Patient Registry Software Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Type of Registry (Disease Registries, Health Service Registries, Product Registries), By Type of Software (Stand-alone Software, Integrated Software), By End User (Hospitals, Government Organizations and Third-Party Administrators (TPAs), Pharmaceutical, Biotechnology, and Medical Device Companies, Other), By Region and Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 2.68 Billion
CAGR (2026-2031)	9.85%
Fastest Growing Segment	Hospitals
Largest Market	North America
Market Size (2031)	USD 4.71 Billion

Market Overview

The Global Patient Registry Software Market will grow from USD 2.68 Billion in 2025 to USD 4.71 Billion by 2031 at a 9.85% CAGR. Patient registry software is a specialized digital solution designed to collect, store, and analyze uniform data regarding individuals diagnosed with specific diseases or conditions. These systems are essential for evaluating clinical outcomes, supporting post-marketing surveillance, and facilitating the development of orphan drugs. The market is primarily driven by the escalating demand for Real-World Evidence (RWE) by regulatory bodies to substantiate clinical trial results and accelerate drug approval processes. Furthermore, the rising global prevalence of chronic and rare diseases necessitates robust longitudinal tracking mechanisms, while the industry-wide shift toward value-based care models incentivizes healthcare providers to adopt these platforms for improved population health management.

However, the market faces a significant challenge regarding data interoperability and the lack of standardized formats across fragmented healthcare systems, which impedes seamless data integration. This fragmentation often results in information silos that hinder the comprehensive analysis required for multi-site clinical studies. To illustrate the current scale of adoption within niche sectors, according to the National Organization for Rare Disorders, in 2025, the IAMRARE registry platform hosted over 70 patient-powered natural history studies representing more than 20,000 participants across 165 rare diseases.

Key Market Drivers

The increasing demand for Real-World Evidence (RWE) in drug development is the primary catalyst propelling the expansion of the patient registry software market. As regulatory bodies and pharmaceutical developers seek to substantiate clinical trial results with longitudinal data from diverse populations, the need for platforms that can aggregate and analyze massive datasets has surged. This shift is transforming registries from passive data repositories into dynamic tools for post-marketing surveillance and synthetic control arm generation, requiring sophisticated software infrastructure. Illustrating the scale of data now being leveraged for this purpose, according to Verana Health, in March 2025, the company enhanced its research capabilities by integrating a real-world database containing de-identified records from up to 80 million patients to support more inclusive clinical studies. Such extensive data access allows stakeholders to generate high-quality evidence that accelerates the approval of novel therapies while reducing the cost and complexity of traditional trials.

Concurrently, the rising prevalence of chronic and rare diseases is driving the widespread implementation of registry solutions to facilitate population health management and value-based care. Healthcare systems are increasingly relying on these digital platforms to track disease progression, monitor long-term outcomes, and identify eligible participants for niche research programs. This trend is exemplified by major national initiatives; according to the National Institutes of Health, in February 2025, the All of Us Research Program expanded its dataset to include information from over 633,000 participants, marking a 50% increase in the volume of data available to study complex health conditions. Furthermore, public sector commitment to these systems remains robust, as evidenced by fresh funding allocations. According to Sur in English, in January 2026, the Andalucía Government announced an investment of €8.7 million for a new care plan that includes the deployment of a specialized registry system to improve knowledge and services for rare diseases.

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Key Market Challenges

Data interoperability and the lack of standardized formats across fragmented healthcare systems represent a critical barrier to the expansion of the Global Patient Registry Software Market. Patient registries rely fundamentally on the aggregation of longitudinal health data from diverse sources, including disparate electronic health records, laboratory information systems, and pharmacy databases. When these systems operate in silos due to incompatible technical standards, the seamless flow of information is obstructed. This fragmentation compels organizations to resort to labor-intensive manual data entry or complex custom interfaces, which significantly inflates the operational costs and implementation time for registry solutions, effectively discouraging potential adopters who require efficient, automated data capture.

This technical friction directly impedes market growth by limiting the scalability and immediate utility of registry initiatives for research and value-based care. Healthcare providers are hesitant to invest in platforms that cannot communicate fluidly with their existing infrastructure. According to the 'Healthcare Information and Management Systems Society', in '2024', 42% of healthcare organizations cited integrating data from multiple electronic health record systems as their most significant obstacle to improving interoperability. This high level of difficulty in harmonizing data sources diminishes the return on investment for registry buyers, thereby slowing the broader adoption of these software platforms across the healthcare ecosystem.

Key Market Trends

The integration of Artificial Intelligence (AI) for predictive analytics is fundamentally reshaping patient registry software by enabling the automated extraction of insights from unstructured data sources. Traditionally, registries relied on structured fields, but advanced machine learning algorithms can now process clinical notes, imaging, and pathology reports to identify eligible trial participants and forecast disease progression with greater precision. This capability effectively converts dormant text into actionable datasets for complex research, moving platforms beyond passive data storage. For instance, according to Verana Health, February 2025, in a corporate press release regarding a new strategic partnership, the company deployed AI tools to analyze unstructured clinical notes, thereby accurately identifying patients with Retinitis Pigmentosa for gene therapy development who would have been missed by standard coding queries.

Simultaneously, the utilization of wearable devices for real-time data capture is expanding the scope of registries beyond episodic clinical visits to continuous physiological monitoring. By ingesting high-frequency patient-generated health data, such as heart rate variability and activity levels, modern platforms can construct a more holistic view of patient health and treatment efficacy in real-world settings. This trend is rapidly scaling the volume and granularity of longitudinal data available for post-marketing surveillance and chronic disease management. Illustrating this growth, according to Validic, October 2025, in a statement regarding its ecosystem expansion at the HLTH conference, the company’s wearable data integration platform now supports over 600 connected devices, a capability that enabled a single national provider to enroll more than 500,000 patients into continuous remote monitoring programs.

Segmental Insights

The Hospitals segment represents the fastest-growing category within the Global Patient Registry Software Market, primarily driven by the increasing adoption of value-based care models. Medical facilities are actively implementing registry solutions to improve population health management and track clinical outcomes with greater precision. This expansion is further accelerated by stringent requirements from regulatory bodies, such as the Centers for Medicare & Medicaid Services, which mandate comprehensive quality reporting. As a result, hospitals are integrating these software platforms with electronic health records to streamline data collection, ensure regulatory compliance, and enhance overall operational efficiency.

Regional Insights

North America maintains a leading position in the global patient registry software market due to its established healthcare infrastructure and the widespread adoption of electronic health records. The region benefits from substantial government initiatives and funding aimed at enhancing population health management and clinical research. Organizations such as the National Institutes of Health actively support registry programs to track disease trends and treatment outcomes. Additionally, the United States Food and Drug Administration promotes the use of registry-based real-world evidence for regulatory decision-making, creating a favorable environment for software implementation throughout the sector.

Recent Developments

• In January 2025, ImageTrend announced the acquisition of Biospatial, a company specializing in data-driven health and safety analytics. This strategic move was designed to combine ImageTrend’s extensive data collection capabilities in the emergency medical services and hospital registry space with Biospatial’s advanced analytics platform. The acquisition aimed to provide deeper insights into community health and safety by linking pre-hospital data with outcome measures, thereby enhancing the value of patient registries for researchers, healthcare providers, and public health organizations.
• In September 2024, SEQSTER announced a strategic partnership with PatientsLikeMe to power a connected patient health hub using real-time electronic health record data. Through this collaboration, SEQSTER was selected to serve as the electronic health record provider for the partner's platform, enabling rapid patient screening and improving the onboarding experience for clinical trials. The integration allowed for ongoing surveillance and the collection of real-world data within condition-specific communities, specifically addressing the growing requirements for robust patient registry solutions and longitudinal health data tracking.
• In June 2024, Medidata launched Clinical Data Studio, a unified experience designed to unlock the potential of clinical research data and modernize the data management process. This new technology provided stakeholders with greater control over data quality and the ability to integrate data from both Medidata and non-Medidata sources. By leveraging artificial intelligence, the platform aimed to accelerate clinical trials and deliver safer therapies to patients faster, directly supporting the data aggregation and analysis needs of complex research studies and patient registries.
• In April 2024, IQVIA and Salesforce announced an expansion of their global strategic partnership to accelerate the development of a next-generation life sciences cloud platform. This collaboration aimed to integrate IQVIA’s Orchestrated Customer Engagement innovations with Salesforce’s technology to create a comprehensive engagement platform for the industry. The initiative focused on enhancing capabilities in data, artificial intelligence, and technology to support decision-making across various areas, including real-world evidence generation and patient engagement, which are critical components of patient registry functions.

Key Market Players

• IBM Corporation
• IQVIA Holdings, Inc.
• Optum, Inc.
• Oracle Corporation
• McKesson Corporation
• ImageTrend, Inc.
• Dacima Software Inc.
• Syneos Health Inc.
• Global Vision Technologies, Inc.
• Evado eClinical Solutions

By Type of Registry	By Type of Software	By End User	By Region
Disease Registries Health Service Registries Product Registries	Stand-alone Software Integrated Software	Hospitals Government Organizations and Third-Party Administrators (TPAs) Pharmaceutical Biotechnology Medical Device Companies Other	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Patient Registry Software Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Patient Registry Software Market, By Type of Registry:

• Disease Registries
• Health Service Registries
• Product Registries

• Patient Registry Software Market, By Type of Software:

• Stand-alone Software
• Integrated Software

• Patient Registry Software Market, By End User:

• Hospitals
• Government Organizations and Third-Party Administrators (TPAs)
• Pharmaceutical
• Biotechnology
• Medical Device Companies
• Other

• Patient Registry Software Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE