Urinalysis Market Analysis & Forecast: 2025-2032

Urinalysis Market Size and Forecast – 2025 to 2032

Urinalysis Market is estimated to be valued at USD 1,941.8 Mn in 2025 and is expected to reach USD 3,017.5 Mn in 2032, exhibiting a compound annual growth rate (CAGR) of 6.5% from 2025 to 2032.

Key Takeaways

• By Product Type, Consumables hold the largest market share of 64.2% in 2025 owing to the high usage & repetition.
• By Test Type, Biochemical expected to hold largest market share in 2025 owing to its increasing prevalence of chronic & metabolic diseases.
• By Application, Disease Screening acquired the prominent market share in 2025 owing to the rising prevalence of chronic and lifestyle diseases.
• By Region, North America dominates the overall market with an estimated share of 43.5% in 2025 owing to the high prevalence of chronic & lifestyle diseases.

Market Overview

The urinalysis market continues to grow as healthcare providers increasingly focus on early disease detection and routine health screening. The rising cases of chronic conditions such as diabetes, kidney disorders, and urinary tract infections are boosting the demand for regular urine tests. Manufacturers are introducing advanced automated analyzers and point-of-care devices that enhance testing speed and accessibility. Healthcare systems are expanding diagnostic infrastructure, promoting preventive care, and raising awareness, which actively drives the adoption of urinalysis across hospitals, clinics, and home settings.

Current Events and their Impact on the Urinalysis Market

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End-user Feedback and Unmet Needs in the Urinalysis Market

• Accuracy and Reliability Concerns: End-users frequently highlight inconsistencies in test accuracy, leading to mistrust in results. There is a demand for more precise, error-resistant devices that minimize false positives or negatives, ensuring confident clinical decisions. Improved reagent stability and standardized calibration are critical unmet needs for better diagnostic confidence.
• User-friendly Interface and Ease of Use: Many clinicians and lab technicians find current urinalysis systems complicated or time-consuming. Simplified interfaces, intuitive workflows, and quicker sample processing would enhance usability. Portable, easy-to-maintain devices that require minimal training are in demand, especially for point-of-care settings and remote healthcare facilities.
• Integration with Healthcare Systems: End-users’ express frustration over the lack of seamless integration with electronic health records (EHR) and laboratory information systems (LIS). There is a growing need for urinalysis solutions that offer automatic data transfer, interoperability, and real-time reporting to streamline clinical workflows and reduce manual errors.

Segmental Insights 

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Urinalysis Market Insights, by Product Type: Consumables contribute the highest share of the market owing to its preventive healthcare & routine screening.

Consumables hold the largest urinalysis market share of 64.2% in 2025. Healthcare providers are driving demand for consumables in the urinalysis market by relying on them for routine diagnostic procedures. Regular screening for chronic conditions like diabetes and kidney disease increases the use of test strips, reagents, and sample containers. Laboratories and clinics consistently consume these single-use items during daily operations. The rising adoption of point-of-care and home testing further boosts usage. Manufacturers continue to enhance the accuracy, shelf life, and usability of consumables, making them more effective and accessible in various healthcare settings. For instance, Beckman Coulter and U.S. ARKRAY, Inc. have announced a new partnership along with the launch of the iQ Urinalysis Workcell. Under this collaboration, Beckman Coulter would offer and support the iChemVELOCITY urinalysis instrument internationally, while also providing service, parts, and consumables for it within the United States.

Urinalysis Market Insights, by Test Type: Biochemical contribute the highest share of the market owing to its need for early disease detection & monitoring.

Healthcare providers are driving growth in the biochemical segment of the urinalysis market by focusing on early detection of metabolic and renal conditions. They use routine urine tests to monitor markers like glucose, protein, and ketones, which help diagnose illnesses such as diabetes and kidney disease. Manufacturers are enhancing reagent strip technologies and developing automated chemistry analyzers to improve testing speed and accuracy. The rising demand for preventive care and the move toward decentralized, point-of-care testing are further advancing the segment’s expansion. For instance, Israel-based startup Olive Diagnostics, has launched an AI-powered urinalysis device that eliminates the need for patients to pee in a cup. The team includes experts in health business development, biochemistry, physics, data analytics, and optics.

Urinalysis Market Insights, by Application: Disease Screening contribute the highest share of the market owing to its technological advances enabling easier, faster screening.

The urinalysis market is expanding as healthcare providers focus on disease screening to identify conditions such as urinary tract infections, diabetes, and kidney disorders at an early stage. They rely on non-invasive and cost-effective urine tests to enhance preventive care and routine examinations. Manufacturers contribute by creating portable and automated screening devices that extend testing beyond conventional laboratories. Increased public awareness and government initiatives advocating for regular health screenings further drive the widespread adoption of urinalysis, aiding in better disease management and prompt intervention. For instance, in February 2025, Lynx Dx launched MyProstateScore 2.0 (MPS2), a urine test kit for prostate cancer that patients can use at home. Chief Medical Officer Spencer Heaton said home testing adds convenience, reduces stigma, and improves access to screening. Such instances are accelerating the urinalysis market share.

Regional Insights 

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North America Urinalysis Market Trends

North America dominates the overall market with an estimated share of 43.5% in 2025. Advanced diagnostic technologies and rising demand for point-of-care testing are driving growth in the North American urinalysis market. Healthcare providers are adopting automated analyzers and digital tools to enhance testing accuracy and efficiency. The aging population and high rates of chronic diseases fuel ongoing screening requirements. Telehealth services are expanding, and increased awareness of preventive healthcare motivates more people to use home-based urinalysis kits, making diagnostic testing more accessible and convenient in various healthcare environments. For instance, Sysmex Corporation has launched its PS-10 sample preparation system in North America. The system uses flow cytometry, a technique also used in Sysmex’s hematology and urinalysis analyzers to analyze particles as they flow through optical channels.

Europe Urinalysis Market Trends

Investments in healthcare infrastructure and the adoption of innovative diagnostic technologies are driving the growth of the urinalysis market in Europe. Healthcare providers prioritize early disease detection and preventive care, increasing the use of automated urinalysis systems and reagent strips. Rising awareness of chronic diseases, along with government programs promoting regular health screenings, further supports this growth. The expansion of point-of-care testing and home-based diagnostics enhances patient access, enabling faster results and more effective disease management across hospitals, clinics, and remote locations. For instance, Sysmex Europe has launched its Flow Cytometer XF-1600, which has received CE marking for compliance with the European IVD Regulation and intended use in in vitro diagnostics. The company provides automated workflow solutions in hematology, urinalysis, and hemostasis.

United States Urinalysis Market Trends

Cutting-edge technologies like automation and digital diagnostics are driving the evolution of the urinalysis market in the United States. Healthcare providers are adopting advanced analyzers and point-of-care testing to improve workflow efficiency and diagnostic accuracy. The rising prevalence of chronic diseases and an aging population fuel steady demand for routine screenings. Telemedicine and home testing options are also expanding, increasing access to urinalysis, enabling timely diagnoses, and enhancing patient outcomes across diverse healthcare environments. For instance, Sysmex America, Inc., a leading provider of diagnostic solutions in hematology, urinalysis, and flow cytometry, has announced the launch of its first fully automated urine particle counter and digital imaging system, the UN-2000.

United Kingdom Urinalysis Market Trends

Healthcare providers in the United Kingdom are advancing the urinalysis market by adopting advanced diagnostic technologies and emphasizing preventive healthcare. They are integrating automated urinalysis systems to boost test accuracy and efficiency. Increased awareness of chronic diseases and government-supported screening programs motivate regular urine testing. Expanding point-of-care and home-based testing options improve patient convenience and accessibility. This approach enables faster diagnoses and more effective disease management across hospitals, clinics, and community healthcare centers throughout the UK. For instance, UK company Clinical Design unveiled the world’s only hygienic, easy-to-use, and accurate digital point-of-care urine test at Arab Health.

Urinalysis Market Trend

Shift Towards Digital and Automated Urinalysis

The market is witnessing a rapid transition from manual dipstick tests to fully automated digital urinalysis systems. These systems offer enhanced accuracy, faster processing times, and reduced human error. Integration of AI and machine learning is improving image analysis of urine sediments, enabling better diagnosis. Automation also supports high-throughput laboratories by streamlining workflows, making urinalysis more efficient and scalable across clinical and point-of-care environments.

Growing Demand for Point-of-Care Testing

There is a significant trend toward portable urinalysis devices designed for point-of-care (POC) applications. These compact, easy-to-use tools allow rapid diagnostics outside traditional labs—in clinics, ambulances, and remote areas—facilitating immediate clinical decisions. This shift supports decentralized healthcare, improving patient outcomes through faster detection of urinary tract infections, kidney diseases, and metabolic disorders in diverse settings.

Urinalysis Market Opportunity

Development of Multiparametric and Biomarker-rich Tests

There is growing potential for creating advanced urinalysis tests that assess a wider array of biomarkers linked to chronic diseases, infections, and metabolic disorders. These enhanced diagnostics offer more comprehensive patient profiles and improved clinical decision-making. Market players can innovate by integrating novel biomarkers, expanding test menus, and providing customizable panels to meet evolving clinical demands for personalized healthcare.

Market Report Scope 

Urinalysis Market News

• In July 2025, the FDA granted Breakthrough Device Designation to the TOBY Test, a noninvasive, AI-powered tool designed for detecting bladder cancer.
• In April 2025, Healthy.io announced its acquisition of Labrador Health, a startup specializing in advanced quantitative home testing technology. This strategic move enhances Healthy.io’s mission to deliver lab-quality diagnostics via smartphone. By combining Labrador’s innovation with its own FDA-cleared and CE-marked products, Healthy.io aims to launch next-generation at-home kidney tests and expand global access to high-quality diagnostics

Analyst Opinion (Expert Opinion)

• The urinalysis market is undergoing a transformative phase, driven by technological innovation and shifting healthcare paradigms. A critical observation is that despite decades of reliance on traditional dipstick tests, the industry is finally embracing automation and AI-driven diagnostics, which are fundamentally improving accuracy and workflow efficiency. For example, digital urine analyzers like Siemens’ Clinitek Advantus are reducing manual errors, and AI-powered sediment analysis systems such as Iris Diagnostics’ Iris iQ demonstrate superior detection of pathological elements that manual microscopy often misses.
• However, the market still suffers from fragmentation and underutilization of these advanced technologies in many clinical settings. A 2023 study published in Clinical Chemistry reported that automated urinalysis systems reduced diagnostic turnaround times by over 30% compared to conventional methods, yet adoption rates in mid-tier hospitals remain below 40%. This discrepancy highlights a persistent gap between technological capability and practical implementation, often due to budget constraints and insufficient training.
• Another key factor shaping the market is the rising demand for point-of-care testing, particularly in ambulatory and remote environments. Devices like the Siemens Multistix 10 SG offer portability and rapid results but often lack comprehensive biomarker panels that clinicians need for complex diagnostics. This gap presents an opportunity for next-gen solutions that combine portability with multiparametric testing—a niche currently underexploited.
• Moreover, the growing emphasis on integrating urinalysis data into digital health records and telemedicine platforms cannot be overstated. Real-time data sharing, enabled by cloud-connected analyzers, enhances patient management, particularly in chronic kidney disease and diabetes care. For instance, Mayo Clinic’s pilot program integrating automated urinalysis results into its EHR system reported improved patient follow-up and reduced hospital readmissions, showcasing the tangible benefits of digital convergence.
• Despite these advancements, sustainability remains an overlooked aspect. The excessive use of plastic test strips and hazardous reagents poses environmental and regulatory risks. Innovative companies like Healthy.io are pioneering smartphone-based urinalysis kits that significantly cut consumable waste, pointing towards a more sustainable future. The market must accelerate adoption of such eco-friendly alternatives to align with global healthcare sustainability goals.

Market Segmentation

• Global Urinalysis Market, By Product Type
  • Instruments
  • Consumables
• Global Urinalysis Market, By Test Type
  • Biochemical
  • Pregnancy and Fertility
  • Sediment
• Global Urinalysis Market, By Application
  • Disease Screening
  • Pregnancy and Fertility
• Global Urinalysis Market, By Geography
  • North America
    • U.S.
    • Canada
  • Latin America
    • Brazil
    • Mexico
    • Argentina
    • Rest of Latin America
  • Europe
    • Germany
    • U.K.
    • France
    • Italy
    • Spain
    • Russia
    • Rest of Europe
  • Asia Pacific
    • China
    • India
    • Japan
    • Australia
    • South Korea
    • ASEAN
    • Rest of Asia Pacific
  • Middle East
    • GCC
    • Israel
    • Rest of Middle East
  • Africa
    • South Africa
    • Central Africa
    • North Africa
• Key Players Insights
  • Arkray Inc.
  • Abbott Laboratories
  • Eiken Chemical Co. Ltd.
  • Sysmex Corporation
  • Siemens Healthineers AG
  • Cardinal Health Inc.
  • Acon Laboratories Inc.
  • Bio-Rad Laboratories Inc.
  • Hoffmann-La Roche Ltd.
  • Becton Dickinson and Company
  • Danaher Corporation (Beckman Coulter Inc.)

Sources

Primary Research Interviews

• Interviews with clinical laboratory directors and urinalysis device users
• Discussions with nephrologists and urologists regarding diagnostic preferences
• Conversations with healthcare IT specialists focusing on digital integration

Databases

• PubMed
• ClinicalTrials.gov
• National Center for Biotechnology Information (NCBI)
• FDA medical device databases

Magazines

• Clinical Laboratory News
• Medical Device and Diagnostic Industry
• Healthcare IT News

Journals

• Clinical Chemistry
• Journal of Clinical Microbiology
• American Journal of Kidney Diseases
• Urinalysis and Clinical Chemistry

Newspapers

• The New York Times (Health Section)
• The Guardian (Health & Science)
• The Washington Post (Medical & Health Reports)

Associations

• American Association for Clinical Chemistry (AACC)
• American Urological Association (AUA)
• International Federation of Clinical Chemistry (IFCC)
• Kidney Disease Improving Global Outcomes (KDIGO)

Public Domain Sources

• World Health Organization (WHO) reports
• Centers for Disease Control and Prevention (CDC) publications
• National Institutes of Health (NIH) data repositories
• U.S. Environmental Protection Agency (EPA) health guidelines

Proprietary Elements

• CMI Data Analytics Tool
• Proprietary CMI Existing Repository of information for last 8 years