eConsent in Healthcare

Global eConsent in Healthcare Market to Reach US$981.7 Million by 2030

The global market for eConsent in Healthcare estimated at US$519.4 Million in the year 2024, is expected to reach US$981.7 Million by 2030, growing at a CAGR of 11.2% over the analysis period 2024-2030. Cloud-based Platform, one of the segments analyzed in the report, is expected to record a 12.5% CAGR and reach US$669.7 Million by the end of the analysis period. Growth in the Web-based Platform segment is estimated at 8.7% CAGR over the analysis period.

The U.S. Market is Estimated at US$136.5 Million While China is Forecast to Grow at 10.2% CAGR

The eConsent in Healthcare market in the U.S. is estimated at US$136.5 Million in the year 2024. China, the world`s second largest economy, is forecast to reach a projected market size of US$150.5 Million by the year 2030 trailing a CAGR of 10.2% over the analysis period 2024-2030. Among the other noteworthy geographic markets are Japan and Canada, each forecast to grow at a CAGR of 10.1% and 9.0% respectively over the analysis period. Within Europe, Germany is forecast to grow at approximately 8.6% CAGR.

Global eConsent in Healthcare Market – Key Trends & Drivers Summarized

Why Is eConsent Emerging as a Cornerstone of Patient-Centric Healthcare Transformation?

As healthcare shifts toward greater transparency, digitization, and patient empowerment, electronic consent (eConsent) is emerging as a pivotal component in redefining how patient permissions are captured, managed, and documented. Traditionally, consent procedures were paper-based, inconsistent, and prone to errors or miscommunication, often leading to legal vulnerabilities and patient confusion. Today, eConsent systems are transforming this process into an interactive, transparent, and compliant experience that improves understanding and engagement. Especially in clinical research, where regulatory scrutiny and informed participation are vital, eConsent platforms are enabling standardized, trackable, and multilingual consent workflows that align with ethical and legal standards. Furthermore, the rise of decentralized clinical trials and virtual care delivery has necessitated the shift from in-person signing to remote, digital experiences—making eConsent indispensable in ensuring continuity of care and compliance across geographies. By incorporating multimedia content, real-time analytics, digital signatures, and cloud-based access, these platforms are simplifying complex clinical jargon, improving patient comprehension, and creating auditable consent trails. Whether for routine surgical procedures, vaccinations, genetic testing, or experimental therapies, eConsent is bringing efficiency, security, and inclusivity to the heart of patient-provider interaction, reshaping consent from a mere formality into a meaningful, patient-driven process.

How Are Technology Advancements Enhancing the Security, Accessibility, and Integration of eConsent Platforms?

Rapid advancements in digital health technologies are reshaping eConsent platforms into sophisticated tools capable of secure, scalable, and patient-friendly deployment across diverse healthcare settings. Cloud-based architectures are now enabling seamless, real-time access to consent documents, while end-to-end encryption, multi-factor authentication, and blockchain integration ensure the integrity and confidentiality of patient data. The rise of AI and natural language processing has allowed for dynamic content personalization, translating complex medical concepts into easily understandable language and visuals tailored to each patient’s literacy level and language preferences. Additionally, integrations with electronic health records (EHRs), clinical trial management systems (CTMS), and digital front-door platforms have made eConsent a natural extension of broader digital health ecosystems. Mobile optimization, electronic signature capture, and offline access features are supporting consent in remote and underserved areas, improving equity in access. Smart consent platforms also offer real-time analytics and audit logs, enabling healthcare providers and sponsors to track who has signed, when, and what version of the document was used—greatly enhancing regulatory compliance and operational efficiency. These innovations are not only making consent more secure and user-friendly but are also streamlining documentation workflows for researchers, clinicians, and administrators, reducing administrative overhead and legal risk.

How Are Shifting Clinical, Regulatory, and Consumer Expectations Reshaping eConsent Adoption?

A confluence of shifting stakeholder expectations is accelerating the adoption of eConsent in both clinical and commercial healthcare environments. Regulatory bodies such as the FDA, EMA, and MHRA have issued supportive guidance on the use of electronic consent in clinical trials, validating its legality and encouraging digital transition in informed consent processes. In parallel, the decentralization of clinical trials—driven by COVID-19 and ongoing digital transformation—is pushing sponsors and CROs to adopt remote-friendly technologies like eConsent to engage geographically dispersed participants. In clinical care, hospital systems are incorporating eConsent to streamline pre-surgical documentation, remote diagnostics, telemedicine consultations, and outpatient procedures, addressing both safety and efficiency imperatives. Meanwhile, patients themselves are demanding greater autonomy and clarity in their care journeys. With rising awareness about health data rights, personal privacy, and medical literacy, many patients now expect consent to be more interactive, informative, and accessible. This has led healthcare providers to view eConsent as a strategic tool for building trust, reducing no-shows, and improving treatment adherence. Health systems that once saw consent as a legal necessity are now treating it as a key moment of engagement. Whether in clinical trials, routine care, or data-sharing agreements, eConsent is becoming integral to modern, patient-first care models where communication, compliance, and user experience are all paramount.

What Factors Are Driving the Growth of the eConsent in Healthcare Market?

The growth in the eConsent in healthcare market is driven by several critical factors tied to regulatory evolution, digital infrastructure expansion, patient engagement strategies, and operational efficiency goals. Technological advancements—such as cloud computing, mobile device penetration, AI-powered content customization, and EHR integration—have enabled the widespread deployment of user-friendly eConsent platforms across both clinical trials and routine care settings. The increase in decentralized clinical trials, remote patient monitoring, and virtual care models has heightened the demand for digital-first consent workflows that ensure compliance without in-person interaction. Regulatory clarity from global health authorities has reinforced the legitimacy and necessity of electronic consent, creating favorable conditions for adoption across regions and sectors. Moreover, growing consumer expectations around transparency, privacy, and digital literacy are pushing providers to modernize their consent processes in order to enhance the overall patient experience. Hospitals, academic medical centers, and pharmaceutical sponsors are also recognizing the cost and time savings associated with paperless consent systems, particularly in reducing administrative burdens, minimizing errors, and accelerating enrollment processes. Data privacy laws such as HIPAA, GDPR, and evolving national regulations are further emphasizing the need for secure, auditable, and easily retrievable consent records. Collectively, these drivers are accelerating the integration of eConsent into mainstream healthcare operations, transforming it into a foundational element of digital health and patient-centric care delivery.

SCOPE OF STUDY:

The report analyzes the eConsent in Healthcare market in terms of units by the following Segments, and Geographic Regions/Countries:

Segments:
Platform (Cloud-based Platform, Web-based Platform); Enrollment (On-Site Enrollment, Remote Enrollment); Form (General Consent Form, General Consent with Specific Denial Form, General Denial with Specific Consent Form, General Denial Form)

Geographic Regions/Countries:
World; United States; Canada; Japan; China; Europe (France; Germany; Italy; United Kingdom; and Rest of Europe); Asia-Pacific; Rest of World.

Select Competitors (Total 41 Featured) -

• Advarra
• Castor
• Clinical Ink
• CRF Health (Now part of Signant Health)
• DrugDev (An IQVIA Company)
• eClinicalWorks
• FIRECREST (An ICON plc Company)
• Florence Healthcare
• Greenphire
• IQVIA
• Medable
• Medidata Solutions
• Medrio
• ObvioHealth
• OpenClinica
• PAREXEL International Corporation
• Sano Genetics
• Science 37
• Signant Health
• Veeva Systems

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