Urinalysis Market to Reach US$ 5.9 Bn by 2031, Growing at 7% CAGR as Automation and Kidney Disease Screening Expand: Wissen Research

SHERIDAN, Wyo., Oct. 20, 2026 /PRNewswire/ -- The global urinalysis market is valued at USD 4.2 billion in 2026 and is projected to reach USD 5.9 billion by 2031, growing at a CAGR of 7% over the forecast period (2026-2031), according to a new study by Wissen Research.

Urinalysis is one of the most routine tests in medicine. Hospitals, clinics and laboratories use it to screen for urinary tract infections, kidney disorders and diabetes-related complications, and to monitor patients over time. The market covers reagent strips, reagents, automated and point-of-care analyzers, and the consumables that go with them. Growth is being shaped by heavier lab workloads, a sharper focus on early kidney disease detection, and a steady move toward automated, connected testing.

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From Manual Microscopy to Automated, Connected Workflows

Laboratories are replacing manual steps with systems that combine urine chemistry and particle analysis in a single workflow. The aim is straightforward: fewer repetitive manual reviews, more consistent results and the capacity to handle growing test volumes. Digital imaging and automated particle classification are doing more of the sediment work, and analyzers increasingly link to laboratory information systems and electronic medical records.

The workload behind this shift is large. Beckman Coulter Diagnostics notes that roughly one in three U.S. emergency department visits includes a urine test, and nearly half of hospital admissions involve urinalysis. On July 23, 2026, the company launched its DxU 1800 System in the United States, pairing a chemistry analyzer that handles up to 300 samples per hour with a microscopy analyzer. According to the company, the integrated system brings manual microscopic review below 3%.

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Compact Systems Open the Market Beyond Large Labs

Automation is no longer limited to high-volume hospital laboratories. Sysmex Corporation's UF-1500 particle analyzer runs up to 60 samples per hour and is about 30% smaller than the company's UF-5000, which suits laboratories with limited space. On the connectivity side, Siemens Healthineers offers the CLINITEK Status Connect system, which links point-of-care urinalysis devices to laboratory and hospital information systems and electronic records using HL7 and POCT1-A2 protocols.

The report adds a caution here: these specifications show how the technology is developing, but they are not independent measures of how widely it has been adopted.

What's Fueling Growth in the Urinalysis Market

• Kidney Disease Screening: Urine albumin and protein testing is central to detecting kidney damage, particularly in people with diabetes or hypertension.
• Infection Assessment: Reagent strips and automated sediment analysis help clinicians quickly check for leukocytes, nitrites and blood when a urinary tract infection is suspected.
• Laboratory Automation: Large laboratories are adopting automated analyzers to standardize results, avoid manual microscopy and manage growing routine workloads.
• Point-of-Care Testing: Compact analyzers let clinics and emergency settings test on site rather than waiting on a central laboratory.
• Hospital Testing Volumes: Urine tests are used to evaluate infection and renal function in pre-operative and in-patient care, which keeps consumables demand steady.

Kidney Disease Is Creating a Clear Testing Opportunity

The World Health Organization reported on April 20, 2026 that an estimated 674 million people worldwide have chronic kidney disease, and it identifies urine albumin testing as an important tool for early detection. The American Diabetes Association recommends assessing both urine albumin-to-creatinine ratio (UACR) and estimated glomerular filtration rate in all people with type 2 diabetes. In May 2025, the National Kidney Foundation reported that an expert workshop recommended urinary albumin measurement as the preferred approach to screening and monitoring high-risk adults, and noted that the test remains underused because of limited awareness and cost.

For manufacturers, this points toward quantitative albumin and creatinine assays, UACR-capable analyzers and affordable systems for diabetes clinics and primary care. The report is careful to note that the opportunity rests on clinical guidelines and disease burden, not on the assumption that every person with kidney disease needs the same urine test.

Challenges Facing the Urinalysis Market

Accuracy and follow-up remain the biggest issues. Standard reagent strips give qualitative or semi-quantitative readings that can be thrown off by urine concentration, sample handling and interference, and a urinalysis alone is often not enough for a conclusive diagnosis. A study published in Urology in September 2025 covered 37,300 patients across 109 U.S. health systems who had positive dipstick results. It found that 31% did not receive confirmatory microscopic urinalysis, and that 7.5% of patients tested by dipstick without microscopy went on to imaging or cystoscopy.

Cost is the second barrier. Automated analyzers require upfront investment, maintenance, staff training and a reliable supply of reagents, which can be difficult for smaller facilities. Manufacturers must also meet regulatory requirements and demonstrate that their systems perform as claimed.

Recent Strategic Developments in the Urinalysis Market

In July 2026, Beckman Coulter Diagnostics of the United States launched the DxU 1800, a fully automated urinalysis system that integrates urine chemistry and microscopy. The company reports that it processes up to 300 samples per hour and reduces manual microscopic review to below 3%.

In March 2026, Siemens Healthineers AG of Germany expanded access to point-of-care urinalysis with its Atellica LumIQ Analyser, introduced on March 25. Manufactured in Sudbury, United Kingdom, the analyser automates reagent-strip interpretation, supports urine and hCG pregnancy testing, and enables connected near-patient testing to support earlier kidney disease detection.

Both launches reflect a market competing on throughput, workflow integration and connectivity.

Key Insights from Urinalysis Market Analysis

• Consumables held a leading position by product type in 2025. Reagent strips, liquid reagents, calibrators and quality-control materials are used repeatedly alongside installed analyzers, which creates recurring demand. Sysmex Corporation reported urinalysis sales of JPY 40.838 billion in fiscal 2025, up from JPY 39.031 billion in fiscal 2024.
• Biochemical tests held a leading position by test type in 2025, supported by routine strip-based screening for glucose, protein, blood, ketones, nitrites and pH.
• North America held a leading regional position in 2025, backed by extensive laboratory infrastructure. The CDC reported in November 2025 that healthcare professionals order more than 14 billion laboratory tests a year in the United States, and the National Kidney Foundation estimates more than 35 million U.S. adults have chronic kidney disease.
• Asia Pacific is the fastest-growing region.
• The market is moderately consolidated at the advanced instrument level, where established diagnostics companies compete on automated analyzers, integrated platforms and laboratory relationships. It remains fragmented across reagent strips, consumables, point-of-care devices and regional manufacturers.

Key Players in the Urinalysis Market

Leading companies are focusing on automated diagnostic systems, urine chemistry and sediment analysis, digital imaging, product innovation and expansion across laboratories, hospitals, clinics and point-of-care settings.

Company Name Key Focus Area

• Siemens Healthineers AG Laboratory and point-of-care urinalysis, including the CLINITEK Novus chemistry analyzer, connected CLINITEK Status Connect and the Atellica LumIQ Analyser.
• F. Hoffmann-La Roche Ltd Established diagnostics portfolio serving laboratory urinalysis.
• Sysmex Corporation Modular laboratory systems, automated particle analyzers such as the UF-1500, and digital imaging with the UD-10.
• Beckman Coulter, Inc. Integrated chemistry-and-microscopy automation through the DxU 1800 System.
• ARKRAY, Inc. Urinalysis diagnostics for laboratories and clinical settings.

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Regional Analysis and Growth Opportunities

North America led the market in 2025, helped by the scale of its laboratory network. The CDC reports approximately 266,000 CLIA-certified laboratories operating across the United States, and regulators continue to clear new urine-testing products, including Healgen Scientific's URS Test Strips in December 2025.

Asia Pacific is expected to grow the fastest as access to primary care improves and the need to monitor chronic conditions rises. Manufacturers see opportunity in India, China, Indonesia and Thailand, where affordable automated systems and local laboratory networks are expanding. The report points to the World Health Organization's 2026 report on diabetes treatment in Southeast Asia, which documents stronger diabetes care systems across several countries in the region and supports earlier diagnosis. Europe, Latin America and the Middle East & Africa complete the report's regional coverage.

Market Segmentation Snapshot

The global urinalysis market is segmented across product type, test type, application type, end user type and region:

• By Product Type:
  • Consumables (reagent strips, reagents and related materials)
  • Instruments (integrated, sediment and biochemical urine analyzers)
• By Test Type:
  • Biochemical Tests
  • Microscopic and Sediment Tests
  • Pregnancy and Fertility Tests
  • Other Tests
• By Application Type:
  • Urinary Tract Infection
  • Kidney Disease
  • Diabetes
  • Liver Disease
  • Pregnancy and Fertility
  • Other Applications
• By End User Type:
  • Diagnostic Laboratories
  • Hospitals and Clinics
  • Home-Care Settings
  • Research Laboratories and Institutes
• By Region:
  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East & Africa

Frequently Asked Questions

Q: What is the size of the urinalysis market? A: The global urinalysis market is estimated at USD 4.2 billion in 2026 and is projected to reach USD 5.9 billion by 2031.

Q: What is the growth rate of the urinalysis market? A: The market is projected to grow at a CAGR of 7% between 2026 and 2031.

Q: What is urinalysis used for? A: Urinalysis analyzes urine samples to help detect, diagnose and monitor urinary tract infections, kidney disorders, diabetes and other conditions. It is also used for general health checks and pregnancy testing.

Q: Which product type leads the urinalysis market? A: Consumables held a leading position by product type in 2025, supported by recurring demand for reagent strips, reagents, calibrators and quality-control materials.

Q: Which test type leads the urinalysis market? A: Biochemical tests held a leading position by test type in 2025, driven by routine strip-based screening.

Q: Which region leads the urinalysis market? A: North America held a leading regional position in 2025, while Asia Pacific is the fastest-growing region.

Q: Who are the top players in the urinalysis market? A: Leading companies include Siemens Healthineers AG, F. Hoffmann-La Roche Ltd, Sysmex Corporation, Beckman Coulter, Inc. and ARKRAY, Inc.

Q: How consolidated is the urinalysis market? A: It is moderately consolidated at the advanced instrument level and fragmented across reagent strips, consumables, point-of-care devices and regional manufacturers.

As laboratories look for faster, more consistent workflows and clinicians push for earlier kidney disease detection, urinalysis is moving beyond a simple dipstick test. Suppliers that pair reliable consumables with automated, connected and affordable systems are best placed to capture the next wave of demand.

Expert Profile | Mayur Jain, Wissen Research 

Mayur Jain is a Research Expert at Wissen Research with multidomain expertise with more than 12+ years of experience in market research industry. 

Email: mayur@wissenresearch.com
LinkedIn:  https://www.linkedin.com/in/mayur-jain-0190542a/ 

About Wissen Research

Wissen Research is a global market intelligence and consulting firm specializing in healthcare, life sciences, technology, and emerging industries. The company provides data-driven insights, strategic market analysis, and industry forecasts to help organizations make informed business decisions and identify new growth opportunities across global markets

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