AI in Clinical Trials Market Industry Trends and Global Forecasts to 2035: By Trial Phase, Target Therapeutic Area, End-User and Key Geographical Regions

The global AI in clinical trials market is estimated to grow from USD 1.42 billion in 2025, to USD 8.5 billion by 2035, at a CAGR of 16% during the forecast period, till 2035.

AI in Clinical Trials Market: Growth and Trends

Artificial intelligence has demonstrated immense potential in transforming the healthcare industry by revolutionizing drug discovery, clinical trials, treatment, diagnosis, and development, leading to significant improvements in patient outcomes. Currently, it is being used to optimize clinical trial processes and mitigate challenges, such as poor patient recruitment, engagement, monitoring, and study design. In addition, advanced speech and text recognition systems enable effective remote physician-patient communication. Further, predictive AI models can aggregate and analyze large volumes of data for future therapy development. Nevertheless, the integration of clinical datasets with regulatory authorities and their databases is crucial for the widespread application of AI in healthcare. It is worth mentioning that over the years, AI-based technologies have been explored to improve the efficiency of clinical trials for different biologics, with significant funding and partnership activity in this domain.

Additionally, with consistent innovation in the field, a substantial improvement during clinical trials is anticipated by making the trials more efficient, cost-effective and patient-centric. Moreover, machine learning, natural language processing, deep learning and data science are expected to simplify complex and time-consuming clinical studies, making them more structured and convenient. Driven by the benefits of AI in clinical trials and ongoing advancements, the demand for AI-based platforms is expected to continue in the coming years.

AI in Clinical Trials Market: Key Insights

The report delves into the current state of the AI in clinical trials market and identifies potential growth opportunities within the industry.

Some key findings from the report include:

• Presently, over 120 AI software and service providers claim to offer AI products / technologies for clinical trials to multiple end-users; over 90% of the players are headquartered in developed geographies.
• A large number of players involved in offering AI software and services have incorporated various types of AI technologies and adopted different business models to cater to the needs of end-users.
• The annual number of clinical studies, based on AI, has steadily evolved; this indicates the growing adoption of AI solutions by pharmaceutical and biotechnology companies, hospitals, research institutes and CROs.
• The rising interest is also evident from the partnership activity; more than 55% of the deals have been focused on oncological disorders.
• Given the vast potential of AI software and services in clinical studies for improving productivity and research outcomes, many investors have extended financial support; over USD 2.3 billion has been invested till date.
• Over time, several big pharma players have adopted AI software and services in clinical trials to speed up drug discovery and development programs across different therapeutic areas.

• AI solutions hold significant cost saving potential, along with the ability to expedite trial outcomes and success, across various trial phases.
• The overall opportunity of AI in clinical trials is likely to grow at a CAGR of more than 15%; this opportunity is expected to be well distributed across clinical trial phases, therapeutic areas, end-users and geographical regions.

Report Segmentation

Trial Phase

• Phase I
• Phase II
• Phase III

Target Therapeutic Area

• Cardiovascular Disorders
• CNS Disorders
• Infectious Diseases
• Metabolic Disorders
• Oncological Disorders
• Other Disorders

End-user

• Pharmaceutical and Biotechnology Companies
• Other End-users

Key Geographical Regions

• North America
• Europe
• Asia-Pacific
• Middle East and North Africa
• Latin America

AI in Clinical Trials Market: Key Segments

Phase III Clinical Studies Segment is the Fastest Growing Segment of the AI in Clinical Trials Market During the Forecast Period

Based on the trial phase, the market is segmented into phase I, phase II and phase III. At present, phase II clinical studies hold the maximum share of the AI in clinical trial market. This trend is unlikely to change in the near future. It is worth highlighting that AI in clinical trials market for phase III clinical studies is likely to grow at a higher CAGR.

Oncological Disorders Segment is Likely to Dominate the AI of Clinical Trials Market During the Forecast Period

Based on therapeutic areas, the market is segmented into cardiovascular disorders, CNS disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders. It is worth highlighting that, at present, oncological disorders segment holds the larger share in the AI in clinical trials market.

Currently, Biotechnology and Pharmaceutical Companies Segment Occupies the Largest Share of the AI in Clinical Trial Market

Based on end-users, the market is segmented into pharmaceutical and biotechnology companies, and other end-users. It is worth highlighting that, at present, pharmaceutical and biotechnology companies hold a larger share in the AI in clinical trials market. This trend is likely to remain the same in the coming decade.

North America Accounts for the Largest Share of the Market

Based on key geographical regions, the market is segmented into North America, Europe, Asia-Pacific, Middle East and North Africa, and Latin America. Majority share is expected to be captured by players based in North America and Europe. It is worth highlighting that, over the years, the market in North America is expected to grow at a higher CAGR.

Sample Players in the AI in Clinical Trials Market, Profiled in the Report Include:

• AiCure
• Antidote Technologies
• Deep 6 AI
• Innoplexus
• IQVIA
• Median Technologies
• Medidata
• Phesi
• Saama Technologies
• Signant Health

Primary Research Overview

The opinions and insights presented in this study were influenced by discussions conducted with multiple stakeholders. The research report features detailed transcripts of interviews held with the following industry stakeholders:

• Co-Founder, Chief Executive Officer and Chief Technology Officer, Ancora.ai
• Founder and Chief Executive Officer, Deep 6 AI
• Co-Founder and Executive Director, Intelligencia
• Founder and Chief Executive Officer, nQ Medical
• Chief Technology Officer, Chief Commercial Officer, Chief Delivery Officer and Head of Marketing, Science 37

AI in Clinical Trials Market: Research Coverage

• Market Sizing and Opportunity Analysis: The report features an in-depth analysis of the AI in clinical trials market, focusing on key market segments, including [A] trial phase, [B] target therapeutic area, [C] end-user and [D] key geographical regions.
• Market Landscape: A comprehensive evaluation of companies offering AI software and services for clinical trials, based on various parameters, such as [A] year of establishment, [B] company size (in terms of number of employees), [C] location of headquarters, [D] key offering(s), [E] business model(s), [F] deployment option(s), [G] type of AI technology, [H] application area(s) and [I] potential end-user(s).
• Company Profiles: In-depth profiles of key industry players offering AI software / AI solutions and services for clinical trials, focusing on [A] company overviews, [B] financial information (if available), [C] AI-based clinical trial offerings portfolio, [C] recent developments and [D] an informed future outlook.
• Clinical Trials Analysis: Examination of completed, ongoing, and planned clinical studies leveraging AI, based on parameters like [A] trial registration year, [B] number of patients enrolled, [C] trial phase, [D] trial status, [E] type of sponsor, [F] patient gender, [G] patient age, [H] emerging focus areas, [I] target therapeutic area, [J] patient allocation model used, [K] trial masking adopted, [L] type of intervention, [M] trial purpose, [N] most active players (in terms of number of clinical trials sponsored) and [O] geography.
• Partnerships and Collaborations: An analysis of partnerships established in this sector, since 2018, covering various types of partnership models, such as licensing agreements, R&D agreements, M&A and service alliance.
• Funding and Investment Analysis: A detailed evaluation of the investments made in this domain, encompassing seed financing, venture capital financing, capital raised from IPOs, grants, debt financing and other equity, and subsequent offerings.
• Big Pharma Initiatives: A detailed analysis of various initiatives focused on AI in clinical trials undertaken by big pharma companies based on multiple relevant parameters, such as [A] year of initiative, [B] type of initiative, [C] application area of AI, [D] target therapeutic area and [E] leading big pharma players (in terms of number of AI in clinical trials focused initiatives).
• Value Creation Framework: An insightful framework depicting the implementation of several advanced tools and technologies, such as blockchain, big data analytics, real-world evidence, digital twins, cloud computing and internet of things (IoT) at different steps of a clinical study, which can assist service providers in addressing existing unmet needs. Further, it provides a comprehensive analysis on ease of implementation and associated risk in integrating above-mentioned technologies, based on the trends highlighted in published literature and patents.
• Cost Saving Analysis: A comprehensive cost-saving analysis, highlighting the potential of AI to reduce expenses in clinical trials by 2035. We have outlined the cost-saving opportunities of AI across various trial phases (Phase I, Phase II, and Phase III) and procedures, including patient recruitment, patient retention, staffing and administration, site monitoring, source data verification, and other related processes.

Key Questions Answered in this Report

• How many companies are currently engaged in this market?
• Which are the leading companies in this market?
• What kind of partnership models are commonly adopted by industry stakeholders?
• What factors are likely to influence the evolution of this market?
• What is current and future market size?
• What is the CAGR of this market?
• How is the current and future market opportunity likely to be distributed across key market segments?

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