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市場調查報告書
商品編碼
2046630
醫療保健領域電子同意(eConsent)市場:全球產業規模、佔有率、趨勢、機會和預測(按平台、註冊方法、表單類型和地區分類),競爭格局(2021-2031 年)EConsent In Healthcare Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Platform, By Enrollment Type, By Form Type, By Region & Competition, 2021-2031F |
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全球醫療保健領域的電子同意(eConsent)市場預計將從 2025 年的 3.7289 億美元大幅成長至 2031 年的 7.4354 億美元,複合年成長率高達 12.19%。
該市場涵蓋了透過多媒體和電子簽章實現醫療保健領域知情同意流程現代化、教育患者並確保患者自願參與臨床試驗的數位化平台。關鍵成長要素包括對以患者為中心的試驗設計的迫切需求,以及監管機構對需要遠端招募功能的分散式臨床試驗日益成長的支持。業界對科技的正面影響充滿信心,73%的臨床研究專業人士預計,到2025年,技術供應商將在未來十年內推動顯著改進,這凸顯了數位化解決方案在最佳化研究營運和確保資料合規性方面發揮的關鍵作用。然而,市場成長的主要限制因素是電子知情同意系統與現有研究機構基礎設施整合的技術挑戰。與傳統電子健康記錄系統互通性差會導致資料孤島和管理負擔加重,從而減緩技術的應用。
| 市場概覽 | |
|---|---|
| 預測期 | 2027-2031 |
| 市場規模(2025 年) | 3.7289億美元 |
| 市場規模(2031年) | 7.4354億美元 |
| 複合年成長率(2026-2031) | 12.19% |
| 快速成長的細分市場 | 基於雲端的 |
| 最大的市場 | 北美洲 |
分散式和混合式臨床試驗 (DCT) 的擴展是推動電子知情同意解決方案普及的主要動力,它改變了不同地理受試者的參與方式。隨著業界逐漸擺脫傳統的基於研究中心的模式,電子知情同意平台對於遠端受試者招募和確保持續合規至關重要,從而避免了現場訪視。研究中心傾向於採用能夠減輕行政負擔的靈活運作模式,這進一步強化了這一趨勢。根據塔夫茨大學藥物開發研究中心 (Tufts CSDD) 2024 年 3 月發表的一篇報導,61.4% 的研究中心傾向於採用混合式或完全分散式試驗模式,凸顯了數位化工具的關鍵作用。因此,電子知情同意系統正擴大被整合到研究方案中,以連接遠端參與者和研究人員。同時,對以病人為中心和增強理解的日益重視也在推動市場發展,相關人員正在尋求能夠幫助參與者透過互動式多媒體更深入地理解複雜醫學資訊的工具。與靜態的紙本表格不同,數位平台透過提供影片和多層次信息,幫助患者做出真正知情的決定,並提高參與者的保留率。根據 OpenClinica 2024 年 5 月的一篇報導,61% 的受訪者認為電子知情同意書“非常容易理解”,這表明其優於傳統方式。這種方便用戶使用的設計顯著提升了參與者的體驗,並加速了技術的普及應用。 Florence Healthcare 報告稱,自 2020 年以來,其電子知情同意平台的使用量增加了三倍,這表明醫療服務正大力轉向數位化優先的模式。
全球醫療保健電子知情同意市場成長面臨的主要障礙之一是電子知情同意系統與現有研究機構基礎設施整合的複雜技術挑戰。儘管電子知情同意工具的設計初衷是用於遠端註冊,但它們與醫院和臨床中心廣泛使用的傳統電子健康記錄 (EHR) 系統之間的互通性往往存在問題。這種連結性的缺失導致嚴重的資料孤島,迫使研究人員處理碎片化的工作流程,而非受益於整合系統。整合失敗造成的這種操作摩擦阻礙了研究機構全面採用電子知情同意平台,因為該技術通常會增加操作的複雜性,而不是簡化操作。這種分散化直接阻礙了市場擴張,因為它給臨床試驗負責人被迫手動解決這些技術上的不一致之處。據臨床研究專業人員協會 (ACRP) 稱,到 2025 年,約 60% 的研究機構工作人員將報告由於臨床技術缺乏整合而頻繁重複輸入數據。這種大規模的手動重複操作增加了出錯的風險,並佔用了本可用於患者照護的寶貴時間。因此,許多相關人員不願採用獨立的電子同意解決方案,這限制了市場的進一步擴張。
一個關鍵趨勢是將人工智慧 (AI) 整合到患者理解分析中,其應用範圍從簡單的數位化呈現發展到主動、即時地檢驗理解程度。人工智慧驅動的演算法和自然語言處理 (NLP) 技術透過在知情同意過程中評估參與者的理解程度,並動態簡化複雜的醫學術語,從而確保真正知情的決策。隨著試驗方案日益複雜,這項功能變得至關重要,但該技術的廣泛應用仍處於早期階段。根據 2025 年 6 月發表在《應用臨床試驗在線》(Applied Clinical Trials Online) 上的一篇報導,在約 80 家公司中,只有 11% 的公司在其臨床試驗活動中充分利用了人工智慧/機器學習 (AI/ML) 技術,這表明隨著這些先進的理解評估工具的巨大潛力不斷發展,其應用巨大潛力。同時,市場正見證與電子健康記錄(EHR) 和電子臨床系統的日益融合,旨在消除目前困擾研究機構的營運孤島。相關人員積極推動建立一個整合生態系統,使電子知情同意平台能夠與現有設施技術無縫整合,實現單一登入 (SSO) 和自動資料傳輸至病患記錄。這一趨勢直接解決了碎片化系統帶來的過重管理負擔,促使供應商優先考慮整合而非提供獨立產品。對營運效率的需求顯而易見。根據 Greenphire 在 2024 年 10 月進行的一項調查,95% 的受訪研究機構優先考慮能夠減少營運工作量和時間的技術,從而加速了互聯電子臨床環境的普及應用。
The Global EConsent In Healthcare Market is anticipated to expand significantly, rising from USD 372.89 Million in 2025 to USD 743.54 Million by 2031, demonstrating a robust CAGR of 12.19%. This market encompasses digital platforms that modernize the informed consent process in healthcare through multimedia and electronic signatures, educating patients and securing their voluntary involvement in clinical trials. Key growth catalysts include the urgent demand for patient-centric trial designs and growing regulatory support for decentralized clinical trials, which require remote enrollment features. Industry confidence in technology's positive impact is high, with 73% of clinical research professionals in 2025 expecting technology providers to drive significant improvements over the next decade, underscoring the vital role of digital solutions in optimizing study operations and ensuring data compliance. However, a major impediment to market growth is the technical challenge of integrating eConsent systems with existing research site infrastructures, as poor interoperability with legacy electronic health record systems often leads to data silos and increased administrative workload, slowing technology adoption.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 372.89 Million |
| Market Size 2031 | USD 743.54 Million |
| CAGR 2026-2031 | 12.19% |
| Fastest Growing Segment | Cloud-based |
| Largest Market | North America |
Market Driver
The expansion of Decentralized and Hybrid Clinical Trials (DCTs) is a key driver for eConsent solution adoption, transforming participant engagement across diverse geographical areas. As the industry shifts from traditional site-based models, electronic consent platforms are crucial for remote enrollment and continuous compliance, eliminating the need for physical visits. This trend is reinforced by investigative sites' preference for adaptable operational models that reduce administrative tasks; a March 2024 Tufts CSDD article reported that 61.4% of sites favor hybrid or fully decentralized trial models, highlighting the indispensable role of digital tools. As a result, eConsent systems are increasingly incorporated into study protocols to connect remote participants with research investigators. Concurrently, the growing focus on patient-centricity and enhanced comprehension is propelling the market, as stakeholders seek tools that improve participants' understanding of complex medical information via interactive multimedia. Unlike static paper forms, digital platforms provide videos and layered information, empowering patients to make truly informed decisions and boosting retention. An OpenClinica article from May 2024 indicated that 61% of respondents found eConsent forms "very easy" to understand, proving their advantage over traditional methods. This user-friendly design significantly enhances the participant experience and accelerates technology adoption, with Florence Healthcare noting a threefold increase in eConsent platform usage since 2020, signifying a strong move towards digital-first engagement.
Market Challenge
A major impediment to the growth of the Global EConsent In Healthcare Market is the intricate technical challenge of integrating eConsent systems with existing research site infrastructures. Despite their design for remote enrollment, digital consent tools often struggle with seamless interoperability with legacy Electronic Health Record (EHR) systems prevalent in hospitals and clinical centers. This lack of connectivity results in considerable data silos, compelling research staff to handle fragmented workflows instead of benefiting from a unified system. Such operational friction, caused by integration failures, discourages research sites from fully embracing eConsent platforms, as the technology frequently adds complexity rather than streamlining operations. This fragmentation directly hinders market expansion by imposing excessive administrative loads on clinical trial personnel, who are required to manually bridge these technical discrepancies. In 2025, about 60% of research site staff reported frequently performing redundant data entry due to unintegrated clinical technologies, according to the Association of Clinical Research Professionals. This significant manual duplication elevates the risk of errors and diverts valuable time from patient care. Consequently, many stakeholders are reluctant to adopt standalone eConsent solutions, thereby restricting the market's broader scalability.
Market Trends
A pivotal trend is the integration of Artificial Intelligence for Patient Comprehension Analysis, moving beyond mere digital presentation to active, real-time verification of understanding. AI-driven algorithms and Natural Language Processing (NLP) now evaluate participant literacy during the consent process, dynamically simplifying complex medical terms to ensure genuinely informed decisions. This feature is becoming critical as protocols become more intricate, though the technology is still in its nascent stages of widespread adoption. An Applied Clinical Trials Online article from June 2025 noted that only 11% of approximately 80 companies fully use AI/ML in clinical trial activities, suggesting substantial growth potential as these advanced comprehension tools evolve. Concurrently, the market observes a convergence with Electronic Health Records and eClinical Systems, aiming to eliminate the operational silos that currently burden research sites. Stakeholders are actively pursuing unified ecosystems where eConsent platforms seamlessly interact with existing site technologies, enabling Single Sign-On (SSO) and automated data transfer into patient records. This trend directly addresses the excessive administrative burden imposed by fragmented systems, prompting vendors to prioritize integration over standalone offerings. The demand for operational efficiency is evident; a Greenphire survey from October 2024 revealed that 95% of sites value technology that reduces effort and time spent on tasks, thereby accelerating the adoption of these interconnected eClinical environments.
Report Scope
In this report, the Global EConsent In Healthcare Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global EConsent In Healthcare Market.
Global EConsent In Healthcare Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: