Decentralized Clinical Trials Market Size, Share and Trends Analysis, By Component (Hardware & Devices, Software Platforms, and Support Services), By Modality (Hybrid and Fully decentralized), By Trial Phase (Phase I, Phase II, Phase III, and Phase IV), By Therapeutic Area, By End-Use, and By Region, Forecast 2025-2032

Decentralized Clinical Trials Market Overview and Key Insights:

The decentralized clinical trials market size reached USD 8.87 billion in 2024 and is expected to register a revenue CAGR of 10.2% during the forecast period. A decentralized clinical trial (DCT) is one in which part or all trial-related activities take place in locations other than standard clinical trial sites. They can provide numerous benefits to pharmaceutical firms, including cost savings, greater patient recruitment and retention, and higher data quality.

Market Drivers:

Rising demand for patient-centric trial models is a key driver of revenue growth in the decentralized clinical trials market. DCTs are transforming clinical research. This novel approach to trials provides a fast, cost-effective, and dependable way to carry out a clinical investigation. Remote studies are also more accessible and patient-centered, allowing sponsors to reach a broader range of patients. As healthcare systems around the world strive to become more inclusive, accessible, and efficient, DCTs stand out as a transformative paradigm that stresses patient-centricity while maintaining scientific integrity.

Recent worldwide events, like as the COVID-19 pandemic, have highlighted the shortcomings of conventional clinical trial designs. Many ongoing experiments were disrupted by social distancing measures and travel restrictions, emphasizing the importance of more adaptive methodologies. As a result, the use of decentralized and patient-centric trial models has increased, indicating their ability to preserve continuity, broaden access, and improve convenience for participants. Clinical trials are rapidly developing, with advancements in bioanalytical procedures, digital monitoring, decentralized trials, and artificial intelligence (AI). These technologies and approaches have improved dramatically and have the potential to greatly improve patient comfort and engagement

On June 2025, Medable Inc., a leading provider of clinical development technology, has announced its new Partner Program, which aims to provide contract research organizations (CROs) and other partners with generative AI-driven, self-service eCOA build capabilities for digitally enabled clinical trials. Medable has used its software-as-a-service platform in over 300 decentralized and digitally enhanced clinical trials across 70 countries, reaching over one million patients and research participants worldwide.

Market Opportunity:

Integration of artificial intelligence and big data analytics act as an opportunity for decentralized clinical trials market. AI tools increase efficiency, such as trial size and duration, and are especially useful in decentralized trials. AI-based sensors and wearable devices also improve patient monitoring. With growing data generation from remote monitors and computerized patient-reported outcomes gathering, AI analysis helps clinical trials meet their statistical requirements. Wearables and AI approaches can collect data on a continuous basis, alleviating patients of the data collection burden. Deep learning algorithms can also be used to assess data while simultaneously logging relevant occurrences, resulting in disease diaries. Deep learning models can be periodically retrained with new metrics and even become patient-specific dependent on patient behavior.

As the use of DCTs grows, regulatory authorities are improving guidelines to accommodate these approaches. The FDA and other worldwide regulatory authorities are rapidly realizing the benefits of decentralized systems, which provide frameworks that balance innovation, patient safety, and data integrity. AI, POCT, and wearable technologies are at the vanguard of this transition, resulting in unparalleled efficiency and inclusion in clinical research. As the sector embraces these improvements, stakeholders must maintain a commitment to regulatory compliance, data security, and patient-centered innovation.

Recent Trends:

Emerging trends include wearables & remote monitoring devices, telehealth / virtual visits & eConsent processes, AI/machine learning, Real-World Evidence (RWE) & integration with Real-World Data (RWD), and growth of hybrid trial models.

Decentralized clinical trials (DCTs) are gaining traction in clinical research because they can be carried out remotely via telemedicine and mobile/local healthcare professionals. Digital biomarkers, which allow for continuous measurement of physiologic parameters outside of the clinical environment, are also opening new and enhanced opportunities for patient care and biomedical research, such as remote monitoring and DCTs.

DCTs typically use wearables and mobile health devices to gather patient data remotely. These gadgets, which range from smartwatches that monitor heart rate and sleep patterns to specialized devices that measure specific health parameters, allow for continuous data collecting while keeping participants comfortable. As DCTs gain traction, regulatory authorities around the world are updating their standards to include this new concept. The emergence of new and evolving DCT technologies has prompted governmental initiatives and raised severe concerns regarding data privacy and security.

On January 2024, Blue Spark Technologies, Inc., a global pioneer in clinical-grade wearable and digital health technology, has launched VitalTraq, the industry’s first multi-sensor remote patient monitoring platform. VitalTraq contains Remote Photoplethysmography (rPPG), one of the most innovative contactless vital sign measuring sensors to date. Patients, physicians, and researchers can collect digital measures, including Heart Rate, Heart Rate Variability, Blood Pressure, and Respiratory Rate vital signs, in a single contactless patient experience with a simple 30- to 60-second selfie. The increased demand for decentralized clinical trials necessitates wearable and non-contact vital sign monitoring technologies such as VitalTraq.

Restraints & Challenges:

Decentralized clinical trials (DCTs) have transformed the scientific landscape by delivering studies directly to patients, increasing accessibility and lowering the burden of participation. While DCTs provide tremendous benefits, they also create new complexity that sponsors, CROs, and sites must traverse for the trial to be successful.

Decentralized clinical trials have a significantly higher chance of protocol deviations than standard centralized studies. Although coming to the research location for every appointment is inconvenient for patients and results in less data collection, it ensures that research guidelines are strictly followed. Decentralized clinical trials necessitate technology that can rapidly send data from wearable devices or remote places to research facilities, and ultimately to sponsors and CROs. However, sites, sponsors, and CROs may have difficulty finding safe, private technology built for decentralized trials.

Component Segment Insights and Analysis:

Based on the component, the decentralized clinical trials market is segmented into hardware & devices, software platforms, and support services.

Hardware & devices segment contributed the largest market share in 2024. Advances in digital health technologies (DHTs) have expanded the amount of trial-related data that can be collected remotely, allowing patients to avoid traveling to central trial locations. Most wearable devices used in DCTs, such as fitness trackers, smartwatches, or specialist medical wearables, collect health data from the user and send it to a coupled smartphone or tablet over Bluetooth.

Health monitoring devices, often known as wearables, are frequently used to collect real-time data from participants. Depending on the trial, participants may be required to wear health monitoring devices such as smartwatches, fitness bands, glucose monitors, blood pressure monitors, or other specialist medical equipment. These gadgets should be easy to use and capable of securely transmitting data.

On February 2025, Tasso, Inc., the leading provider of patient-centric, clinical-grade blood collection solutions, announced the release of its next-generation technology for dried blood spot (DBS) sample collection. The unique collection solution combines Tasso’s revolutionary Tile-T20 dried whole blood cartridge with a Tasso Mini device, allowing for the precise and convenient collection of DBS samples for clinical trials and sports antidoping testing. Tasso’s novel collection system outperforms traditional DBS methods, enhancing and speeding the clinical trial procedure.

Modality Segment Insights and Analysis:

Based on the modality, the decentralized clinical trials market is segmented into hybrid and fully decentralized.

Hybrid segment contributed the fastest growth rate in 2024. Hybrid clinical trials enable sponsors to intentionally combine decentralized clinical trial (DCT) components into research designs. Although hybrid clinical trials are used in a variety of therapeutic areas, they are especially beneficial in studies with difficult-to-recruit patient populations or those with restrictions on frequent site visits. New research suggests that hybrid trials are most common in metabolic and central nervous system diseases. Hybrid trials also have a strong representation of genetic disorders, cardiovascular diseases, and respiratory therapies.

To manage costs and timetables, start-up biotech businesses with limited funds and low-risk therapies are progressively incorporating more distant features into their hybrid trials. Hybrid trials give sponsors more options in meeting their study objectives. With the flexibility provided by a modular, hybrid research design, sponsors can combine remote outcomes capture via digital instruments (ePerfO), outcomes capture during an on-site visit (ClinRO, eClinRO), or both—all subject to and geared to deliver on specified endpoints.

On March 2025, Jeeva Clinical Trials, a pioneer in decentralized and hybrid clinical trial technology, has announced the launch of its Contract Research Organizations (CRO) Partnership Program, which invites forward-thinking CROs to join the era of real-time collaboration, AI-powered trial management, and seamless site-sponsor connectivity via its unified Clinical Trial Management System (CTMS). This strategic project aims to empower specialty CROs focused on obesity, dermatology, oncology, and rare diseases by providing them with best-in-class digital solutions that improve research speed, compliance, patient retention, and cost effectiveness.

Therapeutic Area Segment Insights and Analysis:

Based on the therapeutic area, the decentralized clinical trials market is segmented into oncology, cardiology, neurology, infectious diseases, rare diseases, and others.

Oncology segment contributed the largest market share in 2024. Clinical trials can provide new hope for people suffering from uncommon, incurable, or life-threatening diseases. Cancer patients are generally strongly motivated to participate in research, especially if their cancer is advanced or resistant to treatment. DCTs give clinicians access to a broader range of clinical trials for cancer to recommend to patients who may be eligible. Rural physicians may be able to contribute to ongoing research by referring patients to trials that do not overburden a small community hospital, which cannot sustain a large, centralized experiment.

Moreover, the incorporation of mobile health (mHealth) technology into decentralized clinical trials (DCTs) could constitute a paradigm change in oncology research, providing novel answers to long-standing issues in clinical trial design and execution. Wearable biosensors, telemedicine platforms, and AI-driven analytics are examples of mHealth solutions that have the potential to enable real-time patient monitoring, participant engagement, and remote data collecting.

On February 2023, Medable, a leading clinical trials technology platform provider, announced a new cooperation with the Nova Scotia Health Innovation Hub for a two-year pilot study to increase oncology trial access for rural Nova Scotia patients using Medable’s decentralized clinical trial (DCT) platform. The technology allows for remote patient monitoring, telemedicine, real-time access to patient data, and data streaming.

Geographical Outlook:

Decentralized clinical trials market is strategically segmented by geography to provide a comprehensive understanding of regional market dynamic. Discover demand analysis, emerging trends, and growth opportunities shaping market performance across different region and countries.

North America Decentralized Clinical Trials Market:

North America is registered to have highest market share in decentralized clinical trials market in 2024. This is mainly driven by rising demand for patient-centric trial models and technological advancements in digital health tools. Major regulatory authorities across the world have acknowledged the increasingly digital future of clinical trials. In recent years, the FDA has issued regulatory guidance on the use of technology in clinical studies. On 2015, the FDA solicited feedback on “using technologies and innovative methods” to conduct clinical trials. In line with the 21st Century Cures Act and PDUFA VI, the FDA has prioritized patient-focused drug development. This program aims to help stakeholders obtain, use, and submit valuable patient experience data for medication and device development, as well as maximize its utility for regulatory decision-making.

On March 2023, IQVIA Consumer Health, in collaboration with ObvioHealth, has initiated a fully decentralized clinical study with Jovie USA to introduce the first FDA-approved goat milk-based infant formula in the United States. The novel study design is the first of its type for infant formula, allowing parents and their newborns to participate in the trial from home, eliminating the need for in-clinic visits. The study, designed in collaboration with the FDA to increase the likelihood of regulatory success after the trial is completed, will determine whether babies fed Jovie’s goat milk-based formula grow similarly to babies fed cow milk-based formula or breast milk, the CDC’s growth standard.

Asia Pacific Decentralized Clinical Trials Market:

Asia Pacific is expected to register the fastest growth rate during the forecasted period, driven by technological advancements in digital health tools and increased adoption post-covid-19 pandemic. The rapid growth of the Asia-Pacific clinical trials (APAC clinical trials) industry has provided significant prospects for conducting decentralized clinical trials in the area. APAC’s use of digital health and health technology, such as telemedicine, electronic medical records, and electronic data collection, is encouraging for DCT adoption in the area.

APAC’s huge patient population and low overall study volume result in reduced trial density and a lesser danger of competing trials. For example, in the United States, there are 3.8 recruiting sites for non-Hodgkin lymphoma trials per million urban people, compared to 0.4 in Asia-Pacific. In addition, the trial density for T-cell lymphoma clinical trials in APAC is approximately four times lower than in the United States.

On May 2024, Chugai Pharmaceutical Co., Ltd., National Cancer Center Hospital, Osaka Medical and Pharmaceutical University, and MICIN have announced the implementation of a novel decentralized clinical trial framework and the commencement of DCT in a Chugai-sponsored phase I clinical trial for patients with advanced solid tumors. NCCH and OMPU will collaborate via telemedicine as the major and satellite institutions, respectively, and several tests and evaluations that were previously performed at institutions will now be performed at the satellite institution.

Europe Decentralized Clinical Trials Market:

Europe is expected to register a considerable market share during the forecasted period. The European Commission (EC), the Heads of Medicines Agencies (HMA), and the European Medicines Agency (EMA) have issued recommendations aimed at facilitating the conduct of decentralized clinical trials (DCTs) while protecting participants’ rights and well-being, as well as the robustness and reliability of the data collected. This is the result of their collaborative program, Accelerate Clinical Trials in the European Union (ACT EU).

On March 2023, LEO Pharma, a global leader in medical dermatology, and ICON plc have announced a strategic partnership that will allow LEO Pharma to scale patient-centric and cost-effective clinical trial execution, as well as support the company’s overall goal of becoming one of the most effective and efficient clinical portfolio execution organizations in the industry. The partnership’s purpose is to improve the lives of dermatological patients by providing access to breakthrough clinical trials and launching novel treatments.

Competition Analysis:

The decentralized clinical trials market is characterized by a fragmented structure, with several players competing across various segments and regions. List of major players included in the decentralized clinical trials market report are:

• Medrio
• HCL Technologies Limited
• Curebase, Inc. 
• Oracle
• Medidata (Dassault Systèmes)
• Veeva Systems Inc.
• IQVIA
• ProPharma Group Holdings, LLC
• Castor
• Clario
• Hangzhou Tigermed Technology Co., LTD.
• ICON plc
• CMIC HOLDINGS Co., LTD. 
• Thermo Fisher Scientific Inc.
• Parexel International Corporation

Strategic Developments in Decentralized Clinical Trials Market:

• In August 2024, Walgreens and the Biomedical Advanced Research and Development Authority (BARDA), a division of the Administration for Strategic Preparedness and Response (ASPR) in the United States Department of Health and Human Services (HHS), have announced a strategic partnership to boost innovation in decentralized clinical trials as part of the Decentralized Clinical Operations for Healthcare and Research (D-COHRe) program. The program is meant to expand US decentralized clinical research capacity to support development of FDA-regulated products, enhance clinical innovation, and execute more efficient and relevant clinical research.
• In January 2024, Labcorp, a global leader in innovative and comprehensive laboratory services, and Hawthorne Effect, Inc., a complete clinical trials solution that integrates technology, have announced a strategic partnership to advance decentralized clinical trial capabilities for pharmaceutical, biotech, and medical device sponsors looking to increase patient diversity and inclusion, reduce site burden, and accelerate enrollment and clinical study timelines. Labcorp and Hawthorne Effect intend to merge their services and develop new, differentiated service offerings to enable decentralized clinical trials.

Key Advantages for Stakeholders:

Navistrat Analytics’ industry report provides an in-depth quantitative analysis of various market segments, historical and current trends, market forecasts, and dynamics within the global market. The historical years covered in this report are 2022 to 2023, with 2024 serving as the base year for market size calculations. The forecast period extends from 2025 to 2032.

The report includes an executive summary and a comprehensive overview of market drivers, restraints, opportunities, and challenges (DROC), along with insights into regulatory standards. It features detailed analyses such as PORTER’s Five Forces, SWOT, and PESTLE, as well as assessments of technological trends and the competitive landscape.

PORTER’s Five Forces analysis helps stakeholders evaluate the impact of new entrants, competitive rivalry, supplier power, buyer power, and substitution threats, enabling them to assess the level of competition and the attractiveness of the global market. The competitive landscape provides stakeholders with a clear understanding of the current market positions of key players, offering valuable insights into their competitive environment.

Scope And Key Highlights Of The Decentralized Clinical Trials Market Report:

The Decentralized Clinical Trials market report offers a detailed analysis of market size, including historical revenue (in USD Billion) data for 2022-2023 and revenue forecasts for 2025-2032 across the following segments:

• Component Outlook (Revenue, USD Billion; 2022-2032)
  • Hardware & Devices
  • Software Platforms
  • Support Services

• Modality Outlook (Revenue, USD Billion; 2022-2032)
  • Hybrid
  • Fully decentralized

• Trial Phase Outlook (Revenue, USD Billion; 2022-2032)
  • Phase I
  • Phase II
  • Phase III
  • Phase IV

• Therapeutic Area Outlook (Revenue, USD Billion; 2022-2032)
  • Oncology
  • Cardiology
  • Neurology
  • Infectious diseases
  • Rare diseases
  • Others

• End-Use Outlook (Revenue, USD Billion; 2022-2032)
  • Pharmaceutical & Biotech sponsors
  • Contract Research Organizations (CROs)
  • Medical device manufacturers
  • Academic and Research Institutions
  • Others

• Regional Outlook (Revenue, USD Billion; 2022-2032)
  • North America
    • U.S.
    • Canada
    • Mexico
  • Europe
    • Germany
    • France
    • U.K.
    • Italy
    • Spain
    • Benelux
    • Nordic Countries
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • South Korea
    • Oceania
    • ASEAN Countries
    • Rest of APAC
  • Latin America
    • Brazil
    • Rest of LATAM
  • Middle East & Africa
    • GCC Countries
    • South Africa
    • Israel
    • Turkey
    • Rest of MEA

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