[Research Report] The Clinical Trial Management System Market size is expected to grow from US$ 1410.98 million in 2022 to US$ 2061.86 million by 2030; the market is estimated to register a CAGR of 12.56% from 2022 to 2030.

Analyst’s Viewpoint

The Clinical Trial Management System Market analysis entails market drivers, such as the rising number of novel chronic diseases and drug development activities, which have resulted in an increasing number of clinical trials. The increasing number of clinical trials, in turn, propels the demand for clinical trial management systems. However, the budget constraint is expected to hinder the growth of the market during the forecast period. Based on type, the market is segmented into enterprise and on-site; the software segment accounted for the largest market share in 2022. Further, the integration of CTMS with existing software is creating opportunities in the Clinical Trial Management System Market during 2023–2030. Based on type, the Clinical Trial Management System Market is segmented into Enterprise and On-Site. The Enterprise segment accounted for the largest market share in 2022 and is anticipated to grow with the highest CAGR.

Clinical trials are experiments conducted to ensure the safety and effectiveness of new treatments. Pharmaceutical, biotechnical, or medical device companies sponsor these trials to seek approval from the FDA or an international regulatory authority for their medication or device. Clinical Trial Management System (CTMS) is designed to track intuitively and logically structure information, enabling life science teams to monitor and report on clinical trial progress, make better-informed decisions, and provide the best quality data while ensuring patient safety.

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Clinical Trial Management System Market: Strategic Insights

Clinical Trial Management System Market

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  CAGR (2023 - 2031)

  12.56%
• Market Size 2023
  US$ 1.59 Billion
• Market Size 2031
  US$ 4.09 Billion

Market Dynamics

GROWTH DRIVERS

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FUTURE TRENDS

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OPPORTUNITIES

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Key Players

• Oracle
• Medidata Solutions Inc.
• PAREXEL International Corporation.
• MedNet Solutions, Inc.
• Bioclinica
• BioOptronics, Inc.
• DATATRAK Int.
• ERT Clinical
• FORTE

Regional Overview

• North America
• Europe
• Asia-Pacific
• South and Central America
• Middle East and Africa

Market Segmentation

Type

• Enterprise and On-Site

Delivery

• Web-Hosted
• Cloud-Based
• On-Premise End-user

Geography

• North America
• Europe
• Asia-Pacific
• Middle East & Africa
• South & Central America

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Market Insights

Increasing Number of Clinical Trials Propel Market Growth

Clinical trials are an important component of evidence-based medicine because they assist in determining how new medical treatments, diagnostics, or vaccines will perform. They frequently involve large groups of people to ensure that the new intervention is safe and effective. The trials are mainly carried out during drug development. According to the data provided by the National Library of Medicine (NLM), ~52,000 new studies were registered with NLM (ClinicalTrials.gov) in 2020, which increased to ~58,000 in 2023. In January 2023, the NLM reported 38,837 active clinical trials in the US and 105,172 active trials worldwide. According to the European Medicine Agency, in the European Union (EU), ~4,000 clinical trials are authorized annually, of which about 60% of clinical trials are associated with the pharmaceutical industry. An increasing number of clinical trials for developing different effective treatments due to the rising prevalence of chronic diseases globally is fueling the growth of the clinical trials market. With bigger sample sizes, diversified patient demographics, and multiple study sites, clinical trials are becoming more complex. CTMS systems help to streamline trial operations, improve data management, and improve stakeholder cooperation. In addition, clinical studies create massive volumes of data that must be carefully collected, processed, and analyzed. CTMS platforms include data integration, real-time reporting, and data visualization features, allowing researchers and sponsors to make educated decisions and increase trial efficiency. Moreover, compliance with regulatory requirements is critical in the pharmaceutical sector, which is highly regulated. CTMS systems enhance compliance activities by providing tools for managing regulatory documentation, guaranteeing protocol adherence, and maintaining data integrity.

Furthermore, the launch of advanced innovations by market players is boosting the growth of the market during 2022-2030. For instance, in 2023, Oracle Corporation, a prominent technology company, introduced its newest CTMS solution, called Oracle Health Sciences Clinical One CTMS. This new solution boasts advanced features such as real-time data analytics, centralized data management, and improved compliance capabilities that aim to simplify clinical trial processes and enhance overall efficiency.

Opportunities

Integration of CTMS with Existing Systems is Creating Opportunities for CTMS Market

CTMS systems that seamlessly integrate with EHR systems can better manage patient data throughout clinical trials. Integrating electronic medical record (EMR) software with clinical trial software is seen as the logical next step in data processing, following the introduction of electronic data capture (EDC) technology that replaced paper. This integration would enable more accurate and efficient clinical trial data collection, particularly in multi-site trials. According to an article published by BMC in April 2023, a study was carried out to develop an integrated clinical trial management system to optimize the management process of clinical trials through system development methods, standardization protocols, efficient integration with external business systems, and data security and privacy protection. Efficient data integration was achieved through the use of extract-transform-load, message queue, and remote procedure call services, which connected the CTMS with external systems such as the Hospital Information System (HIS), Laboratory Information System (LIS), Electronic Medical Record (EMR), and Clinical Data Repository (CDR).

In October 2022, RealTime Software Solutions, LLC collaborated with Aspen Insights to incorporate world-class EMR/EHR patient identification technologies into RealTime's world-class Clinical Trial Management System (CTMS). The company's integration allowed clinical research sites to mine structured and unstructured EMR/EHR data for study feasibility analysis, practice population eligibility analysis, physician evaluation, and direct delivery of pre-qualified participants into RealTime-CTMS.

Report Segmentation and Scope

Type-Based Insights

Based on type, the clinical trial management system market is segmented into enterprise CTMS and on-site CTMS. The enterprise segment held the largest market share in 2022; it is anticipated to register the highest CAGR during 2022–2030. The enterprise CTMS is a complete clinical research management system for mid-to large-sized organizations with demanding requirements. The segment is growing due to technological advancements in the healthcare sector and growing product launches by the leading market players in the CTMS market.

In October 2022, Veeva Vault CTMS, launched by Veeva Systems, was chosen by 40 Contract Research Organizations (CROs), including four of the top six global CROs, to ensure faster and more efficient clinical trials. Vault CTMS is an enterprise trial management system that has been selected by more than 120 sponsors, including 9 of the top 20 pharmaceutical companies.

Delivery-Based Insights

Based on delivery, the clinical trial management system market is segmented into web-hosted, cloud-based, and on-premise. The web-hosted segment held the largest market share in 2022 owing to its benefits, including improved clinical trial quality and efficiency, better time management, and ease of access. The cloud-based segment is anticipated to register the highest CAGR during 2022–2030 owing to the various product launches by leading market players. In December 2021, SureClinical, a leading provider of cloud-native eClinical applications, announced the launch of their new Clinical Ecosystem (ECO) Applications and Platform Bundle. The ECO Bundle is specifically designed to cater to the unique needs of Clinical Research Organizations. It connects people, programs, projects, and processes across the board for a seamless view of clinical data. The ECO Bundle centralizes clinical intelligence and reporting across multiple applications, data points, and systems, thus enabling distributed clinical research teams to collaborate within a single, modern, and easy-to-use application experience.

End User-Based Insights

In terms of end-users, the clinical trial management system market is classified into pharmaceutical and biotechnology companies, medical device companies, CROs, and others. The pharmaceutical and biotechnological companies segment held the largest share of the market in 2022, and the CROs segment is anticipated to register the highest CAGR during 2022–2030 owing to the shift of clinical trial studies to the CROs as the life science sector is actively involved in outsourcing the drug development and clinical trial studies to CROs. CROs assist in successfully implementing clinical trials through the services offered using high-quality facilities and deep subject matter expertise. CROs have begun acting as a backbone of the clinical trial industry through their efficient and cost-effective operations benefitting trial sponsors. According to the blog published on Thermo Fisher Scientific, in 2022, ~3 out of 4 clinical trials were carried out by CROs to reassure the clinical programs of drug developers, provide a wealth of expertise, drive time and cost efficiencies, and deliver customized, high-quality data. Thus, the development of cost-effective solutions and decreasing errors in CROs during the drug development process are driving the clinical trials market growth.

Regional Analysis

The North American clinical trial management system market is segmented into the US, Canada, and Mexico. The market growth is attributed to the increasing number of clinical trials due to ongoing drug development studies. The US has emerged as a leading clinical research destination. Nearly half of the total clinical trials are conducted in the US. Additionally, most pharma research companies prefer to perform clinical trials in the US owing to established medical infrastructure, fast approval timelines, a favorable regulatory framework, and accepted clinical trial-generated data globally. A World Health Organization (WHO) report states that the US registered the highest number of clinical trials (157,618) in 2021. Further, the Asia-Pacific region is expected to grow with the highest CAGR during 2022-2030. 

The report profiles leading players operating in the global clinical trial management system market. These include Advarra Inc., Clario, Deloitte Touche Tohmatsu Limited, IBM Corporation, Medideta Solution Inc., Mednet Solution Inc., Oracle Corporation, PAREXEL International Corporation, Thermo Fisher Scientific, Inc., and Veeva System Inc. These players focus on expanding and diversifying their market presence and acquiring a novel customer base, tapping prevailing business opportunities in the clinical trial management system market.

A few of the examples of recent developments in the clinical trial management system market are mentioned below:

• In September 2023, Zelta partnered with BSI Life Sciences, which is an important move towards creating a seamless experience for CROs and sponsors in accessing and integrating their data throughout the clinical trial process. The CTMS and eTMF capabilities offer comprehensive functionalities for every aspect of a clinical trial, from study setup to closeout. These capabilities include management and monitoring of sites and investigators, fully integrated trial master files (eTMF), and trial supply management, making them accessible and suitable for clinical trials worldwide.
• In April 2022, Bristol Myers Squibb implemented Veeva Vault CTMS globally, replacing a heritage Celgene CTMS and a heritage Bristol Myers Squibb CTMS. Veeva Vault CTMS is now tightly integrated with Veeva’s eTMF and Study Startup applications. By implementing Veeva’s industry-leading trial management and monitoring solution companywide, Bristol Myers Squibb aims to simplify trial processes, making clinical trials faster and more efficient. This unified and agile solution is expected to drive end-to-end trial management.
• In February 2021, eClinical Solutions LLC, a global provider of cloud-based enterprise software and software-driven clinical data services, launched the Elluminate Clinical Trial Management System (CTMS). The Elluminate platform accelerates digitization and reduces clinical data review cycle times. The introduction of Elluminate CTMS facilitated faster and more informed decision-making.

Clinical Trial Management System Market Report Scope

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