AI in Clinical Trials Market Size - By Component (Software, Service), By Technology (Machine Learning (ML), Natural Language Processing (NLP), Computer Vision, Contextual Bots), By Application, By End User & Forecast, 2024 – 2032

AI in Clinical Trials Market Size

AI in Clinical Trials Market size was valued at USD 1.3 billion in 2023 and is estimated to register a CAGR of over 14% between 2024 and 2032. AI technology can analyze vast datasets from biological research, clinical studies, and medical records more quickly and accurately than traditional methods. It reduces the time required for drug discovery and development by identifying potential drug candidates and predicting their effectiveness early in the process.
 

AI can sift through Electronic Health Records (EHRs) and other data sources to identify potential candidates who meet the specific criteria for a trial. This targeted approach increases recruitment efficiency. For instance, in April 2024, Tempus announced its AI-based platform, which identified eligible candidates for cancer trials 50% faster than traditional methods. This capability enhances the recruitment process, reducing the time to reach trial endpoints.
 

Running clinical trials is an expensive endeavor. AI can help reduce these costs by automating various aspects of the trial process, such as monitoring, data management, and even regulatory compliance. AI's ability to analyze genetic and molecular data allows for the development of personalized treatment plans tailored to individual patients' needs. For instance, in June 2024, Novartis used AI to design personalized treatment regimens for patients in its breast cancer trials. The AI models helped tailor treatments based on genetic profiles, leading to higher response rates and better patient outcomes.
 

The market faces several pitfalls and challenges that can impede its growth. AI algorithms require large volumes of high-quality, well-annotated data to function effectively. However, clinical trial data can be fragmented, inconsistent, and incomplete, leading to potential biases and inaccuracies in AI models. Integrating AI systems with existing clinical trial infrastructure, such as EHRs and clinical data management systems, can be technically challenging and resource intensive. Furthermore, AI models can inadvertently perpetuate existing biases present in the training data. In clinical trials, this can lead to inaccurate results and unequal treatment outcomes across different demographic groups.
 

AI in Clinical Trials Market Trends

Regulatory bodies, such as the FDA and EMA, are becoming more receptive to the use of AI in clinical trials. Efforts are underway to develop frameworks and guidelines for integrating AI technologies while ensuring patient safety and data integrity. The use of wearable devices and remote monitoring technologies is increasing, allowing continuous data collection outside of clinical settings. AI algorithms process this data to monitor patient health in real time and detect any adverse event promptly.
 

AI-driven predictive analytics are increasingly used to forecast patient responses to treatment and potential side effects, optimizing the decision-making process. Natural Language Processing (NLP) techniques are being used to extract valuable information from unstructured data sources such as clinical notes, research papers, and patient records. AI is facilitating the shift toward decentralized clinical trials, where participants can contribute data from their homes via wearable devices and tele-health services. Advanced AI algorithms are being used to analyze medical images for better diagnostics and monitoring in clinical trials.
 

AI in Clinical Trials Market Analysis

Based on component, the market is divided into software and service. The software segment was valued at over USD 800 million in 2023. AI software provides sophisticated tools that can process and interpret large volumes of clinical data efficiently, automating repetitive tasks, such as data entry, monitoring, and reporting, thereby reducing human errors. It integrates diverse data sources, including genomic data, medical images, and patient records and works with wearable devices and remote monitoring technologies, allowing continuous data collection outside of clinical settings.
 

AI enables real-time monitoring of trial data and patient health metrics, facilitating the development of personalized treatment plans based on genetic, phenotypic, and lifestyle information. For instance, in April 2024, BioXcel announced the success of its AI-driven platform in analyzing clinical trial data for its neuroscience drug candidates. The AI software helped identify patterns and biomarkers, enabling more precise patient stratification and improving trial outcomes.
 

Based on application, the AI in clinical trials market is categorized into drug development, drug discovery, clinical trial management, and others. The drug development segment is anticipated to register a CAGR of over 12% from 2024 to 2032. AI accelerates drug development by automating tasks such as data analysis, target identification, and clinical trial design, reducing development time and enabling faster time-to-market for new drugs. It also reduces costs by automating labor-intensive processes, optimizing trial designs, and improving patient recruitment and monitoring, making drug development more feasible and attractive.
 

Generative AI, an emerging subset, has the potential to create novel drug compounds, enhancing the R&D process of companies. For instance, in June 2024, Recursion announced the launch of BioHive-2, a supercomputer powered by NVIDIA's DGX AI technology. This new infrastructure significantly enhances Recursion's capabilities in AI-based drug development by training larger and more advanced AI models that accelerate the drug discovery process.
 

North America dominated the global AI in clinical trials market with a major share of over 40% in 2023. North America, particularly the U.S., hosts many of the leading pharmaceutical and biopharmaceutical companies, which are heavily investing in AI technologies to streamline clinical trials.
 

The region has a robust infrastructure and a high rate of adoption for advanced AI tools. There are substantial investments in R&D within the region, aimed at developing innovative AI solutions for clinical trials. This is further supported by governmental and private sector funding, enhancing the region’s capacity for cutting-edge clinical research. For instance, in January 2024, Accenture invested in QuantHealth, which uses AI to design and conduct clinical trials in the cloud, significantly accelerating the drug development process and reducing costs.
 

The AI in clinical trials market in Europe is experiencing significant growth due to several factors. Programs, such as the Horizon Europe framework, provide funding for AI and digital health projects. Europe has advanced digital infrastructure and widespread adoption of AI technologies in healthcare. European Medicines Agency (EMA) is actively promoting AI integration with guidelines for use in clinical trials, focusing on data quality, transparency, and ethical use.
 

In the Asia Pacific region, there is an increasing demand for efficient clinical trials due to the increase in chronic diseases and an aging population. Countries, such as China and India, are investing heavily in AI technology and healthcare innovation to reduce the burden of chronic diseases. Lower operational costs and a large patient pool make Asia Pacific an attractive destination for clinical trials.
 

AI in Clinical Trials Market Share

IBM, NVIDIA Corporation, and Insilico Medicine held significant market share of over 10% market share in 2023. The major players are leveraging their technological expertise and vast resources to drive innovation and efficiency in drug development processes. Companies like IBM and NVIDIA are utilizing advanced machine learning algorithms and data analytics to enhance patient recruitment, streamline data management, and predict clinical trial outcomes with greater accuracy. These technologies enable more efficient trial designs, reduced costs, and accelerated timelines, making the drug development process more effective and responsive to emerging healthcare needs.
 

Additionally, these companies are developing sophisticated AI-driven tools to analyze real-world evidence and genomic data, thereby improving patient stratification and treatment personalization. Through strategic partnerships and acquisitions, like IBM’s recent partnership with Bristol Myers, these major players are expanding their capabilities and strengthening their portfolios.
 

AI in Clinical Trials Market Companies

Major players operating in the AI in clinical trials industry are:

• Exscientia Ltd.
• International Business Machines Corporation (IBM)
• Insilico Medicine, Inc.
• IQVIA Holdings Inc.
• Medidata Solutions, Inc.
• Nuance Communications, Inc.
• NVIDIA Corporation
• Owkin Inc.
• Saama Technologies, Inc.
• Sensyne Health plc
• TrialTrove Inc.
   

AI in Clinical Trials Industry News

• In June 2024, Medidata Solutions announced the launch of its new AI-driven platform, ‘Medidata AI Insight’ aimed at enhancing real-time analytics and decision-making in clinical trials.
   
• In April 2024, IBM Watson Health formed a strategic partnership with Bristol Myers Squibb to integrate Watson’s AI technology into its clinical trial processes, focusing on accelerating patient recruitment and improving data analysis.
   

The AI in clinical trials market research report includes in-depth coverage of the industry with estimates & forecast in terms of revenue ($Bn) from 2021 to 2032, for the following segments:

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Market, By Component

• Software
  • Phase I
  • Phase II
  • Phase III
• Service
  • Phase I
  • Phase II
  • Phase III

Market, By Technology

• Machine learning
• Natural Language Processing (NLP)
• Computer vision
• Contextual bots
• Others

Market, By Application

• Drug development
• Drug discovery
• Clinical trial management
  • Patient recruitment
  • Clinical trial monitoring
  • Clinical data management
  • Risk-based monitoring
• Others

Market, By End User

• Pharmaceutical and biotechnology companies
• Contract Research Organizations (CROs)
• Academic and research institutes
• Others

The above information is provided for the following regions and countries:

• North America
  • U.S.
  • Canada
• Europe
  • UK
  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Nordics
  • Rest of Europe
• Asia Pacific
  • China
  • India
  • Japan
  • Australia
  • South Korea
  • Southeast Asia
  • Rest of Asia Pacific 
• Latin America
  • Brazil
  • Mexico
  • Argentina
  • Rest of Latin America
• MEA
  • UAE
  • South Africa
  • Saudi Arabia
  • Rest of MEA