デジタルバイオマーカーの市場規模、シェア、成長分析：タイプ別、臨床実践別、治療領域別、エンドユーザー別、地域別 - 産業予測 2025～2032年

デジタルバイオマーカーの世界市場規模は、2023年に39億米ドルと評価され、2024年の50億2,000万米ドルから2032年には380億5,000万米ドルに成長し、予測期間（2025～2032年）のCAGRは28.8％で成長する見通しです。

デジタルバイオマーカー市場は、ヘルスケア技術の急速な進歩や医療費の増加に加え、遠隔介護サービスや遠隔患者モニタリングに対する需要の高まりによって力強い成長を遂げています。この市場を後押しする主な要因としては、分散型臨床試験への投資の拡大、治療アプリケーションの拡大、スマートフォンの普及に伴うウェアラブルデバイスの急増などが挙げられます。呼吸、音声、熱、眼球運動などのバイタル指標を検出できる革新的技術により、複雑な疾患のリアルタイム・モニタリングが可能になっています。特筆すべきは、音声によるデジタルバイオマーカーに大きな成長機会があることです。ルクセンブルグ健康研究所によるCoLive Voiceのような取り組みは、遠隔リスク評価と疾病管理の可能性を浮き彫りにしています。スマートウォッチやフィットネストラッカーを利用する消費者の増加により、市場は継続的に拡大する態勢が整っています。

目次

イントロダクション

• 調査の目的
• 調査範囲
• 定義

調査手法

• 情報調達
• 二次と一次データの方法
• 市場規模予測
• 市場の前提条件と制限

エグゼクティブサマリー

• 世界市場の見通し
• 供給と需要の動向分析
• セグメント別機会分析

市場力学と見通し

• 市場概要
• 市場規模
• 市場力学
  • 促進要因と機会
  • 抑制要因と課題
• ポーターの分析

主な市場の考察

• 重要成功要因
• 競合の程度
• 主な投資機会
• 市場エコシステム
• 市場の魅力指数（2024年）
• PESTEL分析
• マクロ経済指標
• バリューチェーン分析
• 価格分析
• 規制情勢
• ケーススタディ
• 技術分析

デジタルバイオマーカー市場規模：タイプ別

• 市場概要
• ウェアラブル
• モバイルベースのアプリケーション
• センサー
• その他

デジタルバイオマーカー市場規模：臨床実践別

• 市場概要
• 診断デジタルバイオマーカー
• モニタリングデジタルバイオマーカー
• 予測と予知デジタルバイオマーカー
• その他

デジタルバイオマーカー市場規模：治療領域別

• 市場概要
• 心血管および代謝疾患（CVMD）
• 呼吸器疾患
• 精神障害
• 睡眠と運動障害
• 神経疾患
• 筋骨格系障害
• その他

デジタルバイオマーカー市場規模：エンドユーザー別

• 市場概要
• ヘルスケア企業
• ヘルスケア提供者
• 支払者
• その他

デジタルバイオマーカー市場規模

• 北米
  • 米国
  • カナダ
• 欧州
  • ドイツ
  • スペイン
  • フランス
  • 英国
  • イタリア
  • その他欧州地域
• アジア太平洋地域
  • 中国
  • インド
  • 日本
  • 韓国
  • その他アジア太平洋地域
• ラテンアメリカ
  • ブラジル
  • その他ラテンアメリカ地域
• 中東・アフリカ
  • GCC諸国
  • 南アフリカ
  • その他中東・アフリカ

競合情報

• 上位5社の比較
• 主要企業の市場ポジショニング（2024年）
• 主な市場企業が採用した戦略
• 最近の市場動向
• 企業の市場シェア分析（2024年）
• 主要企業の企業プロファイル
  • 企業の詳細
  • 製品ポートフォリオ分析
  • 企業のセグメント別シェア分析
  • 収益の前年比比較（2022～2024年）

主要企業プロファイル

• BioSensics（United States）
• AliveCor（United States）
• BACtrack（United States）
• Eyenuk（United States）
• Quibim（Spain）
• Biofourmis（United States）
• Fitbit（United States）
• Evidation Health（United States）
• Empatica（United States）
• Philips Healthcare（Netherlands）
• Medtronic（Ireland）
• Akili Interactive（United States）
• Apple Inc.（United States）
• Biotricity（United States）
• Tempus（United States）
• Pear Therapeutics（United States）
• BioBeats（United Kingdom）
• Oura Health（Finland）
• ActiGraph（United States）
• Koneksa（United States）

結論と提言

Global Digital Biomarkers Market size was valued at USD 3.9 billion in 2023 and is poised to grow from USD 5.02 billion in 2024 to USD 38.05 billion by 2032, growing at a CAGR of 28.8% during the forecast period (2025-2032).

The digital biomarkers market is experiencing robust growth, driven by rising demand for telecare services and remote patient monitoring, alongside rapid advancements in healthcare technology and increased healthcare expenditure. Key factors propelling this market include growing investments in decentralized clinical trials, expanding therapeutic applications, and the surge in wearable devices amid widespread smartphone usage. Innovative technologies capable of detecting vital indicators such as breathing, voice, heat, and eye movements are enabling real-time monitoring of complex diseases. Notably, vocal digital biomarkers present significant growth opportunities. Initiatives like the CoLive Voice by the Luxembourg Institute of Health highlight the potential for remote risk assessment and disease management. With an increasing number of consumers utilizing smartwatches and fitness trackers, the market is poised for continued expansion.

Top-down and bottom-up approaches were used to estimate and validate the size of the Global Digital Biomarkers market and to estimate the size of various other dependent submarkets. The research methodology used to estimate the market size includes the following details: The key players in the market were identified through secondary research, and their market shares in the respective regions were determined through primary and secondary research. This entire procedure includes the study of the annual and financial reports of the top market players and extensive interviews for key insights from industry leaders such as CEOs, VPs, directors, and marketing executives. All percentage shares split, and breakdowns were determined using secondary sources and verified through Primary sources. All possible parameters that affect the markets covered in this research study have been accounted for, viewed in extensive detail, verified through primary research, and analyzed to get the final quantitative and qualitative data.

Global Digital Biomarkers Market Segments Analysis

Global Digital Biomarkers Market is segmented by Type, Clinical Practice, Therapeutic Area, End Users and region. Based on Type, the market is segmented into Wearable, Mobile based Applications, Sensors and Others. Based on Clinical Practice, the market is segmented into Diagnostic digital biomarkers, Monitoring digital biomarkers, Predictive and Prognostic digital biomarkers and Others. Based on Therapeutic Area, the market is segmented into Cardiovascular and metabolic disorders (CVMD), Respiratory disorders, Psychiatric disorders, Sleep & Movement Disease, Neurological disorders, Musculoskeletal disorders and Others. Based on End Users, the market is segmented into Healthcare companies, Healthcare Providers, Payers and Others. Based on region, the market is segmented into North America, Europe, Asia Pacific, Latin America and Middle East & Africa.

Driver of the Global Digital Biomarkers Market

The rise in the prevalence of diabetes, hypertension, and cardiovascular diseases is driving the demand for digital biomarkers. These advanced health indicators provide essential insights that enable healthcare systems to respond promptly and maintain continuous monitoring of chronic conditions. By facilitating optimal management practices, digital biomarkers empower patients to maintain their health for extended periods and minimize hospital visits. This proactive approach not only enhances patients' quality of life but also helps reduce overall healthcare costs. Consequently, the increasing focus on managing chronic illnesses is significantly fueling the global market for digital biomarkers, highlighting their importance in modern healthcare.

Restraints in the Global Digital Biomarkers Market

While digital biomarkers show significant potential, a major challenge lies in their lack of clinical validation, which is essential for their widespread acceptance among medical professionals. Due to insufficient rigorous research to establish their effectiveness in real-world applications, concerns regarding their accuracy and reliability are prevalent. This gap in validation hinders the broader acceptance and integration of digital biomarkers into standard treatment protocols, as healthcare providers prefer to utilize evidence-based tools that have proven efficacy. Consequently, the limited clinical validation of these biomarkers may impede their ability to gain traction in routine medical practice, posing a significant restraint in the global digital biomarkers market.

Market Trends of the Global Digital Biomarkers Market

The Global Digital Biomarkers market is witnessing a significant trend towards the integration of artificial intelligence (AI), which enhances the capability of wearables and health applications to generate data. By employing advanced AI algorithms to analyze and interpret this data, healthcare providers can uncover patterns and insights that might not be readily apparent, leading to more proactive and individualized healthcare approaches. This trend is pivotal in improving illness management and optimizing patient outcomes, as it amplifies the predictive power of digital biomarkers. Consequently, the market is positioned for robust growth, driven by the increasing reliance on technology for personal health monitoring and disease management.

Table of Contents

Introduction

• Objectives of the Study
• Scope of the Report
• Definitions

Research Methodology

• Information Procurement
• Secondary & Primary Data Methods
• Market Size Estimation
• Market Assumptions & Limitations

Executive Summary

• Global Market Outlook
• Supply & Demand Trend Analysis
• Segmental Opportunity Analysis

Market Dynamics & Outlook

• Market Overview
• Market Size
• Market Dynamics
  • Drivers & Opportunities
  • Restraints & Challenges
• Porters Analysis
  • Competitive rivalry
  • Threat of substitute
  • Bargaining power of buyers
  • Threat of new entrants
  • Bargaining power of suppliers

Key Market Insights

• Key Success Factors
• Degree of Competition
• Top Investment Pockets
• Market Ecosystem
• Market Attractiveness Index, 2024
• PESTEL Analysis
• Macro-Economic Indicators
• Value Chain Analysis
• Pricing Analysis
• Regulatory Landscape
• Case Studies
• Technology Analysis

Global Digital Biomarkers Market Size by Type & CAGR (2025-2032)

• Market Overview
• Wearable
• Mobile based Applications
• Sensors
• Others

Global Digital Biomarkers Market Size by Clinical Practice & CAGR (2025-2032)

• Market Overview
• Diagnostic digital biomarkers
• Monitoring digital biomarkers
• Predictive and Prognostic digital biomarkers
• Others

Global Digital Biomarkers Market Size by Therapeutic Area & CAGR (2025-2032)

• Market Overview
• Cardiovascular and metabolic disorders (CVMD)
• Respiratory disorders
• Psychiatric disorders
• Sleep & Movement Disease
• Neurological disorders
• Musculoskeletal disorders
• Others

Global Digital Biomarkers Market Size by End Users & CAGR (2025-2032)

• Market Overview
• Healthcare companies
• Healthcare Providers
• Payers
• Others

Global Digital Biomarkers Market Size & CAGR (2025-2032)

• North America (Type, Clinical Practice, Therapeutic Area, End Users)
  • US
  • Canada
• Europe (Type, Clinical Practice, Therapeutic Area, End Users)
  • Germany
  • Spain
  • France
  • UK
  • Italy
  • Rest of Europe
• Asia Pacific (Type, Clinical Practice, Therapeutic Area, End Users)
  • China
  • India
  • Japan
  • South Korea
  • Rest of Asia-Pacific
• Latin America (Type, Clinical Practice, Therapeutic Area, End Users)
  • Brazil
  • Rest of Latin America
• Middle East & Africa (Type, Clinical Practice, Therapeutic Area, End Users)
  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Intelligence

• Top 5 Player Comparison
• Market Positioning of Key Players, 2024
• Strategies Adopted by Key Market Players
• Recent Developments in the Market
• Company Market Share Analysis, 2024
• Company Profiles of All Key Players
  • Company Details
  • Product Portfolio Analysis
  • Company's Segmental Share Analysis
  • Revenue Y-O-Y Comparison (2022-2024)

Key Company Profiles

• BioSensics (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• AliveCor (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BACtrack (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Eyenuk (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Quibim (Spain)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biofourmis (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Fitbit (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Evidation Health (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Empatica (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Philips Healthcare (Netherlands)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Medtronic (Ireland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Akili Interactive (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Apple Inc. (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Biotricity (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Tempus (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Pear Therapeutics (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• BioBeats (United Kingdom)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Oura Health (Finland)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• ActiGraph (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments
• Koneksa (United States)
  • Company Overview
  • Business Segment Overview
  • Financial Updates
  • Key Developments

Conclusion & Recommendations