Global Digital Biomarkers Market by Type (Wearables, Sensors, and Other Types), By Clinical Practice (Monitoring Digital Biomarkers, and Other Clinical Practices), By  Application, By End-User, By Region and Companies - Industry Segment Outlook, Market Assessment, Competition Scenario, Trends and Forecast 2023-2032

Report Overview

The Global Digital Biomarkers Market size is expected to be worth around USD 24.3 Billion by 2033, from USD 3.4 Billion in 2023, growing at a CAGR of 21.7% during the forecast period from 2024 to 2033.

The last ten years have seen a revolution in medical research, diagnostics, and therapies due to increased digitization throughout the healthcare industry.

By enabling the collection of health-related data outside the conventional clinical context, digitization has accelerated the development and use of digital health technology (DHT) by consumers, researchers, and clinicians. The broad adoption of mobile technologies can satisfy the aging population’s requirement for health monitoring while laying the groundwork for the delivery of digital therapies. Digital biomarkers, in particular, offer continuous, non-invasive illness monitoring at a significantly cheaper cost than conventional episodic follow-ups and clinic visits (which can happen months apart).

In order to explain health-related outcomes, digital biomarkers are described as devices used for collecting objective, quantifiable physiological and behavioral data by digital devices. The information gathered is often used to forecast, explain, and/or change health-related outcomes. Digital biomarkers offer another chance to gather factual, clinically useful data.

The market growth is stimulated by several key factors, such as rising smartphone usage, quick uptake of connected digital devices and mobile health applications, the introduction of new wearable devices, and expanding therapeutic area applications. Moreover, the rising prevalence of chronic diseases over the globe is projected to boost the adoption of digital biomarkers for remote patient monitoring. Furthermore, the market is expected to witness strong growth during the forecast period due to a rise in the number of clinical trials and investment in research and development of various therapies to manage chronic diseases and ailments.

Key Takeaways

• Market Growth: Expected USD 24.3 Billion by 2033, with 21.7% CAGR from 2024. Driven by healthcare digitization.
• Driving Factors: Rising smartphone usage, chronic disease prevalence, and a surge in clinical trials propel market demand.
• Restraining Factors: Lack of clinical evidence, regulatory hurdles, and data privacy concerns impede market growth.
• Dominant Type: Wearables hold over 39.2% market share in 2023, driven by tech advancements and investments.
• Clinical Practice: Monitoring Digital Biomarkers captured 34.7% market share in 2023, driven by chronic disease monitoring.
• Application Focus: Cardiovascular and Metabolic Disorders segment dominates with a 42.2% market share in 2023.
• End-user Landscape: Pharmaceutical Companies lead with 46.5% market share in 2023, driven by research investments.
• Growth Opportunity: High healthcare investments in developing nations like India and China offer significant growth prospects.
• Latest Trends: New product developments through collaborations between pharmaceutical and tech firms drive market innovation.
• Regional Analysis: North America leads with 55.2% market share in 2023; Asia Pacific expected to grow rapidly.

Driving Factors

Rising smartphone penetration

Global adoption of mobile technology has been accelerating. According to Pew Research Centre, more than 5 billion people use mobile devices, with smartphones accounting for more than half of these connections. According to the most recent Oberlo data, more people use smartphones yearly. Global smartphone usage is anticipated to reach 6.8 billion users in 2023, a growth of 4.2% annually.

Additionally, there are 3.2 billion more smartphone users today, or 86.5% more than there were in 2016, which was only seven years ago. In reality, the overall number of smartphone users worldwide increased by 9.5% annually on average from 2016 to 2023, with 2017 seeing the most growth. Users of smartphones increased by 20.9% in that year.

Reports also estimate that there will be 7.1 billion smartphone users worldwide by 2024, which is a significant increase. By 2023, there will be over 8 billion people living on the planet, which indicates that 89% of people will own a smartphone. In other words, almost 90% of individuals will own a smartphone. Thus, rising smartphone penetrations are likely to fuel the demand for digital biomarkers during the projection period, as most smartphones nowadays consist of different advanced features like motion sensors that are beneficial for monitoring an individual’s health.

Increasing prevalence of chronic diseases

The health and quality of life are impacted by chronic disease. The World Health Organization (WHO) claims chronic disease is the biggest cause of death worldwide. Liver cancer claimed more than 830,000 lives in 2020, but lung cancer alone claimed about 1.8 million lives. Most deaths in the United States are caused by chronic diseases, with all forms of cancer and heart disease accounting for nearly 40% of all fatalities. In addition, 18.1 million Americans had experienced cancer at some point in their lives as of 2022. The CDC estimates that individuals with chronic diseases and mental health disorders are responsible for 90% of the country’s $3.8 trillion in annual healthcare costs.

Additionally, there were 619 thousand malaria-related deaths in 2021 and an estimated 247 million recorded cases of infection worldwide. India has the greatest prevalence of diabetes in the world, with an estimated 77 million people currently living with the disease and a predicted 134 million by 2045, according to the International Diabetes Federation. Therefore, the rising prevalence of chronic diseases is anticipated to promote the demand for digital biomarkers, as these devices help in tracking health conditions in patients suffering from chronic or long-term illnesses. This is a key factor driving the growth of the market during the projected time period.

Rise in the number of clinical trials

In recent years, there have been a lot more registered clinical trials over the globe. As per the information released by the WHO International Clinical Trials Registry Platform (ICTRP), in 2020, more than 59,000 clinical trials were proceeding worldwide.

This number is high and unparalleled in this format; it is up 93 percent from 673 in 2020 and up 28% from 2021, which held the previous record for more than 1,000. Moreover, according to the latest records, as of November 24, 2022, there were more than 434 thousand clinical studies registered all over the world.

Since there were only 2,119 registered clinical trials in the year 2000, the number of clinical studies or trials has greatly expanded in the last 20 years. Thus, a high increase in the number of ongoing clinical trials is likely to fuel the demand for digital biomarkers in the upcoming time period.

Restraining Factors

Lack of sufficient evidence

The largest obstacle to the widespread use of digital biomarkers is the lack of necessary and adequate analytical as well as clinical data to support them. For instance, the fact that a physical function measure correlates well with a six-minute walk test conducted in a clinical setting does not imply that the test is appropriate for that particular task.

It is imperative for researchers to ensure that digital metrics are clinically relevant to hospitalization, patient population survival, or other concrete clinical outcomes. Therefore, as the technology is constantly evolving, a lack of sufficient evidence regarding the efficacy of digital biomarkers is a key factor that may limit its adoption over the forecast period.

Regulatory issues

Digital biomarkers’ (DBM) regulatory oversight and control is currently at a developing stage. Given the extensive uses of DBMs, there is no unified regulatory framework over the globe. A key component of the successful adoption of digital endpoints, according to The Innovative Medicines Initiative, a joint venture between the European Union and the European pharmaceutical industry, is cooperation across international regulatory authorities.

In order to ensure unambiguous guidelines about hardware, Software, and digital endpoint validation, collaboration between regulatory and technical stakeholders will also be essential. An important element in removing this obstacle appears to be uniform and understandable instructions on the regulatory procedure. As a result, the lack of unified regulatory guidelines and oversight may restrain the growth of the market during the estimated time period.

Concerns regarding data privacy

Data privacy issues are still a problem. Despite the recent rise in the acceptability of remote healthcare technologies, some people are still apprehensive about the possibility of privacy violations. There is rising worry about how health insurance firms use the personal information obtained by wearables, particularly in the US. To stimulate patient adoption of DBMs, there needs to be strict regulation regarding the misuse of personal data and enough patient education regarding the same. Therefore, issues related to data privacy are expected to hamper the market growth during the projected time period.

Type Analysis

In 2023, Wearables segment held a dominant market position, capturing more than a 39.2% share. In order to perform rapid, unobtrusive, and scalable screening of complex physiological states, wearable digital biomarkers collect fine-grained sensor data describing the behavior and physiology of individuals.

Technological advancements, along with key investments in the development of wearable solutions, are key factors driving the growth of the segment. Also, mobile-based applications are expected to grow at a high rate during the forecast period. An increase in mobile phone usage, along with the launch of new products and the implementation of novel strategies by key players, are key factors stimulating the growth of the segment.

Clinical Practice Analysis

In 2023, Monitoring Digital Biomarkers segment held a dominant market position, capturing more than a 34.7% share, and are likely to exhibit the highest growth during the forecast period. These biomarkers are useful for monitoring vital signs in patients suffering from a variety of chronic conditions, such as respiratory, metabolic, and cardiovascular diseases.

The need for monitoring digital biomarkers is anticipated to increase in the near future due to the rising prevalence of chronic diseases. According to a report released by the World Health Organisation in May 2022, close to 246 million people worldwide will have respiratory disorders in 2022. Thus, the rise in the prevalence of chronic diseases is expected to contribute to the segment growth throughout the projection period. Moreover, diagnostic digital biomarkers are projected to witness significant growth during the estimated time period.

Digital biomarkers, which continually and remotely collect trustworthy clinical data and enable ongoing monitoring and evaluation, can improve diagnostic and treatment precision in the contemporary healthcare system. Overall, digital biomarkers are important for precision medicine because they can lower medical errors, increase the precision of diagnostic techniques, and promote individualized therapeutic decisions. Therefore, these advantages offered by diagnostic digital biomarkers are likely to boost their adoption in the upcoming years.

Application Analysis

In 2023, the Cardiovascular and Metabolic Disorders segment held a dominant market position, capturing more than a 42.2% share. The increasing popularity of smart wearables, which largely monitor heart rate and the rising incidence of cardiovascular disorders, can be credited with the segment’s growth. Heart disease, which claims over 659,000 lives annually, is the main cause of mortality in the US, according to the CDC. Given the figures, it is possible to create digital biomarkers for cardiovascular diseases.

Also, the neurological disorders segment is anticipated to witness high growth during the forecast period. The growth of the segment is driven by a rise in the prevalence of neurological disorders. As of 2021, the number of Americans suffering from Alzheimer’s disease was expected to reach close to 6.2 million, followed by 1 million people with Parkinson’s disease and close to 400,000 persons with multiple sclerosis (MS), according to the National Institute of Environmental Health Sciences. Thus, the increasing prevalence of neurological disorders will likely boost the demand for digital biomarkers during the forecast period.

End-user Analysis

In 2023, Pharmaceutical Companies segment held a dominant market position, capturing more than a 46.5% share. The key factor fuelling the growth of the segment during the estimated time period is the increasing number of investments by several pharmaceutical companies aimed at accelerating digital biomarker research. For example, a USD 6.3 million Series A investment was received by Altoida, Inc. in May 2020 from Hikma Pharmaceuticals PLC.

Altoida’s technology involves the combination of digital biomarkers with new innovations in virtual reality, artificial intelligence, and algorithms. It is beneficial in providing a new way for healthcare professionals to improve clinical outcomes for neurological conditions and categorize patients’ risk of moderate cognitive impairment. Such key investments by pharmaceutical companies are likely to contribute to the segment’s overall growth.

On the other hand, the healthcare providers segment is likely to experience high growth over the projected time period. The segment’s growth is stimulated by the rise in demand for efficient and advanced remote health monitoring devices and solutions, along with increasing investments in the development of digital solutions by healthcare providers. Also, as more healthcare providers over the globe are focusing on providing cost-effective, technologically advanced, and beneficial solutions like digital biomarkers, it is likely to positively influence the overall segment growth during the forecast period.

Market Segmentation

By Type

• Wearables
• Mobile based Applications
• Sensors
• Other Types

By Clinical Practice

• Monitoring Digital Biomarkers
• Diagnostic Digital Biomarkers
• Predictive and Prognostic Digital Biomarkers
• Other Clinical Practices

By Application

• Cardiovascular and Metabolic Disorders
• Respiratory Disorders
• Neurological Disorders
• Musculoskeletal Disorders
• Psychiatric Disorders
• Other Applications

By End-User

• Pharmaceutical Companies
• Healthcare Providers
• Payers
• Other End-Users

Growth Opportunity

Healthcare investment in developing nations

Investments in the healthcare industry have remained a prime focus of many developing countries over the globe. The India Brand Equity Foundation estimates that the country’s healthcare market will reach US$ 372 billion by 2022. According to the 2023 Economic Survey, India’s public healthcare spending increased to 2.1% during 2021–2022 from 1.8% of GDP during 2020–2021.

The Ministry of Health and Family Welfare (MoHFW) received Rs. 89,155 crores (US$ 10.76 billion) funding from the Central government in the Union Budget for the year 2023–24. Also, investment in China’s healthcare sector will increase to 65.7 billion yuan ($9.47 billion) in 2022, from 53.5 percent in 2017. This prediction was made in a recent story from China Daily. Thus, high investment in the healthcare sector among several developing nations is expected to provide lucrative growth opportunities for key players operating in the market in the upcoming years.

Latest Trends

New product developments

More governments, as well as private organizations, are expressing interest in developing digital biomarker-based treatment. AstraZeneca, a British-Swedish multinational pharmaceutical and biotechnology company, for example, joined forces with a UK-based medical technology company named Huma Therapeutics in March 2022 to develop Software as a Medical Device (SaMD) companion applications for a wide range of therapeutic disorders and ailments. Predictive algorithms, digital biomarkers, and real-world data were all incorporated into these applications. Therefore, such developments can be considered a positive trend that is likely to boost the market’s overall growth in the upcoming time period.

Regional Analysis

In 2023, North America held a dominant market position, capturing more than a 55.2% share and holds USD 1.87 Billion market value for the year. Key factors such as rising chronic illness prevalence, increased clinical trials in the United States, and the availability of technologically advanced products are expected to drive market growth in the region during the projection period.

According to the CDC or Centres for Disease Control and Prevention, by 2022, about 20.1 million adults in the United States will suffer from coronary artery disease, and 805,000 Americans will have a heart attack. Furthermore, more than 11,000 clinical trials are underway in the United States, according to data published by the International Clinical Trials Registry Platform (ICTRP). As a result, the region’s market expansion is aided by the vast number of current clinical trials and the growing number of chronic diseases.

Furthermore, large R&D spending and implementation of strategic initiatives by several market players are projected to boost market growth over the forecast period. In 2021, for example, Med Able announced a collaboration with Aural Analytics to examine remote speech pattern recording in cancer patients to track patient deterioration and well-being.

The Asia Pacific market is projected to grow rapidly over the forecast period. Increased disposable income, healthcare spending, and the prevalence of chronic disorders like diabetes, cardiovascular diseases, etc. are some of the primary drivers projected to drive growth in the region’s Digital Biomarkers market.

Key Regions

• North America
  • US
  • Canada
  • Mexico
• Europe
  • Germany
  • UK
  • France
  • Italy
  • Russia
  • Spain
  • Rest of Europe
• APAC
  • China
  • Japan
  • South Korea
  • India
  • Rest of Asia-Pacific
• South America
  • Brazil
  • Argentina
  • Rest of South America
• MEA
  • GCC
  • South Africa
  • Israel
  • Rest of MEA

Key Players Analysis

The global Digital Biomarkers market is regarded as moderately competitive. Major market players focus on technological advancements and new product launches to gain market share. Also, several players emphasize strategic initiatives such as collaborations, mergers, and acquisitions to expand their product lines and geographical footprint. It is likely to positively contribute to the market’s growth in the upcoming years.

Top Key Players in the Market

• F. Hoffmann-La Roche Ltd.
• ActiGraph
• Koneksa
• Altoida Inc.
• Adherium Limited
• Neurotrack Technologies, Inc.
• Biogen Inc.
• Empatica Inc.
• Fitbit Health Solutions
• AliveCor Inc.
• Aural Analytic
• Other Key Players

Recent Developments

• In December 2023, Fitbit Health Solutions introduced the Fitbit Sense 2, featuring advanced stress monitoring capabilities such as electrodermal activity (EDA) and skin temperature sensors. This addition expands Fitbit’s offerings in mental health and wellbeing, providing personalized insights and tools for stress management.
• In November 2023, Aural Analytic received FDA clearance for its AI-powered cough analysis platform. This innovative technology uses cough acoustics to identify and differentiate various respiratory conditions, making strides in remote patient monitoring and early disease detection.
• In October 2023, Biogen joined forces with Apple to create a digital biomarker for tracking Parkinson’s disease progression. By combining Biogen’s knowledge in neurodegenerative diseases with Apple’s technology and user base, they aim to enhance diagnosis and treatment monitoring.

Report Scope