Urinalysis Market By Product Type (Devices and Equipment {Automated Urinalysis Analyzers, Manual Urinalysis Kits, Portable and Point-of-Care Devices, Reagent-based Testing Systems, Microscopic Analyzers}, Consumables { Urine Test Strips, Reagents and Chemicals, Urine Collection Kits}, Software {Diagnostic Software, Data Management and Reporting Software}), By Application (Disease Diagnosis {Urinary Tract Infections, Diabetes, Kidney Diseases, Liver Diseases, Hypertension}, Pregnancy and Fertility, Drug Screening) By Test Type (Physical Test {Color Examination, Odor Examination, Turbidity Testing}, Chemical Test {pH Testing, Protein Testing, Glucose Testing, Ketone Testing, Bilirubin Testing, Nitrite Testing, Specific Gravity Testing}, Microscopic Test {Cellular Examination, Crystals Examination, Bacteria and Parasites}) By End-user (Hospitals & Clinics, Diagnostic Laboratories, Home Care Settings, Research Laboratories & Academic Institutes), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Urinalysis market accounted for USD 3.85 Billion in 2024 and is expected to reach USD 7.86 Billion by 2035, growing at a CAGR of around 6.7% between 2025 and 2035. The urinalysis market comprises businesses that deal with the manufacture, sale, and application of tests and equipment that are used in the assessment of urine samples. Urinalysis is a useful diagnostic tool in medicine applied for diagnosing different diseases concerning the urinary system, diabetes, or diseases of the kidneys. The products that can be associated with the market are reagent strips, automated analyzers, and other consumables that allow the testing of urine samples.

Driving forces of the market include the rising incidence of chronic diseases, enhancing healthcare consciousness, and the development of point-of-care testing. Since healthcare providers always look for better and more economical diagnostic procedures, there is a steady demand for urinalysis tools. This market also extends the advantages of developments that are in the digital urine analysis and mobile health service industries.

Report Scope:

Market Dynamics

Rising Prevalence of Chronic and Infectious Diseases in the Global Population.

The Urinalysis Market is widely growing due to the increasing rates of chronic and infectious diseases. Diabetes, kidney diseases, UTIs, and liver disorders are diagnosed and monitored using urine testing. The prevalence of these diseases has risen due to factors such as increasing age of people, less active lifestyles, and poor nutrition, which has in one way or another enhanced the use of urinalysis. Further, by doing urine tests early, people receive treatments early, thus cutting the costs of having to spend a lot of money on numerous hospital visits and complications.

The markets are being driven by awareness regarding wellness, along with the efforts of governments and healthcare organizations for early diagnosis and caution, all of which are contributing to the growth of the market. Data by the CDC further estimated that in 2022, 37.3 million people in the United States, which is about 11.3% of the population, had the disease and required routine urinalysis. This growing patient population underlines the need for more sophisticated as well as cost-effective urinary diagnostic tests.

Growing Geriatric Population and Increasing Healthcare Expenditure Across Regions.

Factors such as an aging population and the rising costs of healthcare are major factors contributing to the growth of the Urinalysis Market. With the aging population across the world, diseases associated with old age, such as kidney diseases, diabetes, and urinary tract infections, become common, leading to frequent urinalysis. This is more so because the elderly group has increased health complications, and hence, more regular health checkups, such as through urinalysis, are useful in geriatric medicine.

When the regions raise overall expenditure in healthcare, it raises accessibility to the new diagnostic measures that help to diagnose the diseases at early stages. US CMS notes that total health spending in the United States only grew to 9.7% in 2020, which underlines the global increase in health investment, which is key to operational diagnostic services such as urinalysis.

Regulatory and Compliance Barriers in Urinalysis System Adoption.

Legalization and compliance hurdles play an important role in restricting the Urinalysis Market systems, which serve as constraints in the Urinalysis Market. These systems should conform to highly set statutory requirements by the central authorities in health care to promote the creation of accurate, reliable, and safe systems. Such rules take time to implement and may delay a company's product releases because they require thorough clearances and documentation.

Regional variations in requirements have an impact on the production process and are challenging for manufacturers looking to reach a global market. Such rules can hinder innovation and market access, and they are quite costly, particularly for startups. Furthermore, ongoing modifications to the regulatory framework suggest that improvements are required and require consistent investment, which continues to make the urinalysis system market difficult.

Growing Demand for Point-of-Care Urinalysis Testing.

 One of the key trends that has a positive impact on the Urinalysis Market is the increasing adoption of point-of-care urinalysis testing. Such testing makes POC testing more popular in the numerous healthcare sectors because it produces quick and effective results that create the foundation for diagnosis and treatment. This movement toward decentralization of testing means that quicker decisions can be made that improve patient care in locations that are far removed or where they may be resource-poor.

Due to their portability and ease of use, POC testing can be fittingly aligned with the current trend toward individualized medicine and thus would be embraced widely. High levels of accuracy and reliability of results provided by technological extensions of POCs are also making these devices popular among providers. Since the use of rapid, point-of-care tests is extending, the Urinalysis Market is likely to grow and seize this opportunity to diversify the healthcare market’s needs.

Integration of AI and automation improves urinalysis efficiency and accuracy.

The application of artificial intelligence and automation in the global Urinalysis Market holds a lot of promise for increased productivity and reliability. Using AI in analyzing urine samples is more efficient than manually analyzed samples, as there is little or no human error, and the results obtained have improved accuracy. This eliminates the need for manual interaction along the process or procedure and is much more suitable for a high-throughput clinical setting.

They also enable the real-time analysis of data, hence quicker time in diagnosis and quicker time to decision in handling patients. With the advance of AI in the later years, there are possibilities where diagnostic skills, accuracy of identification of diseases, and other conditions are likely to advance drastically. This technological change is one of the main influencing factors in the increased rate of development and new opportunities in the market for urinalysis.

Industry Experts Opinion

"Urinalysis continues to be an essential diagnostic tool in clinical practice, enabling healthcare providers to detect early signs of kidney disease, urinary tract infections, and metabolic disorders. Advances in automated systems are enhancing accuracy and speed, allowing for more efficient patient care."

• Dr. Lisa H. Jacobs, Clinical Pathologist at Metro Health Center

Segment Analysis

Based on the product type, the urinalysis Market is classified into Devices and Equipment, Consumables, and Software. In the Urinalysis Market, devices and equipment stand out as the biggest segment, spearheaded by automated urinalysis combination analyzers. These analyzers are characterized by high accuracy, speed, and scalability, which makes them crucial to use in clinical laboratories and hospitals. The need for the automation of these processes can be said to be due to the need for accurate diagnosis and also due to the wish to reduce human interference. The combination of these analyzers with enhanced technologies such as artificial intelligence/machine learning raises them to prominence in diagnostics. This proves that these devices play important roles in the existing and emerging markets for urinalysis diagnostics for the developed and developing worlds alike.

Based on the test type, the urinalysis Market is classified into Physical Tests, Chemical Tests, and Microscopic Tests. The chemical test segment is the largest segment of the global Urinalysis Market. This prominence is attributed to its capacity to pick a variety of substances in the body, such as proteins, glucose, ketones, and nitrites, which are imperative in determining different medical ailments such as diabetes, kidney ailments, and urinary tract infections.

They are crucial since they are quick, simple methods that provide crucial diagnostic information. They are regarded as essential parts of regular working diagnostics since they also readily integrate with both automated and manual urinalysis procedures. Because they may be used in a range of settings and because urinalysis is a diagnostic procedure, chemical tests have a clear advantage over other test types. As a result, they hold a strong hold on the market.

Regional Analysis

The North American Urinalysis Market is characterized by an integrated approach to healthcare, high technological penetration in the form of automating and applying AI in the analysis of laboratory samples, and focusing on the prevention of diseases. The United States occupies the most advantageous position in the world because of its well-established healthcare system, strong investment in research and development, and rising rates of chronic illnesses like diabetes and kidney disorders, all of which increase the use of urinalysis testing equipment.

Additionally, the regional market has been driven by the growing popularity of point-of-care and home testing, which is similar to other regions. The market's expansion can be largely explained by market participants and international regulatory assistance. Similarly, the market continues to be appealing as the need for more effective urine diagnostic solutions in the healthcare systems of Canada and Mexico increases.

Asia Pacific holds a promising economic environment for the global Urinalysis Market due to a rising geriatric population, increasing health awareness, and the establishment of several healthcare facilities. The global population, especially in Asia, such as Japan, China, and India, is aging, and the occurrence of such diseases as diabetes, kidney diseases, and UTIs is driving the growth of urinalysis need.

Also, enhancing the ratio of healthcare expenditure and advances in the technique of diagnostics equipment boosts the market. Health campaigns and lobbying for the availability of diagnostic centers have played a large role in increasing the adoption of urinalysis systems.

Competitive Landscape 

The global Urinalysis Market is driven by constantly evolving technology and some market leaders that are supplying a broad portfolio. Large industry players in the Urinalysis Market include Siemens Healthineers, Abbott Laboratories, and Roche. Diagnostics, Danaher Corporation, and Becton Dickinson. These final companies hold the market with choice inventory when it comes to automated urinalysis analyzers, test strips, and reagent solutions. They contribute to innovation. Product development and enhancing the diagnostic accuracy of the products are considered key growth drivers in the market. More recent changes that have occurred in the Urinalysis Market present a focus on point-of-care testing and the use of technologies such as artificial intelligence and machine learning to enhance diagnostic results.

 The Atellica Solution was only launched by Siemens Healthineers in the year before this report, with the solution being automation and AI in urine analysis. These innovations are redrawing the competitive perspective of the Urinalysis Market, as they are attesting to the emergent need for quicker and more accurate diagnostic mechanisms in the healthcare sector.

Urinalysis Market, Company Shares Analysis, 2024

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Recent Developments:

• In January 2024, Siemens Healthineers incorporated AI technologies into its urinalysis systems, improving diagnostic accuracy and enabling early disease detection through machine learning algorithms.

Report Coverage:

By Product Type

• Devices and Equipment
  • Automated Urinalysis Analyzers
  • Manual Urinalysis Kits
  • Portable and Point-of-Care Devices
  • Reagent-based Testing Systems
  • Microscopic Analyzers
• Consumables
  • Urine Test Strips
  • Reagents and Chemicals
  • Urine Collection Kits
• Software
  • Diagnostic Software
  • Data Management and Reporting Software

By Application

• Disease Diagnosis
  • Urinary Tract Infections (UTI)
  • Diabetes
  • Kidney Diseases
  • Liver Diseases
  • Hypertension
• Pregnancy and Fertility
• Drug Screening

By Test

• Physical Test
  • Color Examination
  • Odor Examination
  • Turbidity Testing
• Chemical Test
  • pH Testing
  • Protein Testing
  • Glucose Testing
  • Ketone Testing
  • Bilirubin Testing
  • Nitrite Testing
  • Specific Gravity Testing
• Microscopic Test
  • Cellular Examination
  • Crystals Examination
  • Bacteria and Parasites

By End-User

• Hospitals & Clinics
• Diagnostic Laboratories
• Home Care Settings
• Research Laboratories & Academic Institutes

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Siemens Healthineers
• F. Hoffmann-La Roche Ltd.
• Cardinal Health, Inc.
• Abbott Laboratories
• Sysmex Corporation
• ARKRAY, Inc.
• Beckman Coulter
• Bio-Rad Laboratories, Inc.
• 77 Elektronika Kft.
• Thermo Fisher Scientific Inc.
• Nova Biomedical
• Quidel Corporation
• Medica Corporation
• Diatron
• Danaher Corporation

Frequently Asked Questions (FAQs)