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AI in Clinical Trials for Drugs Market Size, Trends and Opportunities

AI in Clinical Trials for Drugs Market Strategic Forecast with Trends

AI in clinical trials for drugs market is growing due to its use in clinical research to monitor and improve medication adherence. This is particularly through the use of applications, such as facial, digital biomarkers, and vocal expression. AI reduces the expenses of trial and support success rates. North America is dominated by the increasing prevalence of chronic disease and significant R&D investment.

Category: Healthcare Services Insight Code: 5703 Format: PDF / PPT / Excel

AI in Clinical Trials for Drugs Market Size, Key Drivers and Innovation

The global AI in clinical trials for drugs market is on an upward trajectory, poised to generate substantial revenue growth, potentially climbing into the hundreds of millions over the forecast years from 2025 to 2034. This surge is attributed to evolving consumer preferences and technological advancements reshaping the industry.

Automating clinical trials with AI-algorithm-based solutions speeds up the medication development process, improving its effectiveness and reducing expenses. In terms of the future of clinical trials, artificial intelligence (AI) is unquestionably a sophisticated technology impacting the drug discovery process. The concept of establishing a systemic channel to more precisely evaluate the enormous amounts of data generated during drug development is the foundation for the use of AI-driven technology in clinical trials. Researchers are now using AI algorithms to understand patient sickness patterns and identify drug molecules.

Key Takeaways

  • North America is dominant in the AI in clinical trials for drugs market share in 2024.
  • Asia Pacific is expected to grow at the fastest CAGR during the forecast period.
  • By offering the software segment for the largest market revenue in 2024.
  • By offering, the services segment is expected to register the fastest growth over the forecast period.
  • By process, the trial design segment accounted for the largest market revenue in 2024.
  • By process, the patient selection segment is expected to register the fastest growth over the forecast period.
  • By clinical trial phase, the phase II segment accounted for the largest market revenue in 2024.
  • By clinical trial phase, the phase I segment is expected to register the fastest growth over the forecast period.
  • By therapeutic area, the oncology segment accounted for the largest market revenue in 2024.
  • By therapeutic area, the cardiovascular disease segment is expected to register the fastest growth over the forecast period.
  • By technology, the deep learning segment accounted for the largest market revenue in 2024.
  • By technology, the generative AI segment is expected to register the fastest growth over the forecast period.
  • By end-user, the pharmaceutical companies segment accounted for the largest market revenue in 2024.
  • By end-user, the contract research organizations (CROs) segment is expected to register the fastest growth over the forecast period.

Market Overview

AI in clinical trials for drugs market is growing rapidly because this technology potentially enhances retention and participants’ access to related trial information. AI modernises clinical trials by predicting outcomes, optimizing protocols, and analysing big datasets. It aids participant recruitment through matching suitable patients to trials. AI-driven enhances safety monitoring with real-time alerts for adverse effects. It supports decision-making power and improves efficiency in data management with advanced predictive models. AI is not replacing clinical researchers, but could enlarge their work. Researchers continue to be essential for interpreting AI productivity, validating results, and making decisions, which contributes to the growth of the market. AI transforms protocol design through analyzing big datasets. These datasets come from earlier trials, real-world evidence, and patient records.

For Instance,

  • In June 2024, Lokavant, the clinical trial intelligence platform company, announced Spectrum, the first AI clinical trial feasibility software solution for trial optimization in the entire clinical development value chain. Spectrum allows study teams to predict, optimize, and control trial timelines and costs in real-time, allowing iterative feasibility analysis and mid-study course correction, critical to success in a hyper-complex trial environment. (Source - Businesswire)
  • In 2025, the FDA published a draft guidance titled “Considerations for the Application of Artificial Intelligence to Support Regulatory Decision Making for Drug and Biological Products.”  This guidance offers recommendations to the manufacturing sector on the use of AI to produce information or data intended to support regulatory decision-making regarding safety. (Source - U.S. Food & Drug)
  • In May 2025, the FDA announced the Completion of the First AI-assisted scientific Review Pilot and an Aggressive Agency-Wide AI Rollout Timeline. The generative AI tools enable FDA scientists and subject-matter experts to spend minimal time on repetitive, tedious tasks that often slow down the review process. (Source - U.S. Food & Drug)
  • In January 2025, the U.S. government joined the movement, launching the Stargate AI Initiative under President Trump to strengthen AI’s role in medical care. With support from both government and industry, AI is poised to transform clinical research, expediting drug development and bringing treatments to patients faster than before. (Source - TriNet X)

Market Dynamics

Driver

Increasing Applications of AI in Clinical Trials

Artificial intelligence (AI) can considerably lower pharmaceutical R&D expenses by enhancing drug discovery, refining clinical trials, and decreasing expensive failures via data-driven predictions and effectiveness evaluations. It can further improve drug development procedures using predictive modeling and simulation techniques, which bolster decision-making while cutting costs. AI-driven platforms allow companies to process vast data sets more swiftly than humans or traditional computing methods. This advancement facilitates quicker and more precise predictions regarding drug-target interactions and the discovery of promising compounds, resulting in reduced time and overall R&D expenditures, thereby contributing to the expansion of the AI in clinical trials for drugs market.

Restraint

Challenges in Computer Vision

AI in clinical trials faces challenges like concerns of data privacy, algorithm bias, and regulatory compliance issues. Clinical trial models must be interpretable and transparent to ensure trust. Utilizing AI requires advanced infrastructure and training for researchers, which limits the growth of the market.

Opportunity

Artificial Intelligence in Decentralized Clinical Trials

Artificial intelligence in decentralized clinical trials can transform how these trials are conducted, providing opportunities to improve both quality and efficiency. By utilizing remote monitoring, point-of-care testing, and AI-driven analytics, DCTs enhance patient accessibility, engagement, and data quality while speeding up trial timelines. As global regulatory authorities issue clearer guidelines on decentralized methods, the future of clinical research is increasingly leaning towards being decentralized, data-centric, and focused on patients. In contrast to traditional trials, which necessitate numerous in-person visits to specific research sites, DCTs employ telemedicine, home diagnostics, wearable technology, and remote monitoring systems. This strategy reduces the burden on patients while allowing for ongoing data collection and oversight of trials, establishing a pathway for the expansion of AI in the clinical drug trial market.

Segmental Insights

Why the Software Segment Dominated the Market in 2024?

By offering, the software segment dominated in the AI in clinical trials for drugs market in 2024, as AI software transformed innovative ways of gathering information, early disease diagnosis, and bio simulation for clinical trials. It predicts potential outcomes and identifies challenges in clinical trials. It supports overcoming several challenges posed by conventional drug discovery procedures.  By lowering uncertainty and enhancing decision-making early in the process, AI reduces the development expenses and increases the rate of success. 

The services segment is expected to be the fastest-growing in AI in clinical trials for drugs market because these services help clinical trials by improving patient recruitment, predicting the efficacy of treatment, enhancing safety monitoring, and automating data analysis. Furthermore, it speeds up trial processes, lowers expenses, enhances data quality, and leads to efficient, successful, and personalized clinical trials. It is applied in clinical research to improve medication adherence. This is particularly through the use of various healthcare trial applications.

Why is the Trial Design Segment Dominant in the Market in 2024?

By process, the trial design segment is dominant in the AI in clinical trials for drugs market, as AI renovates key steps of clinical trial design from study preparation to execution towards enhancing trial success rates, thus lowering the burden of pharma R&D. Clinical trial design is a significant aspect of interventional trials that helps to ergonomise, optimize and economize the clinical trial conduct. A properly conducted study with a good design based on a robust hypothesis evolved from clinical practice goes a long way in enabling the implementation of the best tenets of evidence-based practice.

The patient selection segment is expected to be the fastest growing because suitable patient selection is a significant step in clinical research, shaping the safety of the trial and the relevance of its results. Selecting participants who meet particular standards allows scientists to test interventions in populations that best align with the study’s objectives. The integration of AI in clinical trials leads to improved data analysis capabilities and enhances prediction accuracy.

Why is Phase II Segment Dominant in the Market in 2024?

By clinical trial phase, the phase II segment is dominant in the AI in clinical trials for drugs market, as it creates insights on adverse effect and their management, and the best schedule for future use in a later phase, based on the trial design. AI helps with the phase II of clinical trial design, along with tools to support to enhance hypothesis generation and optimize protocol design. Phase 2 trials are generally randomized, controlled trials evaluating the efficacy and safety of a drug for a specific condition and involve participants selected using narrow criteria to enable close monitoring in phase II.

The phase I segment is expected to be the fastest-growing in the market due to its role in regulating the correct drug dosage through evaluating drug safety and determining if there are any adverse effects. Phase 1 trials are conducted in healthy patients. Researchers in phase I goal to identify the safe dosage range of a novel drug with the least side effects. Phase 1 Clinical trials are an important component of appraising products and services, together with medications, medication combinations, and more.

Why Oncology Segment Dominant in the Market in 2024?

By therapeutic area, the oncology segment is dominant in the AI in clinical trials for drugs market, as AI has great potential to initiate greater efficiency, lower trial expenses, and enhance patient results in oncology research, eventually growing the development of novel, promising treatments for cancer patients across the world. AI provides endless potential to drive cancer care to novel frontiers by allowing early diagnoses, providing more precise estimates of challenges, updating effective treatment regimens, and freeing clinician time for patient-centric interactions.

The cardiovascular disease segment is expected to be the fastest-growing in the market as AI supports physicians in diagnosing cardiac disease and optimizing treatment processes. Instead of applying outdated medical procedures, AI can lower the rate of misdiagnosis and improve diagnostic efficiency. AI can recognize medical images and offer clinicians more reliable imaging diagnostic data. The ability of clinical trials to bring novel cardiovascular therapies to patients requires recent approaches to curtail cost and maintain the quality of future trials.

Why Deep Learning Segment Dominant in the Market in 2024?

By technology, the deep learning segment is dominant in the AI in clinical trials for drugs market, as deep learning is instrumental in investigating medical images and patient information for improved treatment and diagnosis. It identifies early signs of conditions such as heart disease or cancer, supports physicians in making more informed decisions, and improves patient outcomes. Deep learning is a subset of AI that is concerned with pattern recognition. 

The Generative AI segment is expected to be the fastest-growing in the market, as it improves accuracy, ensures consistency, and minimizes human error across data sets, streamlining the research process. This technology can revolutionize early-stage drug discovery and enhance decision-making in healthcare development.

For Instance,

  • In June 2025, the U.S. Food and Drug Administration (FDA) launched Elsa, a generative Artificial Intelligence (AI) tool designed to help employees, from scientific reviewers to investigators, work efficiently. This innovative tool modernizes agency functions and leverages AI capabilities to serve the American people. (Source - U.S. Food & Drug)

Why is the Pharmaceutical Companies Segment Dominant in the Market in 2024?

By end user, the pharmaceutical companies segment is dominant in the AI in clinical trials for drugs market, as pharmaceutical companies will be using AI applications for developing patient-centric drugs with seamless accuracy, therefore bridging the gap between development, drug discovery, approval, clinical trials, and market supply. These advancements speed up drug development while lowering expenses.

For Instance,

  • In May 2024, Sanofi, Formation Bio, and OpenAI partnered to build AI-powered software to accelerate drug development and bring novel medicines to patients efficiently. The three teams will bring together data, software, and tuned models to develop custom, purpose-built solutions across the drug development lifecycle. (Source - Sanofi)

The contract research organizations (CROs) segment is expected to be the fastest-growing in the market as CROs incorporate AI to achieve significant value by streamlining recruitment, data management, monitoring, and compliance, reducing expenses while improving trial integrity. Automation reduces errors and allows proactive interventions for improved patient engagement and safety.

Regional Insight

Why is North America Dominated in AI in Clinical Trials for Drugs Market?

North America dominated the AI in clinical trials for drugs market as a strong presence of pharmaceutical and biotech companies in North America because to a large and growing population, strong R&D investment, robust intellectual property protection, an aging population and chronic diseases, innovation in drug discovery, and high spending on healthcare. With the continuously increasing demand for innovative treatments and a strong commitment to addressing chronic diseases, this increases the demand for AI in clinical trials for drug services.

For Instance,

  • In May 2025, FDA Commissioner Martin A. Makary, M.D., M.P.H., announced an aggressive timeline to scale use of artificial intelligence (AI) internally across all FDA centers, following the completion of a new generative AI pilot for scientific reviewers. The generative AI tools allow FDA scientists and subject-matter experts to spend less time on tedious, repetitive tasks that often slow down the review process. (Source - U.S. Food & Drug)

United States AI in Clinical Trials for Drugs Market Trends

Increasing technological developments, particularly in the sectors of artificial intelligence and machine learning in the United States, are due to a strong research and innovation ecosystem. Research labs such as DeepMind and OpenAI USA drive demand. The US government is increasing funding programs to support the healthcare sector. The United States has been a dominant force due it its hub of clinical research, and the presence of clinical trial infrastructure confirms that processes are streamlined and efficient in this region, which contributes to the growth of the market. 

For Instance,

  • In March 2025, Suvoda LLC, a global clinical trial technology company that specializes in complex studies in therapeutic areas like oncology, central nervous system (CNS), and rare disease, announced the early adopter launch of Sofia, an artificial intelligence assistant designed to simplify how study teams access and review clinical trial information. (Source - Suvoda)

Canada AI in Clinical Trials for Drugs Market

Canada captures 4% of worldwide clinical trials, is fourth in the rank of clinical trial sites, and is the G7 leader in clinical trial productivity. The country ranked third globally for the total number of advanced clinical trials and fourth for the total number of active trials in 2023, which is a major driver of the market. The increasing financial spending made by various drug companies operating clinical trial sites in Canada sets money back in the research sector, which contributes to the growth of the market.

Why Asia Pacific Region the Fastest Growing in Market?

The Asia Pacific region is projected to experience the fastest growth in AI in clinical trials for drugs market during the forecast period, due to with increasing population, Asia Pacific becoming a popular region for conducting clinical trials by providing lower trial expenses, access to large patient pools, and a favourable government environment. In APAC countries like Australia, Japan, and South Korea, there exists a properly established framework for clinical trials, with protocols and guidelines designed to create the highest standards of patient safety and data quality, which contributes to the growth of the market.

China AI in Clinical Trials for Drugs Market Trends

China has become a significant player in global drug development, driven by a rising focus on advanced therapies. This growth is strengthened by a supportive government environment that encourages innovation and accelerates drug approvals, which increases AI in clinical trials for drugs market. China has made noteworthy strides in digital healthcare, driven by a requirement to overcome systemic challenges like unequal access to quality medical care and an overburdened hospital system, which drives the growth of the market.

India AI in Clinical Trials for Drugs Market Trends

The increasing demand for reliable clinical research organizations in India has increased due to the growing focus on drug efficacy and safety. The significant role of the government in attracting India's participation in clinical trials. Also, growing spending in research and development, rising government initiatives, and worldwide collaborations drive the growth of the market.

Recent Advances in Technology are Driving Europe

Europe is expected to grow significantly in AI in clinical trials for drugs market during the forecast period, as it increases clinical trial capacity and improves infrastructure, and reduces bottlenecks through advanced site readiness, addressing staffing challenges, and lowering the inconsistency in health system awareness of clinical trials. Improving novel, patient-focused clinical trial designs to expand delivery efficiency at the same time as growing attractiveness to patients, which contributes to the growth of AI in clinical trials for drugs market.

Germany AI in Clinical Trials for Drugs Market Trends

Germany takes a significant step towards revitalizing the clinical trial sector in Europe. By addressing crucial operational risks and offering greater support for RP, DCTs, and CGT trials, these renovations can expressively impact the declining trend of clinical trial activity in the region. Germany is increasing modern technology and growing investment in clinical trials, which drives the growth of the market.

Top Companies in the AI in Clinical Trials for Drugs Market

AI in Clinical Trials for the Drugs Market Companies

Latest Announcements by Industry Leaders

In March 2025, Eric Lefkofsky, Founder and CEO of Tempus, stated, “Tempus Next, the platform’s infrastructure aligns with Tempus' strategy to improve clinical connectivity and enhance health care delivery.” (Source - Bio Pharma Trend)

Recent Developments in AI in clinical trials for drugs market

  • In May 2025, Fujitsu Limited and Tokai National Higher Education and Research System (THERS) announced the completion of field trials using generative AI to process clinical data for use in the selection of clinical trial participants. The effort goal to address the issue of drug loss in Japan. (Source - Fujitsu)
  • In July 2024, Exscientia plc announced expanding its work with Amazon Web Services (AWS) to use the cloud provider’s artificial intelligence and machine learning services to power its platform for end-to-end drug discovery and automation. Exscientia’s platform uses generative AI models and the flexibility and scalability of AWS to securely, rapidly, and efficiently design drug candidates that aim to better target specific diseases and patients, to accelerate early drug development at a lesser cost. (Source - Exscientia)
  • In April 2025, the Icahn School of Medicine at Mount Sinai launched the AI Small Molecule Drug Discovery Center, a bold endeavor that harnesses artificial intelligence (AI) to revolutionize drug development. The new Center will integrate AI with traditional drug discovery methods to identify and design new small-molecule therapeutics with unprecedented speed and precision. (Source - Mountsinai)

Segments Covered in the Report

By Offering

  • Software
  • Services

By Process

  • Trial Design
  • Patient Selection
  • Site Selection
  • Patient Monitoring
  • Data Management and Quality Control
  • Adverse Event Prediction & Detection
  • Drug Repurposing
  • Regulatory Compliance

By Clinical Trial Phase

  • Phase II
  • Phase I
  • Phase III
  • Phase IV

By Therapeutic Area

  • Oncology
  • Cardiovascular Disease
  • Neurological Disorders
  • Metabolic Diseases
  • Infectious Diseases
  • Immunology
  • Others

By Technology

  • Deep Learning
  • Generative AI
  • Natural Language Processing (NLP)
  • Machine Learning
  • Computer Vision
  • Other AI Technologies

By End-User

  • Pharmaceutical Companies
  • Contract Research Organizations (CROs)
  • Biotechnology Firms
  • Academic and Research Institutions
  • Regulatory Bodies
  • Others

By Region

  • North America
    • U.S.
    • Canada
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Thailand
  • Europe
    • Germany
    • UK
    • France
    • Italy
    • Spain
    • Sweden
    • Denmark
    • Norway
  • Latin America
    • Brazil
    • Mexico
    • Argentina
  • Middle East and Africa (MEA)
    • South Africa
    • UAE
    • Saudi Arabia
    • Kuwait
  • Last Updated: 10 June 2025
  • Report Covered: [Revenue + Volume]
  • Historical Year: 2021-2023
  • Base Year: 2024
  • Estimated Years: 2025-2034

Meet the Team

Shivani Zoting is a dedicated research analyst specializing in the healthcare industry. With a strong academic foundation, a B.Sc. in Biotechnology and an MBA in Pharmabiotechnology, she brings a unique blend of scientific understanding and strategy.

Learn more about Shivani Zoting

Aditi Shivarkar, with over 14 years of experience in consumer goods, leads research at Towards Consumer Goods, ensuring precise, actionable insights on trends, consumer preferences, and sustainable packaging for businesses.

Learn more about Aditi Shivarkar

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FAQ's

AI streamlines clinical trials by optimizing protocol design, predicting outcomes, and analyzing big datasets. It can aid participant recruitment by matching eligible patients to trials.

AI protocol design refers to the methodical process of incorporating artificial intelligence technologies into the preparation and execution of clinical trials.

Government of India, National Institutes of Health, FDA, WHO, PIB, CDC.