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美国肾臟生物标记市场规模、份额和趋势分析报告：按生物标记、诊断技术、最终用途和细分市场预测（2025-2033 年）

U.S. Renal Biomarkers Market Size, Share & Trend Analysis Report By Biomarkers, By Diagnostic Technique, By End-use, And Segment Forecasts, 2025 - 2033
出版日期: | 出版商: Grand View Research | 英文 150 Pages | 商品交期: 2-10个工作天内

价格

美国肾臟生物标记市场摘要

2024年美国肾臟生物标记市场规模估计为5.9295亿美元，预计2033年将达到12.0775亿美元。

预计2025年至2033年，肾臟疾病的复合年增长率（CAGR）将达到8.4%。肾臟疾病，尤其是慢性肾臟病（CKD）和急性肾损伤（AKI）的盛行率不断上升，使得临床上迫切需要超越传统检测法的更早期、更精准的检测手段。 CKD通常在晚期之前没有症状，因此人们对能够揭示无症状性疾病和早期损伤的生物标记产生了浓厚的兴趣。在美国，估计有3550万成年人患有慢性肾臟病（CKD），其中许多人并不知道自己患病。在全球范围内，CKD影响约8.5亿人，约占成年人口的9%。一项2024年的研究预测，到2032年，八个主要国家将有近1.25亿人患有进行性CKD，比2022年增加25%。

根据美国疾病管制与预防中心（CDC）2024年的数据，65岁以上族群中约有三分之一患有慢性肾臟病（CKD），相较之下，45-64岁族群的盛行率约为12%，而18-44岁族群的盛行率仅为6%。女性的盛行率（14%）略高于男性（12%）。不同种族和族裔群体之间也存在显着差异：非西班牙裔黑人成年人的盛行率最高（20%），其次是非西班牙裔亚裔和西班牙裔成年人（均为14%），非西班牙裔白人成年人的盛行率为12%。这些数据凸显了加强筛检计画和早期疗育策略的迫切性。

由于慢性肾臟病 (CKD) 盛行率不断上升、检查室自动化程度提高、FDA核准流程清晰明确，以及保险公司愿意承保符合实证标准的新型检测，美国医疗保险 (Medicare) 的基于绩效的奖励支付系统将肾臟科诊疗评分与年度蛋白尿率挂钩，从而提高了检测频率并促使通讯协定更新。雅培 (Abbott Laboratories) 和生物梅里埃 (bioMérieux) 等主要企业积极开发和商业化肾臟生物标记检测，也推动了该市场的扩张。 2025 年 8 月，BioPort 和罗氏诊断 (Roche Diagnostics) 合作，透过罗氏 cobas c 501 分析仪向美国检查室推广基于 NGAL 生物标记的 ProNephro AKI 检测。 NGAL 是一种指示肾细胞损伤的蛋白质，其检测能力优于血清肌酸酐等标准检测方法。该测试也获准用于儿童（3 个月至 21 岁），可在 48 至 72 小时内识别中度至重度急性肾损伤 (AKI)，从而实现早期干预。

此外，美国疾病管制与预防中心（CDC）2024年5月发布的数据显示，美国超过七分之一的成年人，约3,550万人（占成年人口的14%），患有慢性肾臟病（CKD）。令人担忧的是，CKD常常未被诊断出来：高达十分之九的CKD患者并不知道自己患有此病，即使在重度CKD患者中，也有大约三分之一未被确诊。

目录

第一章美国肾臟生物标记市场：调查方法和范围

第二章美国肾臟生物标记市场：执行摘要

  • 市场概述
  • 细分市场简介
  • 竞争格局概览

第三章美国肾臟生物标记市场变数、趋势和范围

  • 市场区隔和范围
  • 市场体系展望
    • 母市场展望
    • 相关/附随市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 全球基于生物标记的免疫检测市场分析工具
    • 产业分析—波特五力分析
    • PESTEL 分析

第四章美国肾臟生物标记市场：生物标记估算与趋势分析

  • 美国肾臟生物标记市场：生物标记变异分析
  • 功能性生物标记
    • 血清肌酸酐
    • 血中尿素氮（BUN）
    • 估算肾丝球过滤率（eGFR）
  • 蛋白质水平升高
    • 肾损伤分子-1 (KIM-1)
    • 嗜中性白血球明胶酶相关脂质运载蛋白（NGAL）
    • Cystatin C
    • 白细胞介素-18 (IL-18)
    • 其他的
  • 其他新型生物标记
    • 微型RNA生物标记
    • 蛋白质体/代谢体学标记物

第五章美国肾臟生物标记市场：诊断技术/平台估算及趋势分析

  • 美国肾臟生物标记市场：诊断技术/平台差异分析
  • 酵素免疫分析法（ELISA）
  • 分子诊断
  • 免疫检测
  • 临床化学检测
  • 就地检验（POC​​T）设备
  • 其他新兴平台

第六章美国肾臟生物标记市场：终端用途估算与趋势分析

  • 美国肾臟生物标记市场：终端用途差异分析
  • 医院和诊所
  • 诊断实验室
  • 学术研究机构
  • 製药和生物技术公司
  • 其他的

第七章 竞争情势

  • 公司分类
  • 策略规划
    • 新生物标誌上市
    • 伙伴关係
    • 获得
    • 合作
    • 资金筹措
  • 主要企业市占率分析，2024 年
  • 公司热力图分析
  • 公司简介
    • Thermo Fisher Scientific Inc.
    • Company Overview
    • Siemens Healthineers AG
    • BioPorto Diagnostics A/S
    • SEKISUI Medical Co., Ltd
    • BioMerieux SA
    • SphingoTec GmbH
    • Randox Laboratories Ltd
    • Beckman Coulter Inc.
    • QIAGEN NV
    • EKF Diagnostics Holdings plc
Product Code: GVR-4-68040-774-9

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 bioMerieux 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
    • Serum Creatinine
    • Blood Urea Nitrogen (BUN)
    • Estimated Glomerular Filtration Rate (eGFR)
  • Upregulated Proteins
    • Kidney Injury Molecule-1 (KIM-1)
    • Neutrophil Gelatinase-Associated Lipocalin (NGAL)
    • Cystatin C
    • Interleukin-18 (IL-18)
    • Others
  • Other Novel Biomarkers
    • microRNA biomarkers
    • 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

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

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