Global Electronic Data Capture (EDC) Systems Market – Industry Trends and Forecast to 2031

Global Electronic Data Capture (EDC) Systems Market, By Delivery Mode (Web-hosted, Cloud-based, Licensed Enterprise), Clinical Trial Phase (Phase I, Phase II, Phase III and Phase IV), End-User (Contract Research Organizations (CROs), Pharmaceutical and  Biotechnology Companies, Medical Device Companies and Hospitals) – Industry Trends and Forecast to 2031.

Electronic Data Capture (EDC) Systems Market Analysis and Size

The electronic data capture (EDC) systems market has witnessed significant growth over the recent years, driven by the increasing demand for efficient data collection, management, and analysis across the clinical research sector. The growing number of clinical trials in pharmaceutical and biotechnology sectors is also contributing to the EDC systems market growth. For instance, according to World Health Organization International Clinical Trials Registry Platform (ICTRP), the clinical trials globally increased from 57,039 in 2019 to 65,409 in 2021. Thus, EDC becomes a crucial tool or solution for efficiently managing vast amounts of clinical trial data, leading to their widespread adoption, thereby fostering the market growth.                                

Data Bridge Market Research analyses that the global electronic data capture (EDC) systems market, which was USD 1.7 billion in 2023, is expected to reach USD 3.81 billion by 2031, and is expected to undergo a CAGR of 10.6% during the forecast period 2024 to 2031. In addition to the insights on market scenarios such as market value, growth rate, segmentation, geographical coverage, and major players, the market reports curated by the Data Bridge Market Research also include depth expert analysis, patient epidemiology, pipeline analysis, pricing analysis, and regulatory framework.

Report Scope and Market Segmentation

Market Definition

Electronic data capture systems (EDC) are designed for the collection of clinical trial data in an electronic format. The majority of data collected in an EDC system is primarily related to managing electronic case report form (eCRF) data. The common function of EDC includes a graphical-user interface component for data entry and unique and secure user permission within the system. In addition, these systems are used to replace traditional paper-based data collection methods, allowing organizations to streamline data-related processes and improve data accuracy and efficiency.              

Global Electronic Data Capture (EDC) Systems Market Dynamics

Drivers

• Increasing Clinical Trials and Research Activities

The global pharmaceutical and biotechnology industries are experiencing a surge in clinical trials and research activities, driven by factors such as the growing prevalence of chronic diseases, the need for innovative treatments, and regulatory requirements for drug development and approval. EDC systems play a crucial role in streamlining data collection, management, and analysis in clinical trials, offering efficiency, accuracy, and real-time access to data. The rising number of clinical trials worldwide fuels the demand for EDC systems, driving market growth.

• Advancements in Healthcare Technology and IT infrastructure

Technological advancements in healthcare IT infrastructure, including cloud computing, mobile technologies, and data analytics, have transformed the landscape of clinical data management. EDC systems leverage these advancements to offer scalable, secure, and user-friendly platforms for capturing, storing, and analyzing clinical trial data. The adoption of EDC systems is driven by the need for interoperability, data integration, and real-time access to clinical data across geographically dispersed sites, facilitating efficient collaboration among stakeholders and accelerating clinical trial timelines.

• Growing Investment for Healthcare Facilities

Surging focus towards improving the condition of healthcare facilities and improving the overall healthcare infrastructure another important factor fostering the growth of the market. Rising number of partnerships and strategic collaborations between the public and private players pertaining to funding and application of new and improved technology is further creating lucrative market opportunities. 

Opportunities

• Expansion in Emerging Markets

Emerging economies, particularly in Asia-Pacific, Latin America, and the Middle East, are witnessing rapid growth in clinical research and pharmaceutical industries. The increasing prevalence of chronic diseases, rising healthcare expenditure, and improvements in regulatory frameworks present significant opportunities for the adoption of EDC systems in these regions. EDC vendors can capitalize on the growing demand for clinical trial solutions by expanding their presence in emerging markets, customizing offerings to meet local regulatory requirements, and addressing the unique needs of diverse healthcare ecosystems.

• Integration with Real-World Data (RWD) Sources

The integration of EDC systems with real-world data (RWD) sources such as electronic health records (EHRs), wearable devices, and patient-generated health data (PGHD) presents opportunities to enhance the value proposition of EDC platforms. EDC systems can provide comprehensive insights into patient health outcomes, treatment efficacy, and safety profiles, enabling researchers to conduct more robust real-world evidence (RWE) studies and post-marketing surveillance. EDC vendors can seize opportunities to develop interoperable solutions that bridge the gap between clinical trials and real-world practice, offering holistic data management solutions to sponsors, regulators, and healthcare stakeholders.

Restraints

• High Implementation and Maintenance Costs

The initial investment required for implementing EDC systems, including software licensing, hardware infrastructure, and staff training, can be substantial. Additionally, ongoing maintenance and support costs further contribute to the total cost of ownership. For smaller organizations, especially those in resource-constrained settings or with limited budgets, the high upfront and recurring costs associated with EDC systems may act as a barrier to adoption, restraining market growth.

• Data Security and Privacy Concerns

EDC systems involve the collection, storage, and transmission of sensitive clinical trial data, including patient health information and study outcomes. Ensuring data security, protecting patient privacy, and complying with regulatory requirements such as the Health Insurance Portability and Accountability Act (HIPAA) in the U.S and the General Data Protection Regulation (GDPR) in Europe are critical considerations for EDC vendors and healthcare organizations. Concerns about data breaches, cybersecurity threats, and regulatory non-compliance may deter adoption or slow the implementation of EDC systems, particularly among organizations with stringent data security requirements.

Challenges

• Complexity of System Integration and Interoperability

EDC systems need to integrate seamlessly with existing electronic health record (EHR) systems, laboratory information management systems (LIMS), and other clinical trial management platforms to enable data exchange and interoperability. However, the complexity of system integration, compatibility issues, and interoperability challenges between disparate systems can hinder the implementation process. Healthcare organizations may face difficulties in achieving seamless integration, leading to delays, increased costs, and operational disruptions.

• Resistance to Change and Staff Training

The implementation of EDC systems often requires changes to existing workflows, roles, and processes within healthcare organizations and clinical research teams. Resistance to change among stakeholders, including investigators, research coordinators, and study personnel, can pose a significant barrier to adoption. Additionally, inadequate training and support for end-users may result in low user acceptance, reduced system utilization, and inefficiencies in data capture and management.

This global electronic data capture (EDC) systems market report provides details of new recent developments, trade regulations, import-export analysis, production analysis, value chain optimization, market share, impact of domestic and localized market players, analyses opportunities in terms of emerging revenue pockets, changes in market regulations, strategic market growth analysis, market size, category market growths, application niches and dominance, product approvals, product launches, geographic expansions, technological innovations in the market. To gain more info on the global electronic data capture (EDC) systems market contact Data Bridge Market Research for an Analyst Brief, our team will help you take an informed market decision to achieve market growth.

Recent Development

• In February 2022, Clinixir Company Limited, a leading Thailand-based CRO, opted for Oracle’s pharmacovigilance and clinical research solutions as its eClinical platform. This included the Oracle Clinical One EDC as part of the solutions implemented. This strategy helped the company to boost their revenue growth
• In March 2020, Elsevier, a key information analytics provider, launched Veridata EDC to capture patient data for clinical research. The solution was made available for free to researchers working to develop COVID-19 vaccines and other therapies. This helped company to expand their product offerings and customer base

Global Electronic Data Capture (EDC) Systems Market Scope

The global  electronic data capture (EDC) systems market is segmented on the basis of delivery mode, clinical trial phase and end-user. The growth amongst these segments will help you analyze meagre growth segments in the industries and provide the users with a valuable market overview and market insights to help them make strategic decisions for identifying core market applications.

Delivery Mode

• Cloud-Based (SAAS) Solutions
• Web-Hosted (on-demand) Solutions
• Licensed Enterprise (on-premise) Solutions

Clinical Trial Phase

• Phase I
• Phase II
• Phase III
• Phase IV

 End-User

• Contract Research Organizations (CROs)
• Pharmaceutical and Biotechnology Companies
• Medical Device Companies
• Hospitals
• Other End-Users

Global Electronic Data Capture (EDC) Systems Market Regional Analysis/Insights

The global electronic data capture (EDC) systems market is analysed and market size insights and trends are provided by country, delivery mode, clinical trial phase and end-user as referenced above.

The countries covered in the global electronic data capture (EDC) systems market report are U.S., Canada, Mexico, U.K., Germany, France, Spain, Italy, Netherlands, Switzerland, Russia, Belgium, Turkey, Rest of Europe, China, Japan, India, Australia, South Korea, Singapore, Thailand, Malaysia, Indonesia, Philippines, rest of Asia-Pacific (APAC), Brazil, rest of South America in South America, South Africa, and rest of Middle East and Africa in Middle East and Africa (MEA).

North America electronic data capture (EDC) systems market is dominating due to the strong foothold of major pharmaceutical and biotechnology companies, medical device companies and research and academic institutions boost the market growth. In addition, availability of sophisticated infrastructure further drives the regional growth.

Asia-Pacific is projected to observe significant amount of growth in the electronic data capture (EDC) systems market due to the rapid necessity for telemedicine and healthcare support. Moreover, the modernization and development in telecommunication is further anticipated to propel the growth of the electronic data capture (EDC) systems market in the region in the coming years.

The country section of the report also provides individual market impacting factors and changes in regulation in the market domestically that impacts the current and future trends of the market. Data points such as down-stream and upstream value chain analysis, technical trends and porter's five forces analysis, case studies are some of the pointers used to forecast the market scenario for individual countries. Also, the presence and availability of global brands and their challenges faced due to large or scarce competition from local and domestic brands, impact of domestic tariffs and trade routes are considered while providing forecast analysis of the country data.   

Healthcare Infrastructure GROWTH INSTALLED BASE and New Technology Penetration

The global electronic data capture (EDC) systems market also provides you with detailed market analysis for every country growth in healthcare expenditure for capital equipment, installed base of different kind of products for global electronic data capture (EDC) systems market, impact of technology using life line curves and changes in healthcare regulatory scenarios and their impact on the global electronic data capture (EDC) systems market . The data is available for historic period 2016-2021.

Competitive Landscape and Global Electronic Data Capture (EDC) Systems Market Share Analysis

The global electronic data capture (EDC) systems market competitive landscape provides details by competitor. Details included are company overview, company financials, revenue generated, market potential, investment in research and development, new market initiatives, global presence, production sites and facilities, production capacities, company strengths and weaknesses, product launch, product width and breadth, application dominance. The above data points provided are only related to the companies' focus related to global electronic data capture (EDC) systems market .

Some of the major players operating in the global electronic data capture (EDC) systems market are:

• OpenClinica, LLC  (U.S.)
• Medidata Solution, Inc.  (U.S.)
• Datatrak International, Inc.  (U.S.)
• Eclinical solutions  (U.S.)
• Acceliant  (U.S.)
• Oracle - (U.S.)
• Omni Comm Systems, Inc.  (U.S.)
• DSG, Inc.  (U.S.)
• Veeva Systems -(U.S.)
• MedNet  (U.S.)