Clinical Trials Market Size & Forecast

The Clinical Trials Market is projected to reach $102.20 billion by 2031, growing at a CAGR of 7.2% from 2024 to 2031. The growth of this market can be attributed to various factors, including increasing focus on rare diseases, rise in adoption of personalized medicine, increasing research and development expenditure, and improving recruitment in clinical trials resulting in the retention of participants.

Furthermore, patient-centric clinical trials using the Internet of Medical Things (IoMT), advancements in cloud-based systems for pharmacovigilance, and integration of AI in clinical trials are expected to offer growth opportunities.

Clinical Trial Market Growth Drivers

Increasing Focus on Rare Diseases

Rare diseases are characterized by a wide range of symptoms and signs that vary not only from disease to disease but also from patient to patient suffering from the same condition. According to the National Organization for Rare Disorders, Inc. (U.S.), more than 10,000 rare diseases have affected approximately 30 million Americans. Additionally, according to the European Commission, up to 36 million people in the European Union live with a rare disease, and more than 6000 distinct rare diseases prevail in the European Union. Owing to the increasing cases, various companies have started clinical trials for rare diseases. For instance, Pfizer Inc. (U.S.) conducted clinical trials for hemophilia, transthyretin amyloidosis, and Duchenne muscular dystrophy. Also, in February 2024, AstraZeneca PLC (U.K.) proposed an innovative open-label clinical trial design before regulators for utilizing a control group from prior trials for neuromyelitis optica spectrum disorder (NMOSD), a rare autoimmune disease, instead of a placebo group. This also led to significant interest from the patient community. Thus, the increasing cases of rare diseases are expected to propel the demand for new drugs, which is expected to drive the clinical trials market.

Increasing Pharmaceutical R&D Expenditure

Pharmaceutical companies constantly focus on R&D, which is a core aspect of drug development processes. The biotechnology industry also invests heavily in R&D to cater to the growing demand for innovation and new medical breakthroughs. The importance of R&D is evident due to the rising number of drug approvals. For instance, according to the Congressional Budget Office report of April 2021, the expenditure on research and development has risen by nearly 50 percent in the years 2015 to 2019. Clinical trials have allowed the pharmaceutical industry to develop precision medicines and discover new biomarkers in a shorter period and with low costs. Increasing R&D investments in the pharmaceutical & biotechnology sectors are expected to boost the utilization of advanced clinical trial services, driving the clinical trials market.

Clinical Trials Market Trends

Use of Wearable Technology for Clinical Trials

In clinical trials, remote patient monitoring makes it easier for patients to participate and improves recruitment through greater access to diverse patient populations. The use of wearable technology for clinical trials has offered new opportunities for better understanding patients and improving their experience in their journey of clinical trials. Wearable devices have become essential for clinical research as they enable research studies to collect health-related data. For instance, Avantor, Inc. (U.S.), a company providing clinical trial services, reported that around 1,400 clinical trials had been conducted using clinical trials. The studies included therapeutic areas such as cancer, asthma, diabetes, and schizophrenia. Wearable sensors and devices enable the collection of more insightful data for enhancing the understanding of the effects of treatment. Such advantages of wearable technology have further enhanced the use of wearable technology, further easing the way clinical trials are conducted, which is driving the growth of the market.

Incorporating Digital Health Technologies into Clinical Trial

Big Data and AI technologies can work in tandem and serve a major purpose in conducting clinical trials, as AI can assist in analyzing and integrating the mounting data. Advanced analytics and AI are considered the most advanced digital technologies with a high capability to improve clinical research and development productivity. AI technologies are capable of transforming clinical trials, which include developing new patient-centered endpoints, combining phase I and II of clinical trials, and evaluating and collecting real-world data. For instance, in April 2024, Risklick AG (Switzerland) launched Protocol AI, an AI-based software designed to cut down the time required to make a study protocol for a clinical trial. Similarly, in February 2024, Castor Research Inc. (U.S.) collaborated with Microsoft Corporation (U.S.) to bring Microsoft Azure, a modern artificial intelligence tool, into clinical trials. Such instances and the use of AI in modern clinical trials are expected to drive the clinical trials market.

Clinical Trial Market Opportunity

Patient-centric Clinical Trials with the Internet of Medical Things (IoMT)

Internet of Medical Things (IoMT) includes medical devices, applications, and wearable monitors that connect to healthcare information systems that can increase clinical trial efficiency and enhance the ability to support patients throughout their clinical trial journey. Connected devices and applications incorporate the Internet of Medical Things that assist in continuous data monitoring, improve study oversight, reduce site visits, and ensure patient safety, leading to reduced costs and reduced study timelines. Furthermore, the incorporation of electronic health records (EHR) for study design offers participants greater access to trials. Incorporating IoMT has proven to improve the participant experience in clinical trial designs, eventually bringing new and advanced treatments for patients as soon as possible. Such advantages offered by the Internet of Medical Things are expected to drive the growth of the clinical trials market.

Clinical Trials Market Analysis: Key Findings

By Phase: In 2024, the Phase III Segment to Dominate the Clinical Trials Market

Based on phase, the clinical trials market is segmented into pre-clinical trials, phase I, phase II, phase III, and phase IV. In 2024, the phase III segment is expected to account for the largest share of 68.4% of the clinical trials market. Phase III clinical trials use large groups of people to observe the adverse effects of treatment and utilize sophisticated services for studying the efficacy and safety of the drugs. Such factors have contributed to the largest share of the segment. Additionally, many pharmaceutical and biotechnology companies outsource their phase III clinical trials to service providers has supported the largest share of the segment.

By Service Type: In 2024, the Patient Recruitment Services Segment is Projected to Witness the Fastest Growth in the Forecast Period

Based on Service Type, the clinical trials market is segmented into consulting services, safety & regulatory compliance services, site & patient support services, marketing authorization holder-related services, data management services, decentralized clinical trials (DCT) / virtual clinical trials (VCT) services, patient recruitment services, statistical analysis services, bioanalytical services, and other services. The fastest growth rate of the segment is attributed to the increasing number of drugs reaching the phase III clinical trials, the large number of patients pool with required medical conditions, and rising spent on patient recruitment and screening process.

By Therapeutic Area: In 2024, the Oncology Segment to Dominate the Clinical Trials Market

Based on therapeutic area, the clinical trials market is segmented into oncology, infectious diseases, cardiology, metabolism & endocrinology, central nervous system (CNS)/neurology, dermatology, orthopedic and rheumatology, rare diseases, gastroenterology & hepatology, respiratory, women's health, urology, mental health, and ophthalmology. In 2024, the oncology segment is expected to account for the largest share of 33.2% of the clinical trials market. The largest share of the segment is attributed to the increasing prevalence of cancer, increasing R&D for cancer drugs, and technological advancements in cancer treatments. For instance, cancer is the leading cause of death worldwide. The most common cancers are breast, lung, colon, rectum, and prostate cancers. According to the World Health Organization February 2022 report, approximately 10 million deaths in 2020 were caused due to cancer.

By End Users: In 2024, the Pharmaceuticals & Biotechnology Companies Segment to Dominate the Clinical Trials Market

Based on end users, the clinical trials market is segmented into pharmaceuticals & biotechnology companies, medical device companies, and other end users. In 2024, the pharmaceuticals & biotechnology companies’ segment is expected to account for the largest share of the clinical trials market. The largest share of the segment is attributed to the high investments in R&D for the development of new drugs and therapies by pharmaceutical and biotechnology companies, increasing demand for innovative therapies for various diseases leading to high demand from pharmaceutical and biotechnology companies for outsourcing clinical trials for bringing new treatments to market.

Geographical Analysis

In 2024, North America is expected to account for the largest share of 41.6% of the clinical trials market. North America's significant market share is attributed to an increase in R&D investments, a rise in the adoption of new technologies in clinical trials, and the presence of key market players in this region. For instance, in March 2024, Laboratory Corporation of America Holdings (U.S.) launched pTau217, a biomarker test for accelerating the path to diagnosis of Alzheimer’s disease, which is also used for clinical trials. Additionally, according to the National Library of Medicine (U.S.), as of April 2024, approximately 149,999 clinical trial studies are registered in the U.S.

Clinical Trials Market: Key Companies

The report offers a competitive landscape based on an extensive assessment of the product offerings and geographic presence of leading market players and the key growth strategies adopted by them over the past few years 2020–2024. The key players operating in the global clinical trials market are Laboratory Corporation of America Holdings (U.S), Medpace, Inc. (U.S), Charles River Laboratories International, Inc. (U.S.), IQVIA Inc. (U.S.), Parexel International Corporation (U.S.), Syneos Health (U.S), ICON plc (Ireland), WuXi AppTec Co., Ltd. (China), Thermo Fisher Scientific Inc. (U.S), Fortrea Inc. (U.S), Celerion Inc. (U.S.), Novotech Health Holdings (Australia), SGS Société Générale de Surveillance SA. (Switzerland), CTI Clinical Trial and Consulting, Inc. (U.S.), and Linical USA, Inc. (U.S.).

Clinical Trials Industry Overview: Latest Developments from Key Industry Players

• In April 2024, Parexel International Corporation (MA) Corporation (U.S.) partnered with Palantir Technologies Inc. (U.S.) to utilize AI to enhance and accelerate the delivery of safe and effective clinical trials while maintaining the highest level of regulatory integrity and safety.
• In June 2023, Syneos Health (U.S.) collaborated with uMotif Limited (U.K.) to accelerate clinical trials and to bring new therapies for patients through an efficient and faster end-to-end digital system that includes Electronic Patient-reported Outcomes (ePRO), and Electronic Clinical Outcome Assessment (eCOA) capabilities.
• In September 2023, ICON plc (Ireland) launched a next-generation Clinical Trial Tokenisation solution, which combines all the important components for allowing the collation of patient data in a discreet, confidential, and non-intrusive way with Privacy Protected Record Linkage (PPRL) across source and time.
• In November 2023, Ichor Life Sciences, Inc. (U.S.) launched Ichor Clinical Trials Services. The newly launched service will combine a spectrum of clinical trial solutions ranging from individual services to full CRO services.

Clinical Trials Market Research Summary

Key questions answered in the clinical trials market report: