블록체인과 디지털 트윈을 활용한 분산형 임상시험

This report examines how decentralized clinical trials (DCTs), enabled by blockchain, digital twins, and artificial intelligence, are reshaping global clinical research. It traces the shift from site-centric to patient-centric models and quantifies the growing scale, globalization, and complexity of clinical trials that make decentralization necessary.

The study analyzes three technology pillars: blockchain infrastructure for secure consent, data integrity, and smart-contract automation; digital twins for virtual patient modeling, synthetic control arms, and protocol simulation; and AI/ML as the intelligence layer for recruitment, monitoring, and predictive analytics. It maps the technology maturity, key innovators, funding activity, and strategic partnerships defining the landscape, and evaluates the clinical trial value chain and economic impact, including faster enrollment, improved retention, greater diversity, and stronger returns on investment.

Evidence indicates hybrid trial models are becoming the industry standard, with the strongest gains realized before trial execution begins. Finally, the report assesses stakeholder roles and offers strategic recommendations for sponsors, CROs, technology providers, healthcare organizations, and regulators preparing for an intelligent, connected, and patient-centric clinical development ecosystem.

Clinical research is entering a new era.

Blockchain, digital twins, and AI are transforming clinical trials into intelligent, connected, and patient-centric ecosystems- accelerating enrollment, reducing costs, improving diversity, and enhancing data integrity.

This report explores the technologies, market trends, key innovators, investment landscape, and strategic opportunities driving the next generation of clinical research. Featuring insights for sponsors, CROs, technology providers, healthcare organizations, and regulators, it provides a practical roadmap for navigating the future of decentralized and AI-enabled clinical trials.

Discover the technologies redefining drug development-and the strategies needed to stay ahead.

Table of Contents

Scope and Segmentation

• Scope of Analysis
• Key Terminologies Used in the Report
• Clinical Trials is the Foundation of Evidence-Based Medicine
• Clinical Research Is Increasingly Global, Creating the Need for Decentralized Trial Models
• Clinical Trials Are Extending Beyond Drugs to Devices and Behavioral Interventions
• Decentralized Clinical Trial Landscape Overview
• Analyst Insights on the Decentralized Clinical Trial Landscape
• Segmentation

Strategic Imperatives

• Why Is It Increasingly Difficult to Grow? The Strategic Imperative 8™: Factors Creating Pressure on Growth
• The Strategic Imperative 8™
• The Impact of the Top 3 Strategic Imperatives on the Decentralized Clinical Trials Industry
• Growth Opportunities Fuel the Growth Pipeline Engine™
• Research Methodology

Growth Opportunity Analysis

• Growth Drivers
• Growth Restraints

Blockchain-Enabled Clinical Trial Infrastructure

• Blockchain in Clinical Trials
• Conventional Clinical Trials vs Blockchain-Based Clinical Trials
• Blockchain Architecture for Clinical Trials
• Layer 1: Identity and Clinical Data Capture Management
• Layer 2: Consent and Patient Governance Layer
• Layer 3: Data Integrity and Provenance Layer
• Layer 4: Smart Contracts and Automation Layer
• Layer 5: Blockchain Network and Integration Infrastructure Layer
• Technology Analysis: Blockchain in Clinical Trials
• Analyst Insights

Digital Twins-Based Clinical Trial Technologies

• Digital Twins in Clinical Trials
• Digital Twin Architecture for Clinical Trials
• Key Players in Digital Twin-Powered Clinical Trial
• Technology Analysis: Digital Twins in Clinical Trials
• Analyst Insights

Role of AI/ML in Decentralized Clinical Trials

• Role of AI/ML in Blockchain-Enabled Clinical Trials
• Role of AI/ML in Digital Twin Development
• Regulations and Guidance with Direct Impact on AI-Enabled Clinical Trials
• AI Regulatory Sandboxes Accelerating Clinical Trial Innovation
• Leading AI Platforms Enabling Decentralized Clinical Trials

Clinical Trial Value Chain and Economic Impact Analysis

• Clinical Trial Value Chain Analysis: Impact of Decentralized Clinical Trials
• Economic Impact of Decentralized Clinical Trials
• Shifting Clinical Trial Value Creation from Site Infrastructure to Connected Care Ecosystems

Stakeholder Analysis

• Key Partnerships Within Decentralized Clinical Trial Landscape
• Funding Activities Within Decentralized Clinical Trial Landscape

Strategic Outlook for Decentralized Clinical Trial Ecosystem

• Emerging Strategic Focus
• Strategic Recommendations for Clinical Trial Stakeholders
• Strategic Priorities for Stakeholders

Growth Opportunity Universe

• Growth Opportunity 1: AI-Native Clinical Trial Orchestration Platforms
• Growth Opportunity 2: Digital Twin-Enabled Adaptive Clinical Development
• Growth Opportunity 3: Trusted and Interoperable Clinical Trial Networks

Appendix

• Technology Readiness Levels (TRL): Explanation

Next Steps

• Benefits and Impacts of Growth Opportunities
• Next Steps
• Legal Disclaimer