US Patient Registry Software Market 2026 – 2035

The market size of the US patient registry software is estimated to be USD 0.55 billion in 2025 and is expected to grow by USD 0.60 billion in 2026, to close to USD 1.58 billion in 2035 with a CAGR of 11.02%.

The evolving nature of market growth can be attributed to the increasing prevalence of chronic and rare diseases, increased uptake of electronic health records, the increasing need to use real-world evidence in clinical research, government efforts to support the digital development of health infrastructure, the transition of care models to value-based care, and the rise of technologies in AI and cloud computing.

Market Highlight

• Approximately, 48.6% of the total patient registry software market in the world is in the US, indicating that it has the largest single country market.

• By type of registry, the disease registries division procured up to 52.4% of the market share in 2025.

• The product registries segment is the fastest-growing segment with CAGR of 12.8% between 2026-2035 by type of registry.

• By software type, standalone software will have the biggest market share (68.5) in 2025 and integrated software will grow with a CAGR of 13.4%.

• By end user, government agencies and TPAs took up 44.2% of the market share in 2025, and the pharmaceutical and biotechnology companies increased with a CAGR of 13.6%.

• By functionality, population health management secured 37.6% market share and medical research and clinical studies segment is growing at 13.2% CAGR.

Significant Growth Factors

The US Patient Registry Software Market Trends present significant growth opportunities due to several factors:

• Escalating Chronic Disease Burden and Aging Demographics:

The growing number of chronic and rare diseases throughout the United States is the main force of the patient registry software market, with health organizations, research institutes, and governmental bodies in need of complex systems to trace, administer, and examine the patient groups in need of chronic monitoring and exclusive treatment. CDC statistics indicate that more than 60% of US adults have one or more chronic conditions and about 40% have two or more chronic illnesses such as diabetes, heart disease, cancer, and chronic respiratory conditions where constant surveillance, clinical follow-up, and re-evaluation of outcomes are required which patient registries enable.

The American Cancer Society estimated there would be 1.95 million new cancer cases diagnosed in the United States in 2023, and cancer is the second leading cause of death nationally, leading to significant demand for cancer registries which track incidence, treatment patterns, outcomes and survival rates supporting cancer clinical research, quality improvement and public health surveillance. The World Health Organization estimates that 40.3% of all deaths taking place in the United States are a result of cardiovascular diseases, or about 17.9 million deaths in total, which underlines the urgent necessity to establish cardiovascular disease registries to track the population of patients and the effectiveness of the treatment and identify the risks that can be reflected in preventive measures and treatment plans.

The diabetes epidemic is ever growing stronger, and more than 37 million American people are diagnosed with diabetes, and another 96 million adults have prediabetes, necessitating steady and full registry systems to track glycemic control, complication onset, adverse drug compliance, and healthcare usage patterns to determine diabetes management programs and population health efforts. Uncommon diseases are unique challenges, with about 30 million Americans affected by 7,000 different diseases, and the patient registries are the valuable resources to identify the affected patients, learn how the natural diseases develop, recruit patients to clinical trials, and help develop specific therapies to address the disease where conventional research designs are limited by the number of patients available. The elderly population increases the prevalence of chronic diseases, with the elderly (age 65 and above) making up a proportion of 21% of the total population and this demographic is overrepresented with various chronic diseases in need of integrated care management and comprehensive data tracking solutions that the patient registry software can provide through integrated workflows, automated data gathering, and advanced analytics that support evidence-based interventions. Neurodegenerative diseases such as Alzheimer's disease and Parkinson's disease are on the increase in numbers with the prevalence of Alzheimer's disease projected to rise to 14 million cases by 2050 in the United States alone serving as a force behind the creation of specialized registries to monitor cognitive decline and treatment responsiveness and quality of life outcomes and in clinical research to explore disease-modifications therapies and innovations in care provision.

• Real-World Evidence Generation and Value-Based Care Transition:

The shift in the healthcare sector towards evidence-based medicine and value-based payment models is fundamentally transforming the concepts of patient registry software needs, as stakeholders throughout the healthcare ecosystem increasingly look to real-world evidence as a basis of their regulatory decisions, inform their clinical practice, establish the value of a treatment, and manage the approaches to care delivery. A combination of real-world evidence produced via patient registries offers complementary information to standard randomized controlled trials because it strives to capture a wider range of patients, longer-term follow-ups, a wide range of care settings, and real-world treatment patterns that can inform the understanding of the effectiveness of therapeutic interventions, safety, and maximum use in real clinical practice and not necessarily in controlled studies. FDA is also progressively using real-world evidence in regulatory decision-making, and guidance documents have described frameworks on the use of registry data to support label expansions, post-market safety surveillance, and in some cases as an external control arm, which removes the need to use placebo groups in clinical trials especially in rare diseases where the standard trial designs are ethically and practically challenging. Accountable care organizations, bundled payments, and quality incentive programs are value-based care programs that develop explicit financial incentives for healthcare providers to enhance outcomes, reduce complications, improve care coordination, and improve population health management to efficiently measure performance and outcomes that are necessary to determine reimbursement in alternative payment models.

The current list of approximately 455,000 studies of ClinicalTrials.gov has locations in all 50 states, serving to illustrate the magnitude of clinical research activity where the use of patient registries is possible to recruit and screen participants, collect baseline data, and conduct long-term follow-up and to alleviate the burden of site management and enhance the quality of data collected via automated processes and standardized data capture procedures. Companies in value-based agreements have a 36% higher probability of investing in sophisticated patient engagement software that combines clinical, financial, and behavioral data into holistic records with patient registries forming the backbone infrastructure that allows proactive population management, care gap detection, and activity that enhances quality metrics and manages costs.

To enhance precision medicine and targeted therapies, patient populations need detailed phenotypic and genotypic characterization, and registries can include biomarker phenotypes, genomic phenotypes and molecular profiles that can be used to identify treatment-responsive subpopulations, predict the risk of adverse events, and select treatment based on the biological characteristics of individual patients instead of just demographic factors. Medical devices, pharmaceuticals, and biologic post-market surveillance programs are starting to be more based on registry-based methods of tracking the safety and effectiveness of products in real-world settings, and the FDA is mandating post-approval studies on many products that need long-term maintenance that registries are very effective in supporting through their systematic data collection across a variety of healthcare settings and patient populations which provides more robust evidence about the benefit-harm profiles of products when used in actual settings.

What are the Major Advances Changing the US Patient Registry Software Market Today?

• Artificial Intelligence and Machine Learning Integration:

The most revolutionary technological development is the incorporation of artificial intelligence and machine learning into patient registry software, which will allow the systems to automatically extract data from dissimilar sources and improve data quality by applying intelligent validation, find patterns and trends by using advanced analytics, and provide predictive data that can be used to manage a population proactively and conduct clinical research. Natural language processing algorithms based on AI extract structured information in unstructured clinical notes, pathology reports, radiology findings, and other narrative text in electronic health records, removing manual abstraction demands that used to occupy significant registry personnel time and introducing transcription errors and constraining completeness of data.

Machine learning models can detect missing or inconsistent data and resolve it, detect any potential quality problems with the use of anomaly detection, and propose the right values according to similar cases of patients, enhancing the completeness and accuracy of the data that directly affect the research validity and regulations acceptability. Machine learning-based predictive analytics of registry data can identify at-risk patients with a high probability of adverse eventualities such as disease progression or treatment complications, emergency department use, or death to initiate proactive interventions and enhance monitoring and resource allocation to optimize care delivery and enhance outcomes and cost control. Patient matching algorithms based on AI are used to match records across disparate data sets such as multiple EHR systems, claims repositories, laboratory repositories and patient-reported outcome platforms to formulate comprehensive longitudinal patient portraits that include all of the care trajectories even in cases where patients may receive care in multiple health systems or have mixed data exchange.

Clinical trial recruitment using AI on registry data to find eligible individuals based on inclusion/exclusion criteria and accelerate enrollment processes, enhance diversity in participants, minimize screening failures and offer patients new therapies and contribute to medical knowledge through research participation. Royal Philips announced their partnering with Mass General Brigham in developing the state-of-the-art data infrastructure and AI to connect and process live healthcare data across a range of sources to assist patient care as an example of the industry shift to AI-based health data platforms where patient registries will be important data collection and analysis tools in February 2025. Healthcare AI breakout success is evidenced by AI ambient scribers bringing in 600 million dollars in the year 2025 with a 2.4x growth rate annually which means that these technologies will be integrated with registry systems, meaning that the appropriate patient interactions, clinical outcomes and medical decisions will be correctly documented without the need to manually enter data which had previously scared clinicians from participating in registry-based research and quality programs.

• Cloud-Based Deployment and Advanced Interoperability:

Cloud-based patient registry software has dominated the market because it offers superior scalability to support increasing patient counts and larger amounts of data, reduced start-up capital needs as businesses no longer need to invest in costly on-premise infrastructure, automatic software updates so organizations are always up to date with their functionality and security patches, high accessibility so that distributed research teams and multi-site collaborations can be conducted, and advanced integration capabilities so that registries can be interoperable with electronic health records, laboratory systems, and claims databases.

The latest cloud-based registry solutions have API-based architecture that enables two-way data exchange with major EHRs such as Epic, Cerner/Oracle Health, athenahealth, and MEDITECH allowing automated data extraction that replaces manual chart abstraction and privacy of data quality through use of standardized mapping and validation rules that ensure that clinical information transfers well between systems. The Fast Healthcare Interoperability Resources (FHIR) standards are transforming how health care is exchanged with FHIR-enabled registries being able to readily access, harmonize and integrate patient medical records across health systems safeguarding patient privacy as well as building up comprehensive images of patient care patterns in terms of diagnoses, medications, procedures, laboratory findings, and clinical outcomes across multiple providers. As of 2024, 99% of US hospitals had provided patients with electronic access to their health records with 96% allowing the downloading of records and 84% allowing transmission to third parties, which created a chance to have patient-mediated contributions of data to the registry so that people could participate in research without violation of data sovereignty and privacy controls. The past decade experienced a large-scale adoption of EHR due to government incentives via the HITECH Act Meaningful Use program, and this base digital infrastructure is now used to achieve registry interoperability, which was impossible in the past when the majority of records were paper-based and data silos could not be used to provide population-level analysis.

The proportion of interoperability engagement in hospitals grew by 54% between 2018 and 2023, and 70% of non-federal acute care hospitals were engaged in all four interoperability domains (send, receive, find, integrate) in 2023, which offers growing opportunities to use registry software platforms to exploit such data exchange opportunities to reduce the burden of manual data collection and enhance completeness and timeliness of information to support research and quality improvement. Registry data integrity and security Registries are looking at blockchain technology as potential remedy to ensure no tampering of the audit trail, open data provenance, and decentralized governance frameworks which are of particular value in multi-stakeholder registries where trust and data authenticity are significant issues around research credibility and regulatory acceptance.

• Patient-Generated Data and Remote Monitoring Integration:

Increasingly, modern patient registry software supports patient-generated health data (wearable devices, mobile applications, home monitors, patient-reported outcome measures, etc.) and forms more detailed longitudinal datasets to understand patient health between clinical visits without requiring participants to overburden the system or to enhance their engagement with research activities in the registry. Activity monitors, heart rate monitors, sleep monitors, and other types of wearable sensors generate continuous data streams that give detailed information on the health progress of patients, their response to treatment, and their lifestyle habits that are not reflected in the records of individual clinic visits, and these data streams are integrated into registries to give a complete picture of patient health.

Connected glucose meters (medicine) used in diabetes management, spirometers (respiratory disease monitoring), blood pressure monitors (hypertension management), and cardiac rhythm devices (arrhythmia detection) are among some of the many examples of remote patient monitoring technologies that allow registries to integrate objective physiological data collected in the natural environment of the patients in order to minimize recall bias and enhance real world evidence of treatment adherence and efficacy. Patient-reported outcomes such as levels of symptom severity, functional status, quality of life indicators, and treatment satisfaction represent patient insights to supplement clinical measures, and electronic PRO software combined with registry software facilitates standard collection of outcomes in web-based or mobile formats, completed remotely by patients living with diseases under study, and these outcomes are more likely to be the most relevant outcome of individuals living with diseases being studied.

Combining social determinants of health information such as housing stability, food security, access to transport, educational attainment, and environmental exposures allows registries to integrate non-clinical determinants of health outcomes, support health equity studies, identify populations at risk that may need extra assistance, and specify interventions to help address health disparity root causes instead of merely treating their clinical manifestations. Mobile-first design principles appreciate the fact that 92% smartphone penetration is estimated by 2030, based on 76% by 2022, with patients accessing health information, completing surveys, reporting symptoms, and participating in research using mobile devices, and regulatory platforms are needed to provide responsive and friendly mobile experiences to them with data security and regulatory compliance. In April 2024, Synchron announced the introduction of a patient registry that manages US patients receiving the Strentrode brain-computer interface device, which can serve as an example of how innovative medical technologies need a complex system of registries that help track the performance of the device, patient outcomes, and long-term safety to enable the adoption of new therapeutic methods and develop new scientific knowledge.

• Government Initiatives and Regulatory Mandates:

Government agencies at federal, state, and local levels are increasingly requiring registry participation, funding registry development and maintenance, and using registry data to support public health surveillance, measure quality, and develop policy, which is creating a sustained market demand for patient registry software and is driving requirements of standardization and interoperability, which shape market development. The CDC has many disease registries such as cancer registries which record data on about 97% of the cancer cases in the US; birth defects registries which record information on congenital anomalies, and infectious disease registries which records information on communicable diseases that need public health intervention with state health departments using specialized registry software in managing this information collection, quality assurance and reporting to the national surveillance programs.

The CMS quality reporting programs such as Hospital Inpatient Quality Reporting, Hospital Outpatient Quality Reporting, and many other programs, mandate that a hospital and a physician participate in a clinical data registry to track their performance on quality measures and submit the data in a registry that proves that they meet the standards and can receive full reimbursement by Medicare without paying the payment penalty due to non-participation. The Sentinel Initiative of the FDA is a huge distributed data network surveillance of medical product safety by analyzing electronic health data such as registry data, and this active surveillance system monitors over 500 million patient records, detecting safety signals, and assists in regulating measures to keep people safe by quickly detecting adverse events and treatment complications. State regulations that call for healthcare facilities to report certain conditions to the public health registries impose compliance pressure on healthcare providers, and the use of the software to submit data to the registry has the benefit of reducing administrative load and providing the complete and accurate reporting of data to the registries to comply with regulatory requirements and avoid fines due to non-compliance.

In February 2025, Health P.E.I. introduced an updated patient registry system developed on client relationship management systems, which authenticate and cross-reference data and decrease duplication and errors, proving that the government invests in the modernization of registry infrastructure that improves the efficiency and quality of data in support of population health management and healthcare system planning. In November 2025, the National Organization for Rare Disorders (NORD) also posted a request to nonprofit patient advocacy organizations to implement two new patient registries on the IAMRARE platform of data and research, which is an example of collaboration between government agencies, patient organizations, and technology vendors in the development of the registry infrastructure to support research and therapeutic development of rare diseases.

Category Wise Insights

By Registry Type

Why Disease Registries Lead the Market?

Disease registries are the biggest segment, which will capture around 52.4% of the market share in 2025. This preeminence denotes the essential aspect in keeping track of patient populations affected by specific diseases, conducting clinical studies, monitoring treatment results, supporting quality improvement efforts, and informing the decisions of the government concerning the health of the population. Disease registries play several important roles such as epidemiological surveillance to monitor disease occurrence, prevalence and geographic distribution trends; natural history to study disease progression, complication formation and mortality rates; treatment effectiveness to compare outcomes across therapeutic methods; quality measurement to measure compliance with clinical practice and performance on evidence-based care processes; and patient identification to recruit patients to clinical trials to accelerate research enrollment.

The most developed category of disease registries is cancer registries, and thorough population-based surveillance by the National Program of Cancer Registries and the SEER program (both covering about 97% of all cancer cases in the US) serves as a vital source of data used in research, quality measurement, and health policy formulation and can be used to analyze survival, pattern of treatment, and disparity within demographic groups. Cardiovascular disease registries follow the cases of heart attacks, stroke, heart failure and other heart diseases in millions of Americans each year, and some registries such as the NCDR suite presented by the American College of Cardiology, give benchmarking data, quality measures and research infrastructure to support the improvement of cardiovascular care in thousands of participating hospitals and practices across the country. Sources state that as of August 2025, 828 clinical trials are in Mississippi and 6,595 in Florida comprising not yet recruiting, recruiting, and active non-recruiting studies indicating extensive research effort in which disease registries are used to identify participants, characterize baseline, and perform longitudinal follow-up to support the conduct and generation of evidence of trials.

Product registries are the most rapidly expanding category with a forecasted CAGR of 12.8% between 2026 and 2035 due to the rising amount of FDA mandated post-market surveillance on medical devices and pharmaceuticals, rising levels of focus on real-world evidence to support regulatory decision-making and label expansion, and a recognition of the efficiency of product registries to monitor safety and effectiveness in a wide range of patient populations and clinical settings. Product registries are a mechanism that tracks a given medication, medical device or procedure where utilization patterns, adverse events, patient outcomes, and long-term safety are recorded which produces evidence in support of regulatory compliance, risk management, and product optimization. Medical device registries monitor such implants as orthopedic devices, cardiac implants, and neurostimulators that allow surveillance of device failures, complications, and revision surgeries as well as support comparative effectiveness studies that can be used to direct decision-making in selecting and using devices. Pharmaceutical product registries are used to track high-risk drugs, specialty drugs, and recently approved drugs that need increased post-marketing surveillance and have registries that record the actual use, dose administration, comorbid drugs, and adverse event data that guides prescribing decisions and risk-benefit regulatory risk-benefit decisions.

By Software Type

Why Standalone Software Dominates the Market?

Stand-alone software is the biggest market segment with some 68.5% market share in 2025, and the trend is towards more specialized registry software with its own development profiles, flexibility of customization, vendor independence, and niche orientation of its software development processes to registry-specific needs and not to the overall priorities of healthcare IT systems. Standalone registry systems offer full functionality of patient enrollment, data collection in many modalities, quality assurance processes, regulation reporting, sophisticated analytics, and research data exports, and can be deployed in any organizational setting, such as multi-site research consortia, public health agencies, and patient advocacy organizations that do not have standardized IT infrastructure. These specialized applications provide very high levels of customization to support tailored registry needs such as disease-specific data elements, complex eligibility criteria, specialized outcome measures, and regulatory reporting templates that generic healthcare IT systems cannot easily support, and vendors are well versed in clinical research and epidemiology as well as in registry strategies that inform product development and support. Standalone platforms support cross-institutional cooperation that allows distributed data entry across a variety of sites and yet provides centralized data management, data quality control, and analytical functions, which are necessary in multi-center research studies, national surveillance programs, and post-market surveillance studies sponsored by industry across hundreds of participating organizations. These end users have the largest market share (44.2%), and they are government agencies and third-party administrators, who often choose standalone solutions that enable them to flexibly bring together data available at different vendors without relying on particular EHR providers that dominate provider organizations, facilitating a standardized data collection system in heterogeneous healthcare delivery settings.

Integrated software is recording the most rapid growth with a projected CAGR of 13.4% between 2026 and 2035 as a result of massive adoption of EHRs to create openings to seamless data exchange, increased focus on minimizing the burden of duplicate documentation, increased interoperability standards leading to automated data extraction, and an acknowledgment that registry integration with the clinical workflows can enhance the quality of data and decrease the burden per participant site, promoting more widespread participation in research. Integrated registry software is linked with EHR systems allowing two way flow of information with clinical information auto populating registry fields to eliminate manual transcription, and registry specific data elements can be recorded in familiar EHR interfaces used to provide normal clinical care, and there is no need for other system access and data entry. This combination can significantly decrease site burden with research indicating that automated data extraction of EHRs can save 60-80 minutes of abstraction time relative to human manual review of charts and increase data completeness and accuracy by removing transcription errors and data omissions due to oversight or time limitations. Modern integrated platforms make use of FHIR APIs that allow standardized and secure data transfer with any FHIR-compliant EHR system without proprietary integrations with each vendor relationship, and the move to use FHIR enables easier integration feasibility and lowers the costs of implementation such that many previously resource-unable organisations can now engage in research making use of registries, such as community hospitals and physician practices.

By End User

Why Government Agencies & TPAs Lead Adoption?

The largest end user market, with a share of about 44.2% in the total market share in 2025, is represented by government agencies and third-party administrators showing prevalent activities in the sphere of public health surveillance, quality measurement programs, disease monitoring activities, and population health management tasks, which demand sophisticated registry software that supply the needs of data collection, analysis, and reporting at local, state, and federal levels. The state and federal public health departments have many disease registries such as cancer surveillance, immunization tracking, birth defects reporting, infectious disease reporting, and chronic disease epidemiology, and the population based registries play crucial public health roles such as identifying clusters of diseases, tracking outbreaks, assessing vaccination coverage, assessing the quality of healthcare, and helping to determine the allocation of resources that guide prevention initiatives and clinical services development.

The National Program of Cancer Registries at the CDC funds and technically aids state cancer registries that track about 97% of cancer cases in the US or one of the most extensive disease surveillance systems in the world, and are in need of sophisticated registry software to manage data collection processes at the thousands of healthcare facilities, provide data quality by standard editing and validation, ensure patient confidentiality by secure systems and generate standard report data to support cancer control programs and health policy development. The CMS quality reporting initiatives use clinical data registries as methods of submissions by hospitals and physicians who have shown adherence to quality measures, the registries provide standardized data collection, risk adjustment mechanisms, benchmarking, and performance reporting to support the value based payment models and minimize the reporting burdens using simplified data submission mechanisms. Registry software that tracks populations in health plans, workers' compensation programs, and employee health benefits are the third-party administrators who coordinate a care management intervention, measure the performance of a program and other factors, and show value to the employer clients and other agencies who regulate health insurance operations.

The pharmaceutical and biotechnology companies are the most rapidly expanding end user market segment with a forecasted CAGR of 13.6% between 2026 and 2035, due to the growing focus of FDA on real-world evidence used to support regulatory submissions, the growing regulatory post-market follow-up demands of new therapeutic products, expanding clinical development programs requiring patient identification and recruitment, and the industry acknowledgment that registries are an effective way of generating evidence that shows value of products to payers, prescribers, and patients. Product registries sponsored by pharmaceutical industries are depicting the use of medication in true clinical practice, patient features, treatment reactions, frequency of adverse events, and long-term results to furnish evidence of label expansions, risk control initiatives, and worth demonstrations to the healthcare stakeholders engaged in coverage and prescribing choices.

Registries are also useful in the recruitment of clinical trials because they help identify patients who fit into the study requirements, save on screening expenses, shorten enrollment times, and enhance the diversity of participants which addresses FDA concerns about trial generalizability and representativeness to the general patients in routine clinical settings who will ultimately benefit through the approved therapies. Patient advocacy organizations that store rare disease registries funded by the pharmaceutical industry are essential infrastructure in the development of an orphan drug, and small patient populations require registries to conduct natural history research, determine the feasibility of conducting clinical trials, and monitor safety after approval to submit regulatory reports and continue the development of therapeutic products to treat diseases in fewer than 200,000 Americans.

Report Scope

Top Players in the Market and Their Offerings

• IQVIA Holdings Inc.

• Optum Inc. (UnitedHealth Group)

• Premier Inc.

• Syneos Health

• FIGmd Inc.

• ImageTrend Inc.

• DACIMA Software Inc.

• Global Vision Technologies Inc.

• OpenText Corporation

• Liaison Technologies

• Others

Key Developments

• In November 2025: National Organization for Rare Disorders declared that nonprofit patient advocacy organizations should submit their proposals to open two new patient registries on the IAMRARE platform. This demonstrates continued investment into rare disease registry infrastructure that can be used to aid drug development and natural history research.

• In February 2025: Health P.E.I. introduced a new patient registry system that is constructed on a customer relationship management system. The system cross-checks data and removes duplication and errors. It shows the way government has been changing the registry infrastructure, making it modern, data-driven, and operationally efficient.

The US Patient Registry Software Market is segmented as follows:

By Registry Type

• Disease Registries

o   Cancer Registries

o   Cardiovascular Registries

o   Diabetes Registries

o   Rare Disease Registries

o   Immunization Registries

• Product Registries

o   Medical Device Registries

o   Pharmaceutical Product Registries

• Health Services Registries

By Software Type

• Standalone Software

• Integrated Software

By Deployment Model

• On-Premise

• Cloud-Based

• Hybrid

By Functionality

• Population Health Management

• Medical Research & Clinical Studies

• Quality Measurement & Reporting

• Patient Care Management

By End User

• Government Agencies & TPAs

• Hospitals & Medical Practices

• Pharmaceutical & Biotechnology Companies

• Medical Device Companies

• Research Organizations