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市場調查報告書
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1869604

美國腎臟生物標記市場規模、佔有率和趨勢分析報告：按生物標記、診斷技術、最終用途和細分市場預測（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個工作天內

價格

美國腎臟生物標記市場摘要

2024年美國腎臟生物標記市場規模估計為5.9295億美元，預計2033年將達到12.0775億美元。

預計2025年至2033年，腎臟疾病的複合年成長率（CAGR）將達到8.4%。腎臟疾病，尤其是慢性腎臟病（CKD）和急性腎損傷（AKI）的盛行率不斷上升，使得臨床上迫切需要超越傳統檢測法的更早期、更精準的檢測手段。 CKD通常在晚期之前沒有症狀，因此人們對能夠揭示無症狀性疾病和早期損傷的生物標記產生了濃厚的興趣。在美國，估計有3550萬成年人患有慢性腎臟病（CKD），其中許多人並不知道自己患病。在全球範圍內，CKD影響約8.5億人，約佔成年人口的9%。一項2024年的研究預測，到2032年，八個主要國家將有近1.25億人患有進行性CKD，比2022年增加25%。

根據美國疾病管制與預防中心（CDC）2024年的數據，65歲以上族群中約有三分之一患有慢性腎臟病（CKD），相較之下，45-64歲族群的盛行率約為12%，而18-44歲族群的盛行率僅為6%。女性的盛行率（14%）略高於男性（12%）。不同種族和族裔群體之間也存在顯著差異：非西班牙裔黑人成年人的盛行率最高（20%），其次是非西班牙裔亞裔和西班牙裔成年人（均為14%），非西班牙裔白人成年人的盛行率為12%。這些數據凸顯了加強篩檢計畫和早期療育策略的迫切性。

由於慢性腎臟病 (CKD) 盛行率不斷上升、檢查室自動化程度提高、FDA核准流程清晰明確，以及保險公司願意承保符合實證標準的新型檢測，美國醫療保險 (Medicare) 的基於績效的獎勵支付系統將腎臟科診療評分與年度蛋白尿率掛鉤，從而提高了檢測頻率並促使通訊協定更新。雅培 (Abbott Laboratories) 和生物梅里埃 (bioMérieux) 等主要企業積極開發和商業化腎臟生物標記檢測，也推動了該市場的擴張。 2025 年 8 月，BioPort 和羅氏診斷 (Roche Diagnostics) 合作，透過羅氏 cobas c 501 分析儀向美國檢查室推廣基於 NGAL 生物標記的 ProNephro AKI 檢測。 NGAL 是一種指示腎細胞損傷的蛋白質，其檢測能力優於血清肌酸酐等標準檢測方法。該測試也獲準用於兒童（3 個月至 21 歲），可在 48 至 72 小時內識別中度至重度急性腎損傷 (AKI)，從而實現早期干預。

此外，美國疾病管制與預防中心（CDC）2024年5月發布的數據顯示，美國超過七分之一的成年人，約3,550萬人（佔成年人口的14%），患有慢性腎臟病（CKD）。令人擔憂的是，CKD常常未被診斷出來：高達十分之九的CKD患者並不知道自己患有此病，即使在重度CKD患者中，也有大約三分之一未被確診。

目錄

第1章美國腎臟生物標記市場：調查方法和範圍

第2章美國腎臟生物標記市場：執行摘要

  • 市場概述
  • 細分市場簡介
  • 競爭格局概覽

第3章美國腎臟生物標記市場變數、趨勢和範圍

  • 市場區隔和範圍
  • 市場體系展望
    • 母市場展望
    • 相關/附隨市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 全球基於生物標記的免疫檢測市場分析工具
    • 產業分析—波特五力分析
    • PESTEL 分析

第4章美國腎臟生物標記市場：生物標記估算與趨勢分析

  • 美國腎臟生物標記市場：生物標記變異分析
  • 功能性生物標記
    • 血清肌酸酐
    • 血中尿素氮（BUN）
    • 估算腎絲球過濾率（eGFR）
  • 蛋白質水平升高
    • 腎損傷分子-1 (KIM-1)
    • 嗜中性白血球明膠酶相關脂質運載蛋白（NGAL）
    • Cystatin C
    • 白細胞介素-18 (IL-18)
    • 其他
  • 其他新型生物標記
    • 微型RNA生物標記
    • 蛋白質體/代謝體學標記物

第5章美國腎臟生物標記市場：診斷技術/平台估算及趨勢分析

  • 美國腎臟生物標記市場：診斷技術/平台差異分析
  • 酵素免疫分析法（ELISA）
  • 分子診斷
  • 免疫檢測
  • 臨床化學檢測
  • 就地檢驗（POC​​T）設備
  • 其他新興平台

第6章美國腎臟生物標記市場：終端用途估算與趨勢分析

  • 美國腎臟生物標記市場：終端用途差異分析
  • 醫院和診所
  • 診斷實驗室
  • 學術研究機構
  • 製藥和生物技術公司
  • 其他

第7章 競爭情勢

  • 公司分類
  • 策略規劃
    • 新生物標誌上市
    • 夥伴關係
    • 獲得
    • 合作
    • 資金籌措
  • 主要企業市佔率分析，2024 年
  • 公司熱力圖分析
  • 公司簡介
    • 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