デジタルバイオマーカーの世界市場

世界のデジタルバイオマーカーの市場規模は、2025年の50億米ドルから、予測期間中は30.4％のCAGRで推移し、2030年末には188億米ドルに成長すると予測されています。

モニタリング用デジタルバイオマーカーの市場は、2025年の26億米ドルから、2030年末には95億米ドルに成長すると予測され、2025年から2030年までのCAGRは29.7%です。予測用デジタルバイオマーカーの市場は、2025年の9億2,070万米ドルから、2030年末には37億米ドルに成長し、2025年から2030年までのCAGRは32.3％と推定されています。

当レポートでは、世界のデジタルバイオマーカーの市場を調査し、市場概要、市場影響因子および市場機会の分析、市場規模の推移・予測、各種区分・地域別の詳細分析などをまとめています。

目次

第1章 エグゼクティブサマリー

• 市場見通し
• 調査範囲
• 市場サマリー
• 市場成長要因
• 新興技術
• セグメント分析
• 地域分析
• 総論

第2章 市場概要

• 概要と市場定義
• デジタルバイオマーカーの種類
• 従来のバイオマーカーとデジタルバイオマーカーの比較
• PESTEL分析
• 米国関税法がデジタルバイオマーカー市場に与える影響
• 製品コストの増加
• サプライチェーンへの影響
• 現地生産の機会
• 総論

第3章 市場力学

• 市場力学
• 市場促進要因
• mヘルスアプリとウェアラブルの普及拡大
• 神経変性疾患および精神疾患におけるデジタルバイオマーカーの応用拡大
• 臨床試験におけるデジタルバイオマーカーの役割の増大
• 企業の健康増進プログラムとインセンティブ
• 市場抑制要因
• データの標準化と解釈の問題
• バイオマーカーの検証における難しさ
• データのプライバシーと保護
• 市場機会
• 成長する技術革新
• 研究協力とパートナーシップの拡大

第4章 規制状況

• 規制シナリオ
• 米国
• カナダ
• 欧州
• アジア太平洋

第5章 新興技術と開発

• AIベースのデジタルバイオマーカー
• AIとMLによるデジタルバイオマーカーの強化
• AI駆動型デジタルバイオマーカーのメリット

第6章 市場セグメンテーション分析

• セグメンテーションの内訳
• 市場内訳：システムコンポーネント別
• 重要ポイント
• データ収集ツール
• データ統合システム
• 市場内訳：用途別
• 重要ポイント
• 診断用デジタルバイオマーカー
• モニタリング用デジタルバイオマーカー
• 予測用デジタルバイオマーカー
• その他
• 市場内訳：治療領域別
• 重要ポイント
• 心血管および代謝疾患
• 精神疾患
• 神経疾患
• 筋骨格系障害
• 呼吸器疾患
• その他
• 市場内訳：エンドユーザー別
• 重要ポイント
• 製薬会社・研究機関
• 医療提供者
• 患者・介護者
• 雇用主
• 保険者
• 地理的内訳
• 市場内訳：地域別
• 重要ポイント
• 北米
• 欧州
• アジア太平洋
• 世界のその他の地域

第7章 競合情報

• 重要ポイント
• 主要デジタルバイオマーカー企業
• 企業タイプとその戦略
• 戦略分析
• 協定、協力、パートナーシップ
• 新製品の発売
• M&A
• 規制当局の承認

第8章 デジタルバイオマーカー市場における持続可能性：ESGの観点

• 持続可能性要因
• 環境の持続可能性
• 社会的持続可能性
• 経済の持続可能性
• その他の要因
• 医療における持続可能な実践の拡大
• 持続可能なソリューションを実装するビジネスプラクティス
• 総論

第9章 付録

• 調査手法
• 出典
• 略語
• 企業プロファイル
• ACTIGRAPH LLC.
• AKILI INC.
• ALIVECOR INC.
• ALTOIDA
• EMBIC CORP.
• EMPATICA INC.
• EVIDATION HEALTH INC.
• FEEL THERAPEUTICS
• HUMA
• IXICO PLC
• KINSA INC.
• KONEKSA HEALTH
• NEUROTRACK TECHNOLOGIES INC.
• VIVOSENSMEDICAL GMBH
• WINTERLIGHT LABS

List of Tables

• Summary Table : Global Market for Digital Biomarkers, by Application, Through 2030
• Table 1 : Digital Biomarker Types
• Table 2 : Traditional and Digital Biomarker Comparison
• Table 3 : Digital Biomarkers Examples
• Table 4 : Technology Innovations by Digital Biomarker Companies
• Table 5 : Key Research Collaborations and Partnerships, 2023-2025
• Table 6 : Global Market for Digital Biomarkers, by System Component, Through 2030
• Table 7 : Global Digital Biomarkers Market for Data Collection Tools, by Type, Through 2030
• Table 8 : Global Digital Biomarkers Market for Data Collection Tools, by Region, Through 2030
• Table 9 : Global Digital Biomarkers Market for Mobile and Web Apps, by Region, Through 2030
• Table 10 : Global Digital Biomarkers Market for Wearables, by Region, Through 2030
• Table 11 : Global Digital Biomarkers Market for Implantables and Ingestibles, by Region, Through 2030
• Table 12 : Global Digital Biomarkers Market for Other Data Collection Tools, by Region, Through 2030
• Table 13 : Global Digital Biomarkers Market for Data Integration Systems, by Region, Through 2030
• Table 14 : Global Market for Digital Biomarkers, by Application, Through 2030
• Table 15 : Global Market for Diagnostic Digital Biomarkers, by Region, Through 2030
• Table 16 : Global Market for Monitoring Digital Biomarkers, by Region, Through 2030
• Table 17 : Global Market for Predictive Digital Biomarkers, by Region, Through 2030
• Table 18 : Global Market Other Applications of Digital Biomarkers, by Region, Through 2030
• Table 19 : Global Market for Digital Biomarkers, by Therapeutic Area, Through 2030
• Table 20 : Global Digital Biomarkers Market for Cardiovascular and Metabolic Disorders, by Region, Through 2030
• Table 21 : Global Digital Biomarkers Market for Psychiatric Disorders, by Region, Through 2030
• Table 22 : Global Digital Biomarkers Market for Neurological Disorders, by Region, Through 2030
• Table 23 : Global Digital Biomarkers Market for Musculoskeletal Disorders, by Region, Through 2030
• Table 24 : Global Digital Biomarkers Market for Respiratory Disorders, by Region, Through 2030
• Table 25 : Global Digital Biomarkers Market for Other Therapeutic Areas, by Region, Through 2030
• Table 26 : Global Market for Digital Biomarkers, by End User, Through 2030
• Table 27 : Global Digital Biomarkers Market for Pharmaceutical Companies and Research Institutions, by Region, Through 2030
• Table 28 : Global Digital Biomarkers Market for Healthcare Providers, by Region, Through 2030
• Table 29 : Global Digital Biomarkers Market for Patients and Caregivers, by Region, Through 2030
• Table 30 : Global Digital Biomarkers Market for Employers, by Region, Through 2030
• Table 31 : Global Digital Biomarkers Market for Payers, by Region, Through 2030
• Table 32 : Global Market for Digital Biomarkers, by Region, Through 2030
• Table 33 : North American Market for Digital Biomarkers, by System Component, Through 2030
• Table 34 : North American Market for Data Collection Tools, by Type, Through 2030
• Table 35 : North American Market for Digital Biomarkers, by Application, Through 2030
• Table 36 : North American Market for Digital Biomarkers, by Therapeutic Area, Through 2030
• Table 37 : North American Market for Digital Biomarkers, by End User, Through 2030
• Table 38 : North American Market for Digital Biomarkers, by Country, Through 2030
• Table 39 : European Market for Digital Biomarkers, by System Component, Through 2030
• Table 40 : European Market for Data Collection Tools, by Type, Through 2030
• Table 41 : European Market for Digital Biomarkers, by Application, Through 2030
• Table 42 : European Market for Digital Biomarkers, by Therapeutic Area, Through 2030
• Table 43 : European Market for Digital Biomarkers, by End User, Through 2030
• Table 44 : European Market for Digital Biomarkers, by Country, Through 2030
• Table 45 : Asia-Pacific Market for Digital Biomarkers, by System Component, Through 2030
• Table 46 : Asia-Pacific Market for Data Collection Tools, by Type, Through 2030
• Table 47 : Asia-Pacific Market for Digital Biomarkers, by Application, Through 2030
• Table 48 : Asia-Pacific Market for Digital Biomarkers, by Therapeutic Area, Through 2030
• Table 49 : Asia-Pacific Market for Digital Biomarkers, by End User, Through 2030
• Table 50 : Asia-Pacific Market for Digital Biomarkers, by Country, Through 2030
• Table 51 : RoW Market for Digital Biomarkers, by System Component, Through 2030
• Table 52 : RoW Market for Data Collection Tools, by Type, Through 2030
• Table 53 : RoW Market for Digital Biomarkers, by Application, Through 2030
• Table 54 : RoW Market for Digital Biomarkers, by Therapeutic Area, Through 2030
• Table 55 : RoW Market for Digital Biomarkers, by End User, Through 2030
• Table 56 : RoW Market for Digital Biomarkers, by Sub-Region, Through 2030
• Table 57 : Prominent Digital Biomarkers Companies
• Table 58 : Agreements, Collaborations and Partnerships in the Digital Biomarkers Market, 2023-2025
• Table 59 : New Product Launches in the Digital Biomarkers Market, 2022-2025
• Table 60 : Acquisitions and Mergers in the Digital Biomarkers Market, 2024 and 2025
• Table 61 : Regulatory Approvals in the Digital Biomarkers Market, 2022-2025
• Table 62 : Information Sources for this Report
• Table 63 : Abbreviations Used in this Report
• Table 64 : ActiGraph LLC.: Company Snapshot
• Table 65 : ActiGraph LLC.: Product Portfolio
• Table 66 : ActiGraph LLC.: News/Key Developments, 2023-2025
• Table 67 : Akili Inc.: Company Snapshot
• Table 68 : Akili Inc.: Product Portfolio
• Table 69 : Akili Inc.: News/Key Developments, 2024
• Table 70 : Alivecor Inc.: Company Snapshot
• Table 71 : AliveCor Inc.: Product Portfolio
• Table 72 : AliveCor Inc.: News/Key Developments, 2024 and 2025
• Table 73 : Altoida: Company Snapshot
• Table 74 : Altoida: Product Portfolio
• Table 75 : Embic Corp.: Company Snapshot
• Table 76 : Embic Corp.: Product Portfolio
• Table 77 : Empatica Inc.: Company Snapshot
• Table 78 : Empatica Inc.: Product Portfolio
• Table 79 : Empatica Inc.: News/Key Developments, 2023 and 2024
• Table 80 : Evidation Health Inc.: Company Snapshot
• Table 81 : Evidation Health Inc.: Product Portfolio
• Table 82 : Evidation Health Inc.: News/Key Developments, 2022-2024
• Table 83 : Feel Therapeutics: Company Snapshot
• Table 84 : Feel Therapeutics: Product Portfolio
• Table 85 : Feel Therapeutics: News/Key Developments, 2022 and 2023
• Table 86 : Huma: Company Snapshot
• Table 87 : Huma: Product Portfolio
• Table 88 : Huma: News/Key Developments, 2023-2025
• Table 89 : IXICO plc: Company Snapshot
• Table 90 : IXICO plc: Financial Performance, FY 2023 and 2024
• Table 91 : IXICO plc: Product Portfolio
• Table 92 : IXICO plc: News/Key Developments, 2024 and 2025
• Table 93 : Kinsa Inc.: Company Snapshot
• Table 94 : Kinsa Inc.: Product Portfolio
• Table 95 : Kinsa Inc.: News/Key Developments, 2024
• Table 96 : Koneksa Health: Company Snapshot
• Table 97 : Koneksa Health: Product Portfolio
• Table 98 : Koneksa Health: News/Key Developments, 2023 and 2024
• Table 99 : Neurotrack Technologies Inc.: Company Snapshot
• Table 100 : Neurotrack Technologies Inc.: Product Portfolio
• Table 101 : Neurotrack Technologies Inc.: News/Key Developments, 2022
• Table 102 : VivoSensMedical GmbH: Company Snapshot
• Table 103 : VivoSensMedical GmbH: Product Portfolio
• Table 104 : VivoSensMedical GmbH: News/Key Developments, 2021
• Table 105 : Winterlight Labs: Company Snapshot
• Table 106 : Winterlight Labs: Product Portfolio

List of Figures

• Summary Figure : Global Market Share of Digital Biomarkers, by Application, 2024
• Figure 1 : PESTEL Analysis: Digital Biomarkers Market
• Figure 2 : Digital Biomarkers Market Dynamics
• Figure 3 : Distribution of Clinical Trials with Digital Biomarkers as Endpoints, by Therapeutic Area
• Figure 4 : Global Market Shares of Digital Biomarkers, by System Component, 2024
• Figure 5 : Global Digital Biomarkers Market Share of Data Collection Tools, by Type, 2024
• Figure 6 : Global Digital Biomarkers Market Share of Mobile and Web Apps, by Region, 2024
• Figure 7 : Global Digital Biomarkers Market Share of Wearables, by Region, 2024
• Figure 8 : Global Digital Biomarkers Market Share of Implantables and Ingestibles, by Region, 2024
• Figure 9 : Global Digital Biomarkers Market Share of Other Data Collection Tools, by Region, 2024
• Figure 10 : Global Digital Biomarkers Market Share of Data Integration Systems, by Region, 2024
• Figure 11 : Global Market Share of Digital Biomarkers, by Application, 2024
• Figure 12 : Global Market Share of Diagnostic Digital Biomarkers, by Region, 2024
• Figure 13 : Global Market Share of Monitoring Digital Biomarkers, by Region, 2024
• Figure 14 : Global Market Share of Predictive Digital Biomarkers, by Region, 2024
• Figure 15 : Global Market Share of Other Applications of Digital Biomarkers, by Region, 2024
• Figure 16 : Global Market Share of Digital Biomarkers, by Therapeutic Area, 2024
• Figure 17 : Global Digital Biomarkers Market Share of Cardiovascular and Metabolic Disorders, by Region, 2024
• Figure 18 : Global Digital Biomarkers Market Share of Psychiatric Disorders, by Region, 2024
• Figure 19 : Global Digital Biomarkers Market Share of Neurological Disorders, by Region, 2024
• Figure 20 : Global Digital Biomarkers Market Share of Musculoskeletal Disorders, by Region, 2024
• Figure 21 : Global Digital Biomarkers Market Share of Respiratory Disorders, by Region, 2024
• Figure 22 : Global Digital Biomarkers Market Share of Other Therapeutic Areas, by Region, 2024
• Figure 23 : Global Market Share of Digital Biomarkers, by End User, 2024
• Figure 24 : Global Digital Biomarkers Market Share of Pharmaceutical Companies and Research Institutions, by Region, 2024
• Figure 25 : Global Digital Biomarkers Market Share of Healthcare Providers, by Region, 2024
• Figure 26 : Global Digital Biomarkers Market Share of Patients and Caregivers, by Region, 2024
• Figure 27 : Global Digital Biomarkers Market Share of Employers, by Region, 2024
• Figure 28 : Global Digital Biomarkers Market Share of Payers, by Region, 2024
• Figure 29 : Global Market Share of Digital Biomarkers, by Region, 2024
• Figure 30 : North American Market Share of Digital Biomarkers, by Country, 2024
• Figure 31 : U.S. Elderly* Population, 2010-2050
• Figure 32 : European Market Share of Digital Biomarkers, by Country, 2024
• Figure 33 : Asia-Pacific Market Share of Digital Biomarkers, by Country, 2024
• Figure 34 : RoW Market Share of Digital Biomarkers, by Sub-Region, 2024
• Figure 35 : Digital Biomarkers: Competitor Types and Their Strategies
• Figure 36 : Sustainability Factors in the Digital Biomarkers Industry
• Figure 37 : Scaling Sustainable Practices in Healthcare
• Figure 38 : IXICO plc: Revenue Share, by Country/Region, FY 2024

The global market for digital biomarkers is estimated to grow from $5 billion in 2025 to $18.8 billion by the end of 2030, at a compound annual growth rate (CAGR) of 30.4% from 2025 through 2030.

The global market for monitoring digital biomarkers is estimated to grow from $2.6 billion in 2025 to $9.5 billion by the end of 2030, at a CAGR of 29.7% from 2025 through 2030.

The global market for predictive digital biomarkers is estimated to grow from $920.7 million in 2025 to $3.7 billion by the end of 2030, at a CAGR of 32.3% from 2025 through 2030.

Report Scope

This report provides an overview of the global market for digital biomarkers and analyzes market trends. It includes global revenue ($ millions) for the base year data of 2024, estimates for 2025 and projections of compound annual growth rates (CAGRs) from 2025 through 2030. The market is segmented based on system components, applications, therapeutic areas, end users and regions. The regions covered in this study include North America, Europe, Asia-Pacific and the Rest of the World (RoW), focusing on major countries in these regions.

The report focuses on the significant driving trends and challenges that affect the market and vendor landscape. It analyzes environmental, social and governance (ESG) developments and discusses emerging technologies related to the market.

Report Includes

• 53 data tables and 54 additional tables
• An overview of the global market for digital biomarkers
• Estimation of the market size and analyses of global market trends, with data from 2022 to 2024, estimates for 2025, and projected CAGRs through 2030
• Information regarding major market drivers, opportunities and challenges, industry chain structure, distribution channel and technological advancements that are affecting the overall market
• Evaluation of market potential and revenue forecast for the digital biomarkers market based on system component, application, therapeutic area, end user and region
• Insights into the industry structure, current competitive scenario, R&D activities, growth strategies and ESG trends of the market
• Identification of companies best positioned to meet this demand due to their proprietary technologies, mergers and acquisitions, joint ventures and strategic alliances
• Profiles of the leading companies, including Actigraph LLC., AliveCor Inc., Altoida, Evidation Health Inc., and IXICO Plc.

Table of Contents

Chapter 1 Executive Summary

• Market Outlook
• Scope of Report
• Market Summary
• Market Growth Factors
• Emerging Technologies
• Segmental Analysis
• Regional Analysis
• Conclusion

Chapter 2 Market Overview

• Overview and Market Definition
• Digital Biomarker Types
• Comparison of Traditional and Digital Biomarkers
• PESTEL Analysis
• Political
• Economic
• Social
• Technological
• Environmental
• Legal
• Impact of U.S. Tariff Laws on the Digital Biomarkers Market
• Increase in Product Costs
• Effects on Supply Chain
• Opportunities for Local Production
• Conclusion

Chapter 3 Market Dynamics

• Market Dynamics
• Market Drivers
• Rising Adoption of mHealth Apps and Wearables
• Growing Application of Digital Biomarkers in Neurodegenerative and Psychiatric Disorders
• Increasing Role of Digital Biomarkers in Clinical Trials
• Corporate Wellness Programs and Incentives
• Market Restraints
• Data Standardization and Interpretation Issues
• Difficulties in Validation of Biomarkers
• Data Privacy and Protection
• Market Opportunities
• Growing Technology Innovations
• Increasing Research Collaborations and Partnerships

Chapter 4 Regulatory Landscape

• Regulatory Scenario
• The U.S.
• Canada
• Europe
• Asia-Pacific

Chapter 5 Emerging Technologies and Developments

• Artificial Intelligence-based Digital Biomarkers
• Enhancement of Digital Biomarkers by AI and ML
• Benefits of AI-Driven Digital Biomarkers

Chapter 6 Market Segmentation Analysis

• Segmentation Breakdown
• Market Breakdown by System Component
• Key Takeaways
• Data Collection Tools
• Data Integration Systems
• Market Breakdown by Application
• Key Takeaways
• Diagnostic Digital Biomarkers
• Monitoring Digital Biomarkers
• Predictive Digital Biomarkers
• Other Applications
• Market Breakdown by Therapeutic Area
• Key Takeaways
• Cardiovascular and Metabolic Disorders
• Psychiatric Disorders
• Neurological Disorders
• Musculoskeletal Disorders
• Respiratory Disorders
• Other Therapeutic Areas
• Market Breakdown by End User
• Key Takeaways
• Pharmaceutical Companies and Research Institutions
• Healthcare Providers
• Patients and Caregivers
• Employers
• Payers
• Geographic Breakdown
• Market Breakdown by Region
• Key Takeaways
• North America
• Europe
• Asia-Pacific
• Rest of the World

Chapter 7 Competitive Intelligence

• Key Takeaways
• Prominent Digital Biomarkers Companies
• Competitor Types and Their Strategies
• Pharmaceutical Companies
• Large Technology Companies
• Small and Medium-Size Technology Companies
• Strategic Analysis
• Agreements, Collaborations and Partnerships
• New Product Launches
• Acquisitions and Mergers
• Regulatory Approvals

Chapter 8 Sustainability in Digital Biomarkers Market: ESG Perspective

• Introduction
• Sustainability Factors
• Environmental Sustainability
• Social Sustainability
• Economic Sustainability
• Other Factors
• Scaling Sustainable Practices in Healthcare
• Business Practices Implementing Sustainable Solutions
• Conclusion

Chapter 9 Appendix

• Methodology
• Sources
• Abbreviations
• Company Profiles
• ACTIGRAPH LLC.
• AKILI INC.
• ALIVECOR INC.
• ALTOIDA
• EMBIC CORP.
• EMPATICA INC.
• EVIDATION HEALTH INC.
• FEEL THERAPEUTICS
• HUMA
• IXICO PLC
• KINSA INC.
• KONEKSA HEALTH
• NEUROTRACK TECHNOLOGIES INC.
• VIVOSENSMEDICAL GMBH
• WINTERLIGHT LABS