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デジタルバイオマーカーの世界市場：2025年～2033年

Global Digital Biomarkers Market - 2025-2033

出版日
ページ情報
英文 210 Pages
納期
即日から翌営業日
カスタマイズ可能
適宜更新あり
価格
価格表記: USDを日本円(税抜)に換算
本日の銀行送金レート: 1USD=144.06円
デジタルバイオマーカーの世界市場：2025年～2033年
出版日: 2025年02月13日
発行: DataM Intelligence
ページ情報: 英文 210 Pages
納期: 即日から翌営業日
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  • 概要
  • 目次
概要

デジタルバイオマーカーの世界市場は、2024年に41億6,000万米ドルに達し、2033年までには266億9,000万米ドルに達すると予測され、予測期間中の2025年から2033年のCAGRは22.7%で成長する見込みです。

デジタルバイオマーカーは、ウェアラブル、スマートフォン、センサー、モバイルアプリケーションなどのデジタル機器を通じて収集される客観的で定量化可能なデータです。健康状態のモニタリング、疾病進行の追跡、リアルタイムでの治療反応の評価に不可欠です。これらのバイオマーカーは、心拍数、血圧、グルコースレベル、睡眠パターン、活動レベル、認知パフォーマンスなどの生理学的指標を捉えます。また、神経疾患の音声や会話パターンの分析、運動障害の歩行や動作の評価、精神的健康の変化のための眼球運動や表情のモニターも可能です。

市場力学：

促進要因と抑制要因

ウェアラブルデバイスとモバイルヘルス技術の採用拡大

世界のデジタルバイオマーカー市場は、ウェアラブルデバイスとモバイルヘルス技術の使用の増加によって牽引されています。心血管障害、糖尿病、神経疾患などの慢性疾患では、継続的な健康モニタリングが極めて重要です。スマートウォッチ、フィットネストラッカー、バイオセンサーのようなウェアラブルデバイスは、リアルタイムデータを収集し、病気の早期発見、個別化治療、患者の転帰改善に役立ちます。この成長は、臨床および非臨床環境におけるデジタルバイオマーカーの原動力となっています。

例えば、2024年12月、デジタル医療とバイオマーカーの主要企業であるElectronRxは、CES 2025で医療機器基準を満たすように設計された心肺評価アプリpurpleDxを発表しました。purpleDxは、喘息、慢性閉塞性肺疾患、間質性肺疾患、肺高血圧症などの肺疾患の検出、監視、治療を目的として、呼吸器クリニックや欧州肺高血圧協会と共同で開発されました。

データセキュリティとプライバシーに関する懸念

デジタルバイオマーカーは、コネクテッドデバイスを通じて機密性の高い健康データを収集・分析するため、データプライバシーとセキュリティに関する重大な課題に直面しています。欧州のGDPRや米国のHIPAAといった厳しい規制への準拠は、市場に複雑さをもたらし、潜在的にユーザーの採用を制限し、デジタルバイオマーカーを日常ケアに組み込む医療提供者や組織に障壁をもたらします。

目次

第1章 調査手法と調査範囲

第2章 定義と概要

第3章 エグゼクティブサマリー

第4章 市場力学

  • 影響要因
    • 促進要因
      • ウェアラブルデバイスとモバイルヘルス技術の導入拡大
    • 抑制要因
      • データセキュリティとプライバシーに関する懸念
    • 機会
    • 影響分析

第5章 戦略的洞察と業界展望

  • 市場のリーダーと先駆者
    • 新たな先駆者と著名企業
    • 最大の売上を誇るブランドを確立したリーダー
    • 確立された製品を持つ市場リーダー
  • CXOの視点
  • 最新の開発とブレークスルー
  • ケーススタディ/進行中の調査
  • 規制と償還の情勢
    • 北米
    • 欧州
    • アジア太平洋
    • ラテンアメリカ
    • 中東・アフリカ
  • ポーターのファイブフォース分析
  • サプライチェーン分析
  • 特許分析
  • SWOT分析
  • アンメットニーズとギャップ
  • 市場参入と拡大のための推奨戦略
  • シナリオ分析ベストケース、ベースケース、ワーストケースの予測
  • 価格分析と価格市場力学
  • キーオピニオンリーダー

第6章 システムコンポーネント別

  • ウェアラブルデバイス
  • モバイルアプリケーション
  • センサー
  • デジタルプラットフォーム
  • データ統合・分析プラットフォーム
  • その他

第7章 用途別

  • 心血管疾患
  • 神経疾患
  • 呼吸器疾患
  • 代謝障害
  • 胃腸障害
  • その他

第8章 エンドユーザー別

  • 製薬会社
  • ヘルスケア提供者
  • 支払者
  • 学術・研究機関
  • その他

第9章 地域別

  • 北米
    • 米国
    • カナダ
    • メキシコ
  • 欧州
    • ドイツ
    • 英国
    • フランス
    • スペイン
    • イタリア
    • その他欧州地域
  • 南米
    • ブラジル
    • アルゼンチン
    • その他南米
  • アジア太平洋
    • 中国
    • インド
    • 日本
    • 韓国
    • その他アジア太平洋
  • 中東・アフリカ

第10章 競合情勢

  • 競合シナリオ
  • 市況・シェア分析
  • M&A分析

第11章 企業プロファイル

  • Koneksa Health
    • 会社概要
    • 製品ポートフォリオ
      • 製品説明
      • 製品の主要業績評価指標（KPI）
      • 過去および予測の製品販売
      • 製品販売量
    • 財務概要
      • 会社の収益
      • 地域別収益分配
      • 収益予測
    • 主な発展
      • 合併と買収
      • 主な製品開発活動
      • 規制当局の承認等
    • SWOT分析
  • Biobeat Technologies Ltd.
  • Empatica Inc.
  • Evidation Health, Inc.
  • ActiGraph LLC
  • mHealth Technologies
  • Quartet Health
  • Fitabase（Small Steps Labs LLC）
  • Spire Health
  • Mindstrong Health
  • Koneksa Health
    • パイプライン製品の説明
    • 製品の主要業績評価指標（KPI）
    • 主な活動
    • 市場参入のタイムライン
    • 製品普及率
    • 売上予測と予測
  • Biobeat Technologies Ltd.
  • Empatica Inc.
  • Evidation Health, Inc.
  • 各市場参入企業に対しても同様のデータが提供されます。

第12章 付録

目次
Product Code: MD9132

The Global Digital Biomarkers Market reached US$ 4.16 Billion in 2024 and is expected to reach US$ 26.69 Billion by 2033, growing at a CAGR of 22.7% during the forecast period 2025-2033.

Digital biomarkers are objective, quantifiable data collected through digital devices like wearables, smartphones, sensors, and mobile applications. They are crucial for monitoring health conditions, tracking disease progression, and evaluating treatment responses in real-time. These biomarkers capture physiological metrics like heart rate, blood pressure, glucose levels, sleep patterns, activity levels, and cognitive performance. They can also analyze voice and speech patterns for neurological conditions, assess gait and movement for mobility disorders, and monitor eye movements and facial expressions for mental health changes.

Market Dynamics: Drivers & Restraints

Growing Adoption of Wearable Devices and Mobile Health Technologies

The global digital biomarkers market is driven by the increasing use of wearable devices and mobile health technologies. With chronic diseases like cardiovascular disorders, diabetes, and neurological conditions, continuous health monitoring is crucial. Wearable devices like smartwatches, fitness trackers, and biosensors collect real-time data, aiding in early disease detection, personalized treatment, and improved patient outcomes. This growth is driving digital biomarkers in clinical and non-clinical settings.

For instance, in December 2024, ElectronRx, a leading digital medicine and biomarker company, launched purpleDx, a cardiopulmonary assessment app designed to meet medical device standards at CES 2025. The app allows chronic respiratory disease patients to monitor digital biomarkers of lung function at home, providing real-time data for clinicians to customize treatment plans and improve patient outcomes. purpleDx was developed in collaboration with respiratory clinics and the European pulmonary hypertension association, aiming to detect, monitor, and treat pulmonary diseases like asthma, chronic obstructive pulmonary disease, interstitial lung disease, and pulmonary hypertension.

Data Security and Privacy Concerns

Digital biomarkers face significant data privacy and security challenges due to the collection and analysis of sensitive health data through connected devices. Compliance with strict regulations like GDPR in Europe and HIPAA in the U.S. adds complexity to the market, potentially limiting user adoption and creating barriers for healthcare providers and organizations integrating digital biomarkers into routine care.

Segment Analysis

The global Digital Biomarkers market is segmented based on, System Component, Application, End User and Region.

System Component:

Wearable Devices segment is expected to dominate the Digital Biomarkers market share

The wearble devices segment holds a major portion of the Digital Biomarkers market share and is expected to continue to hold a significant portion of the Digital Biomarkers market share during the forecast period.

Wearable devices, such as smartwatches, fitness trackers, and biosensors, are crucial in the Global Digital Biomarkers Market for real-time monitoring of physiological and behavioral data. They track key health metrics, enabling informed decision-making by patients and healthcare providers. Wearables are essential for disease management, early detection, and personalized healthcare, providing objective data for conditions like cardiovascular diseases, diabetes, and neurological disorders.

End User:-

Pharmaceutical Companies segment is the fastest-growing segment in Digital Biomarkers market share

The pharmaceutical companies segment is the fastest-growing segment in the Digital Biomarkers market share and is expected to hold the market share over the forecast period.

Pharmaceutical companies are utilizing digital biomarkers to accelerate drug development, improve clinical trials, and optimize patient outcomes. These biomarkers enable real-time monitoring of trial participants, enabling more comprehensive data on disease progression, treatment efficacy, and patient adherence. This helps identify potential adverse effects earlier and aids in personalized treatments. Digital biomarkers also aid in regulatory processes by providing accurate data for FDA and EMA approvals. As a result, pharmaceutical companies are embracing digital biomarkers to drive innovation, improve patient care, and streamline the drug development process.

For instance, in November 2024, Neuron23, a biotechnology company, has partnered with Roche to use a digital biomarker developed by Roche Information Solutions as the primary endpoint in the global Phase 2 NEULARK clinical trial of NEU-411, a potent inhibitor of LRRK2 in early-stage Parkinson's disease, as the primary endpoint.

Geographical Analysis

North America is expected to hold a significant position in the Digital Biomarkers market share

North America holds a substantial position in the Digital Biomarkers market and is expected to hold most of the market share due to high healthcare expenditure and advanced infrastructure are driving the digital biomarkers market. The US and Canada invest heavily in healthcare technology, enabling the adoption of innovative solutions like digital biomarkers for chronic disease management and clinical trials. The growing prevalence of chronic diseases like diabetes, cardiovascular conditions, and mental health disorders has increased the demand for continuous health monitoring. The widespread adoption of smartphones, wearable devices, and telemedicine further enhances the integration of digital biomarkers in everyday healthcare.

For instance, in May 2024, the Digital Biomarker Summit USA, held in Tarrytown, NY in May 2024, discussed the use of digital biomarkers in clinical trials, the integration of wearable devices with AI, and the impact of digital phenotyping on observational research.

Europe is growing at the fastest pace in the Digital Biomarkers market

Europe holds the fastest pace in the Digital Biomarkers market and is expected to hold most of the market share is due to the country's focus on healthcare innovation and regulatory support. Strong regulatory frameworks like the European Medicines Agency and GDPR ensure patient safety and data security, encouraging the use of digital biomarkers in clinical trials and healthcare applications. The region is also investing in preventive healthcare and personalized medicine, with high adoption of digital health solutions like wearables and mobile health apps, and increasing consumer demand for continuous healthcare monitoring.

Competitive Landscape

The major global players in the digital biomarkers market include Koneksa Health, Altoida Inc, Empatica Inc, Evidation Health, Inc., ActiGraph LLC, Quartet Health, IXICO plc, Vivo Sense, Aural Analytic, Neurotrack Technologies, Inc and among others.

Key Developments

  • In February 2024, Biofourmis, a global leader in digital biomarker development and decentralized clinical trial solutions, has formed four new partnerships with top pharmaceutical companies, leveraging their expertise in digital biomarker innovation and strengthening clinical trial programs across the US, Europe, Asia-Pacific, and MEA.
  • In March 2024, Indivi and Biogen have partnered to develop digital biomarkers for Parkinson's disease. The collaboration will use the Konectom platform, managed in the Phase 2b LUMA study, which evaluates the effectiveness and safety of BIIB122 for early-stage Parkinson's patients. The study is in partnership with Denali Therapeutics Inc.

Why Purchase the Report?

  • Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
  • Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
  • Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
  • Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
  • Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
  • Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
  • Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
  • Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
  • Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
  • Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
  • Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
  • Post-market Surveillance: Uses post-market data to enhance product safety and access.
  • Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global Digital Biomarkers market report delivers a detailed analysis with 61 key tables, more than 59 visually impactful figures, and 210 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

  • Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
  • Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
  • System Component & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
  • Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
  • Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
  • Supply Chain: Distribution and Supply Chain Managers.
  • Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
  • Academic & Research: Academic Institutions.

Table of Contents

1. Methodology and Scope

  • 1.1. Research Methodology
  • 1.2. Research Objective and Scope of the Report

2. Definition and Overview

3. Executive Summary

  • 3.1. Snippet by System Component
  • 3.2. Snippet by Application
  • 3.3. Snippet by End User
  • 3.4. Snippet by Region

4. Dynamics

  • 4.1. Impacting Factors
    • 4.1.1. Drivers
      • 4.1.1.1. Growing Adoption of Wearable Devices and Mobile Health Technologies
    • 4.1.2. Restraints
      • 4.1.2.1. Data Security and Privacy Concerns
    • 4.1.3. Opportunity
    • 4.1.4. Impact Analysis

5. Strategic Insights and Industry Outlook

  • 5.1. Market Leaders and Pioneers
    • 5.1.1. Emerging Pioneers and Prominent Players
    • 5.1.2. Established leaders with largest selling Brand
    • 5.1.3. Market leaders with established Product
  • 5.2. CXO Perspectives
  • 5.3. Latest Developments and Breakthroughs
  • 5.4. Case Studies/Ongoing Research
  • 5.5. Regulatory and Reimbursement Landscape
    • 5.5.1. North America
    • 5.5.2. Europe
    • 5.5.3. Asia Pacific
    • 5.5.4. Latin America
    • 5.5.5. Middle East & Africa
  • 5.6. Porter's Five Force Analysis
  • 5.7. Supply Chain Analysis
  • 5.8. Patent Analysis
  • 5.9. SWOT Analysis
  • 5.10. Unmet Needs and Gaps
  • 5.11. Recommended Strategies for Market Entry and Expansion
  • 5.12. Scenario Analysis: Best-Case, Base-Case, and Worst-Case Forecasts
  • 5.13. Pricing Analysis and Price Dynamics
  • 5.14. Key Opinion Leaders

6. By System Component

  • 6.1. Introduction
    • 6.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 6.1.2. Market Attractiveness Index, By System Component
  • 6.2. Wearable Devices*
    • 6.2.1. Introduction
    • 6.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 6.3. Mobile Applications
  • 6.4. Sensors
  • 6.5. Digital Platforms
  • 6.6. Data Integration & Analytics Platforms
  • 6.7. Others

7. By Application

  • 7.1. Introduction
    • 7.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 7.1.2. Market Attractiveness Index, By Application
  • 7.2. Cardiovascular Diseases*
    • 7.2.1. Introduction
    • 7.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 7.3. Neurological Disorders
  • 7.4. Respiratory Disorders
  • 7.5. Metabolic Disorders
  • 7.6. Gastrointestinal Disorders
  • 7.7. Others

8. By End User

  • 8.1. Introduction
    • 8.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 8.1.2. Market Attractiveness Index, By End User
  • 8.2. Pharmaceutical Companies*
    • 8.2.1. Introduction
    • 8.2.2. Market Size Analysis and Y-o-Y Growth Analysis (%)
  • 8.3. Healthcare Providers
  • 8.4. Payers
  • 8.5. Academic & Research Institutions
  • 8.6. Others

9. By Region

  • 9.1. Introduction
    • 9.1.1. Market Size Analysis and Y-o-Y Growth Analysis (%), By Region
    • 9.1.2. Market Attractiveness Index, By Region
  • 9.2. North America
    • 9.2.1. Introduction
    • 9.2.2. Key Region-Specific Dynamics
    • 9.2.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 9.2.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.2.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.2.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.2.6.1. U.S.
      • 9.2.6.2. Canada
      • 9.2.6.3. Mexico
  • 9.3. Europe
    • 9.3.1. Introduction
    • 9.3.2. Key Region-Specific Dynamics
    • 9.3.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 9.3.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.3.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.3.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.3.6.1. Germany
      • 9.3.6.2. U.K.
      • 9.3.6.3. France
      • 9.3.6.4. Spain
      • 9.3.6.5. Italy
      • 9.3.6.6. Rest of Europe
  • 9.4. South America
    • 9.4.1. Introduction
    • 9.4.2. Key Region-Specific Dynamics
    • 9.4.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 9.4.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.4.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.4.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.4.6.1. Brazil
      • 9.4.6.2. Argentina
      • 9.4.6.3. Rest of South America
  • 9.5. Asia-Pacific
    • 9.5.1. Introduction
    • 9.5.2. Key Region-Specific Dynamics
    • 9.5.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 9.5.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.5.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User
    • 9.5.6. Market Size Analysis and Y-o-Y Growth Analysis (%), By Country
      • 9.5.6.1. China
      • 9.5.6.2. India
      • 9.5.6.3. Japan
      • 9.5.6.4. South Korea
      • 9.5.6.5. Rest of Asia-Pacific
  • 9.6. Middle East and Africa
    • 9.6.1. Introduction
    • 9.6.2. Key Region-Specific Dynamics
    • 9.6.3. Market Size Analysis and Y-o-Y Growth Analysis (%), By System Component
    • 9.6.4. Market Size Analysis and Y-o-Y Growth Analysis (%), By Application
    • 9.6.5. Market Size Analysis and Y-o-Y Growth Analysis (%), By End User

10. Competitive Landscape

  • 10.1. Competitive Scenario
  • 10.2. Market Positioning/Share Analysis
  • 10.3. Mergers and Acquisitions Analysis

11. Company Profiles

Key Market Players

  • 11.1. Koneksa Health*
    • 11.1.1. Company Overview
    • 11.1.2. Product Portfolio
      • 11.1.2.1. Product Description
      • 11.1.2.2. Product Key Performance Indicators (KPIs)
      • 11.1.2.3. Historic and Forecasted Product Sales
      • 11.1.2.4. Product Sales Volume
    • 11.1.3. Financial Overview
      • 11.1.3.1. Company Revenue's
      • 11.1.3.2. Geographical Revenue Shares
      • 11.1.3.3. Revenue Forecasts
    • 11.1.4. Key Developments
      • 11.1.4.1. Mergers & Acquisitions
      • 11.1.4.2. Key Product Development Activities
      • 11.1.4.3. Regulatory Approvals etc.
    • 11.1.5. SWOT Analysis
  • 11.2. Biobeat Technologies Ltd.
  • 11.3. Empatica Inc.
  • 11.4. Evidation Health, Inc.
  • 11.5. ActiGraph LLC
  • 11.6. mHealth Technologies
  • 11.7. Quartet Health
  • 11.8. Fitabase (Small Steps Labs LLC)
  • 11.9. Spire Health
  • 11.10. Mindstrong Health
  • Similar data will be provided for each market player.

Emerging Market Players

  • 11.11. Koneksa Health*
    • 11.11.1. Pipeline Products Description
    • 11.11.2. Product Key Performance Indicators (KPIs)
    • 11.11.3. Key Activities
    • 11.11.4. Market Entry Timelines
    • 11.11.5. Product Penetration Rate
    • 11.11.6. Sales Estimation and Projections
  • 11.12. Biobeat Technologies Ltd.
  • 11.13. Empatica Inc.
  • 11.14. Evidation Health, Inc.
  • Similar data will be provided for each market player.

LIST NOT EXHAUSTIVE

12. Appendix

  • 12.1 About Us and Services
  • 12.2 Contact Us