Electronic Data Capture Market Size, Share & Industry Analysis, By Component (Software and Services), By Deployment (Cloud/SaaS and On-premise), By Development Phase (Phase I, Phase II, Phase III, and Phase IV), By End User (Pharmaceutical & Biotechnology Companies, Contract Research Organizations (CROs), Hospitals & Clinics, Academic & Research Institutes, and Others), and Regional Forecast, 2026-2034

The global electronic data capture market size was valued at USD 1.84 billion in 2025. The market is projected to grow from USD 2.07 billion in 2026 to USD 5.73 billion by 2034, exhibiting a CAGR of 13.57% during the forecast period.

Electronic Data Capture (EDC) is a software-based system used to collect, manage, and store data electronically most commonly in clinical trials instead of paper forms. This market space is driven by increasing clinical trial volume along with rising digital trial operations.

Moreover, major players in the industry, such as Veeva Systems Inc., Dassault Systèmes, Oracle, and IQVIA Inc. are operating in the market, introducing innovative solutions to meet the growing global demand for EDC. 

ELECTRONIC DATA CAPTURE MARKET TRENDS

EHR-to-EDC Interoperability is a Significant Trend Observed in Market

In recent years, the market is witnessing a shift in EHR-to-EDC interoperability. This is due to the fact that sponsors and CROs are under pressure to reduce site workload and avoid transcription errors that happen when staff re-type EHR data into eCRFs. Then EHR data can flow directly into EDC, teams spend less time on data entry and reconciliation, which can improve data quality and shorten cycle times. It also supports more hybrid/decentralized execution, since data can be captured closer to routine care rather than only at trial visits. These factors are supporting the overall global market growth.

• For instance, in August 2025, Oracle announced enhancements to Oracle Clinical One Data Collection adding AI-enabled interoperability with EHR systems and tighter end-to-end integration with Oracle Safety One Argus to streamline clinical workflows and reduce data friction.

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MARKET DYNAMICS

MARKET DRIVERS

Rising Clinical Trial Volume and Ongoing Global Research Activity is Propelling Market Growth

Rising clinical trial activity is a key driver for the global electronic data capture market growth. This is due to the reason that more studies mean more sites, patients, and data points that must be captured in a compliant and auditable way. As this study load expands, sponsors and CROs need EDC platforms that can be deployed faster, scaled across global site networks, and standardized across portfolios. Furthermore, higher trial volume also increases demand for EDC-related services such as study build, integrations, training, and support to keep timelines on track. In effect, growth in trials directly increases the installed base of active studies that require ongoing data capture, cleaning, and oversight, sustaining recurring software revenue and services pull-through. All these factors cumulatively drive the overall market growth.

• For instance, in October 2024, Medidata announced Rave Lite to help support growth across early- and late-stage clinical trials.

MARKET RESTRAINTS

Data Privacy and Cross-border Constraints to Limit Market Growth

Data privacy concerns and cross-border restrictions are key market restraining factors. This occurs as multinational trials often need data to move quickly between sites, sponsors, CROs, and central data teams. However, regulations can limit where patient data is stored or processed and how it is accessed outside a jurisdiction. This forces sponsors to choose hosting locations carefully, add extra legal/IT controls, and sometimes run region-specific instances instead of one global environment. The result is longer implementations, higher validation/documentation effort, and more complex integrations especially when trials span the EU and other markets with strict data governance. This results in limiting the market growth to a certain extent.

• For instance, companies such as Oracle, Veeva, and others have invested in expanding their footprints in Europe through cloud infrastructure.

MARKET OPPORTUNITIES

AI-assisted Operations to Offer Market Growth Opportunities

SI shifting from only insights to automation of core data-management tasks is a major market opportunity for EDC vendors. This is due to sponsors and CROs facing rising trial complexity and persistent operational capacity constraints. When AI can automate repetitive work such as data entry support, verification, document-to-structured extraction, and routine checks, teams can shorten cycle times, reduce manual errors, and scale programs without adding proportional headcount. This creates a clear upsell path for vendors. All these factors would drive the market growth in the coming years.

• For instance, in October 2025, Castor announced Castor Catalyst, an AI-powered platform built on Google Cloud designed to automate burdensome clinical study tasks and enable self-driving, human-supervised studies to reduce time, cost, and errors.

MARKET CHALLENGES

Decentralized and Hybrid Trial Execution Pose a Significant Challenge to Market Growth

Decentralized and hybrid trial execution is a market challenge for EDC as it usually expands the technology stack beyond EDC-only into telehealth, home nursing, local labs, eConsent/eCOA, and sometimes EHR/eSource. This creates more integration points and handoffs. As the U.S. FDA’s final guidance makes decentralized elements more mainstream, sponsors must operationalize remote activities in a controlled, GCP-ready way, which increases workflow design, vendor coordination, and site enablement burden. All the factors cumulatively affect the market growth.

Segmentation Analysis

By Component

Rising Demand for Software Solutions to Propel Segmental Growth

Based on the component, the market is divided into software and services.

The software segment is anticipated to capture the largest global electronic data capture market share. This can be attributed to increasing adoption of these solutions, increasing number of subscriptions, and other factors. Additionally, an increasing number of advanced product launches by operating players also supported the segment growth.

• For instance, in February 2025, Viedoc announced the release of Viedoc software version 4.82, adding new and improved capabilities across its eClinical platform.

The services segment is anticipated to rise with a CAGR of 15.63% over the forecast period. 

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By Deployment

Shift Towards Cloud-based Solutions to Enhance Segmental Growth

On the basis of deployment, the market is divided into on-premise and cloud/SaaS.

In 2025, the global market was dominated by the cloud/SaaS segment with the highest market share. This can be attributed to factors such as easier integration with multi-source data, shifting preference towards cloud-based solutions, and others. Moreover, SaaS deployments make it easier to scale users and studies on demand, support remote access for distributed trial teams, and keep systems current through standardized vendor updates. Furthermore, the segment is set to hold 72.3% share in 2026.

• For instance, in March 2024, Veeva announced that Veeva Vault EDC-a cloud EDC surpassed 1,000 study starts, with multiple top biopharma’s and CROs standardizing on it as a foundation for modern clinical data management.

The on-premise segment is anticipated to rise with a CAGR of 9.49% over the forecast period. 

By Development Phase

High Volume of Clinical Trials in Phase III Supported Segmental Dominance

Based on the development phase, the market is divided into phase I, phase II, phase III, and phase IV.

In 2025, the phase III segment dominated with the largest global market share. The segment growth is driven by high spend on data systems due to large patient pool, highest number of trial sites, and overall larger volume of data generation. Furthermore, the segment is set to hold 43.7% share in 2026.

• For instance, in March 2025, IgniteData announced deployment of its Archer EHR-to-EDC automation in an AstraZeneca-sponsored Phase 3 study at Memorial Sloan Kettering.

The phase IV segment is anticipated to rise with a CAGR of 16.43% over the forecast period. 

By End User

Increasing Number of Clinical Trials by Pharmaceutical & Biotechnology Companies Supported their Leading Position

Based on end user, the market is segmented into pharmaceutical & biotechnology companies, hospitals & clinics, contract research organizations (CROs), academic & research institutes, and others.

In 2025, the pharmaceutical & biotechnology companies segment captured the leading share in the global market. This is as they are the primary sponsors/funders of regulated clinical studies and therefore control the budget and vendor selection for core trial systems. These companies run multi-site, multi-country trials and must maintain audit-ready data integrity, so they standardize on enterprise EDC platforms to reduce risk and accelerate database lock for filings. Furthermore, the segment is set to hold 43.9% share in 2026.

• For instance, in September 2025, MassBio published a case study showing how Visby Medical, a diagnostics company, used Medrio CDMS/EDC to run a pivotal study, deploy the database in under a month, and support an FDA submission timeline.

In addition, contract research organizations (CROs) are projected to grow at a CAGR of 15.56% during the study period.

Electronic Data Capture Market Regional Outlook

By region, the market is segmented into North America, Europe, Asia Pacific, Latin America, and the Middle East & Africa.

North America

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North America market size was USD 0.69 billion in 2024 and captured the dominating position. The region also maintained its dominance in 2025, with USD 0.78 billion. The region benefits from mature cloud adoption and a dense ecosystem of integrated eClinical tools, which makes it easier to connect EHR/eSource feeds, monitoring, and safety workflows into EDC.

U.S. Electronic Data Capture Market

The U.S. market led the North American market and can be analytically approximated at around USD 0.81 billion in 2026, accounting for roughly 39.0% of the global market.

Europe

Europe market size is projected to witness a CAGR of 13.21% in the coming years. The region is anticipated to become the second highest among all regions. Europe’s growth is driven by the increasing need to run multi-country trials efficiently as more languages, more site types, and more cross-border coordination increases the value of standardized EDC workflows and integrations.

U.K. Electronic Data Capture Market

The U.K. market in 2026 is estimated at around USD 0.12 billion, representing roughly 6.0% of global revenues.

Germany Electronic Data Capture Market

Germany market size is projected to reach approximately USD 0.11 billion in 2026, equivalent to around 5.5% of global sales.

Asia Pacifi

Asia Pacific market size is projected to be valued at USD 0.48 billion in 2026 and secure the position of the third-largest region in the global industry. Asia Pacific growth is supported by expanding trial activity and capability-building across major markets, which increases the number of studies and sites that must be boarded, trained, and monitored digitally.

Japan Electronic Data Capture Market

The Japan market in 2026 is estimated at around USD 0.09 billion, accounting for roughly 4.3% of global revenues.

China Electronic Data Capture Market

China’s market is projected to reach revenues of around USD 0.15 billion in 2026, representing roughly 7.1% of global sales.

India Electronic Data Capture Market

The India market in 2026 is estimated at around USD 0.08 billion, accounting for roughly 3.7% of global revenues.

Latin America and Middle East & Africa

The Latin America and the Middle East & Africa regions are witnessing a growing adoption throughout the forecast period. The Latin America market size is set to reach a valuation of USD 0.09 billion in 2026. Latin America grows as it remains an important region for multinational execution and enrollment, which raises demand for reliable, cloud-based EDC that can be rolled out consistently across diverse site networks. Moreover, growth in the Middle East & Africa is increasingly driven by cloud infrastructure build-out and digital health investment, as modern EDC adoption depends heavily on reliable regional hosting, security, and performance. The GCC market in 2026 is estimated at around USD 0.03 billion, accounting for roughly 1.5% of global revenues.

COMPETITIVE LANDSCAPE

Key Industry Players

Emphasis on Strategic Initiatives by Prominent Companies to Strengthen Market Share

The global market is moderately consolidated, with a few vendors capturing a large share as they offer end-to-end clinical suites, enterprise-grade compliance controls, and proven global deployment at scale. Prominent companies such as Medidata (Dassault Systèmes), Veeva, Oracle, and IQVIA focus on expanding platform unification, interoperability, and productivity features that reduce study build time and data friction.

Other key players in the EDC competitive landscape include Signant Health, Calyx, Castor, OpenClinica, Medrio, Viedoc, MedNet Solutions (iMednet), ClinCapture, DATATRAK, and Clario, among others.  Their strategies typically focus on differentiated modules, faster deployment for mid-market sponsors, improved site usability, and partnerships that expand ecosystem reach.

• For instance, in September 2024, Signant Health joined IQVIA’s One Home for Sites initiative to broaden availability of its eClinical solutions and strengthen site-facing connectivity.

LIST OF KEY ELECTRONIC DATA CAPTURE COMPANIES PROFILED

• Veeva Systems Inc. (U.S.)
• Dassault Systèmes (France)
• Oracle (U.S.)
• IQVIA Inc. (U.S.)
• Medrio (U.S.)
• OpenClinica, LLC (U.S.)
• Castor (The Netherlands)
• Viedoc Technologies (Sweden)
• ClinCapture (U.S.)
• CRSCUBE INC. (South Korea)

KEY INDUSTRY DEVELOPMENTS

• November 2025: CRSCUBE INC. acquired Mednet, combining EDC-centric capabilities and expanding CRScube’s footprint into North America.
• July 2025: PHARMASEAL announced a technology integration partnership with Viedoc, connecting Engility (CTMS/eTMF) with Viedoc’s EDC to improve end-to-end workflow continuity.
• June 2025: Arkivum announced a partnership with Viedoc via the Viedoc Verified ecosystem to support long-term preservation/access of clinical trial records tied to EDC output.
• March 2025: ClinCapture launched feature enhancements, including Enhanced Subject Audit Log Export, aimed at streamlining audit processes and documentation workflows tied to EDC usage.
• December 2024: OpenClinica announced it acquired BuildClinical to strengthen patient recruitment capabilities that complement its eClinical/EDC offering.

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