Urinalysis Market Size, Share & Trends Analysis Report By Product (Instruments, Consumables), By Application (Disease Screening, Pregnancy & Fertility Testing), By End-use (Hospitals, Home Care), By Region- Global Industry Analysis, Share, Growth, Regional Outlook and Forecasts, 2024-2033

The global urinalysis market size was exhibited at USD 3.14 billion in 2023 and is projected to hit around USD 5.07 billion by 2033, growing at a CAGR of 4.9% during the forecast period 2024 to 2033.

Key Takeaways:

• North America dominated the market and accounted for the largest revenue share of 40.0% in 2023.
• The consumables segment held the dominant market share of 80.0% in terms of revenue in 2023.
• The urinary tract infection screening segment dominated the market and accounted for a revenue share of 25.06% in 2023, due to the rising incidence of UTIs worldwide.
• The clinical laboratories segment accounted for the highest revenue share of around 46.15% in 2023.

Urinalysis Market Report Scope

The market is witnessing growth due to factors including the rising incidence of diseases such as Urinary Tract Infections (UTIs), diabetes, and kidney diseases. For instance, according to the National Diabetes Statistics Report, 2020, around 34.1 million adults aged 18 years and above had diabetes in the U.S. About one-third of diabetic people have kidney-related comorbidities due to high blood sugar and blood pressure. Urinalysis is an informative and noninvasive diagnostic tool accessible to clinicians to diagnose kidney diseases. Hence, the rising prevalence of kidney ailments is anticipated to increase demand for products used in urinalysis, thereby driving market growth.

During the initial phase of the COVID-19 pandemic, the market for urinalysis was moderately impacted due to low hospitalization rates and declining sales of urine analysis tests. Nationwide lockdowns imposed by governments to control the spread of infection restricted people’s access to diagnostic and hospital services leading to low demand for diagnostics products. However, a resurgence in testing numbers is seen as countries eased restrictions on movement.

The growing importance of urinalysis for detecting post-COVID-19 diseases, such as acute kidney & tubular injuries, is anticipated to drive market growth. According to a study published by the Columbia University in 2021, kidney injury marker-1 (KIM-1) and urinary NGAL were two sensitive biomarkers for detecting tubular and kidney injury patients.

Developing countries such as South Korea, Brazil, India, and Mexico are expected to offer potential growth opportunities for key players in the market for urinalysis. This can be attributed to the increasing burden of chronic diseases, improved healthcare infrastructure, a large patient base, and increased disposable income in these economies. For instance, the healthcare expenditure in India increased from USD 232.73 million in 2020 to USD 507.97 million in 2021.

Furthermore, screening programs are undertaken by governments for the early detection of diseases such as urinary and renal disorders. For instance, around 12,497 students of primary and secondary schools from Pingyang, Cangnan, and Yongjia in Wenzhou, China, were screened for urinalysis under school urinary analysis programs for a decade ending March 2021. Urine abnormalities were observed in primary school students and secondary school students with a detection rate of 36% and 95% respectively. The rising number of such programs is expected to drive the demand for urinalysis tests.

Increased investments in developing home-based urine testing kits for disease diagnosis contributes to segment growth. For instance, in November 2021, Vivoo raised funding of USD 6 million to develop at-home urine tests to provide lifestyle and nutrition guidance. Developing countries are price-sensitive and prefer inexpensive and equally functional analyzers for routine urinalysis tests. Hence, developing low-cost urinalysis tests is expected to fuel market growth. In 2023, Maple Syrup Urine Disease Fund raised over USD 1 million through their ‘Million Dollar Bike Ride’ initiative to support research for improved treatments and potential cures for maple syrup urine disease (MSUD).

Segments Insights:

Product Insights

The consumables segment held the dominant market share of 80.0% in terms of revenue in 2023. This dominance can be attributed to the increasing demand and frequent purchases of reagents and dipsticks by clinical and hospital laboratories. Dipsticks are the most common type of consumable in urinalysis, accounting for the largest share of the market. Reagents measure the levels of specific substances in the urine. The development of new and innovative consumables, such as rapid test kits and point-of-care testing devices, makes urinalysis more accessible and convenient, which drives demand.

Many major providers, such as Siemens Healthcare GmBH, Abbott, and Roche, provide high-quality consumables for urinalysis testing, which is expected to boost segment growth. For instance, Siemens Healthineers GmBH offers Multistix 10 SG Reagent Strips to diagnose UTI, diabetes, and kidney diseases. In September 2023, Sysmex Corp. announced the launch of its UF-1500 Fully Automated Urine Particle Analyzer that helps in urine sediment testing. The National Kidney Foundation raised over USD 600 million in 2023 to fund research, offer patient care, and advocate for people with kidney disease.

The instruments segment is expected to advance at the fastest CAGR of 5.1% over the forecast period owing to the rising approval rate and the launch of new instruments for urinalysis. For instance, in January 2019, Bio-Rad Laboratories, Inc. launched qUAntify Advance Control to monitor the precision urinalysis test procedure in clinical labs. This instrument increased the effectiveness of the laboratory’s statistical process control and product demand in the coming years. In 2023, Olive Diagnostics launched Olive KG, an AI device to analyze urine samples rapidly. Also, Alere came up with a rapid test kit named UrineSTAT which can detect various urinary tract infections in minutes.

Application Insights

The urinary tract infection screening segment dominated the market and accounted for a revenue share of 25.06% in 2023, due to the rising incidence of UTIs worldwide. According to the National Center for Biotechnology Information (NCBI), around 150 million people suffer from urinary tract infections each year worldwide.

On the other hand, the diabetes screening segment is expected to expand at the fastest CAGR of 7.3% during the forecast period. Urinalysis is an important screening test to find out about diabetes. According to the CDC, in 2023, around 37.3 million people in the U.S. will be affected by diabetes. Of these, about 28.7 million people are diagnosed, and 8.5 million are undiagnosed. Thus, the steadily increasing number of patients with diabetes acts as a major market driver.

Obesity is the leading risk factor for type 2 diabetes. The prevalence of obesity has been increasing in recent decades, and this is one of the main reasons why diabetes incidences have also been rising. As per IDF Diabetes Atlas (2021), around 10.5% of adults aged 20 to 79 years have diabetes, and almost half of them are unaware of their condition.

IDF projections indicate that by 2045, around 783 million adults, or 1 in 8, will be living with diabetes, representing a 46% increase. Type 2 diabetes is the most prevalent form, affecting over 90% of diabetic people. Various factors, including socioeconomic status, demographics, environment, and genetics, influence this type of diabetes.

End-use Insights

The clinical laboratories segment accounted for the highest revenue share of around 46.15% in 2023. This can be attributed to their easy accessibility to patients and the availability of advanced products in these laboratories. For instance, in the U.S., more than 20,000 clinical laboratories perform clinical tests, including urinalysis. New test methods have been used to improve the detection of kidney diseases, such as proteomics, genetic testing, microarrays, biomarkers, etc.

The home care segment is estimated to expand at the fastest CAGR of 5.8% over the forecast period due to the increasing launch of home-based UTI test kits. The increasing demand for convenience & privacy and the low cost of home urinalysis tests, compared to clinical tests, are driving segment growth. For instance, in August 2020, TestCard launched its non-invasive at-home UTI test kit in the UK. Users can access testing results through the accompanying mobile app and share information with a healthcare professional. This test kit is available at retail pharmacies at a cost of USD 12.06.

Several innovative home UTI kits and services have been introduced in 2023 from companies such as TestCard and Scanwell Health, including smartphone-based UTI tests that use a disposable strip, as well as by ‘myLAB Box’, which is a home testing service that offers a variety of tests, including UTI testing. Additionally, Uqora’s UTI Emergency Kit is a notable home UTI test and treatment kit.

Regional Insights

North America dominated the market and accounted for the largest revenue share of 40.0% in 2023. This dominance can be attributed to strategic initiatives undertaken by key players, such as licensing agreements, to expand their business footprint. For instance, in August 2020, Sysmex and Siemens Healthcare GmbH signed an exclusive licensing agreement to distribute and service the latter’s automated urine analyzer CLINITEK Novus to hospitals and reference laboratories in North America. Such agreements have had a positive impact on market growth.

According to a study by the National Center for Biotechnology Information (NCBI) in November 2021, it is estimated that approximately 40% of women in the U.S. are likely to develop a UTI during their lifetime due to high prevalence of uncomplicated urinary tract infections. Moreover, as per a report published by the National Kidney Foundation in 2021, chronic diseases are the main reason for deaths as opposed to prostate and breast cancer. Approximately 37.0 million people (around 15% of the adult population) in the U.S. is mainly affected by CKD. Thus, the increasing need for appropriate treatment of chronic diseases is driving the growth of the urinalysis market in the region.

On the other hand, the Asia Pacific region is estimated to be the fastest-growing region at a CAGR of 5.7% over the forecast period. The presence of domestic urine analyzer manufacturers, such as VSI Electronics Pvt. Ltd. and Medical Equipment India, as well as the increasing adoption of advanced urine analysis services and a large patient base with unmet clinical needs are some of the major factors boosting regional market growth.

Some of the prominent players in the Urinalysis market include:

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

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global urinalysis market.

Product

• Instrument

• • Biochemical urine analyzers

• • • Automated biochemical analyzers
    • Semi-automated biochemical analyzers

• • Automated urine sediment analyzers

• • • Microscopic urine analyzers
    • Flow-cytometric urine analyzers

• • Point-of-care urine analyzers

• Consumables

• • Dipsticks
  • Reagents
  • Disposables
  • Pregnancy and fertility kits

Application

• Disease Screening

• • UTIs
  • Diabetes
  • Kidney disease
  • Hypertension
  • Liver disease
  • Others

• Pregnancy and Fertility Testing

End-use

• Hospitals
• Clinical Laboratories
• Home Care
• Research and Academics
• Others

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)