医疗保健电子知情同意市场规模、份额和成长分析（按平台、註册类型、表单类型、最终用途和地区划分）—2025-2032 年产业预测

全球医疗保健电子同意书（eConsent）市场规模预计在 2023 年达到 4.332 亿美元，从 2024 年的 4.8345 亿美元增长到 2032 年的 11.6323 亿美元，在预测期（2025-2032 年）内复合年增长率为 1.6%。

在全球医疗保健领域，电子知情同意书市场正经历强劲成长，这主要得益于医疗保健环境中数位化工具的快速普及。临床试验和远端医疗等领域对更有效率、合规且使用者友善的流程的需求日益增长，推动了电子知情同意系统的采用。这些数位化解决方案使患者能够随时随地管理自己的文檔，从而显着减少错误并提高资料完整性。此外，相关法规的支持也促使临床研究转向以病人为中心的模式。製药和生物技术公司正在利用电子知情同意来提高患者参与度和透明度，同时确保符合严格的国际标准。医院和研究机构正在转向云端基础的系统，这些系统能够实现安全身份验证、即时追踪和多语言支持，从而加快研究进程并支持远端参与分散式试验。

全球医疗保健市场中电子同意的驱动因素

全球医疗保健电子知情同意市场的主要驱动因素之一是对以患者为中心的医疗服务和加强资料隐私保护日益增长的需求。随着医疗服务提供者将透明度和患者参与度置于优先地位，电子知情同意系统使患者能够轻鬆理解和管理其治疗和数据共用的知情同意。这种向数位化解决方案的转变符合日益增长的需求，即在优先保护个人健康资讯的同时，促进患者与医疗服务提供者之间的高效沟通。此外，要求更清晰的知情同意流程的监管变化进一步推动了电子知情同意技术的应用，有助于改善医疗保健效果并提高医疗产业的营运效率。

全球医疗保健电子同意市场面临的限制因素

全球医疗保健电子知情同意市场发展面临的主要限制因素之一是各种电子健康记录 (EHR) 系统和电子知情同意平台之间缺乏标准化和互通性。这种碎片化使得电子知情同意解决方案难以整合到现有的医疗保健工作流程中，并可能导致病患资料管理的不一致。此外，不同地区的监管要求各异，也为医疗服务提供者采用普遍适用的电子知情同意解决方案带来了挑战。病患资料隐私和安全问题，以及潜在的技术障碍，进一步阻碍了电子知情同意技术的广泛应用，限制了其在医疗保健领域的有效性和吸引力。

全球医疗保健电子知情同意市场趋势

全球医疗电子知情同意市场正呈现出人工智慧 (AI) 和自动化融合的显着趋势，这正在革新患者知情同意流程。这些先进技术透过提供个人化的知情同意书，并利用对患者回馈的即时分析确保全面理解，从而提升用户体验。人工智慧驱动的自动化系统能够精准识别不一致之处并监控合规性，使医疗机构能够显着提高准确性，同时减轻临床人员的行政负担。因此，在电子知情同意平台中采用人工智慧和自动化技术，不仅简化了工作流程，还有助于提高病患参与度和满意度，最终推动电子知情同意市场的成长。

目录

介绍

• 调查目标
• 调查范围
• 定义

调查方法

• 资讯收集
• 二手资料和一手资料方法
• 市场规模预测
• 市场假设与限制

执行摘要

• 全球市场展望
• 供需趋势分析
• 细分市场机会分析

市场动态与展望

• 市场概览
• 市场规模
• 市场动态
  • 驱动因素和机会
  • 限制与挑战
• 波特分析

关键市场考察

• 关键成功因素
• 竞争程度
• 关键投资机会
• 市场生态系统
• 市场吸引力指数（2024）
• PESTEL 分析
• 总体经济指标
• 价值链分析
• 定价分析
• 技术评估
• 监管环境
• 管道分析

医疗保健电子知情同意市场规模（按平台划分）及复合年增长率（2025-2032 年）

• 市场概览
• 云端基础的
• 基于网路的

医疗保健电子知情同意市场规模（按註册类型和复合年增长率划分）（2025-2032 年）

• 市场概览
• 现场
• 偏僻的

医疗保健电子同意书市场规模（按形式类型划分）及复合年增长率（2025-2032 年）

• 市场概览
• 一般同意
• 一般同意，但有具体拒绝
• 一般拒绝但有特定同意
• 普遍否认

医疗保健电子知情同意市场规模（按最终用途划分）及复合年增长率（2025-2032 年）

• 市场概览
• 临床试验/合约研究组织
• 医院和诊所
• 製药和生物技术公司
• 远端医疗/远距护理服务提供者

医疗保健电子知情同意市场规模及复合年增长率（2025-2032）

• 北美洲
  • 美国
  • 加拿大
• 欧洲
  • 德国
  • 西班牙
  • 法国
  • 英国
  • 义大利
  • 其他欧洲地区
• 亚太地区
  • 中国
  • 印度
  • 日本
  • 韩国
  • 亚太其他地区
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地区
• 中东和非洲
  • 海湾合作委员会国家
  • 南非
  • 其他中东和非洲地区

竞争资讯

• 前五大公司对比
• 主要企业的市场定位（2024 年）
• 主要市场参与者所采取的策略
• 近期市场趋势
• 公司市占率分析（2024 年）
• 主要企业公司简介
  • 公司详情
  • 产品系列分析
  • 依业务板块进行公司股票分析
  • 2022-2024年营收年比比较

主要企业简介

• Veeva Systems
• Florence Healthcare
• Cloudbyz
• Concentric Health Ltd
• 5thPort, LLC
• Advarra
• Castor
• Climedo Health GmbH
• Calysta EMR
• Interlace Health
• Thieme Compliance GmbH
• Signant Health
• Y-Prime, LLC
• Medidata Solutions
• DocuSign
• Net Health
• Cognizant
• Formstack
• EvidentIQ Group
• Salesforce

结论与建议

Global eConsent In Healthcare Market size was valued at USD 433.2 million in 2023 and is poised to grow from USD 483.45 million in 2024 to USD 1163.23 million by 2032, growing at a CAGR of 11.6% during the forecast period (2025-2032).

The global eConsent in healthcare market is experiencing robust growth, propelled by the rapid adoption of digital tools across the healthcare landscape. The demand for more efficient, compliant, and user-friendly processes in areas like clinical trials and telemedicine is fostering the uptake of electronic consent systems. These digital solutions allow patients to manage their documents at their convenience, significantly minimizing errors and enhancing data integrity. Additionally, supportive regulations are promoting a shift towards patient-centered approaches in clinical research. Pharmaceutical and biotechnology firms are leveraging eConsent to boost patient engagement and transparency while ensuring compliance with stringent global standards. Hospitals and research organizations are transitioning to cloud-based systems, which facilitate secure authentication, real-time tracking, and multilingual support, thereby enabling faster studies and accommodating remote participation in decentralized trials.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global eConsent In Healthcare market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global eConsent In Healthcare Market Segments Analysis

Global eConsent In Healthcare Market is segmented by Platform, Enrollment Type, Form Type, End-Use and region. Based on Platform, the market is segmented into Cloud-based and Web-based. Based on Enrollment Type, the market is segmented into On-site and Remote. Based on Form Type, the market is segmented into General Consent, General Consent with Specific Denial(s), General Denial with Specific Consent(s) and General Denial. Based on End-Use, the market is segmented into Clinical Trials / CROs, Hospitals & Clinics, Pharmaceutical & Biotechnology Companies and Tele-medicine / Remote Care Providers. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global eConsent In Healthcare Market

One of the key market drivers for the global eConsent in healthcare market is the increasing demand for patient-centric care and enhanced data privacy. As healthcare providers prioritize transparency and patient engagement, eConsent systems enable patients to easily understand and manage their consent for treatment and data sharing. This shift towards digital solutions aligns with the growing emphasis on safeguarding personal health information while facilitating efficient communication between patients and providers. Additionally, regulatory changes mandating clearer consent processes further drive the adoption of eConsent technologies, contributing to improved healthcare outcomes and streamlined operational efficiencies within the healthcare industry.

Restraints in the Global eConsent In Healthcare Market

One of the key market restraints for the global eConsent in healthcare market is the lack of standardization and interoperability among various electronic health record (EHR) systems and eConsent platforms. This fragmentation complicates the integration of eConsent solutions into existing healthcare workflows and can lead to inconsistencies in patient data management. Additionally, varying regulatory requirements across regions create challenges for healthcare providers in implementing eConsent solutions that comply universally. Concerns regarding data privacy, security, and potential technological barriers among patients further hinder the widespread adoption of eConsent technologies, limiting their effectiveness and appeal in the healthcare sector.

Market Trends of the Global eConsent In Healthcare Market

The Global eConsent in Healthcare market is witnessing a significant trend towards the integration of artificial intelligence and automation, revolutionizing patient consent processes. These advanced technologies enhance user experiences by providing tailored consent documents and ensuring comprehensive understanding through real-time analysis of patient responses. With AI-driven automated systems flagging inconsistencies and monitoring compliance, healthcare providers can significantly improve accuracy while alleviating the administrative burden on clinical staff. As a result, the adoption of AI and automation in eConsent platforms not only streamlines workflows but also contributes to enhanced patient engagement and satisfaction, ultimately driving growth in the eConsent market.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Technology Assessment
• Regulatory Landscape
• Pipeline Analysis

Global eConsent In Healthcare Market Size by Platform & CAGR (2025-2032)

• Market Overview
• Cloud-based
• Web-based

Global eConsent In Healthcare Market Size by Enrollment Type & CAGR (2025-2032)

• Market Overview
• On-site
• Remote

Global eConsent In Healthcare Market Size by Form Type & CAGR (2025-2032)

• Market Overview
• General Consent
• General Consent with Specific Denial(s)
• General Denial with Specific Consent(s)
• General Denial

Global eConsent In Healthcare Market Size by End-Use & CAGR (2025-2032)

• Market Overview
• Clinical Trials / CROs
• Hospitals & Clinics
• Pharmaceutical & Biotechnology Companies
• Tele-medicine / Remote Care Providers

Global eConsent In Healthcare Market Size & CAGR (2025-2032)

• North America (Platform, Enrollment Type, Form Type, End-Use)
  • US
  • Canada
• Europe (Platform, Enrollment Type, Form Type, End-Use)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Platform, Enrollment Type, Form Type, End-Use)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Platform, Enrollment Type, Form Type, End-Use)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Platform, Enrollment Type, Form Type, End-Use)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• Veeva Systems
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Florence Healthcare
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cloudbyz
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Concentric Health Ltd
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• 5thPort, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Advarra
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Castor
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Climedo Health GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Calysta EMR
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Interlace Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Thieme Compliance GmbH
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Signant Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Y-Prime, LLC
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medidata Solutions
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• DocuSign
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Net Health
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Cognizant
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Formstack
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• EvidentIQ Group
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Salesforce
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations