PUBLISHER: Roots Analysis | PRODUCT CODE: 1319262
PUBLISHER: Roots Analysis | PRODUCT CODE: 1319262
The global AI in clinical trials market is estimated to be worth $ 1.4 billion in 2023 and expected to grow at compounded annual growth rate (CAGR) of 16% during the forecast period.
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 $ 2.5 billion capital investment, before reaching the market. , In this process, clinical trials play a crucial role for 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, sponsors face financial burdens and significant delays in marketing drugs due to unsuccessful clinical trials. Over the past few decades, the success rate of a drug candidate advancing the clinical trials to obtaining marketing approval has remained relatively constant at approximately 10% - 20%. This can be attributed to the factors contributing to clinical stage intervention failure, including inadequate study design, incomplete patient recruitment, improper subject stratification and high rate of clinical trial participant attrition. In order to overcome these challenges and streamline the clinical trial processes, stakeholders in the pharmaceutical industry are exploring innovative solutions and strategies. 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. Moreover, in the first nine months of 2021, more than $20 billion was invested into artificial intelligence companies focused on healthcare, exceeding the prior investment, which was around $15 billion in 2020. Therefore, 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.
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 (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa ): 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 given forecast period. 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 report are briefly discussed below.
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 helps increasing patient recruitment and retention, reduces trial time and cost, and provides more accurate clinical data analysis, personalized medicine, trial design and real-time patient monitoring. 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. 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; the company believes that this can reduce the clinical trial failure rates in randomized clinical trial. Further several artificial intelligence companies have developed AI-powered platforms that optimize patient identification for clinical trials. Additionally, AI algorithms can be trained to analyze large amounts of data in electronic health records to identify eligible participants.
Owing to these applications and recognition of the immense potential of AI by researchers and sponsors, the demand for AI clinical trials is likely to continue to grow and transform the landscape of drug development by improving patient outcomes in clinical trials.
The AI in clinical trials market landscape features a mix of large, mid-sized and small companies. Currently, around 130 players have the required expertise to offer various software and services to streamline clinical studies. Notably, at present, around 80% of these AI in clinical trials software and service providers are focusing on leveraging machine learning and deep learning algorithms, as they minimize 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.
In recent years, several artificial intelligence companies have inked partnerships related to AI in clinical trials domain with other industry / non-industry players. 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, stakeholders are acquiring other industry players offering AI solutions / AI software 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 (GSK), Johnson & Johnson, Merck, Pfizer and Roche, have also taken partnership initiatives related to AI in clinical trials, indicating the promise and benefits that AI technology holds in clinical trials.
In the past six years, around 600 completed / ongoing clinical trials utilized AI tools and technologies for evaluating drugs / therapies for different therapeutic areas, indicating the substantial efforts made by researchers engaged in this domain. Further, most of the clinical studies were designed for the purpose of diagnostics and treatment. It is worth noting that the University of California, the National Institute of Allergy and Infectious Diseases, and Mayo Clinic are among the most active sponsors of completed / ongoing clinical trials involving AI solutions.
The heightened interest in the AI in clinical trials market can be validated by the fact that, in the last five years, close to $2.5 billion has been invested in companies engaged in providing AI software and services for clinical trials by several investors based across the globe. 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 raised $23 million to expand its digital patient engagement programs and clinical trial recruitment services.
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 market for AI in clinical trials is anticipated to grow at a significant pace, with a CAGR of 16% during the forecast period. Among the therapeutic areas for which AI tools are leveraged in clinical trials, oncological disorders 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 terms of end-users, biotechnology and pharmaceutical companies are likely to hold the majority share (75%) of the AI in clinical trials market.
Examples of the key companies engaged in the AI in clinical trials domain (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 also includes an easily searchable excel database of all the AI software / AI solutions and service providers for clinical trials worldwide.
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:
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. Additionally, historical trends of the market have also been presented for the time period, 2018-2022. Further, our year-wise projections of the current and forecasted opportunity have been 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 (North America, Europe, Asia-Pacific, Latin America, and Middle East and North Africa). 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 also 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.
The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.
While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.
Answer: AI and machine learning are used to enhance various aspects of the clinical trial process. They can help in patient recruitment by analyzing large datasets to identify suitable candidates, improving the 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. Additionally, AI and ML can contribute to diverse event detection and monitoring, improving safety and efficiency in clinical trials.
Answer: AI and machine learning can help reduce the time and cost associated with conducting clinical studies.
Answer: Integrating AI in clinical trials involves 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 logistic and operational complexities.
Answer: AI in electronic health records (EHRs) of clinical trials offer several benefits. It 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. Furthermore, AI can assist in identifying potential eligibility criteria for clinical trials and facilitate the identification of suitable participants.
Answer: The field of AI is rapidly evolving; new trends and advancements of artificial intelligence in clinical trials include the integration of tools and technologies, such as digital twins, real-world evidence, blockchain, big data analytics, cloud computing and internet of things (IoT) in order to streamline clinical trials and achieve desired outcome.
Answer: The global AI in clinical trials market is estimated to be worth $ 1.4 billion in 2023.
Answer: In terms of target therapeutic area, oncological disorders are likely to capture close to 35% of the current market.
Answer: Presently, the AI in clinical trials market is dominated by North America, capturing around 35% of the overall market size, followed by Asia-Pacific.
Answer: The AI in clinical trials market is projected to grow at an annualized rate (CAGR) of 16%, during the forecast period 2023-2035.
Answer: At present, around 130 companies are engaged in providing AI software / AI solutions 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.
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