Published Date : 2025-Mar-19
The Global Clinical Trial Management System (CTMS) Market is experiencing robust growth, driven by the increasing complexity of clinical trials, stringent regulatory requirements, and the rising adoption of advanced technologies in clinical research.
The global clinical trial management system market is likely to see healthy growth throughout the forecast period. The key drivers for this market are increasing volume of studies, increasing adoption of CDMS by the pharmaceutical industry, growing outsourcing activity for effective clinical trial management services, and development of advanced technology in emerging economies.
The clinical trial management system market around the globe is anticipated to grow at a CAGR of nearly 13% through the forecast period 2025–2034. Clinical Trial Management Systems enable the company conducting the clinical trials to save on operational costs while still fulfilling all the regulatory requirements. The most significant factor influencing this market is the rising clinical trials worldwide.
Clinical Trials are imperative phases in pharma industry, hence strict regulations have been created to facilitate transparency during the clinical trial management. Clinical Trial Management System is engineered to satisfy all necessary regulatory norms by facilitating systematic documentation processes, randomized allocation of test samples, documentation of all data with corresponding fields thus avoiding inaccuracies and managing tasks in different functions. Over the past few years, the global market has witnessed growth in projects being outsourced owing to several advantages related to Clinical Trial Outsource (CTO) services like reduced financial risk, access to voluminous clinical trial history, and access to high-quality Clinical Trial systems. Clinical Trials are conducted for drugs, biologics, devices, and medical products like therapeutics/biologics/devices or MRD (Medical Readiness Development) in clinical trial management system market.
The health care need has been rising quickly because of the progress made in medicine, thus the patient population is increasing. Clinical trials are performed on such patients suffering from a particular disease or disorder. As per the Clinical Trials Transformation Initiative (CTTI), more than 85% of all drugs that make it to Phase I testing fail in their development stage, either because they prove to be unsafe or ineffective. The effort that goes into carrying out clinical trials thus must be augmented through the incorporation of information technology. To this end, CTMSs are necessary so that the cost of research and development decreases and compliance improves. Since clinical trial management systems can effect such changes, the need for them is arising. Clinical Trial Management Systems permit clinical trial investigators to enter their trial data into a shared database, which can be accessed by sponsors, consultants and third-party sites.
CTMSs protect the integrity of the research data as well as assist companies in following good business practices about keeping records of evidence audits conducted in development processes as well as in recording all actions performed on these tasks. This is critically vital to ensure drug efficacy and safety of drugs taken by patients globally. Clinical trials management systems allow storage, handling, and safeguarding of clinical trial documents through all stages of theirs. They aid in compliance with ethics committee rules through tracking of document authenticity.
Therefore, they form a part of the research process right from the initial to the final stage. CTMSs have been on the radar of companies worldwide as an essential component in conducting clinical trials more effectively overall. Companies which have not already done so will notice this investment become even higher priority in the future. This trend is expected to fuel growth of the clinical trial management system market.
In the past five years, the number of clinical trials has grown 22%, according to figures that have been assembled by Quintiles Transnational Holdings. There are around 11,000 more trials ongoing this year than 2018. The growth is due to an increase in drug approvals and novel applications for products that have already been created, and more attempts at finding cures for rare diseases that previously had none. The recent surge in clinical trials will continue to expand at a very fast rate since more than 50% of drugs under development are for orphan diseases that require small numbers of patients. Rare disease trials, such as those for cancer and Alzheimer's disease, have long been difficult to fund. Greater levels of collaboration between the public and private sectors have resulted in the continued growth of trials for the diseases.
A drive by the regulators in the European clinical trial management system market to adopt newer clinical trial management practices has led to an increase of trials for such conditions. The European Medicines Agency, which regulates medical products for use in the European Union, in February 2019 launched a new clinical practice guideline that is aimed at helping its member states overcome constraints in the way they carry out trials. The EMA also has a running project aimed at eventually making electronic data capture part of each process step within initiatives to lower both research and administrative expenses, as well as allow for more rapid patient enrollment. Despite all these recent innovations in CTMS, nearly 40% of clinical trials remain incomplete or publish their results too late.
The Asia Pacific region provides a promising opportunity for Clinical Trial Management System market with its huge growth prospects and growing use of the systems. As of now, the Asia Pacific clinical trial management system market is controlled by giants such as ICON PLC (UK), Covance Inc. (U.S.), Quintiles Transnational Holdings Inc. (U.S.), and PPD Inc. (U.S.) but players such as Acerta Pharma BV (Netherlands), Green Cross Corp. (South Korea) are starting to realize untapped potential in the region and are refocusing their efforts there.
There are several reasons for the Asia Pacific CTMS market growth specifically evolving healthcare regulations, use of sophisticated technology in clinical trials, rising trend of outsourcing and enhanced expenditure on pharmaceutical research activities in the region. The Asia Pacific clinical trial management market is anticipated to develop at the highest CAGR of 15.6%, between 2021 and 2027. Wherein, India is predicted to grow at the fastest rate. The Asia Pacific CTMS market is influenced by evolving healthcare regulations, rising outsourcing trend and higher expenditure on pharmaceutical research activities in the region.
The North America clinical trial management system market is expected to expand at a CAGR of 12%. The rate of adoption of clinical trial management system has been increasing over the last couple of years owing to stringent FDA regulations for clinical trials and thereby higher number of sponsors looking toward automation tools like clinical trial management system. Also, market penetration of small & medium biotech firms has been adding to the growth in this area because of low cost-to-implement functionalities offered by clinical trial management systems.
Clinical trial management systems assist pharmaceutical firms to manage the process of drug development from research to commercialization through a centralized web-based platform to handle all elements of clinical data collection and regulatory compliance. Clinical Trial Management System software is a business application used to manage clinical trial processes of Pharmaceutical & Biotechnology firms. Clinical Trial Management System software generates reports, statistical analysis tools and assists in tracking patient safety. For instance, clinical trials are very sophisticated in terms of size and design that necessitates a different strategy to make such endeavors successful. The National Institutes of Health (NIH) performs large-scale medical research on human beings through CTMSs with more than 20,000 active protocols in 500 hospitals globally. An example of open-source Clinical Trial Management System (web-based electronic system) would be Veeva. AstraZeneca, Eli Lilly & Company and Pfizer utilize Veeva for Clinical Trial Management, Electronic Lab Notebook (ELN), Sample Management and Contract Research Organizations (CROs).
An example of closed source Clinical Trial Management Software would be Oracle's Hyperion Solutions.
Another category of software utilized to manage clinical trials is on-demand software. One of the companies that offer this is RecEng Ltd. Clinical trial management systems are usually built using object-oriented programming languages such as Java or C++ which enables quicker development of new features without re-writing significant chunks of code because any adjustments do not affect other areas of the system. Because there are so many requirements and regulations, it is not uncommon for the clinical trial management systems to be integrated into laboratory information systems (LIMS) and hospital information systems (HIS).
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