Digital Biomarkers Market: Industry Trends and Global Forecasts, till 2035: Distribution by Type of Product, Purpose of Solution, Type of Biomarker, Therapeutic Area, Business Model and Key Geographical Regions

Digital Biomarker Sector Surpasses $1.6 Billion in Funding Since 2022, With Venture Capital Leading Investments

The global digital biomarkers market is estimated to be USD 5.55 billion in 2024 and is projected to reach USD 35.8 billion in 2035. The market is anticipated to grow at a CAGR of 18.5%, during the forecast period 2024-2035. The conventional approach of manually tracking the health data of individuals is associated with several challenges, including delay in timely assessment of critical health information, susceptibility to errors, time and cost-intensive process, and risk of loss / damage of health records, thereby hindering timely treatment of patients (specifically the aging population). It is estimated that 65% of hospital patients and more than 90% of post-acute care patients are manually tracked for vitals and patient-specific parameters, every four to eight hours. As a result, there has been a rising prominence of telemedicine that leverages digital tools in order to provide remote consultations and services.

Notably, digital health technologies enable continuous patient monitoring, thereby allowing health practitioners to timely track the baseline changes in individual patients. Additionally, the implementation of continuous monitoring system has proven to significantly reduce adverse events and hospital re-admissions. The growing field of digital biomarkers as well as digital therapeutics are a part of the broader digital health market.

Further, as per the World Health Organization, by 2030, one-sixth of the global population will be aged over 60 years. Hence, detecting their symptoms proactively at an early stage is intuitively better than treating patients who are seriously ill (due to longer waiting time). Studies have shown that continuous symptom tracking with early intervention has not only led to remarkable improvement in quality of life of patients, but also led to reduced healthcare costs.

The rising digitalization in the healthcare industry has led to the development of several digital solutions, that are capable of generating, collecting and tracking medical information (via biomarkers in the body). Digital solutions for biomarkers are defined as digital devices (such as smartphones, sensors and wearable devices) that measure / quantify the physiological and behavioral or biometric data (including blood pressure, emotional health, heart rate, glucose level, physical activity, respiratory function and sleep pattern).

These advanced solutions enable real-time monitoring of an individual’s health (specifically in chronic disease management), encourage proactive participation of individuals in wellness activities, and allow personalized healthcare by tailoring the treatments based on individual data. With the rising prevalence of chronic diseases, growing emphasis on remote patient monitoring and continuous advancements in the technologies, the digital biomarkers market size is prepared for growth, in the foreseen future.

Digital Biomarkers Market Share Insights

The digital biomarkers market research report presents an in-depth analysis of various companies that are involved in the global digital biomarkers industry, across different segments, as defined below:

• Historical Trend: 2018-2023
• Base Year: 2023
• Forecast Period: 2024-2035
• Market Size 2024: USD 5.55 Billion
• Market Size 2035: USD 35.84 Billion
• CAGR: 18.5%
• PowerPoint Presentation (Complimentary)
• Customization Scope: 15% Free Customization
• Type of Product:
  • Software / Applications
  • Wearables
  • Sensors
  • Gaming Solutions
• Purpose of Solution:
  • Diagnosis
  • Early Detection
  • Monitoring
  • Predictive Insights
• Type of Biomarker:
  • Cognitive Biomarkers
  • Idiosyncratic Biomarkers
  • Physiological Biomarkers
  • Vocal Biomarkers
  • Other Biomarkers
• Therapeutic Area:
  • Autoimmune Disorders
  • Cardiovascular Disorders
  • Infectious Diseases
  • Mental Health Disorders
  • Neurological Disorders
  • Respiratory Disorders
  • Substance Abuse Disorders
  • Others
• Business Model:
  • B2B
  • B2C
• Key Geographical Regions:
  • North America
  • Europe
  • Asia-Pacific
  • Middle East and North Africa (MENA)
  • Rest of the World
• Key Companies Profiled:
  • Acculi Labs
  • ActiGraph
  • AliveCor
  • ATCOR
  • BACtrack
  • Biogen
  • BioSerenity
  • BioSensics
  • Eyenuk
  • Empatica
  • Feel Therapeutics
  • icometrix
  • iMediSync
  • IXICO
  • Kinsa
  • Koneksa Health
  • Kontigo Care
  • Progentec Diagnostics
  • Quibim
  • Vocalis Health
  • (Full list of 130+ companies captured is available in the report)
• Excel Data Packs (Complimentary):
  • Market Overview
  • Product Competitiveness Analysis
  • Partnership and Collaboration Analysis
  • Funding and Investments Analysis
  • Global Events Analysis
  • Patent Analysis
  • Big Pharma Initiatives
  • Market Forecast and Opportunity Analysis

Digital Biomarkers Market Segmentation Overview

Market Share by Type of Product

The digital biomarkers market highlights the market segmentation of digital biomarkers, based on the type of product, into software / applications, wearables, sensors and gaming solutions. Currently, the wearables market segment captures maximum share (50%) of the overall market; this can be attributed to the shifting preference of patients towards virtual consultations and telemedicine, leading to an increased demand for technologies that can monitor patients remotely. However, the market for sensors is likely to grow at a relatively faster pace in the next decade.

Market Share by Purpose of Solution

The digital biomarkers market highlights the market segmentation of digital biomarkers, based on the purpose of solution, into diagnosis, early detection, monitoring, and predictive insights. Currently, the monitoring segment captures the highest share of the market and is expected to dominate during the forecast period. Further, the digital biomarker solutions market for predictive insights is anticipated to capture 30% of the overall market in 2035, owing to the likely advancements in artificial intelligence and machine learning based technologies for predicting patient outcomes based on large amounts of historical data.

Market Share by Type of Biomarker

The digital biomarkers market is segmented based on the type of biomarker, into cognitive, idiosyncratic, physiological, vocal, and other biomarkers. The digital biomarker solutions that capture physiological biomarkers occupy the highest market share in 2024; this can be attributed to availability of clinically validated data on reliability of physiological biomarkers. Further, vocal digital biomarkers segment is expected to witness substantial market growth in the coming years.

Market Share by Therapeutic Area

The digital biomarkers market highlights various therapeutic areas such as autoimmune disorders, cardiovascular disorders, infectious diseases, mental health disorders, neurological disorders, respiratory disorders, substance abuse disorders and others. Among these segments, the market for neurological disorders is likely to capture the highest market share, followed by mental health disorders.

Market Share by Key Geographical Regions

This segment highlights the distribution of digital biomarkers market across various geographies, such as North America, Europe, Asia-Pacific, Middle East and North Africa (MENA) and Rest of the World. According to the projections, North America is likely to capture the majority share (44%) of this market, and this trend is unlikely to change in the future as well. It is worth highlighting that the market in Asia-Pacific is expected to grow at a CAGR of 21.8%, during the forecast period 2024-2035.

Digital Biomarkers Market Key Insights

The market report features an extensive study of the current market landscape, market size and future opportunities for digital biomarker companies, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging segment of the pharmaceutical industry. Key takeaways of the global digital biomarkers market report are briefly discussed below.

Competitive Landscape of Digital Biomarkers

The digital biomarkers market features over 220 digital biomarkers. Majority (80%) of these solutions are software / applications which digitally identify various types of biomarkers. Further, over 75% of the solutions are data collection tools which capture biomarker data via various types of sensors, including accelerometers, cameras, spirometers and temperature sensors. It is noteworthy that more than 25% of the digital biomarkers detect / monitor physiological biomarkers, while close to 20% of these solutions are used as imaging biomarkers, for analyzing images and scans. In addition, majority (60%) of the digital biomarkers are used for monitoring patients suffering from wide range of diseases.

The current market landscape features the presence of more than 125 developers of digital biomarkers, across the globe. Overall, the market seems to be dominated by the presence of small and very small digital biomarker companies. Notably, 50% of the companies in the digital biomarkers industry are based in North America, followed by companies-based Europe (39%).

Emergence of Artificial Intelligence in the Digital Biomarkers Market

During the research, we came across nearly 135 digital biomarker solutions that integrate artificial intelligence -based algorithms to detect / monitor numerous biomarkers. More than 40% of these solutions are currently under research and development while around 25% of these are approved by the regulatory agencies. It is worth highlighting that, in December 2023, Quibim announced the launch of QP-Brain®, FDA 510(k) cleared, and CE marked artificial intelligence (AI)-based software for the detection of early-stage neurodegenerative disorders. In February 2022, AliveCor received FDA clearance for its KardiaMobile Card, which provides medical grade ECG in 30 seconds, thereby allowing for early diagnosis of cardiac arrhythmias.

Digital Biomarkers Transforming Treatment for Neurological Disorders and Other Indications

Currently, the digital biomarker solutions are intended for applications across a plethora of disease indications; over 35% of the solutions are neurological digital biomarkers that are used for monitoring patients with different neurological disorders, including attention deficit hyperactivity disorder (ADHD), Alzheimer’s disease, dementia, epilepsy and Parkinson’s disease. It is worth noting that, Akili Interactive’s EndeavorRx™ is a unique video game-based prescription treatment useful for children with ADHD. Further, several innovative digital solutions are currently available / being developed for cardiovascular and oncological disorders.

Digital Biomarkers in Clinical Trials

Recent emergence of digital technologies in healthcare, increasing number of decentralized clinical trials and the increasing adoption of such technologies among consumers has led to increased research in this domain (to further identify relevant clinical end-points). The ANeED Joint Effort 21 clinical study aims to develop predictive algorithms to detect disease fluctuations in lewy-body dementia patients. In addition, DreaMS clinical study was designed to evaluate the feasibility of DreaMS app, which collected patient health data via smartphone sensors and wearable devices, for monitoring patients with Multiple Sclerosis.

Digital Biomarkers Market Trends: Partnerships and Collaborations on the Rise for Digital Biomarker Solutions

In recent years, several partnerships have been inked by the industry stakeholders, in order to consolidate their presence in this field. It is worth highlighting that nearly 25% of deals have been forged since 2023. Interestingly, most of the agreements (21%) were product / technology integration agreements, followed by product / technology utilization agreements (16%). In November 2023, Oura entered into an agreement with Clue in order to offer integrated services to their customers, wherein the Oura ring could be paired with the Clue app for tracking health parameters.

Market Trends: Upward Trend in Funding and Investments for Digital Biomarkers

Several stakeholders in this domain have raised funds in order to fuel their growth operations. It is noteworthy that companies offering digital biomarker solutions have raised a cumulative sum of more than USD 1.6 billion, since 2022. Further, majority of the funding instances are venture capital investments (46%), followed by grants (24%) and seed funding (20%). In September 2023, BioSensics received a grant worth USD 3 million, from the National Institutes of Health (NIH) for development of a wearable device designed for tracking vocal biomarkers.

Market Trends: Increasing Number of Global Events for Digital Biomarkers

Since 2021, more than 55 global events have been organized across the globe for discussing the innovations being made in the field of digital biomarkers. Majority (36%) of the events held were conferences, followed by summits (33%). Further, the agenda of many of these events was to discuss the results of digital biomarker focused clinical trials. Notably, artificial intelligence (AI) was an important topic that was conversed about in multiple events.

Market Trends: Surge in the Number of Patent Applications for Digital Biomarkers

In the past five years, over 765 patents focused on digital biomarkers have been granted / filed, indicating the substantial efforts made by the researchers in this market. It is worth highlighting that majority of the patents (70%) in this domain were patent applications (not having received approval yet), followed by granted patents (27%). Further, most of the patents have been filed by non-academic players in this industry.

Digital Biomarkers Market Analysis

The digital biomarkers market is estimated to be worth USD 5.55 billion in 2024. Further, driven by the rise in the incidence of chronic diseases, surge in the ageing population and increasing adoption of digital technologies in healthcare, the digital biomarkers market is anticipated to grow at a CAGR of 18.5% during the forecast period. In terms of purpose of solution, the digital biomarker solutions market for monitoring is expected to capture the majority of market share during the forecast period.

Regional Analysis: North America to Hold the Largest Market Share in Digital Biomarkers Market

Majority of the digital biomarker companies are headquartered in North America, followed by those based in Europe. Consequently, nearly 40% of the digital biomarkers market is anticipated to be captured by the developers based in North America, in 2035. Further, the digital biomarkers market in Asia-Pacific is expected to grow at a relatively higher CAGR during the forecast period (2024-2035).

Leading Digital Biomarkers Companies

Examples of key digital biomarkers companies (which have also been profiled in this report) include (in alphabetical order) AliveCor, BACtrack, Biogen, BioSensics, empatica, Eyenuk, Feel Therapeutics, icometrix, and Quibim.

Further, examples of other key players involved in the development of digital solutions for biomarkers include (in alphabetical order) Acculi Labs, ActiGraph, ATCOR, BioSerenity, iMediSync, IXICO, Kinsa, Koneksa Health, Kontigo Care, Progentec Diagnostics, and Vocalis Health.

Recent Developments in the Digital Biomarkers Market

Several recent developments have taken place in the field of digital biomarkers market, some of which have been outlined below. These developments, even if they took place post the release of the market report, substantiate the overall market trends that the analyst outlined in the analysis.

• In January 2024, Quibim signed a product / technology integration agreement with Merck to develop ground-breaking precision medicine technologies targeting a wide range of oncological indications.
• In November 2023, The Power of Digital Biomarkers 2023 conference was held in Paris, France. Several players, such as Empatica and Biogen, participated in the event to discuss the significance of digital biomarkers in improving treatment outcomes and enhancing patient satisfaction.
• In April 2023, Aiforia Technologies raised a debt financing worth EUR 7.3 million from Business Finland, in order to expand the existing features of their software offerings for accelerating business growth.

Digital Biomarkers Market Report Coverage

The digital biomarkers market report presents an in-depth analysis, highlighting the capabilities of various stakeholders in this industry, across different geographies. Further, the market report includes:

• A preface providing an introduction to the full report, Digital Biomarkers Market (2nd Edition), till 2035.
• An outline of the systematic research methodology adopted to conduct the study on global digital biomarkers market, providing insights on the various assumptions, methodologies, and quality control measures employed to ensure accuracy and reliability of the findings.
• An overview of economic factors that impact the overall digital biomarkers industry, including historical trends, currency fluctuation, foreign exchange impact, recession, and inflation measurement.
• An executive summary of the key insights captured during the research, offering a high-level view of the current state of the digital biomarkers market and its likely evolution in the short to mid and long term.
• A general overview of various solutions that enable digital monitoring / detection of biomarkers. The chapter provides information on the different types of digital biomarkers, along with details related to the various biological signals captured by these biomarkers. It also outlines the key advantages of digital biomarkers that have led to their growing adoption over the last several years, along with the existing concerns related to reliability and credibility of analyzed health data, and lack of guidelines. Further, the chapter highlights the product development and commercialization path for digital biomarkers. Furthermore, it concludes with a discussion on recent advances in the field of digital biomarkers and their prevalent trends.
• A detailed assessment of the current market landscape of digital biomarker solutions based on several relevant parameters, such as type of product (software / applications, wearables and others), type of digital biomarker solution (data collection tool and data integration tool), type of biomarker (behavioral, cognitive, idiosyncratic, physiological, vocal, and others), status of development (approved, FDA registered, marketed, research and development), purpose of biomarker (diagnosis, disease risk management, early detection, monitoring, prognosis, and treatment), target therapeutic area (autoimmune disorders, cardiovascular disorders, infectious diseases, mental health disorders, metabolic disorders, neurological disorders, respiratory disorders, substance abuse disorders, and others), target population (children, teenagers, adults and older adults), type of end-user (clinics and hospitals, healthcare providers, patients, trial sponsors and others), clinical validation of biomarker solution and AI integration within biomarker solution. Further, the chapter provides a detailed analysis of digital biomarkers developers, along with information on their year of establishment, company size (in terms of employee count), location of headquarters, type of business model and most active players (in terms of number of digital biomarker solutions offered).
• An insightful analysis of digital solutions for biomarkers, based on developer strength (in terms of years of experience, company size, business model and number of solutions offered), product competitiveness (in terms of type of digital biomarker solution, type of biomarker, purpose of solution, clinical validation of digital biomarkers and AI integration within digital biomarker), and status of development.
• Elaborate profiles of key digital biomarkers developers (shortlisted based on the number of solutions in their product portfolio). Each profile features a brief overview of the company (including information on year of establishment, location of headquarters, number of employees, leadership team and annual revenues (if available)), details related to its digital biomarker portfolio, recent developments and an informed future outlook.
• A detailed analysis of the partnerships inked between stakeholders in this industry, during the period pre-2019-2024, based on several parameters, such as year of partnership, type of partnership, type of biomarker, target therapeutic area, type of partner and most active players (in terms of the number of partnerships signed). It also provides the regional distribution of digital biomarkers companies involved in these agreements.
• The chapter features detailed analysis of funding and investments raised by digital biomarker developers, based on relevant parameters such as year of funding, type of funding, amount invested (USD million), type of biomarker, therapeutic area, most active players (in terms of number of funding instances and amount raised), most active investors (in terms of number of funding instances) and regional distribution of funding.
• A detailed analysis of global events attended by the companies in the digital biomarkers industry, based on relevant parameters such as year of event, type of event, event platform, event organizer, location of event, and most active players, speakers and designations (in terms of number of events).
• An in-depth analysis of patents related to digital biomarkers, filed / granted, since 2019, based on the type of patent (granted patents, patent applications and others), publication year, application year, patent jurisdiction, cooperative patent classification (CPC) symbols, type of applicant and most active players (in terms of the number of patents filed / granted). In addition, the chapter includes patent benchmarking and an insightful patent valuation analysis, highlighting the leading patents (in terms of number of citations).
• A detailed analysis of the initiatives taken by big pharma players related to digital biomarkers, based on various relevant parameters, such as number of clinical trials, number of collaborations, number of conferences attended, number of funding instances, and number of publications.
• An in-depth analysis of the factors that can impact the growth of digital biomarkers market. It also features identification and analysis of key drivers, potential restraints, emerging opportunities, and existing challenges.
• A detailed digital biomarkers market forecast analysis in order to estimate the existing market size and future opportunity in the market, till the year 2035. Based on multiple parameters, such as likely adoption trends and through primary validations, the analyst has provided an informed estimate on the market evolution during the forecast period 2024-2035. The report also features the likely distribution of the current and forecasted opportunity within the digital biomarkers market. Further, in order to account for future uncertainties and to add robustness to the model, the analyst has provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the market growth.
• Detailed projections of the current and future opportunity within the digital biomarkers market across type of product, such as software / applications, wearables, sensors and gaming solutions.
• Detailed projections of the current and future opportunity within the digital biomarker industry across purpose of solution, such as diagnosis, early detection, monitoring and predictive insights.
• Detailed projections of the current and future opportunity within the digital biomarkers market across type of biomarker, such as cognitive, idiosyncratic, physiological, vocal, and others.
• Detailed projections of the current and future opportunity within the digital biomarkers market across therapeutic area, such as autoimmune disorders, cardiovascular disorders, infectious diseases, mental health disorders, neurological disorders, respiratory disorders, substance abuse disorders and others.
• Detailed projections of the current and future opportunity within the digital biomarkers market across business model, such as B2B and B2C.
• Detailed projections of the current and future opportunity within the digital biomarkers industry across key geographical regions, such as North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World.

One of the key objectives of this market report was to estimate the current market size, opportunity and the future potential of the global digital biomarkers market growth, over the forecast period. The analyst has provided informed estimates on the likely evolution of the market during the forecast period, 2024-2035.

the year-wise projections of the current and future opportunity within the digital biomarkers market have been segmented based on relevant parameters, such as type of product (software / applications, wearables, sensors and gaming solutions), purpose of solution (diagnosis, early detection, monitoring, and predictive insights), type of biomarker (cognitive, idiosyncratic, physiological, vocal and others), therapeutic area (autoimmune disorders, cardiovascular disorders, infectious disorders, mental health disorders, neurological disorders, respiratory disorders, substance abuse disorders and others), business model (B2B and B2C) and key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World).

In order to account for future uncertainties associated with some of the key parameters and to add robustness to the model, the analyst has provided three market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of the industry’s evolution.

The opinions and insights presented in the market report were influenced by the discussions with stakeholders in the industry. The report features detailed transcripts of interviews held with the following individuals:

• Founder and Chief Executive Officer, Small Company, India
• Co-founder and Chief Executive Officer, Small Company, France
• Business Development Manager, Mid-sized Company, UK
• Former Chief Commercial Officer, Small Company, Israel

Further, all actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this market report are in USD, unless otherwise specified.

Key Benefits of Buying this Report

• The report offers market leaders and newcomers valuable insights into revenue estimations for both the overall market and its sub-segments.
• Stakeholders can utilize the report to enhance their understanding of the competitive landscape, allowing for improved business positioning and more effective go-to-market strategies.
• The report provides stakeholders with a pulse on the digital biomarkers market, furnishing them with essential information on significant market drivers, barriers, opportunities, and challenges.