美國阿茲海默症診斷血液生物標記市場規模、佔有率和趨勢分析（按類型、技術、最終用途和細分市場預測），2025 年至 2033 年

市場規模與趨勢：

預計 2024 年美國阿茲海默症診斷血液生物標記市場規模將達到 5,964 萬美元，2025 年至 2033 年的複合年成長率將達到 14.60%。

這一成長的促進因素包括阿茲海默症率的上升、對非侵入性診斷的需求不斷成長，以及美國食品藥物核准（FDA）批准血液體外診斷檢測等監管部門的批准。超靈敏免疫測量和多重檢測技術的進步，使血液生物標記成為早期檢測和治療的重要工具，進一步推動了其應用。

美國血液生物標記市場最重要的成長動力之一是FDA核准的體外診斷（IVD）檢測方法的核准。 Lumipulse G pTau217/B-澱粉樣蛋白1-42血漿比值檢測就是一個很好的例子，該檢測方法已於2025年獲得上市許可（Grand View Research；GlobeNewswire）。監管部門的核准不僅降低了臨床應用的門檻，也檢驗了血液檢測的實際可靠性。同時，超靈敏免疫測量和人工智慧驅動的多重檢測的進步正在提高診斷準確性。這些技術有助於減少對PET成像和腰椎穿刺等昂貴且侵入性方法的依賴。監管部門的核准和技術創新相結合，正在創造強勁的發展勢頭，增強醫療服務提供者、付款人和患者的信心。

人口趨勢也是一個關鍵促進因素。隨著美國人口老化，失智症盛行率迅速上升，65歲及以上人口的盛行率約為4%，85歲及以上人口的盛行率約為13%（Grand View Research；GlobeNewswire）。這迫切需要擴充性的早期診斷解決方案。血液生物標記透過提供微創檢測、實現早期療育和簡化患者護理途徑來彌補這一差距。它們還支持向精準醫療的轉變，即生物診斷指南治療方法選擇和監測。重要的是，抗澱粉樣蛋白藥物現在需要生物標記確認，這使得血液檢測成為符合治療評估條件的患者必不可少的第一線分診工具。

目錄

第 1 章美國阿茲海默症診斷血液生物標記市場：調查方法和範圍

第 2 章美國阿茲海默症診斷血液生物標記市場：執行摘要

• 市場概述
• 類型和技術簡介
• 最終用途簡介
• 競爭格局簡介

第3章美國阿茲海默症診斷血液生物標記市場變數、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/輔助市場展望
• 市場動態
• 市場促進因素分析
  • 監管部門核准和臨床檢驗
  • 對早期非侵入性診斷的需求不斷增加
  • 與疾病修正治療（DMTS）的整合
• 市場限制因素分析
  • 報銷和覆蓋範圍挑戰
  • 標準化和檢驗的障礙
• 波特五力分析
• PESTLE分析
• 管道分析

第4章美國阿茲海默症診斷市場血液生物標記：類型估計和趨勢分析

• 美國阿茲海默症診斷血液生物標記市場：類型變異分析
• 澱粉樣蛋白相關標記物
• Tau相關標誌物
• 神經退化
• 其他

第5章美國阿茲海默症診斷血液生物標記市場：技術評估與趨勢分析

• 美國阿茲海默症診斷血液生物標記市場：技術變革分析
• 免疫檢測
• 基於質譜的檢測
• 下一代平台
• 其他

第6章美國阿茲海默症診斷血液生物標記市場：最終用途估計和趨勢分析

• 美國阿茲海默症診斷血液生物標記市場：最終用途變異分析
• 臨床和醫院實驗室
• 製藥和生物技術
  • 2021-2033年收益估算與預測
• 學術研究機構
• 其他

第7章 競爭態勢

• 公司分類
• 戰略地圖
  • 新產品發布
  • 夥伴關係
  • 獲得
  • 合作
  • 資金籌措
• 2024年主要企業市佔率分析
• 公司熱圖分析
• 公司簡介
  • F. Hoffmann-La Roche Ltd
  • Quanterix
  • Fujirebio
  • C2N Diagnostics
  • Labcorp
  • Quest Diagnostics Incorporated
  • Siemens Healthineers
  • Diadem srl
  • Abbott
  • BioArctic
  • Grifols

Market Size & Trends:

The U.S. blood-based biomarker for alzheimer's disease diagnostics market size was estimated at USD 59.64 million in 2024 and is expected to grow at a CAGR of 14.60% from 2025 to 2033. This growth is fueled by rising Alzheimer's prevalence, increasing demand for non-invasive diagnostics, and regulatory approvals such as the FDA's clearance of blood-based IVD assays. Technological advancements in ultrasensitive immunoassays and multiplex testing further support adoption, positioning blood biomarkers as essential tools in early detection and treatment pathways.

One of the most significant growth drivers for the U.S. blood-based biomarker market is the approval of FDA-cleared IVD assays. A prime example is the Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio, which gained marketing authorization in 2025 (Grand View Research; GlobeNewswire). Regulatory recognition not only lowers clinical adoption barriers but also validates the reliability of blood-based tests in practice. At the same time, advances in ultra-sensitive immunoassays and AI-powered multiplex testing are enhancing diagnostic accuracy. These technologies help reduce dependence on costly, invasive methods such as PET imaging and lumbar punctures. The combination of regulatory approval and innovation is creating strong momentum, boosting confidence among healthcare providers, payers, and patients alike

Demographic trends are another critical driver. As the U.S. population ages, the prevalence of dementia is rising rapidly-about 4% of individuals aged 65+ are affected, and the rate climbs to 13% among those over 85 (Grand View Research; GlobeNewswire). This has created an urgent need for scalable, early diagnostic solutions. Blood-based biomarkers address this gap by offering less invasive testing, enabling earlier intervention, and streamlining patient care pathways. They also support the shift toward precision medicine, where biologically driven diagnostics guide therapy selection and monitoring. Importantly, anti-amyloid drugs now require biomarker confirmation of pathology, making blood tests an essential first-line triage tool for patients being evaluated for treatment.

U.S. Blood-based Biomarker For Alzheimer's Disease Diagnostics Market Report Segmentation

This report forecasts revenue growth at country level 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. blood-based biomarker for alzheimer's disease diagnostics market based on type, technology, and end use:

• Type Outlook (USD Million, 2021 - 2033)
  • Amyloid-related markers
  • Tau-related markers
  • Neurodegeneration
  • Others
• Technology Outlook (USD Million, 2021 - 2033)
  • Immunoassays
  • Mass spectrometry-based assays
  • Next-generation platforms
  • Others
• End Use Outlook (USD Million, 2021 - 2033)
  • Clinical laboratories & hospital labs
  • Pharma & biotech
  • Academic & research institutes
  • Others

Table of Contents

Chapter 1. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Methodology and Scope

• 1.1. Market Segmentation and Scope
  • 1.1.1. Segment Definitions
    • 1.1.1.1. Type Segment
    • 1.1.1.2. Technology Segment
    • 1.1.1.3. End Use Segment
• 1.2. Estimates and Forecast Timeline
• 1.3. Objectives
  • 1.3.1. Objective - 1
  • 1.3.2. Objective - 2
  • 1.3.3. Objective - 3
• 1.4. Research Methodology
• 1.5. Information Procurement
  • 1.5.1. Purchased Database
  • 1.5.2. GVR's Internal Database
  • 1.5.3. Secondary Sources
  • 1.5.4. Primary Research
• 1.6. Information or Data Analysis
  • 1.6.1. Data Analysis Models
• 1.7. Market Formulation & Validation
• 1.8. Model Details
  • 1.8.1. Commodity Flow Analysis
• 1.9. List of Secondary Sources
• 1.10. List of Abbreviations

Chapter 2. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Executive Summary

• 2.1. Market Snapshot
• 2.2. Type and Technology Snapshot
• 2.3. End Use Snapshot
• 2.4. Competitive Landscape Snapshot

Chapter 3. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics 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
• 3.4. Market Drivers Analysis
  • 3.4.1. Regulatory approvals and clinical validation
  • 3.4.2. Rising demand for early and non-invasive diagnosis
  • 3.4.3. Integration with disease-modifying therapies (DMTS)
• 3.5. Market Restraint Analysis
  • 3.5.1. Reimbursement and coverage challenges
  • 3.5.2. Standardization and validation barriers
• 3.6. Porter's Five Forces Analysis
• 3.7. PESTLE Analysis
• 3.8. Pipeline Analysis

Chapter 4. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Type Estimates & Trend Analysis

• 4.1. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Type Movement Analysis
• 4.2. Amyloid-related markers
  • 4.2.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.3. Tau-related markers
  • 4.3.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.4. Neurodegeneration
  • 4.4.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)
• 4.5. Others
  • 4.5.1. Market Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 5. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Technology Estimates & Trend Analysis

• 5.1. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: Technology Movement Analysis
• 5.2. Immunoassays
  • 5.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.3. Mass spectrometry-based assays
  • 5.3.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.4. Next-generation platforms
  • 5.4.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 5.5. Others
  • 5.5.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)

Chapter 6. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: End Use Estimates & Trend Analysis

• 6.1. U.S. Blood-based Biomarker for Alzheimer's Disease Diagnostics Market: End Use Movement Analysis
• 6.2. Clinical laboratories & hospital labs
  • 6.2.1. Market Revenue Estimates and Forecasts, 2021 - 2033 (USD Million)
• 6.3. Pharma & biotech
  • 6.3.1. 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. Others
  • 6.5.1. 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 PRODUCT 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. F. Hoffmann-La Roche Ltd
    • 7.5.1.1. Company Overview
    • 7.5.1.2. Financial Performance
    • 7.5.1.3. Product Benchmarking
    • 7.5.1.4. Strategic Initiatives
  • 7.5.2. Quanterix
    • 7.5.2.1. Company Overview
    • 7.5.2.2. Financial Performance
    • 7.5.2.3. Product Benchmarking
    • 7.5.2.4. Strategic Initiatives
  • 7.5.3. Fujirebio
    • 7.5.3.1. Company Overview
    • 7.5.3.2. Financial Performance
    • 7.5.3.3. Product Benchmarking
    • 7.5.3.4. Strategic Initiatives
  • 7.5.4. C2N Diagnostics
    • 7.5.4.1. Company Overview
    • 7.5.4.2. Financial Performance
    • 7.5.4.3. Product Benchmarking
    • 7.5.4.4. Strategic Initiatives
  • 7.5.5. Labcorp
    • 7.5.5.1. Overview
    • 7.5.5.2. Financial Performance
    • 7.5.5.3. Product Benchmarking
    • 7.5.5.4. Strategic Initiatives
  • 7.5.6. Quest Diagnostics Incorporated
    • 7.5.6.1. Company Overview
    • 7.5.6.2. Financial Performance
    • 7.5.6.3. Product Benchmarking
    • 7.5.6.4. Strategic Initiatives
  • 7.5.7. Siemens Healthineers
    • 7.5.7.1. Company Overview
    • 7.5.7.2. Financial Performance
    • 7.5.7.3. Product Benchmarking
    • 7.5.7.4. Strategic Initiatives
  • 7.5.8. Diadem srl
    • 7.5.8.1. Company Overview
    • 7.5.8.2. Financial Performance
    • 7.5.8.3. Product Benchmarking
    • 7.5.8.4. Strategic Initiatives
  • 7.5.9. Abbott
    • 7.5.9.1. Company Overview
    • 7.5.9.2. Financial Performance
    • 7.5.9.3. Product Benchmarking
    • 7.5.9.4. Strategic Initiatives
  • 7.5.10. BioArctic
    • 7.5.10.1. Company Overview
    • 7.5.10.2. Financial Performance
    • 7.5.10.3. Product Benchmarking
    • 7.5.10.4. Strategic Initiatives
  • 7.5.11. Grifols
    • 7.5.11.1. Company Overview
    • 7.5.11.2. Financial Performance
    • 7.5.11.3. Product Benchmarking
    • 7.5.11.4. Strategic Initiatives

List of Tables

• Table 1 List Of Abbreviation
• Table 2 U.S. Blood-Based Biomarker For Alzheimer's Disease Diagnostics Market, By Type, 2021 - 2033 (USD Million)
• Table 3 U.S. Blood-Based Biomarker For Alzheimer's Disease Diagnostics Market, By Technology, 2021 - 2033 (USD Million)
• Table 4 U.S. Blood-Based Biomarker For Alzheimer's Disease Diagnostics Market, By End Use, 2021 - 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. blood-based biomarker for Alzheimer's disease diagnostics market - Key market driver analysis
• Fig. 7 U.S. blood-based biomarker for Alzheimer's disease diagnostics market - Key market restraint analysis
• Fig. 8 Penetration & growth prospect mapping
• Fig. 9 U.S. blood-based biomarker for Alzheimer's disease diagnostics market - Porter's analysis
• Fig. 10 U.S. blood-based biomarker for Alzheimer's disease diagnostics market - PESTEL analysis
• Fig. 11 U.S. blood-based biomarker for Alzheimer's disease diagnostics market Type outlook key takeaways
• Fig. 12 U.S. blood-based biomarker for Alzheimer's disease diagnostics market : Type movement analysis
• Fig. 13 Amyloid-related markers market estimates, 2021 - 2033 (USD Million)
• Fig. 14 Tau-related markers market estimates, 2021 - 2033 (USD Million)
• Fig. 15 Neurodegeneration market estimates, 2021 - 2033 (USD Million)
• Fig. 16 Others market estimates, 2021 - 2033 (USD Million)
• Fig. 17 U.S. blood-based biomarker for Alzheimer's disease diagnostics market technology outlook key takeaways
• Fig. 18 U.S. blood-based biomarker for Alzheimer's disease diagnostics market : technology movement analysis
• Fig. 19 Immunoassays market estimates, 2021 - 2033 (USD Million)
• Fig. 20 Mass spectrometry-based assays market estimates, 2021 - 2033 (USD Million)
• Fig. 21 Next-generation platforms market estimates, 2021 - 2033 (USD Million)
• Fig. 22 Others market estimates, 2021 - 2033 (USD Million)
• Fig. 23 U.S. blood-based biomarker for Alzheimer's disease diagnostics market end use outlook key takeaways
• Fig. 24 U.S. blood-based biomarker for Alzheimer's disease diagnostics market : end use movement analysis
• Fig. 25 Clinical laboratories & hospital labs market estimates, 2021 - 2033 (USD Million)
• Fig. 26 Pharma & biotech market estimates, 2021 - 2033 (USD Million)
• Fig. 27 Academic & research institutes market estimates, 2021 - 2033 (USD Million)
• Fig. 28 Others market estimates, 2021 - 2033 (USD Million)
• Fig. 29 Regional marketplace: Key takeaways
• Fig. 30 Strategy framework