Urinalysis Market Report Scope & Overview:

The Urinalysis Market was valued at USD 4.03 billion in 2023 and is expected to reach USD 8.52 billion by 2032, growing at a CAGR of 8.7% over the forecast period 2024-2032.

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Urinalysis Market Report provides key statistics on the market status of the Urinalysis manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the Urinalysis. It examines the incidence and prevalence of conditions such as UTIs, kidney diseases, and diabetes, which has been triggering the need for urinalysis test. The report provides trends in testing volume, showcasing the growing shift towards automated urine analyzers and reagent strips. A breakdown of health care spending by the government, the insurer, and out-of-pocket. The report also reviews technology advancements such as AI-based urine diagnostics and analyzes regulatory compliance trends in major markets. Such insights helps the stakeholders to know about the market dynamics, investment opportunities and future growth trajectory. The urinalysis market is significantly growing at a rapid pace owing to the increasing prevalence of chronic diseases and urinary tract infection (UTI). About 1 in 3 U.S. adults are at risk for kidney disease, with diabetes and high blood pressure the most common causes, according to the Centers for Disease Control and Prevention (CDC).

Urinalysis Market Dynamics

Drivers

• The rising prevalence of urinary tract infections (UTIs) and kidney diseases increases the demand for urinalysis tests.

The increasing prevalence of urinary tract infections (UTIs) and chronic kidney diseases (CKD) is a significant driver for the urinalysis market. There is however an increase in UTIs worldwide according to recent data which shows that infections increased by 68%. This surge is partly attributed to a growing elderly population and sexually active young individuals. This is particularly remarkable as urinary tract infections (UTI) are observed to affect nearly 50-60% of women at some point in their lives, but due to anatomical reasons, they are more susceptible to urinary tract infections than men. CKD, in parallel, represents an increasing health issue. A 2024 modeling analysis by AstraZeneca projects that up to 16.5% of the population across eight countries including the United States, Brazil, the United Kingdom, Spain, Germany, the Netherlands, China, and Australia will suffer from CKD by 2032. This represents a significant increase from previous years, highlighting the escalating burden of kidney-related ailments.

The growing prevalence of these disorders highlights the importance of early diagnosis and proper treatment, which can be performed by urinalysis. For example, there is about 4.9 percent of children are facing CKD in India, with 5.6 percent in the age of 5–9, 3.4 percent at the age of 10–14, and 5.2 percent in the age of 15–19, having different prevalence. As early intervention can help to identify renal problems before they progress, urinalysis tests show great promise as a helpful additional tool in the kidney pathophysiology spectrum, especially for pediatric populations. Untreated UTIs (Urinary Tract Infections) can worsen causing severe problems like sepsis, threatening life. Around a quarter of sepsis cases are caused by UTIs, underscoring the need for rapid diagnosis and treatment.

Restraints:

• High costs associated with advanced urinalysis devices and a lack of skilled healthcare professionals may hinder market growth.

The costs of advanced diagnostic devices are high, and there is a lack of skilled healthcare professionals, which is limiting the growth of the urinalysis market. The sophisticated nature of urinalysis machines like automatic analyzers and POC testing machines bears a cost and is more accessible for smaller general practices and healthcare facilities with limited budgets. As a consequence, low-income and middle-income countries may fall behind in patient outcomes related to urinary disorders, due to the high cost of the new technologies that hinder their adoption.

Additionally, the effective operation of these sophisticated devices requires trained personnel proficient in their use and maintenance. However, there is a notable shortage of such skilled professionals in the healthcare sector. For example, one recent survey reported that 35% of laboratories faced challenges in recruiting qualified personnel to operate advanced diagnostic equipment. Such a shortage limits not only the effectiveness of current urinalysis technologies but also stops healthcare facilities from investing in new entrants that may never reach their maximum potential due to the limitations of the workforce.

Opportunities:

• Integration of artificial intelligence and machine learning in urinalysis devices offers potential for improved diagnostics.

The application of artificial intelligence (AI) and machine learning (ML) within urinalysis diagnostics represents a promising opportunity to improve diagnostic sensibility and efficacy. AI-driven models provide promising predictive capabilities for urinary tract infections (UTIs) and associated conditions, as recent studies have illustrated. For instance, a 2024 study developed AI models that achieved an area under the receiver operating characteristic curve (AUROC) of 0.967 for UTI prediction and 0.955 for urinary tract-related bloodstream infections, indicating excellent discriminative performance. In a separate study, tests of Urine strips using smartphone cameras were accurately interpreted with an AI-based program. The nitrite and glucose detection system achieved 98.7% and 97.3% accuracy separately, making it suitable for point-of-care testing when combined with mobile integration.

Importantly, in August 2024, a meta-analysis examined multiple AI/ML models aimed at documentation and prediction of UTIs. The pooled results showed a sensitivity of 78% and a specificity of 89%, with an overall AUROC of 0.89, underscoring the robustness of AI applications in this domain. These tools illustrate the potential of AI and ML to transform urinalysis diagnostics, yielding more accurate, efficient, and accessible diagnostic solutions for healthcare providers and patients.

Challenges:

• Stringent regulatory requirements for urinalysis device manufacturers pose challenges to market expansion.

Urinalysis device manufacturers face unique challenges in navigating the regulatory landscape, notably due to the need to adhere to increasingly rigorous requirements and updated regulations established by health authorities globally e.g. the U.S. FDA and the EMA. In the United States, urinalysis devices are categorized based on risk, with advanced automated analyzers often falling into Class II or III, necessitating rigorous pre-market reviews. This process requires significant investments in quality management systems, validation studies, and clinical trials that provide evidence for the establishment of safety and efficacy resulting in increased development costs and extended timelines. A well-known example of this is the European Union ́s new basis for In Vitro Diagnostics under the In Vitro Diagnostic Medical Devices Regulation (IVDR), which requires many SMEs to demonstrate their devices with high-quality and continuous post-market evidence, which also contributes to the burden of compliance. Moreover, with the advent of digital technologies in urinalysis devices, manufacturers have to consider data privacy and cyber security topics and act by directives protecting patients. As these frameworks are quite complex, they can be a heavy burden for smaller companies that have fewer resources available and can potentially inhibit innovation, and delay the availability of new diagnostic solutions in the market. Therefore, staying abreast of regulatory changes and engaging proactively with regulatory bodies are essential strategies for manufacturers aiming to navigate these challenges effectively.

Urinalysis Market Segmentation Analysis

By Product

In 2023, the consumables segment accounted for 77% of total revenue. The large share of this market is due to a number of reasons such as the frequency and volume of urinalysis tests being performed and the consumables being disposable. According to the National Health and Nutrition Examination Survey (NHANES) conducted by the CDC, urinalysis is one of the most common laboratory tests performed, with millions of tests conducted annually in the United States alone. The dominance of consumables is further supported by the increasing prevalence of chronic diseases that require regular monitoring. According to the CDC’s National Diabetes Statistics Report 2023, around 38.4 million Americans, or 11.6% of the population, currently have diabetes. Many patients require repeated urinalysis for their disease. Moreover, the surging geriatric population prone to urinary tract infections and renal diseases drives the demand for urinalysis consumables. The rise in the preventive healthcare agenda by the government has further fueled the growth of the consumables segment. As an example, the recommendations by the U.S. Preventive Services Task Force for regular screening in specific populations have led to increased use of urinalysis testing in primary care. The cost-effectiveness and ease of use of urinalysis consumables, such as dipsticks and reagent strips, make them the preferred choice for both healthcare providers and patients, further solidifying their market dominance.

By Test

The Biochemical Urinalysis segment held a significant revenue share in 2023. This dominance can be attributed to the comprehensive nature of biochemical urinalysis and its critical role in diagnosing and monitoring a wide range of health conditions. Biochemical urinalysis is vital in the early detection of signs of kidney disease, diabetes, and other metabolic disorders according to (NIDDK) the National Institute of Diabetes and Digestive and Kidney Diseases. The high incidence of these diseases highlights the employ of biochemical urinalysis. Over 1 in 7 U.S. adults is estimated to have a condition known as chronic kidney disease (CKD), according to the Centers for Disease Control and Prevention (CDC). According to the American Diabetes Association, in 2023, 37.3 million Americans or 11.3% of the population were living with diabetes. These numbers certainly reflect the extensive patient base in need of routine biochemical urinalysis for disease management and monitoring. Furthermore, the U.S. Preventive Services Task Force recommends screening for abnormal blood glucose as part of the cardiovascular review in adults aged 40 to 70 years who are overweight or obese. This recommendation has led to an increase in biochemical urinalysis in primary care. The ability of biochemical urinalysis to detect multiple parameters simultaneously, including glucose, protein, pH, and ketones, makes it a cost-effective and efficient diagnostic tool, contributing to its significant market share.

By Application

In 2023, the largest segment of the urinalysis market was the disease screening segment. Urinalysis because of its importance in the early detection and monitoring of disease plays a very pivotal role, and the prognosis is the biggest factor for this dominance. Urinalysis is an important tool used in screening for kidney disease, urinary tract infections, and diabetes, according to the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK). The high prevalence of this disease necessitates screening by urinalysis. According to the CDC, 37 million American adults have chronic kidney disease (CKD) many of whom are undiagnosed. Moreover, according to the American Urological Association, there are an estimated 150 million UTIs annually across the globe, with 8.1 million in this country. According to the CDC’s National Diabetes Statistics Report 2023, 38.4 million Americans have diabetes with 23% undiagnosed.

Disease screening has been promoted by government initiatives as well. Identifying chronic kidney disease (CKD) in asymptomatic adults has become a more common practice since the U.S. Preventive Services Task Force began recommending screening, leading to increased use of urinalysis in primary care. In addition, the discrepancy between the preventive nature of the KEEP Healthy program offering free kidney health screenings and the lifecycle of urinalysis-based disease screening has increased awareness of nephroprotection among healthcare providers and led to more demand for such tests.

By end use

The clinical Laboratories segment constituted the highest revenue share of 46% in 2023. The extensive market share is primarily due to the increased number of urinalysis tests performed in clinical laboratories, coupled with advanced technology capabilities. In 2023, the Centers for Medicare & Medicaid Services (CMS) reported there are around 260,000 laboratories in the United States with a Clinical Laboratory Improvement Amendments (CLIA) certificate thus, there is a robust network of clinical laboratories capable of performing urinalysis testing. This is even more powerful in the case of clinical laboratories where they can perform a massive amount of tests with a detailed diagnosis. Population-level health assessment is primarily dependent on clinical laboratories including urinalysis, conducted within the Center for Disease Control and Prevention's National Health and Nutrition Examination Survey (NHANES). Furthermore, the College of American Pathologists (CAP) estimates that billions of laboratory tests are performed in clinical laboratories each year, and urinalysis consistently ranks among the most common.

Government regulations and quality standards have also played a role in the growth of clinical laboratories as the primary providers of urinalysis testing. The Clinical Laboratory Improvement Amendments (CLIA) require rigorous standards for laboratory testing so that gives accurate results. This regulatory infrastructure has made clinical laboratory services increasingly reliable to healthcare providers and patients, thus pushing additional urinalysis tests to these laboratories.

Regional Insights

In 2023, the North American region held the largest share 38% of the urinalysis market. This growth is driven by, high healthcare expenditure, and increased incidence of diseases. According to the Centers for Medicare & Medicaid Services (CMS), U.S. healthcare spending reached $4.3 trillion in 2023, representing 18.3% of the GDP. This significant healthcare investment bolsters the implementation of advanced urinalysis technologies as well as routine screening initiatives. North America holds the largest market share due to the high prevalence of chronic diseases in the region. Some chronic diseases require urinalysis monitoring, and nearly 6 in 10 adults in the U.S. have a chronic disease, according to the CDC. Moreover, government initiatives, including one known as the National Kidney Disease Education Program (NKDEP) are focusing on raising awareness of kidney disease and screening-related issues, thus further bolstering the growth of the urinalysis market.

During the forecast period, the Asia-Pacific region is anticipated to register the highest CAGR.  Factors such as increasing healthcare awareness, improving healthcare infrastructure, and rising disposable incomes in countries such as China and India have driven this rapid growth. According to the World Health Organization (WHO), the prevalence of diabetes in the Western Pacific Region which covers many Asian countries is projected to increase by 27% by 2030, thereby leading to maximum demand for urinalysis. This robust growth in Asia-Pacific is supported by government initiatives to enhance healthcare accessibility. Such as China's Healthy China 2030 initiative seeks to achieve universal health coverage and improve chronic disease management, resulting in increasing demand for diagnostic tests including urinalysis. In India, the Ayushman Bharat scheme, launched to provide health insurance to 500 million citizens, is likely to boost healthcare utilization and diagnostic testing.

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Key Players in the Urinalysis Market

Key Service Providers/Manufacturers

• Abbott (Urisys 1100 Urine Analyzer, Multistix 10 SG Reagent Strips)

• F. Hoffmann-La Roche Ltd. (Urisys 1100 Urine Analyzer, Combur-Test Strips)

• Siemens Healthineers AG (CLINITEK Status+ Analyzer, Multistix 10 SG Reagent Strips)

• Sysmex Corporation (UF-5000 Automated Urine Particle Analyzer, UC-3500 Fully Automated Urine Chemistry Analyzer)

• ARKRAY, Inc. (AUTION MAX AX-4030 Urine Analyzer, AUTION Sticks)

• ACON Laboratories, Inc. (Mission U120 Urine Analyzer, Mission Urinalysis Reagent Strips)

• Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (H50 Urine Analyzer, Urine Reagent Strips)

• Quidel Corporation (Triage Micro Urine Analyzer, QuickVue Urinalysis Reagent Strips)

• Bio-Rad Laboratories, Inc. (D-10 Hemoglobin Testing System, Liquichek Urinalysis Control)

• Danaher Corporation (Beckman Coulter, Inc.) (Iris iQ200 Elite Urine Microscopy Analyzer, iChemVELOCITY Urine Chemistry Analyzer)

• 77 Elektronika Kft. (UriSed 3 Automated Urine Sediment Analyzer, LabUMat 2 Urine Chemistry Analyzer)

• Eiken Chemical Co., Ltd. (Uropaper III 'Eiken' Urine Test Strips, Uropaper III 'Eiken' Urine Analyzer)

• Scanadu (ScanaFlo Urinalysis Test Kit, ScanaFlu Saliva Test)

• Healthy.io (Dip.io Home Urinalysis Test Kit, Digital Wound Management Solution)

• Alere Inc. (now part of Abbott) (Alere iCup Drug Screen, Alere Triage TOX Drug Screen)

• Lupin Limited (LupiMitra Urine Collection Kit, Lupin Diagnostics Services)

• Vivoo (Vivoo Urine Test Strips, Vivoo App)

• Copan Diagnostics (UriSponge Urine Collection and Transport Device, ESwab Collection and Transport System)

• Alpha Laboratories Ltd. (Urine Monovette Collection System, UriSystem Urine Analysis Containers)

• Clinical Design Technologies Ltd. (Digital Closed Urine Testing System, Urine Testing System)

Recent Developments in the Urinalysis Market

• In January 2024, Vivoo launched an at-home digital UTI test that provides results in two minutes via a smartphone app, enhancing accessibility to urinalysis testing.

• In December 2023, Siemens Healthineers AG introduced the Atellica UAS 60 Analyzer, a compact solution for urine sediment analysis that uses neural network-based post-processing to identify sediment particles, advancing the field of automated urinalysis.

Urinalysis Market Report Scope