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/β-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, the analyst 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
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- Comprehensive Market Analysis: Gain detailed insights into the global market across major regions and segments.
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This report addresses:
- Market intelligence to enable effective decision-making
- Market estimates and forecasts from 2018 to 2030
- Growth opportunities and trend analyses
- Segment and regional revenue forecasts for market assessment
- Competition strategy and market share analysis
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Table of Contents
Chapter 1. Methodology and Scope
Chapter 2. Executive Summary
Chapter 3. U.S. Alzheimer’s Disease Diagnostics Market Variables, Trends and Scope
Chapter 4. U.S. Alzheimer’s Disease Diagnostics Market: Diagnostic Technique Estimates and Trend Analysis
Chapter 5. U.S. Alzheimer’s Disease Diagnostics Market: Type Estimates and Trend Analysis
Chapter 6. U.S. Alzheimer’s Disease Diagnostics Market: End Use Estimates and Trend Analysis
Chapter 7. Competitive Landscape
List of Tables
List of Figures
Companies Mentioned
- GE HealthCare
- Siemens Healthineers AG
- Canon Medical Systems Corporation
- Cerveau Technologies, Inc.
- Neurovision Imaging, Inc.
- Thermo Fisher Scientific Inc.
- Bio-Rad Laboratories, Inc.
- Quanterix Corporation
- Alzheon Inc.
- NanoSomiX, Inc.
- DiamiR Biosciences
Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 80 |
| Published | June 2025 |
| Forecast Period | 2024 - 2030 |
| Estimated Market Value ( USD | $ 3.53 Billion |
| Forecasted Market Value ( USD | $ 6.43 Billion |
| Compound Annual Growth Rate | 10.6% |
| Regions Covered | United States |
| No. of Companies Mentioned | 11 |
