Global Clinical Trials Software Market - Focused Insights 2024-2029

MARKET INSIGHTS

The global clinical trials software market, valued at USD 1.25 billion in 2023, is projected to reach USD 3.12 billion by 2029, growing at a CAGR of 16.40% during the forecast period. This growth is driven by advances in clinical trial sites, including the increasing adoption of digital tools and technologies to boost trial efficiency and improve success rates. As clinical trial sites strive to meet evolving standards and regulatory requirements, clinical trial software plays a crucial role by ensuring accurate data collection, analysis, and interpretation. In addition, new regulatory norms also encourage the integration of digital solutions such as clinical trial software, further fueling market expansion.

MARKET DEFINITION

Clinical trial software, commonly referred to as Clinical Trial Management Systems (CTMS), is a digital platform designed to streamline and optimize clinical trial processes. They oversee all operational aspects of clinical studies, from initiation to completion, thus minimizing human errors and improving workflow efficiency. Clinical research sites use this software to centralize and manage critical data related to procedures, patient enrollment, workforce management, financials, and compliance tracking. Increasing digitalization of the healthcare sector, from patient management in hospitals to drug development in biopharma, medical devices, and contract research organizations (CROs), significantly boosting the demand for clinical trial software. Furthermore, the rising number of clinical trials conducted by biopharma and medical device manufacturers, along with the adoption of advanced and technology-driven trial approaches, is accelerating the widespread use of clinical trial software in routine clinical research.

MARKET TRENDS & GROWTH DRIVERS

Increased Focus on Data Privacy and Security

As the advances in clinical trials deliver better opportunities, the use of digital tools and software has been imminent. However, the growing focus on data privacy and security is forging a new wave of evolution that clinical trial software must embrace with enhanced security features. Components such as better encryption, adherence to data security regulations, and application of blockchain for secure and immutable records have grown increasingly popular.

Rapid Advances in Clinical Trials

Innovation is changing the environment of clinical trials, creating a wealth of opportunity for growth. New technologies are accelerating the advent of personalized medicines, remote Patient Monitoring, and hybrid/decentralized trial models. AI and ML are optimizing drug discovery and development, enhancing trial efficiencies, automating tasks, and improving data accuracy. The trend towards hybrid and decentralized clinical trials, strengthened by sophisticated digital tools, is also influencing the clinical trial software demands.

Cost Reduction with Clinical Trial Software

Implementing clinical trial software can lead to significant cost savings in trials, with some studies showing a reduction in overall expenses by as much as 30%. Decentralized clinical trial models enhance research efficiency by decreasing the dependence on physical locations and in-person visits, thus reducing overhead costs and improving processes for patient monitoring and enrollment. Traditional paper documentation is increasingly being replaced by digital alternatives like Electronic Data Capture (EDC), electronic Patient-Reported Outcomes (ePRO), and electronic Clinical Outcome Assessments (eCOA), which minimizes errors and enhances efficiency. eConsent solutions are also on the rise, streamlining the patient consent process and boosting participation rates.

MARKET CHALLENGES

Slower Adoption and Implementation of Clinical Trail Software

Even with increasing awareness, the uptake of clinical trial software is not meeting expectations. Obstacles include insufficient digital infrastructure, significant upfront costs, and uncertainties regarding return on investment. Numerous clinical trial sites function with limited budgets and workforce challenges, which hinders the adoption of new technologies. The implementation of clinical trial software necessitates thoughtful evaluation of elements like functionality, adherence to regulations, compatibility with existing systems, and ongoing maintenance expenses.

GLOBAL CLINICAL TRIALS SOFTWARE MARKET INSIGHTS

• By Development: The global clinical trials software market is divided into on-enterprise and on-site deployment models. In 2023, the on-enterprise segment dominated the market. This model provides numerous benefits when compared with on-site delivery, such as total control over trial-related processes including data storage, system configuration, real-time modifications, security, and remote oversight by trial sponsors or owners. This deployment approach boosts trial efficiency and increases the chances of achieving successful results.
• Functioning as a centralized hub, on-enterprise clinical trial software facilitates the management of all trial activities, ensuring that each stage is carried out effectively, efficiently, and adheres to regulatory standards. It improves visibility and transparency throughout all trial processes through a well-organized and standardized clinical trial management system, which fuels the growth of the segment.
• By Delivery: The market is divided into web-based, Software-as-a-Service (SaaS), and on-premises options. The SaaS segment is projected to experience the fastest-growing CAGR of 17.14% during the forecast period. At present, clinical trials show immense reliability on SaaS providers to optimize efficiencies. This is because SaaS-based platforms consolidate data, optimize trial operations, and improve collaboration. They also alleviate the workload on clinical trial personnel, enhance data precision, and provide cost-saving advantages. The rising trend of digital transformation in clinical trials is fueling the swift uptake of SaaS-based solutions globally.
• By Features: The Electronic Data Capture (EDC) segment maintains the largest share of the global clinical trials software market. EDC serves as a tool for documenting and compiling clinical trial data. It is the most used e-clinical instrument in clinical studies. Compared with traditional paper-based methods, an EDC system offers numerous benefits for data collection. These systems facilitate data gathering, and sites participating in clinical trials can conveniently access these systems from any computer. This platform guarantees the authenticity, security, and integrity of the data while enabling easy data retrieval. It also speeds up the data-cleaning process. An EDC system gathers a variety of data types from clinical trials across numerous therapeutic areas. Presently, over 50% of hybrid trials and nearly all fully decentralized trials incorporate EDC as a key element. EDC can be implemented as either an on-premise solution or a web-based system. In clinical trial software, EDC provides enhanced information collection and management capabilities within a unified platform, offering greater control over clinical trial data, collaboration, and security for clinical trial operators, contributing to the growth of this segment.
• By End-User: Based on end-users, the CROs segment leads the global market share for clinical trial software and exhibits the highest growth. CROs are becoming increasingly essential in clinical trials, covering everything from patient recruitment to the execution of trials, to ensure safety and adherence to regulations. The processes involved in clinical trials and obtaining approvals from regulatory agencies are highly intricate. They necessitate substantial financial investments, a skilled and knowledgeable workforce, and ongoing communication between patients and clinical trial sites. Numerous biopharmaceutical and medical device firms lack the necessary infrastructure and personnel to carry out these tasks. Advanced clinical trial software offered by CROs streamlines these operations and enhances the transparency of trial activities. The rise in the number of CROs has resulted in a surge in the outsourcing of clinical trials, particularly in developing nations. This trend is anticipated to escalate the demand for clinical trial software within CRO operations in these regions.

REGIONAL INSIGHTS

North America accounted for the largest share of the global clinical trials software market, with a share of over 33%. The region leads the market due to its integration of advanced technologies and digital tools in clinical research. In North America, the US shows a high rate of adopting decentralized clinical trials, supported by a robust infrastructure and broad acceptance of advanced trial models. This existing foundation and openness to innovative technologies have established North America as a frontrunner in the global clinical trials software market. Supportive regulations, governmental aid, and increasing investment are significant contributors to the growth of clinical research in the US. Furthermore, the US and Canada rank as the top two countries in North America, conducting numerous decentralized clinical trials that drive market expansion. 

COMPETITIVE LANDSCAPE 

The global clinical trials software market features exclusive insights from 36 vendors. Notable companies include Dassault Systèmes, BSI Business System Integration AG, Clario, IQVIA, Laboratory Corporation of America Holdings, and Oracle Corporation. These firms consistently innovate their clinical trial software platforms and related tools to enhance their brand presence in the worldwide market. Their dominance is further solidified through software launches, promotional activities, product advancements, collaboration, and partnership strategies. These market players are poised to maintain their leading status through ongoing engagement, innovation, and strategic business actions such as mergers, acquisitions, collaborations, and partnerships.

RECENT VENDOR ACTIVITIES 

• In 2024, Research Solution, a reliable partner in cloud-based workflow solutions, introduced a new software solution for Clinical Trial Landscape aimed at making clinical trial data more accessible, actionable, and insightful. This software is anticipated to improve data management in clinical studies while helping to reduce labor needs and associated expenses. 
• In 2024, IQVIA, a prominent market player, unveiled One Home for Site, a SaaS solution designed to streamline workflows for clinical studies, allowing greater focus on patient care and the advancement of clinical trials. Furthermore, this platform was created to diminish trial delays and boost the number of clinical trials.