米国のアルツハイマー病診断市場規模、シェア、動向分析レポート：診断技術別、タイプ別、最終用途別、セグメント予測、2025～2030年

市場規模と動向：

米国のアルツハイマー病診断市場は、2024年には35億3,000万米ドルとなり、2025年から2030年にかけてCAGR 10.6％で成長すると予測されています。

この成長の原動力は、アルツハイマー病の有病率の上昇と、早期かつ正確な診断の重視の高まりです。米国疾病対策予防センター（CDC）によると、米国では2024年に約670万人の高齢者がアルツハイマー病を患っており、この数は2060年までにほぼ倍増すると予測されています。この病気の有病率の増加により、政府や民間のヘルスケア機関は、PETイメージング、脳脊髄液バイオマーカー、血液ベースの診断などの高度診断技術に多額の投資を行うようになりました。

米国アルツハイマー病診断市場の成長は、先進的な非侵襲的診断技術の最近の承認によるものです。米国FDAは、アルツハイマー病の診断をサポートする血液検査を利用した初の体外診断装置の販売許可を与えました。ルミパルスG pTau217/B-アミロイド1-42血漿中比は、特に、認知機能障害と一致する臨床症状や徴候を示す55歳以上の成人患者において、アルツハイマー病病態の特徴であるアミロイド斑の蓄積を早期に検出することを目的としています。

この開発は、アルツハイマー病診断における大きな進歩であり、PET検査や腰椎穿刺に代わる、費用対効果に優れ、低侵襲の検査法を提供することで、診断への障壁を大幅に下げるものです。FDAは、この承認により米国患者がより早期に、より容易に、よりアクセスしやすくなる可能性があると強調しました。これは、アルツハイマー病の進行の初期段階において、タイムリーな介入と臨床的な意思決定を容易にするというこの検査の価値を強調するものです。

高齢者の認知症診断率の増加が米国アルツハイマー病診断市場の成長を牽引しています。CDCによる2022年国民健康調査（National Health Interview Survey）によると、65歳以上の約4％が認知症と診断されており、この数字は85歳以上では13％に上昇しています。この成長の主な要因は、平均寿命の延長、認知度の向上、臨床現場での診断方法の改善です。早期発見、適切な介入、最適化されたケアプランニングをサポートする、拡張性のある正確な診断ソリューションに対するニーズが高まっています。

目次

第1章 調査手法と範囲

第2章 エグゼクティブサマリー

第3章 米国アルツハイマー病診断市場の変数、動向、範囲

• 市場系統の見通し
• 市場力学
  • 市場促進要因分析
  • 市場抑制要因分析
  • 業界の課題
• 業界分析ツール
  • PORTERの分析
  • PESTEL分析

第4章 米国のアルツハイマー病診断市場：診断技術推定・動向分析

• 米国のアルツハイマー病診断市場（診断技術別）：主なポイント
• 診断技術変動分析と市場シェア、2024年および2030年
• 診断技術別、2018年～2030年
  • バイオマーカー
  • 画像診断技術
  • 遺伝子検査
  • 認知評価テスト

第5章 米国のアルツハイマー病診断市場：タイプ推定・動向分析

• 米国のアルツハイマー病診断市場（タイプ別）：主なポイント
• タイプ変動分析と市場シェア、2024年と2030年
• タイプ別、2018年～2030年
  • トリアージ
  • 診断
  • スクリーニング

第6章 米国のアルツハイマー病診断市場：最終用途推定・動向分析

• 米国のアルツハイマー病診断市場（最終用途別）：主なポイント
• 最終用途変動分析と市場シェア、2024年および2030年
• 用途別、2018年～2030年
  • 病院
  • 診断検査室
  • 学術調査機関

第7章 競合情勢

• 企業分類
• 企業の市場ポジショニング
• 企業ヒートマップ分析
• 企業プロファイル/上場企業
  • 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

List of Tables

• Table 1 List of abbrevation
• Table 2 U.S. alzheimer's disease diagnostics market: key market driver analysis
• Table 3 U.S. alzheimer's disease diagnostics market: Key market restraint analysis
• Table 4 U.S. alzheimer's disease diagnostics market estimates and forecast, by diagnostic technique (USD Million)
• Table 5 U.S. alzheimer's disease diagnostics market estimates and forecast, by type (USD Million)
• Table 6 U.S. alzheimer's disease diagnostics market estimates and forecast, by end use (USD Million)
• Table 7 Recent developments and impact analysis by key market participants
• Table 8 Company heat map analysis, 2024
• Table 9 Companies implementing key strategies

List of Figures

• Fig. 1 U.S. Alzheimer's disease diagnostics market segmentation
• Fig. 2 Market research process
• Fig. 3 Information procurement
• Fig. 4 Primary research pattern
• Fig. 5 Market research approaches
• Fig. 6 Value chain-based sizing and forecasting
• Fig. 7 Parent market analysis
• Fig. 8 Market formulation and validation
• Fig. 9 U.S. Alzheimer's disease diagnostics market snapshot
• Fig. 10 U.S. Alzheimer's disease diagnostics market segment snapshot
• Fig. 11 U.S. Alzheimer's disease diagnostics market competitive landscape snapshot
• Fig. 12 Market research process
• Fig. 13 Market driver relevance analysis (Current and future impact)
• Fig. 14 Market restraint relevance analysis (Current and future impact)
• Fig. 15 U.S. Alzheimer's disease diagnostics market: Diagnostic technique outlook key takeaways (USD Million)
• Fig. 16 U.S. Alzheimer's disease diagnostics market: Diagnostic technique movement analysis 2024 & 2030 (USD Million)
• Fig. 17 Biomarkers market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 18 Imaging diagnostic Techniques market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 19 Genetic testing market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 20 Cognitive assessment tests market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 21 U.S. Alzheimer's Disease Diagnostics market: Type outlook key takeaways (USD Million)
• Fig. 22 U.S. Alzheimer's Disease Diagnostics market: Type movement analysis 2024 & 2030 (USD Million)
• Fig. 23 Triage market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 24 Diagnosis market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 25 Screening market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 26 U.S. alzheimer's disease diagnostics market: End Use outlook key takeaways (USD Million)
• Fig. 27 U.S. alzheimer's disease diagnostics market: End Use movement analysis 2024 & 2030 (USD Million)
• Fig. 28 Hospitals market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 29 Diagnostic Laboratories market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 30 Academic and Research Institutes market estimates & forecasts, 2018 - 2030 (USD Million)
• Fig. 31 Strategy framework
• Fig. 32 Company categorization

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