分散式临床试验市场机会、成长驱动因素、产业趋势分析及预测（2025-2034 年）

2024 年全球分散式临床试验市场价值为 86 亿美元，预计到 2034 年将以 13.3% 的复合年增长率增长至 297 亿美元。

市场快速成长的驱动力来自数位健康解决方案的广泛应用，例如远距医疗平台、电子病患报告结果 (ePRO)、穿戴式医疗设备和电子知情同意系统，这些解决方案正在重塑临床研究的进行方式。分散式模式打破了传统研究中心的限制，使不同地区的患者无需前往中心地点即可参与研究。主要市场的监管机构正日益引入结构化框架，以支持分散式试验方法的实施。这一全球转变反映了人们越来越重视患者便利性、即时资料收集以及研究参与的包容性。随着人口老化、慢性病发病率上升以及个人化医疗的兴起，医疗保健系统正朝着以患者为中心的模式发展，使临床试验更加便捷高效。分散式试验透过整合数位工具来简化流程、降低营运成本并提高患者在整个研究週期中的参与度，从而顺应了这些发展趋势。

在分散式研究中，部分或全部试验相关流程在传统研究场所之外进行，使参与者能够在家中或透过当地医疗机构参与。这些试验利用数位平台、连网设备和远端监测系统收集临床资料，并直接为参与者提供治疗。这种设计有助于最大限度地减少出行需求，增强包容性，从而创造更多样化、更具代表性的研究人群。

2024年，介入性试验领域占据了63.7%的市场份额，预计到2034年将达到186亿美元。这一增长得益于远端参与能力的提升，它最大限度地减少了患者到场的次数，并提高了老年人和居住地分散人群参与试验的便利性。更好的患者体验有助于提高试验的保留率，而行动应用程式、远距医疗和电子病患报告结局（ePRO）平台等互联数位工具则实现了持续的即时监测和更快的资料采集，从而使介入性试验更具规模化和高效性。

预计到2024年，远距医疗平台市场规模将达到18亿美元。这些平台有助于消除出行和地理障碍，并支持更多来自偏远和医疗资源匮乏地区的病患参与研究。它们与连网设备和数位化报告系统的集成，提高了资料收集的品质和速度，从而提升了整体试验效率。远距医疗的数位化特性也降低了研究中心的管理成本，缩短了研究週期，并简化了申办者、研究者和病患之间的协调。透过建构互联互通的数位化框架，远距医疗平台能够实现更精简且灵活的去中心化试验营运。

预计到2024年，北美分散式临床试验市占率将达到44.1%。该地区受益于高度先进的数位基础设施，包括广泛的行动网路、云端系统和互联医疗技术。患者对灵活且便利的参与方式的需求日益增长，推动了分散式临床试验在各个治疗领域的应用。该地区的分散式模式允许患者直接在家中或附近的医疗中心参与试验，从而提高了招募效率和患者留存率。北美的申办方越来越依赖这些模式来优化研发週期、加速产品上市并提高整体投资报酬率。

引领全球分散式临床试验市场发展的领导者包括 OpenClinica、Medidata、Covance、Sano Genetics、PPD（赛默飞世尔科技）、Florence Healthcare、Reify Health、Mahalo Health、Bio-Optronics、Trialize、ClinOne、Veeva Systems、ClinTex、Parexel、PCONron Sciences（IIOCON）。分散式临床试验领域的企业正透过专注于数位化创新、平台整合和全球合作来巩固其市场地位。许多企业正在开发统一的云端系统，将远距医疗、电子病患报告结局（ePRO）和资料分析工具连接起来，以实现无缝的试验管理。与生物製药申办者和技术提供者的策略合作有助于增强互通性并扩展服务组合。

目录

第一章：方法论与范围

第二章：执行概要

第三章：行业洞察

• 产业生态系分析
• 产业影响因素
  • 成长驱动因素
    • 数位健康领域的技术进步
    • 成本效益和加速进度
    • 监管支持和框架制定
    • 提高病患就医便利性和多样性
  • 产业陷阱与挑战
    • 资料完整性和标准化
    • 监理复杂性
  • 市场机会
    • 人工智慧与穿戴式装置的融合
    • 向服务不足的地区扩张
• 成长潜力分析
• 监管环境
  • 北美洲
    • 我们
    • 加拿大
  • 欧洲
  • 亚太地区
  • 拉丁美洲
  • 中东和非洲
• 技术格局
  • 当前技术趋势
  • 新兴技术
• 未来市场趋势
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
  • 全球的
  • 北美洲
  • 欧洲
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 关键进展
  • 併购
  • 伙伴关係与合作
  • 新产品/服务发布
  • 扩张计划

第五章：市场估计与预测：依研究设计划分，2021-2034年

• 主要趋势
• 干预性试验
  • 随机对照试验（RCT）
  • 适应性临床试验
  • 实用性临床试验
• 观察性试验
  • 队列研究
  • 回顾性研究
  • 纵贯研究
• 扩大使用试验

第六章：市场估计与预测：依技术划分，2021-2034年

• 主要趋势
• 远距医疗平台
• 穿戴式装置
• 行动健康应用
• 电子资料撷取（EDC）系统
• 其他技术

第七章：市场估计与预测：依治疗领域划分，2021-2034年

• 主要趋势
• 肿瘤学
• 心臟病学
• 神经病学
• 传染病
• 呼吸系统疾病
• 其他慢性疾病

第八章：市场估算与预测：依研究阶段划分，2021-2034年

• 主要趋势
• 第一阶段
• 第二阶段
• 第三阶段
• 第四阶段

第九章：市场估计与预测：依参与者参与度划分，2021-2034年

• 主要趋势
• 以患者为中心的方法
• 远端监控
• 数位调查
• 虚拟实地考察

第十章：市场估计与预测：依地区划分，2021-2034年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十一章：公司简介

• Propharma
• IQVIA
• Medidata
• Parexel
• Fortrea
• Covance
• PRA Health Sciences (ICON)
• PPD (Thermo Fisher Scientific)
• Mahalo Health
• Clinical Research IO
• Veeva Systems
• OpenClinica
• Bio-Optronics
• Sano Genetics
• ClinOne
• Sanguine Bio
• Florence Healthcare
• Reify Health
• Trialize
• ClinTex

The Global Decentralized Clinical Trials Market was valued at USD 8.6 Billion in 2024 and is estimated to grow at a CAGR of 13.3% to reach USD 29.7 Billion by 2034.

The market's rapid growth is fueled by the widespread use of digital health solutions such as telemedicine platforms, electronic patient-reported outcomes (ePRO), wearable medical devices, and e-consent systems that are reshaping the way clinical research is conducted. Decentralized models remove traditional site constraints, enabling participation from patients across different geographic regions without the need to travel to centralized locations. Regulatory authorities across major markets are increasingly introducing structured frameworks to support the implementation of decentralized trial approaches. This global transition reflects the growing emphasis on patient convenience, real-time data collection, and inclusivity in research participation. With aging populations, higher incidences of chronic diseases, and the shift toward personalized medicine, healthcare systems are moving toward patient-focused models that make clinical trials more accessible and efficient. Decentralized trials align with these evolving trends by integrating digital tools to streamline processes, reduce operational costs, and improve patient engagement throughout the study lifecycle.

In decentralized studies, some or all trial-related procedures occur outside traditional research sites, allowing participants to engage from home or through local medical facilities. These trials use digital platforms, connected devices, and remote monitoring systems to collect clinical data and deliver treatments directly to participants. This design helps minimize travel demands and enhances inclusivity, creating more diverse and representative study populations.

The interventional trials segment captured a 63.7% share in 2024 and is forecast to reach USD 18.6 Billion by 2034. This growth is supported by remote participation capabilities that minimize the need for physical visits and improve trial accessibility for elderly and geographically distributed populations. Enhanced patient experience leads to stronger retention rates, while connected digital tools such as mobile applications, telehealth, and ePRO platforms enable continuous real-time monitoring and faster data acquisition, making interventional trials more scalable and efficient.

The telemedicine platforms segment generated USD 1.8 Billion in 2024. These platforms help eliminate travel and location barriers, supporting wider participation among patients from remote and underserved areas. Their integration with connected devices and digital reporting systems enhances the quality and speed of data collection, improving overall trial efficiency. The digital nature of telemedicine also lowers site management costs, shortens study durations, and simplifies coordination between sponsors, investigators, and patients. By creating an interconnected digital framework, telemedicine platforms allow more streamlined and adaptive decentralized trial operations.

North America Decentralized Clinical Trials Market held 44.1% share in 2024. The region benefits from highly advanced digital infrastructure, including widespread access to mobile networks, cloud-based systems, and connected health technologies. Growing patient demand for flexible, convenient participation options is driving adoption across various therapeutic areas. Decentralized models in this region are improving recruitment efficiency and retention rates by allowing participation directly from patients' homes or nearby healthcare centers. Sponsors in North America are increasingly relying on these models to optimize development timelines, accelerate product launches, and improve overall return on investment.

Leading companies shaping the Global Decentralized Clinical Trials Market include OpenClinica, Medidata, Covance, Sano Genetics, PPD (Thermo Fisher Scientific), Florence Healthcare, Reify Health, Mahalo Health, Bio-Optronics, Trialize, ClinOne, Veeva Systems, ClinTex, Parexel, PRA Health Sciences (ICON), Sanguine Bio, IQVIA, ProPharma, Fortrea, and Clinical Research IO. Companies in the decentralized clinical trials sector are strengthening their market position by focusing on digital innovation, platform integration, and global partnerships. Many are developing unified cloud-based systems that connect telemedicine, ePRO, and data analytics tools for seamless trial management. Strategic collaborations with biopharma sponsors and technology providers are helping enhance interoperability and expand service portfolios.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional trends
  • 2.2.2 Component trends
  • 2.2.3 Application trends
  • 2.2.4 End Use trends
• 2.3 CXO perspectives: Strategic imperatives
  • 2.3.1 Key decision points for industry executives
  • 2.3.2 Critical success factors for market players
• 2.4 Future outlook and strategic recommendations

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Technological advancement in digital health
    • 3.2.1.2 Cost efficiency and accelerated timelines
    • 3.2.1.3 Regulatory support and framework development
    • 3.2.1.4 Improved patient accessibility and diversity
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Data integrity and standardization
    • 3.2.2.2 Regulatory complexity
  • 3.2.3 Market opportunities
    • 3.2.3.1 Integration of AI and wearables
    • 3.2.3.2 Expansion into underserved regions
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
    • 3.4.1.1 U.S.
    • 3.4.1.2 Canada
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East and Africa
• 3.5 Technology landscape
  • 3.5.1 Current technological trends
  • 3.5.2 Emerging technologies
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 Global
  • 4.2.2 North America
  • 4.2.3 Europe
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Merger and acquisition
  • 4.6.2 Partnership and collaboration
  • 4.6.3 New product/services launches
  • 4.6.4 Expansion plans

Chapter 5 Market Estimates and Forecast, By Study Design, 2021 - 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Interventional trials
  • 5.2.1 Randomized controlled trials (RCTs)
  • 5.2.2 Adaptive clinical trials
  • 5.2.3 Pragmatic clinical trials
• 5.3 Observational trials
  • 5.3.1 Cohort studies
  • 5.3.2 Retrospective studies
  • 5.3.3 Longitudinal studies
• 5.4 Expanded access trials

Chapter 6 Market Estimates and Forecast, By Technology, 2021 - 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Telemedicine platforms
• 6.3 Wearable devices
• 6.4 Mobile health applications
• 6.5 Electronic data capture (EDC) systems
• 6.6 Other technologies

Chapter 7 Market Estimates and Forecast, By Therapeutic Area, 2021 - 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Oncology
• 7.3 Cardiology
• 7.4 Neurology
• 7.5 Infectious diseases
• 7.6 Respiratory disorders
• 7.7 Other chronic conditions

Chapter 8 Market Estimates and Forecast, By Study Phase, 2021 - 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Phase I
• 8.3 Phase II
• 8.4 Phase III
• 8.5 Phase IV

Chapter 9 Market Estimates and Forecast, By Participant Engagement, 2021 - 2034 ($ Mn)

• 9.1 Key trends
• 9.2 Patient-centric approaches
• 9.3 Remote monitoring
• 9.4 Digital surveys
• 9.5 Virtual site visits

Chapter 10 Market Estimates and Forecast, By Region, 2021 - 2034 ($ Mn)

• 10.1 Key trends
• 10.2 North America
  • 10.2.1 U.S.
  • 10.2.2 Canada
• 10.3 Europe
  • 10.3.1 Germany
  • 10.3.2 UK
  • 10.3.3 France
  • 10.3.4 Spain
  • 10.3.5 Italy
  • 10.3.6 Netherlands
• 10.4 Asia Pacific
  • 10.4.1 China
  • 10.4.2 India
  • 10.4.3 Japan
  • 10.4.4 Australia
  • 10.4.5 South Korea
• 10.5 Latin America
  • 10.5.1 Brazil
  • 10.5.2 Mexico
  • 10.5.3 Argentina
• 10.6 Middle East and Africa
  • 10.6.1 South Africa
  • 10.6.2 Saudi Arabia
  • 10.6.3 UAE

Chapter 11 Company Profiles

• 11.1 Propharma
• 11.2 IQVIA
• 11.3 Medidata
• 11.4 Parexel
• 11.5 Fortrea
• 11.6 Covance
• 11.7 PRA Health Sciences (ICON)
• 11.8 PPD (Thermo Fisher Scientific)
• 11.9 Mahalo Health
• 11.10 Clinical Research IO
• 11.11 Veeva Systems
• 11.12 OpenClinica
• 11.13 Bio-Optronics
• 11.14 Sano Genetics
• 11.15 ClinOne
• 11.16 Sanguine Bio
• 11.17 Florence Healthcare
• 11.18 Reify Health
• 11.19 Trialize
• 11.20 ClinTex