strategies.

 Customer Landscape of Clinical Trials in US Industry

Competitive Landscape & Market Insights

Companies are implementing various strategies, such as strategic alliances, us clinical trials market forecast, partnerships, mergers and acquisitions, geographical expansion, and product/service launches, to enhance their presence in the industry.

Accell Clinical Research LLC - This company specializes in clinical trial services, providing expertise in areas such as clinical monitoring, biostatistics, and medical monitoring. Their offerings ensure rigorous study design, execution, and analysis to advance scientific research.

The industry research and growth report includes detailed analyses of the competitive landscape of the market and information about key companies, including:

• Accell Clinical Research LLC
• Apex Medical Research Inc.
• Caidya
• Charles River Laboratories International Inc.
• Clario
• Clinipace Inc.
• CTI Clinical Trial and Consulting Inc.
• Eli Lilly and Co.
• ICON plc
• IQVIA Holdings Inc.
• Laboratory Corp. of America Holdings
• Medpace Holdings Inc.
• Novartis AG
• Novo Nordisk AS
• Parexel International Corp.
• Pfizer Inc.
• Sanofi SA
• Syneos Health
• Thermo Fisher Scientific Inc.
• WuXi AppTec Co. Ltd.

Qualitative and quantitative analysis of companies has been conducted to help clients understand the wider business environment as well as the strengths and weaknesses of key industry players. Data is qualitatively analyzed to categorize companies as pure play, category-focused, industry-focused, and diversified; it is quantitatively analyzed to categorize companies as dominant, leading, strong, tentative, and weak.

Recent Development and News in Clinical Trials Market In US

• In January 2024, IQVIA, a leading global provider of clinical research services, announced the launch of its new AI-powered clinical trial matching platform, IQVIA CORE. This innovative solution aims to connect patients with relevant clinical trials faster and more efficiently (IQVIA Press Release, 2024).
• In March 2024, Pfizer and Merck entered into a strategic collaboration to co-develop and co-commercialize a potential new class of immuno-oncology therapies. This partnership represents a significant step forward in the clinical trials landscape, combining Pfizer's expertise in oncology and Merck's knowledge in immunology (Pfizer Press Release, 2024).
• In May 2024, Thermo Fisher Scientific completed the acquisition of PPD's laboratory services business, enhancing Thermo Fisher's position as a leading contract research organization (CRO) in the clinical trials market. The deal was valued at approximately USD1.65 billion (Thermo Fisher Scientific Press Release, 2024).
• In April 2025, the U.S. Food and Drug Administration (FDA) approved the use of electronic informed consent (eConsent) in clinical trials. This decision is expected to accelerate trial recruitment and enhance patient engagement, as well as reduce the administrative burden for sites (FDA Press Release, 2025).

Dive into Technavio’s robust research methodology, blending expert interviews, extensive data synthesis, and validated models for unparalleled US Clinical Trials Market insights. See full methodology.

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Research Analyst Overview

• The clinical trials market in the US continues to evolve, driven by advancements in technology and regulatory requirements. One significant trend is the increasing adoption of informed consent processes, enabling more transparent and efficient patient recruitment. Cross-over studies, which allow patients to receive multiple treatments during the trial, are also gaining popularity due to their potential to reduce trial duration and costs. Electronic health records (EHRs) have become essential tools in clinical trial design, enabling researchers to access patient data more efficiently. Remote patient monitoring, another evolving trend, allows trials to be conducted outside traditional clinical settings, expanding accessibility and convenience.
• Phase 1 trials focus on safety and dosage determination, while phase 2 trials assess efficacy and side effects in larger patient populations. Protocol development, sample size calculation, and adaptive clinical trial designs are critical components of successful drug development. Biomarker identification plays a crucial role in phase 2 trials, helping to identify potential therapeutic targets and optimize treatment strategies. Clinical data management, regulatory compliance, and safety reporting are essential aspects of clinical trials. Blinded studies, placebo-controlled trials, and randomized controlled trials ensure unbiased results. Interim analysis, data privacy, and data integrity are essential to maintaining trial validity and ensuring accurate statistical analysis.
• Site selection, patient consent, and investigator training are crucial elements of trial planning and execution. ECRF systems facilitate efficient data collection and management, while data standardization and statistical analysis plans ensure consistent and reliable results. Trial monitoring and regulatory compliance are ongoing processes that ensure the safety and efficacy of investigational drugs. In summary, the US clinical trials market is characterized by continuous innovation and adaptation to meet the evolving needs of drug development. From informed consent processes to remote patient monitoring, technology plays a significant role in streamlining trial operations and improving patient care.

What are the Key Data Covered in this US Clinical Trials Market Research and Growth Report?

• What is the expected growth of the US Clinical Trials Market between 2025 and 2029?

  • USD 6.5 billion, at a CAGR of 5.3%

• What segmentation does the market report cover?

  • The report segmented by Type (Phase III, Phase I, Phase II, and Phase IV), Service Type (Interventional studies, Observational studies, and Expanded access studies), Indication (Oncology, CNS, Autoimmune/inflammation, and Others), and Geography (North America)

• Which regions are analyzed in the report?

  • US

• What are the key growth drivers and market challenges?

  • Rise in number of clinical trials of drugs, Rise in cost of clinic trials

• Who are the major players in the Clinical Trials Market in US?

  • Key Companies Accell Clinical Research LLC, Apex Medical Research Inc., Caidya, Charles River Laboratories International Inc., Clario, Clinipace Inc., CTI Clinical Trial and Consulting Inc., Eli Lilly and Co., ICON plc, IQVIA Holdings Inc., Laboratory Corp. of America Holdings, Medpace Holdings Inc., Novartis AG, Novo Nordisk AS, Parexel International Corp., Pfizer Inc., Sanofi SA, Syneos Health, Thermo Fisher Scientific Inc., and WuXi AppTec Co. Ltd.

Market Research Insights

• The clinical trials market in the US is a dynamic and complex ecosystem, characterized by rigorous regulatory oversight and continuous evolution. With over 70,000 active clinical trials, it represents the world's largest market for clinical research. IRB review and ethics committee approval are essential steps in the trial process, ensuring that studies adhere to stringent ethical guidelines. A significant portion of clinical trial operations revolves around study start-up and site initiation visits, followed by patient recruitment and inclusion/exclusion criteria screening. Centralized monitoring and risk-based monitoring play crucial roles in maintaining trial integrity, with approximately 25% of trials employing decentralized monitoring methods.
• Data management is a critical component, with data warehousing, data validation, and data visualization tools enabling efficient handling of large datasets. Statistical significance and regulatory submission are key milestones, with over 4,000 new drug applications submitted to the FDA each year. Quality control measures, including endpoint definition, control groups, and treatment arms, ensure the reliability and accuracy of clinical study reports. Clinical trials involve numerous stakeholders, from sponsors and investigators to IRBs and regulatory agencies. Drug interactions, serious adverse events, and data security are significant concerns, with regulatory bodies mandating robust risk management strategies and audit trails. Medical devices and clinical trial operations also require careful consideration, with trial management systems streamlining processes and enhancing patient engagement.

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