Overview


Alzheimer’s disease diagnostics refer to the medical tests and procedures used to identify and confirm Alzheimer’s disease, a condition that affects memory and cognitive abilities. These diagnostics include cognitive assessments, neurological exams, brain imaging (such as MRI or PET scans), and biomarker testing in blood or cerebrospinal fluid. They help detect the disease at an early stage and distinguish it from other forms of dementia.

According to FutureWise analysis, the Alzheimer’s disease diagnostic market in 2026 is US$9.43 billion and is expected to reach US$20.55 billion by 2036 at a CAGR of 8.1%. The Alzheimer's disease diagnostic market is witnessing steady growth driven by the rising global prevalence of dementia and increasing awareness about early detection. Advancements in biomarker-based diagnostics, neuroimaging technologies, and AI-enabled cognitive assessment tools are enhancing diagnostic accuracy and speed. Additionally, increased R&D investments and supportive healthcare policies are accelerating the adoption of innovative diagnostic solutions.

Key developments include:

  • There has been an increase in regulatory approvals and innovative product launches aimed at developing non-invasive and accurate diagnostic tools.
  • The integration of artificial intelligence in diagnostics is enhancing early detection by analyzing neuroimaging, genetic data, and cognitive test results.
  • Advanced imaging techniques are expanding, including MRI, CT, and PET imaging, with a focus on Amyloid and Tau PET scans to detect characteristic changes in the brain.
  • Additionally, there is growth in blood-based biomarker tests that enable easier and earlier assessment of disease risk.

Growth Drivers

  • The prevalence of Alzheimer’s disease is increasing, and the global aging population is rising.
  • There is an increasing emphasis on early diagnosis and a greater awareness of cognitive disorders.
  • Recent advancements in diagnostic technologies, including imaging techniques and biomarker-based tests, have significantly improved medical assessments.
  • Increased spending on healthcare and research initiatives for neurodegenerative diseases.

Key Trends

  • The increasing use of blood-based biomarker tests for early detection is on the rise.
  • The integration of artificial intelligence and advanced analytics in brain imaging diagnostics.
  • The development of faster and noninvasive diagnostic solutions.
  • There is an increasing collaboration between diagnostic and pharmaceutical companies.

Market Segmentation and Key Players

The market is segmented by product type into brain imaging and CSF (cerebrospinal fluid) tests for Alzheimer’s disease. By type, it includes early-onset, late-onset, and familial Alzheimer’s. By end use, the market covers hospitals, specialty clinics/diagnostic centers, ambulatory surgical centers, and academic & research institutes. Regionally, it is segmented into North America, Europe, Asia-Pacific, Latin America, and the Middle East & Africa. For a complete breakdown, refer to the segmentation section below.

Key players in this market include TauRx, Alector LLC, Eli Lilly and Company, Treventis Corporation, Neuro-Bio Ltd, and others.

Research Methodology

The research methodology for the Alzheimer’s disease diagnostics market involves a combination of primary and secondary research. Secondary research includes studying industry reports, company annual reports, investor presentations, regulatory publications, and credible databases to understand market trends and developments related to Alzheimer’s disease diagnostics. Primary research involves interviews with industry experts, healthcare professionals, manufacturers, and key stakeholders to validate data. Market size estimation, data triangulation, and forecasting models are then used to provide accurate market insights and future growth projections.

  • TauRx
  • Alector LLC
  • Eli Lilly and Company
  • Treventis Corporation
  • Neuro-Bio Ltd
  • Accera, Inc.
  • Cognition Therapeutics Inc.
  • Johnson and Johnson
  • F. Hoffmann-La Roche Ltd
  • Quanterix
  • Sysmex
  • Novartis AG
  • Allergan PLC
  • C2N Dignostics
  • Randox Bioscience
  • GE Healthcare
  • MAGQU CO. LTD.
  • Hitachi

(Note: The list of major players will be updated with the latest market scenario and trends)

Recent Developments in Alzheimer’s Disease Diagnostic Market:

GE Healthcare

  • In June 2025, the FDA expanded the approval of Vizamyl (flutemetamol F-18) PET imaging to include quantitative measurements of amyloid and treatment monitoring. This enables clinicians to track changes in amyloid plaque more objectively during therapy.
  • Their MIM software for amyloid PET scans received 510(k) clearance in September 2024, enabling standardized Centiloid scaling, which enhances scan consistency and interpretation.

TauRx

  • After completing the Phase III LUCIDITY trials, TauRx submitted HMTM, a tau aggregation inhibitor, for regulatory approval in the UK in early 2025. This submission marks a significant milestone in the development of tau-targeting diagnostics and therapies.

Alector LLC

  • In November 2024, Alector announced a failure in its Phase 2 trial for the anti-TREM2 antibody, which was partnered with AbbVie, resulting in a 17% reduction in workforce. The company is now focusing on other neurodegenerative programs, including a Phase 3 candidate for FTD.

Eli Lilly and Company

  • Lilly is engaged in diagnostics through plasma biomarker research, contributing to pTau and amyloid assays as part of their therapeutic portfolio.

Treventis Corporation

  • Both companies are recognized as key innovators in diagnostics. Treventis is exploring ultrasound-based biomarkers, while Neuro-Bio is focusing on novel molecular assays that target early signals of neurodegeneration.

 

  • In October 2022, Cyclo Therapeutics, Inc. announced the initiation of its Phase 2b study of Trappsol Cyclo for treating Alzheimer's disease by targeting the reduction of amyloid beta and tau. The study received approval from the IRB.
     
  • In September 2022- Esai Co,. Ltd and Biogen Inc. announced favorable topline outcomes from the large-scale global Phase 3 confirmatory Clarity AD clinical trial of lecanemab. Lecanemab is an investigational anti-amyloid beta (A?) protofibril antibody intended for the treatment of MCI due to Alzheimer's disease and mild Alzheimer's disease.

The increasing public and professional awareness of Alzheimer's disease and the advantages of early detection have resulted in higher demand for diagnostic tests. They are expected to drive the market during the forecast period. Patients are becoming proactive about their health, seeking early diagnosis for potential cognitive issues. Healthcare professionals are also more attentive in identifying early symptoms, leading to a surge in diagnostic screenings. The emphasis on early detection is driven by the understanding that early intervention allows for better disease management, allowing patients to access appropriate care and treatment plans at the earliest stage. Moreover, the growing aging population is the major driver for the Alzheimer's Disease Diagnostic market. With the rise in life expectancy and an increasing aging population, the prevalence of Alzheimer's disease and related cognitive disorders also increases. This demographic shift has led to a greater need for accurate and accessible diagnostic tests to identify and manage these conditions in their early stages. Therefore, healthcare providers and government bodies are encouraged to invest in innovative diagnostic technologies to cater to the increasing demand for early detection and treatment among the elderly population. Furthermore, high development costs are expected to obstruct the Alzheimer’s Disease Diagnostic market. The substantial investments required for research, clinical trials, and regulatory approvals may impede the widespread availability and adoption of new diagnostic tools, particularly in developing regions with limited resources and healthcare infrastructure. The financial burden may deter smaller companies or research organizations from entering the market, potentially slowing innovation and limiting the accessibility of advanced diagnostic solutions in certain areas.
 

By Product Type

  • Brain Imaging
  • CFS Test for Alzheimer's Disease

By Type

  • Early-Onset
  • Late-Onset
  • Familial

By End-Use

  • Hospitals
  • Specialty Clinics/ Diagnostic Centers
  • Ambulatory Surgical Centers
  • Academic and Research Institutes

By Region

  • North America
  • Europe
  • Asia-Pacific
  • Latin America
  • Middle East and Africa

This market research report also highlights the factors influencing the growth rate in the various regions mentioned above. A comprehensive analysis of the region will also be provided in the final version of this market, based on the conclusions drawn from primary interviews and secondary data points gathered during the process.

As of 2025, North America leads the Alzheimer’s disease diagnostic market, primarily due to the high prevalence of Alzheimer's disease, advanced healthcare infrastructure, substantial research funding, and significant healthcare spending in the region, particularly in the United States. Approximately 6.9 million Americans aged 65 and older are currently living with Alzheimer's dementia, and this number is expected to grow significantly, increasing the demand for advanced diagnostic technologies. The region also benefits from continuous regulatory approvals, innovative product launches, and strong collaborations between government and private sectors.

By region, the market is segmented into North America, Latin America, Europe, Asia-Pacific, and the Middle East & Africa. North America registered the highest share in the market in 2022. Growing incidences of Alzheimer's disease with an increase in the geriatric population, huge investment in research and development activities, the launch of new products, and the expansion of technological developments in the region. For instance, as of March 2022, the Alzheimer's Association Report indicated that around 6.2 million individuals aged 65 years and older were living with Alzheimer 's-related dementia in the United States. Estimates suggest that this number will escalate to 13.8 million individuals by 2060. Furthermore, high healthcare expenses and investments by key players are expected to boost the growth of the Alzheimer's disease diagnostic market in the region. The factors mentioned above are expected to drive the market during the forecast period.


  • Tier 1 players- established companies in the market with a major market share
  • Tier 2 players
  • Emerging players which are growing rapidly
  • New Entrants

  • Growth prospects
  • SWOT analysis
  • Key trends
  • Key data-points affecting market growth

  • To provide with an exhaustive analysis on the Alzheimer’s Disease Diagnostic Market By Product Type, By Type, By End-Use and By Region.
  • To cater comprehensive information on factors impacting market growth (drivers, restraints, opportunities, and industry-specific restraints)
  • To evaluate and forecast micro-markets and the overall market
  • To predict the market size, in key regions— North America, Europe, Asia Pacific, Latin America and Middle East and Africa.
  • To record and evaluate competitive landscape mapping- product launches, technological advancements, mergers and expansions

  • We have a flexible delivery model and you can suggest changes in the scope/table of content as per your requirement
  • The customization Mobility Care offered are free of charge with purchase of any license of the report
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Table of Contents


  • 1.   Market Introduction
    •   1. Objectives of the Study
        2. Market Definition
        3. Market Scope
         3.1. Years Considered for the Study
         3.2. Market Covered
        4. Currency
        5. Limitations
        6. Stakeholders
  • 2.   Research Methodology
    •   1. Research Data
         1.1. Secondary Data
          1.1.1. Key Data from Secondary Sources
         1.2. Primary Data
          1.2.1. Key Data from Primary Sources
        2. Market Size Estimation
        3. Market Breakdown and Data Triangulation
        4. Assumptions for the Study
  • 3.   Executive Summary
    •   1. Market Outlook
        2. Segment Outlook
        3. Competitive Insights
  • 4.  Alzheimer’s Disease Diagnostic Market Variables, Trends and Scope
    •   1. Market Lineage Outlook
        2. Penetration and Growth Prospect Mapping
        3. Industry Value Chain Analysis
        4. Cost Analysis Breakdown
        5. Technology Overview
        6. Regulatory Framework
         6.1. Reimbursement Framework
         6.2. Standards and Compliances

  • 5.   Market Overview
    •   1. Market Dynamics
         1.1. Market Driver Analysis
          1.1.1. Increasing focus of Alzheimer’s Disease Diagnostic Market Companies on Brand Protection
          1.1.2. Untapped Opportunities in Emerging Regions
         1.2. Market Restraint Analysis
          1.2.1. High Cost Associated with Implementation of Predictive Analysis
         1.3. Industry Challenges
          1.3.1. Presence of Ambiguous Regulatory Framework
  • 6.   Alzheimer’s Disease Diagnostic Market Analysis Tools
    •   1. Industry Analysis - Porter’s
         1.1. Supplier Power
         1.2. Buyer Power
         1.3. Substitution Threat
         1.4. Threat from New Entrants
         1.5. Competitive Rivalry
        2. Pestel Analysis
         2.1. Political Landscape
         2.2. Environmental Landscape
         2.3. Social Landscape
         2.4. Technology Landscape
         2.5. Legal Landscape
        3. Major Deals And Strategic Alliances Analysis
         3.1. Joint Ventures
         3.2. Mergers and Acquisitions
         3.3. Licensing and Partnership
         3.4. Technology Collaborations
         3.5. Strategic Divestments
        4. Market Entry Strategies
        5. Case Studies
  • 7.   Alzheimer’s Disease Diagnostic Market, By Product Type Historical Analysis and Forecast 2026-2036 (USD Million)
    •   1. Brain Imaging
        2. CFS Test for Alzheimer's Disease

  • 8.  Alzheimer’s Disease Diagnostic Market, By Type Historical Analysis and Forecast 2026-2036 (USD Million)
    •   1. Early-Onset
        2. Late-Onset
        3. Familial

  • 9.   Alzheimer’s Disease Diagnostic Market, By End-Use Historical Analysis and Forecast 2026-2036 (USD Million)
    •   1. Hospitals
        2. Specialty Clinics/ Diagnostic Centers
        3. Ambulatory Surgical Centers
        4. Academic and Research Institutes

  • 10.   North America Alzheimer’s Disease Diagnostic Market Analysis 2019-2025 and Forecast 2026-2036 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2019-2025
         2.1. U.S.A
         2.2. Canada
         2.3. Mexico
        3. Market Size (USD Million) Forecast for North America 2026-2036

  • 11.   Latin America Alzheimer’s Disease Diagnostic Market Analysis 2019-2025 and Forecast 2026-2036 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2019-2025
         2.1. Brazil
         2.2. Venezuela
         2.3. Argentina
         2.4. Rest of Latin America
        3. Market Size (USD Million) Forecast for Latin America 2026-2036

  • 12.   Europe Alzheimer’s Disease Diagnostic Market Analysis 2019-2025 and Forecast 2026-2036 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2026-2036
         2.1. Germany
         2.2. U.K
         2.3. France
         2.4. Italy
         2.5. Spain
         2.6. Russia
         2.7. Poland
         2.8. Rest of Europe
        3. Market Size (USD Million) Forecast for Europe 2026-2036

  • 13.   Asia Pacific Alzheimer’s Disease Diagnostic Market Analysis 2019-2025 and Forecast 2026-2036 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2019-2025
         2.1. Japan
         2.2. China
         2.3. India
         2.4. Australia and New Zealand
         2.5. ASEAN
         2.6. Rest of Asia Pacific
        3. Market Size (USD Million) Forecast for Asia Pacific 2026-2036

  • 14.   Middle East and Africa Market Analysis 2019-2025 and Forecast 2026-2036 (USD Million)
    •   1. Introduction
        2. Historical Market Size (USD Million) Analysis By Country, 2019-2025
         2.1. GCC
         2.2. Israel
         2.3. South Africa
         2.4. Rest of MEA
        3. Market Size (USD Million) Forecast for MEA 2026-2036

  • 15.   Market Share Analysis and Competitive Landscape
    •   1. Global Landscape - Key Players, Revenue and Presence
        2. Global Share Analysis - Key Players (Tier 1, Tier 2, Tier 3)
        3. Global Emerging Companies
        4. North America - Market Share Analysis and Key Regional Players
        5. Europe - Market Share Analysis and Key Regional Players
        6. Asia Pacific - Market Share Analysis and Key Regional Players
        7. Global Key Player - Growth Matrix
  • 16.   Company Profiles (Competition Dashboard, Competitors Deep Dive, Products Offered and Financial Layouts)
    •   1. TauRx
         1.1. Company Overview
         1.2. Product Portfolio
         1.3. SWOT Analysis
         1.4. Financial Overview
         1.5. Strategic Overview
        2. Alector LLC
         2.1. Company Overview
         2.2. Product Portfolio
         2.3. SWOT Analysis
         2.4. Financial Overview
         2.5. Strategic Overview
        3. Eli Lilly and Company
         3.1. Company Overview
         3.2. Product Portfolio
         3.3. SWOT Analysis
         3.4. Financial Overview
         3.5. Strategic Overview
        4. Treventis Corporation
         4.1. Company Overview
         4.2. Product Portfolio
         4.3. SWOT Analysis
         4.4. Financial Overview
         4.5. Strategic Overview
        5. Neuro-Bio Ltd
         5.1. Company Overview
         5.2. Product Portfolio
         5.3. SWOT Analysis
         5.4. Financial Overview
         5.5. Strategic Overview
        6. Accera, Inc.
         6.1. Company Overview
         6.2. Product Portfolio
         6.3. SWOT Analysis
         6.4. Financial Overview
         6.5. Strategic Overview
        7. Cognition Therapeutics Inc.
         7.1. Company Overview
         7.2. Product Portfolio
         7.3. SWOT Analysis
         7.4. Financial Overview
         7.5. Strategic Overview
        8. Johnson and Johnson
         8.1. Company Overview
         8.2. Product Portfolio
         8.3. SWOT Analysis
         8.4. Financial Overview
         8.5. Strategic Overview
        9. F. Hoffmann-La Roche Ltd
         9.1. Company Overview
         9.2. Product Portfolio
         9.3. SWOT Analysis
         9.4. Financial Overview
         9.5. Strategic Overview
        10. Quanterix
         10.1. Company Overview
         10.2. Product Portfolio
         10.3. SWOT Analysis
         10.4. Financial Overview
         10.5. Strategic Overview
        11. Sysmex
         11.1. Company Overview
         11.2. Product Portfolio
         11.3. SWOT Analysis
         11.4. Financial Overview
         11.5. Strategic Overview
        12. Novartis AG
         12.1. Company Overview
         12.2. Product Portfolio
         12.3. SWOT Analysis
         12.4. Financial Overview
         12.5. Strategic Overview
        13. Allergan PLC
         13.1. Company Overview
         13.2. Product Portfolio
         13.3. SWOT Analysis
         13.4. Financial Overview
         13.5. Strategic Overview
        14. C2N Dignostics
         14.1. Company Overview
         14.2. Product Portfolio
         14.3. SWOT Analysis
         14.4. Financial Overview
         14.5. Strategic Overview
        15. Randox Bioscience
         15.1. Company Overview
         15.2. Product Portfolio
         15.3. SWOT Analysis
         15.4. Financial Overview
         15.5. Strategic Overview
        16. GE Healthcare
         1. Company Overview
         2. Product Portfolio
         3. SWOT Analysis
         4. Financial Overview
         5. Strategic Overview
        17. MAGQU CO. LTD.
         17.1. Company Overview
         17.2. Product Portfolio
         17.3. SWOT Analysis
         17.4. Financial Overview
         17.5. Strategic Overview
        18. Hitachi
         18.1. Company Overview
         18.2. Product Portfolio
         18.3. SWOT Analysis
         18.4. Financial Overview
         18.5. Strategic Overview

  • 17.   Pre and Post COVID-19 Impact
    •   1. Positive influence on the healthcare industry
        2. The financial disruption of the manufacturing sector
        3. Impact of COVID-19 on emerging companies
        4. Significant mandates in the regulations initiated by healthcare administrations
        5. The overall economic slowdown of the developing and developed nations
  • 18.   FutureWise SME Key Takeaway Points for Client

FAQ


The Alzheimer’s Disease (AD) diagnostic market encompasses products and services that detect and monitor Alzheimer’s disease, including blood tests, biomarkers, neuroimaging techniques, cognitive assessment tools, and AI-based diagnostic platforms.

Early and accurate diagnosis of Alzheimer’s is crucial for:

  • Starting treatment earlier to slow the progression of the disease.
  • Organizing care and support for patients.
  • Promoting the research and development of new therapies.
  • Shift towards non-invasive blood tests for early detection.
  • Integration of AI and digital tools for cognitive assessment.
  • Increasingly personalized diagnostics based on patient biomarkers.
  • Expansion of home-based and telehealth diagnostic solutions.

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