Summary

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.

U.S. Renal Biomarkers Market Report Segmentation

This report forecasts revenue growth and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the U.S. Renal Biomarkers market based on biomarker, diagnostic technique/platform, and end-use:

• Biomarkers Outlook (Revenue, USD Million, 2021 - 2033)
• Functional Biomarkers
o Serum Creatinine
o Blood Urea Nitrogen (BUN)
o Estimated Glomerular Filtration Rate (eGFR)
• Upregulated Proteins
o Kidney Injury Molecule-1 (KIM-1)
o Neutrophil Gelatinase-Associated Lipocalin (NGAL)
o Cystatin C
o Interleukin-18 (IL-18)
o Others
• Other Novel Biomarkers
o microRNA biomarkers
o Proteomic/metabolomic markers
• Diagnostic technique /Platform Outlook (Revenue, USD Million, 2021 - 2033)
• Enzyme-Linked Immunosorbent Assay (ELISA)
• Immunoassays
• Clinical Chemistry Assays
• Point-of-Care Testing (POCT) Devices
• Molecular Diagnostics
• Other Emerging Platforms
• End-use Outlook (Revenue, USD Million, 2021 - 2033)
• Hospitals & Clinics
• Diagnostic Laboratories
• Academic & Research Institutes
• Pharmaceutical & Biotechnology Companies
• Others

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Table of Contents

Table of Contents

Chapter 1. U.S. Renal Biomarkers Market: Methodology and Scope
1.1. Market Segmentation and Scope
1.1.1. Segment Definitions
1.1.1.1. Biomarkers Segment
1.1.1.2. Diagnostic Technique/Platform Segment
1.1.1.3. End Use Segment
1.2. Regional Scope
1.3. Estimates and Forecast Timeline
1.4. Objectives
1.4.1. Objective - 1
1.4.2. Objective - 2
1.4.3. Objective - 3
1.5. Research Methodology
1.6. Information Procurement
1.6.1. Purchased Database
1.6.2. GVR’s Internal Database
1.6.3. Secondary Sources
1.6.4. Primary Research
1.7. Information or Data Analysis
1.7.1. Data Analysis Models
1.8. Market Formulation & Validation
1.9. Model Details
1.9.1. Commodity Flow Analysis
1.10. List of Secondary Sources
1.11. List of Abbreviations
Chapter 2. U.S. Renal Biomarkers Market: Executive Summary
2.1. Market Snapshot
2.2. Segment Snapshot
2.3. Competitive Landscape Snapshot
Chapter 3. U.S. Renal Biomarkers Market Variables, Trends, & Scope
3.1. Market Segmentation and Scope
3.2. Market Lineage Outlook
3.2.1. Parent Market Outlook
3.2.2. Related/Ancillary Market Outlook
3.3. Market Dynamics
3.3.1. Market driver analysis
3.3.1.1. Rising prevalence of kidney diseases:
3.3.1.2. Government Initiatives and Health Awareness Programs
3.3.1.3. Technological advancements in kidney diagnostics
3.3.2. Market restraint analysis
3.3.2.1. High cost of diagnostics test
3.3.2.2. Limited availability of trained personnel to perform and interpret biomarker tests
3.4. Global Biomarker-Based Immunoassays Market Analysis Tools
3.4.1. Industry Analysis - Porter’s
3.4.2. PESTEL Analysis
Chapter 4. U.S. Renal Biomarkers Market: Biomarkers Estimates & Trend Analysis
4.1. U.S. Renal Biomarkers Market: Biomarkers Movement Analysis
4.2. Functional Biomarkers
4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.2.2. Serum Creatinine
4.2.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.2.3. Blood Urea Nitrogen (BUN)
4.2.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.2.4. Estimated Glomerular Filtration Rate (eGFR)
4.2.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3. Upregulated Proteins
4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3.2. Kidney Injury Molecule-1 (KIM-1)
4.3.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3.3. Neutrophil Gelatinase-Associated Lipocalin (NGAL)
4.3.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3.4. Cystatin C
4.3.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3.5. Interleukin-18 (IL-18)
4.3.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.3.6. Others
4.3.6.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4. Other Novel Biomarkers
4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.2. microRNA biomarkers
4.4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
4.4.3. Proteomic/metabolomic markers
4.4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 5. U.S. Renal Biomarkers Market: Diagnostic Technique /Platform Estimates & Trend Analysis
5.1. U.S. Renal Biomarkers Market: Diagnostic Technique/Platform Movement Analysis
5.2. Enzyme-Linked Immunosorbent Assay (ELISA)
5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.3. Molecular Diagnostics
5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.4. Immunoassays
5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.5. Clinical Chemistry Assays
5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.6. Point-of-Care Testing (POCT) Devices
5.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
5.7. Other Emerging Platforms
5.7.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 6. U.S. Renal Biomarkers Market: End Use Estimates & Trend Analysis
6.1. U.S. Renal Biomarkers Market: End Use Movement Analysis
6.2. Hospitals and clinics
6.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.3. Diagnostics Laboratories
6.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.4. Academic & Research Institutes
6.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.5. Pharmaceutical & Biotechnology Companies
6.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
6.6. Others
6.6.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
Chapter 7. Competitive Landscape
7.1. Company Categorization
7.2. Strategy Mapping
7.2.1. New Biomarkers Launch
7.2.2. Partnerships
7.2.3. Acquisition
7.2.4. Collaboration
7.2.5. Funding
7.3. Key Company Market Share Analysis, 2024
7.4. Company Heat Map Analysis
7.5. Company Profiles
7.5.1. Thermo Fisher Scientific Inc.
7.5.2. Company Overview
7.5.2.1. Financial Performance
7.5.2.2. Biomarkers Benchmarking
7.5.2.3. Strategic Initiatives
7.5.3. Siemens Healthineers AG
7.5.3.1. Company Overview
7.5.3.2. Financial Performance
7.5.3.3. Biomarkers Benchmarking
7.5.3.4. Strategic Initiatives
7.5.4. BioPorto Diagnostics A/S
7.5.4.1. Company Overview
7.5.4.2. Financial Performance
7.5.4.3. Biomarkers Benchmarking
7.5.4.4. Strategic Initiatives
7.5.5. SEKISUI Medical Co., Ltd
7.5.5.1. Company Overview
7.5.5.2. Financial Performance
7.5.5.3. Biomarkers Benchmarking
7.5.5.4. Strategic Initiatives
7.5.6. BioMerieux SA
7.5.6.1. Company Overview
7.5.6.2. Financial Performance
7.5.6.3. Biomarkers Benchmarking
7.5.6.4. Strategic Initiatives
7.5.7. SphingoTec GmbH
7.5.7.1. Company Overview
7.5.7.2. Financial Performance
7.5.7.3. Biomarkers Benchmarking
7.5.7.4. Strategic Initiatives
7.5.8. Randox Laboratories Ltd
7.5.8.1. Company Overview
7.5.8.2. Financial Performance
7.5.8.3. Biomarkers Benchmarking
7.5.8.4. Strategic Initiatives
7.5.9. Beckman Coulter Inc.
7.5.9.1. Company Overview
7.5.9.2. Financial Performance
7.5.9.3. Biomarkers Benchmarking
7.5.9.4. Strategic Initiatives
7.5.10. QIAGEN N.V.
7.5.10.1. Company Overview
7.5.10.2. Financial Performance
7.5.10.3. Biomarkers Benchmarking
7.5.10.4. Strategic Initiatives
7.5.11. EKF Diagnostics Holdings plc
7.5.11.1. Company Overview
7.5.11.2. Financial Performance
7.5.11.3. Biomarkers Benchmarking
7.5.11.4. Strategic Initiatives

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List of Tables/Graphs

List of Tables

Table 1 List of Secondary Sources
Table 2 List of Abbreviation
Table 3 U.S. Renal Biomarkers Market, By Region, 2018 - 2033 (USD Million)
Table 4 U.S. Renal Biomarkers Market, By Biomarkers, 2018 - 2033 (USD Million)
Table 5 U.S. Renal Biomarkers Market, By Diagnostic Technique/Platform, 2018 - 2033 (USD Million)
Table 6 U.S. Renal Biomarkers Market, By End Use, 2018 - 2033 (USD Million)List of Figures

Fig. 1 Market research process
Fig. 2 Information procurement
Fig. 3 Market summary
Fig. 4 Market segmentation & scope
Fig. 5 Market size and growth prospects
Fig. 6 U.S. renal biomarkers market- Key market driver analysis
Fig. 7 U.S. renal biomarkers market - Key market restraint analysis
Fig. 8 Penetration & growth prospect mapping
Fig. 9 U.S. renal biomarkers market - Porter’s analysis
Fig. 10 U.S. renal biomarkers market - PESTEL analysis
Fig. 11 U.S. renal biomarkers market Biomarkers outlook key takeaways
Fig. 12 U.S. renal biomarkers market: Biomarkers movement analysis
Fig. 13 Functional Biomarkers market estimates, 2021 - 2033 (USD Million)
Fig. 14 Serum Creatinine market estimates, 2021 - 2033 (USD Million)
Fig. 15 Blood Urea Nitrogen (BUN) market estimates, 2021 - 2033 (USD Million)
Fig. 16 Estimated Glomerular Filtration Rate (eGFR) market estimates, 2021 - 2033 (USD Million)
Fig. 17 Upregulated Proteins market estimates, 2021 - 2033 (USD Million)
Fig. 18 Kidney Injury Molecule-1 (KIM-1) market estimates, 2021 - 2033 (USD Million)
Fig. 19 Neutrophil Gelatinase-Associated Lipocalin (NGAL) market estimates, 2021 - 2033 (USD Million)
Fig. 20 Cystatin C market estimates, 2021 - 2033 (USD Million)
Fig. 21 Interleukin-18 (IL-18) market estimates, 2021 - 2033 (USD Million)
Fig. 22 Others market estimates, 2021 - 2033 (USD Million)
Fig. 23 Other Novel Biomarkers market estimates, 2021 - 2033 (USD Million)
Fig. 24 microRNA biomarkers market estimates, 2021 - 2033 (USD Million)
Fig. 25 Proteomic/metabolomic markers U.S. renal biomarkers market technology outlook key takeaways
Fig. 26 U.S. renal biomarkers market: diagnostic technique/platform movement analysis
Fig. 27 Immunoassays market estimates, 2021 - 2033 (USD Million)
Fig. 28 Molecular diagnostics market estimates, 2021 - 2033 (USD Million)
Fig. 29 ELISA market estimates, 2021 - 2033 (USD Million)
Fig. 30 Clinical chemistry assays market estimates, 2021 - 2033 (USD Million)
Fig. 31 POCT market estimates, 2021 - 2033 (USD Million)
Fig. 32 U.S. renal biomarkers market end use outlook key takeaways
Fig. 33 U.S. renal biomarkers market: end use movement analysis
Fig. 34 Hospitals and diagnostics laboratories market estimates, 2021 - 2033 (USD Million)
Fig. 35 Diagnostic laboratories market estimates, 2021 - 2033 (USD Million)
Fig. 36 Academic & Research Institutes market estimates, 2021 - 2033 (USD Million)
Fig. 37 Pharmaceutical & biotechnology companies market estimates, 2021 - 2033 (USD Million)
Fig. 38 Others market estimates, 2021 - 2033 (USD Million)
Fig. 39 Strategy framework