Clinical Trial Software Global Market Report 2025

The clinical trial software market size has grown rapidly in recent years. It will grow from $1.16 billion in 2024 to $1.33 billion in 2025 at a compound annual growth rate (CAGR) of 14.4%. The growth during the historic period can be attributed to the rising demand for new software, the increased adoption of emerging technologies, the growing digitalization of clinical trials, the expanding use of cloud computing, and the increasing number of small and mid-size biopharmaceutical companies.

The clinical trial software market size is expected to see rapid growth in the next few years. It will grow to $2.25 billion in 2029 at a compound annual growth rate (CAGR) of 14.1%. The growth in the forecast period can be attributed to rising clinical research activities, the growing popularity of virtual trials, increasing demand for patient-centric clinical trial solutions, the rising need for specialty medicines, and the increasing prevalence of venous diseases. Key trends during this period include technological advancements, the integration of artificial intelligence (AI) and machine learning, innovations in clinical trial technologies, and the incorporation of real-world data sources.

The increasing research and development activities are expected to drive the growth of the clinical trial software market. Research and development refer to the systematic process of investigating, designing, and testing new products or technologies to innovate and improve existing solutions or create entirely new offerings. The rise in research and development activities is fueled by the growing demand for innovation across industries, driven by technological advancements, competitive market pressures, and the need for sustainable solutions. These factors encourage organizations to invest more resources in developing new products, processes, and services. Clinical trial software plays a crucial role in research and development by streamlining the planning, execution, and management of clinical trials, which are essential for testing new drugs and therapies. For instance, in April 2024, the Office for National Statistics, a UK-based government department, reported that the UK government's spending on research and development increased to £15.5 billion ($19.67 billion) in 2022 from £14 billion ($17.77 billion) in 2021, marking a 10.5% rise. Consequently, the increasing research and development activities are propelling the growth of the clinical trial software market.

Leading companies in the clinical trial software market are focusing on technological innovations, such as unified trial solutions, to enhance data collection and integration, improve patient engagement, streamline trial processes, reduce costs, and accelerate drug development. A unified trial solution is a comprehensive digital platform designed to optimize and simplify the clinical trial process. For example, in November 2023, AstraZeneca plc, a UK-based pharmaceutical company, launched Evinova, an AI-powered platform for clinical research. Evinova features automated patient recruitment, utilizing AI algorithms to match candidates with trial criteria, significantly reducing enrollment times. It also offers predictive modeling tools that analyze historical and real-time data to forecast patient responses, enhancing trial design and efficiency. The platform’s user-friendly interface fosters better patient engagement by providing digital communication and feedback channels, allowing participants to share their experiences seamlessly.

In October 2023, Certara Inc., a US-based software company, acquired Formedix LLC for an undisclosed amount. This acquisition strengthens Certara’s clinical trial automation capabilities by integrating Formedix’s expertise in data standardization and CDISC compliance. The merger aims to streamline regulatory submissions, improve trial efficiency, and accelerate drug development for pharmaceutical companies and regulatory agencies. Formedix LLC is a US-based provider of cloud-based software solutions designed to enhance and simplify clinical trial processes.

Major players in the clinical trial software market are International Business Machines Corporation, Oracle Corporation, Wipro Limited, Veeva Systems, Medpace Holdings Inc., Medidata Solutions, Signant Health Inc., Clario Inc., Advarra Inc., Celerion Inc., Veristat LLC, Greenphire Inc., Medrio Inc., Arisglobal LLC, Anju Software Inc., ClinCapture Inc., Palleos Healthcare GmbH, OpenClinica LLC, Pharmaseal International Limited, SoftFormance.

North America was the largest region in the clinical trial software market in 2024. Europe is expected to be the fastest-growing region in the forecast period. The regions covered in clinical trial software report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the clinical trial software market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Clinical trial software refers to specialized applications designed to facilitate the planning, execution, and management of clinical trials. It is utilized for data management, patient recruitment, regulatory compliance, and trial monitoring to ensure accuracy and efficiency in the research process.

The primary deployment types of clinical trial software include on-premises, web-based, cloud-based, and other deployment methods. On-premises deployment involves installing and operating the software on an organization's local servers and computers, offering full control over data and software but requiring substantial IT resources for maintenance and updates. The key types of clinical trial software include electronic data capture (EDC), electronic clinical outcome assessment (eCOA) or electronic patient-reported outcome (ePRO), and electronic informed consent. These solutions are used by various end-users, including pharmaceutical and biotechnology companies, contract research organizations (CROs), medical device manufacturers, and others.

The clinical trial software market research report is one of a series of new reports that provides clinical trial software market statistics, including clinical trial software industry global market size, regional shares, competitors with a clinical trial software market share, detailed clinical trial software market segments, market trends and opportunities, and any further data you may need to thrive in the clinical trial software industry. This clinical trial software market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The clinical trial software market includes revenues earned by entities by providing services such as site management and monitoring, patient recruitment and retention solutions, clinical trial management systems (CTMS), and risk-based monitoring. The market value includes the value of related goods sold by the service provider or included within the service offering. The clinical trial software market consists of sales of electronic data capture (EDC) systems, patient recruitment platforms, randomization and trial supply management (RTSM), and risk-based monitoring solutions. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values and are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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