North America Clinical Trials Market Research Report – Segmented By Phase, Design, Indications and Country (United States, Canada and Rest of North America) - Industry Analysis, Size, Share, Growth, Trends, & Forecast | 2024 to 2029

Updated On: January, 2024
ID: 1576
Pages: 145

North America Clinical Trials Market Size (2023 to 2028)

As per our analysis report, the North American Clinical Trials Market is expected to reach USD 9.31 billion by 2028 from USD 6.51 billion in 2022, growing at a compound annual growth rate (CAGR) of 7.40 % during the forecast period.

The rising prevalence of chronic diseases in the North American region is boosting the clinical trials market in this region. The increasing number of new variant diseases without proper treatment and prevention measures is enhancing the clinical trial market adoption in the region. Government agencies and market players are collaborating to increase the focus on developing the prevention, treatment, and diagnostic methods for the diseases driving the North American clinical trials market. The North American people are found to have varied disease profiles, increasing the number of clinical trials for rare diseases. The number of patients with specific diseases induces the biopharmaceutical companies to invest in the clinical trials.

The increasing investments by the key market players in pharmaceutical research and development activities enhance the growth rate of the North American clinical trials market. According to the United States National Library of Medicine, in September 2022, approximately 13,323 clinical trials were active in different phases of cancer indication in the U.S. The heavy investments by pharmaceutical companies in R&D due to patent expiration and new drug developments are propelling the clinical trials market expansion in this region. The growing advancements in the healthcare infrastructure are moving forward in the R&D sector, which is also increasing the market value for clinical trials. 

The presence of research organizations such as CROs (Contract Research Organizations), which work for pharmaceutical companies. The top companies collaborate with the CROs, which provide research management services. Advancements in biotechnology have increased the number of drug candidates in the pipeline. The rising development of novel pharmaceutical products is expected to accelerate the demand for clinical trial services, which is expected to show substantial growth. 

The need for more skilled personnel is the primary factor impeding the market growth of clinical trials in the North American Region. Research organizations need help selecting the required skilled person. Skilled scientists are in demand among academic research institutes, medical firms, pharmaceutical companies, and medical device makers. The development of new innovative molecules is challenging for research organizations. The various requirements in manufacturing, chemistry, and control for the approval required for Investigational New Drugs and for developing the innovative drug delivery system issue many challenges. All these challenges obstruct the use of novel and innovative analytical techniques for testing new drug molecules. 

Impact of COVID-19 on the North America clinical trials market:

The COVID-19 outbreak has impacted the healthcare system due to adverse impacts on the supply chain of pharmaceuticals and medical devices. At the same time, research and development have gained traction. All the government agencies worked with the healthcare system to provide diagnostic, preventive, and treatment solutions for decreasing the spread of COVID-19. The number of clinical trials had increased for focusing on COVID-19 reduction and widespread, which augmented the clinical trials market growth. 

This report on the North American clinical trials market has been segmented into the following categories:

North America Clinical Trials Market - By Phase:

  • Phase I
  • Phase II
  • Phase III

The Phase III segment dominated the market as it is the largest segment in the clinical trials phases. The Phase I segment is also gaining traction and is expected to grow at a pace with a steady growth rate due to increased investigative new drug applications registered. Phase III is the most significant and crucial Phase, which consists of testing the effectiveness of the developed and its clinical practice. The increasing government initiatives for drug discovery and innovations in drug development in North American countries are propelling market growth. Phase III results determine the developed drug's safety and efficacy in large populations. This phase works for the approval process by playing a significant role in the growth of regional market. The high failure rate in this Phase makes it crucial for the development process.

North America Clinical Trials Market - By Design:

  • Interventional Trials
  • Observational Trials
  • Expanded Access Trials

The interventional segment dominated the North American clinical trials market with the most significant share of 45.7% in 2022. This segment involves the study of drugs or biologics, surgical procedures, and devices. The interventional segment consists of 83.4% of total registered cases in the U.S. by September 2021, where the majority are drug or biologics. The primary factor driving this segment is the innovative studies or methods being developed.

The expanded access trials segment in the North American clinical trials market is projected to grow significantly over the forecast period. It is the prospective approach for patients with severe disease or critical conditions.

North America Clinical Trials Market - By Indications:

  • Autoimmune
  • Blood disorders
  • Cancer
  • Circulatory
  • CNS
  • Congenital
  • CVS
  • Dermatology
  • Ear
  • Gastrointestinal
  • Genitourinary
  • Infections
  • Mental disorders
  • Metabolic
  • Musculoskeletal
  • Nose
  • Ophthalmology  

The cancer segment dominated the market with a market revenue of 26.3% in 2021 and is anticipated to register the fastest growth over the forecast period. The increasing prevalence of cancer and the need for effective treatment procedures drive market growth. The growing investments in R&D by the market players enhance the oncology segment to drive the market value.

The Cardiac segment is also gaining traction due to increasing cases of CVS across the region. This segment is expected to grow significantly in the forecast period. The autoimmune segment is estimated to have decent rapid growth in the upcoming years.

North America Clinical Trials Market - By Country:

  • The U.S.
  • Canada
  • Rest of North America

United States is expected to hold a significant share over the forecast period due to the advanced healthcare system and the increased collaborations and acquisitions in the development of the R&D sector. The growing investments by the market players in developing innovative procedures and drugs are boosting the U.S. clinical trials market value. The increasing number of active phase III clinical trials in the U.S. and Canada are driving the expansion of North American markets. According to the National Clinical Trials Registry, in September 2022, about 3300 active trials under Phase III were in the U.S., whereas around 1478 were being investigated in Canada.

The increasing demand for novel drug compounds in treating various diseases increased the count of clinical trials in the U.S. and Canada. The government initiatives in developing new clinical procedures and drug discoveries propel market growth.


Companies playing a vital role in the North American clinical trials market profiled in this report are Chiltern, Omnicare, PPD, Parexel, Kendle, Quintiles, ICON Plc, and Charles River. In addition, most companies are outsourcing the clinical trials of their newly developed drugs to various contract research organizations as this could save them the hassles of regulatory issues and patient recruitment burden from the research and development phase.

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Frequently Asked Questions

Which country in North America contributes the most to the clinical trials market?

The United States holds the largest share in the North America clinical trials market, driven by its robust healthcare infrastructure and significant research and development activities.

How is the COVID-19 pandemic affecting clinical trials in North America?

The pandemic has led to disruptions in ongoing trials, an increased focus on vaccine development, and a surge in virtual and decentralized trials to adapt to the changing circumstances.

How does the North America clinical trials market differ from other global markets?

The North America clinical trials market is characterized by a strong emphasis on innovation, a well-established regulatory framework, and a high level of investment in research and development compared to other regions.

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