Digital Biomarkers – Thematic Research

The increased use of connected digital devices and health-related mobile apps has produced a novel set of data sets known as 'digital biomarkers.' These are defined as objective, quantifiable, physiological, and behavioral measures that are collected by sensors embedded in portable, wearable, implantable, or digestible devices. They span a broad range of diagnostic and prognostic measurements across a range of disease areas, but are particularly relevant in cardiovascular disease (CVD), diabetes, mental health, neurological disorders, and respiratory conditions.

Digital biomarkers will play a role in both patient care and clinical trials, and will be used to improve patient outcomes through remote patient monitoring (RPM), as well as post-market surveillance by the biopharmaceutical industry. Ultimately, it is expected that digital biomarkers will enable better insights into patient health, disease tracking, and preventive medicine, while reducing the cost associated with care delivery. Digital biomarkers are particularly pertinent with the ongoing COVID-19 pandemic, where RPM strategies are vital to monitoring patients infected with the virus and those at risk of contracting it.

Scope

Components of the report include:

· Key Industry Players: leading companies in the Digital Biomarker space across digital devices, mobile applications, and software.

· Industry Trends: key trends impacting the Digital Biomarkers space classified into healthcare, technology, macroeconomic, and regulatory themes.

· Opportunities & Challenges associated with the use of Digital Biomarkers in clinical research and routine care.

· The Industry Analysis section includes:

– Market values for three of the largest segments of the Digital Biomarker sector; wearable technology, smartphones, and health-related mobile applications.

– A breakdown of the leading Digital Biomarker therapy areas, and an overview of the digitization of clinical trials.

– Key M&A, funding and partnerships in the Digital Biomarker space, including those between healthtech companies and the biopharmaceutical industry.

– There are also a number of case studies including how Digital Biomarkers are emerging as important predictive tools to support the COVID-19 pandemic.

· Value Chain: Overview of the different functions of Digital Biomarkers and different types of sensors used for their collection. This section also provides an overview of portable, wearable, and ingestible technologies, mobile applications and software used to collect and analyze Digital Biomarkers, including leading companies and challengers.

Reasons to buy

Develop business strategies by understanding how digital biomarkers are being used in the biopharmaceutical industry today and how the technology is expected to affect the sector in the future.

Stay up to date on the key players in the digital biomarker space and where they sit in the value chain.

See what activities healthtech or biopharmaceutical companies are undertaking in the space.

Identify emerging industry trends to gain a competitive advantage.

Identify opportunities for partnerships with healthtech companies or the biopharmaceutical industry.

Companies mentioned

Apple, Samsung, Huawei, Xiaomi, Fitbit, Garmin, ResMed, Withings, Emfit, Zenicor Medical Systems, Propeller Health, AliveCor, CardioComm Solutions, OMRON Corporation, Zephyr, ActiGraph, Verily Life Sciences, Proteus Digital Health, Senseonics Holdings, WellDoc, Glooko, Livongo, FibriCheck, Cardiogram, Babylon, Huma, Pear Therapeutics, Koneksa Health, Winterlight Labs, Akili Interactive Labs, Aural Analytics, Biofourmis, AiCure

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Industry Players

3 Industry Trends

3.1 Healthcare Trends

3.2 Technology Themes

3.3 Macroeconomic Themes

3.4 Regulatory Themes

4 Opportunities and Challenges in the Digital Biomarker Space

4.1 Opportunities

4.2 Challenges

5 Value chain

5.1 Functions of Digital Biomarkers

5.2 Devices for Measuring Digital Biomarkers

5.2.1 Device layer – Sensors

5.2.2 Portable Devices

5.2.3 Wearable Devices

5.2.4 Ingestible Devices

5.3 App Layer

5.3.1 Mobile Applications

5.3.2 Software

6 Industry Analysis

6.1 Market Size and Growth Forecasts

6.1.1 Portables

6.1.2 Wearable Technology

6.1.3 Mobile Applications

6.2 Leading Digital Biomarker Therapy Areas

6.3 Digitization of Clinical Trials

6.3.1 What Evidence Is Required to Support the Relationship Between a Digital Biomarker and Clinical Outcome of Interest?

6.4 Deals Related to Digital Biomarkers

6.4.1 Mergers and Acquisitions

6.4.2 Funding

6.4.3 Strategic Alliances and Partnerships

6.5 Timeline

6.6 Digital Biomarker Case Studies

6.6.1 Digital Biomarkers Are Emerging as Important Predictive Tools to Support the Global COVID-19 Pandemic

6.6.2 The Impact of COVID-19 on Ongoing Clinical Trials

6.6.3 Roche: One of the Leading Biopharmaceutical Companies in the Digital Biomarker Space in Neurology

6.6.4 Heartline: Apple and Johnson & Johnson Pave the Way Digitizing Clinical Trials in CVD

6.6.5 FDA Approval of Respiratory Biomarkers

6.6.6 Innovation Challenges to Encourage Collaboration and New Solutions

6.6.7 Digital Biomarkers have the Potential to Transform the Diagnosis of Mental Health

7 Companies

8 Appendix

8.1 Abbreviations

8.2 Bibliography

8.3 Traditional Thematic Research Does a Poor Job of Picking Winners and Losers

8.4 Introducing GlobalData’s Thematic Engine

8.5 This Is How It Works

8.6 How Our Research Reports Fit into Our Overall Research Methodology

8.7 About GlobalData

8.8 About the Authors

8.8.1 Senior Digital Healthcare Analyst

8.8.2 Senior Director, Market Research

8.8.3 Director, Thematic Analysis

8.8.4 Global Head and EVP of Healthcare Operations and Strategy

8.9 Contact Us

8.10 Disclaimer

List of Tables

Table 1: Healthcare Trends

Table 2: Technology Themes

Table 3: Macroeconomic Themes

Table 4: Regulatory Themes

Table 5: Different Uses of Digital Biomarkers

Table 6: Different Device Sensors and Functions

Table 7: Examples of Portable Technologies and Connected Apps

Table 8: Examples of Smartwatches and Fitness Trackers

Table 9: Examples of Skin Patches/Sensors

Table 10: Examples of Smart Wear/Clothing

Table 11: Summary of Ingestible Technologies

Table 12: Examples of Mobile Apps that Can Be Used to Collect Digital Biomarkers

Table 13: Examples of Companies Developing Software for the Collection and Analysis of Digital Biomarkers

Table 14: M&A Activity in the Digital Biomarker Space

Table 15: Funding Activity in the Digital Biomarker Space

Table 16: Healthtech Partnerships Related to Digital Biomarkers

Table 17: Biopharmaceutical Industry Partnerships Related to Digital Biomarkers

Table 18: Healthcare Wearable Companies

Table 19: Abbreviations

List of Figures

Figure 1: Who Are the Leaders and Challengers in the Digital Biomarker Space?

Figure 2: Digital Biomarker Value Chain

Figure 3: Leaders and Challengers in Portable Technology

Figure 4: Leaders and Challengers in Wearable Technology

Figure 5: Wearable Technologies Revenue to More than Double Within Five Years

Figure 6: Smartwatches to Witness Steady Increase in Market Share Between 2019 and 2023

Figure 7: The Market Potential for Apps Connected to Medical Wearables Is Increasing

Figure 8: Digital Biomarkers by Therapy Area

Figure 9: Uptake of Digital Tools in Clinical Trials Has Increased Since 2009

Figure 10: Type of Connected Device Utilized in Clinical Trials in 2019

Figure 11: Digital Biomarkers Timeline

Figure 12: Impact of COVID-19 on Clinical Trial Planning

Figure 13: Roche’s Digital Biomarker PD Trial

Figure 14: The Apple Heartline Mobile Application

Figure 15: The HealthMode Cough Mobile Application

Figure 16: CompanionMx Mobile Application

Figure 17: Five-Step Approach for Generating a Sector Scorecard

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