미국의 알츠하이머병 진단용 혈액 기반 바이오마커 시장 규모, 점유율, 동향 분석 : 유형별, 기술별, 최종 용도별, 부문별 예측(2025-2033년)

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