Digital Biomarkers Market Overview
The Global Digital Biomarkers Market size is expected to grow from USD 3.56 billion in 2023 to USD 75.61 billion by 2032, at a CAGR of 40.43% during the forecast period (2024-2032)
The digital biomarkers industry represents a cutting-edge intersection of healthcare, technology, and data analytics, poised to revolutionize how we monitor and manage health conditions. Unlike traditional biomarkers, which are measurable indicators of biological processes or conditions, digital biomarkers are derived from data collected through digital devices such as smartphones, wearables, or sensors. This data includes physiological measurements, movement patterns, sleep quality, and even speech patterns, all of which can provide valuable insights into an individual's health status.
Digital biomarkers have a significant benefit in their capacity to collect data constantly in real-time, providing a more thorough and dynamic understanding of an individual's health in contrast to occasional clinic appointments or conventional testing procedures. This ongoing observation can facilitate timely identification of health problems, individualized treatments, and more accurate control of chronic conditions. Additionally, digital biomarkers make it easier to monitor patients remotely, which is becoming more important in a healthcare system that is shifting towards decentralized care and telemedicine.
Advancements in sensor technology, artificial intelligence, and data analytics are driving the growth of the digital biomarkers industry by enabling the interpretation and application of large amounts of health-related data. Businesses and research facilities are currently engaged in the creation and verification of fresh digital indicators in various areas such as heart disease, diabetes, mental health ailments, and neurological disorders. Regulatory bodies are also starting to create systems for verifying and authorizing digital biomarkers, enabling their incorporation into healthcare systems and clinical practice globally.
Market Dynamics And Factors Of Digital Biomarkers Market
Drivers:
Need For Improved Diagnostics And Integration of Digital Devices To Monitor Health Propelling The Market
Companion diagnostics and biomarkers have become increasingly relevant in the practice of medicine, leading to improved diagnosis, treatment, and monitoring across several disease areas. It can be used to identify patients likely to respond well to certain drugs or treatment options. These diagnostics are often used in conjunction with a specific drug. For instance, the Oncomine Dx Target Test (Thermo Fisher Scientific, Inc.) helps in biomarker testing of non-small cell lung cancer (NSCLC) patients eligible for ROZLYTREK (entrectinib). The expansion of the digital biomarkers market can be attributed to an increase in the usage of connected digital devices and health-related mobile applications. These devices aid in a range of diagnostic and prognostic measurements over diverse disease areas including mental health, diabetes, neurological diseases, and cardiovascular diseases. Rising usage of smartphones and the emergence of smartwatches, which aid in tracking the physiological details of the person's health, boost the digital biomarkers market. Technological advances in the range of mobiles and digitally connected technologies further propel the digital biomarkers market. Significant product launches and approvals from the FDA also drive the digital biomarkers market. For instance, in April 2020, the U.S. FDA approved KardiaMobile, by AliveCor, an AI-enabled wearable device that is designed to monitor a person's vital signs. It helps detect three highly common forms of heart arrhythmias.
Restraints:
Stringent Regulations And Affordability Impede The Growth Of The Market
There are barriers to broad acceptance, as there are with any emergent technology. Not all health information can be found, collected, or used. Many digital biomarker therapies are still experimental rather than common. Clinical procedures, legacy systems, workplace culture, and EU and international legislation can all make new digital biomarker technology adoption and integration challenges. Furthermore, pricey and intrusive digital biomarker therapies hinder wider adoption and are often ineffective since they lengthen a patient's stay in the hospital rather than at home.
Opportunities:
Voice Based Digital Biomarker Presents Substantial Growth Opportunity
Voice-based digital biomarkers are a forerunner of a biological research and healthcare revolution to come. The quality of a patient's voice is both a clear indicator of their health and a new frontier in health evaluation. Technologies that allow for speech capture on daily consumer devices and then do symptom recognition and prediction have enormous promise in both research and clinical practice. However, because these biomarkers are so new, there are significant uncertainties regarding how to bring them to market and use them effectively. Analytical validation entails verifying the quality and consistency of data processing and computed measures, as well as determining test-retest reliability, demographic variability, and comparing measurements to reference standards. Clinical validity is the process of ensuring that a measure corresponds to clinical outcomes such as diagnosis, illness progression, and therapy response. We give guidelines for the sorts of an evaluation required for speech-based biomarkers in each of these areas, as well as examine published examples. The examples in this study are specific to speech-based biomarkers, but they may be utilized as a model for developing digital biomarkers in general. One of the primary facilitators of voice-based digital biomarkers is EVOCAL Health GmbH.
Segmentation Analysis Of Digital Biomarkers Market
By System Component, Data collection tools dominate the digital biomarkers market. The cheap cost and greater scalability of digital biomarkers based on smartphone applications make it possible to access previously unavailable social, behavioral, psychological, and environmental data. Due to its capacity to evaluate health status, the development and progression of illnesses, and health conditioning monitoring using a non-invasive technique in healthcare research, biosensors had a substantial digital biomarker market share in 2020.
By Therapeutic Area, Cardiovascular Disease accounted for the largest share of digital biomarkers in the market. In cardiovascular disorders, digital biomarkers provide greater in-depth insights into the heart response of individuals during standardized exercise. The data generated by digital biomarkers have the potential to improve cardiac rehabilitation outcomes by optimizing and improving patient-centric treatment techniques.
By End User, Biopharmaceutical dominates the Digital Biomarkers Market. Digital biomarkers are thought to be most useful in the early stages of drug research when pharmaceutical experts need to know if the medicine is successful or not before moving on to a phase III study and validating the results. For example, in the case of Alzheimer's and Parkinson's illnesses, the effectiveness of the treatments cannot be confirmed until the phase III trial, which has resulted in high-profile, cost-prohibitive failures that have cost pharmaceutical companies millions of dollars in the drug development process.
Regional Analysis Of Digital Biomarkers Market
North America remains a frontrunner in the digital biomarkers market, driven by robust investments in healthcare technology and a supportive regulatory environment. The region is home to numerous pioneering companies and research institutions advancing digital biomarker development. Dominance in North America is bolstered by strong collaborations between technology firms, healthcare providers, and academic centers, fostering innovation and commercialization. The United States, in particular, leads in regulatory advancements, with the FDA increasingly engaging in discussions and guidelines for digital biomarker validation and integration into clinical practice.
Europe boasts a robust digital biomarkers landscape, led by countries like Germany, the UK, and France, which serve as key hubs for innovation and research in digital health. The region benefits from a diverse regulatory environment under the European Union, with bodies like the EMA actively paving the way for digital biomarker adoption. Meanwhile, Asia-Pacific is experiencing rapid growth driven by technological advancements and increased healthcare investments in nations such as China, Japan, and South Korea. Despite varying regulatory frameworks, the region's proactive stance on digital healthcare transformation fuels demand for solutions like digital biomarkers, addressing pressing healthcare needs like aging populations and chronic diseases.
The digital biomarkers industry is witnessing global expansion driven by technological innovation, regulatory advancements, and increasing healthcare needs. While North America and Europe lead in terms of market dominance and regulatory maturity, Asia-Pacific and emerging markets offer significant growth opportunities fueled by technological adoption and evolving healthcare landscapes.
Top Key Players Covered In Digital Biomarkers Market
- AliveCor Inc.
- Bayer AG
- Evidation Health Inc.
- Fitbit Inc.
- Happify Health
- Koninklijke Philips NV
- Neurotrack Technologies Inc.
- GlaxoSmithKline Inc.
- Novartis International AG
- F. Hoffmann-La Roche Ltd.
Key Industry Developments in Digital Biomarkers Market
- In March 2024, Koneksa announced Merck's participation in its Data Syndication Partnership program for the LEARNS observational study on Parkinsonās digital biomarkers. Merck, joining as a member, gained real-time access to study data from smartphone-based and wearable technology assessments. The collaboration aimed to advance digital measures for Parkinsonās disease progression and treatment assessment through innovative data-sharing initiatives.
- In February 2024, Biofourmis secured four new agreements with top-20 pharmaceutical firms, driven by its expertise in digital biomarker development and decentralized clinical trial solutions. These partnerships focused on advancing oncology therapies through cutting-edge data science and technology, enhancing remote patient monitoring and safety measures. The agreements expand Biofourmis' global clinical trial footprint, spanning key regions including the United States, Europe, Asia-Pacific, and the Middle East, reflecting a strategic alignment with industry trends towards digital endpoints in drug development.
Global Digital Biomarkers Market |
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Base Year: |
2023 |
Forecast Period: |
2024-2032 |
Historical Data: |
2017 to 2023 |
Market Size in 2023: |
USD 3.56 Bn. |
Forecast Period 2024-32 CAGR: |
40.43% |
Market Size in 2032: |
USD 75.61 Bn. |
Segments Covered: |
By System Component |
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By Therapeutic Area |
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By End-User |
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By Region |
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Key Market Drivers: |
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Key Market Restraints: |
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Key Opportunities: |
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Companies Covered in the report: |
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Chapter 1: Introduction
ā1.1 Research Objectives
ā1.2 Research Methodology
ā1.3 Research Process
ā1.4 Scope and Coverage
āā1.4.1 Market Definition
āā1.4.2 Key Questions Answered
ā1.5 Market Segmentation
Chapter 2:Executive Summary
Chapter 3:Growth Opportunities By Segment
ā3.1 By System Component
ā3.2 By Therapeutic Area
ā3.3 By End User
Chapter 4: Market Landscape
ā4.1 Porter's Five Forces Analysis
āā4.1.1 Bargaining Power of Supplier
āā4.1.2 Threat of New Entrants
āā4.1.3 Threat of Substitutes
āā4.1.4 Competitive Rivalry
āā4.1.5 Bargaining Power Among Buyers
ā4.2 Industry Value Chain Analysis
ā4.3 Market Dynamics
āā3.5.1 Drivers
āā3.5.2 Restraints
āā3.5.3 Opportunities
āā3.5.4 Challenges
ā4.4 Pestle Analysis
ā4.5 Technological Roadmap
ā4.6 Regulatory Landscape
ā4.7 SWOT Analysis
ā4.8 Price Trend Analysis
ā4.9 Patent Analysis
ā4.10 Analysis of the Impact of Covid-19
āā4.10.1 Impact on the Overall Market
āā4.10.2 Impact on the Supply Chain
āā4.10.3 Impact on the Key Manufacturers
āā4.10.4 Impact on the Pricing
Chapter 4: Digital Biomarkers Market by System Component
ā4.1 Digital Biomarkers Market Overview Snapshot and Growth Engine
ā4.2 Digital Biomarkers Market Overview
ā4.3 Data Collection Tools
āā4.3.1 Introduction and Market Overview
āā4.3.2 Historic and Forecasted Market Size (2017-2032F)
āā4.3.3 Key Market Trends, Growth Factors and Opportunities
āā4.3.4 Data Collection Tools: Grographic Segmentation
ā4.4 Data Integration Systems
āā4.4.1 Introduction and Market Overview
āā4.4.2 Historic and Forecasted Market Size (2017-2032F)
āā4.4.3 Key Market Trends, Growth Factors and Opportunities
āā4.4.4 Data Integration Systems: Grographic Segmentation
Chapter 5: Digital Biomarkers Market by Therapeutic Area
ā5.1 Digital Biomarkers Market Overview Snapshot and Growth Engine
ā5.2 Digital Biomarkers Market Overview
ā5.3 Cardiovascular Disease
āā5.3.1 Introduction and Market Overview
āā5.3.2 Historic and Forecasted Market Size (2017-2032F)
āā5.3.3 Key Market Trends, Growth Factors and Opportunities
āā5.3.4 Cardiovascular Disease: Grographic Segmentation
ā5.4 Sleep and Movement Disease
āā5.4.1 Introduction and Market Overview
āā5.4.2 Historic and Forecasted Market Size (2017-2032F)
āā5.4.3 Key Market Trends, Growth Factors and Opportunities
āā5.4.4 Sleep and Movement Disease: Grographic Segmentation
ā5.5 Neurodegenerative Disorders
āā5.5.1 Introduction and Market Overview
āā5.5.2 Historic and Forecasted Market Size (2017-2032F)
āā5.5.3 Key Market Trends, Growth Factors and Opportunities
āā5.5.4 Neurodegenerative Disorders: Grographic Segmentation
ā5.6 Psychiatric Disorder
āā5.6.1 Introduction and Market Overview
āā5.6.2 Historic and Forecasted Market Size (2017-2032F)
āā5.6.3 Key Market Trends, Growth Factors and Opportunities
āā5.6.4 Psychiatric Disorder: Grographic Segmentation
ā5.7 Gastrointestinal Disease
āā5.7.1 Introduction and Market Overview
āā5.7.2 Historic and Forecasted Market Size (2017-2032F)
āā5.7.3 Key Market Trends, Growth Factors and Opportunities
āā5.7.4 Gastrointestinal Disease: Grographic Segmentation
ā5.8 Respiratory Disease
āā5.8.1 Introduction and Market Overview
āā5.8.2 Historic and Forecasted Market Size (2017-2032F)
āā5.8.3 Key Market Trends, Growth Factors and Opportunities
āā5.8.4 Respiratory Disease: Grographic Segmentation
ā5.9 Diabetes
āā5.9.1 Introduction and Market Overview
āā5.9.2 Historic and Forecasted Market Size (2017-2032F)
āā5.9.3 Key Market Trends, Growth Factors and Opportunities
āā5.9.4 Diabetes: Grographic Segmentation
ā5.10 Others
āā5.10.1 Introduction and Market Overview
āā5.10.2 Historic and Forecasted Market Size (2017-2032F)
āā5.10.3 Key Market Trends, Growth Factors and Opportunities
āā5.10.4 Others: Grographic Segmentation
Chapter 6: Digital Biomarkers Market by End User
ā6.1 Digital Biomarkers Market Overview Snapshot and Growth Engine
ā6.2 Digital Biomarkers Market Overview
ā6.3 Biopharmaceutical
āā6.3.1 Introduction and Market Overview
āā6.3.2 Historic and Forecasted Market Size (2017-2032F)
āā6.3.3 Key Market Trends, Growth Factors and Opportunities
āā6.3.4 Biopharmaceutical: Grographic Segmentation
ā6.4 Providers
āā6.4.1 Introduction and Market Overview
āā6.4.2 Historic and Forecasted Market Size (2017-2032F)
āā6.4.3 Key Market Trends, Growth Factors and Opportunities
āā6.4.4 Providers: Grographic Segmentation
ā6.5 Payers
āā6.5.1 Introduction and Market Overview
āā6.5.2 Historic and Forecasted Market Size (2017-2032F)
āā6.5.3 Key Market Trends, Growth Factors and Opportunities
āā6.5.4 Payers: Grographic Segmentation
Chapter 7: Company Profiles and Competitive Analysis
ā7.1 Competitive Landscape
āā7.1.1 Competitive Positioning
āā7.1.2 Digital Biomarkers Sales and Market Share By Players
āā7.1.3 Industry BCG Matrix
āā7.1.4 Ansoff Matrix
āā7.1.5 Digital Biomarkers Industry Concentration Ratio (CR5 and HHI)
āā7.1.6 Top 5 Digital Biomarkers Players Market Share
āā7.1.7 Mergers and Acquisitions
āā7.1.8 Business Strategies By Top Players
ā7.2 ALIVECOR INC.
āā7.2.1 Company Overview
āā7.2.2 Key Executives
āā7.2.3 Company Snapshot
āā7.2.4 Operating Business Segments
āā7.2.5 Product Portfolio
āā7.2.6 Business Performance
āā7.2.7 Key Strategic Moves and Recent Developments
āā7.2.8 SWOT Analysis
ā7.3 BAYER AG
ā7.4 EVIDATION HEALTH INC.
ā7.5 FITBIT INC.
ā7.6 HAPPIFY HEALTH
ā7.7 KONINKLIJKE PHILIPS NV
ā7.8 NEUROTRACK TECHNOLOGIES INC.
ā7.9 GLAXOSMITHKLINE INC.
ā7.10 NOVARTIS INTERNATIONAL AG
ā7.11 F. HOFFMANN-LA ROCHE LTD.
Chapter 8: Global Digital Biomarkers Market Analysis, Insights and Forecast, 2017-2032
ā8.1 Market Overview
ā8.2 Historic and Forecasted Market Size By System Component
āā8.2.1 Data Collection Tools
āā8.2.2 Data Integration Systems
ā8.3 Historic and Forecasted Market Size By Therapeutic Area
āā8.3.1 Cardiovascular Disease
āā8.3.2 Sleep and Movement Disease
āā8.3.3 Neurodegenerative Disorders
āā8.3.4 Psychiatric Disorder
āā8.3.5 Gastrointestinal Disease
āā8.3.6 Respiratory Disease
āā8.3.7 Diabetes
āā8.3.8 Others
ā8.4 Historic and Forecasted Market Size By End User
āā8.4.1 Biopharmaceutical
āā8.4.2 Providers
āā8.4.3 Payers
Chapter 9: North America Digital Biomarkers Market Analysis, Insights and Forecast, 2017-2032
ā9.1 Key Market Trends, Growth Factors and Opportunities
ā9.2 Impact of Covid-19
ā9.3 Key Players
ā9.4 Key Market Trends, Growth Factors and Opportunities
ā9.4 Historic and Forecasted Market Size By System Component
āā9.4.1 Data Collection Tools
āā9.4.2 Data Integration Systems
ā9.5 Historic and Forecasted Market Size By Therapeutic Area
āā9.5.1 Cardiovascular Disease
āā9.5.2 Sleep and Movement Disease
āā9.5.3 Neurodegenerative Disorders
āā9.5.4 Psychiatric Disorder
āā9.5.5 Gastrointestinal Disease
āā9.5.6 Respiratory Disease
āā9.5.7 Diabetes
āā9.5.8 Others
ā9.6 Historic and Forecasted Market Size By End User
āā9.6.1 Biopharmaceutical
āā9.6.2 Providers
āā9.6.3 Payers
ā9.7 Historic and Forecast Market Size by Country
āā9.7.1 U.S.
āā9.7.2 Canada
āā9.7.3 Mexico
Chapter 10: Europe Digital Biomarkers Market Analysis, Insights and Forecast, 2017-2032
ā10.1 Key Market Trends, Growth Factors and Opportunities
ā10.2 Impact of Covid-19
ā10.3 Key Players
ā10.4 Key Market Trends, Growth Factors and Opportunities
ā10.4 Historic and Forecasted Market Size By System Component
āā10.4.1 Data Collection Tools
āā10.4.2 Data Integration Systems
ā10.5 Historic and Forecasted Market Size By Therapeutic Area
āā10.5.1 Cardiovascular Disease
āā10.5.2 Sleep and Movement Disease
āā10.5.3 Neurodegenerative Disorders
āā10.5.4 Psychiatric Disorder
āā10.5.5 Gastrointestinal Disease
āā10.5.6 Respiratory Disease
āā10.5.7 Diabetes
āā10.5.8 Others
ā10.6 Historic and Forecasted Market Size By End User
āā10.6.1 Biopharmaceutical
āā10.6.2 Providers
āā10.6.3 Payers
ā10.7 Historic and Forecast Market Size by Country
āā10.7.1 Germany
āā10.7.2 U.K.
āā10.7.3 France
āā10.7.4 Italy
āā10.7.5 Russia
āā10.7.6 Spain
Chapter 11: Asia-Pacific Digital Biomarkers Market Analysis, Insights and Forecast, 2017-2032
ā11.1 Key Market Trends, Growth Factors and Opportunities
ā11.2 Impact of Covid-19
ā11.3 Key Players
ā11.4 Key Market Trends, Growth Factors and Opportunities
ā11.4 Historic and Forecasted Market Size By System Component
āā11.4.1 Data Collection Tools
āā11.4.2 Data Integration Systems
ā11.5 Historic and Forecasted Market Size By Therapeutic Area
āā11.5.1 Cardiovascular Disease
āā11.5.2 Sleep and Movement Disease
āā11.5.3 Neurodegenerative Disorders
āā11.5.4 Psychiatric Disorder
āā11.5.5 Gastrointestinal Disease
āā11.5.6 Respiratory Disease
āā11.5.7 Diabetes
āā11.5.8 Others
ā11.6 Historic and Forecasted Market Size By End User
āā11.6.1 Biopharmaceutical
āā11.6.2 Providers
āā11.6.3 Payers
ā11.7 Historic and Forecast Market Size by Country
āā11.7.1 China
āā11.7.2 India
āā11.7.3 Japan
āā11.7.4 Southeast Asia
Chapter 12: South America Digital Biomarkers Market Analysis, Insights and Forecast,2017-2032
ā12.1 Key Market Trends, Growth Factors and Opportunities
ā12.2 Impact of Covid-19
ā12.3 Key Players
ā12.4 Key Market Trends, Growth Factors and Opportunities
ā12.4 Historic and Forecasted Market Size By System Component
āā12.4.1 Data Collection Tools
āā12.4.2 Data Integration Systems
ā12.5 Historic and Forecasted Market Size By Therapeutic Area
āā12.5.1 Cardiovascular Disease
āā12.5.2 Sleep and Movement Disease
āā12.5.3 Neurodegenerative Disorders
āā12.5.4 Psychiatric Disorder
āā12.5.5 Gastrointestinal Disease
āā12.5.6 Respiratory Disease
āā12.5.7 Diabetes
āā12.5.8 Others
ā12.6 Historic and Forecasted Market Size By End User
āā12.6.1 Biopharmaceutical
āā12.6.2 Providers
āā12.6.3 Payers
ā12.7 Historic and Forecast Market Size by Country
āā12.7.1 Brazil
āā12.7.2 Argentina
Chapter 13: Middle East & Africa Digital Biomarkers Market Analysis, Insights and Forecast,2017-2032
ā13.1 Key Market Trends, Growth Factors and Opportunities
ā13.2 Impact of Covid-19
ā13.3 Key Players
ā13.4 Key Market Trends, Growth Factors and Opportunities
ā13.4 Historic and Forecasted Market Size By System Component
āā13.4.1 Data Collection Tools
āā13.4.2 Data Integration Systems
ā13.5 Historic and Forecasted Market Size By Therapeutic Area
āā13.5.1 Cardiovascular Disease
āā13.5.2 Sleep and Movement Disease
āā13.5.3 Neurodegenerative Disorders
āā13.5.4 Psychiatric Disorder
āā13.5.5 Gastrointestinal Disease
āā13.5.6 Respiratory Disease
āā13.5.7 Diabetes
āā13.5.8 Others
ā13.6 Historic and Forecasted Market Size By End User
āā13.6.1 Biopharmaceutical
āā13.6.2 Providers
āā13.6.3 Payers
ā13.7 Historic and Forecast Market Size by Country
āā13.7.1 Saudi Arabia
āā13.7.2 South Africa
Chapter 14 Investment Analysis
Chapter 15 Analyst Viewpoint and Conclusion
Global Digital Biomarkers Market |
|||
Base Year: |
2023 |
Forecast Period: |
2024-2032 |
Historical Data: |
2017 to 2023 |
Market Size in 2023: |
USD 3.56 Bn. |
Forecast Period 2024-32 CAGR: |
40.43% |
Market Size in 2032: |
USD 75.61 Bn. |
Segments Covered: |
By System Component |
|
|
By Therapeutic Area |
|
||
By End-User |
|
||
By Region |
|
||
Key Market Drivers: |
|
||
Key Market Restraints: |
|
||
Key Opportunities: |
|
||
Companies Covered in the report: |
|
Frequently Asked Questions :
The forecast period in the market research report is 2024-2032.
AliveCor Inc., Bayer AG, Evidation Health Inc., Fitbit Inc., Happify Health, and Other major players.
The Digital Biomarkers market is segmented into System Component, Therapeutic Area, End-Use ,Region. Digital Biomarkers Market is segmented by, By System Component (Data Collection Tools, Data Integration Systems), By Therapeutic Area (Cardiovascular Disease, Sleep and Movement Disease, Neurodegenerative Disorders, Psychiatric Disorder, Gastrointestinal Disease, Respiratory Disease, Diabetes, Others), By End-User (Biopharmaceutical, Providers, Payers), Region - Global Market Analysis And Forecast 2022- 2028, By region, it is analysed across North America (U.S.; Canada; Mexico), Europe (Germany; U.K.; France; Italy; Russia; Spain etc.), Asia-Pacific (China; India; Japan; Southeast Asia etc.), South America (Brazil; Argentina etc.), Middle East & Africa (Saudi Arabia; South Africa etc.).
Digital biomarkers are physiological and behavioral data that are gathered and assessed using digital devices such as portables, wearables, implantable, or digestible.
The Global Digital Biomarkers Market size is expected to grow from USD 3.56 billion in 2023 to USD 75.61 billion by 2032, at a CAGR of 40.43% during the forecast period (2024-2032)