Urinalysis Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables), By Test Type (Biochemical Urinalysis, Sediment Urinalysis, Microscopic Urinalysis), By Application (Disease Screening, Fertility And Pregnancy Testing), By End-User (Hospitals, Clinical Laboratories, Home Care, Research and Academics, Others) and By Region(North America, Europe, APAC, Middle East and Africa, LATAM) Forecasts, 2025-2033

Urinalysis Market Size

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).

One of the key drivers fostering the global urinalysis market is the technological advancement in automated urinalysis systems. Modern analyzers offer high throughput, minimal human intervention, and integrated digital reporting features, significantly reducing error rates while enhancing diagnostic efficiency. These advancements are increasingly adopted by diagnostic laboratories, clinics, and hospitals to manage large sample volumes effectively.

Additionally, increasing awareness and initiatives for early disease detection are driving market growth. Public and private healthcare organizations are promoting regular urinalysis screening as part of preventive healthcare programs, especially in regions witnessing a surge in lifestyle-related disorders, thereby boosting the uptake of urinalysis products.

Moreover, the expanding network of diagnostic labs and the rising number of wellness centers are ensuring easier access to urinalysis services, further reinforcing market demand. Collectively, these factors are contributing to a strong and sustained growth trajectory for the global market.

Urinalysis Market Trends

Emergence of AI-based urinalysis tools

A prominent trend shaping the market is the integration of artificial intelligence (AI) into diagnostic systems, revolutionizing traditional urine testing methods. AI technologies are increasingly being adopted to enhance accuracy, streamline workflows, and enable faster decision-making in clinical settings. These innovations are especially valuable in detecting complex patterns in urinalysis results that might be missed through manual observation.

• A leading example of this advancement is Biotia's BIOTIA‑ID Urine NGS Assay, which received approval from New York State CLEP in November 2024. This is the first genomics-based urine assay to harness AI for identifying urinary tract infection (UTI) pathogens. Combining next-generation sequencing with machine learning, it offers rapid, culture-free results with 97% sensitivity and 99% specificity.

This breakthrough significantly improves diagnostic precision and plays a critical role in guiding timely, targeted treatment, particularly crucial in addressing antimicrobial resistance.

Urinalysis Market Growth Factors

Rising prevalence of kidney and urinary tract diseases

The surging prevalence of kidney and urinary tract diseases significantly drives the global urinalysis industry. These conditions require regular and accurate diagnostic testing, making urinalysis a vital tool in early detection and disease monitoring.

• According to the Global Burden of Disease Study 2023, CKD affects over 850 million people worldwide, making it the 10th leading cause of death globally. Additionally, as per a 2024 WHO report, over 400 million UTI cases are diagnosed globally each year. Women are disproportionately affected, with about 50-60% experiencing at least one UTI in their lifetime, according to the National Institute of Diabetes and Digestive and Kidney Diseases (2023).

These alarming statistics underscore the importance of routine screening. The increased awareness and emphasis on early intervention are pushing healthcare providers to adopt advanced and automated urinalysis systems, further propelling market growth globally.

Market Restraining Factors

High cost of an advanced urinalysis instrument

The high cost of advanced urinalysis instruments is a significant restraint on market growth, particularly in low- and middle-income countries. Automated analyzers and integrated urinalysis systems require substantial initial investment, in addition to ongoing maintenance and calibration costs.

This financial burden often limits their adoption to large hospitals and diagnostic centers with adequate budgets, leaving smaller clinics and rural healthcare facilities reliant on manual or semi-automated methods. Moreover, the high price point of sophisticated reagents and test strips further adds to operational expenses. This cost-related barrier restricts widespread accessibility, thereby slowing the global adoption of advanced urinalysis technologies despite their clinical benefits.

Market Opportunities

Growing use of point-of-care testing (POCT) kits

The growing use of point-of-care testing (POCT) kits is opening new avenues in the urinalysis market by enabling rapid, decentralized diagnostics. These kits allow healthcare professionals to perform urine tests directly at the site of patient care, eliminating the need for centralized lab processing and delivering results within minutes. This approach is particularly helpful in primary care, emergency settings, and rural clinics where immediate decision-making is crucial.

• For instance, the UTS System by Clinical Design Technologies, distributed by Alpha Laboratories since December 2024, is the world's only digital closed urine testing solution for point-of-care use. It provides a hygienic, accurate analysis of 10 key parameters through a sealed, push-fit cap design. Ideal for clinics and GP surgeries, the system enhances workflow efficiency, reduces contamination risk, and integrates seamlessly with electronic medical records for quick and reliable diagnostics.

As demand for faster and more accessible diagnostics grows, POCT kits are poised to become a cornerstone of future urinalysis strategies.

Regional Insights

The urinalysis market in North America is driven by the presence of well-established healthcare systems and the widespread adoption of advanced diagnostic technologies. High awareness of chronic kidney disorders and diabetes contributes significantly to frequent urine testing. Government initiatives promoting early disease diagnosis and routine screening support market expansion. Additionally, increased investments in laboratory automation and the integration of digital diagnostic tools in clinical workflows foster growth. The region also benefits from a robust presence of key market players focusing on product innovation and next-generation urinalysis systems.

U.S. Urinalysis Market Trends

• The United States market is driven by high rates of diabetes, kidney disease, and urinary tract infections. Advanced diagnostic infrastructure and the adoption of automated analyzers support market growth. For instance, Abbott and Siemens Healthineers dominate with integrated urinalysis solutions in U.S. hospitals. Moreover, the shift towards preventive healthcare and point-of-care testing further boosts demand across clinics and home care settings.
• Canada's urinalysis market benefits from a universal healthcare system, an increasing elderly population, and strong chronic disease management programs. Public health campaigns promoting early screening of renal conditions fuel test volumes. For example, provincial healthcare providers widely deploy automated analyzers from Sysmex and Roche in diagnostic labs. Additionally, Canada's rising adoption of telehealth encourages the integration of urinalysis data with remote monitoring platforms for patient-centric care.

Asia-Pacific Urinalysis Market Trends

The Asia Pacific market for urinalysis is witnessing rapid growth due to rising healthcare expenditures, expanding diagnostic infrastructure, and increasing patient awareness regarding early disease detection. The growing prevalence of lifestyle-related disorders such as diabetes and kidney disease is accelerating the demand for urinalysis tests. Efforts to enhance access to quality healthcare, especially in underserved areas, are encouraging the adoption of point-of-care and portable urinalysis devices. Furthermore, the region's strong focus on technological advancement and investment in local manufacturing of diagnostic tools is significantly supporting market expansion across this region.

• China's urinalysis market is expanding rapidly due to a surge in chronic diseases like diabetes and kidney disorders. The government's Healthy China 2030 initiative promotes early disease detection, boosting diagnostic demand. For instance, Mindray's automatic urinalysis analyzers are widely adopted in major hospitals. Additionally, increasing investment in AI-powered diagnostic technologies is positioning China as a significant player in automated urinalysis systems.
• India's urinalysis industry is driven by rising healthcare awareness and an increasing diabetic population, which reached 101 million in 2023 (ICMR). Government programs like Ayushman Bharat encourage early diagnostics, enhancing urinalysis uptake in rural and urban centers. Companies such as Agappe and Transasia Bio-Medicals are expanding affordable semi-automated and POCT urinalysis solutions, catering to diverse healthcare settings across the public and private sectors.

Europe Urinalysis Market Trends

Europe's market for urinalysis is growing due to a strong emphasis on preventive healthcare and a rising geriatric population prone to urinary and renal disorders. The region shows increasing adoption of point-of-care testing and automated urinalysis platforms in both public and private healthcare institutions. Supportive regulatory frameworks and reimbursement policies are facilitating market penetration. Moreover, growing clinical research activities involving urine biomarker testing and collaborations between healthcare providers and diagnostic companies are driving innovation and product development, making Europe a lucrative region for urinalysis system providers.

• Germany's market is driven by its advanced healthcare infrastructure and strong diagnostic sector. With a high prevalence of chronic kidney disease and diabetes, the demand for routine urinalysis is growing. For instance, Siemens Healthineers, headquartered in Erlangen, provides automated urine analyzers that are widely used across German hospitals. Government initiatives promoting early disease detection further enhance market growth, especially in aging populations.
• The UK market for urinalysis benefits from the increasing adoption of point-of-care testing (POCT) in primary care and pharmacies. The National Health Service (NHS) promotes regular screening for conditions like UTIs and kidney disorders. Companies like Sysmex UK Ltd. supply integrated urinalysis solutions to NHS laboratories. The rising elderly population and prevalence of diabetes are boosting demand for accurate and rapid urine diagnostics across both public and private healthcare settings.

Product Insights

Consumables hold the largest share of the market for urinalysis due to their high usage frequency and cost-effectiveness. Items like dipsticks, reagents, and disposables are essential for both manual and automated urinalysis procedures, driving repeat purchases. The surging prevalence of chronic diseases such as diabetes and kidney disorders has increased the demand for routine urine tests, further boosting consumable usage. Additionally, the availability of user-friendly and point-of-care testing consumables supports widespread adoption across hospitals, clinics, and home settings. The affordability and accessibility of consumables make them a vital and revenue-generating component in the global market.

Test Type Insights

The biochemical urinalysis segment is a key contributor to market growth, primarily due to its ability to rapidly detect vital biomarkers such as glucose, protein, ketones, bilirubin, and pH levels. These parameters provide critical insights into systemic conditions like diabetes, liver disorders, and kidney diseases. Dipstick-based biochemical analysis is widely used owing to its simplicity, cost-efficiency, and suitability for both laboratory and point-of-care settings. The demand for early and non-invasive diagnostic methods, coupled with the increased adoption of automated analyzers, is propelling the expansion of this segment. Biochemical urinalysis remains a preferred choice for its speed and diagnostic utility.

Application Insights

Disease screening dominates the market owing to its crucial role in detecting a range of health illnesses, including urinary tract infections (UTIs), diabetes, and kidney diseases. Early-stage screening helps in prompt diagnosis and treatment, reducing the risk of complications. Urinalysis is widely adopted in routine health check-ups, especially for patients with hypertension, diabetes, or chronic kidney issues. The increasing global burden of these diseases has fueled demand for diagnostic screening tools. Moreover, the integration of urinalysis with preventive healthcare strategies further strengthens its dominance in disease screening applications.

End-User Insights

Hospitals represent the largest end-user segment in the market for urinalysis due to the high volume of diagnostic tests conducted in these settings. They rely heavily on urinalysis for routine health assessments, disease diagnosis, and pre-surgical evaluations. The availability of advanced diagnostic infrastructure, skilled personnel, and integrated laboratory systems in hospitals supports the use of automated urinalysis instruments and consumables. Moreover, rising hospital admissions for chronic conditions such as diabetes, kidney disease, and urinary disorders increase the demand for frequent urine testing. The hospital segment continues to dominate due to its comprehensive diagnostic capabilities and robust patient inflow.

Company Market Share

Companies in the urinalysis market are focusing on expanding their product portfolios through technological advancements, including AI integration and automation. Many are investing in R&D to develop portable and user-friendly point-of-care testing devices. Strategic collaborations with hospitals and diagnostic centers, along with geographic expansion into emerging markets, are also key growth strategies. Additionally, efforts are being made to offer cloud-based data management solutions for improved diagnostic accuracy and accessibility.

Thermo Fisher Scientific: Thermo Fisher Scientific Inc. is a leading player in the global market, offering a broad portfolio of diagnostic tools and laboratory instruments. The company provides advanced urinalysis analyzers, reagents, and consumables used in clinical laboratories for accurate disease detection. With a strong focus on innovation, Thermo Fisher leverages automation and data integration technologies to enhance test efficiency. Its global distribution network and continuous investment in R&D have positioned it as a trusted provider in diagnostics and laboratory testing solutions.

• In May 2024, Thermo Fisher Scientific launched a new urine‑based CXCL10 assay developed by One Lambda Laboratories for monitoring kidney transplant patients. This innovative test can be performed at any local clinic, delivering results within 24 hours. By measuring the CXCL10 chemokine, the assay offers a non‑invasive alternative to biopsies, improving early detection of inflammation or rejection and reducing patient burden and costs.

Recent Developments

• 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.
• April 2025- Fujirebio’s US-based subsidiary, Fluxus, secured a two-year grant (≈ US$ $4.5 million) from the GHIT Fund to develop an ultrasensitive point-of-care urine assay targeting lipoarabinomannan (LAM) for tuberculosis diagnosis. This initiative aims to adapt their benchtop LAM assay into a deployable POC instrument capable of rapid TB detection, potentially transforming testing in resource‑limited settings and enhancing TB surveillance.