Clinical trial management system market Research Report Information By Type (Enterprise CTMS and On-Site CTMS), Delivery Model (Web-Based [Hosted CTMS], Licensed Enterprise, Cloud-Based CTMS [SaaS]), Component (Software, Service, and Hardware), End-User (Pharmaceutical and Biopharmaceutical Companies, Medical Device Manufacturers, Contract Research Organizations, and others), and Region (North America, Europe, Asia-Pacific, and Rest of the World)—Forecast till 2032

Global Clinical Trial Management System Market Overview

Clinical Trial Management System Market Size was valued at USD 1.88 Billion in 2023. The Global Clinical Trial Management System industry is projected to grow from USD 2.16 Billion in 2024 to USD 6.50 Billion by 2032, exhibiting a compound annual growth rate (CAGR) of 14.77% during the forecast period (2024 - 2032).The rapid advancements of CTMS solutions and the low battery life of mobile computers and reimbursement policies are driving the market growth.

Roche Pharma India has officially launched its clinical trial excellence initiative in India in October 2023. This endeavor seeks to bolster the capabilities of public health institutions in the country with regards to the execution of drug research and clinical trials. Furthermore, this will enable these public institutions to ascend the value chain and position themselves as centers of clinical research excellence on a national scale. The primary aim of Roche for this initiative is to form cooperative alliances with ten governmental establishments in order to promote the excellence of clinical research through the improvement of their existing capabilities to carry out trials in adherence to global standards. To achieve this objective, it is imperative to provide training for the research team, enhance existing processes, and digitize dossier submission and evaluation by the Ethics Committee. Such progress will facilitate the advancement of innovative treatments and high-quality clinical research that prioritizes the well-being of patients.

TB Alliance initiated NC-009, an innovative Pan-Phase 2 clinical trial in November 2023, which incorporated elements from Phase 2a, b, and c. The objective of this study was to evaluate the safety and efficacy of TBAJ-876, an innovative experimental compound, when combined with TB Alliance's BPaL regimen components pretomanid and linezolid. This regimen has the potential to decrease the duration of treatment and improve effectiveness for drug-sensitive and drug-resistant tuberculosis (TB), which is recognized as one of the most fatal infectious diseases worldwide. The results of preclinical and Phase 1 studies, which were disseminated during the Union Conference, suggested that the novel compound may have demonstrated a safer profile and a quicker elimination of tuberculosis bacteria when compared to bedaquiline, an analogous medication within the same drug class.

Clinical Trial Management System Market Trends

• The rapid advancements in CTMS solutions to boost the market growth

Clinical trials are carried out by the life science sector in prodigious numbers, and this number is rising constantly. The vast expansion of this system is due to its quick development. Additionally, the rising prevalence of chronic and rare diseases has been a major factor in the market's rise, pushing sales to record highs. Important market participants can now conduct a number of R&D projects with the active backing of the government in an endeavor to bring novel treatments to market.

Furthermore, the government funding that is available for running clinical studies has also greatly increased the market's size. The enormous amounts of data programs at research programs produce are managed using systems for managing clinical trials. Thus, the rising prevalence of rare and chronic diseases has also emerged as a significant market growth factor that is propelling sales to record levels.

Clinical Trial Management System Market Segment Insights

Clinical Trial Management System Type Insights

The clinical trial management system market segmentation, based on type, includes Enterprise CTMS and on-site CTMS. The enterprise CTMS segment is to hold the majority share in 2021 in the market of clinical trial management system revenue. This is due to the collective efforts of the organization/ universities to effectively deploy it. In addition, the role of CTMS in the campus-wide adoption was to support multi-dimensional investigations, cancer trials, and pharmaceutical research. Leading companies in the pharmaceutical industry use enterprise-wide types like impact CTMS.

February 2019: Datatrak Int (US) launched an industry first Electronic Data Capture (EDC) system to unify medical image capture, display, storage, and adjudication through their Enterprise Cloud platform.

Clinical Trial Management System Delivery Model Insights

The market segmentation of clinical trial management system based on a delivery model that includes, web-based (Hosted CTMS), licensed enterprise, and cloud-based CTMS (SaaS). The web-based segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2024-2032. This is due to the various benefits that it offers with the growing number of research and development programs that are carried out by the clinical trial management system. In addition, A web-based method enables research workers to concentrate more on providing direct patient care and less on office duties. Less time is spent manually inputting data into numerous locations by researchers and study coordinators, which decreases trial-related errors. Therefore, due to the increasing need in the current economy, the cloud-based technology sector has also done rather well.

Clinical Trial Management System Component Insights

The market segmentation of clinical trial management system data has been bifurcated into software, service, and hardware. The software segment dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2024-2032. The growth of the software segment in the global market is mainly due to the increasing demand for complex software systems that can process enormous volumes of data or information already existent in the system and which can be accessed whenever necessary, the software segment has grown to become the largest market by component. Furthermore, Investment in software tools is at an all-time high owing to the manufacturers’ effort to constantly engage in funding rounds with potential investors. The funding helps the market to achieve high product development and better serve the customers. Therefore, the development of user-friendly software solutions could be the key factor driving the growth of this segment in the global market.

Figure 2: CLINICAL TRIAL MANAGEMENT SYSTEM MARKET, BY COMPONENT, 2023 & 2032 (USD BILLION)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Clinical Trial Management System End User Insights

The market segment of clinical trial management system is based on end-user that includes pharmaceutical and biopharmaceutical companies, medical device manufacturers, contract research organizations, and others. The contract research organizations segment has dominated the market in 2021 and is projected to be the faster-growing segment during the forecast period, 2024-2032. This is due to the rising inclination towards the transfer of clinical trial studies to the CROs would have a huge bearing on the use of CTMS by the CROs. In addition, the life sciences sector is actively involved in the outsourcing of significant clinical work to CROs, expanding the CROs' market share, and utilizing CTMS on their end.

October 2022: Veeva Systems Inc.(US)  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.

Clinical Trial Management System Regional Insights

By Region, the study segments the market into North America, Europe, Asia-Pacific, and the Rest of the World. The North America clinical trial management system market is expected to account for USD XX billion in 2021 and is expected to exhibit an XX% CAGR during the study period. This is attributed to the rising number of clinical trials and the presence of regulatory authority to approve timely clinical trials. For instance, in February 2021, Clinical Solutions which is a provider of enterprise software of the cloud-based pattern globally and also provides clinical data services which are software-driven has introduced Elluminate CTMS So that drug development can be supported by life sciences industries. Therefore, favorable regulatory policies and increasing investment by pharmaceutical companies can also be attributed to this regional growth.

Further, the major countries studied are the U.S., Canada, Germany, France, the UK, Italy, Spain, China, Japan, India, Australia, South Korea, and Brazil.

Figure 3: CLINICAL TRIAL MANAGEMENT SYSTEM MARKET SHARE BY REGION 2023 (%)

Source: Secondary Research, Primary Research, MRFR Database, and Analyst Review

Europe clinical trial management system market is expected to account for the second-largest market share due to the considerable spending on research and development/R&D in the pharmaceutical sector and the rapid advancements made by the healthcare sector with the help of the government. Further, the Germany market of clinical trial management system is expected to hold a third place for the market share, and the UK market of clinical trial management system is expected to fastest-growing market, and which is in the 4th place in the European region. Furthermore, France market of clinical trial management system will hold the 5th place for the market share.

The Asia-Pacific clinical trial management system market is expected to grow at a CAGR of XX% from 2024 to 2032. This is due to the due to the presence of developing economies such as India, China, and South Korea as well as the growing potential patient population, the region offers lucrative opportunities for players in the market of clinical trial management system. Moreover, Japan’s market of clinical trial management system is expected to hold the largest market share, and China market of clinical trial management system is expected fastest-growing market in the Asia-Pacific region.

For instance, Japan’s clinical trial environment has been a significant transformation. Businesses engaged in clinical trials have a greater need to be aware of the fast-changing environment in order to benefit from the expansion, making it to be the world leader in the market for the clinical trial management system.

The Rest of the World includes the Middle East, Africa, and Latin America. Nevertheless, due to a lack of awareness and low income, particularly in Africa, the Middle East and Africa held the smallest proportion of the clinical trial management system market.

Clinical Trial Management System Key Market Players & Competitive Insights

The clinical trial management system market is characterized by the presence of many global, regional, and local vendors catering to the demand created by research scientists and pharmaceutical and biotechnology companies operating in the industry. The market comprises tier-1, tier-2, and local players. The tier-1 and tier-2 players have reach across the globe with diverse product portfolios. Companies such as Forte Research Systems Inc. (India), EClinForce, Inc. (US), Oracle (US), and Medidata Solutions(US) dominate the clinical trial management system market due to product differentiation, financial stability, strategic developments, and diversified regional presence. The players are focused on investing in research and development. Furthermore, they adopt strategic growth initiatives, such as expansion, product launches, joint ventures, and partnerships, to strengthen their market position and capture a large customer base.

One of the primary business strategies adopted by manufacturers in the global clinical trial management system industry to benefit clients and expand the clinical trial management system market sector is to manufacture locally to reduce operating costs.

Veeva Systems Inc.(US) provides cloud-based software. The Company offers enterprise applications, multichannel platforms, customer relationships, and content management solutions. It also provides professional and support services in the areas of implementation and deployment planning and project management; requirements analysis, solution design, and configuration; systems environment management and deployment services. For instance, in In May 2022, Veeva Systems (US) launched Vault CTMS with Bristol Myers Squibb(US)  to drive end-to-end trial management. The new CTMS replaced a heritage Celgene CTMS and a heritage Bristol Myers Squibb CTMS and is tightly integrated with Veeva’s eTMF and Study Startup applications. The total implementation time was less than 20 months.

Also, Oracle provides integrated cloud applications and enterprise platform services. The company offers cloud infrastructure, applications, and hardware systems. Additionally, it provides integrated cloud solutions such as Infrastructure as a Service (IaaS) and Software as a Service (SaaS). It also offers updates, new software licenses for on-premises usage, and related support services. The company offers its solutions through independent software and hardware manufacturers, system integrators, and resellers. Oracle operates in the Americas, Europe, the Middle East, and Asia-Pacific.

Key Companies in the Clinical Trial Management System Market include

• Forte Research Systems Inc. (India)


• EClinForce, Inc. (US)


• Oracle (US)


• Medidata Solutions(US)


• IWeb Technologies (Canada)


• Bioclinica (US)


• Parexel International Corporation.(US)


• IBM (US)


• Datatrak Int (US)


• Veeva Systems (US)

Clinical Trial Management System Industry Developments

June 2022: Medidata Solutions(US), a Dassault Systèmes company, announced technological improvements to solve challenges in clinical trial management. It will improve data oversight and reporting for contract research organizations (CROs) and sponsors

March 2020: Medidata Solutions(US) launched a new program to support research organizations conducting any type of immunology-related research, including clinical studies on COVID-19 vaccines, diagnostics, and treatments.

February 2021: eClinical Solutions LLC(India), a provider of cloud-based software, launched the elluminate clinical trial management system that accelerates digitalization and shortens cycle times for clinical data review.

June  2019: Parexel International Corporation. (US) launched an integrated outsourcing delivery model for a functional service provider (FSP) services at the DIA 2019  global annual meeting in San Diego(US).

January  2021: Bioclinica (US) partnered with IKCON PHARMA(India) to Deliver Best-in-Class eClinical Solutions to Pharma Industry/Sponsors. As part of the partnership, IKCON PHARMA will have access to Bioclinica's Interactive Response Technology (IRT) and Electronic Data Capture (EDC) platform to help its clients execute and maintain clinical procedures. 

Clinical Trial Management System Market Segmentation

Clinical Trial Management System Type Outlook

• Enterprise CTMS


• On-Site CTMS

Clinical Trial Management System Delivery Model Outlook

• Web-Based (Hosted CTMS)


• Licensed Enterprise


• Cloud-Based CTMS (SaaS)

Clinical Trial Management System Component Outlook

• Software


• Service


• Hardware

Clinical Trial Management System End User Outlook

• Pharmaceutical And Biopharmaceutical Companies


• Medical Device Manufacturers


• Contract Research Organizations


• Others

Clinical Trial Management System Regional Outlook

• North America
  
  
  
  • US
  
  
  • Canada
  
  
  
  


• Europe
  
  
  
  • Germany
  
  
  • France
  
  
  • UK
  
  
  • Italy
  
  
  • Spain
  
  
  • Rest of Europe
  
  
  
  


• Asia-Pacific
  
  
  
  • China
  
  
  • Japan
  
  
  • India
  
  
  • Australia
  
  
  • South Korea
  
  
  • Rest of Asia-Pacific
  
  
  
  


• Rest of the World
  
  
  
  • Middle East
  
  
  • Africa
  
  
  • Latin America