醫療保健電子知情同意市場規模、佔有率和成長分析（按平台、註冊類型、表單類型、最終用途和地區分類）—2025-2032 年產業預測

全球醫療保健電子同意書（eConsent）市場規模預計在 2023 年達到 4.332 億美元，從 2024 年的 4.8345 億美元成長到 2032 年的 11.6323 億美元，在預測期（2025-2032 年）內複合年成長率為 1.6%。

在全球醫療保健領域，電子知情同意書市場正經歷強勁成長，這主要得益於醫療保健環境中數位化工具的快速普及。臨床試驗和遠端醫療等領域對更有效率、合規且使用者友善的流程的需求日益成長，推動了電子知情同意系統的採用。這些數位化解決方案使患者能夠隨時隨地管理自己的文檔，從而顯著減少錯誤並提高資料完整性。此外，相關法規的支持也促使臨床研究轉向以病人為中心的模式。製藥和生物技術公司正在利用電子知情同意來提高患者參與度和透明度，同時確保符合嚴格的國際標準。醫院和研究機構正在轉向雲端基礎的系統，這些系統能夠實現安全身份驗證、即時追蹤和多語言支持，從而加快研究進程並支持遠端參與分散式試驗。

全球醫療保健市場中電子同意的促進因素

全球醫療保健電子知情同意市場的主要促進因素之一是對以患者為中心的醫療服務和加強資料隱私保護日益成長的需求。隨著醫療服務提供者將透明度和患者參與度置於優先地位，電子知情同意系統使患者能夠輕鬆理解和管理其治療和數據共用的知情同意。這種向數位化解決方案的轉變符合日益成長的需求，即在優先保護個人健康資訊的同時，促進患者與醫療服務提供者之間的高效溝通。此外，要求更清晰的知情同意流程的監管變化進一步推動了電子知情同意技術的應用，有助於改善醫療保健效果並提高醫療產業的營運效率。

全球醫療保健電子同意市場面臨的限制因素

全球醫療保健電子知情同意市場發展面臨的主要限制因素之一是各種電子健康記錄 (EHR) 系統和電子知情同意平台之間缺乏標準化和互通性。這種碎片化使得電子知情同意解決方案難以整合到現有的醫療保健工作流程中，並可能導致病患資料管理的不一致。此外，不同地區的監管要求各異，也為醫療服務提供者採用普遍適用的電子知情同意解決方案帶來了挑戰。病患資料隱私和安全問題，以及潛在的技術障礙，進一步阻礙了電子知情同意技術的廣泛應用，限制了其在醫療保健領域的有效性和吸引力。

全球醫療保健電子知情同意市場趨勢

全球醫療電子知情同意市場正呈現出人工智慧 (AI) 和自動化融合的顯著趨勢，這正在革新患者知情同意流程。這些先進技術透過提供個人化的知情同意書，並利用對患者回饋的即時分析確保全面理解，從而提升用戶體驗。人工智慧驅動的自動化系統能夠精準識別不一致之處並監控合規性，使醫療機構能夠顯著提高準確性，同時減輕臨床人員的行政負擔。因此，在電子知情同意平台中採用人工智慧和自動化技術，不僅簡化了工作流程，還有助於提高病患參與度和滿意度，最終推動電子知情同意市場的成長。

目錄

介紹

• 調查目標
• 調查範圍
• 定義

調查方法

• 資訊收集
• 二手資料和一手資料方法
• 市場規模預測
• 市場假設與限制

執行摘要

• 全球市場展望
• 供需趨勢分析
• 細分市場機會分析

市場動態與展望

• 市場概覽
• 市場規模
• 市場動態
  • 促進因素和機遇
  • 限制與挑戰
• 波特分析

關鍵市場考察

• 關鍵成功因素
• 競爭程度
• 關鍵投資機會
• 市場生態系統
• 市場吸引力指數（2024）
• PESTEL 分析
• 總體經濟指標
• 價值鏈分析
• 定價分析
• 技術評估
• 監管環境
• 管道分析

醫療保健電子知情同意市場規模（按平台分類）及複合年成長率（2025-2032 年）

• 市場概覽
• 雲端基礎的
• 基於網路的

醫療保健電子知情同意市場規模（按註冊類型和複合年成長率分類）（2025-2032 年）

• 市場概覽
• 現場
• 偏僻的

醫療保健電子同意書市場規模（按形式類型分類）及複合年成長率（2025-2032 年）

• 市場概覽
• 一般同意
• 一般同意，但有具體拒絕
• 一般拒絕但有特定同意
• 普遍否認

醫療保健電子知情同意市場規模（按最終用途分類）及複合年成長率（2025-2032 年）

• 市場概覽
• 臨床試驗/合約研究組織
• 醫院和診所
• 製藥和生物技術公司
• 遠端醫療/遠距護理服務提供者

醫療保健電子知情同意市場規模及複合年成長率（2025-2032）

• 北美洲
  • 美國
  • 加拿大
• 歐洲
  • 德國
  • 西班牙
  • 法國
  • 英國
  • 義大利
  • 其他歐洲地區
• 亞太地區
  • 中國
  • 印度
  • 日本
  • 韓國
  • 亞太其他地區
• 拉丁美洲
  • 巴西
  • 其他拉丁美洲地區
• 中東和非洲
  • 海灣合作理事會國家
  • 南非
  • 其他中東和非洲地區

競爭資訊

• 前五大公司對比
• 主要企業的市場定位（2024 年）
• 主要市場參與者所採取的策略
• 近期市場趨勢
• 公司市佔率分析（2024 年）
• 主要企業公司簡介
  • 公司詳情
  • 產品系列分析
  • 依業務板塊進行公司股票分析
  • 2022-2024年營收年比比較

主要企業簡介

• 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

結論與建議

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