Artificial Intelligence Clinical Trial Protocol Feasibility Tool Market Report 2025

The artificial intelligence clinical trial protocol feasibility tool market size has grown exponentially in recent years. It will grow from $0.65 billion in 2024 to $0.83 billion in 2025 at a compound annual growth rate (CAGR) of 27.5%. The growth in the historic period is attributed to the increasing complexity of clinical trial protocols, growing volume of clinical trial data, rising costs of traditional trials, increasing adoption of digital health records, and greater focus on patient-centric trials.

The artificial intelligence clinical trial protocol feasibility tool market size is expected to see exponential growth in the next few years. It will grow to $2.17 billion in 2029 at a compound annual growth rate (CAGR) of 27.1%. The growth in the forecast period is driven by rising demand for personalized medicine trials, increased adoption of decentralized clinical trials, growing use of natural language processing, emphasis on patient diversity in trials, and the growing importance of real-time feasibility monitoring. Key trends in the forecast period include the development of adaptive algorithms for site selection optimization, integration of genomic data to enable precision trial protocols, innovation in automated trial cost and timeline estimation, creation of tools to enhance patient diversity, and integration of multi-source real-world evidence for accurate feasibility assessments.

The increasing focus on precision medicine is anticipated to support the growth of the artificial intelligence clinical trial protocol feasibility tool market. Precision medicine is a customized approach to healthcare that utilizes a patient’s genetic profile, environmental exposure, and lifestyle to develop more effective and tailored treatment strategies. This emphasis is accelerating due to ongoing advancements in genomic sequencing and biomarker discovery, which allow for earlier detection and highly targeted therapies. Artificial intelligence-based clinical trial protocol feasibility tools play a critical role in precision medicine by enabling data-driven trial design and enhancing the alignment of study protocols with specific patient subgroups. These tools improve clinical trial efficiency by forecasting patient recruitment success, timelines, and potential risks, ultimately increasing the accuracy and effectiveness of research outcomes. For example, in March 2024, Novotech, a biotechnology company based in Australia, reported that in 2023, forty-three percent of the two hundred seventeen oncology therapies approved by the Food and Drug Administration in the United States were precision treatments. Additionally, seventy-eight of these therapies utilized DNA-based or next-generation sequencing biomarkers. Therefore, the growing emphasis on precision medicine is contributing significantly to the expansion of the artificial intelligence clinical trial protocol feasibility tool market.

Leading companies in this market are prioritizing the development of advanced solutions, such as trial planning tools powered by predictive analytics, to improve protocol accuracy and minimize delays in clinical research. Predictive analytics-driven trial planning refers to the use of historical and real-time data to assess study feasibility, forecast costs and timelines, and identify operational risks. These tools enhance trial design and execution by reducing reliance on manual processes and enabling adaptive responses during the study. For instance, in June 2024, Lokavant Incorporated, a clinical intelligence firm based in the United States, introduced Spectrum, the first artificial intelligence platform designed to support feasibility planning throughout the full clinical trial lifecycle. This platform integrates live clinical trial data and enables continuous forecasting, risk assessment, and enrollment scenario evaluation. Spectrum supports timely, data-informed decision-making by providing accurate estimates of projected timelines, expenditures, and recruitment outcomes, helping study teams improve efficiency and reduce costly delays.

In March 2025, Tempus AI Incorporated, a health technology company based in the United States, completed the acquisition of Deep 6 AI for an undisclosed amount. This strategic move aims to improve patient recruitment efficiency, broaden access to real-world clinical data, and advance the application of artificial intelligence in clinical trial matching and precision medicine. Deep 6 AI is a United States-based technology company that specializes in artificial intelligence tools for evaluating clinical trial protocol feasibility.

Major players in the artificial intelligence clinical trial protocol feasibility tool market are IQVIA Holdings Inc., SAS Institute Inc., Veeva Systems Inc., Tempus AI Inc., Cytel Inc., ArisGlobal LLC., Saama Technologies Inc., Norstella, ConcertAI, Komodo Health Inc., H1 Inc., TriNetX Inc., ObjectiveHealth LLC, Lokavant Inc., Inato Inc., Clinerion Ltd., Faro Health Inc., Lantern Pharma Inc., Ryght AI, and BEKHealth Corporation.

North America was the largest region in the artificial intelligence clinical trial protocol feasibility tool market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in artificial intelligence clinical trial protocol feasibility tool report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa. The countries covered in the artificial intelligence clinical trial protocol feasibility tool market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report’s Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The sudden escalation of U.S. tariffs and the consequent trade frictions in spring 2025 are severely impacting the healthcare sector, particularly in the supply of critical medical devices, diagnostic equipment, and pharmaceuticals. Hospitals and healthcare providers are facing higher costs for imported surgical instruments, imaging equipment, and consumables such as syringes and catheters, many of which have limited domestic alternatives. These increased costs are straining healthcare budgets, leading some providers to delay equipment upgrades or pass on expenses to patients. Additionally, tariffs on raw materials and components are disrupting the production of essential drugs and devices, causing supply chain bottlenecks. In response, the industry is diversifying sourcing strategies, boosting local manufacturing where possible, and advocating for tariff exemptions on life-saving medical products.

An artificial intelligence clinical trial protocol feasibility tool is a software solution that leverages AI algorithms to analyze historical clinical data, patient populations, and trial design parameters to evaluate the feasibility of a proposed clinical trial. Its main purpose is to predict patient recruitment potential, identify protocol risks, and optimize trial design, helping reduce delays and improve trial success rates.

The primary components of the artificial intelligence clinical trial protocol feasibility tool are software and services. Software includes digital platforms that use AI to assess clinical trial protocols, predict patient recruitment, identify risks, and optimize trial design for more efficient studies. These solutions are deployed through cloud-based or on-premises systems. Applications include protocol design, site selection, patient recruitment, risk assessment, and other trial-related functions. Key end-users include pharmaceutical and biotechnology companies, contract research organizations (CROs), academic and research institutes, and related organizations.

The artificial intelligence clinical trial protocol feasibility tool market research report is one of a series of new reports that provides artificial intelligence clinical trial protocol feasibility tool market statistics, including artificial intelligence clinical trial protocol feasibility tool industry global market size, regional shares, competitors with a artificial intelligence clinical trial protocol feasibility tool market share, detailed artificial intelligence clinical trial protocol feasibility tool market segments, market trends and opportunities, and any further data you may need to thrive in the artificial intelligence clinical trial protocol feasibility tool industry. This artificial intelligence clinical trial protocol feasibility tool 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 artificial intelligence clinical trial protocol feasibility tool market includes revenues earned by entities through patient recruitment analysis, site selection optimization, protocol design feasibility, risk assessment and mitigation, and data integration and analytics services. The market value includes the value of related goods sold by the service provider or included within the service offering. Only goods and services traded between entities or sold to end consumers are included.

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 that 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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