United States of America Renal Biomarkers Market Size, Share, And COVID-19 Impact Analysis, By Diagnostic Technique (Immunoassays, Clinical Chemistry Assays, Chemiluminescent Immunoassay, and Others), By Biomarker Type (Functional Biomarkers and Upregulated Proteins), By Disease Indication (Chronic Kidney Disease, Acute Kidney Disease, Drug Induced Kidney Disease, and Others) By End User (Hospitals, Diagnostic Centres, and Others), and United States Of America Renal Biomarkers Market Insights, Industry Trend, Forecasts To 2035

United States of America Renal Biomarkers Market Insights Forecasts to 2035

• The United States of America Renal Biomarkers Market Size Was Estimated at USD 557.7 Million in 2024
• The Market Size is Expected to Grow at a CAGR of Around 8.9% from 2025 to 2035
• The United States of America Renal Biomarkers Market Size is Expected to Reach USD 1,496.1 Million by 2035

According to a research report published by Spherical Insights & Consulting, The United States of America Renal Biomarkers Market Size is Anticipated to reach USD 4536.1 Million by 2035, Growing at a CAGR of 8.9% from 2025 to 2035. The Renal Biomarkers Market in the United States of America is driven by the rising prevalence of chronic kidney disease due to diabetes and hypertension, ageing populations, and advances in rapid diagnostic technologies.

Market Overview 

The United States of America renal biomarkers market refers to the development, commercialisation and clinical application of biological indicators used to examine kidney function and detect renal injury. The biomarkers, ranging from traditional functional markers like serum creatinine and eGFR to novel upregulated proteins such as NGAL and KIM-1, find extensive application in hospital emergency departments, intensive care units, diagnostic laboratories and pharmaceutical research. Renal biomarkers serve as a crucial component for early diagnosis of acute kidney injury (AKI), determination of the stage of chronic kidney disease and monitoring drug-induced toxicity.

The market is primarily propelled by the staggering prevalence of chronic kidney disease (CKD), with 2024 CDC data estimating that 1 in 7 US adults, approximately 35.5 million people, are affected, a demographic shift that creates sustained demand for high-volume screening

The U.S government programs and regulatory frameworks, such as the FDA’s biomarker qualification program, provide critical support for the United States of America renal biomarkers market by establishing clear pathways for the validation of new diagnostic tools. Federal initiatives focused on the Advancing American Kidney Health executive order, together with Medicare reimbursement shifts toward value-based care and NIH-funded research into precision medicine, have increased domestic demand for high-sensitivity assays while decreasing the reliance on delayed, conventional testing methods. These policies help establish integrated diagnostic networks that connect nephrology clinics, academic research centres, and biotechnology firms.

The American diagnostic sector saw a significant milestone in mid-2025 as major players like Abbott Laboratories and Beckman Coulter expanded their automated immunoassay portfolios to include real-time injury markers, resulting in increased clinical adoption and improved patient risk stratification. The healthcare industry and pharmaceutical sector receive further support from the integration of AI-driven prognostic tools and the expansion of point-of-care testing facilities. The upcoming possibilities for development include the standardisation of digital biomarkers through wearable technology and the increasing use of proteomic panels to personalise treatment for the estimated 35.5 million Americans living with kidney disease.

Report Coverage

This research report categorises the United States of America renal biomarkers market based on various segments and regions, and forecasts revenue growth and analyses trends in each submarket. The report analyses the key growth drivers, opportunities, and challenges influencing the United States of America renal biomarkers market. Recent market developments and competitive strategies, such as expansion, product launch, development, partnership, merger, and acquisition, have been included to draw the competitive landscape in the market. The report strategically identifies and profiles the key market players and analyses their core competencies in each sub-segment of the United States of America renal biomarkers market.

Driving Factors

The United States of America renal biomarkers market is driven by the rising prevalence of kidney diseases due to the rising incidence of diabetes and hypertension. Technological and regulatory advancements also serve as critical drivers of the market. Integration of artificial intelligence and expansion of point-of-care testing (POCT) are revolutionising the market, allowing for earlier intervention in cases of acute kidney injury (AKI). The market is characterised by a steady move toward precision nephrology.

Restraining Factors

The United States of America renal biomarkers market is constrained by factors such as the high cost of novel diagnostic assays, strict regulatory requirements for validating new biomarkers, and the complexity of interpreting the advanced markers, which creates hesitation among clinicians.

Market Segmentation

The United States of America renal biomarkers market is segmented into diagnostic technique, biomarker type, disease indication, and end user.

• The immunoassays segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. 

Based on the diagnostic technique, the United States of America renal biomarkers market is segmented into immunoassays, clinical chemistry assays, chemiluminescent immunoassays, and others. Among these, the immunoassays segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. This is because the immunoassays (like ELISA) have high sensitivity and specificity.  It is compatible with high-throughput automated analysers found in almost every central hospital lab allows providers to process hundreds of samples simultaneously without needing specialised, expensive equipment like mass spectrometry.

• The functional biomarkers segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. 

The United States of America renal biomarkers market is segmented by biomarker type into functional biomarkers and upregulated proteins. Among these, the functional biomarkers segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. Because of extremely low cost and established reimbursement codes, widely used method for diagnosing kidney health, making it the default choice for millions of annual check-ups.

• The chronic kidney disease segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. 

The United States of America renal biomarkers market is segmented by disease indication into acute kidney disease, chronic kidney disease, and drug-induced kidney disease. Among these, the chronic kidney disease segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. This is due to the rising prevalence of chronic kidney disease due to diabetes and hypertension, and the need for recurring screening and regular monitoring creates high-volume demand.

• The hospitals segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period.

Based on end user, the United States of America renal biomarkers market is segmented into hospitals, diagnostic centres and others. Among these, the hospitals segment accounted for the largest revenue market share in 2024 and is expected to grow at a significant CAGR during the forecast period. Because they manage the most critical cases of Acute Kidney Injury (AKI) in Intensive Care Units (ICUs) and post-surgical wards, where real-time kidney monitoring is vital to prevent death. Hospitals also have the largest budgets to purchase expensive, novel biomarker kits and point-of-care devices that smaller clinics and diagnostic centres cannot yet afford.

 Competitive Analysis:

The report offers the appropriate analysis of the key organisations/companies involved within the United States of America renal biomarkers market, along with a comparative evaluation primarily based on their product offering, business overviews, geographic presence, enterprise strategies, segment market share, and SWOT analysis. The report also provides an elaborate analysis focusing on the current news and developments of the companies, which includes product development, innovations, joint ventures, partnerships, mergers & acquisitions, strategic alliances, and others. This allows for the evaluation of the overall competition within the market.

List of Key Companies

• Abbott Laboratories
• Beckman Coulter
• Siemens Healthineers
• Roche
• Thermofisher Scientific
• BioPorto Diagnostics
• Randox Laboratories
• SphingoTec GmbH
• Sekisui Medical Co
• Renalytix
• Journey Biosciences
• Bio-Rad Laboratories
• Aiosyn
• Tempus AI
• Medibeacon

Key Target Audience

• Market Players
• Investors
• End-users
• Government Authorities 
• Consulting and Research Firm
• Venture capitalists
• Value-Added Resellers (VARs)

Market Segment

This study forecasts revenue at the US, regional, and country levels from 2020 to 2035. Spherical Insights has segmented the US renal biomarkers market based on the below-mentioned segments:

United States of America Renal Biomarkers Market by Diagnostic Technique  

• Immunoassays
• Clinical Chemistry Assays
• Chemiluminescent Immunoassay
• Others

United States of America Renal Biomarkers Market, By Biomarker Type

• Functional Biomarkers
• Upregulated Proteins

United States of America Renal Biomarkers Market, By Disease Indication

• Chronic Kidney Disease
• Acute Kidney Disease
• Drug-Induced Kidney Disease
• Others

United States of America Renal Biomarkers Market, By End User

• Hospitals
• Diagnostic Centres
• Others