Digital Biomarkers Market is set to hit USD 24.3 billion by 2033, driven by the rising prevalence of chronic diseases

Digital Biomarkers Market is set to hit USD 24.3 billion by 2033, driven by the rising prevalence of chronic diseases

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Continuous advancements in digital health technologies, such as wearable devices, mobile apps, and sensors, are driving the growth of the digital biomarkers market. These innovations enable the collection of real-time, objective data on various health parameters, facilitating early disease detection, monitoring of treatment efficacy, and personalized healthcare interventions.

New York, Feb. 12, 2024 (GLOBE NEWSWIRE) -- According to Market.us, the global *Digital Biomarkers market size *is forecasted to exceed *USD 24.3 Billion* by 2033, with a promising CAGR of *21.7%* from 2024 to 2033.

The digitization of healthcare has revolutionized the way health-related data is collected, utilized, and monitored outside traditional clinical settings. This transformation has propelled the development and utilization of Digital Health Technology (DHT) among consumers, researchers, and clinicians alike. With the widespread adoption of mobile technologies, there's now a viable solution to address the needs of an aging population requiring continuous health monitoring.

Additionally, this trend paves the way for the delivery of digital therapies, offering patients new avenues for managing their health conditions remotely. A notable advancement in this realm is the emergence of digital biomarkers, which enable continuous and non-invasive monitoring of illnesses at a fraction of the cost associated with conventional episodic follow-ups and clinic visits, which may occur months apart. This shift towards digital health technologies signifies a fundamental change in healthcare delivery, promising greater accessibility, efficiency, and affordability for patients worldwide.

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*Key Takeaway:*

· By type, the market is divided into wearables, mobile based applications, sensors, and others; out of which wearables secured *39.2%* of total market revenue.
· As far as clinical practice is concerned, the segments observed in the market are monitoring digital biomarkers, diagnostic digital biomarkers, predictive and prognostic digital biomarkers, and others. Among these, monitoring digital biomarkers maintained their stronghold on the market with a market share of *34.7%*.
· Based on application, cardiovascular and metabolic disorders, respiratory disorders, neurological disorders, musculoskeletal disorders, psychiatric disorders and others. The cardiovascular and metabolic disorders secured the largest market share of *42.2%*.
· When end-users are considered, pharmaceutical companies, healthcare providers, payers and others. Among these, pharmaceutical companies emerged as the dominant segment with *46.5%* market share.
· Region wise, *North America* remained the leading contributor to the market in 2023, with a market share of *55.2%*

*Factors Affecting the Growth of the Digital Biomarkers Market:*

· The digital biomarkers market is driven by rising smartphone penetration, increasing prevalence of chronic diseases, and a rise in the number of clinical trials, although it faces challenges like lack of sufficient evidence, regulatory issues, and data privacy concerns.
· Conversely, there is a growth opportunity in healthcare investment in developing nations.
· Moreover, the latest trend includes new product developments, such as partnerships between pharmaceutical companies and medical technology firms to develop digital biomarker-based treatments, which are expected to positively impact the market's growth in the foreseeable future.

*Top Trends in the Global Digital Biomarkers Market:*

· One of the latest trends in the digital biomarkers market is the surge in new product developments, driven by increased interest from governments and private organizations. For instance, AstraZeneca, a leading pharmaceutical and biotechnology company, partnered with a UK-based medical technology firm called Huma Therapeutics in March 2022. Together, they aimed to develop Software as a Medical Device (SaMD) companion applications tailored for various therapeutic disorders and ailments.
· These applications integrate predictive algorithms, digital biomarkers, and real-world data, reflecting a significant advancement in leveraging digital technologies for healthcare. Such collaborations and innovations underscore a positive trend in the market, poised to enhance overall growth prospects in the foreseeable future. As companies continue to invest in cutting-edge technologies and partnerships, the digital biomarkers market is expected to witness further expansion and adoption, catering to evolving healthcare needs and driving improved patient outcomes.

*Market Growth:*

Market growth in the digital health technology sector is being driven by multiple factors contributing to its expansion. The increasing usage of smartphones, coupled with the rapid uptake of connected digital devices and mobile health applications, has significantly fueled market demand. The introduction of novel wearable devices and their expanding applications across therapeutic areas has further propelled growth. Additionally, the global rise in chronic diseases has spurred the adoption of digital biomarkers for remote patient monitoring, thereby driving market expansion. Furthermore, the anticipated surge in clinical trials and heightened investment in research and development efforts aimed at managing chronic diseases and ailments are expected to sustain strong growth momentum throughout the forecast period.

*Macroeconomic Factors: *

Several macroeconomic factors influence the digital biomarkers market. Economic stability and GDP growth rates impact healthcare spending, affecting the adoption of digital biomarkers. Additionally, government healthcare policies and regulations play a significant role in shaping market dynamics by influencing investment decisions and market access. Technological advancements and infrastructure development, particularly in emerging markets, also contribute to market expansion by facilitating the integration and utilization of digital health technologies.

Furthermore, demographic trends such as population aging and urbanization drive the demand for healthcare services, including digital biomarkers, as the prevalence of chronic diseases rises with changing lifestyles and healthcare needs. These macroeconomic factors collectively shape the growth trajectory of the digital biomarkers market, influencing investment trends, regulatory frameworks, and technological innovation.

*Regional Analysis:*

The North American region is poised to dominate the digital biomarkers market, holding a substantial share of *55.2%*. This dominance is fueled by several key factors, including the increasing prevalence of chronic illnesses such as coronary artery disease and heart attacks among adults in the United States.

Moreover, the region boasts a significant number of ongoing clinical trials, exceeding 11,000, according to data from the International Clinical Trials Registry Platform (ICTRP). This abundance of clinical trials, coupled with the rising incidence of chronic diseases, contributes to the expansion of the market in North America. Additionally, the region benefits from substantial research and development (R&D) investments and strategic initiatives implemented by various market players, such as the collaboration between Med Able and Aural Analytics in 2021, which focused on remote speech pattern recording in cancer patients to monitor patient well-being and deterioration.

Meanwhile, the Asia Pacific market is expected to experience rapid growth during the forecast period, driven by factors such as increased disposable income, rising healthcare spending, and the prevalence of chronic disorders like diabetes and cardiovascular diseases in the region. These drivers create a conducive environment for the growth of the digital biomarkers market in Asia Pacific, presenting significant opportunities for market expansion and development in the region.

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*Scope of the Report*

*Report Attributes* *Details*
Market Value (2023) USD 3.4 Billion
Forecast Revenue 2033 USD 24.3 Billion
CAGR (2024 to 2033) 21.7%
North America Revenue Share 55.2%
Base Year 2023
Historic Period 2018 to 2022
Forecast Year 2024 to 2033

*Market Drivers:*

The driving factors for the growth of digital biomarkers market include the rising penetration of smartphones, which is expected to reach 7.1 billion users globally by 2024, indicating a significant portion of the population owning smartphones with advanced features suitable for health monitoring. Additionally, the increasing prevalence of chronic diseases, such as cancer, diabetes, and mental health disorders, underscores the critical need for digital biomarkers to track and manage these conditions effectively, especially considering chronic diseases account for a substantial portion of global healthcare costs.

Moreover, the surge in the number of clinical trials, with over 59,000 trials worldwide in 2020 and a notable increase in trials incorporating decentralized and virtual components, further drives the demand for digital biomarkers, indicating their integral role in advancing clinical research and patient care.

*Market Restraints:*

The growth of digital biomarkers faces several restraining factors. Firstly, the lack of sufficient evidence regarding their efficacy and clinical relevance poses a significant obstacle to widespread adoption. As the technology evolves, there is a need for comprehensive analytical and clinical data to support the effectiveness of digital biomarkers in various healthcare settings. Secondly, regulatory issues, including the absence of a unified framework for oversight and validation of digital endpoints, hinder the market's growth. Collaboration among international regulatory authorities is crucial to establish clear guidelines and procedures for digital biomarker regulation.

Finally, concerns surrounding data privacy remain a prominent challenge. Despite the increasing acceptance of remote healthcare technologies, apprehensions about potential privacy violations persist, especially regarding the use of personal health data by insurance companies. Addressing these privacy concerns and implementing strict regulations to safeguard patient data will be essential to foster patient trust and promote the adoption of digital biomarkers.

*Market Opportunities:*

Investments in the healthcare sector have emerged as a focal point for many developing nations globally, presenting significant growth opportunities. For instance, India's public healthcare spending saw an increase to 2.1% of GDP during 2021–2022, up from 1.8% in the preceding year, as per the 2023 Economic Survey. Similarly, China's healthcare sector is witnessing a surge in investment, with projections indicating an increase to 65.7 billion yuan ($9.47 billion) in 2022 from 53.5 percent in 2017, as reported by China Daily.

These substantial investments across various healthcare domains in developing nations create promising growth prospects for key players operating in the market in the coming years. As healthcare infrastructure and services expand, there is a growing demand for innovative solutions and technologies, including digital biomarkers, positioning market stakeholders to capitalize on burgeoning opportunities in these dynamic healthcare landscapes.

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*Report Segmentation of the Digital Biomarkers Market:*

*Type Insight*

In the realm of type analysis, wearables emerge as the frontrunners, exhibiting the highest growth trajectory and commanding the largest revenue share, pegged at *39.2%* in 2023. Wearable digital biomarkers, designed to swiftly and inconspicuously screen complex physiological states, harness fine-grained sensor data elucidating individual behavior and physiology. The segment's robust growth is propelled by technological innovations and substantial investments directed towards wearable solutions development. Moreover, mobile-based applications are poised for substantial expansion, driven by the surge in mobile phone usage and propelled by innovative product launches and strategic initiatives undertaken by key industry players.

*Clinical Practice Insight*

In clinical practice analysis, the demand for monitoring digital biomarkers emerges as prominent, expected to seize the largest market share at *34.7%* and demonstrate the highest growth throughout the forecast period. These biomarkers play a crucial role in monitoring vital signs among patients grappling with a spectrum of chronic conditions, including respiratory, metabolic, and cardiovascular diseases.

The escalating prevalence of chronic diseases underscores the burgeoning need for monitoring digital biomarkers. This prevalence trend is poised to sustain the segment's growth trajectory over the forecast period. Concurrently, diagnostic digital biomarkers are poised for substantial growth, heralding an era of enhanced precision in diagnostics and treatment within the healthcare landscape.

*Application Insight*

In application analysis, the cardiovascular and metabolic disorders segment emerges as the frontrunner, commanding a dominant market share of *42.2%* in 2023. This supremacy is attributed to the burgeoning popularity of smart wearables adept at monitoring heart rate, coupled with the escalating incidence of cardiovascular disorders. Notably, heart disease, responsible for claiming over 659,000 lives annually, stands as the foremost cause of mortality in the US, as reported by the CDC. The profound impact of these statistics underscores the potential for developing digital biomarkers tailored to cardiovascular diseases, thereby propelling the segment's growth trajectory.

Concurrently, the neurological disorders segment is poised to experience substantial growth during the forecast period. This surge is propelled by the escalating prevalence of neurological disorders. The burgeoning prevalence of neurological disorders is poised to fuel the demand for digital biomarkers, delineating a promising growth trajectory for the segment in the forecast period.

*End-User Insight*

Pharmaceutical companies emerge as the primary end-users, projected to capture a substantial revenue share of *46.5%* in 2023. This dominance is underpinned by heightened investments from pharmaceutical entities aimed at accelerating digital biomarker research. The pioneering technology amalgamates digital biomarkers with innovations in virtual reality, artificial intelligence, and algorithms, offering novel avenues for healthcare professionals to enhance clinical outcomes for neurological conditions and assess patients' risk of moderate cognitive impairment. Such strategic investments by pharmaceutical giants are poised to catalyze the segment's growth.

Conversely, the healthcare providers segment anticipates robust expansion during the forecast period, driven by escalating demand for advanced remote health monitoring solutions and investments in digital innovations by healthcare entities worldwide. With a growing focus on delivering cost-effective, technologically advanced solutions like digital biomarkers, healthcare providers are poised to fuel the segment's growth trajectory, accentuating its significance in the evolving landscape of healthcare delivery.

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*Recent Development of the Digital Biomarkers Market:*

· *In March 2023*, Koneksa, a company supported by Novartis and Merck, has taken another step forward in its mission to broaden the utilization of digital biomarkers within clinical trials by forming a partnership with life sciences consultant SSI Strategy. This strategic collaboration aligns with Koneksa's overarching goal to advance the integration of digital biomarkers into various facets of clinical research and development. By joining forces with SSI Strategy, Koneksa aims to leverage its expertise and insights to drive innovation and adoption of digital biomarkers across the life sciences sector.
· *In June 2023*, Koneksa has embarked on a collaborative endeavor with Beacon Biosignals, a computational neurodiagnostics company, to initiate a clinical trial aimed at exploring the integration of Beacon's at-home electroencephalogram (EEG) technology into Koneksa's neuroscience solution toolkit. By integrating Beacon's EEG capabilities with Koneksa's comprehensive neuroscience toolkit, the collaboration seeks to provide researchers with advanced tools for capturing, analyzing, and interpreting EEG data remotely, thereby facilitating more efficient and insightful neurological studies.
· *In November 2023*, Empatica, a prominent player in health monitoring technology, obtainined FDA clearance for two additional digital biomarkers: pulse and respiratory rate. With these new additions, Empatica's health monitoring platform now boasts a total of six FDA-cleared digital biomarkers, further enhancing its utility and reliability in clinical and remote care settings. The clearance signifies Empatica's dedication to providing innovative solutions that empower individuals and healthcare professionals to monitor vital health metrics more conveniently and accurately.

*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

*By Geography*

· *North America*

· US
· Canada

· *Europe*

· Germany
· France
· The UK
· Spain
· Italy
· Russia
· Netherland
· Rest of Europe

· *Asia Pacific*

· China
· Japan
· South Korea
· India
· New Zealand
· Singapore
· Thailand
· Vietnam
· Rest of APAC

· *Latin America*

· Brazil
· Mexico
· Rest of Latin America

· *Middle East & Africa*

· South Africa
· Saudi Arabia
· UAE
· Rest of MEA

*Competitive Landscape:*

The global Digital Biomarkers market is considered moderately competitive, with major players striving to enhance their market share through technological advancements and the introduction of new products. Additionally, many companies are prioritizing strategic initiatives like collaborations, mergers, and acquisitions to broaden their product portfolios and geographical presence. These efforts are expected to have a positive impact on the market's growth trajectory in the coming years, fostering innovation and driving competitiveness among industry participants.

*Market Key Players:*

· 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

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