Artificial Intelligence Clinical Trial Protocol Feasibility Tool Market Research Report 2025: Opportunities in Rising Demand for Personalized and Decentralized Trials

Key market opportunities in the AI clinical trial protocol feasibility tool sector include rising demand for personalized and decentralized trials, integration of genomic data for precision medicine, adaptive site selection algorithms, and real-time feasibility monitoring. Rapid growth is anticipated in Asia-Pacific and among key players focusing on predictive analytics and risk assessment.


Dublin, Nov. 04, 2025 (GLOBE NEWSWIRE) -- The "Artificial Intelligence Clinical Trial Protocol Feasibility Tool Market Report 2025" has been added to ResearchAndMarkets.com's offering.

The Artificial Intelligence Clinical Trial Protocol Feasibility Tool Global Market Report 2025 offers crucial insights for strategists, marketers, and senior management to evaluate the rapidly growing market landscape. Positioned as an essential resource, the report encapsulates trends poised to shape the future of this sector over the forthcoming decade and beyond.

The artificial intelligence clinical trial protocol feasibility tool market has recorded extraordinary growth in recent years. It is projected to expand from $0.65 billion in 2024 to $0.83 billion in 2025, achieving a compound annual growth rate (CAGR) of 27.5%. This growth is driven by increasing clinical trial complexity, rising trial data volumes, traditional trial costs, digital health record adoption, and patient-centric trial focus.

Looking forward, the market anticipates continued exponential growth, reaching $2.17 billion by 2029, with a CAGR of 27.1%. Key drivers include the demand for personalized medicine trials, increasing decentralized trials, real-time feasibility monitoring, and natural language processing utilization. The development of adaptive algorithms for site selection, genomic data integration, automated trial cost estimation, and multi-source real-world evidence integration are key trends shaping this period.

With an ever-growing focus on precision medicine, which enables more effective and customized treatment strategies through genetic profiling, the role of AI-based clinical trial protocol feasibility tools becomes crucial. These tools enhance trial efficiency, improve patient recruitment forecasts, and align study protocols with patient subgroups. Highlighting the industry impact, Novotech reported in March 2024 that 43% of FDA-approved oncology therapies in the United States utilized precision treatments, many employing DNA-based or next-generation sequencing biomarkers.

Industry leaders are prioritizing advanced solutions development, such as predictive analytics-driven trial planning tools, which improve protocol accuracy and minimize research delays. Lokavant Incorporated, for instance, unveiled Spectrum in June 2024, an AI platform that supports feasibility planning throughout the clinical trial lifecycle, integrating real-time data for precise forecasting and risk assessment.

In a strategic move in March 2025, Tempus AI Incorporated acquired Deep 6 AI to boost patient recruitment, access real-world data, and advance AI applications in trial matching and precision medicine. Key players in this market include IQVIA Holdings Inc., SAS Institute Inc., Veeva Systems Inc., Tempus AI Inc., and others.

North America emerged as the largest market region in 2024, while Asia-Pacific is anticipated to experience the fastest growth. The market covers regions like Asia-Pacific, Western and Eastern Europe, North and South America, and the Middle East and Africa, focusing on countries like the USA, China, and Germany.

The sudden escalation of U.S. tariffs in 2025 has impacted global trade, affecting healthcare sectors through increased costs of imported medical devices. This has led to delays in equipment upgrades and supply chain bottlenecks. In response, the industry is diversifying sourcing strategies and advocating for tariff exemptions on essential medical products.

The market comprises software and services, with software including digital platforms that use AI for protocol assessment, risk identification, and trial design optimization. The primary application areas are protocol design and patient recruitment, serving pharmaceutical companies, CROs, and research institutes.

Key Attributes:

Report AttributeDetails
No. of Pages250
Forecast Period2025 - 2029
Estimated Market Value (USD) in 2025$0.83 Billion
Forecasted Market Value (USD) by 2029$2.17 Billion
Compound Annual Growth Rate27.1%
Regions CoveredGlobal


Market Dynamics

  • Market Insight: The report articulates market definitions and characteristics. It details market size, including historical growth and forecast projections.
  • External Factors: Considerations for forecasts include technological advancements, geopolitical tensions like the Russia-Ukraine conflict, trade tariffs, and economic indicators such as inflation and interest rates.
  • Market Segmentation: Specific sub-markets are explored for a more granular understanding of market dynamics.
  • Geographical Breakdown: Detailed analyses of regional markets, including size comparisons and growth trajectories.
  • Competitive Landscape: Insight into market competition, including market shares, leading companies, and significant financial transactions shaping the industry.
  • Trend Analysis: Strategies and market transformations are assessed in the context of recovering from global crises.

Report Scope:

  • Markets Covered: Component divisions (Software; Services), Deployment Modes (Cloud-Based; On-Premises), Applications (Protocol Design; Site Selection; Patient Recruitment; Risk Assessment; Other Applications), End-Users (Pharmaceutical And Biotechnology Companies; Contract Research Organizations; Academic and Research Institutes).
  • Subsegments: Software subcategories like Predictive Analytics and AI technologies; Services including Consulting and Managed Services.
  • Key Companies: Noteworthy entities such as IQVIA Holdings Inc., SAS Institute Inc., Veeva Systems Inc., and others.
  • Countries and Regions: Coverage spans Australia, Brazil, China, USA, Europe, among others, with detailed regional insights across Asia-Pacific, Western, and Eastern Europe, North and South America, the Middle East, and Africa.
  • Time Series: Includes five years of historical data and ten years of forecast projections.
  • Data Format: Delivered in multiple formats including PDF, Word, and an Excel Data Dashboard for flexible utility.

Companies Featured

  • 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
  • BEKHealth Corporation

For more information about this report visit https://www.researchandmarkets.com/r/oqq5rk

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Artificial Intelligence Clinical Trial Protocol Feasibility Tool Market

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