The Al in clinical trials market size is poised to reach USD 1,198.76 Million by 2024, with a projected escalation to USD 2,687.66 Million by 2032, reflecting a compound annual growth rate (CAGR) of 11.9% during the forecast period (2024-2032). 

The present times have seen a lot of growth in the market of artificial intelligence in clinical trials because of the growing requirement for patient-centered and patient-driven situated trials, whereby artificial intelligence is being deployed to enhance the remote monitoring of patients while improving retention and recruitment. The increase trend of personalized treatment also supports the expansion of artificial intelligence within the healthcare sector because such a system allows for detailed analysis of DNA information and guides treatment orientation. More than that, the need for artificial intelligence in managing data related to research as well as study data for the design of processes and formulation of decisions to a great extent supports growth. Also, the complexity of clinical data and its processing for the purpose of trials relies upon advanced analytics powered by artificial intelligence to manage volumes of data and to provide insights regarding the progress of trials.

Market Dynamics:

Driver:

Clinical studies act as the backbone for pharmaceutical and biotechnology companies that are developing drugs. Since the last decade, it has been noticed that a great demand for clinical studies is being faced worldwide, and due to the current medicinal needs, pressure to develop new therapeutics has also increased in proportion. By August of 2023, according to ClinicalTrials.gov nearly 461,614 clinical studies documented worldwide have emerged, which has increased very much from 5,475 in the year 2000. More clinical trials in the global market will increase the number of clinical trials in that region, hence the growth of the market. The World Health Organization's clinical trials registry reported in December 2022 that the highest concentration of clinical trials was seen in North America and Europe. The United States performed the largest number of clinical trials, accounting for about 23%, followed by China, Japan, India, and Germany. The pharmaceutical and biotechnology industry in the United States, which is highly developed, significantly contributes to the nation's success in leading the race in this field, alongside the consistently rising expenditure on research and development and the considerable number of contract research organizations.

Restraint:

It faces a problem in recruiting and retaining experienced personnel since CROS is just the same as that being offered by pharmaceutical and biotechnology companies, and that of academia and research, targeting scientists who are well-experienced and qualified. These issues will lead to pressure on firms to pay out better compensations and benefits, thus impacting the profit-making bottom lines, more significantly on smaller analytical testing companies. This can negatively influence the use of new technologies and practices and may hinder the clinical trials market growth over the next few years. The GWI Project recently concluded that, by 2025, there is a high demand-supply gap in the healthcare worker level and the situation will bring out one in three available job vacancies vacant. According to CareerBuilder, as of September 2022, only 5.7 million people are prepared to be hired in the United States, but there are 6.6 million clinical research positions that are open. Furthermore, there are seven positions available for every CRC who is eager to be hired. According to the Association of Clinical Research Organizations, there is a shortage in certain areas, including CTA and CRA. This is a decade-old crisis and mounting because the education of graduates is not suitably conducted by pharmaceuticals companies and CRO's to the end with right skills which match the current research demands of the Industry.

Opportunity:

Traditionally, pharmaceutical, biotechnology, and medical device businesses retained early-phase drug development projects and problem-solving within their firms and outsourced largely to the late stages of drug development and to routine processes. However, within recent years, increasing numbers of firms have allied at earlier stages in drug development in efforts to improve efficiencies. Most impurities would be structural elucidation with these specialized services, while class I and II removes the solvent. Hazard analysis, column chromatography removal, and reducing the costs of the process with all-inclusive efficiency improvement efforts is also made through these facilities. Such tests require expensive equipment, and skilled technicians. These pharma and biotech business desire outsourcing their specialized testing services from the CROS for saving more on equipment and labor. For instance, Pfizer, Merck, and Roche have reduced in-house testing services to fuel their R&D pipelines and satisfy the increasing demand for new drug compounds in a variety of therapeutic areas. Many pharmaceutical and biotechnology companies are focusing on diversifying their portfolios of products and innovating new small and big molecules. Companies are working on developing combination treatments, delivery devices, and reformulated or re-engineered drugs to fulfill the unmet needs. The clinical research industry collaborates directly with clients. It has greater technical depth to understand the complexities of products and devise innovative new solutions to hasten the delivery of life-critical clinical medicines. Other reasons large organizations outsource analytical testing are cost savings, improved efficiency, and ideal personnel. Therefore, the therapeutic pipeline is becoming increasingly complex; pharmaceutical companies are now resorting to outsourcing services to CROS in a quest for access to novel technologies that speed compound development along the product pipeline.

Challenge:

Data integration is shining a light on the big deal about patient privacy. With more and more databases popping up in research places, CROS, partners, and software companies, the chances of data breaches are going up. Remember the 2009 Health Information Technology for Economic and Clinical Health Act (HITECH Act) Well, it says that covered entities have to lock down individual health records and any other identifiable health info by putting good privacy safeguards in place. So, using electronic tools on patient databases brings up concerns about keeping patient records private, which is yet another big hurdle for pharma companies trying to follow privacy rules while using AI in their clinical trial software.

Key Players:

• IQVIA Inc. (US)
• Saama. (US)
• Dassault Systèmes (Medidata) (France)
• Phesi (US)
• PathAI, Inc. (US)
• Unlearn.ai, Inc. (US)
• Deep6.ai (US)
• Microsoft (US)
• IBM (US)
• NVIDIA Corporation (US)
• Insilico Medicine (US)
• ConcertAI. (US)
• AiCure. (US)
• Median Technologies. (France)
• Lantern Pharma Inc. (US)
• Citeline, a Norstella Company (US)
• Tempus AI, Inc. (US)
• TriNetX, LLC (US)
• ReviveMed Inc. (US)
• Euretos. (US)
• VeriSIM Life. (US)
• Triomics (US)
• Ardigen (Poland)
• QuantHealth Ltd. US)
• DEEP GENOMICS. (Canada)

Recent Development:

• In April 2024, IQVIA US collaborated with US-based Salesforce to speed the life sciences cloud development related to customer engagement.

• In February 2024, Saama collaborated with Pfizer Inc. from the US to expand their multi-year agreement to help scale Smart Data Quality, which leverages AI in streamlining and accelerating the review of data across the global clinical research portfolio for Pfizer.

Segment Insights:

By Function

Recruiting and retaining competent patients is one of the biggest challenges in conducting clinical research, and it's reported that about 30% of trials fail due to recruitment issues. AI-guided systems may quickly filter through various elements like EHRs, social networking sites, and databases for genes and identify the best individuals for a certain study, thus improving recruiting accuracy and speed. As a result, making major changes to the recruitment schedules at each step helps streamline the whole process of the trial, reduces costs, and even resources. Moreover, the fact that AI encourages patient participation in the treatment process through methods such as personalized messaging and predictive analytics lowers dropout rates, thus raising the chances of success of the trial. This demand for patient recruitment-focused AI-based development holds significant grounds in both the big pharma businesses and the macro-driven factors, and hence there exists a good likelihood that there will be an investment focus on patient recruitment, leading to a market share of AI within clinical trials.

By Application

Cell & gene therapy market segment to grow at a faster rate during the predicted period. This is one of those sectors that have accelerated further the personalization of medicine; that means therapy will foremost account for an individual's genetic makeup, something thriving in a lot of data and insights specific to that patient. It's easier to manage and analyze the genetic and clinical data due to the use of technology, such as AI. However, it improves the design of the trial and facilitates the selection of patients toward the advancement of cell and gene therapy. Some factors that have fueled investment in artificial intelligence through these clinical trials are the trend towards regulatory predisposition towards precision medicine, as well as the gigantic demand for the drugs focused on the rare diseases. With regard to growing efficiency, safety, and accuracy, the effort of AI solutions in leading the easily addressed issues around cell and gene therapies can support arguments for the sharp expansion of this segment using AI.

Regional Insights:

North America accounted for the biggest share of the AI in clinical trials market in 2023. North America, particularly the United States, has been at the forefront in the realization of artificial intelligence innovation and technology. Many top IT companies, academic institutions, and startups that focus on developing new AI solutions for various industries, including clinical trials and healthcare, are present in the region. It has invested heavily in financial and investment commitments in AI businesses and research projects. Private investors, government funding, and venture capital firms have shown an earnest interest to help advance and apply AI technology in healthcare, such as in clinical trials. North America led the market share of AI in clinical trials. A number of factors have made North America's market share the largest for AI in clinical trials. These include the region's advanced technology, the high expenditure on health care research and development, as well as the already established supportive clinical research environment. The United States has a marketplace that is dotted with strong pharmaceutical and biotechnology companies such as Pfizer, Johnson & Johnson, and Amgen, which invest large amounts of resources into the development of AI tools for drug synthesis, reducing turnarounds in drug designs and clinical trials.

Segmentation:

By Function 

• Clinical trial management

  • Patient recruitment

  • Clinical trial monitoring

  • Clinical data management

  • Risk-based monitoring

• Drug development

• Drug discovery

• Others

By Application 

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

By Application 

• Biomarkers
• Cell & Gene Therapy
• Regenerative Medicine
• Medical Devices & Diagnostics

By End-user 

• Pharma/Biotech
• CRO
• Hospitals
• Others

By Region

North America

• USA
• Canada
• Mexico

Europe

• France
• UK
• Spain
• Germany
• Italy
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• South Korea
• Rest of Asia Pacific

Middle East & Africa

• GCC
• South Africa
• Rest of the Middle East & Africa

South America

• Brazil
• Argentina
• Rest of South America

What to Expect from Industry Profile?

1. Save time carrying out entry-level research by identifying the size, growth, major segments, and leading players in the Al in Clinical Trials market in the world.

2. Use the PORTER’s Five Forces analysis to determine the competitive intensity and therefore market attractiveness of the Global Al in Clinical Trials market.

3. Leading company profiles reveal details of key Al in Clinical Trials market players’ global operations, strategies, financial performance & recent developments.

4. Add weight to presentations and pitches by understanding the future growth prospects of the Global Al in Clinical Trials market with forecast for the decade by both market share (%) & revenue (USD Million).

FAQ’s

1) What are the major factors driving the growth of the Global Al in Clinical Trials Market?

• The rising Adoption of Precision Medicine are the major factors driving the growth of the Global Al in Clinical Trials Market

2) What would be the CAGR of the Global Al in Clinical Trials Market over the forecast period?

• The Global Al in Clinical Trials Market is poised to grow at a CAGR of 11.9% from 2024 to 2032.

3) Which region will provide more business opportunities for the growth of the Global Al in Clinical Trials Market in the future?

• The North America region is expected to create more opportunities in the market.

4) Who are the major players dominating the Global Al in Clinical Trials Market?

• IQVIA Inc. (US), Saama. (US), Dassault Systèmes (Medidata) (France), Phesi (US), PathAI,  Inc. (US), Unlearn.ai,  Inc. (US), Deep6.ai (US), Microsoft (US), IBM (US), NVIDIA Corporation (US), Insilico Medicine (US), ConcertAI. (US), AiCure. (US), Median Technologies. (France), Lantern Pharma Inc. (US), Citeline,  a Norstella Company (US), Tempus AI,  Inc. (US), TriNetX,  LLC (US), ReviveMed Inc. (US), Euretos. (US), VeriSIM Life. (US), Triomics (US), Ardigen (Poland), QuantHealth Ltd. US), DEEP GENOMICS. (Canada), Others.

5) What are the segments in the Global Al in Clinical Trials Market?

• By Function, By Application, By End-user, By Technology are the industry key segments considered for research study.

6) What is the estimated market revenue for the Global Al in Clinical Trials Market in 2032?

The estimated revenue for the Global Al in Clinical Trials Market in 2032 is USD 2,687.66 Million.