The global renal biomarkers market size was estimated at USD 1.53 billion in 2024 and is expected to reach USD 3.16 billion by 2033, growing at a CAGR of 8.54% 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. In April 2024, AstraZeneca’s IMPACT CKD modeling study projected that by 2032, as many as 16.5% of the population across eight countries could be affected by chronic kidney disease (CKD), with advanced-stage cases potentially increasing by up to 59.3%. The findings, presented at the 2024 ISN World Congress of Nephrology (WCN’24) in Buenos Aires, underscored the escalating global health challenge posed by CKD and emphasized its significant economic and environmental consequences. The large and growing base of kidney disease patients ensures a continually rising demand for more sensitive, specific, and multiplex biomarker assays. In addition, co-morbidities such as diabetes, hypertension, and aging populations further exacerbate kidney stress, pushing clinicians and payers to adopt advanced biomarkers (e.g. NGAL, KIM-1, cystatin C) earlier in the disease continuum to improve prognostics, therapy stratification, and monitoring. The high rate of undiagnosed early CKD (sometimes up to 90 % of cases go unnoticed until functional decline) underscores the latent market potential for tools that reliably flag early damage before conventional metrics (eGFR, creatinine) deviate significantly.
One of the most compelling opportunities in the renal biomarker landscape lies in emerging markets-Asia, Latin America, Africa where rising incidence of hypertension, diabetes, and aging populations is intensifying the renal disease burden, yet diagnostic infrastructure remains underdeveloped. As diagnostics penetration is still relatively low in many of these geographies, the entry of affordable, point-of-care biomarker platforms offers a high-growth niche. For example, Sphingotec’s collaborations (e.g. with Beckman Coulter) to release penKid assays on standard clinical lab platforms reflect how a biomarker originally confined to research can scale into broader clinical adoption. (See news of licensing and launch of penKid in central labs) The capacity to deploy multiplex panels, low-volume assays, or simpler rapid tests in decentralized settings could help bridge diagnostic gaps in underserved regions.
Meanwhile, platform diversity is growing enzyme-linked immunosorbent assays (ELISA) still command a significant share, but more sensitive chemiluminescent immunoassays, multiplex panels, mass spectrometry (LC-MS), microfluidics, and point-of-care immunodiagnostic devices are gaining traction. For instance, the penKid assay’s adoption on Beckman Coulter immunoassay platforms exemplifies how a novel biomarker can be integrated lab workflows. In research settings, microfluidic and multi-omics platforms will support novel discovery and multiplex panels opening scope for biomarker companies to offer value-added analytics, software, and interpretation services.
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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. In April 2024, AstraZeneca’s IMPACT CKD modeling study projected that by 2032, as many as 16.5% of the population across eight countries could be affected by chronic kidney disease (CKD), with advanced-stage cases potentially increasing by up to 59.3%. The findings, presented at the 2024 ISN World Congress of Nephrology (WCN’24) in Buenos Aires, underscored the escalating global health challenge posed by CKD and emphasized its significant economic and environmental consequences. The large and growing base of kidney disease patients ensures a continually rising demand for more sensitive, specific, and multiplex biomarker assays. In addition, co-morbidities such as diabetes, hypertension, and aging populations further exacerbate kidney stress, pushing clinicians and payers to adopt advanced biomarkers (e.g. NGAL, KIM-1, cystatin C) earlier in the disease continuum to improve prognostics, therapy stratification, and monitoring. The high rate of undiagnosed early CKD (sometimes up to 90 % of cases go unnoticed until functional decline) underscores the latent market potential for tools that reliably flag early damage before conventional metrics (eGFR, creatinine) deviate significantly.
One of the most compelling opportunities in the renal biomarker landscape lies in emerging markets-Asia, Latin America, Africa where rising incidence of hypertension, diabetes, and aging populations is intensifying the renal disease burden, yet diagnostic infrastructure remains underdeveloped. As diagnostics penetration is still relatively low in many of these geographies, the entry of affordable, point-of-care biomarker platforms offers a high-growth niche. For example, Sphingotec’s collaborations (e.g. with Beckman Coulter) to release penKid assays on standard clinical lab platforms reflect how a biomarker originally confined to research can scale into broader clinical adoption. (See news of licensing and launch of penKid in central labs) The capacity to deploy multiplex panels, low-volume assays, or simpler rapid tests in decentralized settings could help bridge diagnostic gaps in underserved regions.
Meanwhile, platform diversity is growing enzyme-linked immunosorbent assays (ELISA) still command a significant share, but more sensitive chemiluminescent immunoassays, multiplex panels, mass spectrometry (LC-MS), microfluidics, and point-of-care immunodiagnostic devices are gaining traction. For instance, the penKid assay’s adoption on Beckman Coulter immunoassay platforms exemplifies how a novel biomarker can be integrated lab workflows. In research settings, microfluidic and multi-omics platforms will support novel discovery and multiplex panels opening scope for biomarker companies to offer value-added analytics, software, and interpretation services.
Global 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, the analyst has segmented the global renal biomarkers market based on biomarker, diagnostic technique, end use, and region:Biomarkers Outlook (Revenue, USD Million, 2021-2033)
- Kits and reagents
- Functional Biomarkers
- Upregulated Proteins
- Other Novel Biomarkers
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
Regional Outlook (Revenue, USD Million, 2021-2033)
- North America
- Europe
- Asia-Pacific
- Latin America
- Middle East & Africa
Why You Should Buy This Report
- Comprehensive Market Analysis: Gain detailed insights into the market across major regions and segments.
- Competitive Landscape: Explore the market presence of key players.
- Future Trends: Discover the pivotal trends and drivers shaping the future of the market.
- Actionable Recommendations: Utilize insights to uncover new revenue streams and guide strategic business decisions.
Report Deliverables
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
- Product innovation listings for you to stay ahead of the curve
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Table of Contents
Chapter 1. Renal Biomarkers Market: Methodology and Scope
Chapter 2. Renal Biomarkers Market: Executive Summary
Chapter 3. Renal Biomarkers Market Variables, Trends, & Scope
Chapter 4. Renal Biomarkers Market: Biomarkers Estimates & Trend Analysis
Chapter 5. Renal Biomarkers Market: Diagnostic Technique/Platform Estimates & Trend Analysis
Chapter 6. Renal Biomarkers Market: End Use Estimates & Trend Analysis
Chapter 7. Renal Biomarkers Market: Regional Business Analysis
Chapter 8. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
The companies profiled in this Renal Biomarkers market report include:- Siemens Healthineers AG
- BioPorto Diagnostics A/S
- SEKISUI Medical Co., Ltd.
- BioMerieux SA
- SphingoTec GmbH
- Randox Laboratories Ltd
- Beckman Coulter Inc.
- QIAGEN N.V.
- Becton, Dickinson & Co.
- DiaSorin S.p.A.
- Bio-Rad Laboratories Inc.
- EKF Diagnostics Holdings plc.
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 150 |
| Published | October 2025 |
| Forecast Period | 2024 - 2033 |
| Estimated Market Value ( USD | $ 1.53 Billion |
| Forecasted Market Value ( USD | $ 3.16 Billion |
| Compound Annual Growth Rate | 8.5% |
| Regions Covered | Global |
| No. of Companies Mentioned | 13 |
