The global Urinary Tract Infection (UTI) Testing Market was valued at USD 5.47 billion in 2025. The market is anticipated to reach USD 9.98 billion by 2035, expanding at a CAGR of 6.2% during the forecast period. In 2025, the Urinalysis segment accounted for a market share of 63.4%, whereas the Hospital Laboratories segment represented a share of 54.7%.
A key development took place in June 2024 when Sysmex Astrego won the prestigious £8 million Longitude Prize on Antimicrobial Resistance for its PA-100 AST System. This system can detect UTI pathogens and antibiotic susceptibility within 45 minutes, representing a major advancement over conventional methods that take two to three days. This innovation reflects the industry's shift towards rapid, point-of-care diagnostics critical for combating antimicrobial resistance and improving treatment accuracy.
The demand for UTI testing products is being driven by an increasing prevalence of urinary tract infections, particularly in women and elderly populations worldwide. Rising awareness about early detection and the advantages of rapid diagnostic testing are encouraging healthcare providers to adopt cost-effective urinalysis methods. Hospital laboratories dominate the end-user segment owing to their advanced diagnostic infrastructure, high sample volumes, and need for reliable results.
Technological advancements are further shaping the market. Companies are developing home-based testing kits integrated with telehealth platforms, such as Winx Health’s “Test + Treat” UTI kit, enhancing patient convenience. These solutions allow patients to conduct tests at home and receive instant medical consultations, promoting decentralization of diagnostic services.
Regionally, North America leads due to superior healthcare infrastructure and higher disease awareness, while Asia-Pacific and Latin America are set to witness faster growth supported by increasing healthcare spending and accessibility of diagnostics. Rising disposable income and government initiatives to control antimicrobial resistance are spurring market development in these regions.
Leading companies such as Qiagen (Roche), Danaher Corporation, Thermo Fisher Scientific, Bio-Rad Laboratories, Sysmex Corporation, and Accelerate Diagnostics are continuously launching improved test solutions and expanding their geographic presence. These firms focus on enhancing test accuracy, reducing result turnaround times, and integrating digital health technologies.
Market Metrics
| Metric | Value |
|---|---|
| Industry Size (2025E) | USD 5.47 billion |
| Industry Value (2035F) | USD 9.98 billion |
| CAGR (2025 to 2035) | 6.2% |
In 2025, the Urinalysis segment is expected to dominate the UTI Testing Market with a market share of 63.4%, driven by its cost-effectiveness and rapid diagnostic capabilities. Hospital Laboratories are forecasted to lead the end user category, capturing a 54.7% market share owing to advanced diagnostic infrastructure and increased demand for reliable infection detection systems.
The Urinalysis segment will command the largest market share of 63.4% in 2025 within the UTI Testing Market. This growth is driven by urinalysis’ role as a first-line diagnostic tool due to its affordability, rapid turnaround, and high accessibility in hospitals, diagnostic labs, and outpatient settings. Recent advancements in automated urinalysis systems-such as the inclusion of flow cytometry and digital microscopy-enhance the accuracy of results, supporting early-stage UTI detection.
In addition, the rising geriatric population and the growing prevalence of recurrent UTIs are fueling demand for rapid diagnostic solutions. Portable point-of-care (POC) urinalysis devices are increasingly adopted in emergency departments and outpatient clinics for immediate clinical decision-making. The emergence of home-based urinalysis test kits, offering convenience and remote monitoring, is also widening market reach.
Leading diagnostics companies such as Siemens Healthineers, Sysmex Corporation, and Beckman Coulter are focusing on automation and multiplexing innovations to make urinalysis more comprehensive and efficient, ensuring this segment’s continued dominance over traditional culture methods.
Hospital Laboratories are projected to lead the end user segment with a market share of 54.7% in 2025, maintaining their pivotal role in UTI diagnostics. This dominance stems from hospitals’ ability to handle high patient volumes and their investment in modern diagnostic equipment essential for accurate and efficient UTI testing.
Hospitals are increasingly adopting automated urinalysis and culture platforms to improve diagnostic accuracy, minimize manual errors, and accelerate reporting times. Integration with Laboratory Information Systems (LIS) has streamlined sample processing and data management, enhancing overall workflow efficiency.
Furthermore, hospital laboratories conduct the majority of antibiotic susceptibility testing, crucial for tailoring treatments to drug-resistant UTI strains-an escalating concern due to the global rise in antimicrobial resistance. Hospitals also participate actively in antimicrobial stewardship programs, making laboratory-based diagnostics vital for infection control measures.
Prominent players like Becton Dickinson, BioMérieux, and Roche Diagnostics are advancing hospital-grade diagnostic systems with real-time data analysis capabilities. With continuous innovation and automation, hospital laboratories will remain central to driving the UTI testing market’s growth trajectory.
Diagnostic Accuracy and Cost Constraints Limit UTI Testing Adoption
Expensive diagnostic tests with cutting-edge technology, regulatory hurdles, and fear of inaccuracy in home-based testing kits are still significant hindrances. Inadequate awareness in developing markets could also delay the pace of adoption. Antibiotic resistance is a huge challenge resulting in misdiagnosis and suboptimal treatment in certain situations.
The availability of spurious and low-quality test kits in the low and middle income countries makes the scenario even more challenging and thus necessitating increased enforcement of quality control protocols. These challenges need to be addressed with increased investment in awareness campaigns, enhanced diagnostic standardization, and increased affordability of high-quality testing solutions.
PCR Technology Reshaping UTI Diagnostics
Urinary tract infections affect millions of cases worldwide, making timely and accurate diagnosis essential for effective treatment for patients. With technological advancements PCR based testing is revolutionizing UTI diagnostics, offering manufacturers significant growth opportunities.
PCR technology enhances accuracy by amplifying specific DNA sequences which is enabling precise pathogen identification and antibiotic resistance detection. This breakthrough allows manufacturers to develop advanced PCR-based diagnostic tools that address the rising demand for rapid and reliable UTI testing.
Multiplex PCR assays will further improve diagnostics by simultaneously detecting multiple pathogens streamlining testing process and reducing turnaround time for results. Manufacturers are investing in multiplex panels can provide comprehensive, time-efficient solutions for healthcare professionals.
Industry focus towards high-accuracy, rapid and comprehensive diagnostic tools will drive the market expansion and meet evolving healthcare needs, strengthening their competitive position in the urinary tract infection testing market.
Market Outlook
The urinary tract infection testing industry in United States is on growth phase, essentially propelled by the increasing UTI cases each year along with the strides made in diagnostic procedures. In addition to that, the demands for proper testing tools and developments of new testing modalities are also driving the demand for urinary tract infection testing market.
Rising elderly population who are more prone to urinary tract infections also adds value to the overall market. Shift towards the use of rapid point-of-care testing and home-based self-test kits are the new features of the market which are allowing for quantitative testing, early diagnosis, fast treatment and positive patient outcomes
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| United States | 3.3% |
Market Outlook
Urinary tract infection testing market in Germany has experienced significant growth, which is attributable to the very reliable healthcare system. A systematic and proactive approach towards infectious diseases diagnostics that makes this country one of the leading market in Europe contributing a significant market share.
The rise in preventive care and free UTI testing are often offered to patients which remain as a key reasons for the growing demand for UTI testing. The use of modern diagnostic tools remains as another factor driving growth across hospitals and diagnostic laboratory settings which is able to detect UTI much faster and with greater accuracy.
Market Growth Factors
Market Forecast
| Year | CAGR (2025 to 2035) |
|---|---|
| 2025 to 2035 | 2.9% |
Market Outlook
The market for urinary tract infection testing in India is experiencing rapid expansion. This growth is attributed to several key reasons such as increased prevalence of urinary tract infections in both rural and urban areas. The high incidence of diabetes and rising cases of antibiotic-resistant infections are two critical factors driving the need for efficient and accurate UTI testing.
Ongoing efforts include government healthcare campaigns and the establishment of new diagnostic laboratories, particularly benefiting remote locations where UTI testing has become more accessible.
Other contributing factors to market growth are well-furnished healthcare facilities and specialty clinics that provide clear diagnostic testing tools and options. The acceptance of home testing or self-testing has gained importance and is a significant reason for the market's expansion.
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| India | 7.9% |
Market Outlook
The urinary tract infection testing market in Japan is witnessing significant growth owing to the growing of the aging population and development of technological advancement concerning the diagnostic sector. Primarily speaking, the elderly people do have a lot of UTIs and the situation is worsened by the fact that they stay in long-term care settings where the presence of this kind of disease has an impact.
The integration of molecular diagnostics together with the automation of diagnostic labs is the other side of the coin when it comes to the growth of the trend. The popularity of point-of-care (POC) and home-based UTI kits has improved the availability and speed of diagnostics in the market.
Market Growth Factors
Aging Population and Increasing UTI Prevalence: Japan older population is on the rise especially in assisted living and nursing facilities which have observed a consistent increase in UTI cases. Thus, the necessity for dependable disease diagnosis across clinical and home settings has become prominent
Advances in Diagnostic Automation: The focus on automated urinalysis systems and molecular diagnostics has led to the fast testing and accuracy of results.
Strong Emphasis on Preventive Healthcare: Government health screening programs also serve to directly address the issue of infectious diseases by early detection of urinary tract infections, thus inflating the number of diagnostic tests available, and the need for reliable test results.
Increased Demand for Point-of-Care (POC) Testing: The implementation of rapid UTI be at the outpatient clinics and the pharmacies, it has made the treatment decisions faster and less hospital participation, thus making the system better.
Growing Home-Based Testing Solutions: The self-testing kits that are now available for urinary tract infections provide more comfort to users and at the same time, they relieve the hospitals from the burden of carrying out the tests themselves and by doing so, they facilitate the patients with quicker access to the treatment decision.
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| Japan | 3.8% |
Market Outlook
Urinary tract infection testing market in Brazil is growing due to advancement in healthcare infrastructure, increasing penetration of new diagnostic laboratories, increasing installation of Urine Analyzers and heightened awareness of infectious disease prevention.
The government is emphasizing on strengthening public health services, rising testing volume and increasing incidence of UTIs are key reasons for the demand for diagnostic testing
Market Growth Factors
Market Forecast
| Country | CAGR (2025 to 2035) |
|---|---|
| Brazil | 6.2% |
The urinary tract infection testing industry is highly competitive, and it is influenced by major international players and regional players. Increased prevalence of UTIs, evolution of diagnostic technology, and increasing focus on early diagnosis have caused the development of UTI testing technologies.
There is investment in rapid, efficient, and convenient testing solutions to remain competitive. The market is dominated by established diagnostic companies and new brands, each of which plays a part in the dynamic picture of UTI diagnostics.
F. Hoffmann-La Roche AG (18-22%)
Roche is a diagnostics world leader that has a comprehensive product portfolio in urinalysis designed to streamline the detection of UTI and enable clinical decision-making. Innovation and automation are highly valued to enhance diagnostic quality and efficiency.
Siemens Healthineers AG (12-16%)
Siemens Healthineers offers state-of-the-art urinalysis instruments that fit nicely into laboratory practices. Their technologies improve diagnostic efficiency, providing high-throughput analysis for clinical labs.
Danaher (10-14%)
This company, with a wide portfolio of laboratory products, is a category leader and facilitates UTI testing through consistent culture media and quick identification aids. The company serves both clinical and research requirements, providing complete diagnostic capabilities.
Thermo Fisher Scientific Inc (8-12%)
Focusing on microbiology, This organization provides automated systems for urine culture and antimicrobial susceptibility testing to assist with accurate UTI diagnosis and optimal treatment planning.
Abbott (6-10%)
Abbott is dedicated to point-of-care diagnostics, offering easy-to-use urinalysis products that enable timely UTI identification in a variety of healthcare settings.
Beyond the leading companies, several other manufacturers contribute significantly to the market, enhancing product diversity and technological advancements. These include:
These companies focus on expanding the reach of professional and consumer-grade UTI diagnostics, offering competitive pricing and advanced testing methodologies.
| Attribute | Detail |
|---|---|
| Industry Size (2025E) | USD 5.47 billion |
| Industry Size (2035F) | USD 9.98 billion |
| CAGR (2025 to 2035) | 6.2% |
| Forecast Period | 2025 to 2035 |
| Historical Data | 2018 to 2024 |
| Base Year | 2024 |
| Quantitative Units | Value in USD billion, Volume in Number of UTI Test Kits, Urine Analyzers, and Consumables Sold |
| Segments Covered | Product, Test Type, Causative Organism, End User, Region |
| Regions Covered | North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia & Pacific, Middle East & Africa |
| Countries Covered | United States, Canada, Mexico, Brazil, Germany, UK, France, Italy, Spain, Poland, Russia, China, Japan, South Korea, India, Australia, GCC Countries, South Africa |
| By Product | Urine Analyzers, Test Kits, Urine Collection Bags and Reagents, Consumables |
| By Test Type | Urinalysis, Urine Culture Analysis |
| By Causative Organism | Escherichia coli, Klebsiella pneumonia, Staphylococcus saprophyticus, Proteus mirabilis, Others |
| By End User | Hospital Laboratories, Reference Laboratories, Public Health Centres, Specialty Clinic, Ambulatory Surgical Centres, Academics and Research Institutes, Homecare Settings |
| Key Companies Profiled | Becton, Dickinson & Company, Cardinal Health, B. Braun SE, Coloplast, Medtronics, ConvaTec Group Plc, Teleflex Inc., Medline Industries, LP., Optimum Medical Limited, Polymedicure, AdvaCare Pharma, Well Lead Medical Co., Ltd., Advin Health Care |
| Additional Attributes | Market share by test type, unit sales of analyzers and kits, demand in hospital and homecare settings, causative organism detection trends, regional revenue, pricing dynamics, and top suppliers. |
The global Urinary Tract Infection Testing industry is projected to witness CAGR of 6.2% between 2025 and 2035.
The global Urinary Tract Infection Testing industry stood at USD 5.12 billion in 2024.
The global Urinary Tract Infection Testing industry is anticipated to reach USD 9.98 billion by 2035 end.
ASEAN Countries is expected to show a CAGR of 7.5% in the assessment period.
The key players operating in the global Urinary Tract Infection Testing industry are F. Hoffmann-La Roche AG, Siemens Healthineers AG, Danaher, Thermo fisher Scientific, Abbott, QIAGEN N.V., Bio-Rad Laboratories, Inc., Randox Laboratories Ltd., T2 Biosystems, Inc., Shenzhen Mindray Bio-Medical Electronics Co., Ltd, ARKRAY, Inc.AGAPPE DIAGNOSTICS SWITZERLAND GmbH The Menarini Group and others
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Urinary Tract Infection Testing Market
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