U.S. Alzheimer’s Disease Diagnostics Market Size, Share & Trends Analysis Report By Diagnostic Technique (Biomarkers, Imaging Techniques, Genetic Testing, Cognitive Assessment Tests), By Type, By End-use, And Segment Forecasts, 2025 - 2030

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.

Market Concentration & Characteristics

The U.S. market demonstrates great innovation, particularly in developing non-invasive, blood-based biomarker tests. These advancements are expected to improve accessibility and clinical adoption of innovative diagnostic solutions, enabling early detection and cost-effective processes. While progress is substantial, further innovation is needed to enhance accuracy in early-stage and asymptomatic populations. In April 2025, Labcorp, a global company in innovative and comprehensive laboratory services, announced the nationwide launch of pTau-217/Beta Amyloid 42 Ratio, a blood-based test designed to support the detection of amyloid-related pathology linked with Alzheimer’s disease.

The level of mergers and acquisitions (M&A) in this market is moderate, driven by strategic interest from diagnostics companies looking to expand their neurology portfolios. Firms such as Roche, Quanterix, and Eli Lilly have pursued strategic advancements including acquisitions to improve their market share and enhance portfolio offerings. In May 2025, Algernon Pharmaceuticals Inc., a healthcare and clinical-stage drug development company, completed the acquisition of NoBrainer Imaging Centers, Inc. (NIC). The transaction marks Algernon’s entry into the Alzheimer’s disease (AD) diagnostics and treatment market. It builds on its existing neurological research programs, while leveraging exclusive master franchise and licensing rights to establish AD screening, diagnostic, and treatment centers across multiple U.S. locations.

CMS reimbursement policies and clinical trial standards further impact provider uptake and payer decisions. Within this highly regulated environment, product and service expansion is progressing steadily, driven by growing demand and active R&D. Companies are broadening their offerings through multi-modal solutions that combine biomarker data with digital cognitive tools. However, expansion is tempered by lengthy development cycles and stringent validation requirements.

Diagnostic Technique Insights

The imaging techniques segment dominated the industry with a 40.7% revenue share in 2024. This is driven by established clinical reliability and widespread use across specialized diagnostic centers. Despite the rising interest in biomarker-based diagnostics, imaging remains the preferred modality for many healthcare providers, owing to its ability to visually detect hallmark Alzheimer’s features such as amyloid plaques, tau tangles, and brain atrophy. Techniques such as Positron Emission Tomography (PET) and Magnetic Resonance Imaging (MRI) remain critical in confirming diagnoses and guiding treatment pathways, particularly for high-risk or complex cases. While access and cost-related limitations have increased interest in more scalable alternatives, imaging techniques retain a stronghold in clinical and research environments, reinforcing their dominant market position.

The biomarkers segment represents the fastest-growing segment, driven by their ability to detect disease-specific proteins such as amyloid-beta and phosphorylated tau in blood or cerebrospinal fluid. These tests are less invasive than traditional imaging methods and can identify early pathological changes before the onset of clinical symptoms. Blood tests such as PrecivityAD have demonstrated around 81% accuracy in predicting brain amyloid deposits in a 686-participant study, reinforcing their clinical reliability. The increasing focus on early diagnosis and intervention has accelerated the adoption of biomarker-based tests in clinical and research settings.

Type Insights

The diagnosis segment dominated the market with the largest revenue share in 2024, driven by its clinical indispensability in confirming the presence of neuropathological features such as amyloid plaques and tau tangles. According to the National Institutes of Health (NIH), advanced imaging techniques such as PET scans and cerebrospinal fluid (CSF) assays remain the diagnostic gold standard, enabling early and accurate disease characterization. These modalities are essential for differential diagnosis, especially in patients with overlapping neurodegenerative conditions.

The screening segment is witnessing significant growth in the coming years, fueled by increased public health focus on early detection and population-level monitoring of cognitive decline. Government-supported initiatives such as the NIH’s AHEAD study and data infrastructure from the CDC’s Alzheimer’s Disease & Healthy Aging Data Portal enable the integration of blood-based biomarker tests into primary care environments.

End Use Insights

The academic and research institute segment dominated the market in 2024, driven by its central role in early-stage biomarker discovery, clinical validation, and technology development. These institutions lead large-scale longitudinal studies and clinical trials that form the basis for regulatory approvals and commercial adoption. Access to research funding, advanced imaging infrastructure, and collaborations with biotech firms enhances their diagnostic capabilities. Moreover, their involvement in translational research helps bridge the gap between laboratory innovations and clinical practice, reinforcing their position as key end users in this space.

The hospital segment is experiencing significant expansion within the market, driven by increased incorporation of advanced imaging and biomarker testing in neurology and memory care units. NIH-supported initiatives enable hospitals to implement comprehensive diagnostic techniques from cognitive evaluations to confirmatory imaging (PET/MRI) or CSF tests within single visits.

Key U.S. Alzheimer’s Disease Diagnostics Company Insights

GE HealthCare, Quanterix Corporation, and others are key players in the U.S. Alzheimer’s disease diagnostics market.

• GE HealthCare provides advanced PET and MRI imaging systems that are widely used to detect and monitor amyloid plaques and tau tangles, hallmark biomarkers of Alzheimer’s disease.

• Quanterix Corporation is known for its ultra-sensitive Simoa technology, which enables the detection of Alzheimer’s biomarkers from blood samples. It has pioneered non-invasive, high-precision blood tests for early Alzheimer’s diagnosis and is actively partnering with major U.S. health systems to expand access to these tools.

Recent Development

• In October 2024, Siemens Healthineers received FDA clearance for two advanced features in its syngo.PET Cortical Analysis software. The updates enable standardized Centiloid scoring for amyloid plaque and quantitative tau PET imaging using flortaucipir, enhancing Alzheimer's disease diagnosis through improved PET scan interpretation.

• In February 2024, Quanterix Corporation announced its first collaborations with major U.S. health systems such as Mass General Brigham, Mayo Clinic, AdventHealth, UPMC, and MUSC to expand access to blood-based Alzheimer’s diagnostic tests. 

U.S. Alzheimer’s Disease Diagnostics Market Report Scope

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