North America Clinical Trials Market Report by Phases, Indications, Study Designs, Countries and Companies Analysis 2026-2034

North America Clinical Trials Market Size and Forecast

North America Clinical Trials Market is projected to expand from US$ 21.27 billion in 2025 to US$ 35.94 billion by 2034, registering a CAGR of 6.00% during 2026–2034. Market growth is being supported by increasing pharmaceutical and biotechnology R&D investments, rising demand for innovative drugs and therapies, and the growing adoption of advanced clinical research technologies. The region’s well-established healthcare infrastructure, strong presence of contract research organizations (CROs), and supportive regulatory environment further contribute to the expansion of clinical trial activities.

What is the Clinical Trials Market and Its Uses & Popularity in North America

North America Clinical Trials Market comprises services, technologies, research organizations, clinical sites, and supporting infrastructure used to evaluate the safety, efficacy, dosage, and clinical benefits of new drugs, biologics, medical devices, and therapies in human participants. Clinical trials are conducted through multiple phases, from early-stage safety studies to large Phase III trials that generate evidence required for regulatory approval. In North America, particularly the United States, clinical research plays a major role in pharmaceutical innovation and healthcare development. ClinicalTrials.gov listed 593,857 registered studies globally as of July 14, 2026, including 167,622 studies conducted only in the U.S. and 25,887 involving both U.S. and non-U.S. locations. In 2023, biopharmaceutical companies sponsored nearly 5,300 clinical trials in the U.S., involving more than 900,000 participants, demonstrating the scale of clinical research activity in the region. Clinical trials are widely used to support drug development, personalized medicine, rare-disease research, oncology, vaccines, and advanced therapies.

Companies by Clinical Trial Activity in North America in 2025

• AstraZeneca – Approximately 160+ active clinical trials, with major research activity in oncology, respiratory diseases, cardiovascular conditions, and immunology. AstraZeneca also recorded 93 new trial starts in 2025+ in the Intellitrials analysis.
• Eli Lilly and Company – Approximately 140+ active clinical trials, with significant focus on diabetes, obesity, metabolic disorders, and oncology. The company recorded 65 new trial starts in 2025+.
• Pfizer Inc. – Approximately 130+ active clinical trials, spanning vaccines, oncology, infectious diseases, and rare diseases. Pfizer recorded 53 new trial starts in 2025+.
• Merck & Co. – Approximately 120+ active clinical trials, with research concentrated in oncology, infectious diseases, vaccines, and immunology. Merck recorded 64 new trial starts in 2025+ and completed 228 trials in 2024, according to Citeline.
• Novartis AG – Approximately 110+ active clinical trials, covering oncology, cardiovascular and renal diseases, immunology, and gene and cell therapies. Novartis recorded 50 new trial starts in 2025+.
• Roche Holding AG – Approximately 100+ active clinical trials, with a strong focus on oncology, neurology, immunology, and diagnostics-related research. Roche was also among the top five sponsors for completed trials in 2024, with 152 completed trials.
• Johnson & Johnson – Approximately 90+ active clinical trials, with research spanning immunology, oncology, neuroscience, cardiovascular disease, and infectious diseases. Its Janssen research organization remains an important contributor to pharmaceutical clinical development.
• Bristol Myers Squibb – Approximately 85+ active clinical trials, particularly across oncology, hematology, immunology, and cardiovascular diseases. BMS recorded 43 new trial starts in 2025+ and completed 184 trials in 2024.
• Amgen Inc. – Approximately 75+ active clinical trials, with research focused on oncology, cardiovascular and metabolic diseases, inflammation, and rare diseases. Amgen also maintains substantial clinical-development activity across biologic therapies and targeted medicines.
• AbbVie Inc. – Approximately 70+ active clinical trials, with key therapeutic research areas including immunology, oncology, neuroscience, and gastroenterology. AbbVie recorded 53 new trial starts in 2025+, placing it among the leading global pharmaceutical sponsors by new trial activity.

Note: The active-trial figures above are estimated figures from the supplied market table and should not be interpreted as independently verified North America-only counts. Public clinical-trial databases can produce different totals depending on whether they count active, recruiting, industry-sponsored, interventional, completed, or newly initiated studies. For example, a current sponsor tracker reports much higher global active-trial volumes when all locations and study types are included.

Sources: Pharma Board

Growth Drivers

Rising Pharmaceutical and Biotechnology R&D Investment

Increasing investment in pharmaceutical and biotechnology research is a major driver of the North America clinical trials market. Clinical trials represent a critical stage in converting laboratory discoveries into approved medicines and therapies, creating sustained demand for trial management, patient recruitment, clinical data management, monitoring, and regulatory services. PhRMA reports that its member companies invested more than US$900 billion in developing new treatments over the past decade, highlighting the substantial financial commitment to biopharmaceutical innovation.  In addition, PhRMA members spent approximately US$104 billion on R&D worldwide in 2024, with R&D representing around 21% of their combined global revenues. The economic contribution of clinical research is also substantial: biopharmaceutical companies spent more than US$30 billion directly at U.S. clinical trial sites in 2023, generating over US$62 billion in total economic activity. Continued investment in oncology, immunology, rare diseases, gene therapies, and precision medicine is therefore expanding the volume and complexity of clinical trials across North America.

Growing Number of Clinical Studies and Demand for Innovative Therapies

The increasing number of clinical studies and the continued development of innovative therapies are supporting market expansion across North America. ClinicalTrials.gov recorded 42,966 new registered studies during 2025, increasing the cumulative number of registered studies to 563,828 at the end of the year. By July 14, 2026, the total had reached 593,857 registered studies, of which 453,135 were interventional studies. Drug and biologic interventions accounted for 219,299 registered interventional studies, illustrating the importance of clinical research to pharmaceutical development. The U.S. also remains an important location for industry-sponsored research, with nearly 5,300 biopharmaceutical clinical trials conducted in 2023 and more than 900,000 participants enrolled. Meanwhile, the FDA approved 50 novel drugs in 2024, including 24 first-in-class medicines and 26 medicines for rare or orphan diseases. The growing pipeline of innovative drugs, biologics, and targeted therapies consequently creates continuous demand for clinical trial services and infrastructure.

Adoption of Advanced Clinical Trial Technologies and Data-Driven Research

The adoption of digital technologies, advanced data analytics, decentralized trial approaches, and sophisticated clinical research platforms is transforming clinical trial operations in North America. Modern trials increasingly require integrated systems for electronic data capture, remote patient monitoring, patient recruitment, clinical data management, and real-time safety assessment. The growing complexity of drug development also increases the need for technology-supported trial management and data analysis. ClinicalTrials.gov currently reports 79,149 studies with posted results, reflecting the expanding volume of clinical research data available for analysis and evidence generation. Artificial intelligence, machine learning, electronic health records, and digital biomarkers are increasingly being incorporated into clinical research workflows to improve patient identification, data processing, and study monitoring. At the same time, NIH-supported research enrolled 11.05 million participants worldwide in FY2025, including 8.20 million participants at U.S. sites, demonstrating the scale of data generated through clinical research. These developments are encouraging clinical research organizations, pharmaceutical companies, and technology providers to invest in more automated and data-driven trial infrastructure.

Challenges

High Cost and Long Development Timelines

The high cost and lengthy timelines associated with clinical research remain significant challenges for the North America clinical trials market. Pharmaceutical companies must invest heavily in patient recruitment, clinical sites, investigators, regulatory compliance, data management, monitoring, and statistical analysis before a medicine can reach the market. According to PhRMA, developing a new medicine takes at least 10 years on average and costs approximately US$2.6 billion, while fewer than 12% of candidate medicines entering Phase I clinical trials ultimately receive FDA approval. Such high failure rates create substantial financial risk for sponsors and can discourage investment in programs where patient populations are small or trial requirements are particularly complex. Rising costs associated with recruiting suitable participants and conducting increasingly sophisticated trials can further increase development expenses. In addition, delays in enrollment, site activation, regulatory review, and data collection can extend study timelines. Consequently, pharmaceutical companies and CROs are increasingly seeking technology-enabled approaches, optimized trial designs, and more efficient recruitment strategies to control costs and accelerate clinical development.

Patient Recruitment, Diversity, and Retention Challenges

Patient recruitment and retention remain important operational challenges for clinical trials in North America, particularly when studies require specific demographic, genetic, or disease characteristics. Although the region has a large and diverse population, eligible participants can be difficult to identify and retain throughout lengthy clinical studies. FDA data from its 2024 Drug Trials Snapshots show substantial variation in racial and ethnic representation across therapeutic areas; White participants represented more than 50% of trial populations in a majority of drug programs, while Hispanic or Latino participation ranged from 0% to 46% across therapeutic areas. Recent research examining pivotal trials for drugs approved in 2023 found that only 23% of trials had Black participant enrollment representative of the U.S. population, while 30% had representative Hispanic enrollment. NIH-supported clinical research has increasingly emphasized appropriate inclusion across sex, race, ethnicity, and age, with FY2025 U.S. clinical research enrolling 8.20 million participants. Improving recruitment diversity, participant access, and retention remains essential for generating broadly applicable clinical evidence.

Recent Developments

• July 2025 – Regeneron Pharmaceuticals: The U.S. FDA granted accelerated approval to linvoseltamab-gcpt (Lynozyfic), a BCMA-directed CD3 T-cell-engaging bispecific antibody, for adults with relapsed or refractory multiple myeloma following at least four prior treatment regimens. The approval was supported by clinical trial data from the LINKER-MM1 program.
• September 2025 – Amgen and Kyowa Kirin: The companies advanced clinical development of rocatinlimab, an investigational treatment for adults with moderate-to-severe atopic dermatitis, including plans for Phase III evaluation.
• April 2025 – Janssen Pharmaceuticals: Janssen received U.S. FDA approval for a monoclonal antibody therapy for generalized myasthenia gravis, expanding treatment options for patients with this rare neuromuscular disorder and supporting continued clinical research in autoimmune diseases.
• August 2025 – THL Partners and Headlands Research: THL Partners entered into a definitive agreement to acquire Headlands Research, a multinational clinical trial site network. The transaction is intended to support expansion of research-site capabilities and strengthen clinical trial execution.
• July 2025 – Biogen: Biogen announced a US$2 billion investment in its manufacturing operations at Research Triangle Park in North Carolina. The investment is expected to strengthen the company’s development and manufacturing infrastructure supporting its clinical-stage and commercial pipeline.
• February 2025 – Tasso and ARUP Laboratories: Tasso partnered with ARUP Laboratories to develop and operationalize patient-centric, at-home blood collection and testing services for clinical research. The collaboration is aimed at making sample collection more convenient while supporting decentralized and hybrid clinical trial models.
• May 2025 – IQVIA: IQVIA announced its Site Lab Navigator, a technology solution designed to streamline and automate laboratory workflows for clinical trial sponsors and investigator sites. The platform is intended to improve coordination and operational efficiency across clinical trial laboratory activities.
• April 2025 – Thermo Fisher Scientific: Thermo Fisher Scientific introduced an advanced platform using a new CHO K-1 cell line designed to accelerate preclinical biologic development. The technology can potentially reduce the timeline for Investigational New Drug (IND) filing preparation from approximately 13 months to nine months, helping developers move biologic candidates toward clinical evaluation more efficiently.
• January 2025 – ICON: ICON expanded its portfolio of artificial intelligence (AI)-enabled clinical trial tools to improve efficiency across study initiation, document processing, resource forecasting, and performance reporting. The development reflects the increasing integration of AI into clinical research operations.
• September 2025 – Armida Labs: Armida Labs, a University of California, Riverside startup, received a US$2.25 million NIH/NCI Small Business Innovation Research (SBIR) grant to support preclinical studies associated with an IND application, strengthening early-stage oncology research and clinical development capabilities.
• September 2025 – Crystalys Therapeutics: Crystalys Therapeutics emerged from stealth with US$205 million in financing to support global late-stage clinical development of its lead gout treatment, providing substantial funding for Phase III research and regulatory activities.
• September 2025 – City of Hope: City of Hope introduced a national clinical-trials model designed to broaden patient access to emerging cancer therapies and connect more patients with investigational treatment opportunities across the United States.
• January 2025 – Arcturus Therapeutics: Arcturus Therapeutics initiated a Phase I clinical trial of ARCT-2304, a self-amplifying mRNA vaccine candidate targeting H5N1 avian influenza. The study represents continued development of next-generation mRNA vaccine technologies for emerging infectious diseases.
• September 2025 – FDA Oncology Development: The FDA approved imlunestrant for certain adults with advanced or metastatic ER-positive, HER2-negative breast cancer carrying an ESR1 mutation after disease progression following endocrine therapy, demonstrating continued clinical development in biomarker-selected oncology populations.
• 2025 – Canadian Clinical Research: Canadian investigators continued advancing combination approaches in oncology, including trials evaluating radiotherapy alongside immunotherapy for metastatic non-small-cell lung cancer (NSCLC). These studies illustrate the region’s growing focus on multimodal treatment strategies and precision approaches in cancer clinical research.

United States Advanced Research Infrastructure and High Clinical Trial Activity

United States represents the largest clinical research ecosystem in North America, supported by advanced healthcare infrastructure, academic medical centers, pharmaceutical companies, biotechnology firms, and contract research organizations (CROs). ClinicalTrials.gov recorded more than 167,000 studies conducted only in the United States as of July 2026, illustrating the country’s substantial role in global clinical research. The U.S. also benefits from extensive pharmaceutical R&D investment and a large patient population across oncology, immunology, metabolic diseases, neurology, infectious diseases, and rare disorders. In 2023, biopharmaceutical companies sponsored nearly 5,300 clinical trials in the United States, involving more than 900,000 participants. Digital health technologies, artificial intelligence, remote monitoring, electronic data capture, and decentralized trial models are increasingly being incorporated into clinical research to improve operational efficiency. Major CROs and research-service providers, including IQVIA, ICON, Parexel, and Charles River Laboratories, further strengthen the ecosystem. In May 2025, START and OneOncology announced a collaboration involving three early-phase clinical trial sites, supporting broader access to investigational cancer therapies. The U.S. clinical trials market is further supported by substantial pharmaceutical R&D spending and an established regulatory framework led by the FDA. Clinical research generates evidence required to evaluate the safety and efficacy of innovative drugs, biologics, and medical devices before commercialization. The country’s large concentration of biopharmaceutical companies creates continuous demand for Phase I through Phase III studies and post-marketing research. FDA’s Drug Trials Snapshots program also provides demographic information from pivotal trials supporting new drug approvals, increasing transparency around participant representation and trial outcomes.

Canada Established Healthcare System and Research Capabilities

Canada has a well-developed clinical research environment supported by its publicly funded healthcare system, universities, research hospitals, specialized treatment centers, and skilled scientific workforce. Health Canada receives hundreds of new clinical trial applications every year, covering new drugs, vaccines, and new uses of existing medicines. Clinical studies span important therapeutic areas such as oncology, immunology, neurology, infectious diseases, cardiovascular conditions, and rare disorders. Canada’s clinical research environment also benefits from collaboration among pharmaceutical companies, biotechnology firms, academic institutions, hospitals, and research organizations. Its diverse population and network of major healthcare centers provide opportunities for patient recruitment and multicenter research. Increasing interest in biologics, precision medicine, immunotherapies, and advanced therapeutic products is generating demand for specialized clinical development capabilities. In May 2025, AbCellera received a No Objection Letter from Health Canada for its Clinical Trial Application for ABCL575, an investigational OX40L-targeting antibody being developed for moderate-to-severe atopic dermatitis. The planned Phase I study was expected to begin in the third quarter of 2025. Such developments demonstrate Canada’s continued participation in innovative early-stage clinical research. Canada’s clinical trials market is supported by Health Canada’s regulatory oversight and a network of research institutions capable of conducting early- and late-stage studies. Sponsors can conduct clinical investigations across multiple provinces and therapeutic areas, while collaborations between academic researchers and pharmaceutical developers support translational research. Health Canada notes that clinical trials can evaluate new drugs, vaccines, or new uses of approved medicines, making them an important component of the country’s drug-development system. The market is also benefiting from increasing research into biologics, oncology therapies, immunology, rare diseases, and personalized medicine. Continued investment in clinical research infrastructure, streamlined trial processes, stronger industry-academic partnerships, and adoption of decentralized technologies can support Canada’s role in multinational clinical development. The authorization of ABCL575 in 2025 illustrates the country’s ongoing participation in innovative Phase I research.

Mexico Expanding Clinical Research Activity and Regulatory Modernization

Mexico is developing its position as a clinical research destination in North America, supported by its large population, expanding healthcare capabilities, proximity to the United States, and increasing participation in multinational studies. The country’s regulatory authority, COFEPRIS, maintains a National Clinical Trials Registry (RNEC) that provides public information on authorized clinical research protocols. The updated RNEC 2.0 platform was launched in 2023, while current records provide access to authorized protocols from 2024 onward. Regulatory activity remained significant during 2025. COFEPRIS reported that 183 clinical trials were authorized during 2025, alongside 312 pharmaceutical registrations and 2,450 medical-device registrations. Clinical research covered areas including oncology, cardiovascular disease, autoimmune disorders, multiple sclerosis, and rare diseases. For example, COFEPRIS reported six clinical-trial authorizations in March 2025, including two studies evaluating potential oncology treatments. This expanding activity demonstrates Mexico’s growing contribution to regional clinical development. Mexico’s clinical trials market benefits from a large and diverse patient population and its geographic proximity to the United States, which can facilitate participation in multinational research programs. Cost considerations can also make Mexico attractive for sponsors seeking to optimize clinical development expenditure, while the country’s network of hospitals, investigators, and specialized research centers provides access to patients across several therapeutic areas. COFEPRIS has continued to strengthen transparency and regulatory processes through its RNEC and monthly AARSEC reporting system. In 2025, the regulator reported 183 authorized clinical trials, while its public registry provides ongoing access to authorized protocols and information about participating research centers.

Market Segments

Phases

• Phase 1
• Phase 2
• Phase 3
• Phase 4

Indications

• Autoimmune/Inflammation
• Pain management
• Oncology
• CNS Condition
• Diabetes
• Obesity
• Cardiovascular
• Others

Study Designs

• Interventional
• Observational
• Expanded Access

Countries

• United States
• Canada
• Mexico
• Rest of North America

All companies have been covered with 5 Viewpoints

• Overviews
• Key Person
• Recent Developments
• SWOT Analysis
• Revenue Analysis

Company Analysis:

1. ICON Plc
2. Wuxi AppTec
3. SGS SA
4. Syneos Health
5. PRA Health Sciences Inc
6. Pfizer Inc.
7. IQVIA
8. Medpace

Report Details: