数位生物标记市场机会、成长动力、产业趋势分析及 2025 - 2034 年预测

2024 年全球数位生物标记市场规模达到 38 亿美元，预计 2025 年至 2034 年期间将以 28.8% 的复合年增长率大幅扩张。数位生物标记是反映个人生理、行为或环境状况的客观、可测量资料。它们透过穿戴式装置、行动应用程式和感测器等先进的数位工具收集，为现实环境中的个人健康状况、疾病进展和治疗反应提供重要见解。随着医疗保健越来越依赖数据，数位生物标记正在改变病情的监测、检测和管理方式。这些技术不仅提供可检测健康状况细微变化的即时资料，而且还为主动的医疗保健策略铺平了道路，有可能彻底改变预防性护理。透过持续监测健康指标，数位生物标记正在改变疾病管理的格局并帮助临床医生做出更明智的决策。

市场分为穿戴式装置、行动应用程式、感测器和其他数位工具。穿戴式装置目前占据市场主导地位，到 2024 年将占据 42.5% 的份额。穿戴式装置的功能特别强大，因为它们可以持续、即时追踪关键的生理和行为指标，例如心率、睡眠模式、身体活动和血糖水平。与传统的临床评估不同，穿戴式装置能够全天候追踪这些指标，提供更详细的见解，并能够检测到可能预示疾病发作的细微健康状况变化。这种持续监测不仅可以提高早期发现的能力，还可以实现及时的医疗干预，最终改善患者的治疗效果。

当考虑临床实践时，数位生物标记分为诊断、监测、预测和预后类别。监测生物标记领域在 2024 年占据 45.8% 的市场份额，占据市场主导地位，并有望实现大幅增长，预计到 2034 年将达到 214 亿美元。监测生物标记对于检测疾病的早期迹象至关重要，尤其是糖尿病和阿兹海默症等慢性病。它们可以检测出个人健康状况的细微变化，从而采取更有效、更及时的干预措施。随着主动健康管理的需求不断增加，数位生物标记在监测病情方面的作用将持续增长，从而提高医疗保健的整体有效性。

由于美国强大的技术基础设施和强大的创新生态系统，美国数位生物标记市场规模到 2034 年预计将达到 165 亿美元。人工智慧、机器学习和云端运算领域大型科技公司的出现加速了先进数位生物标记的发展。此外，健身追踪器和连续血糖监测仪等穿戴式装置的广泛应用在数位生物标记的日益普及中发挥了重要作用。消费者对这些技术的需求持续推动市场扩张，进一步推动这项变革性医疗保健领域的进步。

目录

第 1 章：方法论与范围

第 2 章：执行摘要

第 3 章：产业洞察

• 产业生态系统分析
• 产业衝击力
  • 成长动力
    • 慢性病盛行率上升
    • 人工智慧和机器学习的进步
    • 穿戴式装置的普及
    • 远端监控日益受到关注
  • 产业陷阱与挑战
    • 先进设备成本高昂
    • 缺乏熟练的专业人员
• 成长潜力分析
• 监管格局
• 技术格局
• 未来市场趋势
• 波特的分析
• PESTEL 分析

第四章：竞争格局

• 介绍
• 公司市占率分析
• 公司矩阵分析
• 主要市场参与者的竞争分析
• 竞争定位矩阵
• 策略仪表板

第 5 章：市场估计与预测：按类型，2021 年至 2034 年

• 主要趋势
• 穿戴
• 基于行动的应用程式
• 感应器
• 其他类型

第 6 章：市场估计与预测：按临床实践，2021 – 2034 年

• 主要趋势
• 诊断数位生物标记
• 监测数位生物标记
• 预测和预后数位生物标记物
• 其他临床实践

第 7 章：市场估计与预测：按治疗领域，2021 年至 2034 年

• 主要趋势
• 心血管和代谢疾病（CVMD）
• 糖尿病
• 呼吸系统疾病
• 精神疾病
• 睡眠和运动疾病
• 神经系统疾病
• 肌肉骨骼疾病
• 其他治疗领域

第 8 章：市场估计与预测：依最终用途，2021 年至 2034 年

• 主要趋势
• 医疗保健提供者
• 付款人
• 製药和生物技术公司
• 学术及研究机构

第 9 章：市场估计与预测：按地区，2021 年至 2034 年

• 主要趋势
• 北美洲
  • 我们
  • 加拿大
• 欧洲
  • 德国
  • 英国
  • 法国
  • 西班牙
  • 义大利
  • 荷兰
• 亚太地区
  • 中国
  • 日本
  • 印度
  • 澳洲
  • 韩国
• 拉丁美洲
  • 巴西
  • 墨西哥
  • 阿根廷
• 中东和非洲
  • 南非
  • 沙乌地阿拉伯
  • 阿联酋

第十章：公司简介

• ActiGraph
• AliveCor
• Altoida
• Amgen Inc.
• Adherium Limited
• Aural Analytic
• Brainomix
• Biogen
• Clario
• Empatica Inc.
• Evidation Health Inc.
• IXICO plc
• Koneksa
• Sonde Health, Inc.
• Vivo Sense

The Global Digital Biomarkers Market reached USD 3.8 billion in 2024 and is expected to expand significantly at a CAGR of 28.8% between 2025 and 2034. Digital biomarkers are objective, measurable data that reflect an individual's physiological, behavioral, or environmental condition. They are collected through advanced digital tools such as wearables, mobile applications, and sensors, offering crucial insights into a person's health status, disease progression, and treatment responses in real-world settings. As healthcare becomes increasingly data-driven, digital biomarkers are transforming how conditions are monitored, detected, and managed. These technologies not only provide real-time data that can detect subtle changes in health but also pave the way for proactive healthcare strategies, offering the potential to revolutionize preventative care. By enabling continuous monitoring of health indicators, digital biomarkers are changing the landscape of disease management and helping clinicians make more informed decisions.

The market is segmented into wearables, mobile applications, sensors, and other digital tools. The wearable segment currently dominates the market, holding a 42.5% share in 2024. Wearables are particularly powerful as they allow for continuous, real-time tracking of key physiological and behavioral indicators, such as heart rate, sleep patterns, physical activity, and glucose levels. Unlike traditional clinical assessments, wearables offer the ability to track these indicators around the clock, providing more detailed insights and the ability to detect even minor changes in health that could signal the onset of disease. This continuous monitoring not only enhances early detection but also enables timely medical intervention, ultimately improving patient outcomes.

When considering clinical practices, digital biomarkers are classified into diagnostic, monitoring, predictive, and prognostic categories. The monitoring biomarkers segment led the market with a 45.8% share in 2024 and is poised for substantial growth, expected to reach USD 21.4 billion by 2034. Monitoring biomarkers are crucial for detecting early signs of diseases, especially chronic conditions like diabetes and Alzheimer's disease. They can detect subtle changes in an individual's health, enabling more effective and timely interventions. As the demand for proactive health management increases, the role of digital biomarkers in monitoring conditions will continue to grow, enhancing the overall effectiveness of healthcare.

The U.S. digital biomarkers market is set to reach USD 16.5 billion by 2034, driven by the country's robust technological infrastructure and a strong innovation ecosystem. The presence of major tech companies in artificial intelligence, machine learning, and cloud computing has accelerated the development of advanced digital biomarkers. In addition, the widespread adoption of wearable devices, such as fitness trackers and continuous glucose monitors, has played a significant role in the growing popularity of digital biomarkers. Consumer demand for these technologies continues to drive market expansion, further fueling advancements in this transformative healthcare sector.

Table of Contents

Chapter 1 Methodology and Scope

• 1.1 Market scope and definitions
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Base estimates and calculations
  • 1.3.1 Base year calculation
  • 1.3.2 Key trends for market estimation
• 1.4 Forecast model
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
  • 1.5.2 Data mining sources

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Rising prevalence of chronic diseases
    • 3.2.1.2 Advancements in AI and Machine learning
    • 3.2.1.3 Adoption of wearable devices
    • 3.2.1.4 Growing focus on remote monitoring
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 High costs of advanced devices
    • 3.2.2.2 Lack of skilled professionals
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
• 3.5 Technological landscape
• 3.6 Future market trends
• 3.7 Porter's analysis
• 3.8 PESTEL analysis

Chapter 4 Competitive Landscape, 2024

• 4.1 Introduction
• 4.2 Company market share analysis
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Strategy dashboard

Chapter 5 Market Estimates and Forecast, By Type, 2021 – 2034 ($ Mn)

• 5.1 Key trends
• 5.2 Wearable
• 5.3 Mobile based applications
• 5.4 Sensors
• 5.5 Others types

Chapter 6 Market Estimates and Forecast, By Clinical Practice, 2021 – 2034 ($ Mn)

• 6.1 Key trends
• 6.2 Diagnostic digital biomarkers
• 6.3 Monitoring digital biomarkers
• 6.4 Predictive and prognostic digital biomarkers
• 6.5 Other clinical practices

Chapter 7 Market Estimates and Forecast, By Therapeutic Area, 2021 – 2034 ($ Mn)

• 7.1 Key trends
• 7.2 Cardiovascular and metabolic disorders (CVMD)
• 7.3 Diabetes
• 7.4 Respiratory disorders
• 7.5 Psychiatric disorders
• 7.6 Sleep and movement diseases
• 7.7 Neurological disorders
• 7.8 Musculoskeletal disorders
• 7.9 Other therapeutic areas

Chapter 8 Market Estimates and Forecast, By End Use, 2021 – 2034 ($ Mn)

• 8.1 Key trends
• 8.2 Healthcare providers
• 8.3 Payers
• 8.4 Pharmaceutical and biotechnology companies
• 8.5 Academic and research institutions

Chapter 9 Market Estimates and Forecast, By Region, 2021 – 2034 ($ Mn)

• 9.1 Key trends
• 9.2 North America
  • 9.2.1 U.S.
  • 9.2.2 Canada
• 9.3 Europe
  • 9.3.1 Germany
  • 9.3.2 UK
  • 9.3.3 France
  • 9.3.4 Spain
  • 9.3.5 Italy
  • 9.3.6 Netherlands
• 9.4 Asia Pacific
  • 9.4.1 China
  • 9.4.2 Japan
  • 9.4.3 India
  • 9.4.4 Australia
  • 9.4.5 South Korea
• 9.5 Latin America
  • 9.5.1 Brazil
  • 9.5.2 Mexico
  • 9.5.3 Argentina
• 9.6 Middle East and Africa
  • 9.6.1 South Africa
  • 9.6.2 Saudi Arabia
  • 9.6.3 UAE

Chapter 10 Company Profiles

• 10.1 ActiGraph
• 10.2 AliveCor
• 10.3 Altoida
• 10.4 Amgen Inc.
• 10.5 Adherium Limited
• 10.6 Aural Analytic
• 10.7 Brainomix
• 10.8 Biogen
• 10.9 Clario
• 10.10 Empatica Inc.
• 10.11 Evidation Health Inc.
• 10.12 IXICO plc
• 10.13 Koneksa
• 10.14 Sonde Health, Inc.
• 10.15 Vivo Sense