Artificial Intelligence (AI) in Clinical Trials - Market Insights, Competitive Landscape, and Market Forecast - 2032

Artificial Intelligence (AI) in Clinical Trials Market by Product (Software and Services), Technology (Machine Learning (ML), Natural Language Processing (NLP), and Others), Application (Clinical Trial Design & Optimization, Patient Identification & Recruitment, Site Identification & Trial Monitoring, and Others), Therapeutic Area (Oncology, Cardiology, Neurology, Infectious Disease, Immunology, and Others), End-User (Pharmaceutical & Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World) is expected to grow at a steady CAGR forecast till 2032 owing to the rising prevalence of chronic diseases and increasing research collaboration and partnership activities among pharma and medical device companies.

The Artificial Intelligence (AI) in clinical trials market was valued at USD 1.35 billion in 2024, growing at a CAGR of 12.04 % during the forecast period from 2025 to 2032 to reach USD 3.33 billion by 2032. The demand for AI in clinical trials is witnessing robust growth, largely driven by the increasing global burden of chronic diseases such as diabetes, cardiovascular conditions, respiratory disorders, and cancer. This surge is further supported by rising investments and funding aimed at advancing drug discovery and development processes.

Moreover, the growing trend of strategic collaborations and partnerships among pharmaceutical, biotechnology, and medical device companies is playing a crucial role in accelerating the adoption of AI-powered clinical trial solutions. Collectively, these factors are expected to propel the expansion of the AI in clinical trials market throughout the forecast period from 2025 to 2032.

Artificial Intelligence (AI) in Clinical Trials Market Dynamics:

The growing prevalence of chronic diseases is expected to drive AI in clinical trial market growth. For instance, according to GLOBOCAN data from 2023, approximately 20 million new cancer cases were reported in 2022, with this number projected to rise to 32.6 million by 2045 around the world.

As per the data from the World Health Organization (WHO) 2024, in the Eastern Mediterranean Region, over 788,000 cancer diagnoses were recorded in 2022. This figure is anticipated to double to approximately 1.57 million cases by 2045.

According to data published by the British Heart Foundation 2024, approximately 640 million people globally were affected by heart and circulatory diseases, with these numbers anticipated to rise in the coming years. The same source notes that around 67 million individuals are diagnosed with heart or circulatory diseases each year.

Similarly, the global diabetes burden is rising rapidly. The International Diabetes Federation reported in 2023 that 537 million adults aged 20-79 were living with diabetes in 2021, a number expected to increase to 643 million by 2030 and 783 million by 2045.

According to the Asthma and Allergy Foundation of America in 2022, in the United States, asthma was a significant health concern affecting over 22 million adults aged 18 and older. Similarly, data from the Australian Bureau of Statistics in December 2023, the prevalence of asthma is increased from 2.7 million people in 2021 to 2.8 million in 2022. In general, females exhibited a higher propensity for asthma compared to males, with a prevalence rate of 12.2% versus 9.4%.

As the number of people suffering from chronic conditions such as diabetes, heart disease, respiratory diseases, and cancer continues to grow, pharmaceutical and biotechnology companies are increasingly conducting clinical trials to develop new treatments, drugs, and therapies specifically targeting these conditions. AI can help interpret vast amounts of trial data much faster than traditional statistical methods. Predictive models can flag inefficacious treatments or predict outcomes for specific patient subgroups. Therefore, the rising prevalence of chronic disease is driving the market growth.

The rising number of clinical trials worldwide is driving significant demand for AI in clinical trial, fueling market growth. According to ClinicalTrials.gov data, by December 2024, approximately 518,210 clinical trials were listed, up from 477,219 in 2023. This increase underscores the growing complexity of managing global trials, necessitating efficient systems for trial administration, patient management, and data collection. As the volume of trials continues to rise, the need for AI-driven clinical trials to streamline these processes becomes more critical, further accelerating the expansion of the AI in clinical trial market.

Increased funding and investment in drug discovery and development are significantly boosting the growth of the AI in clinical trial market. According to the data from the Pharmaceutical Research and Manufacturers of America (PhRMA) in September 2024, global biopharmaceutical R&D investment reached $276 billion in 2022, spread across 4,191 global companies.

This surge in R&D investment is further supported by government initiatives aimed at fostering industry-led research. For example, in August 2024, the UK government allocated EUR 12 million from the Innovate UK Cancer Therapeutics Programme to support the development of life-changing cancer treatments, including therapies for childhood and young adult cancers. Such public and private sector investments are fueling the development of new treatments and technologies, which in turn drives the demand for AI in clinical trial to manage these increasingly complex and diverse trials. This growing focus on R&D and innovation is expected to continue accelerating the market for AI clinical trial.

Additionally, key market players are increasingly leveraging artificial intelligence (AI) to enhance the efficiency of clinical trial feasibility studies. For instance, in June 2024, TrialX launched its AI-powered Clinical Trial Finder tool, designed to simplify access to comprehensive information on over 58,000 active clinical trials worldwide. This advanced tool utilizes cutting-edge AI to translate complex medical and trial-related data into clear, user-friendly language, making clinical research more accessible to a wider audience. Through the platform, patients and caregivers can register as volunteers, receive tailored trial notifications, and engage more effectively in the clinical research process, ultimately supporting greater participation and accelerating trial recruitment.

Thus, the interplay of aforementioned factors the market for the AI in clinical trials is anticipated to register significant growth during the forecast period from 2025 to 2032.

Despite these promising growth factors, the AI in clinical trial market faces challenges. Concerns regarding patient data & privacy and the complexity of AI integration in clinical trials are significant constraints that could potentially hinder market growth during the forecast period.

Artificial Intelligence (AI) in Clinical Trials Market Segment Analysis:

AI in Clinical Trials Market by Product (Software and Services), Technology (Machine Learning (ML), Natural Language Processing (NLP), and Others), Application (Clinical Trial Design & Optimization, Patient Identification & Recruitment, Site Identification & Trial Monitoring, and Others), Therapeutic Area (Oncology, Cardiology, Neurology, Infectious Disease, Immunology, and Others), End-User (Pharmaceutical & Biotechnology Companies and Medical Device Companies), and Geography (North America, Europe, Asia-Pacific, and Rest of the World)

In the product segment of the AI in clinical trials market, the software category is projected to register a significant revenue share in 2024. The growth of the clinical trial software category can be attributed to the increasing number of clinical trials conducted worldwide and rising R&D activities, along with enhanced research collaborations among key players. For example, data from the European Federation of Pharmaceutical Industries and Associations (EFPIA) (2024), revealed that approximately 4,000 trials are authorized annually across the European Economic Area (EEA).

Similarly, WHO (2024) reported 10,966 clinical trials in Southeast Asia in 2022, with this number rising to 11,030 in 2023. This growing volume of clinical trials is driving the demand for AI software and tools in clinical trial, contributing to the overall market growth.

AI software in clinical trial play a crucial role in developing and optimizing trial protocols, selecting appropriate study designs, better data management and study protocol, defining patient populations, and creating strategies to achieve trial objectives. These AI software streamline trial processes by automating administrative tasks, reducing paperwork, and enhancing data collection, allowing sponsors and researchers to focus on core activities and expedite trial execution. AI algorithms can analyze patient data to match eligible participants to trials more efficiently and helps identify patients more likely to stay through the trial, reducing drop-out rates. AI can simulate trial outcomes based on historical data to optimize trial protocols and it enables real-time adjustments to trial parameters for better results.

To address the increasing demands of clinical trials, key players in the market are developing innovative AI tools to enhance trial efficiency and optimization, enhance patient recruitment, and improved clinical trial design at investigator sites. For instance, in January 2025, Risklick launched Protocol AI, the first AI-powered software designed specifically for clinical trials in the medical device industry. Protocol AI streamlines trial development, significantly reducing time, costs, and risk, while accelerating patient access to innovative treatments. This breakthrough technology represents a major advancement in bringing medical devices to market more efficiently and cost-effectively.

Moreover, in April 2023, ConcertAI launched CTO 2.0, a clinical trial optimization solution that leverages publicly available data and partner insights to provide detailed site and physician-level trial information. It offers operational metrics and site profiles to assess trial performance and capabilities. CTO 2.0 also helps sponsors meet FDA mandates for inclusive trial outcomes, supporting the shift toward community-based trials and more efficient, patient-friendly designs.

Given these factors, the software category is expected to witness robust growth during the forecast period, thereby driving the overall expansion of the AI in clinical trials market.

North America is expected to dominate the overall Artificial Intelligence (AI) in Clinical Trials market:

North America is projected to account for the largest share of the AI in clinical trial market in 2024. This dominance can be attributed to several key factors, including the rising prevalence of chronic diseases in the region, significant investments in research and development, and the increasing number of clinical trials being conducted. Additionally, the growing trend of research collaborations and partnerships between pharmaceutical and medical device companies, coupled with the development of advanced AI solutions are fostering the market growth. These factors are fueling demand for AI-driven clinical trial to manage the complexities of trials, ultimately contributing to the growth of the AI in clinical trial market in North America during forecast period from 2025 to 2032.

Data from GLOBOCAN (2024), stated that there were 2,380,189 cancer cases in US in the year 2022, with projections suggesting an increase to 2,791,752 cases by 2030. Data from American Cancer Society (2025), reported that 2,041,910 new cancer cases expected to be diagnosed in 2025 in the US. AI in cancer trials analyzes genomic and imaging data to identify biomarkers and match patients to targeted therapies to assess tumor progression or treatment outcomes, improving trial precision and success rates.

Furthermore, the Centers for Disease Control and Prevention (CDC) (2024), reported that in 2022, there were an estimated 31,800 new cases of HIV infection in the United States. The increasing burden of chronic and infectious disorders is further expected to fuel the demand for AI-driven clinical trials as AI tools accelerates identification of promising candidates and trial participants through data mining thereby streamlining clinical trial conducted in infectious disease drugs.

According to the American Heart Association (2024), approximately 9.7 million adults are living with undiagnosed diabetes, while 29.3 million have been diagnosed. Furthermore, 115.9 million Americans were reported to be dealing with pre-diabetes as of 2021. AI clusters patients based on disease progression, comorbidities, and lifestyle to tailor interventions and integrate CGM data with clinical trial data for real-time insights.

According to an article published by the CDC (2024), approximately 6.2 million adults were suffering from heart failure in the US in 2022. Same sources further stated that around 20.5 million individual were living with coronary heart disease as of 2022. Furthermore, an estimated 6.5 million individuals aged 40 and older were diagnosed with peripheral artery disease (PAD) in the same year. AI is revolutionizing clinical trial in cardiovascular disease by analyzing ECGs, genomic data, and patient histories to identify individuals at high risk for heart failure and other cardiovascular diseases. This data-driven approach enables early intervention and supports the development of advanced therapies.

Moreover, leading industry players in North America are investing heavily in research and development to introduce advanced AI-based tools to accelerate clinical trials. For example, in October 2022, Phesi launched its AI-powered Trial Accelerator™ platform, designed to optimize clinical trial planning through real-time scenario modeling. Leveraging the world’s largest and most dynamic clinical trial database, this SaaS solution enables clinical development teams to simulate trial outcomes and optimize patient recruitment, endpoint selection, country strategy, and investigator site allocation, ultimately enhancing trial efficiency and success.

Similarly, in October 2023, H1 announced the launch of GenosAI™, a generative AI tool integrated into its Trial Landscape platform to enhance clinical trial intelligence. GenosAI empowers pharmaceutical companies to analyze complex datasets, streamline trial-related queries, and accelerate site and principal investigator (PI) selection, enabling faster, more informed clinical trial launches.

Hence, all the above mentioned factors are anticipated to register significant growth during the forecast period from 2025 to 2032 in the AI in clinical trials market.

Artificial Intelligence (AI) in Clinical Trials Market Key Players:

Some of the key market players operating in the AI in Clinical Trials market include TEMPUS, NetraMark, ConcertAI, AiCure, Medpace, Inc., ICON plc, Charles River Laboratories, Dassault Systèmes, Oracle, Certara, Cytel Inc., Phesi, DeepHealth, Unlearn.ai, Inc., H1, TrialX, Suvoda LLC, Risklick, Lokavant, Research Solutions, and others.

Recent Developmental Activities in the Artificial Intelligence (AI) in Clinical Trials Market:

• In March 2025, Suvoda has launched Sofia, an AI-powered assistant designed to streamline clinical trial management. Built to support study teams, Sofia simplifies access to and review of critical trial information by delivering intelligent, real-time insights. This innovation enhances operational efficiency, reduces manual workload, and empowers teams to make faster, data-driven decisions throughout the trial lifecycle.
• In December 2024, ConcertAI and NeoGenomics announced the launch of CTO-H, a next-generation AI software solution for research analytics, clinical trial design, and operational optimization. CTO-H delivers an unparalleled research data platform, offering unmatched scale, longitudinal patient insights, and deep biomarker data, enabling more precise, efficient, and data-driven clinical development strategies.
• In June 2024, Lokavant launched Spectrum™, the first AI-driven clinical trial feasibility solution designed to optimize trial performance across the entire clinical development value chain. Spectrum empowers study teams to predict, manage, and optimize trial timelines and costs in real-time.

Key Takeaways from the Artificial Intelligence (AI) in Clinical Trials Market Report Study

• Market size analysis for current AI in clinical trials market size (2024), and market forecast for 8 years (2025 to 2032)
• Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures happened over the last 3 years.
• Key companies dominating the AI in clinical trials market
• Various opportunities available for the other competitors in the AI in clinical trials market space.
• What are the top-performing segments in 2024? How these segments will perform in 2032?
• Which are the top-performing regions and countries in the current AI in clinical trials market scenario?
• Which are the regions and countries where companies should have concentrated on opportunities for AI in clinical trials market growth in the coming future?

Target Audience Who Can be benefited from this Artificial Intelligence (AI) in Clinical Trials Market Report Study

• AI in clinical trials product providers
• Research organizations and consulting companies
• AI in clinical trials-related organizations, associations, forums, and other alliances
• Government and corporate offices
• Start-up companies, venture capitalists, and private equity firms
• Distributors and traders dealing in AI in clinical trials
• Various end-users who want to know more about the AI in clinical trials market and the latest technological developments in the AI in clinical trials market

Frequently Asked Questions for the Artificial Intelligence (AI) in Clinical Trials Market:

1. What is Artificial Intelligence (AI) in Clinical Trials?

• Artificial Intelligence (AI) in clinical trials refers to the use of advanced algorithms and machine learning techniques to enhance the design, execution, monitoring, and analysis of clinical studies. AI can process large and complex datasets such as electronic health records, genomics, imaging, and real-world data, to optimize patient recruitment, predict trial outcomes, improve protocol design, monitor safety in real-time, and reduce trial costs and timelines. By automating and enhancing decision-making, AI supports more efficient, accurate, and inclusive clinical research.

2. What is the market for Artificial Intelligence (AI) in Clinical Trials?

• The Artificial Intelligence (AI) in clinical trials market was valued at USD 1.35 billion in 2024, growing at a CAGR of 12.04 % during the forecast period from 2025 to 2032 to reach USD 3.33 billion by 2032.

3. What are the drivers for the global Artificial Intelligence (AI) in Clinical Trials market?

• The demand for AI in clinical trials is witnessing robust growth, largely driven by the increasing global burden of chronic diseases such as diabetes, cardiovascular conditions, respiratory disorders, and cancer. This surge is further supported by rising investments and funding aimed at advancing drug discovery and development processes. Moreover, the growing trend of strategic collaborations and partnerships among pharmaceutical, biotechnology, and medical device companies is playing a crucial role in accelerating the adoption of AI-powered clinical trial solutions. Collectively, these factors are expected to propel the expansion of the AI in clinical trials market throughout the forecast period from 2025 to 2032.

4. Who are the key players operating in the global Artificial Intelligence (AI) in Clinical Trials market?

• Some of the key market players operating in the AI in Clinical Trials market include TEMPUS, NetraMark, ConcertAI, AiCure, Medpace, Inc., ICON plc, Charles River Laboratories, Dassault Systèmes, Oracle, Certara, Cytel Inc., Phesi, DeepHealth, Unlearn.ai, Inc., H1, TrialX, Suvoda LLC, Risklick, Lokavant, Research Solutions, and others.

5. Which region has the highest share in the global Artificial Intelligence (AI) in Clinical Trials market?

• North America is projected to account for the largest share of the AI in clinical trial market in 2024. This dominance can be attributed to several key factors, including the rising prevalence of chronic diseases in the region, significant investments in research and development, and the increasing number of clinical trials being conducted. Additionally, the growing trend of research collaborations and partnerships between pharmaceutical and medical device companies, coupled with development of advanced AI solutions are fostering the market growth. These factors are fueling demand for AI-driven clinical trial to manage the complexities of trials, ultimately contributing to the growth of the AI in clinical trial market in North America during forecast period from 2025 to 2032.

This product will be delivered within 2 business days.