AI-Based Clinical Trials Solution Market Size & Share Analysis - Trends, Drivers, Competitive Landscape, and Forecasts (2025 - 2030)

AI-Based Clinical Trials Solution Market Size

AI-Based Clinical Trials Solution Market Trends and Growth Drivers

Increasing Adoption of Real-World Evidence (RWE) Is Key Trend in Market

• A key trend in the AI-based clinical trials solution market is the use of real-world evidence for better trial design and recruitment of patients.
• Real-world evidence is data collected outside the traditional settings of clinical trials-including information from electronic health records, wearables, patient registries, and even social media.
• From the FDA reports, RWE can be a vital tool in understanding patient experiences, treatment efficacy, and safety to improve the designs and execution of clinical trials.
• Companies will come to understand where the patient populations were left unaddressed by traditional studies using RWE, thus enabling a clearer understanding of the efficacy of the drug among various demographics.
• It is expected that the acceptance to consider RWE from agencies such as FDA and EMA will drive the use of RWE in clinical trials. This also leads to increased efficiency in performing the trials but will lead towards a more patient-centric approach with better outcomes, and more accessible innovative therapies.

Adoption of Technology-Based Drug Development Approach Drives Market

• Drug discovery is a cost-intensive and time-consuming process. As per studies, the capital investment required for the complete cycle for a medicine to be available can be more than USD 1.2 billion, and the R&D period could be more than 10 years.
• The adoption of technologically advanced solutions in the drug development process can be beneficial in reducing the time and cost and increasing the safety and accuracy of new medicinal combinations.
• For instance, Exscientia (Recursion Pharmaceuticals) and Sumitomo Dainippon Pharma have embarked on a research collaboration that merges Exscientia’s AI platform with Sumitomo Dainippon Pharma’s expertise in Monoamine GPCR.
• This partnership led to the discovery of DSP-1181 in under 12 months, significantly faster than the traditional average of 4.5 years for drug development.
• In addition to reducing the time consumed by trials, ML-based solutions can also be beneficial in reducing costs by more than 30%.

Ensuring Data Quality and Integrity Are Major Challenge for Market

• Data quality and integrity are a major challenge in the AI-based clinical trials solution market. AI systems rely on the quality and accuracy of their data to assure proper analysis and decision-making.
• Faulty or incomplete data will eventually lead to incorrect results that imperil trust in AI applications.
• Poor data quality may therefore lead to serious implications on patient safety, regulatory compliance, and the validity of results in general clinical trial.
• For instance, AI algorithms can come up with misleading insights, whereby treatments are not efficacious or even not safe to be used in the market in case of erroneous or biased datasets.
• Moreover, if it contains data from various sources such as electronic health record, wearable and lab result, then complexity could be increased.
• Each source may have different formats, standards, and protocols which may give rise to discrepancies and inconsistencies. It is important that all data should be harmonized and standardized before feeding it into AI systems which is resource-intensive and very challenging.

AI-Based Clinical Trials Solution Market Analysis

Clinical Trial Phase Analysis

• The phase II category dominated the clinical trial phase segment with a revenue share of 40% in 2024, owing to the large number of registered validation cases active in the second phase.
• In addition, the category is growing as a result of the booming use of smart technologies for data gathering and the analysis of the immediate results of the study on the desired outcome in this stage.
• During the forecast timeframe, the phase I category is set to advance at the quickest rate. The applications of AI in phase I trials generally include patient recruitment and retention and trial design improvement.
•  Additionally, in phase I studies, these solutions help in creating distinct patient-centric outcomes and gathering real-world data.
• Furthermore, improvements in algorithms on machine learning continue to build the sophistication of predictive modeling in phase I trials that enables safer and more effective predictions at an earlier phase of the process.

The clinical trial phases analyzed in this report are:

• Phase-I (Fastest-Growing Category)
• Phase-II (Largest Category)
• Phase-III

Therapeutic Application Analysis

• The oncology category will hold the largest market share, of 30%, in 2024 and will grow at the highest CAGR of 15.0% in the forecast period.
• It accounts for significant market share as there is high demand for innovative treatments and heavy investment in cancer research and development.
• The growth rate is further fuelled by the increasing prevalence of several cancers across the globe.
• In addition, advancements in therapies, particularly immunotherapy and targeted treatments, are driving rapid change in the domain.
• Furthermore, research in oncology continues to accelerate with new approaches in cancer treatment, resulting in a massive expansion of the oncology market.

The therapeutic applications analyzed in this report are:

• Oncology (Largest and Fastest-Growing Category)
• Cardiovascular Diseases
• Neurological Diseases or Conditions
• Metabolic Diseases
• Infectious Diseases
• Others

End User Analysis

• Pharmaceutical companies will hold the largest market share, of 65%, in 2024, as these companies are the central drug developers and distributors, therefore make huge investment in R&D of drugs and therapies.
• They also have heavy investments in areas such as oncology, with immense demand for clinical trial solutions.
• Additionally, the competitive pharmaceutical industry compels a company to fasten up its timeline on the drugs in progress.
• The ongoing pressure to deliver efficacious therapy faster and faster has caused the need for innovative clinical trial methodologies and solutions to reach an all-time high in history.
• Academia will grow at the highest CAGR of 15.0% in the forecast period. Academia remains well-positioned to drive advancement of science into research and innovation within the clinical trials landscape.
• This category holds a much smaller market share than pharmaceutical companies, but it is growing increasingly important in basic research, early-stage drug discovery, and clinical investigation.

The end users analyzed in this report are:

• Pharmaceutical Companies (Largest Category)
• Academia (Fastest-Growing Category)
• Others

Regional Analysis

• North America dominates the artificial-intelligence-based clinical trial solution market with a revenue share of 45% in 2024, owing to the high R&D investments, growing adoption of technologically advanced solutions, presence of global players, and their efforts to come up with newer patents.
• With the increasing awareness regarding smart-technology-based tools and the rising adoption of AI, numerous startups offering advanced solutions are emerging, to take advantage of the market opportunities.
• The U.S. leads the list with about 150,000 studies conducted since 2008, because of the prominence and size of its pharmaceutical sector.
• Within the country, California accounts for the most studies, in part, because of its robust tech industry and desire for innovation.
• The U.S. is also on top among the investors in healthcare, due to its sizable population, established network of researchers, and expansive healthcare industry.
• Asia-Pacific is expected to exhibit lucrative growth over the forecast period due to the rising penetration of AI-based tools and favorable government initiatives for their adoption in different healthcare fields.
• As countries begin to liberalize the laws related to the usage of artificial intelligence in research, this technology is expected to witness an increasing demand.
• The demand for AI-based solutions is expanding as a result of the increasing use of smart technology in the development of advanced medicinal combinations.

The regions and countries analyzed in this report are:

• North America (Largest Regional Market)
  • U.S. (Larger Country Market)
  • Canada (Faster-Growing Country Market)
• Europe
  • Germany (Largest Country Market)
  • U.K.
  • France (Fastest-Growing Country Market)
  • Italy
  • Spain
  • Rest of Europe
• Asia-Pacific (APAC) (Fastest-Growing Regional Market)
  • Japan
  • China (Largest Country Market)
  • India (Fastest-Growing Country Market)
  • South Korea
  • Australia
  • Rest of APAC
• Latin America (LATAM)
  • Brazil (Largest Country Market)
  • Mexico (Fastest-Growing Country Market)
  • Rest of LATAM
• Middle East and Africa (MEA)
  • Saudi Arabia (Fastest-Growing Country Market)
  • South Africa
  • U.A.E. (Largest Country Market)
  • Rest of MEA

AI-Based Clinical Trials Solution Market Share

The AI-based clinical trials solution market is fragmented in nature. This is because of the wide variety of stakeholders such as pharmaceutical companies, biotechnology firms, CROs, and academic institutions that have different needs and preferences. The rapid rate of technological development produces a large number of new tools and platforms. In addition, a higher demand for targeted solutions that are apt to the specific design and regulatory requirements of diverse trails increases fragmentation.

AI-Based Clinical Trials Solution Company News

• In February 2024, Unlearn.ai Inc. secured USD 50 million in funding from Altimeter Capital, along with returning investors Radical Ventures, Wittington Ventures, Mubadala Capital, Epic Ventures, and Necessary Venture Capital.
• In February 2024, Saama Technologies LLC announced an expansion of its strategic partnership with Pfizer that began in 2020. This year, the collaboration has led to the automation of Pfizer's data review processes using AI technology, significantly streamlining their operations.
• In October 2023, Mendel Health Inc. introduced Hypercube, an AI copilot designed to enable life sciences and healthcare organizations to explore their vast patient data using a user-friendly chat-like interface.
• In January 2023, Deep 6 AI Inc. formed a partnership with Graticule to create advanced research algorithms and real-world data services aimed at enhancing patient identification and prioritization for clinical trials across multiple disease indications.