알츠하이머병 진단 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the alzheimer's disease diagnostics market size is expected to increase from USD 4.81 billion in 2025 to USD 5.22 billion in 2026 and reach USD 7.88 billion by 2031, growing at a CAGR of 8.58% over 2026-2031.

This report is Segmented by Diagnostic Technique (Biomarkers, Imaging Techniques, Genetic Testing, Cognitive Tests), Type (Diagnosis, Screening, Triage), End User (Hospitals, Diagnostic Laboratories, Academic Institutes, Other End Users), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Alzheimer's Disease Diagnostics Market Trends and Insights

Rising Adoption of Blood-Based Biomarkers

The Alzheimer's disease diagnostics market is being reshaped by blood-based biomarkers after the FDA cleared Fujirebio's Lumipulse G pTau217/B-Amyloid 1-42 Plasma Ratio in May 2025 as the first blood-based in vitro diagnostic in the United States designed to identify amyloid pathology associated with Alzheimer's disease. The supporting multicenter study covered 499 cognitively impaired patients and showed a 91.7% positive predictive value and a 97.3% negative predictive value against PET and CSF reference standards, which gave clinicians a benchmark that was much closer to established confirmation methods than earlier screening tools had reached. By October 2025, Roche's Elecsys pTau181 became the only FDA-cleared blood test explicitly intended for primary care, and Labcorp then committed to a nationwide rollout in the United States by early 2026, which moved ordering power beyond the specialist neurologist base and into general practice workflows.

Quest Diagnostics reinforced the same shift by making the Fujirebio test available through its network of nearly 2,000 patient service centers, which gave the reference-lab route an immediate scale advantage in the Alzheimer's disease diagnostics market. The Alzheimer's Association then published its first clinical practice guideline for blood-based biomarker tests in 2025, including threshold expectations for triage and for PET or CSF substitution, which began to act as a practical filter for procurement and clinical adoption decisions. That framework supports faster consolidation around the assays that can meet both performance and workflow expectations, which is why the Alzheimer's disease diagnostics market is likely to reward a smaller group of clinically validated commercial platforms over the near term.

AI-Guided Imaging Triage in Memory Clinics

The Alzheimer's disease diagnostics market is also being supported by AI-guided imaging triage, because memory clinics are under pressure to handle larger referral volumes without relying on PET as the first step for every patient. A 2026 systematic review in the Journal of Medical Internet Research evaluated 66 studies and reported average diagnostic accuracy of 92.5%, with a standard deviation of 3.8%, and MCI-conversion AUCs of 0.922 across multimodal fusion architectures, which clearly outperformed single-modality baselines in the reviewed evidence base. TRACE4AD added a practical clinical example in a multicenter validation study that covered 797 subjects across 66 sites in Italy, the United States, and Canada, where AI-assisted neuropsychological and MRI staging predicted 24-month conversion to Alzheimer's dementia with clinically meaningful accuracy using structural imaging that is already widely available. This does not remove the role of PET from the Alzheimer's disease diagnostics market, because patients with intermediate blood-test results still need escalation and confirmatory imaging remains important for a smaller but higher-yield subset of cases.

Siemens Healthineers extended this direction in April 2026 by joining the Bio-Hermes-002 observational study and contributing Atellica IM biomarker assays to work across more diverse racial and ethnic populations, which addresses a major concern around whether AI and biomarker models trained in narrow cohorts can generalize well in real-world use. As these tools improve clinic throughput and case selection, the Alzheimer's disease diagnostics market is moving toward a model where AI improves the yield of each confirmatory test rather than simply replacing established modalities.

High Reimbursement Friction for Advanced Testing

The Alzheimer's disease diagnostics market still faces a clear commercial barrier in reimbursement, even after clinical validation and regulatory approvals improved materially in 2025 and 2026. After the FDA cleared Fujirebio's blood test in May 2025, CMS initially proposed a reimbursement rate of USD 17 per test while an advisory-panel recommendation pointed to USD 130, which created a large gap between clinical value and economic viability for broad commercial laboratory deployment. A partial improvement took effect in January 2026 with the introduction of CPT codes 82233, 82234, and 84393 for individual analyte billing, which opened the possibility for multi-analyte panels to reach materially higher reimbursement levels than a single bundled rate would allow.

Even with that change, the Alzheimer's disease diagnostics market remains exposed to policy uncertainty because the ASAP Act was still pending in Congress as of mid-2026 and no fully settled Medicare pathway had been established for all FDA-approved blood-based screening tools. This matters beyond diagnostics alone, because therapy use depends on timely confirmation and a slow reimbursement environment can delay the whole care pathway rather than only the laboratory test itself. The underlying policy mechanics, including the Clinical Laboratory Fee Schedule and the Advanced Diagnostic Laboratory Test designation process, continue to shape whether a test is priced on its own merits or benchmarked to broader laboratory coding structures that do not reflect its clinical role.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of Pre-Symptomatic Testing Pathways
2. Wider Use of Cognitive Screening in Primary Care
3. Limited Standardization Across Biomarker Assays

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Imaging Techniques accounted for 38.31% of the Alzheimer's disease diagnostics market share in 2025, which kept this category in the leading position because PET and MRI still anchor the specialist workup for amyloid burden, structural atrophy, and patient confirmation. The Alzheimer's disease diagnostics market still depends on installed imaging capacity in many high-value settings, since hospitals and memory clinics rely on long-established PET and MRI workflows that are already integrated into neurology referral pathways and treatment decisions. Biomarkers are the fastest-growing diagnostic technique with a 12.38% CAGR from 2026 to 2031, reflecting the shift of blood-based assays from research settings into routine in vitro diagnostic use across specialty care and primary care channels. This creates a dual-track structure in the Alzheimer's disease diagnostics industry, where imaging remains central for confirmation and follow-up while biomarker testing expands the number of patients who can enter diagnostic evaluation earlier and at lower operational cost. Genetic Testing remains a smaller category in current clinical use, yet its relevance is rising because ApoE4 status is becoming more important when clinicians assess treatment eligibility and risk discussions around anti-amyloid therapy.

GE HealthCare showed why imaging is unlikely to be displaced in a simple one-for-one manner when it received FDA approval in June 2025 for an expanded Vizamyl label that supports quantitative amyloid PET analysis and patient response monitoring for anti-amyloid therapy. That move extends PET into treatment monitoring, which gives Imaging Techniques a continuing role even as blood tests broaden first-line access inside the Alzheimer's disease diagnostics market. Cognitive Assessment Tests are also gaining steady traction, especially through AI-enabled digital platforms that support remote or front-end screening before patients move into biomarker or imaging confirmation. The interaction among techniques is therefore additive in many real-world settings, because blood-based testing, digital screening, imaging confirmation, and genetic risk assessment are increasingly being used as linked steps rather than isolated choices. Regulatory filters under the FDA 510(k) framework and the EU IVDR continue to determine how quickly newer assays can move from clinical promise into broad commercial use, which means market leadership depends not only on technology performance but also on execution across validation, clearance, and rollout.

Complete Report Scope:

• By Diagnostic Technique
  • Biomarkers
  • Imaging Techniques
  • Genetic Testing
  • Cognitive Assessment Tests
• By Type
  • Diagnosis
  • Screening
  • Triage
• By End User
  • Hospitals
  • Diagnostic Laboratories
  • Academic and Research Institutes
  • Other End Users
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 43.22% of the Alzheimer's disease diagnostics market share in 2025, giving it the largest regional position on the back of FDA regulatory momentum, a dense specialist neurology network, and the highest installed amyloid PET capacity among major regions. The United States has led the Alzheimer's disease diagnostics market regionally because two distinct blood-based in vitro diagnostic tests were cleared during 2025, which expanded commercial confidence and widened the range of clinical settings where testing could begin. Effective January 2026, new analyte-specific CPT codes also improved the route toward more viable Medicare reimbursement for blood-based testing, which matters because laboratory economics are central to scaling national access. Europe remains the second-largest regional block, and the May 2026 CE Mark approvals for Roche's Elecsys pTau217 and Fujirebio's Lumipulse G pTau217 Plasma assay opened the blood-biomarker channel across EU markets with a much broader commercial footprint than isolated country launches would have delivered. Germany adds another structural advantage through DEMREG, a national registry with 22 centers actively recruiting as of mid-2025, because it creates the real-world data base needed for local cutoff validation and ongoing performance assessment under the IVDR framework.

Asia-Pacific is the fastest-growing geography in the Alzheimer's disease diagnostics market, with a 12.15% CAGR projected from 2026 to 2031, and that pace reflects a large aging population, uneven specialist access, and a strong need for lower-friction diagnostic pathways. Japan is a key anchor in this regional shift because a 2025 study from Keio University and the University of Tokyo showed that plasma AB42/40 reached an AUC of 0.937 and detected amyloid accumulation earlier than PET visual reading thresholds in Japanese cohorts. That evidence gives the Alzheimer's disease diagnostics market a stronger local validation base for blood biomarkers in Japan, where domestic commercial positioning is also being supported by Fujirebio's parent group through regulatory steps and regional expansion efforts. China adds scale through policy and treatment dynamics, since lecanemab approval in January 2024 created an immediate need for companion diagnostic capacity in a system where specialist neurology access is still uneven across the country. Across Asia-Pacific, the Alzheimer's disease diagnostics market is therefore growing not only because patient numbers are rising, but also because blood-based and referral-linked tools fit better with the region's need to extend access beyond a narrow set of tertiary centers.

Middle East and Africa and South America remain early-stage territories in the Alzheimer's disease diagnostics market, where penetration is constrained by limited specialist workforces, weaker imaging infrastructure, and lower access outside major urban centers. GCC countries are leading diagnostic investment within the Middle East and Africa through government-backed healthcare expansion programs, which gives that sub-region a stronger foundation than most surrounding markets for future adoption. Brazil leads South America in diagnostic laboratory infrastructure and specialist neurology capacity, while Argentina remains a secondary hub with a smaller but still relevant concentration of expertise. Latent demand remains large across both regions because underdiagnosis is still widespread in lower-resource settings, which means the Alzheimer's disease diagnostics market has room to expand once workforce capacity, laboratory networks, and referral systems improve enough to support regular clinical use.

1. Abbott Laboratories
2. AC Immune SA
3. Alamar Biosciences, Inc.
4. Araclon Biotech S.L.
5. Bio-Rad Laboratories
6. C2N Diagnostics, LLC
7. Canon
8. Cognetivity Ltd.
9. DiaSorin
10. Roche
11. GE HealthCare Technologies Inc.
12. H.U. Group Holdings, Inc. (Fujirebio Holdings, Inc.)
13. LabCorp
14. Lantheus Holdings, Inc.
15. Neurocode
16. Quanterix Corporation
17. Quest Diagnostics
18. Revvity, Inc.
19. Siemens Healthineers
20. Sysmex

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Adoption of Blood-Based Biomarkers
  • 4.2.2 AI-Guided Imaging Triage in Memory Clinics
  • 4.2.3 Expansion of Pre-Symptomatic Testing Pathways
  • 4.2.4 Wider Use of Cognitive Screening in Primary Care
  • 4.2.5 Clinical Trial Companion Diagnostics Demand
  • 4.2.6 Registry-Driven Case Finding and Referral Optimization
• 4.3 Market Restraints
  • 4.3.1 High Reimbursement Friction for Advanced Testing
  • 4.3.2 Limited Standardization Across Biomarker Assays
  • 4.3.3 Specialist Workforce Bottlenecks for Interpretation
  • 4.3.4 Public-Health Stigma and Diagnosis Avoidance
• 4.4 Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Industry Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Diagnostic Technique
  • 5.1.1 Biomarkers
  • 5.1.2 Imaging Techniques
  • 5.1.3 Genetic Testing
  • 5.1.4 Cognitive Assessment Tests
• 5.2 By Type
  • 5.2.1 Diagnosis
  • 5.2.2 Screening
  • 5.2.3 Triage
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Diagnostic Laboratories
  • 5.3.3 Academic and Research Institutes
  • 5.3.4 Other End Users
• 5.4 By Geography
  • 5.4.1 North America
    • 5.4.1.1 United States
    • 5.4.1.2 Canada
    • 5.4.1.3 Mexico
  • 5.4.2 Europe
    • 5.4.2.1 Germany
    • 5.4.2.2 United Kingdom
    • 5.4.2.3 France
    • 5.4.2.4 Italy
    • 5.4.2.5 Spain
    • 5.4.2.6 Rest of Europe
  • 5.4.3 Asia-Pacific
    • 5.4.3.1 China
    • 5.4.3.2 Japan
    • 5.4.3.3 India
    • 5.4.3.4 Australia
    • 5.4.3.5 South Korea
    • 5.4.3.6 Rest of Asia-Pacific
  • 5.4.4 Middle East and Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East and Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share, Products and Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 AC Immune SA
  • 6.3.3 Alamar Biosciences, Inc.
  • 6.3.4 Araclon Biotech S.L.
  • 6.3.5 Bio-Rad Laboratories, Inc.
  • 6.3.6 C2N Diagnostics, LLC
  • 6.3.7 Canon Inc.
  • 6.3.8 Cognetivity Ltd.
  • 6.3.9 DiaSorin S.p.A.
  • 6.3.10 F. Hoffmann-La Roche Ltd
  • 6.3.11 GE HealthCare Technologies Inc.
  • 6.3.12 H.U. Group Holdings, Inc. (Fujirebio Holdings, Inc.)
  • 6.3.13 Laboratory Corporation of America Holdings
  • 6.3.14 Lantheus Holdings, Inc.
  • 6.3.15 Neurocode
  • 6.3.16 Quanterix Corporation
  • 6.3.17 Quest Diagnostics Incorporated
  • 6.3.18 Revvity, Inc.
  • 6.3.19 Siemens Healthineers AG
  • 6.3.20 Sysmex Corporation

7 Market Opportunities & Future Outlook

• 7.1 White-Space and Unmet-Need Assessment