The global clinical trials management system market size was valued at USD 592.07 million in 2016 and is anticipated to register a CAGR of 12.1% over the forecast period. Rapid growth of healthcare IT, extensive R&D by life science and clinical research firms, and increasing adoption of clinical trials management system (CTMS) solutions are the major growth-driving factors.
Moreover, increased funding by government bodies along with pharmaceutical and biotechnology companies is also likely to fuel the market development. According to the estimates of International Federation of Pharmaceutical Manufacturers & Associations, research-based pharmaceutical industry spent around USD 149.8 billion in 2015.
The annual spending of the pharmaceutical industry is 5.5 times greater than the aerospace industry, 1.8 times more than software and computer services industry, and 5 times more than chemical industry. This is also contributing toward the growth of the global market.
Based on type, the market is segmented into enterprise and site. Enterprise CTMS is the dominant segment. Enterprise CTMS offers real-time insights into the operational activities like accruals and deviations, provides robust reporting options, enhances billing compliance, and helps track and manage various regulatory processes.
In addition, it provides stronger support for the financial management and helps bring consistency in the budget, which is also boosting the segment growth. Oracle Corporation; Forte Research Systems, Inc.; and Bio-Optronics, Inc. are some of the companies that offer enterprise CTMS solutions.
Based on delivery mode, the clinical trials management system market is segmented into web-based, cloud-based and on-premise. Web-based systems accounted for the largest share in 2016 owing to their benefits such as remote access of data and minimal technical issues. Web-based systems are the most preferred systems in CTMS.
These systems help minimize the costs associated with system security, backups, upgrades, and uptime consistency. Furthermore, web-based software allows centralization of data, which facilitates remote data access. These factors are expected to drive segment growth during the forecast period. On the other hand, cloud-based system is anticipated to exhibit the fastest growth over the forecast period.
Application of cloud-based systems is continuously increasing. These systems have successfully outgrown web-based systems. Cloud-based technology helps store a large amount of data and maximizes the available storage space, as well as facilitates retrieval of data as required. This technology comprises three services namely, Platform as a Service (PaaS), Infrastructure as a Service (IaaS), and Software as a Service (SaaS).
Cloud-based technology for CTMS offers advantages such as greater study control, wherein the clinical trial managers can manage every trial location and requirements in real-time. Several other advantages are data access from different device and cost reduction, as they automatically update software and patch management systems. In addition, these software eliminate the expenses of hardware acquisition, installation, provisioning, maintenance, support, and software licensing.
Based on components, the market is segmented into software and services. The software segment held a substantial share of the market in 2016 and is expected to expand at a steady CAGR over the forecast period. The software in CTMS can perform critical functions such as comprehensive management of trial planning, country and site progress, monitoring activities, and supplies and finance.
Periodic updates of such software are necessary for synchronization with the latest analytics. In addition, an effective CTMS software solution can help pharmaceutical and medical device companies comply with regulatory norms, which later helps accelerate the market entry. Software segment leads the market as it helps streamline and fine-tune the document management processes, which can otherwise compromise data quality and participant safety.
Based on end use, the market is segmented into pharmaceutical and biotechnology firms, Contract Research Organizations (CROs), and medical device firms. The pharmaceutical and biotechnology firms segment led the market in 2016 and is estimated to witness a steady growth in the coming years. The CTMS solutions play one of the most important roles in developing a new medicine, from drug discovery to FDA approvals.
Iincreasing use of CTMS in clinical trials and drug development studies by major pharmaceutical firms is likely to be the key growth-driving factor. CTMS results in process-driven approach for pharma companies, which is focused on delivering flexibility and affordability throughout the course of trial development.
Various advantages of CTMS such as recording of performance matrix, obtaining financial disclosure, obtaining medical license, budgeting, and management of documents would also drive the segment. However, the market for CROs would register the fastest CAGR during the forecast period.
North America led the global market in 2016 and accounted for around 54.8% of the overall market. This growth was attributed to the availability of favorable regulatory policies and higher investments by the pharma companies. Asia Pacific is expected to be the fastest-growing region during the forecast period Due to increasing costs and time spent on clinical trials and outsourcing of clinical trials in the region. Asian countries offer a less expensive and less time-consuming process for clinical trials, thereby boosting the CTMS market in the region.
Latin America region is also likely to have a significant expansion over the years to come. As per ClinicalTrials.gov, there are more than 16,000 studies in Latin America and the majority of them are conducted in Mexico, Brazil, Argentina, and Columbia. Latin America is one of the unexplored regions for clinical trials. Diverse population, qualified investigator community, proven quality, and substantial market for sales are the key factors driving regional growth.
Key market players include Forte Research Systems, Inc.; Oracle Corporation; Medidata Solutions, Inc.; DataTrak International, Inc.; Medpace Holdings, Inc.; Clinical Data, Inc.; BioClinica; G.Tec Medical Engineering GmbH; Bio-Optronics, Inc.; and PARAXEL International Corporation. In March 2017, PARAXEL International Corp. launched patient sensor solution that securely captures, transmits, stores, and visualizes study subject data in clinical trials.
In June 2016, Oracle announced that Pfizer has selected Oracle Health Sciences In Form Cloud Service and the Oracle Siebel Clinical Trial Management and Monitoring Cloud Service. 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 on 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 market report on the basis of type, delivery mode, component, end use, 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 Use Outlook (Revenue, USD Million, 2014 - 2025)
Pharmaceutical and Biotechnology Firm
Medical Device Firm
Regional Outlook (Revenue, USD Million, 2014 - 2025)
Middle East & Africa
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