The global urinalysis market size was estimated at USD 4.37 billion in 2024 and is projected to reach USD 6.85 billion by 2030, growing at a CAGR of 7.83% from 2025 to 2030. Market growth is being driven by the increasing prevalence of health conditions such as Urinary Tract Infections (UTIs), diabetes, and kidney diseases, all of which require frequent and accurate diagnostic testing. For instance, according to the National Diabetes Statistics Report (2024), an estimated 38.0 million individuals in the U.S. representing 11.6% of the population were living with diabetes, and notably, about 8.7 million adults were unaware of their condition. Globally, the WHO reported in November 2024 that the number of people living with diabetes has exceeded 800 million, highlighting the growing clinical need for continuous monitoring and early detection.

A collaborative study conducted by the NCD Risk Factor Collaboration and the WHO found that adult diabetes prevalence has doubled from 7% to 14% over the past three decades, reflecting the growing burden of chronic metabolic disorders. Approximately one-third of diabetic individuals also suffer from kidney-related complications due to uncontrolled blood glucose and hypertension. Since urinalysis offers an efficient, noninvasive, and accessible method for diagnosing kidney conditions, the increasing incidence of renal diseases is expected to significantly elevate demand for urinalysis products. Consequently, this rising disease burden positions urinalysis as a critical diagnostic tool, further supporting market expansion.

Innovation levels across the urinalysis market remain high, driven by advancements in automation, digitalization, and artificial intelligence (AI). Modern solutions such as automated urine sediment analyzers, intelligent imaging-based systems, and point-of-care testing (POCT) devices have substantially enhanced diagnostic precision, speed, and workflow efficiency. Additionally, the introduction of smartphone-integrated diagnostic tools, such as Vivoo’s at-home UTI test and other app-based platforms, is transforming patient engagement by providing real-time, user-friendly, and personalized insights. These technologies are shaping a shift toward digital health and self-managed diagnostics.

End-user concentration in the market is considered medium, with hospitals and diagnostic laboratories remaining the dominant users of urinalysis systems due to their high patient volume and need for standardized testing. However, the increasing availability of convenient POCT solutions is expanding adoption across clinics, smaller healthcare settings, and home-care environments, diversifying the user base. While at-home diagnostics and personalized testing are expected to grow rapidly, traditional healthcare institutions will continue to account for the majority of market demand.

Key Market Trends & Insights:

  • Region: North America held the largest revenue share at 37.9% in 2024, supported by well-established healthcare infrastructure, high adoption of advanced diagnostics, and growing disease burdens. The urinalysis market in the U.S. is projected to continue expanding steadily over the forecast period. The Asia-Pacific region is anticipated to grow at the fastest CAGR due to rising healthcare expenditure, increasing awareness of chronic illnesses, and rapid improvements in diagnostic accessibility.
  • Product: The consumables segment including reagents, dipsticks, and test strips—accounted for 78.56% of revenue in 2024, reflecting the high frequency of testing and repeated-use nature of these products. The instruments segment is expected to register the fastest CAGR from 2025 to 2030, driven by rising regulatory approvals and growing adoption of advanced urinalysis instruments across laboratories and hospitals.
  • End Use: Clinical laboratories held the highest revenue share at 45.88% in 2024, owing to the large number of tests performed and reliance on advanced diagnostic equipment. The home care segment is projected to grow at the fastest CAGR of 9.09%, fueled by the launch of easy-to-use, home-based UTI and wellness test kits.
  • Application: The urinary tract infection (UTI) screening segment dominated in 2024 with a 24.07% revenue share, supported by the widespread incidence of UTIs globally. Meanwhile, the diabetes screening segment is expected to expand at the fastest CAGR of 10.59%, reflecting the rising global diabetes population and the growing need for continuous monitoring.

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Market Size & Forecast:

  • 2024 Market Size: USD 4.37 Billion
  • 2030 Projected Market Size: USD 6.85 Billion
  • CAGR (2025-2030): 7.83%
  • North America: Largest market in 2024
  • Asia Pacific: Fastest growing market

Key Companies & Market Share Insights:

Some of the leading players operating in the market include Abbott, F. Hoffmann-La Roche Ltd., and Siemens Healthineers AG, who are known for their advanced diagnostic solutions and strong market presence. These companies offer a wide range of urinalysis products, catering to hospitals, diagnostic labs, and point-of-care settings.

Emerging players such as Vivoo are leveraging advances in artificial intelligence, automation, and microfluidics to create next-generation diagnostic tools that promise enhanced sensitivity and convenience.

Key Players

  • Abbott
  • Sysmex Corporation
  • Siemens Healthineers AG
  • ACON Laboratories, Inc.
  • ARKRAY Inc.
  • Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
  • Hoffmann-La Roche Ltd.
  • Quidel Corporation
  • Bio-Rad Laboratories, Inc.

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Conclusion:

The urinalysis market is set for strong growth as the global burden of diabetes, UTIs, and kidney diseases continues to rise, driving consistent demand for efficient diagnostic solutions. Increasing adoption of automated systems, AI-driven tools, and smartphone-enabled testing is enhancing diagnostic accuracy and expanding access, especially in home-care settings. While hospitals and clinical laboratories will remain the primary end users, the rapid growth of point-of-care and at-home testing is expected to broaden the market landscape. Regional growth will be led by North America and Asia-Pacific, supported by advanced healthcare infrastructure and expanding diagnostic capabilities. Additionally, ongoing product innovations, rising regulatory approvals, and the launch of new instruments and consumables are expected to create significant opportunities for market participants. Collectively, these factors position the urinalysis market for sustained and robust expansion through 2030.