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2023-2030 年全球医疗保健市场 EConsentGlobal EConsent in Healthcare Market 2023-2030 |
预计在预测期内(2023-2030 年),全球医疗保健市场的CAGR将达到 9.9%。市场的成长归因于赞助商控制力的增强。 eConsent 解决方案中新增的分层授权选项和额外功能为赞助商提供了更多控制和自订功能。这满足了根据研究需求量身定制同意解决方案的愿望。例如,2021年4月,Signant Health凭藉最新发布的Smart Signals eConsent,拓展了电子知情同意产品并增强了自身能力。关键产品功能增强和分层许可选项为申办者提供了对任何研究设计获得电子知情同意和重新同意的额外控制。
全球医疗保健市场共识按註册类型、部署模式和表单类型细分。根据註册类型,市场分为现场同意和远端同意。根据部署模式,市场分为基于云端的和基于网路的。此外,根据形式类型,市场细分为普遍同意、普遍同意但特定拒绝、普遍拒绝特定同意、普遍拒绝。基于云端的子类别预计将占据部署模式细分市场的很大一部分市场份额。这一增长可归因于越来越多地使用基于云端的解决方案,因为它具有最大限度地减少管理负担并保持站点和研究团队合规性的好处。此外,基于云端的电子同意透过结合创新技术和多媒体来改进流程,为潜在的试验参与者提供互动式知情同意体验。
在这些应用中,内容管理系统(CMS)细分市场预计将在全球医疗保健市场中占据相当大的份额。细分市场的成长归因于不同人群的参与。现场电子同意可以服务于各种人群,包括具有不同程度的数位素养或技术访问受限的人群,从而能够公平地获取试验材料。例如,2021 年 7 月,CASTOR 推出了可扩展的病患登记和 eConsent 平台。临床试验受益于权力下放,因为它使更广泛的个人更容易获得临床试验。该过程还鼓励透明度和效率,透过在整个研究招募和入组过程中提供无缝过渡来减轻患者的负担。
全球医疗保健市场按地理位置进一步细分,包括北美(美国和加拿大)、欧洲(英国、义大利、西班牙、德国、法国和欧洲其他地区)、亚太地区(印度、中国、日本、韩国和亚洲其他地区)以及世界其他地区(中东和非洲以及拉丁美洲)。其中,欧洲预计将在全球市场中占据显着份额,因为该地区的医疗保健系统发达,此外还非常重视资料保护和患者权利,这使得 eConsent 解决方案成为一个有吸引力的选择。日益增多的医疗保健数位化倡议,例如电子健康记录和互通性标准的广泛采用,为电子同意的部署提供了有利的环境。
在所有地区中,北美地区预计在预测期内将以相当大的CAGR成长。区域成长归因于比较理解研究。比较患者对电子同意书与纸本知情同意书 (ICF) 的理解程度的比较研究已经产生了积极的结果。这些研究强调电子同意的改进或可比较知识有助于其被接受。根据美国国立卫生研究院 (gov.) 2023 年 9 月的数据,本次审查总共纳入了 36 项符合资格标准的研究,以及手动检索的额外结果出版物。这些出版品总共描述了 35 项研究,其中 2 项研究各由 2 篇出版品涵盖。大多数研究(28/35,80%)在北美进行,其中美国占 26 项研究,加拿大占 2 项研究。
此外,在对涉及总共 8,778 名参与者的 26 项研究进行的综合分析中,评估了与电子同意相关的患者理解程度。在这些研究中,有 20 项专门比较了电子同意和纸本知情同意书 (ICF) 的理解程度,共有 6,769 名参与者提供了比较资料。研究结果表明,与纸本 ICF 相比,电子同意要么表现出显着更好的理解,要么在没有统计意义的情况下更好地理解,要么总体理解没有显着差异。
Global EConsent in Healthcare Market Size, Share & Trends Analysis Report by Enrollment Type (On-site, and Remote Consent), by Deployment Mode (Cloud-based, and Web-based) and by Form Type (General Consent, General Consent with Specific Denial(s), General Denial with Specific Consent(s), and General Denial), Forecast Period (2023-2030)
The global econsent in healthcare market is anticipated to grow at a CAGR of 9.9% during the forecast period (2023-2030). The market's growth is attributed to the increased sponsor control. The addition of tiered license options and extra features in eConsent solutions offers sponsors more control and customization capabilities. This satisfies the desire for customized consent solutions based on the needs of the study. For instance, in April 2021, Signant Health, with the latest released of Smart Signals eConsent, the company has expanded its electronic informed consent products and strengthened its capabilities. Key product functionality enhancements and tiered license options offer sponsors additional control over getting electronic informed consent and reconsent for any study design.
The global econsent in healthcare market is segmented on the enrollment type, deployment mode, and form type. Based on the enrollment type, the market is sub-segmented on-site, and remote consent. Based on the deployment mode, the market is sub-segmented into cloud-based, and web-based. Furthermore, on the basis of form type, the market is sub-segmented into general consent, general consent with specific denial(s), general denial with specific consent(s), general denial. The cloud-based subcategory is expected to capture a significant portion of the market share within the deployment mode segment. The growth can be attributed to the growing use of cloud-based solutions owing to the benefits of minimizing administrative burden and maintaining compliance for sites and study teams. Furthermore, cloud-based eConsent improves the process by incorporating innovative technology and multimedia to provide potential trial participants with an interactive informed consent experience.
Among the application, the content management systems (CMS) sub-segment is expected to hold a considerable share of the global econsent in healthcare market. The segmental growth is attributed to the diverse populations engagement. On-site eConsent can serve a variety of demographics, including those with various degrees of digital literacy or restricted access to technology, enabling fair access to trial material. For instance, in July 2021,CASTOR Launched Scalable Patient Enrollment and eConsent Platform. Clinical trials benefit from decentralization as it makes them more accessible to a wider range of individual. The process additionally encourages transparency and efficiency, reducing the burden on patients by providing a seamless transition throughout the study recruitment and enrollment process.
The global econsent in healthcare market is further segmented based on geography including North America (the US, and Canada), Europe (UK, Italy, Spain, Germany, France, and the Rest of Europe), Asia-Pacific (India, China, Japan, South Korea, and Rest of Asia), and the Rest of the World (the Middle East & Africa, and Latin America). Among these, Europe is anticipated to hold a prominent share of the market across the globe, owing to the region's healthcare system is well-developed, in addition to is a significant emphasis on data protection and patient rights, making eConsent solutions an appealing option. The increasing healthcare digitization initiatives, such as widespread adoption of electronic health records and interoperability standards, present a conducive climate for eConsent deployment.
Among all regions, the North America regions is anticipated to grow at a considerable CAGR over the forecast period. Regional growth is attributed to the comparative comprehension studies. Comparative research comparing patient comprehension of eConsenting opposed to paper-based Informed Consent Forms (ICFs) has produced positive results. These studies emphasizing improved or comparable knowledge of eConsenting assist to its acceptance. According to the National Institute of Health (gov.) in September 2023, a total of 36 studies meeting the eligibility criteria were included in this review, along with an additional outcomes publication that was retrieved manually. These publications described a total of 35 studies, with 2 studies covered by 2 publications each. The majority of the studies (28/35, 80%) were conducted in North America, with the US accounting for 26 studies and Canada for 2 studies.
Furthermore, in a comprehensive analysis of 26 studies involving a total of 8,778 participants, the aspects of patient comprehension were evaluated in relation to eConsenting. Out of these studies, 20 specifically compared comprehension between eConsenting and paper-based informed consent forms (ICFs), with a total of 6,769 participants contributing comparative data. The findings indicated that eConsenting demonstrated either significantly better understanding, better understanding without statistical significance, or no significant differences in overall comprehension when compared to paper-based ICFs.
The major companies serving the econsent in healthcare market includes Magentus Group Pty Ltd., Medable, Inc., Medrio, Inc., ObvioHealth, and Veeva Systems and others. The market players are considerably contributing to the market growth by the adoption of various strategies including mergers and acquisitions, partnerships, collaborations, funding, and new product launches, to stay competitive in the market. For instance In June 2022, uMotif partnered with ClinOne to provide a seamless experience for patients, caregivers, and sites of proven traditional, DCT, and hybrid trial solutions for eConsent, eCOA / ePRO, behavioral engagement, sensors and wearables, and more.