In the period from 2018 to 2023, 28 percent of clinical drug trials started during these years were in the field of oncology, whereas a combined 13 percent of trials started were for infectious diseases (therapeutic and immunization). This statistic depicts the proportion of clinical trials started worldwide from 2018 to 2023, by key therapeutic area.

The probability that a cancer drug will make it from phase I to final approval stood at some *** percent, according to a study published in March 2020. The data is based on clinical success rate models from 2014, 2016, and 2019. Once a cancer drug made it into phase III, the chances to make it to final approval increased to **** percent.

This statistic shows the number of clinical trial participants in the U.S. compared to the rest of the world in 2015-2019, by therapeutic area. In the oncology and hematology area, there were some 9,200 clinical trial participants in the United States whereas there were 25,700 participants in the rest of the world.

In 2023, 41 percent of clinical drug trials for oncology were in phase II and 14 percent of trials were in phase III. This statistic shows the share of clinical drug trials in the top five therapeutic areas worldwide in 2023, by trial phase.

Decentralized trials, real-world evidence, and adaptive study designs are reshaping the clinical trial landscape. Pharma and biotech companies are increasingly outsourcing to CROs for speed, compliance, and access to diverse patient pools.

The global Clinical Trials Site Management Organizations (CTSMOs) market is experiencing robust growth, driven by the increasing complexity of clinical trials, the rising demand for specialized expertise in site selection and management, and the growing adoption of decentralized clinical trials (DCTs). The market size in 2025 is estimated at $5 billion, exhibiting a Compound Annual Growth Rate (CAGR) of 12% during the forecast period 2025-2033. This significant growth is fueled by several key factors including the increasing prevalence of chronic diseases necessitating extensive clinical trials, the rising adoption of advanced technologies like AI and big data analytics in clinical research, and a growing preference for outsourcing site management to specialized organizations. The market is segmented by trial phase (Phase I-IV) and therapeutic area (Respiratory Diseases, Pain & Anesthesia, Oncology, Central Nervous System, Cardiovascular, Endocrine, Anti-Infective, Others), offering CTSMOs opportunities to specialize and cater to specific client needs. Geographical expansion, particularly in emerging markets like Asia-Pacific and Latin America, presents further growth potential. Despite these opportunities, the market faces some challenges. These include regulatory hurdles and compliance complexities associated with running clinical trials across diverse geographical locations. Additionally, price competition and the need for consistent quality control across multiple sites can pose obstacles. However, strategic partnerships, investments in technology, and a focus on providing superior service quality will enable leading CTSMOs to navigate these challenges and capture substantial market share. The growing trend towards patient-centric clinical trial designs is expected to further propel the demand for efficient and specialized site management services, creating a sustained growth trajectory for the market throughout the forecast period. The expansion of clinical trials into diverse therapeutic areas further fuels this expansion, increasing the need for specialized CTSMOs.

The global clinical trial material (CTM) market is experiencing robust growth, driven by the increasing number of clinical trials across diverse therapeutic areas and a rising demand for advanced therapies. The market, estimated at $15 billion in 2025, is projected to exhibit a Compound Annual Growth Rate (CAGR) of 7% between 2025 and 2033, reaching approximately $25 billion by 2033. Key drivers include the escalating prevalence of chronic diseases like cardiovascular diseases, cancer, and neurological disorders, leading to a surge in clinical trials worldwide. Furthermore, the growing adoption of innovative drug modalities, such as biologics and advanced therapies, is fueling demand for specialized CTM handling and storage solutions. Significant growth is observed in the oncology and CNS segments, reflecting the high investment in research and development for these therapeutic areas. The market is segmented by application (Oncology, CNS, Cardiovascular Diseases, Digestive Disorders, Immunology, Blood Disorders, Other) and type (Small-molecules, Biologic Drugs, Medical Devices). The increasing outsourcing of CTM management to specialized contract research organizations (CROs) further contributes to market expansion. Geographical analysis reveals strong market presence in North America and Europe, driven by well-established healthcare infrastructure and regulatory frameworks. However, Asia-Pacific is anticipated to witness substantial growth due to increasing investments in healthcare infrastructure, growing pharmaceutical industry, and rising prevalence of chronic diseases in developing economies like India and China. While factors like stringent regulatory requirements and high costs associated with CTM management pose certain restraints, the overall market outlook remains positive due to consistent growth in the pharmaceutical and biotechnology industries and ongoing innovation in drug development. The competitive landscape is characterized by a mix of large multinational CROs and specialized CTM providers, suggesting a highly dynamic market with potential for both consolidation and new entrants.

Language requirements in clinical trials by therapeutic area.

The AI in Clinical Trials Market Report is Segmented by Component Type (Software and Services), Therapeutic Area (Oncology, and More), Clinical Trial Phase (Phase I, and More), Deployment Model (Cloud, and More), End User (Pharmaceutical and Biotech Companies, and More), and Geography (North America, Europe, Asia-Pacific, The Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Clinical Trial Investigative Site Network Market size was valued at USD 6.41 Billion in 2024 and is projected to reach USD 14.24 Billion by 2032 growing at a CAGR of 10.5% during the forecast period 2026-2032.A substantial rise in pharmaceutical research and development initiatives is being witnessed globally. New therapeutic compounds are being developed at an accelerated pace, with investigative site networks being utilized to support the growing pipeline of clinical trials across various therapeutic areas.A significant increase in chronic disease burden is being observed worldwide, particularly in aging populations. Clinical trial investigative site networks are being expanded to accommodate the growing demand for innovative treatments targeting cancer, diabetes, and cardiovascular disorders.

Snapshot img

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?

Get Key Insights on Market Forecast (PDF) Request Free Sample

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. TypePhase IIIPhase IPhase IIPhase IVService TypeInterventional studiesObservational studiesExpanded access studiesIndicationOncologyCNSAutoimmune/inflammationOthersGeographyNorth AmericaUS

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.

Request Free Sample

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

Request Free Sample

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 too

Clinical Trial Patient Recruitment Market Outlook

According to our latest research, the global Clinical Trial Patient Recruitment market size reached USD 4.16 billion in 2024, reflecting a dynamic growth trajectory driven by the increasing complexity and number of clinical trials worldwide. The market is projected to grow at a robust CAGR of 7.2% during the forecast period, reaching an estimated USD 7.72 billion by 2033. This upward momentum is primarily attributed to the rising prevalence of chronic diseases, expanding pharmaceutical pipelines, and the growing adoption of digital recruitment strategies, all of which are reshaping the landscape of clinical research globally.

The growth of the Clinical Trial Patient Recruitment market is profoundly influenced by the escalating demand for innovative therapies and personalized medicine. As pharmaceutical and biotechnology companies intensify their research and development activities, the need to efficiently recruit diverse and representative patient populations has become more critical than ever. The rise in complex clinical trial protocols, particularly in therapeutic areas such as oncology, neurology, and rare diseases, necessitates specialized recruitment services that can navigate regulatory requirements and reach specific patient cohorts. Furthermore, the increasing emphasis on patient-centric approaches and real-world evidence collection is compelling sponsors to invest in advanced recruitment methodologies, thereby fueling market expansion.

Another pivotal growth factor is the integration of digital technologies and data analytics in patient recruitment processes. The adoption of digital channels, including social media campaigns, online patient communities, and AI-driven platforms, has revolutionized the way clinical trials identify, engage, and enroll participants. These technologies enable targeted outreach, enhance patient engagement, and streamline the matching of eligible candidates to appropriate studies. Additionally, the use of electronic health records (EHRs), real-time data mining, and predictive analytics is optimizing site selection and reducing recruitment timelines, which is particularly advantageous in fast-paced therapeutic areas such as infectious diseases and cardiovascular disorders.

Strategic collaborations and partnerships among contract research organizations (CROs), pharmaceutical companies, and patient advocacy groups are also playing a significant role in market growth. By leveraging the expertise of specialized recruitment firms and digital health startups, stakeholders are able to broaden their reach, improve patient retention rates, and ensure compliance with regulatory standards. The increasing globalization of clinical trials, with a notable shift towards emerging markets in Asia Pacific and Latin America, is further expanding the market’s scope. These regions offer access to large, treatment-naive patient populations and favorable regulatory environments, making them attractive destinations for multinational clinical research initiatives.

Regionally, North America continues to dominate the Clinical Trial Patient Recruitment market, accounting for the largest share due to its advanced healthcare infrastructure, high R&D expenditure, and robust regulatory frameworks. However, Asia Pacific is emerging as the fastest-growing region, supported by increasing investments in healthcare, rapid urbanization, and the presence of a vast patient pool. Europe also represents a significant market, driven by stringent clinical trial regulations and a strong focus on innovation. Meanwhile, Latin America and the Middle East & Africa are witnessing steady growth, fueled by improving healthcare access and rising participation in global clinical trials. This regional diversification is expected to further intensify competition and innovation across the market landscape.

Service Type Analysis

The Clinical Trial Patient Recruitment market is segmented by service type into Patient Enrollment, Site Identification, Study Design, Data Management, and Others. Among these, Patient Enrollment remains the cornerstone of the market, accounting for the largest revenue share in 2024. The complexity of enrolling eligible patients, especially in trials involving rare diseases or stringent inclusion criteria, has led sponsors to seek specialized patient enrollment services. These services utilize a combination of traditional outreach, digital mark

The Decentralized and Digitalized Clinical Trials market is experiencing robust growth, projected to reach $17.69 billion in 2025 and exhibiting a Compound Annual Growth Rate (CAGR) of 11.1% from 2025 to 2033. This expansion is fueled by several key factors. Increasing adoption of digital technologies throughout the healthcare sector streamlines trial processes, reducing costs and accelerating timelines. The rising prevalence of chronic diseases necessitates faster and more efficient clinical research methods, creating a strong demand for decentralized and digital solutions. Furthermore, patient-centric approaches, including remote data collection and participation options, are gaining traction, improving recruitment and retention rates. This shift allows broader geographic reach, particularly advantageous in accessing underserved populations. The market segmentation reveals strong growth across web-based and cloud-based platforms, with oncology and cardiovascular applications leading the way, reflecting the high prevalence and research intensity in these therapeutic areas. The diverse range of companies involved, including established players like Medidata and IQVIA alongside emerging innovative firms, indicates a competitive but dynamic landscape ripe for further innovation. The geographic distribution showcases significant contributions from North America, driven by advanced technological infrastructure and high healthcare spending. However, the Asia Pacific region presents a considerable growth opportunity, given its expanding healthcare industry and increasing investment in clinical research infrastructure. While challenges remain—such as regulatory hurdles, data security concerns, and the need for robust technological infrastructure in certain regions—the overall market outlook remains exceptionally positive. The continuous evolution of technology, coupled with the inherent advantages of decentralized trials, points towards sustained expansion throughout the forecast period, with opportunities for further market penetration and innovation in therapeutic areas beyond oncology and cardiology.

BackgroundAccess to unpublished clinical study reports (CSRs) is currently being discussed as a means to allow unbiased evaluation of clinical research. The Institute for Quality and Efficiency in Health Care (IQWiG) routinely requests CSRs from manufacturers for its drug assessments.Our objective was to determine the information gain from CSRs compared to publicly available sources (journal publications and registry reports) for patient-relevant outcomes included in IQWiG health technology assessments (HTAs) of drugs.Methods and FindingsWe used a sample of 101 trials with full CSRs received for 16 HTAs of drugs completed by IQWiG between 15 January 2006 and 14 February 2011, and analyzed the CSRs and the publicly available sources of these trials. For each document type we assessed the completeness of information on all patient-relevant outcomes included in the HTAs (benefit outcomes, e.g., mortality, symptoms, and health-related quality of life; harm outcomes, e.g., adverse events). We dichotomized the outcomes as “completely reported” or “incompletely reported.” For each document type, we calculated the proportion of outcomes with complete information per outcome category and overall.We analyzed 101 trials with CSRs; 86 had at least one publicly available source, 65 at least one journal publication, and 50 a registry report. The trials included 1,080 patient-relevant outcomes. The CSRs provided complete information on a considerably higher proportion of outcomes (86%) than the combined publicly available sources (39%). With the exception of health-related quality of life (57%), CSRs provided complete information on 78% to 100% of the various benefit outcomes (combined publicly available sources: 20% to 53%). CSRs also provided considerably more information on harms. The differences in completeness of information for patient-relevant outcomes between CSRs and journal publications or registry reports (or a combination of both) were statistically significant for all types of outcomes.The main limitation of our study is that our sample is not representative because only CSRs provided voluntarily by pharmaceutical companies upon request could be assessed. In addition, the sample covered only a limited number of therapeutic areas and was restricted to randomized controlled trials investigating drugs.ConclusionsIn contrast to CSRs, publicly available sources provide insufficient information on patient-relevant outcomes of clinical trials. CSRs should therefore be made publicly available.Please see later in the article for the Editors' Summary

The global Clinical Trial and Analysis Services market is experiencing robust growth, driven by the increasing prevalence of chronic diseases, a surge in the number of clinical trials, and the escalating demand for faster and more efficient drug development processes. Technological advancements, such as AI and machine learning in data analysis, are further accelerating market expansion. The market's segmentation reflects the diverse needs of the pharmaceutical and biotechnology industries, encompassing services ranging from study design and data management to statistical analysis and regulatory submission support. Key players are strategically investing in expanding their service portfolios, leveraging technological capabilities, and forging strategic partnerships to maintain a competitive edge. This competitive landscape fosters innovation and drives the continuous improvement of service quality and efficiency. We estimate the 2025 market size to be approximately $150 billion, based on industry reports indicating similar markets with comparable growth rates. A conservative CAGR of 7% is projected for the forecast period (2025-2033), driven by sustained demand and technological progress. The market faces certain restraints, including the stringent regulatory environment governing clinical trials, the high cost of conducting trials, and the complexities associated with data management and analysis. However, the increasing adoption of outsourcing strategies by pharmaceutical companies, the emergence of specialized CROs (Contract Research Organizations) focusing on niche therapeutic areas, and the growing adoption of decentralized clinical trials are likely to mitigate these challenges. The regional distribution of the market reflects global healthcare spending patterns, with North America and Europe holding significant market share. Asia-Pacific is expected to witness strong growth in the coming years, fueled by expanding healthcare infrastructure and rising pharmaceutical investment in the region. The competitive landscape is characterized by a blend of large multinational CROs and smaller, specialized service providers, each catering to different segments of the market.

Clinical trial cost per patient was highest in the blood therapeutic area, ranging between 200 thousand and 422 thousand U.S. dollars with a median of some 311 thousand dollars. This statistic shows the estimated per patient trial costs by therapeutic area, for the period 2015-2017.

Clinical Trials Insurance Market Outlook

According to our latest research, the global clinical trials insurance market size reached USD 3.8 billion in 2024 and is expected to grow at a robust CAGR of 6.7% from 2025 to 2033, leading to a projected market size of USD 6.9 billion by 2033. This impressive growth is primarily fueled by the escalating number of clinical trials worldwide, increased regulatory requirements for participant protection, and the rising complexity of clinical research protocols. As the pharmaceutical, biotechnology, and medical device industries continue to expand their research activities, the demand for specialized insurance coverage to mitigate risks in clinical trials has never been more critical.

One of the most significant growth factors for the clinical trials insurance market is the rapid advancement and diversification of clinical research, especially in emerging therapeutic areas such as gene therapy, personalized medicine, and rare diseases. These innovative studies often involve higher risks and uncertainties, increasing the need for comprehensive insurance policies that protect sponsors, investigators, and participants. Additionally, the growing emphasis on patient safety and ethical standards has prompted regulatory bodies to enforce stricter guidelines regarding insurance requirements for clinical trials. This regulatory push has made insurance coverage not only a best practice but a mandatory aspect of conducting clinical research in many regions, thereby driving market expansion.

Another key driver is the globalization of clinical trials, with sponsors increasingly conducting multicenter studies across multiple countries to accelerate drug development and gain access to diverse patient populations. This trend introduces a complex risk landscape due to varying legal, regulatory, and ethical frameworks across jurisdictions. As a result, demand for tailored clinical trials insurance solutions that address cross-border liabilities and compliance requirements is rising. Insurance providers are responding by offering more sophisticated products that can be customized to meet the unique needs of global trials, further propelling the growth of the clinical trials insurance market.

The surge in outsourcing clinical research activities to contract research organizations (CROs) and the proliferation of small and mid-sized biotech firms have also contributed to market growth. These organizations often lack the internal resources to manage risk effectively and therefore rely heavily on insurance solutions to safeguard their operations. Furthermore, the increasing complexity of clinical trial protocols, including adaptive designs and decentralized trials, introduces new risks that necessitate specialized insurance coverage. The evolving risk profile of modern clinical trials is prompting both sponsors and insurers to collaborate more closely to develop innovative insurance products, fostering market development.

Regionally, North America continues to dominate the clinical trials insurance market, driven by the presence of a large number of pharmaceutical and biotechnology companies, a highly developed regulatory environment, and significant investments in R&D. However, Asia Pacific is emerging as a high-growth region due to the increasing number of clinical trials, expanding healthcare infrastructure, and supportive government policies. Europe also maintains a strong position, supported by stringent regulations and a robust clinical research ecosystem. Latin America and the Middle East & Africa, while smaller in market share, are witnessing gradual growth as clinical research activities expand in these regions. The interplay of regional dynamics, regulatory frameworks, and industry trends will continue to shape the global clinical trials insurance market in the coming years.

Type Analysis

The type segment of the clinical trials insurance market is categorized into Phase I, Phase II, Phase III, and Phase IV trials, each representing distinct stages of drug and device development. Phase I trials, which primarily assess safety and dosage in a small group of healthy volunteers or patients, pose unique risks due to the first-in-human administration of investigational products. Insurance coverage for Phase I trials is often tailored to address potential adverse reactions and unforeseen complications, making it a critical component for sponsors aiming to mitigate early-phase risks.

Clinical Trial Patient Matching AI Market Outlook

According to our latest research, the global Clinical Trial Patient Matching AI market size reached USD 1.43 billion in 2024, and is poised to grow at a robust CAGR of 19.7% from 2025 to 2033, projecting a market value of USD 6.94 billion by 2033. This remarkable growth is primarily driven by increasing digitization in clinical research, the rising complexity of clinical trials, and the urgent need to accelerate patient recruitment and improve trial outcomes. As per our comprehensive analysis, the integration of artificial intelligence into patient matching has emerged as a transformative force in clinical research, dramatically enhancing efficiency, accuracy, and patient diversity in clinical trials worldwide.

The growth trajectory of the Clinical Trial Patient Matching AI market is being propelled by several critical factors, most notably the surging volume of clinical trials across therapeutic areas. Pharmaceutical companies and research organizations are under mounting pressure to streamline trial recruitment, which is often cited as the most time-consuming and costly phase of clinical development. AI-powered patient matching solutions address these challenges by leveraging advanced algorithms, natural language processing, and machine learning to analyze vast datasets—including electronic health records, genomic data, and real-world evidence. This enables the rapid identification of eligible participants based on complex inclusion and exclusion criteria, significantly reducing recruitment timelines and costs. As a result, sponsors can accelerate drug development pipelines, bring innovative therapies to market faster, and ultimately improve patient outcomes.

Another significant driver for the Clinical Trial Patient Matching AI market is the increasing focus on personalized medicine and precision healthcare. As clinical trials become more targeted and adaptive, the need for precise patient stratification and matching intensifies. AI technologies facilitate the identification of niche patient populations, including those with rare diseases or specific genetic markers, who may benefit most from novel investigational treatments. This not only enhances trial efficacy and safety but also supports the broader industry shift towards individualized care. Furthermore, regulatory agencies are encouraging the adoption of digital tools to ensure greater transparency and diversity in clinical research, further accelerating the adoption of AI-powered patient matching solutions.

The rapid advancement of healthcare IT infrastructure and the proliferation of interoperable health data platforms are also catalyzing market growth. With increasing investments in electronic health records (EHRs), cloud-based data repositories, and data-sharing collaborations, AI systems can now access richer and more diverse datasets for patient matching. This is particularly crucial in multicenter and global trials, where patient recruitment challenges are often exacerbated by geographic and demographic disparities. The integration of AI into patient matching workflows enables sponsors and investigators to tap into previously underrepresented populations, thereby improving the generalizability and equity of clinical trial outcomes.

Regionally, North America continues to dominate the Clinical Trial Patient Matching AI market, accounting for the largest revenue share in 2024, driven by the presence of leading pharmaceutical companies, advanced healthcare IT infrastructure, and supportive regulatory frameworks. Europe follows closely, benefiting from strong government initiatives and a robust clinical research ecosystem. The Asia Pacific region is emerging as a high-growth market, fueled by expanding clinical trial activity, rising healthcare digitization, and increasing investments in AI-driven healthcare solutions. Latin America and the Middle East & Africa are also witnessing steady growth, albeit from a smaller base, as local governments and healthcare providers recognize the value of AI in enhancing clinical research efficiency and patient access.