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市场调查报告书
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1813976

美国基于生物标记的免疫检测市场规模、份额和趋势分析报告：按样本、产品、生物标记、疾病、最终用途和细分预测，2025-2033 年

U.S. Biomarker-based Immunoassays Market Size, Share & Trends Analysis Report By Sample (Blood, Saliva), By Product (Reagents & Kits, Consumables), By Biomarker, By Diseases, 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

市场规模与趋势：

美国基于生物标记的免疫检测市场规模预计在 2024 年达到 21.7 亿美元，预计到 2033 年将达到 36.8 亿美元，2025 年至 2033 年的复合年增长率为 5.9%。

市场成长的驱动力来自于美国日益加重的慢性疾病负担，例如癌症、心血管疾病和神经系统疾病，这些疾病需要精准的早期诊断工具。塑造该市场规模的关键驱动因素是向个人化医疗的转变。製药和生物技术公司越来越依赖基于生物标记的免疫检测来支持临床试验中的伴随诊断和患者分层。这种整合确保标靶治疗能够涵盖合适的患者群体，从而改善治疗效果并降低医疗成本。美国的法规环境也在塑造这一领域发挥关键作用。

除了治疗用途之外，技术进步和数位化整合也在不断拓展市场。自动化免疫检测平台与人工智慧的结合，为数据分析提供了高通量和高灵敏度的生物标记检测。这种增长不仅限于中心实验室，还延伸至分散式医疗保健模式，例如即时检测和居家检测。基于唾液的生物标记免疫检测因其微创性且易于采集，为不断发展的市场格局带来了另一个重大机会。

此外，美国基于生物标记的免疫检测市场已超越医疗保健领域，涵盖研究和学术机构，这些机构对于生物标记的发现和检验至关重要。这些研究机构在推动创新和与产业领袖建立伙伴关係方面发挥关键作用，从而形成了支持新产品开发和临床应用的良性循环。整体而言，美国市场广阔且充满活力，涵盖常规诊断、治疗监测、药物开发和学术研究。这使得基于生物标记的免疫检测成为不断发展的精准医疗领域的基础技术。

随着临床医生寻求可靠的工具来更早发现疾病并更准确地指导治疗决策，对微创解决方案的需求正在增长。这一趋势促使主要企业专注于血浆和血清生物标记创新，特别是在肿瘤学和神经病学等领域，早期诊断可显着改善患者的预后。在此背景下，多项产品创新凸显了血液生物标记免疫检测在临床实践中日益增长的重要性。例如，2024 年 4 月，罗氏与礼来合作开发的 Elecsys pTau217 血浆生物标记测试获得了美国FDA 的突破性设备称号，展示了其改变阿兹海默症诊断的潜力。此测试可帮助医疗保健提供者识别淀粉样蛋白病理（阿兹海默症的关键方面），从而实现更早、更准确的诊断。透过改善及时诊断的途径，该测试不仅可以改善患者照护，还可以促进患者参与临床试验和获得缓解疾病疗法，进一步增加美国对创新血液生物标记测试的需求。

目录

第一章调查方法与范围

第二章执行摘要

第 3 章美国基于生物标记的免疫检测市场变数、趋势和范围

  • 市场体系展望
    • 母市场展望
    • 相关/辅助市场展望
  • 市场动态
    • 市场驱动因素分析
    • 市场限制因素分析
  • 美国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

第四章美国基于生物标记的免疫检测市场：样本估计和趋势分析

  • 细分仪表板
  • 美国基于生物标记的免疫检测市场的样本变异性分析
  • 美国基于生物标记的免疫检测市场规模和趋势分析（按样本类型），2021-2033 年
  • 血
  • 组织
  • 唾液
  • 尿

第五章美国基于生物标记的免疫检测市场：产品估计和趋势分析

  • 细分仪表板
  • 美国基于生物标记的免疫检测市场产品差异分析
  • 2021-2033 年美国基于生物标记的免疫检测市场规模及趋势分析（按产品）
  • 耗材
  • 仪器/分析仪
  • 试剂和套件
  • 服务

第六章美国基于生物标记的免疫检测市场：生物标记估计和趋势分析

  • 细分仪表板
  • 美国基于生物标记的免疫检测市场中的生物标记变异分析
  • 美国基于生物标记的免疫检测市场规模及趋势分析（2021-2033 年）
  • 安全性和毒性生物标记
  • 疗效和动态学生物标誌物
  • 预测和预后生物标记
  • 替代/探索性生物标誌物

第七章美国基于生物标记的免疫检测市场：疾病估计和趋势分析

  • 细分仪表板
  • 美国基于生物标记的免疫检测市场疾病趋势分析
    • 2021-2033 年美国基于生物标记的免疫检测市场规模及疾病趋势分析
  • 癌症
  • 心血管疾病
  • 神经系统疾病
  • 免疫疾病
  • 其他的

第八章美国基于生物标记的免疫检测市场：最终用途估计和趋势分析

  • 细分仪表板
  • 美国基于生物标记的免疫检测市场的最终用途变化分析
    • 美国基于生物标记的免疫检测市场规模及趋势分析（按最终用途），2021-2033
  • 医院和诊所
  • 诊断实验室
  • 研究和学术机构
  • 其他的

第九章 竞争态势

  • 公司/竞争对手分类
  • 战略地图
  • 2024年公司市占率分析
  • 主要认证提供者/计画所有者列表
  • 公司简介/上市公司
    • F. Hoffmann-La Roche AG
    • Abbott
    • Thermo Fisher Scientific Inc
    • Eurofins Scientific
    • QIAGEN
    • Bio-Rad Laboratories, Inc.
    • Siemens Healthineers AG
    • Merck KGaA
    • PerkinElmer Inc.
    • Agilent Technologies, Inc.
Product Code: GVR-4-68040-724-6

Market Size & Trends:

The U.S. biomarker-based immunoassays market size was estimated at USD 2.17 billion in 2024 and is projected to reach USD 3.68 billion by 2033, growing at a CAGR of 5.9% from 2025 to 2033. The market growth is fueled by the rising U.S. burden of chronic diseases such as cancer, cardiovascular disorders, and neurological conditions, which require precise and early diagnostic tools. A major driver shaping the scope of this market is the shift toward personalized medicine. Pharmaceutical and biotechnology companies increasingly depend on biomarker-based immunoassays to support companion diagnostics and patient stratification in clinical trials. This integration ensures that targeted therapies reach the right patient groups, improving therapeutic outcomes while reducing healthcare costs. The regulatory environment in the U.S. also plays a crucial role in shaping this scope.

Alongside therapeutic uses, the market is expanding due to technological progress and digital integration. Automated immunoassay platforms combined with artificial intelligence for data analysis are supporting high-throughput and very sensitive biomarker testing. This growth is not limited to central labs but also reaches decentralized healthcare models, like point-of-care and at-home testing options. The use of saliva-based biomarker immunoassays, which are less invasive and simpler to collect, presents another major opportunity within the market's evolving landscape.

Furthermore, the U.S. biomarker-based immunoassays market extends beyond healthcare delivery into research and academic institutions, where immunoassays are vital for biomarker discovery and validation. These institutions play a key role in driving innovation and forming partnerships with industry leaders, creating a cycle that supports new product development and clinical translation. Overall, the scope of the U.S. market is broad and dynamic, covering routine diagnostics, therapeutic monitoring, drug development, and academic research. This positions biomarker-based immunoassays as a fundamental technology within the evolving landscape of precision healthcare.

The demand for minimally invasive solutions has increased as clinicians look for reliable tools to detect diseases earlier and guide treatment decisions more accurately. This trend has led leading companies to focus on innovations in plasma and serum biomarkers, especially in fields such as oncology and neurology, where early diagnosis can greatly improve patient outcomes. In this context, several product innovations highlight the growing significance of blood-based biomarker immunoassays in clinical practice. For example, in April 2024 Roche's Elecsys pTau217 plasma biomarker test, developed with Eli Lilly, received Breakthrough Device Designation from the U.S. FDA, showing its potential to transform Alzheimer's diagnosis. This test helps healthcare providers identify amyloid pathology, a key aspect of Alzheimer's disease, which can enable earlier, more accurate diagnoses. By improving access to timely diagnosis, the test not only improves patient care but also encourages patient participation in clinical trials and access to disease-modifying treatments, further increasing the demand for innovative blood-based biomarker tests in the U.S.

U.S. Biomarker-Based Immunoassays Market Report Segmentation

This report forecasts revenue growth and provides an analysis on the latest trends in each of the sub-segments from 2021 to 2033. For the purpose of this report, Grand View Research has segmented the U.S biomarker-based immunoassays market on the basis sample, product, biomarkers, diseases, end use and region.

  • Sample Outlook (Revenue, USD Million, 2021 - 2033)
  • Blood
  • Tissue
  • Urine
  • Saliva
  • Product Outlook (Revenue, USD Million, 2021 - 2033)
  • Consumables
  • Instruments/Analyzers
  • Reagent & Kits
  • Services
  • Biomarker Outlook (Revenue, USD Million, 2021 - 2033)
  • Safety & toxicity biomarkers
  • Efficacy & Pharmacodynamic Biomarkers
  • Predictive & Prognostic Biomarkers
  • Surrogate/Exploratory Biomarkers
  • Diseases Outlook (Revenue, USD Million, 2021 - 2033)
  • Cancer
  • Cardiovascular Diseases
  • Neurological Diseases
  • Immunological Diseases
  • Others
  • End Use Outlook (Revenue, USD Million, 2021 - 2033)
  • Hospitals & Clinics
  • Diagnostic Laboratories
  • Research & Academic Institutes
  • Others

Table of Contents

Chapter 1. Methodology and Scope

  • 1.1. Market Segmentation & Scope
  • 1.2. Market Definitions
    • 1.2.1. Sample Segment
    • 1.2.2. Product Segment
    • 1.2.3. Biomarker Segment
    • 1.2.4. Diseases Segment
    • 1.2.5. End-use Segment
  • 1.3. Information analysis
    • 1.3.1. Market formulation & data visualization
  • 1.4. Data validation & publishing
  • 1.5. Information Procurement
    • 1.5.1. Primary Research
  • 1.6. Information or Data Analysis
  • 1.7. Market Formulation & Validation
  • 1.8. Market Biomarkerl
  • 1.9. Total Market: CAGR Calculation
  • 1.10. Objectives
    • 1.10.1. Objective 1
    • 1.10.2. Objective 2

Chapter 2. Executive Summary

  • 2.1. Market Outlook
  • 2.2. Segment Snapshot
  • 2.3. Competitive Insights Landscape

Chapter 3. U.S. Biomarker-Based Immunoassays Market Variables, Trends & Scope

  • 3.1. Market Lineage Outlook
    • 3.1.1. Parent market outlook
    • 3.1.2. Related/ancillary market outlook.
  • 3.2. Market Dynamics
    • 3.2.1. Market driver analysis
      • 3.2.1.1. Rising demand for precision medicine and personalized therapies
      • 3.2.1.2. Increasing prevalence of chronic and infectious diseases
      • 3.2.1.3. Technological advancements in immunoassay platforms
    • 3.2.2. Market restraint analysis
      • 3.2.2.1. High cost of advanced biomarker assays and platforms
  • 3.3. U.S. Biomarker-Based Immunoassays Market Analysis Tools
    • 3.3.1. Industry Analysis - Porter's
    • 3.3.2. PESTEL Analysis

Chapter 4. U.S. Biomarker-Based Immunoassays Market: Sample Estimates & Trend Analysis

  • 4.1. Segment Dashboard
  • 4.2. U.S. Biomarker-Based Immunoassays Market Sample Movement Analysis
  • 4.3. U.S. Biomarker-Based Immunoassays Market Size & Trend Analysis, by sample, 2021 to 2033 (USD Million)
  • 4.4. Blood
    • 4.4.1. Blood market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.5. Tissue
    • 4.5.1. Tissue market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.6. Saliva
    • 4.6.1. Saliva market estimates and forecasts 2021 to 2033 (USD Million)
  • 4.7. Urine
    • 4.7.1. Urine market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 5. U.S. Biomarker-Based Immunoassays Market: Product Estimates & Trend Analysis

  • 5.1. Segment Dashboard
  • 5.2. U.S. Biomarker-Based Immunoassays Market Product Movement Analysis
  • 5.3. U.S. Biomarker-Based Immunoassays Market Size & Trend Analysis, by product, 2021 to 2033 (USD Million)
  • 5.4. Consumables
    • 5.4.1. Consumables market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.5. Instruments/Analyzers
    • 5.5.1. Instruments/Analyzers market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.6. Reagent & Kits
    • 5.6.1. Reagent & kits market estimates and forecasts 2021 to 2033 (USD Million)
  • 5.7. Services
    • 5.7.1. Services market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 6. U.S. Biomarker-Based Immunoassays Market: Biomarker Estimates & Trend Analysis

  • 6.1. Segment Dashboard
  • 6.2. U.S. Biomarker-Based Immunoassays Market Biomarker Movement Analysis
  • 6.3. U.S. Biomarker-Based Immunoassays Market Size & Trend Analysis, by biomarkers, 2021 to 2033 (USD Million)
  • 6.4. Safety & toxicity biomarkers
    • 6.4.1. Safety & toxicity biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.5. Efficacy & Pharmacodynamic Biomarkers
    • 6.5.1. Efficacy & Pharmacodynamic Biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.6. Predictive & Prognostic Biomarkers
    • 6.6.1. Predictive & prognostic biomarkers market estimates and forecasts 2021 to 2033 (USD Million)
  • 6.7. Surrogate/Exploratory Biomarkers
    • 6.7.1. Surrogate/exploratory biomarkers market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 7. U.S. Biomarker-Based Immunoassays Market: Diseases Estimates & Trend Analysis

  • 7.1. Segment Dashboard
  • 7.2. U.S. Biomarker-Based Immunoassays Market Diseases Movement Analysis
    • 7.2.1. U.S. Biomarker-Based Immunoassays Market Size & Trend Analysis, by diseases, 2021 to 2033 (USD Million)
  • 7.3. Cancer
    • 7.3.1. Cancer market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.4. Cardiovascular Diseases
    • 7.4.1. Cardiovascular diseases market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.5. Neurological Diseases
    • 7.5.1. Neurological diseases market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.6. Immunological Diseases
    • 7.6.1. Immunological diseases testing market estimates and forecasts 2021 to 2033 (USD Million)
  • 7.7. Others
    • 7.7.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 8. U.S. Biomarker-Based Immunoassays Market: End-use Estimates & Trend Analysis

  • 8.1. Segment Dashboard
  • 8.2. U.S. Biomarker-Based Immunoassays Market End-use Movement Analysis
    • 8.2.1. U.S. Biomarker-Based Immunoassays Market Size & Trend Analysis, by End-use, 2021 to 2033 (USD Million)
  • 8.3. Hospitals & Clinics
    • 8.3.1. Hospitals and clinics market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.4. Diagnostic Laboratories
    • 8.4.1. Diagnostic Laboratories market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.5. Research & Academic Institutes
    • 8.5.1. Research & Academic Institutes market estimates and forecasts 2021 to 2033 (USD Million)
  • 8.6. Others
    • 8.6.1. Others market estimates and forecasts 2021 to 2033 (USD Million)

Chapter 9. Competitive Landscape

  • 9.1. Company/Competition Categorization
  • 9.2. Strategy Mapping
  • 9.3. Company Market Share Analysis, 2024
  • 9.4. List of Key Certification Providers/Scheme Owners
  • 9.5. Company Profiles/Listing
    • 9.5.1. F. Hoffmann-La Roche AG
      • 9.5.1.1. Company overview
      • 9.5.1.2. Financial performance
      • 9.5.1.3. Product benchmarking
      • 9.5.1.4. Strategic initiatives
    • 9.5.2. Abbott
      • 9.5.2.1. Company overview
      • 9.5.2.2. Financial performance
      • 9.5.2.3. Product benchmarking
      • 9.5.2.4. Strategic initiatives
    • 9.5.3. Thermo Fisher Scientific Inc
      • 9.5.3.1. Company overview
      • 9.5.3.2. Financial performance
      • 9.5.3.3. Product benchmarking
      • 9.5.3.4. Strategic initiatives
    • 9.5.4. Eurofins Scientific
      • 9.5.4.1. Company overview
      • 9.5.4.2. Financial performance
      • 9.5.4.3. Product benchmarking
      • 9.5.4.4. Strategic initiatives
    • 9.5.5. QIAGEN
      • 9.5.5.1. Company overview
      • 9.5.5.2. Financial performance
      • 9.5.5.3. Product benchmarking
      • 9.5.5.4. Strategic initiatives
    • 9.5.6. Bio-Rad Laboratories, Inc.
      • 9.5.6.1. Company overview
      • 9.5.6.2. Financial performance
      • 9.5.6.3. Product benchmarking
      • 9.5.6.4. Strategic initiatives
    • 9.5.7. Siemens Healthineers AG
      • 9.5.7.1. Company overview
      • 9.5.7.2. Financial performance
      • 9.5.7.3. Product benchmarking
      • 9.5.7.4. Strategic initiatives
    • 9.5.8. Merck KGaA
      • 9.5.8.1. Company overview
      • 9.5.8.2. Financial performance
      • 9.5.8.3. Product benchmarking
      • 9.5.8.4. Strategic initiatives
    • 9.5.9. PerkinElmer Inc.
      • 9.5.9.1. Company overview
      • 9.5.9.2. Financial performance
      • 9.5.9.3. Product benchmarking
      • 9.5.9.4. Strategic initiatives
    • 9.5.10. Agilent Technologies, Inc.
      • 9.5.10.1. Company overview
      • 9.5.10.2. Financial performance
      • 9.5.10.3. Product benchmarking
      • 9.5.10.4. Strategic initiatives

List of Tables

  • Table 1 List of Secondary Sources
  • Table 2 List of Abbreviation
  • Table 3 U.S. biomarker-based immunoassays market, by sample, 2021 - 2033 (USD Million)
  • Table 4 U.S. biomarker-based immunoassays market, by product, 2021 - 2033 (USD Million)
  • Table 5 U.S. biomarker-based immunoassays market, by biomarkers, 2021 - 2033 (USD Million)
  • Table 6 U.S. biomarker-based immunoassays market, by diseases, 2021 - 2033 (USD Million)
  • Table 7 U.S. biomarker-based immunoassays market, by end use, 2021 - 2033 (USD Million)

List of Figures

  • Fig. 1 U.S. biomarker-based immunoassays market segmentation
  • Fig. 2 Data analysis biomarkers
  • Fig. 3 Market formulation and validation
  • Fig. 4 Data validating & publishing
  • Fig. 5 Market research process
  • Fig. 6 Information procurement
  • Fig. 7 Primary research
  • Fig. 8 Value-chain-based sizing & forecasting
  • Fig. 9 QFD biomarker modelling for market share assessment
  • Fig. 10 Market formulation & validation
  • Fig. 11 Commodity flow analysis
  • Fig. 12 Market outlook
  • Fig. 13 Segment snapshot-1
  • Fig. 14 Segment snapshot-2
  • Fig. 15 Competitive landscape snapshot
  • Fig. 16 Market trends & outlook
  • Fig. 17 Porter's five force analysis
  • Fig. 18 PESTEL analysis
  • Fig. 19 U.S. biomarker-based immunoassays market: Sample outlook key takeaways
  • Fig. 20 U.S. biomarker-based immunoassays market: Sample movement analysis
  • Fig. 21 Blood market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 22 Tissue market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 23 Saliva market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 24 Urine market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 25 U.S. biomarker-based immunoassays market: Product outlook key takeaways
  • Fig. 26 U.S. biomarker-based immunoassays market: Product movement analysis
  • Fig. 27 Consumables market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 28 Instruments/Analyzers market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 29 Reagent & kits market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 30 Services market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 31 U.S. biomarker-based immunoassays market: Biomarker outlook key takeaways
  • Fig. 32 U.S. biomarker-based immunoassays market: Biomarker movement analysis
  • Fig. 33 Safety & toxicity biomarkers market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 34 Efficacy & pharmacodynamic biomarkers market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 35 Predictive & prognostic biomarkers market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 36 Surrogate/Exploratory biomarkers estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 37 U.S. biomarker-based immunoassays market: Biomarker outlook key takeaways
  • Fig. 38 U.S. biomarker-based immunoassays market: Biomarker movement analysis
  • Fig. 39 Cancer market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 40 Cardiovascular diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 41 Neurological diseases market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 42 Immunological diseases estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 43 Others market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 44 U.S. biomarker-based immunoassays market: End-use outlook key takeaways
  • Fig. 45 U.S. biomarker-based immunoassays market: End-use movement analysis
  • Fig. 46 Hospitals and clinics market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 47 Diagnostic laboratories market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 48 Research & academic institutes market estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 49 Others estimates and forecasts, 2021 - 2033 (USD Million)
  • Fig. 50 Biomarker-based immunoassays market: Regional outlook and key takeaways, 2024