Digital Biomarkers Market

Digital Biomarkers Market Size, Share and Growth Forecast by Component, by Therapeutic Area, by Clinical Practice, by End User, and by Region for 2024-2031

PMR Provides a Global Market Study on Digital Biomarkers Based on its Applications in Chronic Disease Diagnostics, and Remote Patient Monitoring

Report ID: PMRREP34594

Report Type: Ongoing

Format: PPT*, PDF, EXCEL

Industry: Healthcare

Report Price

$4900*

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Digital Biomarkers Market Size and Share Analysis

The global market for digital biomarkers is estimated to value at US$10.6 Bn by the end of 2031 from US$ 2.2 Bn recorded in 2023. The market is expected to secure a CAGR of 21.8% in the forthcoming years from 2024 to 2031.

Market Attributes

Key Insights

Digital Biomarkers Market Size (2024E)

US$2.7 Bn

Projected Market Value (2031F)

US$10.6 Bn

Forecast Growth Rate (CAGR 2024 to 2031)

21.8%

Historical Growth Rate (CAGR 2018 to 2023)

17.4%

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Market Introduction and Trend Analysis

Digital biomarkers are quantifiable, non-invasive, objective and continuous measurement of physiological, and behavioural measures collected by means of digital devices which are wearable, portable, digestible or implantable.

These biomarkers provide an in depth understanding of the progression of a disease, the effectiveness of treatment and patient response in real-world settings.

Digital biomarkers are thus facilitating the robust and patient-centric research and serving a key tool in clinical trials by serving as digital endpoints.

Over the past decade, several companies have leveraged the emerging technologies, and the capacity of AI and ML algorithms to understand and analyse vast amounts of data generated by wearable devices, and other digital health tools.

These technologies have the potential to identify patterns, make predictions, and derive meaningful insights from biomarker data.

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Historical Growth and Course Ahead

The advancements in wearable technology, and mobile health applications have revolutionized how health data is collected and analyzed in real-time.

Devices like fitness trackers and smart watches track sleep patterns, physical activity levels, monitor vital signs, and even glucose levels non-invasively, providing continuous stream of data.

This, in turn, allows development of digital biomarkers with accuracy to predict disease progression, assess treatment efficacy, and provide personalized health recommendations.

Harnessing the power of digital technologies and digital biomarkers is set to open new prospects for healthcare practitioners and researchers in the field of personalized medicine, remote patient monitoring, early disease detection, and cost-effective data collection.

The advancement within this industry is likely to enhance the efficiency and accuracy of clinical studies, offering more personalized and effective interventions, ultimately improving the quality of healthcare and advancing medical knowledge.

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Market Growth Drivers

Growing Demand for Personalized Remote Patient Care

As healthcare shifts towards value-based models, digital biomarkers market offer promise in enhancing patient outcomes and reshaping healthcare delivery. One significant driver of the market for digital biomarkers is their ability to facilitate personalized care.

By tracking physiological parameters, behavioural patterns, and environmental factors in real-time, digital biomarkers provide a comprehensive view of an individual's health status.

This personalized approach allows healthcare providers to tailor treatment plans based on precise data insights, leading to more effective disease management and improved patient outcomes.

Digital biomarkers also support early detection of health deterioration or disease progression by detecting subtle changes in biomarker patterns.

Digital biomarkers offer a promising solution by enabling more efficient resource allocation, reducing unnecessary healthcare utilization, and enhancing the overall quality of care delivery.

Growing Intervention of Cutting-Edge Technologies

Digital biomarkers represent a paradigm shift in clinical trials by harnessing cutting-edge technology to enhance efficiency, precision, and patient-centricity.

Digital biomarkers utilize data from wearable technologies, mobile apps and other digital health technologies to improve clinical practice and patient care.

Capturing real-time data enables researchers to monitor patient responses to treatments more comprehensively and detect subtle changes during clinical trials.

Digital biomarkers further facilitate remote patient monitoring, reducing the need for frequent site visits and enhancing participant retention rates. Thus, benefitting trials involving geographically dispersed populations or patients with chronic conditions.

Furthermore, digital biomarkers enhance data quality and reliability by minimizing human error in data collection and transcription.

Automated data capture from digital sources ensures consistency and accuracy, thereby reducing variability and enhancing the robustness of trial findings.

Factors Impeding the Market

Reimbursement Challenges for Digital Biomarker-based Services, and Interventions

Securing reimbursement for digital biomarker-based services and interventions presents significant challenges rooted in the complexities of healthcare reimbursement systems globally.

Digital biomarkers often lack clear reimbursement frameworks, unlike traditional medical treatments with established reimbursement pathways.

Many countries regulate digital therapeutics (DTx) as medical devices or software integrated with a medical device, and some have a more specific pathway than others.

While Australia has more specific regulations classifying software used in IVD, some European countries are adopting similar processes which deems DTx eligible for reimbursement during the fast access pathway.

This ambiguity stems from evolving healthcare policies, varying payer perspectives on digital health innovations, and the necessity to demonstrate tangible benefits in terms of cost-effectiveness and clinical utility.

Furthermore, the challenge extends to aligning reimbursement strategies with the rapid pace of technological advancements in digital health.

Complex, and Evolving Regulatory Landscapes

Navigating regulatory compliance in the digital biomarkers market is a multifaceted challenge. The landscape spans diverse global regions with varying regulatory frameworks, each requiring meticulous understanding and adherence.

Compliance demands robust resources and specialized expertise to interpret and implement regulations effectively, ensuring adherence to stringent data privacy laws such as GDPR in Europe, or HIPAA in the US.

Handling sensitive health information intensifies the complexity, necessitating secure data management practices and protocols that safeguard patient privacy and confidentiality. 

Further, standardization of digital biomarkers is quite complicated due to variations in healthcare settings in different countries. Sometimes, standardization causes changes in digital biomarkers’ value.

Companies within this industry need to establish comprehensive data protection measures, including encryption, access controls, and secure data storage solutions, to mitigate risks of breaches and unauthorized access.

Future Opportunities Digital Biomarkers Market Players

Blockchain Technology for Enhanced Data Security

Blockchain technology offers a robust solution to address the critical need for secure and private handling of biomarker data. By leveraging decentralized and immutable ledgers, blockchain ensures the sensitive health information to remain protected from breaches, and tampering.

This presents an opportunity for technology firms to develop innovative blockchain-based solutions that meet stringent regulatory requirements, thereby gaining trust and credibility among healthcare providers, researchers, and patients alike.

In addition to enhancing data security, digital biomarkers hold significant promise for pharmaceutical companies. These biomarkers, enabled by advanced technologies like blockchain, not only improve the accuracy and efficiency of clinical trials but also expedite drug development processes.

Furthermore, the insights derived from digital biomarkers contribute to the broader goal of advancing precision medicine. Pharmaceutical firms use these biomarkers to identify subpopulations that respond better to specific therapies, thereby optimizing treatment strategies and increasing market potential.

Collaboration with Healthcare Providers, and Research Institutions

Collaborations and partnerships among healthcare providers, technology firms, pharmaceutical companies, and research institutions are pivotal in advancing digital biomarkers.

By combining expertise in technology, scientific research, drug development, and clinical practice, these alliances accelerate innovation and adoption in the field.

Together, these partnerships foster synergies to drive the development of robust digital biomarkers, facilitate faster regulatory approval, and expedite their integration into clinical workflows.

The collaborative approach not only expands market opportunities but also enhances the effectiveness of personalized medicine and transforms healthcare delivery by leveraging cutting-edge technologies and interdisciplinary insights.

  • In October 2023, Gates Ventures partnered with National Alzheimer's Coordinating Center (NACC) to initiate Digital Biomarker Pilot Program to accelerate the pace of digital innovation in Alzheimer's Disease and Related Dementias (AD/ADRD) research. The program is focussed on advancing the development and/or validation of digital biomarkers for early detection, diagnosis, prognosis, or monitoring.
     
  • In March 2024, Koneksa and Merck (MSD) joined a Data Syndication Partnership program for the LEARNS observational study. The study aimed at developing digital biomarkers in neurodegenerative disorders from wearable technologies and smart phone-based assessments.

Category-wise Analysis

Category

Projected CAGR through 2031

Therapeutic Area Category - CVMD

21.7%

Clinical Practice Category - Monitoring Digital Biomarkers

22.5%

CVMD Represent a Sizeable Market Share

The cardiovascular and metabolic disorders (CVMD) segment accounted for nearly one-third of the global digital biomarkers market revenue in 2023 and is likely to maintain its dominance during in the forthcoming years recording a CAGR of 21.7%.

Growing prevalence and impact of cardiovascular diseases (CVDs) and metabolic disorders such as diabetes at an alarming rate globally affect a substantial portion of the population. Thereby, contributing significantly to healthcare costs and morbidity rates.

Digital biomarkers offer a promising avenue for early detection, continuous monitoring, and personalized management of these chronic diseases.

  • As per the World Health Organization’s statistics 2023, an estimated 17.9 million deaths occur due to cardiovascular diseases (CVDs) each year globally. Heart attacks and strokes are the key reason in four out of five CVDs death.

Monitoring Digital Biomarkers to be Preferred in Clinical Practice

Monitoring digital biomarkers is the most preferred and utilised category within the clinical practice owed to its ability to provide real-time, objective, and continuous data. Thus, enhancing patient management and improving healthcare outcomes.

Digital biomarkers increase the diagnostic and therapeutic precision of the modern healthcare system by allowing remote and continuous monitoring of patients by tracking patients' health metrics outside of traditional clinical settings.

Furthermore, integrating digital biomarkers data with electronic health records (EHRs) facilitates seamless data sharing and collaboration among healthcare teams.

Thus, supporting more informed clinical decision-making, enabling predictive analytics, enhancing patient care, optimizing healthcare resource allocation, and improving overall health outcomes.

Region-wise Analysis

Region

CAGR through 2031

North America

20.4%

East Asia

25.3%

North America to Account for the Significant Market Share

North America is a significant shareholder in the global market and is expected to grow at a CAGR of 20.4% during the forecast period.

North America market accounts for the notable share owing to the factors such as presence of key players in the region offering digital biomarker products and services and increasing prevalence of cardiovascular and metabolic disorders.

  • As per the US Centers for Disease Control and Prevention 2024 updates, around 38.4 million individuals in the U.S. have diabetes with 29.7 million diagnosed population, while 22.8% of adults with diabetes remains undiagnosed.

Furthermore, regulatory agencies in the region have started to recognize the value of digital biomarkers in clinical trials, and healthcare settings.

This offers a way to objectively measure health outcomes, and therapeutic responses, potentially speeding up drug development processes and improving patient stratification in trials.

In turn, it is driving the regional market, creating a favorable environment for continued growth, and innovation.

East Asia to Exhibit a Notable CAGR in the Digital Biomarkers Market

East Asia Market is projected to secure a CAGR of 25.3% in the forecast period from 2024 to 2031. An increasing burden of chronic diseases such as respiratory illnesses, cardiovascular disorders, and diabetes, in this region has necessitated continuous monitoring and personalized management.

  • As per The Global Burden of Disease study 2023, East Asis was ranked seventh in 1990 and eleventh in 2022 for age-standardized CVD mortality. Ischemic heart disease had the highest age-standardized DALYs in 2022 at 1,917.9 per 100,000; Ischemic stroke at 1,072.0 and hypertensive heart disease at 269.3.

Further, technological advancements, and infrastructural developments have facilitated the integration of digital health solutions like wearable technologies in healthcare systems. 

Moreover, government initiatives and policies supporting digital health innovation and telemedicine has further accelerated the uptake of digital biomarkers in East Asia.

Regulatory frameworks in countries like Japan, and South Korea are increasingly accommodating to digital health technologies, fostering a conducive environment for market growth and investment.

Competitive Landscape Analysis

Product launches and collaborations among the leading industry players and healthcare institutions are some of key strategies being undertaken to leverage the AI technologies and develop innovative solutions, thereby, boosting the global market for digital biomarkers.

Recent Developments in the Digital Biomarkers Market

January 2023

Aculys Pharma and Four H initiated and exploratory research collaboration using wearable devices to help patients with narcolepsy and excessive daytime sleepiness (EDS) associated with obstructive sleep apnea syndrome (OSAS). The study is focussed to help Aculys collect subjective assessments of trial participant’s data on their sleep, activities, and heart rate acquired from wearable devices during the clinical trial period.

January 2023

Koneksa launched a clinical trial to evaluate at-home mobile spirometry in moderate asthma using digital measures. The study to aims to compare the treatment effect of at-home mobile spirometry using digital biomarkers and in-clinic spirometry in patients with moderate asthma on long-acting beta-agonist (LABA) treatment.

November 2022

Shimmer Research launched Verisense® Digital Health Panel (DHP) to provide clinical researchers with a universal, device independent, digital health ground-truth sensor data, to provide a complete longitudinal view of participant health.

March 2023

Koneksa extended its partnership with a life sciences consulting firm, SSI Strategy. The partnership will help both firms to accelerate and scale the adoption of evidence-based digital biomarkers in clinical trials.

Report Scope

Attributes

Details

Forecast Period

2024 to 2031

Historical Data Available for

2018 to 2023

Market Analysis

US$ Million for Value

Key Regions Covered

  • North America
  • Europe
  • East Asia
  • South Asia & Oceania
  • Latin America
  • Middle East and Africa

Key Market Segments Covered

  • Component
  • Therapeutic Area
  • Clinical Practice
  • End User
  • Region

Key Companies Profiled in the Report

  • ActiGraph LLC
  • AliveCor Inc.
  • Koneksa Health
  • Altoida Inc.
  • Biogen
  • Empatica Inc.
  • Vivo Sense
  • IXICO plc
  • Aural Analytic
  • Huma
  • Sonde Health, Inc.
  • Akili Interactive Labs, Inc.
  • Cambridge Cognition Ltd.
  • Dassault Systemes (Medidata)
  • Shimmer
  • Feel Therapeutics
  • Clario
  • Imagene AI
  • Brainomix
  • Kinsa Inc.
  • Pfizer Hellas S.A.
  • Human API
  • Evidation Health, Inc.
  • Verily
  • electronRx

Report Coverage

  • Market Forecast and Trends
  • Company Share Analysis
  • Competitive Intelligence
  • DROT Analysis
  • Market Dynamics and Challenges
  • Strategic Growth Initiatives  

Customization & Pricing

Available upon request

Digital Biomarkers Market Segmentation

By Component

  • Data Collection Tools
    • Wearable Devices
    • Implantable
    • Mobile Applications
    • Others
  • Data Integration Software

By Therapeutic Area

  • Cardiovascular and Metabolic Disorders (CVMD)
  • Neurodegenerative Disorders
  • Diabetes
  • Respiratory Disorders
  • Sleep and Movement Disorders
  • Others

By Clinical Practice

  • Diagnostic Digital Biomarkers
  • Monitoring Digital Biomarkers
  • Predictive and Prognostic Digital Biomarkers
  • Others

By End User

  • Healthcare Consumers
  • Healthcare Providers
  • Others

By Region

  • North America
  • Europe
  • East Asia
  • South Asia and Oceania
  • Latin America
  • Middle East and Africa

For report customisation and delivery information contact our sales representative.

Companies Covered in This Report

Frequently Asked Questions

Rising prevalence of chronic disorders, advancements in wearable technology offering convenient, non-invasive data collection, and shift towards value-based care and personalized medicine is surging the demand for digital biomarkers.

Some of the key players operating in the market are Koneksa Health, Altoida Inc., AliveCor Inc., ActiGraph LLC, Biogen, and Empatica Inc.

The cardiovascular and metabolic disorders segment recorded the significant market share in 2023.

 

Leveraging AI algorithms to analyse vast data collected from wearable devices enabling identification of subtle patterns and correlations, enhancing predictive capabilities for early disease detection, treatment response prediction, and personalized intervention strategies is estimated to present opportunities for the market players.

 

North America is set to account for the significant share in the market.

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