Clinical Trial Management System Market Size, Share and Analysis By Delivery Mode (On-premise and Cloud-based), By Component (Software and Services), By End-User (Pharmaceuticals, Clinical Research Organizations, and Others) and Regional Forecast, 2025-2032

The global clinical trials management system market size was valued at USD 2.43 billion in 2025. The market is projected to grow from USD 2.79 billion in 2026 to USD 8.42 billion by 2034, exhibiting a CAGR of 14.82% during the forecast period.

Clinical trials are research projects conducted on human subjects to assess a therapeutic, surgical, or behavioral intervention. They are the primary method researchers use to determine whether a new treatment, such as a new drug or medical device, is safe and efficient. The biotechnology and pharmaceutical sectors utilize the clinical trial management systems (CTMS), a tool to manage clinical trials. This system maintains and administers the planning, performing, and reporting functions along with participant contact details, tracking deadlines, and milestones.

The growing number of clinical trials, as well as government funding for research studies, are driving the development of the clinical trial management system market. The National Institutes of Health (NIH) invests approximately USD 41.7 billion in medical research for the benefit of the American people each year.

The clinical trial management system is also driven by an increase in chronic diseases and lifestyle-related disorders, and the number of clinical trials is increasing.

• Recently, according to the WHO International Clinical Trials Registry Platform (ICTRP), there were approximately 12,869 clinical trials registered in 2016, which expected to reach 16,256 in 2020.
• During the period 1999-2021, the United States of America (157,618) had the most trials (80,333), followed by China (80,333), and Japan (80,333).

Based on grants, contracts, and other funding mechanisms used across the National Institutes of Health (NIH), as well as disease burden data published by the National Center for Health Statistics (NCHS) at the Centers for Disease Control and Prevention, the table below shows the annual support level for various research, condition, and disease categories (CDC).

• Estimates of Funding for Various Research, Condition, and Disease Categories (USD Million)

Source: National Institutes of Health (2022)

Impact of COVID-19 on the Clinical Trial Management System Market

As a result, over the projection period, COVID-19 is expected to have a positive impact on market growth. In July 2020, IMPAQ launched a COVID-19 clinical trials tracker to increase access to the latest data on potential treatments.

Key Insights

The report will cover the following key insights:

• Research funding for various therapeutic areas
• Government initiatives to promote clinical trial research
• Number of clinical trials by year in the WHO region
• Impact of COVID-19 on the clinical trial management system market

Analysis by End User

Pharmaceuticals account for the largest proportion of the global clinical trial management system market.

• The pharmaceutical sector spent USD 83 billion on research & development in 2019, according to the Congressional Budget Office.
• Over the last decade, the number of new pharmaceuticals approved each year has increased as well. From 2010 through 2019, the Food and Drug Administration (FDA) approved an average of 38 new medications per year (with a high of 59 in 2018), which is 60% more than the previous decade's average.

Regional Analysis

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North America accounts for the largest share of the global clinical trial management system market due to the growing number of clinical trials and government funding for research studies. According to the WHO International Clinical Trials Registry Platform, around 10,870 clinical trials were registered in the United States in 2021, accounting for about 18.13 percent of all clinical trials registered worldwide.

Number of Trials by WHO Region (2021)

• Western Pacific – 16,860
• Europe – 14,879
• Americas – 12,969
• South-East Asia – 9,374
• Africa – 851

Key Players Covered

The report will include the profiles of key players such as Oracle Corporation, Medidata Solutions, Parexel International, Bioclinica, IBM, Bio-Optronics, Datatrak, Veeva Systems, DSG, MasterControl, and among others.

Segmentation

Key Industry Developments

• ERT launched Data Insights to its Trial Oversight Solution in December 2020, allowing users to discover and manage endpoint data while collecting data.
• eClinical Solutions launched the Elluminate Clinical Trial Management System (CTMS) for Faster Drug Development in February 2021.
• Bristol Myers Squibb is using Veeva Vault CTMS globally in April 2022 to drive end-to-end trial management.