Clinical Trials Management System Market Size, Share & Trends Analysis Report By Solution Type, By Delivery Mode (Web & Cloud-based, On-premise), By Component (Software, Services), By End-user, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global clinical trials management system market size was valued at USD 1.66 billion in 2022 and is estimated to expand at a compound annual growth rate (CAGR) of 14.3% from 2023 to 2030. The rapid growth of healthcare IT, preference for decentralized clinical trials, initiatives by key companies, and an increasing number of clinical studies are anticipated to drive the growth of the market. According to the WHO, about 65,409 clinical trials were conducted in 2020 across the globe. This number was notably greater than the 60,543 trials conducted in 2019. This is estimated to boost demand for CTMS solutions.

The COVID-19 pandemic significantly impacted the Clinical Trials Management System (CTMS) market. This included disruption in clinical trials, hurdles in patient recruitment, and canceled or delayed studies. However, the negative impact was gradually reduced by several strategic measures taken by governments, regulatory bodies, and market stakeholders to ensure the continuity of R&D. The need to develop vaccines for the coronavirus also boosted the adoption of decentralized clinical trials. The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) released guidelines to urgently advance COVID-19 vaccine equity. The IFPMA reported that 5 of its members had received approval for COVID-19 vaccines while 14 more were under clinical development. Also, as per COVID-NMA (an initiative by WHO), over 750 studies were registered for COVID-19 vaccine development as of February 2022. This is expected to increase the adoption of CTM systems.

As per a study published in the U.S. National Library of Medicine in 2020, the pandemic resulted in delayed subject enrollment and operational gaps in most ongoing clinical trials. This in turn negatively impacted trial programs and data integrity. Globally, most sites conducting clinical trials other than COVID-19 were found to experience delays in timelines. In some cases, clinical trials were found to reach a complete halt of operations, thus impacting clinical research outcomes. In March 2020, the U.S. FDA published a guidance document on the Conduct of Clinical Trials of Medical Products during the pandemic. Similar guidelines supported the recovery of the clinical trial operations, and the number is anticipated to increase over time.

Rising government funding and investments by biotechnology and pharmaceutical firms are promoting medical research activities. This factor combined with technological advancements is anticipated to boost the market growth over the forecast period. For instance, cloud-based CTMS eliminates the expenses of hardware acquisition, installation, provisioning, maintenance, support, and software licensing. These systems automatically update software and patch management systems, which reduces the burden of in-house IT staff and saves costs. Furthermore, the cloud-based software enables access to the server through mobile with maximum data security.

The increasing number of decentralized clinical trials is anticipated to boost market growth in the coming years. These are also referred to as virtual, digital, mobile, siteless, and remote trials that often utilize telemedicine solutions. Labcorp's decentralized clinical trials (DCTs) solution for instance offers a suite of solutions to design and implement decentralized clinical trials, including the necessary infrastructure, technology, and services. Increasing product availability from key companies is also estimated to fuel market growth. Rave CTMS by Medidata, for instance, offers an intelligent automation and workflow management solution to efficiently manage and oversee clinical trials.

Delivery Mode Insights

Web & cloud-based systems held the largest share in 2022 owing to benefits such as remote access to data and minimal technical issues. These are the most preferred CTM systems. They help minimize costs associated with system security, backups, upgrades, and uptime consistency. Furthermore, web & cloud-based systems support the storage of large amounts of data as well as the centralization of data, which facilitates access to data from any location. These factors are expected to drive growth during the forecast period.

The segment is also anticipated to exhibit the fastest growth over the forecast period. This is owing to the increased adoption of AI, analytics, and machine learning algorithms. The advanced automation thus contributes to the increased utility of web & cloud-based solutions. The technology comprises three services - Platform as a Service (PaaS), Infrastructure as a Service (IaaS), and Software as a Service (SaaS). Cloud-based technology offers greater study control to CTMS, wherein clinical trial managers can manage location and other research study requirements in real-time. Another advantage is access to data from any device such as mobile, workstations, laptops, and tablets through software.

Component Insights

The highest share of the global Clinical Trials Management System (CTMS) market, in terms of components, was held by the software segment in 2022. The services segment on the other hand is expected to grow at the fastest rate of over 14% in the coming years. The software helps perform critical functions such as comprehensive management of trial planning, country and site progress, monitoring activities, regulatory procedures, supplies, and finance. These are deployed mostly on a subscription basis at enterprise or site levels. Periodic software upgrades and add-ons may also add to the revenue.

In addition, an effective CTMS software solution can help pharmaceutical and medical device companies comply with regulatory norms, which helps accelerate market entry. Hence, the software segment dominates the market as it helps to streamline and fine-tune the document management processes, which can otherwise compromise the data quality and participant safety. Clinion, for example, provides comprehensive software for clinical trial setup and management. The software comes with a host of integrated offerings including CTMS, IWRS/RTSM, EDC, and eCOA to meet the needs of small- and medium-sized companies.

Solution Type Insights

Enterprise accounted for the largest share of the Clinical Trials Management System (CTMS) market by solution type in 2022 and is also expected to expand at the fastest CAGR of about 14% over the forecast period. The key factors contributing to this share include associated benefits such as end-to-end insights into operational activities, such as accruals and deviations, scalability of the solution, robust reporting, enhanced billing compliance, and tracking and management of regulatory processes.

RealTime’s Enterprise CTMS, for example, offers a comprehensive solution for centralizing recruitment, eRegulatory, eSOURCE, accounting, and aggregate reporting across large site networks, universities, and hospitals. The network-wide visibility and oversight provided by enterprise-level solutions present an ideal solution for large biopharmaceutical companies and CROs.

End-user Insights

By end-user, the CROs & others segment held the largest share of over 35% of the Clinical Trials Management System (CTMS) market in 2022. It is also projected to grow at the fastest rate of about 15% in the coming years. The trends of globalization, digitalization, and personalized medicine have led to increased outsourcing & externalization of clinical trials by healthcare and life sciences companies to CROs. This is because it may not be feasible for sponsors to fulfill all operational requirements, especially with many trials being multinational. Partnerships with multinational companies or local CROs simplify this task.

Clario, for instance, offers solutions for all trial models: site-based, decentralized, and hybrid clinical trials. It generates rich, diverse, and reliable evidence via its 30 facilities spread across 9 countries in North America, Europe, and Asia Pacific. In October 2022, Veeva Systems partnered with about 40 CROs to deploy its suite of clinical trial management tools, including the Veeva Vault CTMS. Moreover, the company reported rapid growth during the COVID-19 pandemic, as virtual or hybrid clinical trials became necessary.

Regional Insights

North America held about 50% of the revenue share of the Clinical Trials Management System (CTMS) market in 2022. The large share of the North American region can be attributed to the presence of key companies and the rising adoption of technology in R&D. Favorable regulatory policies and increasing investment by pharmaceutical companies can also be attributed to this regional growth. In November 2021, a clinical endpoint technology leader, ERT, merged with Bioclinica to form Clario. This enabled the company to deliver technology-based therapeutic area solutions to meet clinical trial objectives.

Asia Pacific is estimated to attain the fastest CAGR of about 18% in the next few years. This is owing to increasing R&D activities in the region, the availability of a large patient pool, an increasing number of clinical trials conducted across the region, and outsourcing of clinical trials. Asian countries offer a less expensive process for clinical research studies. This factor is anticipated to boost the regional market over the forecast period. Latin America is another emerging market for clinical trials. As per clinicaltrials.gov, an increasing number of clinical trials are being conducted in Latin American countries including Mexico, Brazil, and Argentina.

Key Companies & Market Share Insights

The Clinical Trials Management System (CTMS) market is competitive in nature. Major companies deploy strategic initiatives, such as solution upgrades and launches, expansion of services, partnerships, collaborations, mergers & acquisitions, and customer acquisition, among others. For instance, in February 2021, eClinical Solutions LLC launched elluminate CTMS for life sciences companies to support drug development. In June 2016, Oracle announced that Pfizer had selected Oracle Health Sciences InForm Cloud Service and the Oracle Siebel Clinical Trial Management and Monitoring Cloud Service to manage and monitor its 300+ annual clinical trials. In March 2021, Peachtree BioResearch Solutions, Inc., a CRO serving emerging mid-sized companies, adopted Oracle Health Sciences Cloud Services and the Siebel Clinical Trial Management System (CTMS) to streamline clinical trials start-up and monitoring. Some of the prominent players in the global clinical trials management system market include:  

• IQVIA Inc.

• Medidata (Dassault Systèmes)

• Oracle

• DATATRAK International, Inc.

• Clario

• SimpleTrials

• Calyx

• RealTime Software Solutions, LLC

• Laboratory Corporation of America Holdings

• Veeva Systems

• Wipro Limited

• PHARMASEAL International Ltd.

Clinical Trials Management System Market Report Scope

Global Clinical Trials Management System Market Segmentation

This report forecasts revenue growth at the global, regional & country levels and provides an analysis of the latest industry trends and opportunities in each of the sub-segments from 2017 to 2030. For this report, Grand View Research has segmented the global Clinical Trials Management System (CTMS) market report based on solution type, delivery mode, component, end-user, and region:

• Solution Type Outlook (Revenue, USD Million, 2017 - 2030)

  • Enterprise

  • Site

• Delivery Mode Outlook (Revenue, USD Million, 2017 - 2030)

  • Web & Cloud-based

  • On-premise

• Component Outlook (Revenue, USD Million, 2017 - 2030)

  • Software

  • Services

• End-user Outlook (Revenue, USD Million, 2017 - 2030)

  • Pharmaceutical and Biotechnology Firms

  • Medical Device Firms

  • CROs & Others

• Regional Outlook (Revenue, USD Million, 2017 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • Germany

    • U.K.

    • France

    • Italy

    • Spain

    • Netherlands

    • Belgium

    • Russia

    • Rest of Europe

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

    • Thailand

    • Singapore

    • Malaysia

    • Indonesia

    • Philippines

    • Rest of APAC

  • Latin America

    • Brazil

    • Mexico

    • Argentina

    • Rest of Latin America

  • MEA

    • South Africa

    • Saudi Arabia

    • UAE

    • Rest of Middle East & Africa