美国阿兹海默症诊断血液生物标记市场规模、份额和趋势分析（按类型、技术、最终用途和细分市场预测），2025 年至 2033 年

市场规模与趋势：

预计 2024 年美国阿兹海默症诊断血液生物标记市场规模将达到 5,964 万美元，2025 年至 2033 年的复合年增长率将达到 14.60%。

这一增长的驱动因素包括阿兹海默症率的上升、对非侵入性诊断的需求不断增长，以及美国食品药物核准（FDA）批准血液体外诊断检测等监管部门的批准。超灵敏免疫测量和多重检测技术的进步，使血液生物标记成为早期检测和治疗的重要工具，进一步推动了其应用。

美国血液生物标记市场最重要的成长动力之一是FDA核准的体外诊断（IVD）检测方法的核准。 Lumipulse G pTau217/B-淀粉样蛋白1-42血浆比值检测就是一个很好的例子，该检测方法已于2025年获得上市许可（Grand View Research；GlobeNewswire）。监管部门的核准不仅降低了临床应用的门槛，也检验了血液检测的实际可靠性。同时，超灵敏免疫测量和人工智慧驱动的多重检测的进步正在提高诊断准确性。这些技术有助于减少对PET成像和腰椎穿刺等昂贵且侵入性方法的依赖。监管部门的核准和技术创新相结合，正在创造强劲的发展势头，增强医疗服务提供者、付款人和患者的信心。

人口趋势也是一个关键驱动因素。随着美国人口老化，失智症盛行率迅速上升，65岁及以上人口的盛行率约为4%，85岁及以上人口的盛行率约为13%（Grand View Research；GlobeNewswire）。这迫切需要扩充性的早期诊断解决方案。血液生物标记透过提供微创检测、实现早期疗育和简化患者护理途径来弥补这一差距。它们还支持向精准医疗的转变，即生物诊断指南治疗方法选择和监测。重要的是，抗淀粉样蛋白药物现在需要生物标记确认，这使得血液检测成为符合治疗评估条件的患者必不可少的第一线分诊工具。

目录

第 1 章美国阿兹海默症诊断血液生物标记市场：调查方法和范围

第 2 章美国阿兹海默症诊断血液生物标记市场：执行摘要

• 市场概述
• 类型和技术简介
• 最终用途简介
• 竞争格局简介

第三章美国阿兹海默症诊断血液生物标记市场变数、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/辅助市场展望
• 市场动态
• 市场驱动因素分析
  • 监管部门核准和临床检验
  • 对早期非侵入性诊断的需求不断增加
  • 与疾病修正治疗（DMTS）的整合
• 市场限制因素分析
  • 报销和覆盖范围挑战
  • 标准化和检验的障碍
• 波特五力分析
• PESTLE分析
• 管道分析

第四章美国阿兹海默症诊断市场血液生物标记：类型估计和趋势分析

• 美国阿兹海默症诊断血液生物标记市场：类型变异分析
• 淀粉样蛋白相关标记物
• Tau相关标誌物
• 神经退化
• 其他的

第五章美国阿兹海默症诊断血液生物标记市场：技术评估与趋势分析

• 美国阿兹海默症诊断血液生物标记市场：技术变革分析
• 免疫检测
• 基于质谱的检测
• 下一代平台
• 其他的

第六章美国阿兹海默症诊断血液生物标记市场：最终用途估计和趋势分析

• 美国阿兹海默症诊断血液生物标记市场：最终用途变异分析
• 临床和医院实验室
• 製药和生物技术
  • 2021-2033年收益估算与预测
• 学术研究机构
• 其他的

第七章 竞争态势

• 公司分类
• 战略地图
  • 新产品发布
  • 伙伴关係
  • 获得
  • 合作
  • 资金筹措
• 2024年主要企业市占率分析
• 公司热图分析
• 公司简介
  • 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