Artificial Intelligence (AI)-Based Clinical Trials Solution Provider Market

Market Overview

The global artificial intelligence (AI)-based clinical trials solution provider market size was valued at USD 1.8 billion in 2022. It is estimated to reach USD 12.4 billion by 2031, growing at a CAGR of 22.6% during the forecast period (2023–2031).

Artificial intelligence (AI) is the word utilized to describe the development of original systems using software and algorithms capable of carrying out specific activities without the assistance or direction of humans. Several technologies, like natural language processing, ML, reasoning, and vision, are combined to create artificial intelligence. Pharmaceutical businesses can use healthcare AI development services to streamline the planning and execution of their clinical studies.

Artificial Intelligence-powered capabilities, such as data integration and interpretation, pattern recognition, and evolutionary modeling, are essential for collecting, normalizing, analyzing, and utilizing the expanding masses of data that drive the development of contemporary therapies. In addition, AI and advanced analytics hold the most promise for enhancing clinical R&D productivity. AI has many possible uses in both short- and long-term clinical studies. Clinical trial improvements made possible by AI technology include seamlessly integrating phases I, II, and III of trials, creating new patient-centered endpoints, and gathering and analyzing Real World Data.

Highlights

• Phase II dominates the clinical trial phase segment
• Oncology dominates the therapeutic application segment
• Pharmaceutical companies dominate the end-user segment
• North America is the highest shareholder in the global market

Market Dynamics

Market Drivers

Shift from Traditional Practices of Drug Development to a Technology-Based Approach

Adopting AI solutions in clinical trials can be beneficial in reducing clinical trial cycle time and cost and increasing productivity and accuracy of clinical development. For instance, a research collaboration of Exscientia and Sumitomo Dainippon Pharma combined Exscientia's AI-platform offering and Sumitomo Dainippon Pharma's expertise and experience in Monoamine GPCR to discover DSP-1181 in less than 12 months compared to the average time of 4.5 years using traditional drug development practices.

In addition to reducing the time in drug development, AI-based solutions can also be beneficial in reducing costs by more than 30%. The benefits of AI-based solutions in clinical trials support pharmaceutical companies' rising adoption of these solutions. For instance, as per an article published by GlobalData analysis and Clinical Trials Arena in 2021, the number of partnerships or collaborations between major AI-based drug discovery companies and pharmaceutical companies increased from 4 in 2015 to 27 in 2020. Such growing partnership activities further signify the development potential of the market for AI-based clinical trial solution providers in the coming years.

Growing Penetration of AI-Based Technologies in Various Healthcare Sectors

AI technology is used in multiple applications in healthcare areas, such as drug development and designing, automated imaging, and AI surgical robots. Technology giants, such as IBM and Google, are using historical patient data, both unstructured and structured, by mining medical records. Moreover, multiple national companies are investing in the AI space by acquiring smaller technology players, which depicts the growth potential of AI in the coming years. For instance 2014, Google acquired DeepMind to gain a competitive edge. These factors indicate the rising penetration of AI, which is likely to propel the adoption of AI in clinical trials, thereby boosting market growth.

Market Restraint

Shortage of Technologically Skilled Personnel

An increase in demand and supply gap concerning skilled professionals may be a key challenge for this market. AI technology is a highly advanced application of information technology, which requires technologically skilled employees to operate, upgrade, and access data within healthcare technology. Thus, the market is likely to witness hurdles in growth due to a shortage of skilled professionals. As per the statement by a cofounder of Holberton School, a U.S.-based coding academy, the shortage of software engineers is a real problem, and approximately 0.5 million computer jobs in the U.S. are vacant. Therefore, the shortage of workforce skilled in AI technology in healthcare challenges market growth.

Market Opportunities

Growing Government Support and Initiatives for Clinical Trials and Research

Favorable government support and stringent regulations about clinical trials are anticipated to boost the demand for adopting AI-based technologies, tools, and solutions. For instance, in 2020, the FDA launched a CTAP (Coronavirus Treatment Acceleration Program) to determine the possible therapies that would help speed up the development of treatment for the global disease burden caused by coronavirus. Advantages provided by AI-based technologies in better detection, enrollment, and management in clinical trials are anticipated to enhance market expansion during the forecast period.

In addition, governments of various developing and developed countries are striving hard to increase awareness regarding clinical trials and motivate patients to enroll. For instance, the UK government has launched a clinical trial program, "ACCORD"—The Accelerating COVID-19 Research and Development Platform—to fast-track the development of new drug candidates to treat hospitalized COVID-19 patients. Therefore, growing support from the governments of various countries concerning clinical research and development and increasing awareness regarding technologies such as AI for better clinical research are expected to create opportunities for market growth in the coming years.

Regional Analysis

Based on region, the global artificial intelligence (AI)-based clinical trials solution provider market is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the most significant global artificial intelligence (AI)-based clinical trials solution provider market shareholder and is anticipated to exhibit a CAGR of 18.9% during the forecast period. North America dominated the market with the biggest market share due to significant R&D expenditures, quick technological breakthroughs, increased use of technologically advanced solutions, the presence of international competitors, and their attempts to develop newer patents. In addition, there are increased funding and growth opportunities for startups in the region, which is expected to promote market growth. For instance, in 2020, Unlearn.AI, a U.S.-based company, received series A funding from 8VC, the country's leading venture capital company. This will help Unlearn expand its reach and increase its product portfolio. Such instances signify the growth potential of the market.

In addition, industry players are advancing their efforts to decrease timelines by adopting advanced technologies. Moreover, disruption caused by the COVID-19 pandemic has led to an increase in the adoption of AI-based clinical trial solutions in the region, which is expected to boost the market during the forecast period.

Europe is estimated to exhibit a CAGR of 21.0% over the forecast period. Countries like Germany and the UK have a large patient pool and advanced medical expertise. Doctors support clinical trials because it helps patients and research by attracting more participants. This acceptance and support from the medical fraternity have led to an increase in the adoption of patient-friendly and technologically advanced clinical trial solutions in the European region. In addition, legal aspects are developing in Germany but fully evolved in the UK and France. The regulations are formulated to ensure volunteers' safety, rights, and proper reimbursement. With clearer protocols and increased funding, Europe is expected to be a promising region for clinical trials. These factors are also expected to boost the adoption of AI-based solutions for clinical trial analysis and interpretation, propelling market growth. Other factors, such as greater access to a treatment-naïve patient pool, a higher concentration of patients near sites, cheap labor costs, and close relationships between doctors and patients, drive the market growth of AI-based clinical trial solution providers in Europe.

Asia-Pacific is the fastest-growing market, as many developed nations are investing in this region. It is also developing regarding healthcare infrastructure, technology, clinical research, and the adoption of advanced solutions. Compared to North America and Europe, clinical trial recruitment is growing in Asia. This is because there is a vast patient pool, and the trials are inexpensive. Additionally, according to the CEO of Novotech, clinical phase biotechnology companies now recognize Asia Pacific for accelerated patient enrollment, particularly in infectious diseases, oncology, metabolic disorders, immune-oncology, and rare diseases, as well as low cost of clinical research combined with skilled investigators and research teams. Clinical research activity has also increased by 10% yearly in the past few years. These factors support the penetration of technologically advanced solutions for clinical trials in the region.

In Latin America, 80% of the people reside in metropolitan cities. Megacities such as Sao Paulo, Buenos Aires, and Mexico City have a large patient pool. Although long regulatory timelines in Latin America are a drawback, the time saved in patient recruitment compensates for it. In addition to patient recruitment, patient retention is very high due to cooperative patient-physician relationships. Lower cost, highly qualified investigators, medical personnel, and study coordinators with GCP-compliant knowledge contribute to a higher clinical trial success rate. These factors support the adoption of advanced technological solutions in clinical research in the region.

In the Middle East and Africa, there are advantages to conducting clinical trials, such as patient diversity, cost advantage, well-developed infrastructure in some countries, and availability of world-class medical facilities. The only drawback is discrepancies between the laws of different countries. Many countries are trying to adapt to global standards and collaborating with other global pharmaceutical companies to mark their presence. These factors contribute to increased awareness and adoption of advanced solutions in the region for clinical research.

Segmental Analysis

The global artificial intelligence (AI)-based clinical trials solution provider market is segmented by clinical trial phase, therapeutic application, and end-user.

Based on the clinical trial phase, the global artificial intelligence (AI)-based clinical trials solution provider market is segmented into Phase-I, Phase II, and Phase III. 

The Phase-II segment owns the highest market share and is estimated to exhibit a CAGR of 18.5% during the forecast period. Phase 2 studies are performed in two parts: in the first part, the dose range is explored along with efficacy studies, while in further studies, the dose is finalized. In the case of oncology, phase 2 studies act as pivotal trials. In addition, Phase 1 evaluates the tolerability or PK of molecules as the endpoint to help approve the trial. Phase 2 clinical trials had the highest number of projects in 2016, and continuous investments in R&D by industry and non-industry sponsors are expected to boost the market's growth.

Phase 1 study assesses the safety of a device or drug, and this stage involves the evaluation of the tolerability and pharmacokinetics of molecules. It evaluates the absorption, metabolism, and excretion of a device or substance in humans. It also examines the adverse effects of drugs in case of increased dosage levels. The stage includes 20 to 100 healthy volunteers or people with the disease.

Based on therapeutic application, the global artificial intelligence (AI)-based clinical trials solution provider market is divided into oncology, cardiovascular diseases, neurological diseases or conditions, metabolic diseases, infectious diseases, and others. 

The oncology segment is the most significant contributor to the market and is estimated to exhibit a CAGR of 17.0% over the forecast period. The surging incidence of cancer across the globe is driving the need for increased clinical trials in the oncology space. As per WHO, in 2019, cancer was the first- or second-leading cause of death before 70 years of age in 112 countries out of 183 and was the third or fourth-leading cause of death in 23 countries. Furthermore, the number of clinical trials in the oncology field is increasing every year, boosting the adoption of AI-based solutions in oncology clinical trials.

Central nervous system diseases represent one of the major public healthcare challenges. CNS disorders account for about 600 disease conditions, including rare and well-known disorders like multiple sclerosis and Parkinson's disease. The cost and incidence of neurological disorders are anticipated to increase with the growing aged American population of 65 years and above. This number is projected to double from 43.1 million in 2011 to 83.7 million in 2050. Hence, the increasing population drives demand for effective treatments, aiding segment growth.

Based on the end-user, the global artificial intelligence (AI)-based clinical trials solution provider market is pharmaceutical companies, academia, and others. 

The pharmaceutical companies segment dominates the global market and is projected to exhibit a CAGR of 19.8% over the forecast period. The growing prevalence of chronic health conditions and deteriorating healthcare standards of the global population are boosting demand for innovation in the pharmaceutical place. In addition, major pharmaceutical companies are focusing on adopting AI-based solutions for their drug discovery and clinical trial studies to expand their business offerings rapidly. The utilization of these technological solutions enables pharmaceutical companies to enhance the accuracy and reliability of their clinical trial studies and eventually reduce the time taken as well as costs.

Academic institutes are focused on education, research, and clinical care. Research activities face challenges with several obstacles, such as a lack of funding. Over recent years, a reduction in funding has led academic institutes to explore new strategies and methods to continue their research activities. One such example is the adoption of AI and machine learning modules to provide data-driven insights to sponsors and stakeholders and enable efficient decision-making. The lack of research staff and other human resources restrains the growth of clinical trials undertaken by academic institutes.

Recent Developments

• June 2023- Saama introduced its unified platform of SaaS-based products to complement its existing tailored solutions and services portfolio. The new Saama platform utilizes its proven artificial intelligence (AI) and machine learning (ML)-enhanced solutions to automate important clinical development processes and provide a centralized view of trial operations and patient progress.
• April 2023- Vuno, a medical artificial intelligence (AI) solutions provider, was designated a U.S. patent for its AI-based medical image analysis technology. This patent covers a technology designed to facilitate rectifying lesion areas identified by medical personnel during the analysis of medical images.