United States Kidney Function Test Market, By Type (Urine Tests and Blood Tests), By Component (Dipsticks, Reagents, Kits & Assays, Others), By End User (Hospitals & Clinics, Diagnostic Laboratories, Others), By Region, Competition Forecast & Opportunities, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 378.48 Million
CAGR (2026-2031)	5.58%
Fastest Growing Segment	Dipsticks
Largest Market	Midwest
Market Size (2031)	USD 524.24 Million

Market Overview

The United States Kidney Function Test Market will grow from USD 378.48 Million in 2025 to USD 524.24 Million by 2031 at a 5.58% CAGR. Kidney function tests are diagnostic assessments utilized to evaluate the efficacy of the kidneys in filtering waste products from the blood, typically involving the analysis of blood and urine samples to determine glomerular filtration rates. The primary drivers fueling market expansion include the escalating prevalence of chronic conditions such as diabetes and hypertension which are leading causes of renal impairment. Additionally, the steadily aging demographic in the United States necessitates frequent monitoring of renal health and generates sustained demand for these diagnostic procedures.

The market faces a significant impediment regarding the underdiagnosis of early-stage renal conditions due to their asymptomatic nature which often delays testing until the disease has advanced significantly. This lack of early symptom presentation limits the addressable patient pool within the preventative care segment. According to the American Kidney Fund, in 2025, an estimated 35.5 million Americans were living with kidney disease with a vast majority remaining unaware of their condition. This gap in early detection presents a substantial challenge to market penetration as the target population often fails to engage with the healthcare system for timely diagnosis.

Key Market Drivers

The rising prevalence of chronic kidney disease (CKD), particularly among high-risk demographic groups, acts as the primary catalyst for the kidney function test market. As the burden of diabetes and hypertension intensifies, the demand for frequent renal profiling has surged to mitigate progression to end-stage renal disease (ESRD). This urgency is underscored by disparities in disease burden; according to the Centers for Disease Control and Prevention, May 2024, in the 'Chronic Kidney Disease in the United States, 2024' report, CKD is significantly more common in non-Hispanic Black adults, affecting 20% of this population compared to other racial groups. This prevalence directly correlates with soaring healthcare costs, creating a financial imperative for early detection. Emphasizing this economic weight, according to the National Institute of Diabetes and Digestive and Kidney Diseases, October 2024, in the '2024 USRDS Annual Data Report', total Medicare fee-for-service spending for beneficiaries with CKD and ESRD exceeded $120 billion, highlighting the critical need for diagnostic interventions to manage these expenditures.

Simultaneously, favorable reimbursement policies for novel diagnostic assays are removing barriers to entry and accelerating the adoption of advanced prognostic solutions. The establishment of specific coverage codes and sustainable pricing structures incentivizes laboratories and healthcare providers to integrate next-generation testing into routine clinical practice. A pivotal development occurred when federal payers finalized coverage for AI-enabled prognostic testing, which validates the clinical utility of advanced biomarkers. For instance, according to Renalytix, June 2024, in the 'Medicare Issues Final Coverage Determination' press release, the Centers for Medicare & Medicaid Services established a price of $950 per test for the company’s FDA-authorized prognostic assay. This distinct reimbursement mechanism ensures financial viability for providers and directly fuels market penetration by encouraging the uptake of innovative diagnostic technologies over traditional methods.

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Key Market Challenges

The asymptomatic nature of early-stage renal conditions constitutes a formidable barrier to the growth of the United States Kidney Function Test Market. Because the initial phases of renal decline rarely present physical symptoms, a vast segment of the at-risk population does not proactively engage with healthcare providers. This absence of clinical indicators prevents the initiation of routine diagnostic protocols, effectively keeping millions of potential patients out of the preventative screening funnel. Consequently, the market remains heavily reliant on monitoring patients with advanced, known pathologies, rather than capturing the high-volume revenue associated with early detection and broad-scale preventative testing.

This disconnect significantly limits the industry's ability to penetrate its primary target demographic. According to the National Institute of Diabetes and Digestive and Kidney Diseases, in 2024, approximately one in three adults with diabetes and one in five adults with high blood pressure were estimated to have kidney disease. Despite the high prevalence of renal impairment within these chronic condition groups, the lack of symptoms means these individuals often remain untested. This gap directly hampers market expansion by reducing the frequency of test orders in the segment where they are most critically needed.

Key Market Trends

The emergence of smartphone-enabled digital urinalysis solutions is revolutionizing the testing landscape by decentralizing diagnostics and directly addressing the adherence gap in at-risk populations. By leveraging computer vision and colorimetric analysis, these platforms allow patients to conduct clinical-grade albumin-to-creatinine ratio (uACR) tests from their homes, effectively bypassing the logistical barriers associated with traditional laboratory visits. This technology is particularly impactful for closing the screening gap among diabetic and hypertensive patients who frequently miss routine checks. According to Healthy.io, June 2025, in the 'Healthy.io, Geisinger and Boehringer Ingelheim Study Reveals Significant Increase in Albuminuria Identification' press release, the implementation of this smartphone-based screening model resulted in a 53.1% test completion rate among previously untested patients, representing a 2.5-fold increase compared to the standard of care.

Simultaneously, the market is witnessing a robust expansion of point-of-care diagnostic capabilities within retail clinics, transforming community pharmacies into primary hubs for renal health monitoring. Major retail health chains are integrating comprehensive kidney function screenings into their service portfolios, capitalizing on their extensive footprint to offer immediate access to testing services outside of hospital settings. This shift not only alleviates the burden on specialized nephrology centers but also facilitates earlier intervention through convenient, walk-in access for preventative profiling. According to CVS Health, October 2025, in the '2025 Rx Report: Community Pharmacy Reimagined' press release, the company is aggressively scaling this community-centric model by opening nearly 100 new community locations in a single year to enhance local access to pharmacy-led healthcare services.

Segmental Insights

The Dipsticks segment is currently recognized as the fastest-growing category within the United States Kidney Function Test Market, primarily driven by the increasing demand for cost-effective and rapid diagnostic solutions. This expansion is heavily influenced by the rising prevalence of chronic conditions, such as diabetes and hypertension, which necessitate frequent and convenient monitoring of renal health. Furthermore, the availability of CLIA-waived dipstick tests has significantly broadened their accessibility, allowing for widespread adoption in physician offices and point-of-care settings. This regulatory clearance facilitates decentralized testing, reducing reliance on traditional hospital laboratories and enabling earlier disease management.

Regional Insights

The Midwest stands as the leading region in the United States Kidney Function Test Market, driven by a robust healthcare infrastructure and the presence of prominent diagnostic manufacturers. Industry giants like Abbott Laboratories, headquartered in Illinois, anchor the region’s market strength through continuous innovation in renal diagnostics. Furthermore, the concentration of world-class medical institutions, including the Mayo Clinic, fosters a high volume of reference laboratory testing. According to the Centers for Disease Control and Prevention, the rising incidence of lifestyle-associated conditions such as diabetes in Midwest states significantly propels the demand for regular kidney function screenings.

Recent Developments

• In August 2025, Quest Diagnostics completed the acquisition of select renal-specific laboratory testing assets from a major dialysis service provider. This strategic transaction positioned the company to deliver comprehensive laboratory services to independent dialysis clinics and expanded its testing capabilities for patients with end-stage renal disease. The integration of these assets was intended to enhance the delivery of diagnostic insights for chronic kidney disease management and optimize turnaround times for critical renal function tests across the country.
• In September 2024, Healthy.io, in collaboration with Geisinger and Boehringer Ingelheim, released research results from a study evaluating a smartphone-enabled home urine albumin-to-creatinine ratio test. The findings, presented at a scientific session, demonstrated that the digital testing method significantly increased adherence rates for chronic kidney disease screening among at-risk individuals compared to standard clinical approaches. This breakthrough highlighted the potential of using smartphone technology to close gaps in care and improve early detection of renal dysfunction in the United States.
• In May 2024, Nova Biomedical announced that it had received 510(k) clearance from the U.S. Food and Drug Administration for a micro capillary sample mode on its critical care analyzer. This regulatory approval enabled the device to perform a comprehensive profile of tests, including creatinine and estimated glomerular filtration rate, using a very small volume of capillary blood. The enhancement was developed to support blood conservation and improve the efficiency of kidney function screening at the point of care in hospital settings.
• In February 2024, Simple HealthKit launched a new renal evaluation test aimed at improving the diagnosis of chronic kidney disease in the United States. This diagnostic solution was designed to be accessible for both clinical and at-home settings, facilitating broader availability of preventive screening for patients with diabetes and other risk factors. The launch addressed the need for convenient and early detection tools in the market, allowing healthcare providers and patients to monitor kidney health more effectively and manage potential renal complications.

Key Market Players

• Abbott Laboratories
• Roche Diagnostics
• Siemens Healthineers
• Bio-Rad Laboratories
• Beckman Coulter
• Thermo Fisher Scientific
• Quest Diagnostics Incorporated
• Laboratory Corporation of America Holdings
• Nipro Medical Corporation
• Ortho Clinical Diagnostics

By Type	By Component	By End User	By Region
Urine Tests Blood Tests	Dipsticks Reagents Kits & Assays Others	Hospitals & Clinics Diagnostic Laboratories Others	Northeast Midwest South West

Report Scope:

In this report, the United States Kidney Function Test Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• United States Kidney Function Test Market, By Type:

• Urine Tests
• Blood Tests

• United States Kidney Function Test Market, By Component:

• Dipsticks
• Reagents
• Kits & Assays
• Others

• United States Kidney Function Test Market, By End User:

• Hospitals & Clinics
• Diagnostic Laboratories
• Others

• United States Kidney Function Test Market, By Region:

• Northeast
• Midwest
• South
• West