Product Code: GVR-4-68040-628-1
Market Size & Trends:
The U.S. Alzheimer's disease diagnostics market was valued at USD 3.53 billion in 2024 and is expected to grow at a CAGR of 10.6% from 2025 to 2030. This growth is driven by the rising prevalence of Alzheimer's disease and increasing emphasis on early and accurate diagnosis. According to the U.S. Centers for Disease Control and Prevention (CDC), approximately 6.7 million older adults in the U.S. were living with Alzheimer's disease in 2024, a number projected to nearly double by 2060. The growing prevalence of the disease prompted government and private healthcare bodies to invest heavily in advanced diagnostic technologies such as PET imaging, cerebrospinal fluid biomarkers, and blood-based diagnostics.
The growth of the U.S. Alzheimer's disease diagnostics market is due to the recent regulatory approval of advanced, non-invasive diagnostic technologies. The U.S. FDA granted marketing clearance for the first in vitro diagnostic device that utilizes a blood test to support the diagnosis of Alzheimer's disease. The Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio is specifically intended for the early detection of amyloid plaque accumulation, a hallmark of Alzheimer's pathology, in adult patients aged 55 years and older who are exhibiting clinical signs and symptoms consistent with cognitive impairment.
This development represents a major advancement in Alzheimer's diagnostics, significantly lowering access barriers by providing a cost-effective and minimally invasive alternative to PET scans and lumbar punctures, which often carry procedural risks. The FDA highlighted that this approval makes it easier and potentially more accessible for U.S. patients earlier in the disease. It underscores the test's value in facilitating timely intervention and clinical decision-making in the early stages of Alzheimer's disease progression.
The increasing rate of dementia diagnosis among older adults is driving the growth of the U.S. Alzheimer's diagnostics market. According to the 2022 National Health Interview Survey by the CDC, approximately 4% of individuals aged 65 and older have been diagnosed with dementia, with this figure rising to 13% among those aged 85 and above. This growth is primarily attributed to longer life expectancy, enhanced awareness, and improved diagnostic practices across clinical settings. The rising need for scalable, accurate diagnostic solutions to support early detection, appropriate intervention, and optimized care planning.
U.S. Alzheimer's Disease Diagnostics Market Report Segmentation
This report forecasts revenue growth at the country level and analyzes the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the U.S. Alzheimer's disease diagnostics market report based on diagnostic technique, type, and end-use:
- Diagnostic Technique Outlook (Revenue, USD Million, 2018 - 2030)
- Biomarkers
- CSF Biomarkers
- Blood-Based Biomarkers
- Imaging Diagnostic Techniques
- Genetic Testing
- Cognitive Assessment Tests
- Type Outlook (Revenue, USD Million, 2018 - 2030)
- Triage
- Diagnosis
- Screening
- End Use Outlook (Revenue, USD Million, 2018 - 2030)
- Hospitals
- Diagnostic Laboratories
- Academic & Research Institutes
Table of Contents
Chapter 1. Methodology and Scope
- 1.1. Market Segmentation and Scope
- 1.2. Market Definition
- 1.3. Information Procurement
- 1.3.1. Purchased Database
- 1.3.2. GVR's Internal Database
- 1.3.3. Secondary Sources and Third-Party Perspectives
- 1.3.4. Primary Research
- 1.4. Information Analysis
- 1.4.1. Data Analysis Models
- 1.5. Market Formulation and Data Visualization
- 1.6. Data Validation and Publishing
Chapter 2. Executive Summary
- 2.1. Market Snapshot
- 2.2. Segment Snapshot
- 2.3. Competitive Landscape Snapshot
Chapter 3. U.S. Alzheimer's Disease Diagnostics Market Variables, Trends and Scope
- 3.1. Market Lineage Outlook
- 3.2. Market Dynamics
- 3.2.1. Market Driver Analysis
- 3.2.2. Market Restraint Analysis
- 3.2.3. Industry Challenge
- 3.3. Industry Analysis Tools
- 3.3.1. PORTER's Analysis
- 3.3.1.1. Bargaining power of the suppliers
- 3.3.1.2. Bargaining power of the buyers
- 3.3.1.3. Threats of substitution
- 3.3.1.4. Threats from new entrants
- 3.3.1.5. Competitive rivalry
- 3.3.2. PESTEL Analysis
- 3.3.2.1. Political landscape
- 3.3.2.2. Economic and social landscape
- 3.3.2.3. Technological landscape
Chapter 4. U.S. Alzheimer's Disease Diagnostics Market: Diagnostic Technique Estimates and Trend Analysis
- 4.1. U.S. Alzheimer's Disease Diagnostics Market, By Diagnostic Technique: Key Takeaways
- 4.2. Diagnostic Technique Movement Analysis and Market Share, 2024 and 2030
- 4.3. Market Estimates and Forecasts, By Diagnostic Technique, 2018 - 2030 (USD Million)
- 4.3.1. Biomarkers
- 4.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.1.2. CSF Biomarkers
- 4.3.1.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.1.3. Blood-Based Biomarkers
- 4.3.1.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.2. Imaging Diagnostic Techniques
- 4.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.3. Genetic Testing
- 4.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 4.3.4. Cognitive Assessment Tests
- 4.3.4.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 5. U.S. Alzheimer's Disease Diagnostics Market: Type Estimates and Trend Analysis
- 5.1. U.S. Alzheimer's Disease Diagnostics Market, By Type: Key Takeaways
- 5.2. Type Movement Analysis and Market Share, 2024 and 2030
- 5.3. Market Estimates and Forecasts, By Type, 2018 - 2030 (USD Million)
- 5.3.1. Triage
- 5.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.3.2. Diagnosis
- 5.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 5.3.3. Screening
- 5.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 6. U.S. Alzheimer's Disease Diagnostics Market: End Use Estimates and Trend Analysis
- 6.1. U.S. Alzheimer's Disease Diagnostics Market, By End Use: Key Takeaways
- 6.2. End Use Movement Analysis and Market Share, 2024 and 2030
- 6.3. Market Estimates and Forecasts, By End Use, 2018 - 2030 (USD Million)
- 6.3.1. Hospitals
- 6.3.1.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.3.2. Diagnostic Laboratories
- 6.3.2.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
- 6.3.3. Academic and Research Institutes
- 6.3.3.1. Market Revenue Estimates and Forecasts, 2018 - 2030 (USD Million)
Chapter 7. Competitive Landscape
- 7.1. Company Categorization
- 7.2. Company Market Positioning
- 7.3. Company Heat Map Analysis
- 7.4. Company Profiles/Listing
- 7.4.1. GE HealthCare
- 7.4.1.1. Company Overview
- 7.4.1.2. Financial Performance
- 7.4.1.3. Diagnostic Technique Portfolio
- 7.4.1.4. Recent Developments/ Strategic Initiatives
- 7.4.2. Siemens Healthineers AG
- 7.4.2.1. Company Overview
- 7.4.2.2. Financial Performance
- 7.4.2.3. Diagnostic Technique Portfolio
- 7.4.2.4. Recent Developments/ Strategic Initiatives
- 7.4.3. Canon Medical Systems Corporation
- 7.4.3.1. Company Overview
- 7.4.3.2. Financial Performance
- 7.4.3.3. Diagnostic Technique Portfolio
- 7.4.3.4. Recent Developments/ Strategic Initiatives
- 7.4.4. Cerveau Technologies, Inc.
- 7.4.4.1. Company Overview
- 7.4.4.2. Financial Performance
- 7.4.4.3. Diagnostic Technique Portfolio
- 7.4.4.4. Recent Developments/ Strategic Initiatives
- 7.4.5. Neurovision Imaging, Inc.
- 7.4.5.1. Company Overview
- 7.4.5.2. Financial Performance
- 7.4.5.3. Diagnostic Technique Portfolio
- 7.4.5.4. Recent Developments/ Strategic Initiatives
- 7.4.6. Thermo Fisher Scientific Inc.
- 7.4.6.1. Company Overview
- 7.4.6.2. Financial Performance
- 7.4.6.3. Diagnostic Technique Portfolio
- 7.4.6.4. Recent Developments/ Strategic Initiatives
- 7.4.7. Bio-Rad Laboratories, Inc.
- 7.4.7.1. Company Overview
- 7.4.7.2. Financial Performance
- 7.4.7.3. Diagnostic Technique Portfolio
- 7.4.7.4. Recent Developments/ Strategic Initiatives
- 7.4.8. Quanterix Corporation
- 7.4.8.1. Company Overview
- 7.4.8.2. Financial Performance
- 7.4.8.3. Diagnostic Technique Portfolio
- 7.4.8.4. Recent Developments/ Strategic Initiatives
- 7.4.9. Alzheon Inc.
- 7.4.9.1. Company Overview
- 7.4.9.2. Financial Performance
- 7.4.9.3. Diagnostic Technique Portfolio
- 7.4.9.4. Recent Developments/ Strategic Initiatives
- 7.4.10. NanoSomiX, Inc.
- 7.4.10.1. Company Overview
- 7.4.10.2. Financial Performance
- 7.4.10.3. Diagnostic Technique Portfolio
- 7.4.10.4. Recent Developments/ Strategic Initiatives
- 7.4.11. DiamiR Biosciences
- 7.4.11.1. Company Overview
- 7.4.11.2. Financial Performance
- 7.4.11.3. Diagnostic Technique Portfolio
- 7.4.11.4. Recent Developments/ Strategic Initiatives