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美國基於生物標記的免疫檢測市場規模、佔有率和趨勢分析報告：按樣本、產品、生物標記、疾病、最終用途和細分預測，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個工作天內

價格

市場規模與趨勢：

美國基於生物標記的免疫檢測市場規模預計在 2024 年達到 21.7 億美元，預計到 2033 年將達到 36.8 億美元，2025 年至 2033 年的複合年成長率為 5.9%。

市場成長的驅動力來自於美國日益加重的慢性疾病負擔，例如癌症、心血管疾病和神經系統疾病，這些疾病需要精準的早期診斷工具。塑造該市場規模的關鍵促進因素是向個人化醫療的轉變。製藥和生物技術公司越來越依賴基於生物標記的免疫檢測來支持臨床試驗中的伴隨診斷和患者分層。這種整合確保標靶治療能夠涵蓋合適的患者群體，從而改善治療效果並降低醫療成本。美國的法規環境也在塑造這一領域發揮關鍵作用。

除了治療用途之外，技術進步和數位化整合也在不斷拓展市場。自動化免疫檢測平台與人工智慧的結合，為數據分析提供了高通量和高靈敏度的生物標記檢測。這種成長不僅限於中心實驗室，還延伸至分散式醫療保健模式，例如即時檢測和居家檢測。基於唾液的生物標記免疫檢測因其微創性且易於採集，為不斷發展的市場格局帶來了另一個重大機會。

此外，美國基於生物標記的免疫檢測市場已超越醫療保健領域，涵蓋研究和學術機構，這些機構對於生物標記的發現和檢驗至關重要。這些研究機構在推動創新和與產業領袖建立夥伴關係方面發揮關鍵作用，從而形成了支持新產品開發和臨床應用的良性循環。整體而言，美國市場廣闊且充滿活力，涵蓋常規診斷、治療監測、藥物開發和學術研究。這使得基於生物標記的免疫檢測成為不斷發展的精準醫療領域的基礎技術。

隨著臨床醫生尋求可靠的工具來更早發現疾病並更準確地指導治療決策，對微創解決方案的需求正在成長。這一趨勢促使主要企業專注於血漿和血清生物標記創新，特別是在腫瘤學和神經病學等領域，早期診斷可顯著改善患者的預後。在此背景下，多項產品創新凸顯了血液生物標記免疫檢測在臨床實踐中日益成長的重要性。例如，2024 年 4 月，羅氏與禮來合作開發的 Elecsys pTau217 血漿生物標記測試獲得了美國FDA 的突破性設備稱號，展示了其改變阿茲海默症診斷的潛力。此測試可幫助醫療保健提供者識別澱粉樣蛋白病理（阿茲海默症的關鍵方面），從而實現更早、更準確的診斷。透過改善及時診斷的途徑，該測試不僅可以改善患者照護，還可以促進患者參與臨床試驗和獲得緩解疾病療法，進一步增加美國對創新血液生物標記測試的需求。

目錄

第1章調查方法與範圍

第2章執行摘要

第 3 章美國基於生物標記的免疫檢測市場變數、趨勢和範圍

  • 市場體系展望
    • 母市場展望
    • 相關/輔助市場展望
  • 市場動態
    • 市場促進因素分析
    • 市場限制因素分析
  • 美國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章美國基於生物標記的免疫檢測市場：樣本估計和趨勢分析

  • 細分儀表板
  • 美國基於生物標記的免疫檢測市場的樣本變異性分析
  • 美國基於生物標記的免疫檢測市場規模和趨勢分析（按樣本類型），2021-2033 年
  • 血
  • 組織
  • 唾液
  • 尿

第5章美國基於生物標記的免疫檢測市場：產品估計和趨勢分析

  • 細分儀表板
  • 美國基於生物標記的免疫檢測市場產品差異分析
  • 2021-2033 年美國基於生物標記的免疫檢測市場規模及趨勢分析（按產品）
  • 耗材
  • 儀器/分析儀
  • 試劑和套件
  • 服務

第6章美國基於生物標記的免疫檢測市場：生物標記估計和趨勢分析

  • 細分儀表板
  • 美國基於生物標記的免疫檢測市場中的生物標記變異分析
  • 美國基於生物標記的免疫檢測市場規模及趨勢分析（2021-2033 年）
  • 安全性和毒性生物標記
  • 療效和動態學生物標記
  • 預測和預後生物標記
  • 替代/探索性生物標記

第7章美國基於生物標記的免疫檢測市場：疾病估計和趨勢分析

  • 細分儀表板
  • 美國基於生物標記的免疫檢測市場疾病趨勢分析
    • 2021-2033 年美國基於生物標記的免疫檢測市場規模及疾病趨勢分析
  • 癌症
  • 心血管疾病
  • 神經系統疾病
  • 免疫疾病
  • 其他

第8章美國基於生物標記的免疫檢測市場：最終用途估計和趨勢分析

  • 細分儀表板
  • 美國基於生物標記的免疫檢測市場的最終用途變化分析
    • 美國基於生物標記的免疫檢測市場規模及趨勢分析（按最終用途），2021-2033
  • 醫院和診所
  • 診斷實驗室
  • 研究和學術機構
  • 其他

第9章 競爭態勢

  • 公司/競爭對手分類
  • 戰略地圖
  • 2024年公司市佔率分析
  • 主要認證提供者/計畫所有者列表
  • 公司簡介/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