U.S. Renal Biomarkers Market (2025 - 2033)

U.S. Renal Biomarkers Market Summary

The U.S. renal biomarkers market size was estimated at USD 592.95 million in 2024 and is projected to reach USD 1,207.75 million by 2033, growing at a CAGR of 8.4% from 2025 to 2033. The rising prevalence of kidney disease, particularly chronic kidney disease (CKD) and acute kidney injury (AKI) along with the urgent clinical need for earlier and more nuanced detection beyond conventional measures. CKD often remains asymptomatic until advanced stages, and biomarkers that can reveal subclinical pathology or early injury are of growing interest. In the U.S., an estimated 35.5 million adults have chronic kidney disease (CKD), and a significant number are unaware of their condition. Globally, CKD affects around 850 million people, which is approximately 9% of the adult population. A 2024 study projects that by 2032, nearly 125 million people across eight major countries will have advanced CKD, a 25% increase since 2022.

Approximately one-third of people 65 and older have chronic kidney disease (CKD), compared to about 12% of people 45 to 64 and only 6% of adults 18 to 44, according to data released by the CDC in 2024. The prevalence is slightly higher in women (14%), than in men (12%). Significant racial and ethnic disparities also exist: the highest prevalence is found among non-Hispanic Black adults (20%), followed by non-Hispanic Asian and Hispanic adults (14% each), and non-Hispanic White adults (12%). The data highlights the critical need for enhanced screening programs and early intervention strategies.

The U.S. renal biomarkers market is growing due to the rising prevalence of CKD and increasing number of the laboratory automation, clear FDA pathways, and insurer willingness to reimburse novel tests that meet evidentiary thresholds. Test ordering frequency has increased, and protocols have been updated as a result of Medicare's Merit-based Incentive Payment System, which ties nephrology practice scores to annual albuminuria rates. The market is expanding as a result of the active development and commercialization of renal biomarker assays by major players such as Abbott Laboratories and bioMérieux SA. Recently, in August 2025, BioPorto and Roche Diagnostics collaboration: The ProNephro AKI test (based on NGAL biomarker) has become commercially available to U.S. labs via Roche’s cobas c 501 analyzers. NGAL is a protein that indicates kidney cell damage and can detect injury earlier than standard tests such as serum creatinine. The test is cleared for pediatric use (ages 3 months to 21 years), helps identify moderate-to-severe acute kidney injury (AKI) within 48-72 hours, enabling earlier interventions.

Moreover, as per CDC data published in May 2024, CDC estimating that more than 1 in 7 adults-around 35.5 million people, or 14% of the adult population are affected in U.S. Alarmingly, CKD often goes undiagnosed: as many as 9 in 10 adults with CKD are unaware of their condition, and even among those with severe CKD, approximately one in three remain undiagnosed.

The table below highlights the prevalence of diabetes in the age group of 20 to 79 years:

Table 1 Kidney Disease Statistics - United States (NIDDK)

Source: NIDDK.NIH., Grand View Research

The NIDDK statistics highlight a significant and growing burden of kidney disease in the United States, underlining the critical role of diagnostics in improving outcomes. With 14% of U.S. adults living with CKD-many of them unaware of their condition until it reaches advanced stages-there is a clear unmet need for early, reliable, and accessible testing solutions. Biomarker-based diagnostics can bridge this gap by identifying CKD and AKI earlier than traditional creatinine or eGFR measurements, allowing for timely interventions.

From a healthcare economics perspective, the USD 77 billion Medicare spending on CKD (excluding ESKD) and the USD 52.3 billion spent on kidney failure underscore the financial burden of late detection and treatment. Diagnostics companies have an opportunity to position renal biomarker assays as cost-saving tools that can reduce hospitalizations, delay progression to dialysis, and improve transplant readiness.

Market Concentration & Characteristics

The U.S. renal biomarkers market is characterized by growth in innovation, especially in the areas of molecular diagnostics and real‐time monitoring. For instance, in June 2025, iMDx released head‐to‐head clinical data showing its digital PCR test for donor-derived cell-free DNA (dd-cfDNA) delivers essentially the same diagnostic information as next-generation sequencing in kidney transplant patients, but with improved sensitivity in low-volume samples. Such advances push the boundaries beyond traditional markers, such as creatinine and albuminuria, toward more precise tools that catch disease earlier or stratify patient risk more sharply. Another innovation underway is the FDA’s acceptance of a biomarker qualification plan for a urine biomarker panel to be used in early-phase drug trials to detect drug-induced kidney injury.

Mergers and acquisitions in the market are driven by the need to consolidate technology portfolios and expand regional reach, a notable example: Quest Diagnostics’ 2025 agreement to acquire select assets from Fresenius Medical Care’s Spectra Laboratories. Through this deal, Quest will integrate dialysis-related water testing and ESKD (end-stage kidney disease) lab services, which strengthens its service offering and reduces turnaround times for patients served by dialysis centers. Another large impending transaction is the planned Reverse Morris Trust merger of Becton Dickinson’s Biosciences & Diagnostic Solutions division with Waters Corporation, worth USD 17.5 billion.

The market for U.S. renal biomarkers is significantly impacted by regulatory frameworks, The FDA has been active for example, it accepted the qualification plan for a urine biomarker panel meant to detect drug-induced kidney injury earlier than existing methods. This qualification provides a framework for how such biomarkers can be used in clinical trials. There’s also specific FDA guidance on qualifying biomarkers such as Total Kidney Volume (TKV) for autosomal dominant polycystic kidney disease (ADPKD), which gives developers clarity on how to validate and use such markers in drug development and regulatory submissions. These regulatory moves are significant: they lower uncertainty for companies, help align biomarker development with regulatory expectations, and permit reimbursement pathways to be more feasible once tests are validated under accepted frameworks.

Product portfolios in the U.S. renal biomarkers market are expanding, for example Quest Diagnostics is adding dialysis-clinic-centric water purity testing and ESKD-specific lab services to its renal diagnostics portfolio via its acquisition of Spectra’s asset. These expansions allow diagnostics firms to move upstream and downstream in the renal care pathway: early injury detection, monitoring, ESKD management, and transplant rejection are all increasingly covered. That gives customers more integrated solutions and firms a chance to capture more value.

The U.S. is already well-served in urban and academic settings, although diagnostics firms are pushing to expand reach into less served geographies, particularly rural and dialysis-center networks. Eurofins Scientific’s acquisition of Ascend Clinical (the U.S. laboratory specializing in renal and transplant testing) expands its geographic footprint and ability to serve clients where access had been more limited.

Biomarkers Insights

The functional biomarkers segment accounted for the largest revenue share of 51.81% in 2024, due to widespread adoption in clinical practice for monitoring kidney function through creatinine, cystatin C, and other well-established measures. Their routine integration into diagnostic workflows, supported by broad availability and clinician familiarity, underpins this dominance. Player such as Cleveland Clinic is a noteworthy competitor in the renal diagnostics landscape through its offering of the Blood Urea Nitrogen (BUN) test, a long-established but essential biomarker in assessing kidney function. The BUN test, available through Cleveland Clinic’s diagnostic services and affiliated laboratories, forms part of routine metabolic panels and is used both for screening and monitoring purposes. Further, in January 2025, the U.S. Food and Drug Administration (FDA) has accepted a Qualification Plan for a new urine biomarker panel aimed at enabling earlier detection of drug-induced kidney injury during clinical trials. The Critical Path Institute (C-Path) and the Foundation for the National Institutes of Health (FNIH) collaborated to create this panel, which is intended to supplement established kidney safety biomarkers such as blood urea nitrogen and serum creatinine. Companies developing renal biomarker assays now have a clearer pathway to regulatory qualification if their biomarkers are part of this panel or meet similar criteria.

The upregulated protein segment in the U.S. renal biomarkers market is anticipated to grow at the fastest rate over the forecast period. This growth is driven by rising research activity into novel proteins such as NGAL (neutrophil gelatinase-associated lipocalin), KIM-1 (kidney injury molecule-1), and PENKID, which provide earlier detection of acute kidney injury and CKD progression compared to traditional functional markers. Increasing partnerships between diagnostic companies and research organizations to validate these biomarkers in diverse patient populations are expected to accelerate their clinical uptake.

Diagnostic Technique/Platform Insights

ELISA segment held the largest market share in 2024, Enzyme-Linked Immunosorbent Assay (ELISA) remains one of the most widely used techniques for the detection and quantification of U.S. renal biomarkers due to its sensitivity, specificity, and ease of use. In May 2025, Nordic Bioscience introduced a new assay called nordicEndotrophin, a fully automated, high‐precision “sandwich” assay that quantifies intact Endotrophin, a 77-amino‐acid signaling hormone. The test is performed in their CAP/CLIA-certified lab in Herlev, Denmark, and it is compatible with high-throughput platforms. The specificity of measuring intact Endotrophin (versus broader collagen markers) provides more precise stratification of risk and prognostic information. This can help in drug trials where anti-fibrotic or inflammation-modulating therapies are tested - by enabling better patient selection, monitoring of therapeutic effect, and potentially dose selection.

The molecular diagnostics segment in the U.S. renal biomarkers market is anticipated to grow at the fastest rate over the forecast period. The surge in this segment is fueled by advances in genomics and transcriptomics, enabling the identification of genetic predispositions and molecular pathways linked to CKD and AKI. Increasing adoption of PCR-based assays and next-generation sequencing platforms, along with ongoing collaborations between biotech firms and academic institutions, are expanding the clinical utility of molecular diagnostics in precision nephrology.

End-use Insights

Hospitals and clinics dominated the market in 2024, accounting for a 54.33% share. Hospitals and clinics remain the primary end-users, accounting for a significant share of the market. This dominance is attributed to the rising incidence of chronic kidney disease (CKD) and the need for early detection and continuous monitoring. For instance, the U.S. Centers for Disease Control and Prevention (CDC) reports that approximately 15% of U.S. adults are estimated to have CKD, highlighting the critical demand for effective diagnostic solutions.

The pharmaceutical & biotechnology companies segment is expected to grow at the fastest rate over the forecast period, fueled by pharmaceutical and biotechnology companies are increasingly investing in renal biomarker research to support the development of targeted therapeutics. At the 2025 Association for Diagnostics & Laboratory Medicine (ADLM) meeting in Chicago, BioPorto showcased its FDA-cleared ProNephro AKI test, an immunoassay that measures neutrophil gelatinase-associated lipocalin (NGAL) levels to assess the risk of acute kidney injury (AKI) in pediatric ICU patients aged 3 months to 21 years. This test is particularly significant as it offers a timelier and sensitive alternative to traditional biomarkers such as serum creatinine and eGFR, which often fail to detect early kidney damage.

Key U.S. Renal Biomarkers Company Insights

The U.S. renal biomarkers market is driven by a mix of established diagnostics companies and specialized innovators focused on expanding access and ease of testing. Major players shaping this landscape include Thermo Fisher Scientific Inc., Siemens Healthineers AG, BioPorto Diagnostics A/S, SEKISUI Medical Co., Ltd., BioMerieux SA, SphingoTec GmbH, Randox Laboratories Ltd, Beckman Coulter Inc., and others.

Recent Developments

• In May 2025, Aptar Digital Health announced a licensing agreement with AstraZeneca to develop and commercialize artificial intelligence (AI) algorithms designed to detect chronic kidney disease (CKD) and other related conditions through eye examinations. The AI-driven technology initially developed by AstraZeneca-analyzes biomarkers from retinal imaging to identify signs of CKD, a condition affecting up to 16% of the global population but often going undiagnosed until advanced stages.

• In January 2025, the FDA accepted a Qualification Plan for a urine biomarker panel aimed at enabling earlier detection of drug-induced kidney injury in clinical trials. The panel, developed through collaborations between the FNIH Biomarkers Consortium, C-Path’s Predictive Safety Testing Consortium, and major industry partners including Amgen, AstraZeneca, Eli Lilly, Johnson & Johnson, Merck, and Pfizer, is designed to complement standard renal safety tests such as serum creatinine and blood urea nitrogen, which often miss early injury signals. The initiative focuses on patients with normal kidney function and includes eight urinary biomarkers that provide improved sensitivity and specificity.

• In June 2024, OncoHost initiated a study to explore whether measuring blood levels of thousands of cancer-related proteins can be used to build personalized, data-driven predictions for patients with renal cell carcinoma (RCC). Currently, there are no blood tests available to assist in making personalized treatment recommendations for RCC patients. This study aims to identify novel biomarkers that could inform treatment decisions and improve patient outcomes by tailoring therapies to individual profiles.

• In May 2024, Thermo Fisher Scientific launched a non-invasive urine-based test for CXCL10 to help monitor kidney transplant patients. Elevated urinary CXCL10 has been linked to inflammation and early graft rejection. The new test is intended to allow faster, cheaper, and more specific detection of graft dysfunction than some existing methods.

U.S. Renal Biomarkers Market