United States AI in Clinical Trials Market 2025: Industry Developments, Future Growth, Share & Industry Insights | Medidata, IQVIA, Saama Technologies, Phesi, Euretos

AI in Clinical Trials Market reached US$1.45 billion in 2024, up from US$1.27 billion in 2023, and is projected to reach US$5.06 billion by 2033, growing at a robust CAGR of 14.55% from 2025 to 2033.

DataM Intelligence has published a new research report on "Al in Clinical Trials Market Size 2025". The report explores comprehensive and insightful Information about various key factors like Regional Growth, Segmentation, CAGR, Business Revenue Status of Top Key Players and Drivers. The purpose of this report is to provide a telescopic view of the current market size by value and volume, opportunities, and development status.

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Key Players: Medidata, IQVIA, Saama Technologies, Phesi, Euretos, Median Technologies, Innoplexus, Deep6.ai, AiCure, Antidote Technologies and Mendel AI.

USA - Industry Latest News:

✅ 29 Oct 2025 - Thermo Fisher to acquire Clario (all-cash deal up to $9.4B). Clario is a clinical-trial software/data company whose platform is widely used to manage trials and generate trial data insights; Thermo Fisher says the deal will deepen its AI and digital capabilities across clinical research.

✅ 02 Jun 2025 - FDA launches agency-wide generative AI tool "Elsa" to speed internal scientific review and operations. Agency says the tool is being used to reduce repetitive tasks in regulatory review workflows.

✅ 08 May 2025 - FDA completes first AI-assisted scientific review pilot. Agency reported faster review cycles using generative AI tools during pilot work.

✅ 22 Aug 2025 - Tempus announces acquisition of Paige (AI pathology / cancer-analytics company). Deal expands Tempus' AI capabilities for clinical and translational oncology data used in trials.

✅ 14 Aug 2025 - Eli Lilly enters deal with Superluminal (AI-driven discovery) to develop obesity candidates; platforms expected to feed programmes that will move into human trials.

✅ 14 Aug 2025 - THL Partners agreement to acquire Headlands (U.S. clinical site network) from KKR - investor activity reflects demand for trial operations boosted by digital/AI tools.

Japan - Industry Latest News:

✅ 16 Oct 2025 - A.D.A.M. Innovations partners with SOPHiA GENETICS to adopt SOPHiA's AI-powered genomics platform for liquid biopsy & companion diagnostics in Japan. Partnership aims to accelerate precision-oncology testing that can be used in clinical trials and diagnostics.

✅ 25 Sep 2025 - Nakanoshima / Osaka initiatives accelerate industry-academia-government ecosystem to attract trials and AI-driven drug development. (Regional program and cluster activity to increase clinical trial inflow and data ecosystem readiness.)

✅ (2025) - Fujitsu launches global initiative to attract clinical trials to Japan and build medical-data ecosystem using advanced AI and trial platforms (collaboration with global partners to connect data and accelerate trial readiness).

South Korea (Korea) - Industry Latest News:

✅ 27 Oct 2025 - Kolmar Korea selected for government-led "AI Factory" initiative (Bio Division) to build integrated data platforms and AI models part of broader national AI push that will support clinical R&D data infrastructure.

✅ 03 Sep 2025 - Korea announces multi-million medical AI projects (e.g., My Healthway) connecting hospitals and data sources to support clinical research and AI-enabled health services. These national projects strengthen data pipelines for future AI-enabled clinical trials.

Europe - Industry Latest News:

✅ 21 Oct 2025 - European Commission launches flagship "Apply AI" initiative to speed up trustworthy AI in healthcare (including diagnostics and drug development support tools). The initiative is intended to accelerate adoption of EU-compliant AI in healthcare and related clinical workflows.

✅ 15 Oct 2025 - EssilorLuxottica acquires RetinAI to accelerate AI and data-powered eye-health solutions (example of health-AI consolidation in Europe with downstream clinical implications).

✅ Oct 2025 - Multiple strategic AI + biotech partnerships and deals reported across Europe (see deal roundups highlighting partnerships using AI for trial design, patient selection and imaging analytics).

Growth Forecast Projected:

The Global Al in Clinical Trials Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Al in Clinical Trials Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Key Segments:

By Offering (Software and Services)

By Trial Phase (Phase I, Phase II, and Phase III)

By Indication (Oncology, Central Nervous System (CNS) Disorders, Cardiovascular (CVS) Diseases, and Other Indications),

By End-user (Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), Other End Users)

By Region (North America, Europe, Asia-Pacific, South America, and the Middle East & Africa)

Regional Analysis for Market:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

Benefits of the Report:

Chapter 1: Sets the stage by outlining the report's coverage, summarizing key market segments by region, product type, and application. Presents a snapshot of market sizes, growth potential across segments, and anticipated industry evolution both short and long term.

Chapter 2: Highlights pivotal market insights and uncovers the most significant emerging trends driving change within the industry.

Chapter 3: Offers an in-depth look at the competitive landscape among Al in Clinical Trials producers, including revenue shares, strategic moves, and recent mergers and acquisitions.

Chapter 4: Presents comprehensive profiles of the market's key players, delving into details such as revenue, profit margins, product portfolios, and company milestones.

Chapters 5 & 6: Analyze Al in Clinical Trials revenue at both regional and country levels, providing quantitative breakdowns of market sizes, growth opportunities, and development prospects worldwide.

Chapter 7: Focuses on different market segments by type, examining their individual sizes and potential, guiding readers toward high-impact, untapped market areas.

Chapter 8: Explores segmentation by application, evaluating industry growth potential in various downstream markets and pinpointing promising sectors for expansion.

Chapter 9: Provides a thorough review of the industry's supply chain mapping out both upstream and downstream activities.

Chapter 10: Concludes with a summary of the report's key findings and highlights the most critical takeaways for industry stakeholders.

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FAQ's

Q1: What is the current size of the Al in Clinical Trials Market?

A: The Al in Clinical Trials Market stood at US$1.45 billion in 2024 and is set to experience remarkable growth, reaching US$5.06 billion by 2033

Q2: How fast is the Al in Clinical Trials Market growing?

A: The Market is on an impressive growth trajectory, expected to expand at a CAGR of 14.55% from 2025 to 2033.

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