PUBLISHER: TechSci Research | PRODUCT CODE: 1770863
PUBLISHER: TechSci Research | PRODUCT CODE: 1770863
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The Global Urinalysis Market was valued at USD 4.39 billion in 2024 and is projected to reach USD 6.84 billion by 2030, growing at a CAGR of 7.67%. This growth is largely driven by the increasing prevalence of chronic diseases such as diabetes and kidney disorders. Urinalysis is a diagnostic method that examines the physical, chemical, and microscopic properties of urine to detect and monitor a range of health conditions, including urinary tract infections, kidney disease, and diabetes. As a non-invasive and informative testing approach, urinalysis is gaining prominence in early diagnosis and disease management. Additionally, rising public awareness about urinary and kidney health, combined with increased government support and healthcare investment, is enhancing accessibility and fueling demand across both developed and developing markets.
Market Overview | |
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Forecast Period | 2026-2030 |
Market Size 2024 | USD 4.39 Billion |
Market Size 2030 | USD 6.84 Billion |
CAGR 2025-2030 | 7.67% |
Fastest Growing Segment | Instruments |
Largest Market | North America |
Key Market Drivers
Rising Prevalence of Chronic Diseases
The global rise in chronic conditions-particularly diabetes and chronic kidney disease (CKD)-is a major factor accelerating the growth of the urinalysis market. Urinalysis is a non-invasive, affordable diagnostic tool that plays a critical role in early detection, ongoing monitoring, and treatment planning for these diseases.
According to the World Health Organization (WHO), the global population aged 60 and above is expected to reach 2.1 billion by 2050, significantly increasing the incidence of age-related illnesses such as diabetes and CKD. The International Diabetes Federation noted that 537 million adults were living with diabetes in 2021, with projections indicating this figure will rise to 643 million by 2030. Urinalysis enables detection of biomarkers like glucose, ketones, and protein in urine, making it essential for effective management and timely intervention.
Key Market Challenges
Regulatory Compliance and Quality Control
The urinalysis market faces significant regulatory and quality assurance challenges. Manufacturers must meet stringent requirements imposed by bodies such as the FDA and EMA, which involve comprehensive product testing, documentation, and adherence to Good Manufacturing Practices (GMP). These compliance processes can be time-consuming and financially demanding.
Ensuring consistency in product performance across production batches is crucial, as any variation can compromise diagnostic accuracy. This necessitates rigorous quality control mechanisms and ongoing surveillance. For example, under the FDA's Medical Device Reporting (MDR) regulation, manufacturers are required to report device-related adverse events, ensuring constant monitoring and safety validation. These high standards increase the operational burden, potentially limiting market entry for smaller players and slowing innovation due to the associated costs and complexities.
Key Market Trends
Shift Towards Point-of-Care Testing
A major trend in the urinalysis market is the transition toward point-of-care testing (POCT), driven by the need for rapid diagnostics and decentralized healthcare services. POCT enables immediate testing and results interpretation at the site of care, which enhances clinical responsiveness and patient outcomes.
Urinalysis has emerged as a key area within POCT, thanks to the development of portable, easy-to-use devices that can be deployed in clinics, emergency rooms, and even at home. These devices offer fast analysis of urine parameters like glucose, protein, and leukocytes, facilitating prompt diagnosis and treatment.
Government support has further strengthened this trend. For instance, the Centers for Medicare & Medicaid Services (CMS) in the U.S. have introduced reimbursement policies that encourage POCT use in primary care. During health crises such as the COVID-19 pandemic, regulatory bodies also accelerated the approval of POCT devices to expand diagnostic capacity, underscoring the growing role of POCT in the future of healthcare.
In this report, the Global Urinalysis Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies presents in the Global Urinalysis Market.
Global Urinalysis Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: