Decentralized and Digitalized Clinical Trials Market Platform Led Virtual Execution and AI Driven Drug Development Infrastructure

Revenue, 2025

USD 8.71 Billion

Forecast, 2035

USD 17.92 Billion

CAGR, 2026-2035

7.48%

Report Coverage

Global

Decentralized & Digitalized Clinical Trials Market Trends for 2026

The global decentralized & digitalized clinical trials market size was estimated at USD 8.71 billion in 2025 and is predicted to increase from USD 9.36 billion in 2026 to approximately USD 17.92 billion by 2035, expanding at a CAGR of 7.48% from 2026 to 2035.

With a significant focus on oncology and neurology, the market is leveraging different advanced RPM solutions, like e-consent, wearable sensors, etc.  Also, several research activities are shifting towards hybrid models, AI-enhanced analytics, and direct-to-patient logistics.

Key Takeaways

• The decentralized & digitalized clinical trials market will likely exceed USD 9.36 billion by 2026.
• Valuation is projected to hit USD 17.92 billion by 2035.
• Estimated to grow at a CAGR of 7.48% starting from 2026 to 2035.
• North America dominated with nearly 48.1% revenue share of the market in 2025.
• Asia Pacific is expected to grow rapidly at 15.3% CAGR during 2026-2035.
• By component, the technology platforms segment held an approximate 58% share of the market in 2025.
• By component, the services segment is expected to be the fastest-growing in the coming years.
• By therapeutic area, the oncology segment led with approximately 46% revenue share of the decentralized & digitalized clinical trials market in 2025.
• By therapeutic area, the neurology segment is expected to grow at nearly 16% CAGR during the forecast period.
• By technology type, the wearables & biosensors segment registered dominance in the market in 2025.
• By technology type, the AI-enabled analytics segment is expected to witness rapid expansion during 2026-2035.

What are the Key Drivers of Decentralized & Digitalized Clinical Trials?

Primarily, these trials involve conducting research activities at locations other than traditional sites, such as home or local clinics, using digital solutions like wearables, telemedicine, and apps. However, the decentralized & digitalized clinical trials market is propelled by the increasing need for raised patient-centricity, enhanced retention, and expedited recruitment. Currently, sponsors are accelerating the adoption of "menu-of-choices" approaches, which enable participants to pick between in-person visits & home-based monitoring.

What are the AI Advances in the Market?

• AI is transforming the decentralized & digitalized clinical trials market by enabling remote, real-time, and more efficient clinical trial management. These advances enhance patient recruitment, engagement, and data accuracy, shifting trials from reactive site-based models to proactive, data-driven approaches.
• The leading companies are widely fostering predictive patient recruitment & matching, whereas TrialMatchAI utilizes large language models (LLMs) to acquire over 90% accuracy in matching patients to trials based on complex biomarker data. In the ongoing breakthroughs, the FDA & EMA are highly accepting data from in silico trials, i.e., computer simulations of human physiology, which replace or supplement control groups, especially in rare illnesses.

Trends & Future Outlook of the Decentralized & Digitalized Clinical Trials Market

Bolstering Operational Efficiency & Data Management

Day by day, the market is seeking integrated, cloud-based, and interoperable platforms, such as the unification of eConsent, electronic patient-reported outcomes (ePRO), and electronic clinical outcome assessments (eCOA) into a single platform to allow real-time, transparent data access.

Strengthening Direct-to-Patient (DTP) Logistics

The market is widely exploring direct shipment of investigational medicinal products (IMP) & specialized, temperature-controlled courier services for sample collection.

Broadening Virtual Site Assistance

For this, the firms are adopting "hub and spoke" models where central, virtual offices support smaller, local clinics or community doctors, and expanding access to various patient populations.

Executive Summary Table

Segmentation Analysis

Component Insights

Which Component Led the Market in 2025?

The technology platforms segment dominated with approximately 58% share of the decentralized & digitalized clinical trials market in 2025. To raise the patient experience & retention, trials are increasingly leveraging cloud-based platforms, like Medable, Oracle, IQVIA, which unite several modules for end-to-end management, & lower data sprawl.  Along with the e-consent solution, these platforms are enabling patients to utilize their own devices (BYOD) for ePRO.

Services

The services segment will expand rapidly. Beyond e-consent & RPM services, the market is focusing on telemedicine & virtual visits, where NCBI NIH’s & Within3’s remote consultations are used for safety checks. Alongside, Castor EDC’s services are offering home delivery of investigational products & at-home sample collection. Extensive efforts in research activities are revolutionizing hybrid models and AI-powered data analytics.

Therapeutic Area Insights

How did the Oncology Segment Dominate the Market in 2025?

In 2025, the oncology segment captured nearly 46% share of the decentralized & digitalized clinical trials market. Its dominance is driven by the growing use of hybrid oncology models, which raises patient accessibility & lowers the need for travel to specialized cancer centers. However, Karkinos Healthcare is broadly using a decentralized approach to facilitate care for patients in rural or underserved areas in India. The TELEPIK trial is emphasizing PIK3CA-mutated breast cancer by using telemedicine and local labs.

Neurology

Moreover, the neurology segment will witness rapid growth, with approximately 15% CAGR during 2026-2025. This is rigorously fueled by the rising need for robust, more patient-centric research for complex diseases, specifically Alzheimer's and Parkinson's. Trials are executing smartphone accelerometers and smartwatches for consistent monitoring of tremors, dyskinesia, and gait, which records real-world symptom data & skips relying on brief, intermittent clinic visits. The ADDRESS-LC trial (NCT06847191) is leveraging digital cognitive assessments, which test a new, brain-permeable agent for Long COVID-associated cognitive impairment.

Technology Type Insights

Why did the Wearables & Biosensors Segment Lead the Market in 2025?

The wearables & biosensors segment held the biggest share of the decentralized & digitalized clinical trials market in 2025. The widespread population is highly demanding at-home platforms, which promote the development of versatile electronics and nanomaterials to smart patches & lab-on-a-patch devices to optimise patient compliance & allow the detection of diverse biomarkers. BioIntelliSense BioSticker & VitalConnect VitalPatch are the latest advances employed for continuous tracking of critical parameters, like heart rate, respiratory rate, skin temperature, & patient mobility, mainly in oncology & chronic disease trials.

AI-Enabled Analytics

Whereas the AI-enabled analytics segment will expand rapidly. This is particularly driven by the greater demand for rapid, more affordable, and patient-centric trials by using AI algorithms for processing large data volumes, automating recruitment, & allowing remote, patient-centric monitoring. Recently, Medidata demonstrated AI tools combined into its Rave EDC system to automate data cleaning, boost patient recruitment, and facilitate real-time monitoring of trial safety in decentralized setups.

Regional Insights

Why did North America Dominate the Market in 2025?

In 2025, North America held approximately 48.1% share of the decentralized & digitalized clinical trials market, due to the supportive FDA guidance and mature telehealth infrastructure in the U.S. Recently, Health Canada introduced a public consultation on draft guidance for decentralized trials, which facilitates, for the first time, specific, promised regulatory clarity for running trials over traditional sites.

U.S. Market Trends

In the U.S. market, decentralized trails and hybrid models are shifting towards a substantial standard of operation, which emphasizes bolstering patient variations, retention, and data quality. Recently, the APPROVE trial used Curavit Clinical Research as a virtual site for Amara Therapeutics' RiSolve.

R&D Investments in Chronic Issues & Regulatory Updates are Driving the Asia Pacific

Asia Pacific is estimated to witnes witness the fastest growth in the decentralized & digitalized clinical trials market, as the region is encouraging broader R&D investments in the booming chronic diseases. Like, MSD (Merck & Co.) began the MOBILIZE-1 Phase 3 clinical trial (V181-005) for a Dengue vaccine, initiating with recruitment in Singapore, and planned to comprise more than 30 sites across the APAC. However, Parexel and the Japanese Foundation for Cancer Research joined to increase digital access to oncology trials in Japan.

China Market Trends

China is focusing on human genetic resources (HGR) and using digital platforms to monitor samples & ensure compliance with the strengthened 2023 Implementation Rules and the 2025 Personal Information Protection Audit requirements.

Surging Regulatory Landscape & Patient Engagement are Fueling Europe

Europe is anticipated to expand notably in the decentralized & digitalized clinical trials market, as recently the European Medicines Agency (EMA) & national agencies evolved guidelines for DCTs, which raises confidence in using wearables & mobile applications for data collection. Alongside, the region is highly using apps and chatbots to handle patient consent, remind them of medication, & record daily symptoms, which rises compliance and data quality.

UK Market Trends

Moreover, Cancer Research UK introduced a landmark trial for a lung cancer vaccine, which utilizes advanced, digitalized approaches to find high-risk patients and manage the trial. Also, the University of Birmingham are conducting the TLC study for Long COVID by using the Atom5 digital platform.

Key Players' Offerings in the Decentralized & Digitalized Clinical Trials Market

SWOT Analysis

Strengths

• These trials are reducing the need for frequent travel to physical sites, which ultimately lowers the burden of participation & offers greater patient satisfaction, with minimal dropout rates.
• Also, digital outreach and remote processes are accelerating patient enrollment and speeding up the overall study timeline.

Weaknesses

• Particularly, remote data collection can result in inconsistent, corrupt, or unauthorized data, especially with wearable devices.
• These solutions lose the investigator-patient relationship, which reduces patient involvement, adherence, & emotional support.

Opportunities

• Many firms are exploring AI to handle the data deluge from wearable devices, which allows real-time detection of adverse events & continuous monitoring of patient behavior.
• Also, the market will implement a "fit-for-purpose" hybrid approach, which combines home-based, local, & site-based care to enhance patient comfort and retention rates.

Threats

• e-consent faces legal acceptance diversity, and the limitation of face-to-face interaction leads to a complex assessment of a participant's competency & voluntary consent.
• RPM solutions are generating huge, continuous, and unstructured data environments.

Key Developments in the Decentralized & Digitalized Clinical Trials Market

• In November 2025, Cary, North Carolina–based analytics stalwart SAS unveiled SAS Clinical Acceleration, a cloud-based software platform to support managing clinical trial data, analysing results and preparing regulatory submissions.
• In June 2025, Medable Inc. introduced its new Partner Program to reinforce contract research organizations (CROs) & other partners with generative AI-enabled, self-service eCOA development capabilities for digitally powered clinical trials.
• In May 2025, Fujitsu Limited and Tokai National Higher Education and Research System (THERS) completed trials employing generative AI to process clinical data for application in the selection of clinical trial participants. 

Segments Covered in the Report

By Component

• Technology Platforms
• Services

By Therapeutic Area

• Oncology
• Neurology

By Technology Type

• Wearables & Biosensors
• AI-Enabled Analytics

By Region

• North America
  • U.S.
  • Canada 
  • Mexico 
  • Rest of North America
• South America
  • Brazil
  • Argentina
  • Rest of South America
• Europe 
  • Western Europe 
    • Germany 
    • Italy
    • France
    • Netherlands
    • Spain
    • Portugal 
    • Belgium
    • Ireland
    • UK 
    • Iceland 
    • Switzerland
    • Poland
    • Rest of Western Europe
  • Eastern Europe 
    • Austria
    • Russia & Belarus 
    • Türkiye
    • Albania 
    • Rest of Eastern Europe 
• Asia Pacific
  • China 
  • Taiwan
  • India 
  • Japan 
  • Australia and New Zealand
  • ASEAN Countries (Singapore, Malaysia)
  • South Korea 
  • Rest of APAC 
• MEA 
  • GCC Countries
    • Saudi Arabia 
    • United Arab Emirates (UAE)
    • Qatar 
    • Kuwait 
    • Oman 
    • Bahrain 
  • South Africa
  • Egypt 
  • Rest of MEA