환자 레지스트리 소프트웨어 : 시장 점유율 분석, 업계 동향과 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the patient registry software market size is projected to expand from USD 1.95 billion in 2025 and USD 2.18 billion in 2026 to USD 3.94 billion by 2031, registering a CAGR of 12.57% between 2026 to 2031.

This report is Segmented by Type of Registry (Disease, and More), Software Solution (Stand-Alone, Integrated EHR-Embedded, and More), End User (Hospitals & Health Systems, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, and South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Patient Registry Software Market Trends and Insights

Implementation of Government Initiatives and Funding for Large-Scale Patient Registries

Public funding is transforming registries from discretionary tools into compliance requisites. The FDA's TEMPO pilot, launched in December 2025, enables device makers to fulfill surveillance duties through structured registry submissions, resulting in approximately 30% cost savings for sponsors. Australia's National Cancer Data Framework earmarked grants in 2025 to test a shared oncology-registry platform and automate stage-at-diagnosis capture from radiology reports. Within the European Medicines Agency's DARWIN EU network, 30 data partners covering 160 million lives now require registries that export OMOP-formatted datasets for multinational studies. India's Ayushman Bharat Digital Mission has linked over 6.5 billion health records to unique identifiers, making registry enablement a prerequisite for public-sector contracts. Collectively, these programs accelerate procurement cycles and favor vendors that ship out-of-the-box FHIR and OMOP connectors.

Rising Adoption of Electronic Health Records and Interoperability Mandates

The ONC HTI-4 Final Rule, effective August 2025, expanded the USCDI to version 4 and prohibited information blocking for matching and consent APIs, providing registry vendors with real-time access to standardized data . TEFCA, operational since December 2024, provides a nationwide query-based exchange, enabling registries to pull longitudinal records without one-off data-use agreements. Michigan's CHRONICLE pilot proved that HL7 ADT feeds can populate chronic-disease registries at scale, although inconsistent ICD-10 coding still hampers analytics. Faced with this momentum, EHR incumbents, such as Oracle Health, embedded registry modules to defend their installed bases and monetize incremental data flows. FHIR compatibility has therefore become a core requirement for tenders.

Privacy and Data-Security Concerns Amid Expanding Data-Sharing Ecosystems

Change Healthcare's February 2024 ransomware breach, affecting 100 million records, heightened scrutiny of third-party processors under HIPAA and GDPR. Ascension Health's 2024 cyberattack exposed the operational fragility of interconnected systems. Fragmented EU and U.S. rules add 3-6 months to the activation of multinational registries, as Ireland's registry task force observed in 2025. TEFCA's patient-access features introduce identity-proofing liabilities that smaller vendors struggle to absorb. Consequently, many sponsors demand federated architectures that keep data on hospital servers, adding 15-20% to the total cost of ownership and slowing uptake among budget-constrained societies.

Other drivers and restraints analyzed in the detailed report include:

1. Increasing Utilization of Registry Data for Post-Marketing Surveillance and Real-World Evidence
2. Growth of Chronic-Disease Burden Requiring Longitudinal Outcomes Tracking
3. Shortage of Trained Clinical Abstractors and Informatics Personnel

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Pregnancy and maternal-child registries experienced the fastest 14.65% CAGR to 2031, following the TEMPO pilot, which enabled obstetric-device sponsors to rely on registry data for post-market safety, thereby reducing compliance timelines. The Coordinated Registry Network's FHIR guide further cut per-registry setup costs by 25% and enabled multi-sponsor collaboration. Disease registries retained 42.45% of the 2025 patient registry software market share, anchored by mature oncology and cardiovascular systems. Yet the regulatory tilt toward rare exposures favors pregnancy registries for sustained outperformance.

Oncology registries remain the largest disease sub-segment, while cardiovascular cohorts rapidly expand as structural-heart intervention data sets mature . Diabetes registries address device-data integration, and rare-disease groups collaborate across 24 European nations through ERDRI. Product registries for implants gain traction with EU conditional approvals, and quality-improvement programs evolve into real-time decision-support engines.

Complete Report Scope:

• By Type Of Registry
  • Disease Registries
  • Health Service Registries
  • Product Registries
  • Quality Improvement Registries
  • Pregnancy & Maternal-Child Registries
• By Software Solution
  • Stand-Alone Registry Software
  • Integrated EHR-Embedded Software
  • Cloud-Deployed SaaS Platforms
  • On-Premise Installed Systems
• By End User
  • Hospitals & Health Systems
  • Government Agencies & Third-Party Administrators
  • Pharmaceutical, Biotechnology & Medical-Device Firms
  • Research Institutes & Academic Medical Centers
  • Other End Users
• Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest Of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest Of Asia-Pacific
  • Middle East And Africa
    • GCC
    • South Africa
    • Rest Of Middle East And Africa
  • South America
    • Brazil
    • Argentina
    • Rest Of South America

Geography Analysis

North America remained the largest region, accounting for 44.32% of the 2025 revenue, supported by CMS quality programs and the ACC's multi-hospital cardiovascular network. HTI-4 and TEFCA sharply reduce data-exchange friction, while Canadian provinces consolidate on integrated records such as Alberta's Netcare platform. Growth slows, however, as U.S. health systems prioritize EHR optimization over new registry rollouts amid budget pressure.

Asia-Pacific is the fastest-growing geography, advancing at a 13.54% CAGR through 2031. India's ABDM has linked 6.5 billion health records, creating vast addressable cohorts for FHIR-enabled registries. Australia's National Cancer Data Framework funds shared platforms, and China's provincial-registry mandates expand demand despite localization constraints. Japan's expansion of My Number health cards underpins registry readiness that accommodates kanji and hiragana data.

Europe accounts for approximately 25% of the patient registry software market. EHDS rules require registries to export OMOP datasets for secondary research by 2029, driving upgrades to open, cloud-native architectures. Ireland's 2025 roadmap proposes a cloud hub across five disease areas to share costs, signaling broader regional consolidation. GDPR raises compliance expenses, yet clarity on pseudonymisation and federated queries speeds adoption. Emerging markets in the Middle East, Africa, and South America remain nascent but show proof-of-concept pilots supported by cloud infrastructure.

1. ArborMetrix
2. Armus Corporation
3. Axis Clinical Software Inc.
4. BayaTree LLC
5. CardioPulse (Intelligent Business Solutions)
6. Carta Healthcare
7. Cerner
8. Dacima Software
9. Epic Systems
10. FIGmd
11. Global Vision Technologies
12. IBM
13. ImageTrend Inc.
14. Intelerad (LUMEDX) Corporation
15. IQVIA
16. Mckesson
17. PatientIQ
18. Q-Centrix LLC
19. Syneos Health
20. Velos

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Implementation of Government Initiatives and Funding for Large-Scale Patient Registries
  • 4.2.2 Rising Adoption of Electronic Health Records and Interoperability Mandates
  • 4.2.3 Increasing Utilization of Registry Data for Post-Marketing Surveillance and Real-World Evidence
  • 4.2.4 Growth of Chronic Disease Burden Requiring Longitudinal Outcomes Tracking
  • 4.2.5 Emergence of AI-Powered Automated Abstraction Reducing Registry Costs
  • 4.2.6 Transition Toward Patient-Generated Health Data Integration from Wearables and Mobile Apps
• 4.3 Market Restraints
  • 4.3.1 Privacy and Data Security Concerns Amid Expanding Data Sharing Ecosystems
  • 4.3.2 Shortage of Trained Clinical Abstractors and Informatics Personnel
  • 4.3.3 Vendor Lock-In and Interoperability Gaps Between Specialty Registries
  • 4.3.4 Variable Registry Data Quality Undermining Reimbursement Tied to Outcomes
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat Of New Entrants
  • 4.7.2 Bargaining Power Of Buyers/Consumers
  • 4.7.3 Bargaining Power Of Suppliers
  • 4.7.4 Threat Of Substitute Products
  • 4.7.5 Intensity Of Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Type Of Registry
  • 5.1.1 Disease Registries
  • 5.1.2 Health Service Registries
  • 5.1.3 Product Registries
  • 5.1.4 Quality Improvement Registries
  • 5.1.5 Pregnancy & Maternal-Child Registries
• 5.2 By Software Solution
  • 5.2.1 Stand-Alone Registry Software
  • 5.2.2 Integrated EHR-Embedded Software
  • 5.2.3 Cloud-Deployed SaaS Platforms
  • 5.2.4 On-Premise Installed Systems
• 5.3 By End User
  • 5.3.1 Hospitals & Health Systems
  • 5.3.2 Government Agencies & Third-Party Administrators
  • 5.3.3 Pharmaceutical, Biotechnology & Medical-Device Firms
  • 5.3.4 Research Institutes & Academic Medical Centers
  • 5.3.5 Other End Users
• 5.4 Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest Of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest Of Asia-Pacific
  • 5.4.4 Middle East And Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest Of Middle East And Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest Of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles {(Includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)}
  • 6.3.1 ArborMetrix
  • 6.3.2 Armus Corporation
  • 6.3.3 Axis Clinical Software Inc.
  • 6.3.4 BayaTree LLC
  • 6.3.5 CardioPulse (Intelligent Business Solutions)
  • 6.3.6 Carta Healthcare
  • 6.3.7 Cerner Corporation
  • 6.3.8 Dacima Software Inc.
  • 6.3.9 Epic Systems Corporation
  • 6.3.10 FIGmd Inc.
  • 6.3.11 Global Vision Technologies Inc.
  • 6.3.12 IBM Corporation
  • 6.3.13 ImageTrend Inc.
  • 6.3.14 Intelerad (LUMEDX) Corporation
  • 6.3.15 IQVIA
  • 6.3.16 McKesson Corporation
  • 6.3.17 PatientIQ
  • 6.3.18 Q-Centrix LLC
  • 6.3.19 Syneos Health
  • 6.3.20 Velos Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-Space & Unmet-Need Assessment