eConsent In Healthcare Market Size, Share & Trends Analysis Report By Platform (Cloud-based, Web-based), By Enrollment Type (On-site, Remote), By Form Type, By Region, And Segment Forecasts, 2024 - 2030

eConsent In Healthcare Market Trends

The global eConsent in healthcare market size was estimated at USD 432.15 million in 2023 and is projected to grow at a compound annual growth rate (CAGR) of 11.3% from 2024 to 2030. Increasing adoption of eConsent in clinical trials, aided by mobile technology advancements that have revolutionized process of informed consent and improved patient comprehension, is expected to drive growth in eConsent market within healthcare industry over the forecast period. For instance, according to the “14 Drivers of eConsent Adoption in Clinical Trials - Infographic” published by Signant Health, leading pharmaceutical companies invest in adopting eConsent in their clinical trial systems.

The aforementioned document states that 100% of top 10 pharmaceutical companies have implemented eConsent initiatives, while 88% of top 25 pharmaceutical companies have also implemented eConsent. In addition, 66% of top 50 pharmaceutical companies are engaged or planning to initiate an eConsent program over the forecast period.

COVID-19 pandemic positively impacted the global eConsent market by accelerating the adoption of eConsent globally through regulatory flexibility. Europe made significant progress in implementing eConsent, with regulatory authorities actively developing recommendations and document drafting in multiple regions. For instance, Medidata Solutions' whitepaper "Electronic Informed Consent in Clinical Research" stated that pandemic led to a more flexible acceptance of technologies, such as eConsent, which enable trial continuation while mitigating infection risk.

Market Dynamics

Furthermore, market growth is driven by the healthcare industry's emphasis on streamlining processes and reducing reconciliation through eConsent integration with other eClinical solutions, as well as a surge in strategic acquisitions & partnership deals. For instance, in June 2022, uMotif & ClinOne partnered to provide a single, integrated solution that delivers best-in-class electronic informed consent (eConsent) and electronic clinical outcome assessments technology to tackle the challenges faced by patients & clinical research coordinators in navigating multiple systems apps, & sensors for each protocol in life sciences industry.

In addition, eConsent has been identified as an acceptable alternative during the COVID-19 pandemic in certain clinical trial guidance documents. The global lack of regulatory clarity on eConsent has been a longstanding issue, but progress is being made. For instance, draft ICH GCP E6 (R3) references “the potential use of technology to inform participants and obtain informed consent.” However, eConsent adoption has been variable in Europe due to a lack of regulatory clarity and operational issues, such as the accepting of electronic signatures for eConsent documents.

Platform Insights

In 2023, cloud-based segment gained a major market share of 92.6%. The segment growth can be attributed to increasing usage of cloud-based platforms due to advantage of reducing administrative burden and ensuring compliance for sites & study teams. Besides, cloud-based eConsent enhances process by deploying modern technology and multimedia to create an interactive informed consent experience for potential trial participants. It adds immediate customer value, accelerates timelines, and maintains study budgets.

Furthermore, a cloud-based platform saves time for clinical trials with multiple sites of patient enrollment, remotely monitored participants, and other large, randomized studies. It also supports data aggregation into a central repository, significantly reducing duration of a clinical trial. For instance, in November 2022, YPrime, LLC launched an eConsent platform that helps study teams present complex patient information in digestible components, making it highly navigable with improved understanding and engagement. This platform is expected to streamline the clinical trial process and improve patient recruitment and retention.

On the other hand, web-based eConsent is based on obtaining information through a website or web-based application. It allows sites to obtain information unavailable over a paper process. This consent is accessible online; hence, users can access it as part of their website usage and get an online experience.

Enrollment Type Insights

The onsite segment dominated the market in 2023 with a revenue share of over 83.9%. Onsite enrollment refers to participants providing consent for a study in person using the eConsent platform in a clinical setting. Growth of this segment is driven by increasing adoption of eConsent in clinical trials and the demand for technologically advanced platforms to boost productivity. In addition, eConsent simplifies administrative processes and minimizes site visits. Onsite enrollment has increased eConsent usage for disease registries, clinical study consents, and biobanking registries in healthcare. These factors have contributed to the rising market demand for eConsent solutions.

Remote enrollment segment is anticipated to witness the fastest CAGR over the forecast period. Remote enrollment for screening or clinical trials can be facilitated through standalone eConsent platforms or integrated eClinical solutions. Furthermore, launch of new platform solutions that support eConsent/re-consent for remote, traditional, or hybrid trials is anticipated to support market growth further. For instance, in April 2021, Signant Health expanded its electronic informed consent offerings by releasing SmartSignals eConsent. This offering supports global eConsent/re-consent for various trials, such as remote, traditional, or hybrid.

Form Type Insights

The general consent forms segment held the largest revenue share in 2023, accounting for over 39.7%. These forms are widely adopted in healthcare facilities and clinical trials due to their simplicity compared to other forms. General consent forms do not require detailed information about past healthcare experiences, reducing the burden of maintaining patient records. They are typically used for patient care processes that do not pose significant risks, such as collecting blood samples, physical examinations, or administering fluids.

On the other hand, general denial with specific consent(s) segment is anticipated to witness a lucrative CAGR over the forecast period. This form is specifically created for patients who want to restrict access to their health data, except in specific situations outlined in the consent. For instance, patients may authorize their primary care provider to send a body fluid sample to a diagnostic service with only the necessary data for conducting tests and reporting results.

Regional Insights

In 2023, North America held the largest market share of 39.2%. The region has witnessed successful wide-scale implementation of eConsent in Healthcare, driven by high demand and growing digitalization of patient health information. Adopting advanced eConsent solutions is essential for improving healthcare outcomes and supporting regional clinical trials. The market has also benefited from increased need for remote data collection and government initiatives during COVID-19 pandemic. Government support in the U.S. and Canada further fuels adoption of eConsent processes and contributes to the regional market's growth.

The market in Europe is driven by various factors, including healthcare regulations, growing patient population, rise in clinical trials, impact of COVID-19 pandemic, and regulations surrounding electronic informed consent. Several European countries also implement eConsent solutions by introducing new updates and features. In March 2021, European Contract Research Organisation Federation (EUCROF) published a guide on electronic informed consent implementation, highlighting that the general eIDAS regulation on eSignatures lacks specific guidance for using eSignatures in clinical studies. These developments contribute to growth and advancement of the eConsent market in Europe.

Demand for eConsent in Healthcare in the Asia Pacific region is increasing across multiple countries due to rising disease burden, rapid economic development, and growing adoption of technology-based solutions, including cloud and web-based platforms, in clinical trials. Moreover, there is a strong focus on research and clinical trials in hospitals and research centers, leading to an increased need for digital solutions such as eConsent. An example is the selection of Signant Health in September 2019 to provide electronic informed consent for a neuroscience study conducted by the Shanghai Mental Health Center (SMHC). This study, which enrolled hundreds of patients at various sites, marked initial implementation of Signant's Trial Consent solution in China. These developments highlight emerging requirements and adoption of eConsent solutions in the Asia Pacific for improved clinical trial processes and patient engagement.

Key Companies & Market Share Insights

The global market for e-Consent in healthcare is highly competitive, with notable players such as Veeva Systems, Wellbeing Software, Citadel Group, Catalyst EMR and Cloud BYZ, among others. These companies are constantly engaged in launching new products, partnerships and collaborations, conducting clinical trials, and other related developments to stay ahead of the competition.

• For instance, in October 2020, Veeva Systems launched two new applications built on Veeva Clinical Network - Veeva Site Connect and Veeva eConsent. Veeva Site Connect facilitates paperless information exchange between clinical research and sponsor sites throughout a trial. With Veeva eConsent, researchers can digitize the consent process with review boards and patients while ensuring transparency for sponsors.

• For instance, in June 2022, uMotif and ClinOne announced a partnership to address the challenges faced by patients & clinical research coordinators who struggle to navigate multiple systems, apps, and  sensors for each protocol. To overcome these challenges, these two companies aim to provide life sciences industry with a single, integrated solution that delivers best-in-class Electronic Clinical Outcome Assessments (eCOA) and Electronic Informed Consent (eConsent) technology.

eConsent In Healthcare Market Report Scope

Global eConsent In Healthcare Market Report Segmentation

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global eConsent in healthcare market report based on platform, enrollment type, form type, and region:

• Platform Outlook (Revenue, USD Million, 2018 - 2030)

  • Cloud-based

  • Web-based

• Enrollment Type Outlook (Revenue, USD Million, 2018 - 2030)

  • On-site

  • Remote

• Form Type Outlook (Revenue, USD Million, 2018 - 2030)

  • General Consent

  • General Consent with Specific Denial(s)

  • General Denial with Specific Consent(s)

  • General Denial

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • UK

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • Japan

    • China

    • India

    • Australia

    • Thailand

    • South Korea

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE