Decentralized Clinical Trials Market Size, Share, Industry, Forecast and outlook (2024-2031)

Market Size

The Global Decentralized Clinical Trials Market reached US$ 5.39 billion in 2023 and is expected to reach US$ 9.27 billion by 2031, growing at a CAGR of 7.1% during the forecast period 2024-2031.

Decentralized clinical trials are defined by the decentralization of clinical trial operations where technology is used to communicate with study participants and collect data. Decentralized clinical trials use digital health technology and telemedicine to conduct various trial functions remotely, allowing patients to participate from their homes or local healthcare providers. Through a blend of telemedicine, wearables, electronic data capture and flexible protocols, decentralized clinical trials aim to streamline the clinical trial process, reduce costs and accelerate time to market while maintaining data quality and regulatory compliance.

The demand for decentralized clinical trials is rising significantly, driven by technological advancements, regulatory support and the need for more patient-centric and efficient trial models. For instance, according to TrialX, it is estimated that the incorporation of decentralization components in clinical trials rose by 17% in 2023 and remote data collection technologies are an integral part of decentralized clinical trials. Researchers see mobile research apps as versatile tools with many advantages that cannot be realized with other modalities, allowing the collection of a variety of data in different research study settings. 

Market Summary

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Market Dynamics: Drivers & Restraints

Rising advancements in digital health technologies

Rising advancements in digital health technologies are significantly driving the decentralized clinical trials market and are expected to drive the market over the forecast period, making trials more efficient, patient-centric and scalable. Wearable devices allow continuous real-time monitoring of health metrics, such as heart rate, blood pressure, glucose levels and physical activity, directly from patients' homes. This data is crucial in decentralized clinical trials, where in-person monitoring is limited, allowing sponsors to collect rich, continuous data without requiring site visits.

For instance, the Clinical Trials Arena analysis shows that Takeda Pharmaceuticals decentralized 33% of its clinical trials in 2022, Bayer decentralized 22%, Sanofi decentralized 17%, Vertex Pharmaceuticals decentralized 17%, AstraZeneca Plc decentralized 15%, Novartis AG decentralized 14%, Merck KGaA decentralized 14%, Pfizer Inc decentralized 12%, Biogen Incdecentralized 11% and F. Hoffmann-La Roche Ltd decentralized 11% of its clinical trials.

Digital health technologies, including wearables, telemedicine, AI and machine learning, are transforming decentralized clinical trials by enhancing data accuracy, patient engagement, accessibility and regulatory compliance. The widespread adoption of these tools, backed by significant market growth projections, highlights their role as fundamental enablers of decentralized clinical trials. These technologies not only address traditional trial challenges, such as recruitment and retention, but also improve overall trial efficiency and data quality, fueling the rapid expansion of the decentralized clinical trials market.

Data privacy and security concerns

Data privacy and security concerns are significant barriers to the growth of the decentralized clinical trials market. As decentralized clinical trials rely heavily on digital data collection, remote monitoring and electronic patient records, they introduce new risks related to cybersecurity, patient data protection and regulatory compliance. 

For instance, a Colorado-based pathology laboratory is notifying more than 1.8 million patients that their sensitive information was compromised one of the largest breaches reported by a medical testing lab to US federal regulators, making the healthcare industry especially vulnerable to hackers. 

Many patients are concerned about sharing their personal health information digitally, fearing potential breaches, unauthorized access or misuse of their data. For instance, according to the HHS Cybersecurity Program, 630+ total healthcare organizational breaches and 29 million healthcare records were breached. This hesitation impacts recruitment and retention rates, which are essential to the success of any decentralized clinical trials.

Market Segment Analysis

The global decentralized clinical trials market is segmented based on study type, component, therapeutic area, end-user and region.

Therapeutic Area:

The oncology segment is expected to dominate the global decentralized clinical trials market share

The oncology segment holds a major portion of the decentralized clinical trials market share and is expected to hold a major portion over the forecast period. According to the World Health Organization (WHO), over 35 million new cancer cases are predicted in 2050, a 77% increase from the estimated 20 million cases in 2022. Thus, rising cancer cases increase the need for further oncology trials, which often require continuous monitoring and long-term follow-up to assess the efficacy and safety of treatments, especially for conditions like metastatic cancer, where disease progression needs regular tracking. 

Decentralized clinical trials facilitate remote monitoring through wearable devices and telemedicine, enabling oncologists to observe changes in real time without the patient needing to make frequent clinic visits. For instance, according to the American Society of Clinical Oncology, many sponsors intend to incorporate some degree of decentralization in future cancer clinical trials, with remote site monitoring (95%), remote collection of patient-reported outcomes (68%), telemedicine (68%) and electronic informed consent (58%) being deemed "highly likely" or "likely" for future adoption.

Oncology trials benefit from diverse patient populations to ensure comprehensive data on drug efficacy and safety. Traditional oncology trials often struggle with diversity, as patients from underserved or rural areas find it difficult to participate due to travel and logistical issues. Decentralized clinical trials can recruit more diverse participants by reaching patients directly in their communities.

The rare diseases segment is the fastest-growing segment in the decentralized clinical trials market 

The rare diseases segment is expected to be the fastest-growing segment in the decentralized clinical trials market over the forecast period. This is driven by several unique factors that make decentralized approaches particularly beneficial for the study of rare diseases. These diseases, by definition, affect a small percentage of the population, often leading to difficulties in recruiting patients and ensuring comprehensive data collection. Decentralized clinical trials offer solutions to many of these challenges, facilitating faster, more efficient and more inclusive trials.

According to the National Organization for Rare Diseases, rare diseases affect fewer than 200,000 Americans. There are over 10,000 rare diseases that together affect more than 30 million Americans. This presents a major challenge for patient recruitment. Decentralized clinical trials provide a solution by allowing researchers to reach patients from diverse geographical locations, including rural or underserved areas, without requiring them to travel to centralized trial sites. Remote monitoring, telemedicine and digital health technologies allow for more inclusive recruitment and broader geographic reach.

Market Geographical Share

North America is expected to hold a significant position in the global decentralized clinical trials market 

North America region is expected to hold the largest share in the decentralized clinical trials market over the forecast period. North America especially the United States, has been a leader in pioneering new clinical trial models, with early adopters of decentralized clinical trial technologies making significant strides in remote patient monitoring, virtual visits, e-consent and mobile health tools.

For instance, in November 2024, Medable Inc. released Medable AI – generative AI capabilities that help sponsors and clinical research organizations (CROs) build digital and decentralized trials faster with complete visibility and control over technology setup. Medable is the first to incorporate generative AI in the study-build process, ultimately driving the industry to a breakthrough, one-day study startup. Medable AI integrated with Medable Studio automates repetitive, time-intensive manual tasks to decrease time to First Patient In (FPI) for digital and decentralized clinical trials, dramatically accelerating study startup.

North America has a large, tech-savvy population that is increasingly comfortable with digital tools such as telemedicine, mobile apps and wearable devices. For instance, the Pew Internet Project study, based on a survey of 1,677 Americans in October 2002, finds that 31% of Americans can be considered highly tech-savvy. This cultural readiness to adopt new technologies is a significant factor in the rapid growth of decentralized clinical trials.

Asia Pacific is growing at the fastest pace in the decentralized clinical trials market 

The Asia Pacific region is experiencing the fastest growth in the decentralized clinical trials market. Asia Pacific is home to a vast and diverse population, with over 4.56 billion people across the region. This diverse population, especially in countries like China and India, presents significant opportunities for clinical trials that benefit from both a high volume of potential participants and varied demographics.

Clinical trials in Asia Pacific are often more cost-effective compared to Western regions. For instance, according to the Clinical Leader, clinical trials in APAC countries cost 30%-40% less than in other regions, making the area very attractive to pharmaceutical and biotech companies. Lower costs of healthcare, patient recruitment and infrastructure mean that pharmaceutical companies and contract research organizations (CROs) can run decentralized clinical trials at reduced costs. This makes it an attractive option for both global pharmaceutical companies and local biotech firms.

Market Companies

The major global players in the decentralized clinical trials market include ICON plc, Parexel International Corporation, Laboratory Corporation of America Holdings, Medpace, Inc., Science 37, THREAD, Inc., Curebase, Castor, IQVIA Inc., Medable Inc. and among others.

Emerging Players

The emerging players in the decentralized clinical trials market include Veeva Systems Inc., PRAXIS, Advarra, The Emmes Company, LLC, Syneos Health and among others.

Key Developments

• In October 2024, Adaptive Research announced its participation in groundbreaking decentralized clinical trials for Parkinsons’ Disease sponsored by PhotoPharmics Inc. California Movement Disorders Center, part of Adaptive Research’s network, will serve as a site for PhotoPharmics’ LIGHT-PD trial, testing the efficacy of Celeste Specialized Phototherapy in treating Parkinson’s symptoms.
• In August 2024, Walgreens and the Biomedical Advanced Research and Development Authority (BARDA), cleared a strategic partnership to increase innovation in decentralized clinical trials as part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. The program is designed to strengthen U.S. decentralized clinical trials capabilities to support the development of U.S. Food and Drug Administration (FDA)-regulated products, enhance clinical innovation to execute more efficient and relevant clinical research and evaluate other medical countermeasures in real-world environments that may be used in a public health emergency.
• In February 2023, Syneos Health launched a Decentralized Clinical Trial (DCT) Site Network to drive appropriate DCT adoption and enable high-quality delivery of decentralized clinical trials and digital health technology solutions. The introduction of the Syneos Health DCT Site Network complements the Company’s existing Site Advocacy Group, continuing the momentum for decentralized solutions to bring clinical trials closer to the patient.

Why Purchase the Report?

• To visualize the global decentralized clinical trials market segmentation based on study type, component, therapeutic area, end-user and region and understand key commercial assets and players.
• Identify commercial opportunities by analyzing trends and co-development.
• Excel data sheet with numerous data points of the decentralized clinical trials market with all segments.
• PDF report consists of a comprehensive analysis after exhaustive qualitative interviews and an in-depth study.
• Product mapping is available in excel consisting of key products of all the major players.

The global decentralized clinical trials market report would provide approximately 62 tables, 53 figures and 197 pages.

Target Audience 2024

• Manufacturers/ Buyers
• Industry Investors/Investment Bankers
• Research Professionals
• Emerging Companies