Global Clinical Trials Software Market - Focused Insights 2024-2029

MARKET INSIGHTS

The global clinical trials software market was valued at USD 1.25 billion in 2023 and is expected to reach USD 3.12 billion by 2029, growing at a CAGR of 16.40% during the forecast period. The market is driven by the growing advancement in clinical trial sites, such as the increasing incorporation of digital tools and technologies to maximize the effect in clinical trial operations, thus increasing the success rate of clinical trials with higher efficacy and better outcomes, clinical trial sites become more alert and try to meet standards and regulations. In contrast, clinical trial software supports meeting these standards with error-free data collection, analysis, and interpretation. In addition, the new regulatory norms support increased integration of digital tools and technologies, such as clinical trial software, boosting market growth. 

Clinical trial software, also known as clinical trial management systems (CTMS), is a digital platform used to manage clinical trial activities more efficiently. This software system manages the overall operational aspects of clinical studies from study startup to closeout, incorporating digital tools and technologies that reduce human interference and errors in complex trial operations. Clinical research sites use clinical trial software to centralize data related to procedures, subjects, workforce, billing, financials, and much more. Globally, the growing digitalization across the healthcare sector, from patient management in health settings to drug discovery and development in biopharma, medical devices, and CROs, is propelling the demand for clinical trial software. The increasing volume of clinical trials by biopharma and medical device manufacturing companies with advanced and smart clinical trial approaches accelerates the adoption of clinical trial software in regular clinical studies. 

RECENT VENDORS ACTIVITIES

1. In 2024, the Research Solution company- a trusted partner cloud-based workflow solutions launched a new Clinical Trial Landscape software solution to make clinical trial data more accessible, actionable, and insightful. This software is expected to enhance data management in clinical studies and will help reduce workforce requirements and associated costs.
2. In 2024, IQVIA, one of the leading market players, launched One Home for Site, a SaaS-based solution to simplify the workflow for clinical studies, enabling more focus on patient care and advancing clinical trials. This platform was also developed to reduce trial delays and increase the number of clinical trials.
3. In 2024, a new AI software that writes clinical studies protocols was developed and launched by Risklick. This software claims to reduce development time and cost by 35%. This software integrates Natural Language Processing and large language model technologies to analyze historical and current data and support clinical trial operators.
4. In 2024, Revvity launched the Signals Clinical solution, a SaaS platform to centralize complete clinical trial data.

KEY TAKEAWAYS

1. Market Growth: The global clinical trials software market was valued at USD 1.25 billion in 2023 and is expected to reach USD 3.12 billion by 2029, growing at a CAGR of 16.40% during the forecast period.
2. By Development: The on-enterprise segment accounted for the dominant market share, and the increasing adoption of advanced and new clinical trial model approaches by CROs and biopharmaceutical companies drives the growth.
3. By Delivery: The SaaS segment showcases the highest CAGR of 17.14%, as it helps reduce the organization's staff burden and improve data accuracy.
4. By Feature: The EDC segment holds the largest market share and shows the highest growth as it collects, cleans, and analyzes patient data to streamline clinical trial studies.
5. By End-Users: The CROs segment dominates the global clinical trials software market share as it has a vital role in clinical trials from patient enrollment through trial execution to ensure safety and compliance.
6. By Geography: North America dominates and has the largest market share of 33%. It has a high adoption rate of decentralized clinical trials, with a strong foundation and wide acceptance of advanced clinical trial models.
7. Growth Factor: The global clinical trials software market is set to grow due to rapid development in clinical trials and the increasing attention toward patient-centric approaches.

MARKET TRENDS & DRIVERS

Growing Attention to Enhance Data Privacy and Security

Clinical trials are becoming more advanced, and integrating new digital tools, technologies, and software is essential. However, with the growing attention towards data privacy and security, future clinical database software is incorporating advanced security features while using clinical trial software solutions. In recent years, advanced features have gained huge attention in the clinical trials software industry, like sophisticated encryption techniques, data security regulations, and blockchain technologies for immutable data records.

Rapid Development in Clinical Trials

Innovations are revolutionizing the clinical trials industry and delivering potential growth opportunities. In addition, technology advancement and integration accelerate the development of personalized medicines and treatments, remote patient monitoring, and hybrid & fully decentralized clinical trials. Machine learning (ML) and artificial intelligence (AI) are rapidly integrated into numerous drug discovery and development procedures. AI facilitates drug development, speeding up operations, improving trial efficiency, increasing the precision of data analysis, and automating testing. Moreover, the expanding hybrid and decentralized trial models and associated tools and technologies create huge opportunities for the clinical trials software market.

Reduction in Trials Expenses with Clinical Trials Software

Incorporating clinical trial software is an effective approach, enabling significant cost savings for organizers and sponsors. Clinical trials software solution reduced around 30% of overall clinical trials cost. By reducing reliance on physical sites or in-person visits, with a decentralized clinical trials model, clinical trials software streamlines research procedures, decreases overhead costs, and saves on patient travel, site operations, patient monitoring visits, shortened enrolment periods, reduced patient dropout, expedited data collection, and accuracy. Clinical trials are notoriously complex, lengthy, and expensive, imposing a significant financial burden on healthcare companies. Clinical trial software features like EDC enhanced clinical trial and patient data and reduced associated traditional paper-based documents. ePRO and eCOA enhanced patient health-related data, reducing human errors and associated costs. eConsent has become a major choice for reducing paper-based and traditional consent forms and patient attitudes toward participation in clinical trials.

INDUSTRY RESTRAINTS

Lack of Adoption & Acceptance

During the COVID-19 pandemic, the popularity and awareness of clinical trial software have increased significantly. However, the acceptance of clinical trial software in clinical studies is still lower. Several factors hamper the adoption of clinical trial software, including the lack of supportive digital infrastructure, the required investment cost, the return on investment in clinical trials, and the lack of resources to handle them. Clinical trial sites already face huge costs and employee/workforce burdens, where incorporating clinical trial software poses an additional burden. Several factors need to be considered when incorporating clinical trial software, which requires huge investment costs, including features and functionality, technology stack, regulatory compliance, development team, integration, maintenance, and support.

SEGMENT INSIGHTS

INSIGHT BY DEVELOPMENT

The global clinical trials software market is segmented into on-enterprise and on-site. The on-enterprise segment dominated the global market share in 2023. On-enterprise clinical software deployment provides several advantages over on-site delivery. On-enterprise delivery allows full control over associated trial activities, including data storage, system configuration, and associated changes on-time, security, and remote monitoring by trial owner/sponsor. It helps to increase the efficiency of trials and the chances of successful clinical trials. On-enterprise deployment of clinical trials software serves as a centralized hub for managing all trial activities and ensuring that each trial phase is conducted effectively, efficiently, and in compliance with regulatory standards. It gives more visibility and transparency in all clinical trial activities with a proven, comprehensive, standardized clinical trial management system, thus helping segmental growth.

INSIGHT BY DELIVERY

The global clinical trials software market is categorized into web-based, SaaS, and on-premises. The SaaS segment shows significant growth, with the fastest-growing CAGR of 17.14% during the forecast period. Software-as-a-Service (SaaS) is a cloud-based platform delivery that enables centralizing data, streamlining processes, and enhancing collaborations. Currently, clinical trials are increasingly relying on SaaS providers to optimize efficiencies. SaaS can reduce the burden on the staff of organizations, improve data accuracy, and optimize costs. With the increasing digitalization in clinical trials, the demand for clinical trials SaaS is growing rapidly across global clinical trial activities. SaaS enables clinical trial operators to subscribe to an application rather than purchase a complete software platform that delivers more cost benefits and can manage it themselves, giving a better customization experience.

INSIGHT BY FEATURE

Based on the feature, the Electronic Data Capture (EDC) segment holds the largest global clinical trials software market share. Electronic Data Capture (EDC) is a clinical trials software tool that records and collects clinical documents. It is the most widely used e-clinical tool in clinical trials. An EDC system has many advantages over paper-based data collection. An EDC system streamlines data collection, and clinical trial sites can easily access the EDC systems from any computer. This platform ensures data authenticity, security, and integrity and helps access data easily. It also accelerates data cleaning. An EDC system collects different data types from clinical trials for various therapeutic areas. Currently, more than 50% of hybrid and almost every single fully decentralized clinical trials uses EDC as a major component in clinical trials. EDC can be deployed as an on-premise or web-based EDC. In Clinical trials software, EDC allows for optimized information collection and management within a single platform, which offers more control of clinical trial data, collaboration, and security for clinical trial operators, helping the segment’s growth.

INSIGHT BY END-USERS

Based on the end-users, the CROs segment dominates the global clinical trials software market share and shows the highest growth. CROs play an increasingly vital role in clinical trials, from patient enrollment through trial execution, to ensure safety and compliance. Clinical trials and approval from regulatory bodies are highly complex procedures. It requires high capital investments, well-experienced and expert staff, and constant contact between patients and clinical trial sites. Many biopharmaceutical and medical device manufacturing companies are not equipped to perform these procedures due to the lack of infrastructure and staff. CROs with advanced clinical trial software simplify these operations and improve trial activity transparency. The increasing number of CROs has led to increased clinical trial outsourcing, which is growing rapidly in developing countries. This is expected to drive the demand for clinical trial software in CRO activities in developing countries.

GEOGRAPHICAL ANALYSIS

North America held the largest market share, over 33% of the global clinical trials software market. North America dominates the market by adopting advanced technologies and digital tools in clinical studies. The U.S. has a high adoption rate of decentralized clinical trials in North America, with a strong foundation and wide acceptance of advanced clinical trial models. This existing infrastructure and willingness to embrace innovative technologies have positioned North America as a global clinical trials software market leader. Favorable guidelines, government support, and rising expenditure are key factors contributing to the growth of clinical research in the US. The US and Canada are the top two countries in North America, and they conduct many decentralized clinical trials and contribute to market growth.

COMPETITIVE LANDSCAPE

The global clinical trials software market report consists of exclusive data from 36 vendors. Dassault Systèmes, BSI Business System Integration AG, Clario., IQVIA, Laboratory Corporation of America Holdings, and Oracle Corporation are some leading companies. These vendors continuously develop innovative clinical trial software platforms and associated tools and maintain their brand image in the global market. Software launches, promotion activities, product development and advancements, collaborations, and partnerships also strengthen their position in the market. These market players are expected to dominate with continued engagement, innovation, and business strategic initiatives like M&A, collaboration, and partnership.