Global Urinalysis Market Share Grows Steadily at a CAGR of 7.53%

Introduction

A major factor fueling the growth of the global urinalysis market is the rapid advancement in automated urinalysis technologies. Modern systems are equipped with features such as high processing capacity, reduced need for manual input, and integrated digital reporting, which together minimize errors and enhance diagnostic accuracy. These innovations are being widely implemented in hospitals, clinics, and diagnostic laboratories to efficiently handle large volumes of samples.

Furthermore, growing awareness and proactive efforts towards early disease detection are positively influencing market expansion. Both governmental and private healthcare entities are encouraging routine urinalysis as part of preventive health measures, particularly in regions experiencing a rise in lifestyle-related illnesses.

In addition, the continual expansion of diagnostic laboratories and wellness centers is improving access to urinalysis services, thereby accelerating product adoption. These combined trends are positioning the global urinalysis market on a steady path of long-term growth.

Market Dynamics

Rising prevalence of kidney and urinary tract diseases drives the global market

The surging incidence of kidney and urinary tract disorders is a major factor fueling the expansion of the global urinalysis market. These health conditions demand consistent and precise diagnostic evaluations, positioning urinalysis as an essential method for early detection and continuous monitoring.

• As highlighted in the Global Burden of Disease Study 2023, chronic kidney disease (CKD) impacts more than 850 million individuals worldwide and ranks as the 10th leading cause of death globally. Moreover, a 2024 report by the World Health Organization (WHO) reveals that over 400 million urinary tract infection (UTI) cases are reported annually. Women are particularly vulnerable, with approximately 50–60% experiencing at least one UTI during their lifetime, according to the National Institute of Diabetes and Digestive and Kidney Diseases (2023).

These concerning figures highlight the critical need for routine diagnostic testing. The growing awareness of early detection and preventive healthcare is prompting medical institutions to adopt advanced, automated urinalysis technologies, thereby accelerating market growth on a global scale.

The growing use of point-of-care testing (POCT) kits creates tremendous opportunities

The rising adoption of point-of-care testing (POCT) kits is transforming the urinalysis market by enabling quick and decentralized diagnostic solutions. These kits empower healthcare providers to conduct urine tests directly at the point of care, bypassing traditional lab processes and delivering results in just minutes. This is specifically valuable in primary care settings, emergency departments, and rural healthcare facilities where timely clinical decisions are vital.

• A notable example is the UTS System developed by Clinical Design Technologies and distributed by Alpha Laboratories since December 2024. As the world’s only digital closed urine testing solution for POCT, it utilizes a sealed, push-fit cap design to hygienically and accurately assess 10 essential parameters. The system is well-suited for general practice clinics, improving workflow efficiency, minimizing contamination, and integrating smoothly with electronic medical records to provide fast, dependable results.

As the demand for rapid and accessible diagnostics increases, POCT kits are expected to play a key role in shaping the future of urinalysis.

Regional Analysis

In North America, the urinalysis market is witnessing strong growth driven by the high prevalence of lifestyle-related diseases such as diabetes, hypertension, and chronic kidney disorders. According to the CDC, over 37 million adults in the U.S. have kidney disease, highlighting the demand for early diagnostic tools like urinalysis. The region’s advanced healthcare infrastructure and high adoption of automated diagnostic systems further support market expansion.

For instance, Becton, Dickinson and Company (BD) has been enhancing their urinalysis portfolio with AI-powered diagnostic solutions tailored for U.S. hospitals. Moreover, increased point-of-care testing in outpatient settings and pharmacies is gaining traction. CVS Health’s initiative to integrate diagnostic services, including urinalysis, into MinuteClinic locations exemplifies this shift. With favorable reimbursement policies and increasing telehealth usage, North America continues to offer lucrative prospects for urinalysis device and reagent manufacturers.

Key Highlights

• The global urinalysis market size was valued at USD 4.12 billion in 2024 and is estimated to grow from USD 4.43 billion in 2025 to reach USD 7.92 billion by 2033, growing at a CAGR of 7.53% during the forecast period (2025–2033).

• By product, the global urinalysis market includes instruments and consumables. The consumables segment held a dominant market share.

• By test type, the market is categorized into biochemical urinalysis, sediment urinalysis, and microscopic urinalysis.
• By application, the market is divided into disease screening and fertility and pregnancy testing. The disease screening segment held the largest market share.
• By end-user, the market includes hospitals, clinical laboratories, home care, research and academics, and others. The hospital segment dominated the market.
• North America is the highest shareholder in the global market.

Competitive Players

1. Siemens Healthineers
2. F. Hoffmann-La Roche Ltd
3. Abbott Laboratories
4. Beckman Coulter Inc. (a subsidiary of Danaher Corporation)
5. Sysmex Corporation
6. Bio-Rad Laboratories, Inc.
7. ARKRAY Inc.
8. 77 Elektronika Kft.
9. Thermo Fisher Scientific Inc.
10. Mindray Medical International Limited

Recent Developments

• In June 2025, PanGIA Biotech revealed clinical trial data for its AI‑driven urine test designed to detect early-stage prostate cancer non-invasively. Based on proprietary chemistry + machine learning, it identifies cancer-specific biosignatures in urine. In a cohort of 197 prostate cancer patients vs 84 healthy controls, the test achieved an F1 score ≈ of 0.84 and recall of around 0.97, showing excellent sensitivity even for low/intermediate Gleason scores.

Segmentation

1. By Product
   1. Instruments
      1. Biochemical Urine Analyzer
         1. Automated Biochemical Analyzers
         2. Semi-automated Urine Sediment Analyzers
      2. Automated Urine Sediment Analyzers
         1. Microscopic Urine Analyzers
         2. Flowcytometric Urine Analyzers
   2. Consumables
   3. Dipsticks
   4. Reagents
   5. Disposables
2. By Test Type
   1. Biochemical Urinalysis
   2. Sediment Urinalysis
   3. Microscopic Urinalysis
3. By Application
   1. Disease Screening
   2. Fertility And Pregnancy Testing
4. By End-User
   1. Hospitals
   2. Clinical Laboratories
   3. Home Care
   4. Research and Academics
   5. Others
5. By Regions
   1. North America
   2. Europe
   3. Asia-Pacific
   4. Latin America
   5. The Middle East and Africa