신장 바이오마커 시장 : 점유율 분석, 산업 동향, 통계, 성장 예측(2025-2030년)

The renal biomarkers market is valued at USD 1.61 billion in 2025 and is forecast to climb to USD 2.32 billion by 2030, registering a 7.58% CAGR through the period.

This expansion reflects a steady pivot from single-analyte, creatinine-centric testing toward high-content multiplex panels that track functional, structural and inflammatory kidney injury signals in one run. Laboratories in high-income countries are automating these panels on AI-enabled platforms that flag assay drift in real time, allowing faster clinical decisions and lower repeat-test rates. Broader adoption is further propelled by value-based reimbursement schemes that reward early CKD detection, while digital wearables capable of estimating real-time eGFR are opening a path for community screening programs and home-based monitoring. Despite technical advances, reimbursement for newly cleared biomarkers remains inconsistent and a lack of harmonized reference standards slows cross-lab result comparability, creating a measured but unmistakable evolution in diagnostic protocols.

Global Renal Biomarkers Market Trends and Insights

Rising Prevalence of Chronic Kidney Disease (CKD) & Acute Kidney Injury (AKI)

CKD affects 37 million U.S. adults and prevalence is projected to reach 17% among people aged 30 and older by 2030, driving a structural jump in test volumes as health systems move screening from nephrology clinics into primary care workflows . Up to 90% of CKD cases remain undiagnosed until advanced stages, inflating treatment costs and dialysis dependence; payers therefore endorse comprehensive biomarker panels that flag injury before eGFR declines. Clinical pathways now combine creatinine with cystatin C, NGAL and urinary albumin to stratify risk and chart therapy intensity, supporting sustained demand for functional and up-regulated proteins. Population health contracts in the United States and Germany reimburse multi-analyte panels that demonstrate cost offsets from reduced hospitalization, turning renal biomarker testing into a preventive rather than confirmatory tool. Emerging-market governments are watching these outcomes closely, suggesting a long runway for global adoption momentum.

Growing Diabetic & Hypertensive Population Base

Diabetes and hypertension account for more than 60% of end-stage kidney disease referrals worldwide, and KDIGO's 2024 guideline now directs quarterly renal biomarker testing for high-risk diabetics, not yearly reviews. Clinical laboratories are responding by bundling albumin-to-creatinine ratio, serum creatinine, cystatin C and NGAL in one orderable code that suits value-based payment metrics. SGLT2 inhibitors have added a therapeutic incentive because their dose adjustments hinge on early eGFR changes, raising clinician reliance on precise, high-frequency biomarker readings. Asia-Pacific faces the steepest uptick in type 2 diabetes incidence, so ministries in China and India are funding community screening vans that use finger-stick creatinine plus point-of-care NGAL cartridges, signaling the renal biomarkers market will embed itself in chronic-disease management pathways.

Lack of Universal Reference Standards Across Laboratories

NGAL, KIM-1 and penKid still lack harmonized calibrators, so inter-laboratory coefficient of variation can exceed 18%, undermining physician confidence and delaying guideline endorsement. While the International Federation of Clinical Chemistry has convened a global reference system for cystatin C, comparable workstreams for tubular injury proteins remain underfunded and technically complex. Emerging markets feel the impact most: procurement teams in Brazil and Nigeria report assay selection paralysis because platforms report different absolute values. Academic consortia in Japan and Canada are pooling biobanks to establish ethnicity-specific reference intervals, but until a certification scheme mirrors the success of IDMS-traceable creatinine, novel biomarker roll-outs will stay patchy.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Adoption of High-Throughput Multiplex Assays in Nephrology Labs
2. Government CKD Screening Mandates
3. Stringent Reimbursement Hurdles for Novel Biomarkers

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Functional biomarkers generated USD 0.84 billion in 2024, equal to 52.32% of the renal biomarkers market. Creatinine remains ubiquitous for eGFR calculation, yet its blind spot in early injury means clinicians frequently pair it with serum cystatin C, whose broader dynamic range improves accuracy in pediatrics and the elderly. Albuminuria screening volumes are rising fastest within the functional block because diabetic care pathways link microalbumin results to therapy intensification. The segment is gaining incremental lift from smartphone-enabled dipsticks that photograph colorimetric albumin changes and relay data to cloud dashboards, widening access in rural Asia and Africa.

Up-regulated proteins are forecasted to climb at an 8.31% CAGR, outpacing all other categories. NGAL grabs the spotlight owing to its 2-hour post-insult detection window; emergency departments in Germany now add plasma NGAL to their sepsis panels to flag impending renal injury earlier than creatinine . KIM-1 assays approved in 2025 for drug-induced nephrotoxicity surveillance in oncology trials are expected to pull incremental orders from CROs. The renal biomarkers market size for up-regulated proteins could hit USD 0.49 billion by 2030 if guideline committees broaden indications as anticipated, underlining the segment's accelerator role in overall market growth.

The Renal Biomarkers Market is Segmented by Biomarker Type (Functional Biomarker [Serum Creatinine and More], Up-Regulated Protein, Other Biomarker Types), Diagnostic Technique (Enzyme-Linked Immunosorbent Assay (ELISA), and More), End User (Hospitals, Diagnostic Laboratories, and More), and Geography (North America, Europe, Asia-Pacific, and More). The Market and Forecasts are Provided in Terms of Value (USD).

Geography Analysis

North America held 42.23% revenue in 2024, equal to USD 0.68 billion of the renal biomarkers market size, underpinned by robust laboratory automation, clear FDA pathways and insurer willingness to reimburse novel tests that meet evidentiary thresholds. Medicare's Merit-based Incentive Payment System links nephrology practice scores to annual albuminuria rates, sparking protocol updates and higher test ordering frequency. U.S. vendors leverage proximity to academic medical centers for rapid clinical trial enrollment, shortening biomarker validation cycles and keeping the region at the forefront of first-to-market launches.

Asia-Pacific is the growth engine at 8.64% CAGR, with China, India and South Korea combining public health mandates and cashback insurance schemes to subsidize early CKD detection. Provincial governments in China partnered with leading IVD firms to deploy mobile labs testing serum creatinine and NGAL in factory clinics, a model expected to scale to 100 units by 2027. In India, Ayushman Bharat insurance packages now remunerate albumin-to-creatinine ratio tests twice yearly for diabetic policyholders, driving steep volume increases in tier-2 cities. This policy pull, coupled with local reagent manufacturing that trims cost per test, secures enduring lift for the renal biomarkers market in the region.

Europe contributes stable, mid-single-digit revenue growth anchored in evidence-based policy frameworks. Germany's IQWiG approved cystatin C reimbursement in 2025 following a meta-analysis that demonstrated 12% reclassification improvement in CKD staging over creatinine alone. The United Kingdom's NICE is piloting a combined NGAL and KIM-1 panel in six NHS trusts, with early health-economic modeling suggesting dialysis deferral savings offset assay costs within 24 months. Scandinavian countries remain early adopters of digital health; Swedish startups now integrate eGFR readings from smart rings into electronic medical records, ensuring biomarker data loop seamlessly between consumer devices and clinical decision support. Collectively, European vigilance for cost-effectiveness tempers headline growth but cements long-term adoption of validated assays, maintaining a 27% slice of the renal biomarkers market.

1. Abbott Laboratories
2. F.-Hoffmann-La Roche AG
3. Thermo Fisher Scientific
4. Siemens Healthineers
5. BioPorto Diagnostics A/S
6. SEKISUI Medical Co., Ltd.
7. bioMerieux
8. SphingoTec GmbH
9. Randox Laboratories
10. Enzo Biochem
11. Beckton Dickinson
12. QIAGEN
13. DiaSorin
14. Beckton Dickinson
15. Bio-Rad Laboratories
16. EKF Diagnostics Holdings plc
17. Proteomics International Labs Ltd
18. Arkray
19. Sysmex
20. Danaher Corp. (Cepheid)

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Prevalence of Chronic Kidney Disease (CKD) & Acute Kidney Injury (AKI)
  • 4.2.2 Growing Diabetic & Hypertensive Population Base
  • 4.2.3 Rapid Adoption of High-Throughput Multiplex Assays in Nephrology Labs
  • 4.2.4 Government CKD Screening Mandates
  • 4.2.5 AI-Enabled Urinary Proteomics for Ultra-Early Detection
  • 4.2.6 Integration of Digital Wearables Generating Real-Time eGFR
• 4.3 Market Restraints
  • 4.3.1 Lack Of Universal Reference Standards Across Laboratories
  • 4.3.2 Stringent Reimbursement Hurdles for Novel Biomarkers
  • 4.3.3 Pre-Analytical Sample Variability in Point-Of-Care Settings
  • 4.3.4 Limited Validation Data in Minority Ethnic Populations
• 4.4 Regulatory Landscape
• 4.5 Porters Five Forces Analysis
  • 4.5.1 Bargaining Power of Suppliers
  • 4.5.2 Bargaining Power of Buyers
  • 4.5.3 Threat of New Entrants
  • 4.5.4 Threat of Substitutes
  • 4.5.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Biomarker Type
  • 5.1.1 Functional Biomarkers
    • 5.1.1.1 Serum Creatinine
    • 5.1.1.2 Serum Cystatin C
    • 5.1.1.3 Urine Albumin
  • 5.1.2 Up-regulated Proteins
    • 5.1.2.1 NGAL
    • 5.1.2.2 Kidney Injury Molecule-1
    • 5.1.2.3 Interleukin-18
  • 5.1.3 Other Biomarker Types
• 5.2 By Diagnostic Technique
  • 5.2.1 Enzyme-Linked Immunosorbent Assay (ELISA)
  • 5.2.2 Particle-Enhanced Turbidimetric Immunoassay (PETIA)
  • 5.2.3 Colorimetric Assay
  • 5.2.4 Chemiluminescent Immunoassay (CLIA)
  • 5.2.5 Liquid Chromatography-Mass Spectrometry (LC-MS)
  • 5.2.6 Others
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Academic & Research Institutes
  • 5.3.4 Other End Users
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products & Services, and Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 F.-Hoffmann-La Roche AG
  • 6.3.3 Thermo Fisher Scientific Inc.
  • 6.3.4 Siemens Healthineers AG
  • 6.3.5 BioPorto Diagnostics A/S
  • 6.3.6 SEKISUI Medical Co., Ltd.
  • 6.3.7 BioMerieux SA
  • 6.3.8 SphingoTec GmbH
  • 6.3.9 Randox Laboratories Ltd
  • 6.3.10 Enzo Life Sciences Inc.
  • 6.3.11 Beckman Coulter Inc.
  • 6.3.12 QIAGEN N.V.
  • 6.3.13 DiaSorin S.p.A.
  • 6.3.14 Becton, Dickinson & Co.
  • 6.3.15 Bio-Rad Laboratories Inc.
  • 6.3.16 EKF Diagnostics Holdings plc
  • 6.3.17 Proteomics International Labs Ltd
  • 6.3.18 Arkray Inc.
  • 6.3.19 Sysmex Corporation
  • 6.3.20 Danaher Corp. (Cepheid)

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment