AI in Clinical Trials Market Report 2025

The AI in clinical trials market size has grown exponentially in recent years. It will grow from $6.57 billion in 2024 to $9.21 billion in 2025 at a compound annual growth rate (CAGR) of 40.2%. The growth in the historic period can be attributed to data accumulation in healthcare, computing power advancements, FDA support for AI, rise of wearable devices, early AI algorithms development.

The AI in clinical trials market size is expected to see exponential growth in the next few years. It will grow to $38.7 billion in 2029 at a compound annual growth rate (CAGR) of 43.2%. The growth in the forecast period can be attributed to real-world data integration, ai-powered patient recruitment, AI-driven biomarker identification, AI-driven trial design optimization, continuous monitoring technology. Major trends in the forecast period include federated learning approaches, AI in adaptive trials, AI-supported outcome prediction, ai-driven drug development, ai-powered drug repurposing.

The increasing prevalence of chronic and infectious diseases is expected to drive the growth of the AI in clinical trials market in the future. Chronic diseases are defined as illnesses that persist for three months or longer and can worsen over time. The application of artificial intelligence in clinical trials is beneficial for developing various drugs aimed at treating chronic conditions. For example, in June 2022, data released by Macmillan Cancer Support, a UK-based cancer charity, indicated that the number of individuals living with cancer reached 3 million in 2022 and is projected to rise to nearly 3.5 million by 2025 and 4 million by 2030 in the UK. Furthermore, in August 2024, the UK Health Security Agency, a UK-based executive agency, reported 368 cases of measles in England for 2023, which represents a nearly sevenfold increase from the 53 cases reported in 2022, with the West Midlands and London contributing to 44% and 33% of the cases, respectively. Therefore, the rising incidences of chronic and infectious diseases are driving the growth of the AI in clinical trials market.

The burgeoning pharmaceutical sector is anticipated to be a driving force behind the expansion of AI implementation in the clinical trials domain. This sector encompasses the discovery, development, and manufacturing of drugs and medications by governmental and private entities alike. Artificial intelligence integration within clinical trials within the pharmaceutical industry serves to heighten efficiency, hasten drug development processes, and refine decision-making protocols. AI technologies meticulously analyze extensive datasets, forecast patient responses, identify suitable trial participants, and optimize trial frameworks, resulting in more cost-efficient and streamlined clinical trials. For instance, statistics from the European Federation of Pharmaceutical Industries and Associations (EFPIA) as of June 2023 indicate that the overall pharmaceutical production in Europe reached $384.2 billion (€340,000 million) in 2022, marking an approximate 4.95% increase from $366.26 billion (€323,950 million) in 2021. Consequently, the escalating expansion of the pharmaceutical industry is a driving force behind the growth of AI integration in the clinical trials sector.

The surge in technological advancements stands as a pivotal trend gaining traction within the AI in clinical trials market. Entities entrenched in this market segment are actively embracing novel technologies to fortify their standing. An illustrative instance is the introduction, in February 2023, by Lantern Pharma, a US-based clinical-stage oncology company, of its distinctive RADR artificial intelligence (AI) and machine learning (ML) platform. This innovation aims to revolutionize the cost, pace, and duration associated with discovering and developing oncology medications. The RADR advancements primarily focus on pioneering AI and ML methodologies tailored to craft antibody-drug conjugates (ADCs). These ADCs, comprised of precisely targeted antibodies linked to potent anti-tumor small molecules, offer promising treatment avenues for cancer.

Major players within the AI in clinical trials sector are embracing a strategic partnership approach to introduce enhanced research tools and workflow efficiencies, leading to augmented timelines and improved patient recruitment. Strategic partnerships signify a collaborative process wherein companies capitalize on each other's strengths and resources to achieve mutual advantages and success. An exemplification of this strategy occurred in February 2023 when a US-based pharmaceutical commercial company partnered with Haystack Health, a US-based software development enterprise. Their partnership aims to harness the potential of AI and Natural Language Processing (NLP) to expedite clinical trials, enhance patient recruitment, and diminish the screen failure rate, which incurs considerable time and financial costs. This collaboration intends to leverage clinical AI and pre-screening services to achieve these goals effectively.

In October 2022, Beckman Coulter Diagnostics, a clinical diagnostics company based in the United States, successfully acquired StoCastic LLC for an undisclosed amount. This strategic acquisition is poised to enhance evidence-based Clinical Decision Support (CDS) capabilities and leverage Beckman Coulter Diagnostics' biomarkers to generate improved decision-support insights. The integration of StoCastic's artificial intelligence expertise into Beckman Coulter Diagnostics' offerings aims to empower clinicians to make more informed decisions quickly, ultimately contributing to enhanced patient outcomes. StoCastic LLC, based in the United States, is an artificial intelligence company specializing in the development of healthcare software.

Major companies operating in the AI in clinical trials market include Intel, The International Business Machines Corporation (IBM), Koninklijke Philips N.V., ConcertAI, Samaa Technologies, Owkin Inc., Numerate, Neuroute, AiCure, Ardigen, Unlearn AI, PathAI, Exscentia, Aitia Infotech Pvt Ltd., Euretos, VeriSIM Life, Envisagenics, NURITAs, BioSymetrics, BioAge Labs Inc, Trials.Ai, Pharmaseal, Caylx, IQVIA.

North America was the largest region in the AI in clinical trials market in 2024. The regions covered in the ai in clinical trials market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, Africa. The countries covered in the ai in clinical trials market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

AI in clinical trials involves the application of artificial intelligence (AI) technologies and techniques in the planning, design, execution, and analysis of clinical trials. Clinical trials are rigorous research studies that assess the safety and effectiveness of medical interventions, such as new drugs, medical devices, or treatment protocols, in human subjects.

The primary offerings for AI in clinical trials include software and services. AI in clinical trial services encompasses the investigation and generation of insights from past and current clinical trials. Various processes, including trial design, patient selection, site selection, and patient monitoring, leverage technologies such as machine learning, deep learning, supervised learning, and other machine learning technologies. These applications span across various medical fields such as oncology, neurological diseases, cardiovascular diseases, metabolic diseases, infectious diseases, and immunology diseases. The end-users of AI in clinical trials include pharmaceuticals and biotechnology companies, contract research organizations, and others.

The AI in clinical trials market research report is one of a series of new reports that provides AI in clinical trials market statistics, including AI in clinical trials industry global market size, regional shares, competitors with AI in clinical trials market share, detailed AI in clinical trials market segments, market trends, and opportunities, and any further data you may need to thrive in the AI in clinical trials industry. This AI in clinical trials market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The AI in clinical trials market consists of revenues earned by entities by providing AI software solutions and platforms designed to assist in various aspects of clinical trials, such as trial design, patient recruitment, data collection, monitoring, and analysis, data analytics and insights, predictive modeling and simulation, regulatory compliance, and safety monitoring. The market value includes the value of related goods sold by the service provider or included within the service offering. The AI in clinical trials also includes sales of computer vision technology, cognitive computing, and machine translation technologies which are used in providing clinical trials. Values in this market are ‘factory gate’ values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors, and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

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