URINALYSIS MARKET ANALYSIS

The global urinalysis market was valued at US$ 1,609.8 Mn in 2022 and is forecast to reach a value of US$ 2,669.2 Mn by 2030 at a CAGR of 6.5% between 2023 and 2030. The global urinalysis market is experiencing strong growth owing to the increasing prevalence of chronic kidney disease and growing geriatric population across the globe. Moreover, increasing prevalence of urinary tract infections and increasing demand for urinalysis products and services is expected to boost growth of the market. However, factors such as stringent regulatory framework and high cost of research and development are expected to hamper growth of the global urinalysis market.

Global Urinalysis Market: Regional Insights

Based on region, the global urinalysis market is segmented into North America, Latin America, Europe, Asia Pacific, Middle East, and Africa.

Among regions, North America is expected to gain highest share in the market during the forecast period due to the increasing prevalence of chronic kidney disease, Urinary Tract Infections (UTIs), diabetes, growing geriatric population, and increasing awareness among people in the region. For instance, chronic kidney diseases can be diagnosed with blood and urine tests, such as urinalysis. According to the US Centers for Disease Control and Prevention (CDC), 1 in 7 people in the U.S., about 35.5 million adults, are estimated to have CKD in 2023. Moreover, 9 in 10 adults with CKD do not know they have it and 1 in 3 adults with severe CKD do not know they have CKD.

Europe and Asia Pacific are also expected to witness robust growth in the global urinalysis market due to the rise in burden of chronic disease, such as chronic kidney diseases and diabetes, growing geriatric population, and growing preference for point of care testing in these regions. For instance, to identify the glucose level in diabetic people, urine analysis has proven to be an important test. According to the World Health Organization (WHO), an estimated 77 million people above age of 18 years in India are suffering from diabetes (Type 2) and nearly 25 million are pre-diabetics (at a higher risk of developing diabetes in near future).

Figure 1. Global Urinalysis Market Share (%), By Region, 2023

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Global Urinalysis Market Drivers:

Rising prevalence of chronic kidney diseases to propel market growth

One of the key factors expected to augment the growth of the global urinalysis market during the forecast period is the growing prevalence of chronic kidney diseases (CKD) around the world. For instance, early detection of kidney dysfunction is crucial for effective management and to prevent the progression of renal disorders; creating a significant demand for urinalysis tests. According to the European Kidney Health Alliance (EKHA), over 75 million people suffer from CKD in Europe whilst the worldwide frequency has been estimated to 700 to 800 million people, with a projection that CKD will become the 5th cause of death globally in 2040.

Growing geriatric population to underpin market growth

Another factor which is driving the growth of the global urinalysis market is the growing geriatric (aging) population around the world. For instance, kidney disease has also been found to be more prevalent in those over the age of 60 when compared to the rest of the general population. This in turn has increased the demand for urinalysis tests as part of routine health check-ups. According to the World Health Organization (WHO), by 2030, one in six people in the world will be aged 60 years or over, and by 2050, the world’s population of people aged 60 years and older will double (2.1 billion). This in turn is expected to propel the market growth.

Global Urinalysis Market Opportunities:

Increasing prevalence of Urinary Tract Infections (UTIs) is expected to provide significant growth opportunities for players in the urinalysis market. For instance, UTIs are a common health concern, especially among women and the elderly, which in turn increase the demand for urinalysis products and services, as urinalysis plays a vital role in diagnosing and monitoring UTIs. According to the National Institutes of Health (NIH), UTIs are one of the most frequent clinical bacterial infections in women, accounting for nearly 25% of all infections. Over 50-60% of women will develop UTIs in their lifetimes. This in turn is expected to augment the market growth.

High demand for urinalysis products or services is expected to offer lucrative growth opportunities for players in the global urinalysis market. For instance, with the increasing prevalence of chronic diseases, such as CKD, the use and demand for urinalysis products and services is also increasing rapidly. In September 2022, Sysmex Corp. launched the UF-1500 Fully Automated Urine Particle Analyzer (UF-1500), a new product for use in urine sediment testing, to deliver a range of solutions tailored to the customer’s environment and contribute to the streamlining and standardization of urine testing at small and medium-sized facilities.

Global Urinalysis Market Trends:

Rising use of point of care testing is a recent trend

Point-of-care (POC) testing is a medical term used to describe diagnostic testing that is performed in the patient's unit rather than in the hospital's central lab or outside a reference lab. Point-of-care tests can be a vital tool to help patients and their babies across reproductive and fertility medicine. In April 2022, Mankind Pharma announced the launch of the rapid-testing pregnancy device that is used for urinalysis to confirm pregnancy. It is a single-step pregnancy test device that does not require the collection of urine in a dropper or a container, making it the easiest and most convenient method to test pregnancy at home.

Technological advancements is another trend

Continuous technological advancements in urinalysis equipment and point-of-care testing devices have improved accuracy, speed, and ease of use, promoting the adoption of urinalysis tests across various healthcare settings worldwide. New technological advancements have also paved the way for significant progress in automated urinalysis. Each system uses a different technology to classify and quantify urine sediment particles and offers an improvement in standardization over manual microscopy by eliminating potential inter-technician variability during slide interpretation. This in turn is also expected to augment the growth of the market.

Global Urinalysis Market Restraints:

Stringent rules/regulations to hinder market growth

Another factor which is hampering the growth of the global urinalysis market is the stringent rules and regulations or stringent regulatory framework. In the U.S., diagnostic tests (such as urinalysis) are regulated by the Food & Drug Administration (FDA), which means manufacturers must submit studies confirming a test’s accuracy and effectiveness in diagnosing a particular condition before bringing it to market. Moreover, a process required for a new commercial test to gain approval for marketing can be costly and time-consuming, and may sometimes take up to years, depending on the level of complication. Although FDA has a well-developed and structured framework, rules and regulations are essential and must be strictly followed.

High cost of R&D to hamper growth of the market 

One of the key factors expected to hamper growth of the global urinalysis market is the high cost of R&D (research and development). Development expenses driven by continuous improvements and automation in urinalysis may hamper the adoption of advanced urinalysis devices or solutions. Technological advances have paved the way for significant advances in automated urinals, leading to increased R&D expenditure. Moreover, the initial investment required for advanced urinalysis systems can be significant, especially for smaller healthcare facilities, limiting their adoption. This in turn is exported to restrain growth of the market.

Figure 2. Global Urinalysis Market Share (%), By Product Type, 2023

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Global Urinalysis Market Segmentation:

The global urinalysis market report is segmented into Product Type, Test Type, Application, and Geography.

Based on Product Type, the urinalysis market is segmented into Instruments and Consumables. Out of which, Instruments Segment is expected to dominate the global urinalysis market during the forecast period and this is attributed to the high demand for novel and technologically advanced urinalysis devices and solutions across the globe.

Consumables Segment is also expected to witness significant growth during the forecast period and this is owing to increasing demand and frequent purchases of reagents and dipsticks by clinical and hospital laboratories worldwide.

Based on Test Type, the market is segmented into Biochemical, Pregnancy and Fertility, and Sediment. Out of which, Biochemical Segment is expected to dominate the market over the forecast period and this is attributed to the increasing prevalence of chronic disease, such as chronic kidney disease (CKD) and diabetes across the world.

Pregnancy and Fertility Segment is also expected to witness significant growth in the near future and this is owing to increasing prevalence of infertility and rise in first pregnancy age.

Based on Application, the market is segmented into Disease Screening and Pregnancy and Fertility. Out of which, Disease Screening Segment is expected to dominate the market over the forecast period and this is attributed to the rising focus on disease diagnosis.

Pregnancy and Fertility Segment is also expected to witness significant growth in the near future and this is owing to increasing prevalence of infertility.

Global Urinalysis Market: Key Developments

In July 2022, Arkray announced the launch of AUTION AI-4510, an innovative automated urine sediment analyzer with built-in capabilities to speed up operations and with on-board auto dilution that eliminates waste and ensures greater accuracy. 

In June 2022, Mylab Discovery Solutions launched PregaScreen, an at-home pregnancy test kit that allows women to detect their pregnancy status themselves. With the launch of this test kit, the company marks its foray into the female healthcare segment.

In October 2021, Inpeco and Sysmex Europe launched the next game-changer in urinalysis. The collaboration between Sysmex and Inpeco takes advantage of the Sysmex’s UN-Series urinalysis solutions and Inpeco’s FlexLab TM track, together making the next step towards a fully automated urinalysis workflow solution of the highest level.

In September 2021, Beckman Coulter launched a urinalysis analyzer, DxU Iris Workcell, a fully automated system that streamlines urinalysis workflow and reduces manual reviews to 4%.

Global Urinalysis Market: Key Companies Insights

The global urinalysis market is highly competitive. This is attributed to the rise in burden of CKD (chronic kidney disease) and growing geriatric population, as a result, players in the market are focusing on launching novel products in the market.

Some of the key players in the global urinalysis market are Arkray Inc., Abbott Laboratories, Eiken Chemical Co. Ltd., Sysmex Corporation, Siemens Healthineers AG, Cardinal Health Inc., Acon Laboratories Inc., Bio-Rad Laboratories Inc., F. Hoffmann-La Roche Ltd., Becton, Dickinson and Company, and Danaher Corporation (Beckman Coulter Inc.), among others.

*Definition: Urinalysis is a panel of medical tests that includes physical examination of the urine, chemical evaluation, and microscopic examination. It is often done to check for a kidney problems, urinary tract infections, and/or diabetes.