The global Clinical Trials Management System (CTMS) market size was valued at USD 592.07 million in 2016. It is anticipated to expand at a CAGR of 12.1% over the forecast period. Rapid growth of healthcare IT and increasing R&D expenditure by life science and clinical research organization and increasing adoption of CTMS solutions is anticipated to drive the growth of the market.
Rising government funding and investments by biotechnology and pharmaceutical are promoting medical research activities. This factor is anticipated to boost the market growth over the forecast period. According to the estimates of the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), research-based pharmaceutical industry spent around USD 149.8 billion in 2015. Furthermore, annual spending of the pharmaceutical industry is 5.5 times greater than the aerospace industry, 1.8 times more than computer services and software industry, and 5 times more than the chemical industry.
The CTMS solutions are rapidly undergoing technological advancements. Lack of skilled professionals, especially in developing countries, is pushing pharmaceutical and biotechnological firms to invest in staff training programs to make them familiar with various aspects of sophisticated solutions. Furthermore, costs of these systems are high owing to their ability to integrate a wide range of capabilities. Thus, high cost associated with CTMS is anticipated to hinder the adoption by small- and medium-sized companies.
However, increasing number of clinical trials is anticipated to boost the growth of the market for CTMS. According to the International Clinical Trial Registry Platform, the number of clinical research studies increased from nearly 3,294 in 2004 to approximately 23,384 in 2013. Furthermore, the demand for efficient data management and analysis of clinical trial outcomes is also high. All these factors are projected to contribute to market growth.
Based on type, the market for clinical trials management systems is segmented into enterprise and site. Enterprise CTMS is leading the market due to benefits such as real-time insights into the operational activities such as accruals and deviations, robust reporting, enhanced billing compliance, and tracking and management of regulatory processes. In addition, enterprise CTMS provides stronger support for financial management and helps bring consistency in the budget. Oracle Corporation; Forte Research Systems Inc.; and Bio-Optronics, Inc. are some of the companies that offer enterprise CTMS.
Web-based systems held the largest share in 2016 owing to benefits such as remote access to data and minimal technical issues. Web-based systems are the most preferred CTM systems. They help minimize cost associated with system security, backups, upgrades, and uptime consistency. Furthermore, web-based software allows the centralization of data, which facilitates access to data from any location. Web-based CTMS uses secure enterprise-class data centers to store, update, and back-up on a daily basis; minimizing technical concerns for users. These factors are expected to drive growth during the forecast period.
On the other hand, a cloud-based system is anticipated to exhibit the fastest growth over the forecast period. These systems have successfully outgrown web-based systems owing to constantly evolving applications. This technology comprises three services such as 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 the 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.
In addition, 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.
Based on components, the market is segmented into software and services. The software segment held a substantial market share in 2016 and is expected to expand at a steady CAGR over the forecast period. The software performs critical functions such as comprehensive management of trial planning, country and site progress, monitoring activities, and supplies and finance. Periodic software upgrades are necessary for synchronization with latest analytics. 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.
Based on end-use, the market is segmented into pharmaceutical and biotechnology firms, Contract Research Organization (CROs), and medical device firms. The pharmaceutical and biotechnology firms led the market in 2016.CTMS plays a vital role in drug discovery through FDA approval and in developing a new medicine.
Pharmaceutical and biotechnological firms segment occupy the largest revenue share in the CTMS market. This growth can be attributed to rising use in clinical trials and drug development studies by giant pharmaceutical firms. CTMS results in process-driven approach for pharmaceutical companies, which is focused on delivering flexibility and affordability throughout the course of trial development.
Increasing adoption of CTMS can also be attributed to various advantages such as recording of performance matrix, obtaining financial disclosure and medical license, budgeting, and management of documents. However, the market for CROs would grow at the fastest CAGR during the forecast period.
In 2016, North America dominated the clinical trials management system market with over 54.0% market share. Favorable regulatory policies and increasing investment by the pharmaceutical companies can be attributed to this regional growth.
Asia Pacific is expected to be the fastest-growing regional segment during the forecast period. Increasing development cost and time spent on clinical trials and outsourcing of clinical trials has become a viable option. Asian countries offer a less expensive and less time-consuming process for clinical research studies. This factor is anticipated to boost the regional market over the forecast period.
Latin America is one of the unexplored regions for clinical trials. As per clinical trials.gov, majority of clinical trial studies in Latin America are conducted in Mexico, Brazil, Argentina, and Columbia. Diverse population, qualified investigator community, proven quality, and substantial market for sales are a few factors driving growth in Latin America.
Key market contributors are Forte Research Systems Inc.; Bioclinica; Oracle Corporation; Medidata Solutions Inc.; DATATRAK; Medpace Holdings, Inc.; Clinical Data Inc.; BioClinica; G.Tech Medical Engineering GmbH; bio-Optronics, Inc.; and PARAXEL International Corporation.In March 2017, PARAXEL International Corporation launched a patient sensor solution that securely captures, transmits, stores, and visualizes study subject data in clinical trials. It is powered by Perceptive MyTrials Analytics platform enables end-to-end services and technology solution. It facilitates remote collection of study subject data via medical devices. This is expected to boost the service offerings of the company as well as help it deliver high-quality care to consumers and communities.
In June 2016, Oracle announced that Pfizer has selected Oracle Health Sciences InForm Cloud Service and the Oracle Siebel Clinical Trial Management and Monitoring Cloud Service to manage and monitor its more than 300 clinical trials a year and continue to provide solutions. In November 2017, Bioclinica announced the launch of Bioclinica Clinical Adjudication. This new service enables the independent adjudication of clinical events in conformance with regulatory requirements governing clinical trials within all the therapeutic areas.
Base year for estimation
Actual estimates/Historical data
2014 - 2016
2017 - 2025
Revenue in USD Million and CAGR from 2017 to 2025
North America, Europe, Asia Pacific, Latin America, Middle East and Africa
U.S., Canada, Germany, U.K., France, Italy, Spain, Russia, Belgium, Netherlands, Japan, China, India, Thailand, Australia, Singapore, Malaysia, Indonesia, South Korea, Philippines, Brazil, Mexico, Argentina, UAE, Saudi Arabia, South Africa
Revenue forecast, competitive landscape, growth factors and trends
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This report forecasts revenue growth at global, regional, and country levels, and provides an analysis of the latest industry trends in each of the sub-segments from 2014 to 2025. For the purpose of this study, Grand View Research has segmented the global clinical trials management system (CTMS) market report on the basis of type, delivery mode, component, end user, and region:
Type Outlook (Revenue, USD Million, 2014 - 2025)
Delivery Mode Outlook (Revenue, USD Million, 2014 - 2025)
Component Outlook (Revenue, USD Million, 2014 - 2025)
End-User Outlook (Revenue, USD Million, 2014 - 2025)
Pharmaceutical and Biotechnology Firms
Johnson & Johnson
Bristol Myesr Squibb
Medical Device Firms
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
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