AI in Clinical Trials Market

AI In Clinical Trials Market Overview

The global AI in clinical trials market size  is estimated to be worth $ 8.5 billion in 2035, growing at a CAGR of 16% during the forecast period 2023-2035. The process of successfully developing a novel therapeutic intervention is both time and cost intensive. In fact, it is estimated that a drug requires around 10 years and over USD 2.5 billion in capital investment, before reaching the market. In this process, clinical trials play a crucial role by assessing the drug's efficacy and safety in humans. These trials account for nearly 50% of the time and capital expenditure during drug development. However, not all trials are successful, leading to delays and financial burdens for sponsors. Over the past few decades, the likelihood of a drug candidate successfully progressing from the start of clinical trials to obtaining marketing approval has remained relatively constant at approximately 10% - 20%. Factors contributing to clinical stage product failure include inadequate study design, incomplete patient recruitment, improper subject stratification, and high participant attrition. In attempts to address these challenges, stakeholders in the pharmaceutical industry are exploring solutions and strategies to streamline clinical trials.

One such innovative strategy involves integrating AI in drug development, which has the potential to revolutionize traditional methods, particularly in clinical trials. It is worth noting that artificial intelligence in clinical trials can help integrate and analyze large volumes of data, enabling trial sponsors to optimize future research initiatives. Additionally, by addressing issues related to trial design, patient recruitment and retention, site selection, data interpretation, and treatment evaluation, AI has the potential to enhance and refine the entire process of clinical drug development. Hence, with the rising interest of investors in this field, we anticipate the AI in clinical trials market to witness healthy growth during the forecast period.

Key Market Insights

The “AI in Clinical Trials Market (2nd Edition): AI Software and Service Providers, Distribution by Trial Phase (Phase I, Phase II and Phase III), Target Therapeutic Area (Cardiovascular Disorders, CNS Disorders, Infectious Diseases, Metabolic Disorders, Oncological Disorders and Other Disorders), End-user (Pharmaceutical and Biotechnology Companies, and Other End-users) and Key Geographical Regions (Asia-Pacific, Europe, Latin America, Middle East and North Africa, and North America): Industry Trends and Global Forecasts, 2023-2035” report features an extensive study of the current market landscape, market size and future opportunities associated with the AI in clinical trials market, during the forecast period 2023-2035. Further, the report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the AI in clinical trials market analysis are briefly discussed below. 

AI in Clinical Trials Market Landscape: AI Software and Service Providers

The AI in clinical trials market landscape features a mix of large, mid-sized and small companies. Currently, around 130 companies offer various AI based software and services to streamline clinical studies. Nearly 80% of these AI in clinical trials software and service providers leverage machine learning and deep learning algorithms, as it minimizes data-based errors by accessing various data points simultaneously. Recent developments in this field indicate that the artificial intelligence companies in clinical trials are upgrading their capabilities to accommodate the current and anticipated demand for these software and services.

Market Drivers: Increasing Demand for Artificial Intelligence Solutions and Funding Support from Venture Capital Firms

AI solutions have emerged as a promising tool in the drug development process. These AI tools help companies improve the accuracy and efficiency of testing, accelerate drug development and optimize clinical trial outcomes. In addition, leveraging AI software in clinical trials provides more accurate clinical data analysis, personalized medicine, trial design, real-time monitoring, increase patient recruitment and retention, reduces trial time and cost. It is worth highlighting that, the ability of AI to automate and streamline labor-intensive tasks, improve decision-making processes, and identify patterns and trends in complex datasets has garnered significant attention and interest from stakeholders in the pharmaceutical industry.

Furthermore, the venture capital firms are supporting the heightened interest in the AI in clinical trials market. Several investors have invested nearly $2.5 billion in the last five years in companies engaged in providing AI software and services for clinical trials. The majority of the funds have been raised through venture rounds, followed by seed financing rounds. In addition, several big pharma players, such as Bristol Myers Squibb, Merck, Novartis, Pfizer and Sanofi have also invested in AI software and service providers for clinical trials. In June 2021, Antidote Technologies has received a USD 23 million investment to expand its digital patient engagement programs and clinical trial recruitment services.  Such factors will continue to drive the AI in clinical trials market growth over the forecast period.

Market Restraints: Move Away from the Traditional Methods Will Pose Challenges

Although artificial intelligence is proving to be a pathbreaking technology in various industries, their application in clinical trials is still in its infancy. The pharmaceutical industry has an established clinical development process, which has been used since ages. Any new technology takes time to become a norm in the industry. Although, the drug developers are facing the challenge of enormous drug development costs, AI based tools and services will gradually be adopted as successful use cases come to light.

Integrating AI in clinical trials involve various challenges, such as ensuring data quality and availability, enhancing interpretability and transparency of AI algorithms, addressing regulatory compliance and ethical considerations, and relying on human expertise to validate and interpret AI-generated insights. Furthermore, incorporating AI tools into existing clinical trial processes and workflows can give rise to logistical and operational complexities.

Market Opportunity: Widening Application to Provide Growth Opportunities

Several artificial intelligence companies have developed AI-powered platforms that optimize patient identification for clinical trials. The AI algorithms can be trained to analyze large amounts of data in electronic health records to identify the eligible participants. As researchers identify new application areas, the demand for AI clinical trials is expected to continue to grow.

Market Trends Analysis: Increasing Number of Partnerships in the AI in Clinical Trials Market

In recent years, several stakeholders have inked partnerships with other industry / non-industry players related to AI in clinical trials market. It is worth highlighting that, since 2018, a significant number of strategic partnerships have been inked in the AI in clinical trials industry. It is worth highlighting that product / technology utilization and integration agreements are the most common types of partnerships inked by stakeholders in the AI clinical trials field. Owing to several advantages of artificial intelligence in clinical trials, the stakeholders are also acquiring other industry players offering AI solutions for different clinical trial applications in order to expand their capabilities and build a comprehensive product / service portfolio. In February 2023, ZS acquired Trials.ai, an intelligent study design company, to enhance its end-to-end solutions to reimagine study design for its clients. In addition, several big pharma companies, such as Bristol Myers Squibb, GlaxoSmithKline, Johnson & Johnson, Merck, Pfizer and Roche have also taken partnership initiatives related to AI in clinical trials, indicating the promise and benefits AI technology holds in clinical trials.

Market Segmentation

The AI in clinical trials market has been forecast across various segments including by their application in various trial phase (phase I, phase II and phase III). In terms of target therapeutic area market has been analyzed across cardiovascular disorders, CNS disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders. By end user the AI in clinical trials market is segmented across pharmaceutical and biotechnology companies, and other end-users. The market report also includes forecast across key geographical regions including Asia-Pacific, Europe, Latin America, Middle East and North Africa, and North America.

Therapeutic Area Market Segment Analysis: AI to Find Most Application in Clinical Trials for Oncological Disorders

Driven by the rising demand for artificial intelligence in clinical trials, lucrative opportunities are expected to emerge for players offering AI technology for clinical studies. The global AI in clinical trials market is anticipated to grow at a CAGR of 16% during the forecast period 2023-2035. Oncological disorders related clinical trials are most likely to adopt these AI solutions for streamlining processes, such as patient recruitment and retention, trial design, site selection, clinical data analysis, patient monitoring and personalized treatment. In May 2023, US based Owkin received letter of support from the European Medicines Agency (EMA) for the use of proprietary deep learning models for oncology clinical trial analysis, which the company believes can reduce the clinical trial failure rates in randomized clinical trial.

In terms of end-users, the biotechnology and pharmaceutical companies are likely to hold 75% share of the AI in clinical trials market. 

Phase of Development Market Segment Analysis

In the past six years, around 600 completed / ongoing clinical trials utilize AI tools and technologies for different therapeutic areas. This indicates the substantial efforts made by researchers engaged in AI in clinical trials industry. Primarily, most of the clinical studies are designed for the purpose of diagnostic and treatment. Interestingly, University of California, National Institute of Allergy and Infectious Diseases, and Mayo Clinic are among the most active sponsors of completed / ongoing clinical trials involving AI solutions. This market report looks at the phase of development of the clinical trials to understand in which phase are the drug developers most widely adopting AI tools / services.

Competitive Landscape: Top Artificial Intelligence Companies Supporting Clinical Trials

Examples of the key companies engaged in ai in clinical trials industry (the complete list of players is available in the full report) include (in alphabetic order) Acclinate, AiCure, Aidar Health, Aitia, A.I. VALI, Ancora.ai, Antidote Technologies, Beacon Biosignals, BUDDI.AI, ConcertAI, Curify, Deep 6 AI, ICON, Innoplexus, Massive Bio, Median Technologies, Novadiscovery, Owkin, PHASTAR, SiteRx and Viz.ai. This market report includes an easily searchable excel database of all the AI software / solution providers and service providers for clinical trials worldwide.

Recent Developments in AI Clinical Trials Market

Several recent developments have taken place in the field of AI clinical trials. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

• In August 2023, Texas Tech University Health Sciences Center entered into a collaboration with Deep 6 AI in order to launch an AI program for clinical trials. 
• In July 2023, Insilico Medicine announced the initiation of a phase II clinical trial evaluating the first fully AI designed drug, INSO18_055, for the treatment of idiopathic pulmonary fibrosis. 
• In June 2023, Anavex Life Sciences announced a strategic partnership with Partex Group with the aim to leverage Partex’s proprietary Artificial Intelligence (AI) technology to advance the development of Anavex's drug pipeline.

Scope of the Report

The market report presents an in-depth analysis of the various firms / organizations that are engaged in this market, across different segments, as defined in the below table:

AI in Clinical Trials Market (2nd Edition): AI Software and Services, Report Attribute / Market Segmentations

Key Report Attributes	Details
Base Year	2023
Forecast Period	2023 – 2035
Market Size 2023	$1.4 billion
CAGR	16%
Trial Phase	Phase I Phase II Phase III
Target Therapeutic Area	Cardiovascular Disorders CNS Disorders Infectious Diseases Metabolic Disorders Oncological Disorders Other Disorders
End-user	Pharmaceutical and Biotechnology Companies Other End-users
Key Geographical Regions	Asia-Pacific Europe Latin America  Middle East and North Africa North America
Key Companies Profiled	AiCure Antidote Technologies Deep 6 AI Innoplexus IQVIA Median Technologies Medidata Mendel.ai Phesi Saama Technologies Signant Health Trials.ai
Customization Scope	15% Free Customization Option (equivalent to 5 analysts’ working days)
Excel Data Packs (Complimentary)	Market Landscape Analysis Clinical Trial Analysis Funding and Investment Analysis Partnerships and Collaborations Analysis Big Pharma Initiatives Value Creation Framework Cost Saving Analysis Market Forecast and Opportunity Analysis

The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this market, across different geographies. Amongst other elements, the market report includes:

• An executive summary of the insights captured during our research. It offers a high-level view on the current scenario of AI in clinical trials market and its likely evolution in the mid to long term.
• A general overview of artificial intelligence  in clinical trials, highlighting details on artificial intelligence and its subfields. It also presents information on the applications of AI in healthcare and clinical trials, and challenges associated with the adoption of AI. Additionally, it features a discussion on the future perspectives of the AI in clinical trials industry.
• A detailed assessment of the current market landscape of the companies offering AI  software and service for clinical trials, based on several relevant parameters, such as year of establishment, company size (in terms of number of employees), location of headquarters, key offering(s) (device, technology / platform and service), business model(s) (software as a service (SaaS), technology licensing, CRO / fee-for-service model and product provider), deployment option(s) (cloud-based and on-premise), type of AI technology (machine learning, deep learning, natural language processing and others), application area(s) (data analysis, medical imaging, patient recruitment, trial design, site selection, patient engagement, integrated patient care, patient trial monitoring, personalized treatment and report generation) and potential end-user(s) (pharmaceutical / biotechnology companies, hospitals, research institutes and CROs).
• Elaborate profiles of the prominent companies (shortlisted based on a proprietary criterion) developing AI software / AI solutions and offering services for clinical trials. Each profile features a brief overview of the company (including information on its year of establishment, number of employees, location of headquarters and key members of the leadership team), financial information (if available), details related to AI-based clinical trial offerings, recent developments and an informed future outlook. 
• An insightful clinical trial analysis of completed / ongoing clinical trials leveraging AI, based on various relevant parameters, such as trial registration year, number of patients enrolled, trial phase, trial status, type of sponsor, patient gender, patient age, emerging focus areas, target therapeutic area, patient allocation model used, trial masking adopted, type of intervention, trial purpose, most active players (in terms of number of clinical trials sponsored)  and geography.
• A detailed analysis of the partnerships inked between stakeholders in the AI in clinical trials market, since 2018, covering product / technology utilization agreements, product / technology integration agreements, technology licensing agreements, research and development agreements, product development agreements, mergers and acquisitions, service agreements, service alliances and other relevant agreements.
• An analysis of the investments made, including seed financing, venture capital financing, capital raised from IPOs, grants, debt financing and other equity, and subsequent offerings, at various stages of development in start-ups, small and mid-sized companies that are focused on offering AI software and services for clinical trials.
• A detailed analysis of the initiatives taken by big pharma players related to AI in clinical trials, based on various relevant parameters, such as year of initiative, type of initiative, application area of AI, target therapeutic area and leading big pharma players (in terms of number of AI in clinical trials focused initiatives).
• An insightful framework depicting the implementation of several advanced tools and technologies, such as blockchain, big data analytics, real-world evidence, digital twins, cloud computing and internet of things (IoT) at different steps of a clinical study, which can assist service providers in addressing existing unmet needs. Further, it provides a detailed analysis on ease of implementation and associated risk in integrating above-mentioned technologies, based on the trends highlighted in published literature and patents.
• A detailed cost saving analysis, highlighting the overall cost saving potential of AI in clinical trials till 2035. We have highlighted the cost saving potential of AI in clinical trials for different trial phases (phase I, phase II and phase III) and trial procedures (patient recruitment, patient retention, staffing and administration, site monitoring, source data verification and other procedures).

One of the key objectives of this market report was to estimate the current market size, opportunity and the future growth potential of AI in clinical trials market, over the forecast period. We have provided informed estimates on the likely evolution of the market for the forecast period, 2023-2035. Our year-wise projections of the current and forecasted opportunity have been further segmented based on relevant parameters, such as trial phase (phase I, phase II and phase III), target therapeutic area (cardiovascular disorders, CNS disorders, infectious diseases, metabolic disorders, oncological disorders and other disorders), end-user (pharmaceutical and biotechnology companies, and other end-users) and key geographical regions (Asia-Pacific, Europe, Latin America, Middle East and North Africa, and North America). In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three market forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the market growth.

The opinions and insights presented in the report were influenced by discussions held with stakeholders in this industry. The report features detailed transcripts of interviews held with various industry stakeholders.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Frequently Asked Questions

Question 1: How is AI and ML used in clinical trials?

Answer: AI and machine learning are used in clinical trials to help in patient recruitment by analyzing large datasets to identify suitable candidates, improving trial design by simulating and optimizing protocols, and aiding in data analysis by automating the extraction and interpretation of information from medical records and trial data.

Question 2: What is the role of AI in electronic health records of clinical trials data?

Answer: AI can help automate data extraction and analysis from EHRs, improving efficiency and accuracy. Additionally, AI algorithms can identify patterns and trends in patient data, aiding in patient stratification, adverse event detection, and treatment response prediction.

Question 3: What is the global market size of AI in clinical trials market?

Answer: The global AI in clinical trials market is estimated to be worth $1.4 billion in 2023.

Question 4: Which are the leading artificial intelligence companies in clinical trials market?

Answer: At present, around 130 companies are engaged in providing AI software and services for clinical trials. Examples of top players engaged in this market (which have also been captured in this report) include Acclinate, AiCure, Beacon Biosignals, Labcorp, Owkin and SiteRx.

Question 5: How AI can improve clinical trials?

Answer: AI and machine learning can help reduce the time and cost associated with conducting clinical studies.

Question 6: What are the leading market segments in the global AI in clinical trials market ?

Answer: In terms of target therapeutic area, oncological disorders are likely to capture over 35% of the current AI in clinical trials market.

Question 7: Which region captures the largest share in the AI in clinical trials market?

Answer: Presently, the AI in clinical trials market is dominated by Asia-Pacific, capturing around 35% of the overall market size, followed by North America.

Question 8: What are the upcoming trends in AI in clinical trial market?

Answer: Integration of tools and technologies, such as digital twins, real-world evidence, blockchain, big data analytics, cloud computing and internet of things (IoT).

Question 9: What is the AI in clinical trial market growth rate?

Answer: The AI in clinical trials market is projected to grow at an annualized rate (CAGR) of 16%, during the forecast period 2023-2035.