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 Blood-based Biomarker For Alzheimers Disease Diagnostics Market Size, Share & Trends Analysis Report By Type (Amyloid-related Markers, Tau-related Markers, Neurodegeneration), By Technology (Immunoassays), By End-use, By Region, And Segment Forecasts, 2025 - 2033
Blood-based Biomarker For Alzheimer’s Disease Diagnostics Market Summary The global blood-based biomarker for Alzheimer’s disease diagnostics market size was estimated at USD 139.69 million in 2... もっと見る
SummaryBlood-based Biomarker For Alzheimer’s Disease Diagnostics Market SummaryThe global blood-based biomarker for Alzheimer’s disease diagnostics market size was estimated at USD 139.69 million in 2024 and is expected to reach USD 429.31 million by 2033, growing at a CAGR of 15.07% from 2025 to 2033. A pivotal catalyst was the U.S. FDA’s May 16, 2025, marketing clearance of Fujirebio’s Lumipulse G pTau217/β-amyloid 1-42 plasma ratio-the first Alzheimer’s blood test cleared to aid diagnosis-quickly followed by Labcorp’s nationwide launch on Aug 18, 2025. These steps lower adoption friction (regulatory clarity, distribution) and are expected to accelerate payer uptake and clinician ordering, intensifying the growth curve for blood tests relative to imaging and CSF. Guidance presented at AAIC 2025 and published by the Alzheimer’s Association states that blood-based biomarker (BBM) tests with ≥90% sensitivity and ≥75-90% specificity can triage-and at higher performance, substitute for-amyloid PET or CSF testing in appropriate patients. p-tau217-containing panels consistently outperform earlier generations (Aβ42/40 or p-tau181 alone) for detecting amyloid and tau pathology. Real-world product data are converging: Quest’s 2025 AD-Detect™ reported >90% sensitivity and specificity for Alzheimer’s pathology in AAN-presented analyses, while clinical summaries highlight ~92% positive and ~97% negative agreement for the FDA-cleared Lumipulse test. As clinicians gain confidence in rule-in/rule-out accuracy, ordering shifts from specialty memory clinics to broader frontline settings, expanding test volumes and normalizing BBMs as the first diagnostic step. Technology maturation and clinical validation add momentum. Blood assays targeting phosphorylated tau (especially p-tau217) have received Breakthrough Device designations and now full FDA clearance, reflecting strong clinical validity and utility. Academic-industry consortia (e.g., UW-Madison, Johns Hopkins, Lund) supplied pivotal data underpinning the cleared IVD. Published reviews conclude that blood-based biomarker tests (BBMTs) bring value by reducing invasiveness and enabling earlier triage-crucial when disease-modifying therapies are most effective in prodromal/mild stages. Market traction examples include reference-lab launches and hospital adoption for memory-clinic pathways, where a positive p-tau217/Aβ ratio can expedite PET scheduling while a negative result can avoid costly scans. As platforms scale, expect menu expansion (neurofilament light, GFAP, Aβ42/40), reflex algorithms, and bundled panels, improving sensitivity/specificity and supporting longitudinal monitoring-opening recurring-test revenue beyond one-time diagnosis. Global Blood-based Biomarker For Alzheimer’s Disease Diagnostics Market Report Segmentation This report forecasts revenue growth at the global, regional and country levels and provides an analysis of the latest trends in each of the sub-segments from 2021 to 2033. For this study, Grand View Research has segmented the global blood-based biomarker for Alzheimer’s disease diagnostics market report based on type, technology, end-use, and region: • Type Outlook (Revenue, USD Million, 2021 - 2033) • Amyloid-related markers • Tau-related markers • Neurodegeneration • Others • Technology Outlook (Revenue, USD Million, 2021 - 2033) • Immunoassays • Mass spectrometry-based assays • Next-generation platforms • Others • End-use Outlook (Revenue, USD Million, 2021 - 2033) • Clinical laboratories & hospital labs • Pharma & biotech • Academic & research institutes • Others • Regional Outlook (Revenue, USD Million, 2021 - 2033) • North America o U.S. o Canada o Mexico • Europe o UK o Germany o France o Italy o Spain o Denmark o Sweden o Norway • Asia Pacific o Japan o China o India o Australia o South Korea o Thailand • Latin America o Brazil o Argentina • Middle East & Africa o South Africa o Saudi Arabia o UAE o Kuwait Table of ContentsTable of ContentsChapter 1. 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. Regional Scope 1.3. Estimates and Forecast Timeline 1.4. Objectives 1.4.1. Objective - 1 1.4.2. Objective - 2 1.4.3. Objective - 3 1.5. Research Methodology 1.6. Information Procurement 1.6.1. Purchased Database 1.6.2. GVR’s Internal Database 1.6.3. Secondary Sources 1.6.4. Primary Research 1.7. Information or Data Analysis 1.7.1. Data Analysis Models 1.8. Market Formulation & Validation 1.9. Model Details 1.9.1. Commodity Flow Analysis 1.10. List of Secondary Sources 1.11. List of Abbreviations Chapter 2. 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. 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. Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market: Type Estimates & Trend Analysis 4.1. 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. Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market: Technology Estimates & Trend Analysis 5.1. 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. Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market: End Use Estimates & Trend Analysis 6.1. 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. Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market: Regional Business Analysis 7.1. Regional Market Snapshot 7.2. North America 7.2.1. North America Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market Estimates And Forecast, 2021 - 2033 (USD Million) 7.2.2. U.S. 7.2.2.1. U.S. Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.2.2.2. Key Country Dynamics 7.2.2.3. Regulatory Framework 7.2.2.4. Reimbursement Scenario 7.2.2.5. Competitive Scenario 7.2.3. Canada 7.2.3.1. Canada Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.2.3.2. Key Country Dynamics 7.2.3.3. Regulatory Framework 7.2.3.4. Reimbursement Scenario 7.2.3.5. Competitive Scenario 7.2.4. Mexico 7.2.4.1. Mexico Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.2.4.2. Key Country Dynamics 7.2.4.3. Regulatory Framework 7.2.4.4. Reimbursement Scenario 7.2.4.5. Competitive Scenario 7.3. Europe 7.3.1. Europe Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.2. UK 7.3.2.1. UK Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.2.2. Key Country Dynamics 7.3.2.3. Regulatory Framework 7.3.2.4. Reimbursement Scenario 7.3.2.5. Competitive Scenario 7.3.3. Germany 7.3.3.1. Germany Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.3.2. Key Country Dynamics 7.3.3.3. Regulatory Framework 7.3.3.4. Reimbursement Scenario 7.3.3.5. Competitive Scenario 7.3.4. Spain 7.3.4.1. Spain Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.4.2. Key Country Dynamics 7.3.4.3. Regulatory Framework 7.3.4.4. Reimbursement Scenario 7.3.4.5. Competitive Scenario 7.3.5. France 7.3.5.1. France Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.5.2. Key Country Dynamics 7.3.5.3. Regulatory Framework 7.3.5.4. Reimbursement Scenario 7.3.5.5. Competitive Scenario 7.3.6. Italy 7.3.6.1. Italy Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.6.2. Key Country Dynamics 7.3.6.3. Regulatory Framework 7.3.6.4. Reimbursement Scenario 7.3.6.5. Competitive Scenario 7.3.7. Denmark 7.3.7.1. Denmark Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.7.2. Key Country Dynamics 7.3.7.3. Regulatory Framework 7.3.7.4. Reimbursement Scenario 7.3.7.5. Competitive Scenario 7.3.8. Sweden 7.3.8.1. Sweden Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.8.2. Key Country Dynamics 7.3.8.3. Regulatory Framework 7.3.8.4. Reimbursement Scenario 7.3.8.5. Competitive Scenario 7.3.9. Norway 7.3.9.1. Norway Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.3.9.2. Key Country Dynamics 7.3.9.3. Regulatory Framework 7.3.9.4. Reimbursement Scenario 7.3.9.5. Competitive Scenario 7.4. Asia Pacific 7.4.1. Asia-Pacific Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.2. Japan 7.4.2.1. Japan Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.2.2. Key Country Dynamics 7.4.2.3. Regulatory Framework 7.4.2.4. Reimbursement Scenario 7.4.2.5. Competitive Scenario 7.4.3. China 7.4.3.1. China Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.3.2. Key Country Dynamics 7.4.3.3. Regulatory Framework 7.4.3.4. Reimbursement Scenario 7.4.3.5. Competitive Scenario 7.4.4. India 7.4.4.1. India Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.4.2. Key Country Dynamics 7.4.4.3. Regulatory Framework 7.4.4.4. Reimbursement Scenario 7.4.4.5. Competitive Scenario 7.4.5. South Korea 7.4.5.1. South Korea Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.5.2. Key Country Dynamics 7.4.5.3. Regulatory Framework 7.4.5.4. Reimbursement Scenario 7.4.5.5. Competitive Scenario 7.4.6. Thailand 7.4.6.1. Thailand Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.6.2. Key Country Dynamics 7.4.6.3. Regulatory Framework 7.4.6.4. Reimbursement Scenario 7.4.6.5. Competitive Scenario 7.4.7. Australia 7.4.7.1. Australia Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.4.7.2. Key Country Dynamics 7.4.7.3. Regulatory Framework 7.4.7.4. Reimbursement Scenario 7.4.7.5. Competitive Scenario 7.5. Latin America 7.5.1. Latin America Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.5.2. Brazil 7.5.2.1. Brazil Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.5.2.2. Key Country Dynamics 7.5.2.3. Regulatory Framework 7.5.2.4. Reimbursement Scenario 7.5.2.5. Competitive Scenario 7.5.3. Argentina 7.5.3.1. Argentina Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.5.3.2. Key Country Dynamics 7.5.3.3. Regulatory Framework 7.5.3.4. Reimbursement Scenario 7.5.3.5. Competitive Scenario 7.6. MEA 7.6.1. MEA Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.6.2. South Africa 7.6.2.1. South Africa Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.6.2.2. Key Country Dynamics 7.6.2.3. Regulatory Framework 7.6.2.4. Reimbursement Scenario 7.6.2.5. Competitive Scenario 7.6.3. Saudi Arabia 7.6.3.1. Saudi Arabia Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.6.3.2. Key Country Dynamics 7.6.3.3. Regulatory Framework 7.6.3.4. Reimbursement Scenario 7.6.3.5. Competitive Scenario 7.6.4. UAE 7.6.4.1. UAE Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.6.4.2. Key Country Dynamics 7.6.4.3. Regulatory Framework 7.6.4.4. Reimbursement Scenario 7.6.4.5. Competitive Scenario 7.6.5. Kuwait 7.6.5.1. Kuwait Blood-based Biomarker for Alzheimer’s Disease Diagnostics Market, 2021 - 2033 (USD Million) 7.6.5.2. Key Country Dynamics 7.6.5.3. Regulatory Framework 7.6.5.4. Reimbursement Scenario 7.6.5.5. Competitive Scenario Chapter 8. Competitive Landscape 8.1. Company Categorization 8.2. Strategy Mapping 8.2.1. New Production Launch 8.2.2. Patnerships 8.2.3. Acquisition 8.2.4. Collaboration 8.2.5. Funding 8.3. Key Company Market Share Analysis, 2024 8.4. Company Heat Map Analysis 8.5. Company Profiles 8.5.1. F. Hoffmann-La Roche Ltd 8.5.1.1. Company Overview 8.5.1.2. Financial Performance 8.5.1.3. Product Benchmarking 8.5.1.4. Strategic Initiatives 8.5.2. Quanterix 8.5.2.1. Company Overview 8.5.2.2. Financial Performance 8.5.2.3. Product Benchmarking 8.5.2.4. Strategic Initiatives 8.5.3. Fujirebio 8.5.3.1. Company Overview 8.5.3.2. Financial Performance 8.5.3.3. Product Benchmarking 8.5.3.4. Strategic Initiatives 8.5.4. C2N Diagnostics 8.5.4.1. Company Overview 8.5.4.2. Financial Performance 8.5.4.3. Product Benchmarking 8.5.4.4. Strategic Initiatives 8.5.5. Labcorp 8.5.5.1. Company Overview 8.5.5.2. Financial Performance 8.5.5.3. Product Benchmarking 8.5.5.4. Strategic Initiatives 8.5.6. Quest Diagnostics Incorporated 8.5.6.1. Company Overview 8.5.6.2. Financial Performance 8.5.6.3. Product Benchmarking 8.5.6.4. Strategic Initiatives 8.5.7. Siemens Healthineers 8.5.7.1. Company Overview 8.5.7.2. Financial Performance 8.5.7.3. Product Benchmarking 8.5.7.4. Strategic Initiatives 8.5.8. Lilly USA, LLC 8.5.8.1. Company Overview 8.5.8.2. Financial Performance 8.5.8.3. Product Benchmarking 8.5.8.4. Strategic Initiatives 8.5.9. Abbott 8.5.9.1. Company Overview 8.5.9.2. Financial Performance 8.5.9.3. Product Benchmarking 8.5.9.4. Strategic Initiatives 8.5.10. ALZpath 8.5.10.1. Company Overview 8.5.10.2. Financial Performance 8.5.10.3. Product Benchmarking 8.5.10.4. Strategic Initiatives
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