North America Clinical Trials Market Accelerates in Personalized Therapies

North America Clinical Trials Market Size, Top Key Players with Shares and Forecast

The North America clinical trials market size is calculated at US$ 21.76 billion in 2024, grew to US$ 22.52 billion in 2025, and is projected to reach around US$ 30.69 billion by 2034. The market is expanding at a CAGR of 3.50% between 2025 and 2034. 

The U.S. and Canada are focusing on the faster regulatory process for achieving innovative therapies in cancer, rare disease & orphan conditions. Moreover, the North America clinical trials market is exploring innovation in decentralized & virtual clinical trials, with the exploration of various AI-powered tools. At the same time, diverse pharmaceutical & biotechnology companies are putting efforts into the development of personalized therapies used in the growing chronic diseases. As well as the leading players are transforming Phase IV solutions, with novel solutions in patient recruitment and clinical data management systems.

Key Takeaways

• North America clinical trials industry poised to reach USD 21.76 billion by 2024.
• Forecasted to grow to USD 30.69 billion by 2034.
• Expected to maintain a CAGR of 3.50% from 2025 to 2034.
• By country, the United States dominated the North America clinical trials market in 2024.
• By country, Canada is expected to be the fastest-growing country during the forecast period.
• By phase, the phase III segment held a major revenue share of the market in 2024.
• By phase, the phase IV segment is expected to grow rapidly in the studied years
• By therapeutic area, the oncology segment led the North America clinical trials market in 2024.
• By therapeutic area, the rare diseases & orphan conditions segment is expected to grow at the fastest CAGR in the coming years.
• By service type, the site management & monitoring segment dominated the market in 2024.
• By service type, the patient recruitment & retention segment is expected to be the fastest-growing during the forecast period.
• By end-user/sponsor, the pharmaceutical companies segment held the dominating revenue share of the market in 2024.
• By end-user/sponsor, the biotechnology companies segment is expected to witness the fastest expansion in the predicted timeframe.
• By technology, the clinical data management systems (CDMS) segment led the North America clinical trials market in 2024. 
• By technology, the decentralized/virtual clinical trials (DCTs) segment is expected to grow rapidly during 2025-2034.

Quick Facts Table

What are the North America Clinical Trials?

The North America clinical trials market encompasses the ecosystem of research services, technologies, and infrastructure that support the evaluation of new drugs, biologics, devices, and therapies through human clinical studies. It covers the entire lifecycle from Phase I to Phase IV trials, incorporating advanced digital technologies, regulatory compliance, patient recruitment, and contract research partnerships, making North America the largest global hub for clinical trial activities.

North America Clinical Trials Market Outlook:

• Global Expansion: The widespread adoption of AI and decentralized trials, and the region's robust pharmaceutical innovation ecosystem and supportive regulatory landscape, are supporting overall expansion. StarTrials, a global player in contract research organization (CRO) services, expanded into different key Asian markets to explore its clinical trial services and offer localized solutions for pharmaceutical companies.
• Major Investors: AstraZeneca made a $50 billion investment in U.S. R&D and manufacturing facilities over the next five years, with new sites emphasizing clinical trial supply.
• Startup Ecosystem: In September 2025, Armida Labs, Inc., a University of California, Riverside startup company awarded a $2.25 million Small Business Innovation Research, or SBIR, grant from the National Cancer Institute of the National Institutes of Health, to support preclinical investigational new drug (IND) application studies.

What are the Trends in the North America Clinical Trials Market?

• Various regions of North America and their leading companies of clinical trials are fostering their innovation in the ongoing trials by making a huge investment in it, and collaborating with other well-known organizations.
• In August 2025, THL Partners, a premier private equity firm, entered into a definitive agreement to acquire Headlands Research, a leading multinational network of clinical trial sites, to advance site network expansion and escalate clinical trial innovation.
• In July 2025, Biogen Inc. invested $2 billion in its existing manufacturing footprint in North Carolina’s Research Triangle Park (RTP) to continue breakthroughs of Biogen’s late-stage clinical pipeline.
• In February 2025, Tasso Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, and ARUP Laboratories, the largest nonprofit clinical and academic reference laboratory in the United States, partnered to establish and operationalize high-quality, at-home blood testing services to support clinical research.

North America Clinical Trials Market: Notable Initiatives

How is AI Powering the North America Clinical Trials Market?

The widespread adoption of AI algorithms in consistent clinical trials is boosting patient recruitment, simplifying trial design, and empowering drug discovery for new and repurposed therapies. The recent transformation comprises IQVIA's AI-assisted tools for accurate patient recruitment, Antidote's public trial matching platform employing NLP to structure trial criteria, and Pfizer's alliance with IBM Watson to analyze scientific literature for immuno-oncology targets. Alongside, Medable and Science 37 have utilized AI for decentralized trials, whereas Sanofi and Johnson & Johnson have explored AI for virtual patient modeling and drug discovery to expand development timelines. 

Segmental Insights

Which Phase Led the North America Clinical Trials Market in 2024?

In 2024, the phase III segment dominated the market. The major factors, like the presence of a strong life sciences ecosystem, a huge burden of chronic and rare diseases, and rising technological integration, are supporting the overall phase III process. A rise in the need for definitive proof of effectiveness for regulatory approval, the demand for treatments in high-need areas like oncology, as well as the latest efforts, including Alzheimer's with Eli Lilly's donanemab (which showed plaque clearance) and Immunoglobulin A Nephropathy with Sibeprenlimab, have led to the overall expansion. 

However, the phase IV segment is anticipated to expand at a rapid CAGR. North America is experiencing regulatory needs, the demand for real-world evidence (RWE), and the requirement for long-term safety and efficacy data are fueling the phase IV development. Recently, a Roche trial for a multiple sclerosis drug released new standards for inclusive research with emphasis on Black and Hispanic/Latinx participants, and different post-marketing surveillance studies monitoring the long-term safety and efficiency of broadly used drugs. 

How did the Oncology Segment Dominate in the Market in 2024?

The oncology segment registered dominance in the North America clinical trials market in 2024. Ongoing research and development (R&D) investments and faster advancements in tailored medicine and technology are propelling the oncology area. 

In September 2025, Imlunestrant was approved by the FDA for advanced or metastatic ER-positive, HER2-negative breast cancer with an ESR1 mutation that has grown after other endocrine therapy. Additionally, the Canadian BR38 trial integrated radiotherapy with immunotherapy for metastatic NSCLC with restricted growth.

Although the rare diseases & orphan conditions segment is predicted to register the fastest growth, a greater involvement of favorable regulatory incentives, such as market exclusivity from the Orphan Drug Act, a robust biopharmaceutical and biotech research infrastructure, with broader investment in R&D, is assisting the revolution of novel therapies. The region is focusing on gene therapies, monoclonal antibodies, and small-molecule drugs targeting many conditions, specifically Duchenne muscular dystrophy, hemophilia, congenital adrenal hyperplasia, and Niemann-Pick disease.

In April 2025, Janssen Pharmaceuticals received FDA approval for this monoclonal antibody used for treating generalized myasthenia gravis, a rare neuromuscular disorder. 

Which Service Type Was Dominant in the North America Clinical Trials Market in 2024?

In 2024, the site management & monitoring segment accounted for the biggest share of the market. A prominent catalyst is the growing demand for specialized outsourcing solutions is impacting comprehensive services. Besides this, the presence of significant pharmaceutical companies and CROs is supporting the overall monitoring processes. The major contributing tools are Clinical Trial Management Systems (CTMS) to track timelines, manage site activities, monitor key performance indicators (KPIs), and develop real-time reports.

On the other hand, the patient recruitment & retention segment will expand rapidly. A rise in clinical trial complexity, accelerating investment in medical research, and technological innovation are bolstering the segmental expansion. Recent approaches include AI-enabled platforms (e.g., Elligo and Avallano's myTrialsConnectSM), decentralized clinical trial (DCT) approaches applying telemedicine, mobile apps, and online platforms for a broader range of reach, boosting the market progress.

Why did the Pharmaceutical Companies Segment Lead the Market in 2024?

The pharmaceutical companies segment captured a major share of the North America clinical trials market in 2024. The segment is fueled by the escalating investments by these types of companies to fulfill the increasing demand for novel therapies for chronic diseases like cancer and diabetes.

Recently, in September 2025, Pfizer demonstrated Phase 3 data for its updated mRNA-based COVID-19 vaccine formula, which showed a robust immune response in high-challenge populations.

However, the biotechnology companies segment is anticipated to expand at the fastest CAGR during 2025-2034. The expanding developments in precision medicine and the accelerating demand for advanced treatments used in chronic diseases are assisting in the innovative steps of these companies. The latest FDA approval encompasses Linvoseltamab-gcpt (Lynozyfic), a bispecific antibody for relapsed or refractory multiple myeloma, received in July 2025. Also, Amgen and Kyowa Kirin explored a Phase 3 study of rocatilimab in September 2025, a treatment for adults with moderate-to-severe atopic dermatitis.

Which Technology Dominated the North America Clinical Trials Market in 2024?

In 2024, the clinical data management systems (CDMS) segment held a dominant share of the market. Primarily, the segment is driven by the increasing number of clinical trials, the enforcement of strict regulatory requirements from bodies, and the widespread adoption of advanced technologies, including cloud solutions and AI integration. Recent advancements, like MaxisIT's DTect AI and IQVIA's CDAS, are leveraging the industry's movement towards advanced analytics and smarter trial management.

The decentralized/virtual clinical trials (DCTs) segment is estimated to register rapid growth in the coming era. The non-going efforts in patient-centric models powered by digital health technologies, along with the expansion of the pandemic's disruption, are imposing the immersion of innovative trial solutions. A major example is the ADAPTABLE trial, which studied optimal aspirin dosage for heart conditions, conducted at a large-scale, fully decentralized trial. Recently, the TELEPIK trial for advanced breast cancer applied a hybrid model for remote monitoring and a fully remote study on functional constipation in the US.

Country Analysis

What Made the United States Dominant in the Market in 2024?

By capturing the largest revenue share, the United States led the North America clinical trials market in 2024. The presence of a strong hub of academic research and biopharmaceutical innovation, rising investment in R&D, and breakthroughs in technology are fueling the US progress. In the last few days, they have launched a precision medicine trial for myeloid cancers, an AI algorithm adoption for matching volunteers to trials, and the start of trials for a twice-yearly HIV prevention injection.

For instance,

• In May 2025, the US-based START Center for Cancer Research (START) and OneOncology allied to unveil three early-phase trial sites in the US.

A Favourable Regulatory Landscape is Driving Canada

In the prospective period, Canada is predicted to witness the fastest expansion in the North America clinical trials market. A prominent driver is the guidance and favourable regulatory environment, particularly from Health Canada is imposing affordability, protocol changes, and timeline compression in the trials. Also, Health Canada is allowing a 30-day Clinical Trial Application (CTA) review period, which further facilitates efficiency and clarity for sponsors by allowing protocol adjustments and rapid trial timelines. As well, continuous collaborations with Contract Research Organizations (CROs) are fostering Canada’s trials.

For this market,

• In May 2025, AbCellera received a No Objection Letter (NOL) from Health Canada authorizing its Clinical Trial Application (CTA) for ABCL575, an investigational antibody antagonist targeting OX40 ligand (OX40L)

Key Companies and Their contributions and offerings

• IQVIA- A leading player exploring services and solutions for clinical trials, with a focus on boosting development, accelerating patient experiences, and using data, technology, and AI.
• Labcorp Drug Development- It specializes in laboratory services to support early-stage clinical trial testing.
• Parexel International- A major company offering wider clinical trial services across the complete drug development lifecycle, from Phase I to Phase IV. T
• Syneos Health- It is facilitating end-to-end clinical trial services, with coverage of all phases of development, therapeutic areas, and novel trial methodologies.
• ICON plc- A player offering a full suite of services, including specialized lab testing, strategic consulting, and technology-driven solutions for decentralized trials.

Top Companies in the Market

• Medpace Holdings, Inc.
• PRA Health Sciences (part of ICON)
• Charles River Laboratories
• PPD (Thermo Fisher Scientific)
• Worldwide Clinical Trials
• WuXi AppTec (US Operations)
• Veristat

What are the Recent Developments in the North America Clinical Trials Market?

• In September 2025, Crystalys Therapeutics emerged from stealth mode with a funding round of $205 million to assist in financing global late-stage trials of its lead drug as a treatment for gout.
• In September 2025, City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S., introduced a groundbreaking national clinical trials model to enhance access to developing life-saving cancer treatments.
• In January 2025, California vaccine company Arcturus Therapeutics unveiled a Phase I trial of ARCT-2304, a self-amplifying mRNA (sa-mRNA) vaccine candidate created to combat the H5N1 virus, known as bird flu.

Segments Covered in the Report

By Phase

• Phase I
• Phase II
• Phase III
• Phase IV

By Therapeutic Area

• Oncology
• Cardiovascular Diseases
• Central Nervous System (CNS) Disorders
• Infectious Diseases
• Metabolic & Endocrine Disorders
• Immunology & Inflammation
• Rare Diseases & Orphan Conditions
• Other Indications

By Service Type

• Clinical Trial Design & Planning
• Patient Recruitment & Retention
• Site Management & Monitoring
• Data Management & Biostatistics
• Regulatory & Compliance Services
• Laboratory & Bioanalytical Services
• Medical Writing & Pharmacovigilance

By End-User/Sponsor

• Pharmaceutical Companies
• Biotechnology Companies
• Medical Device Manufacturers
• Academic & Research Institutes
• Government & Public Health Agencies 

By Technology 

• Decentralized/Virtual Clinical Trials (DCTs)
• Wearables & Remote Patient Monitoring
• eCOA, ePRO, & eConsent Platforms
• Clinical Data Management Systems (CDMS)
• AI & Machine Learning Platforms
• Blockchain & Data Security Solutions

By Country

• United States
• Canada