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Market Overview

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The global digital biomarkers market is expected to experience significant growth from 2022 to 2028. This growth is driven by factors such as the high prevalence and increasing incidence of chronic diseases, as well as advancements in digital healthcare technology.

The COVID-19 pandemic has further accelerated the growth of the market, with the integration of software and artificial intelligence in wearable devices, the rise of mHealth applications, and the greater adoption of telemedicine and remote patient monitoring systems. According to the global digital biomarkers market report, the market was valued at $1,808 million in 2021 and is projected to reach $16,174 million by 2028, with a compound annual growth rate (CAGR) of 36.06% during the forecast period.

There has been a noticeable shift in the healthcare industry, marked by the integration of technologies such as the Internet of Things (IoT), smart devices, and Big Data. Digitalization, which involves incorporating technology into existing processes to enhance their efficiency and effectiveness, is revolutionizing healthcare. The use of smartwatches and other smart devices allows for the collection of heterogeneous sensor data, enabling extensive data analysis for improved patient-centered preventive and treatment options.

Conventional diagnostics for chronic diseases are subjective and rely on a series of visits, resulting in limited and subjective evidence for drug development decisions. In contrast, digital biomarkers can provide faster prediction of drug efficacy, accelerating product development in certain therapeutic areas. Advancements in technologies such as voice-based digital biomarkers, mHealth applications, and smart wearable devices are gaining popularity among individuals.

The increasing prevalence and incidence of chronic diseases will drive technological adoption and disease diagnosis, leading to the expansion of the global digital biomarkers market. Governments are investing heavily in healthcare insurance to reduce overall healthcare costs and improve the quality and affordability of treatment.

However, there are challenges inhibiting the growth of the global digital biomarkers market, including concerns about return on investment (ROI) and the lack of standardized and interoperable solutions. Additionally, there are concerns among individuals regarding increased risks of medical errors and invasion of privacy when using digital health devices instead of conventional methods.

Opportunities for growth in emerging economies, as well as the emergence of local companies in Asia-Pacific and the Middle East and Africa, offer immense potential for the digital biomarkers market. In an era of machine learning (ML) and artificial intelligence (AI), the extraction of quantitative digital biomarkers that aid in illness detection, characterization, monitoring, and therapy response assessment is becoming increasingly desirable.

The COVID-19 pandemic has had a significant impact on the global healthcare ecosystem, presenting challenges for hospitals and clinics such as resource shortages, high patient volumes, and the risk of infection among healthcare providers. Despite these challenges, the market is expected to witness substantial growth during the forecast period, driven by innovations and product designs in the global market, as well as increased usage in emerging economies.

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Market Segmentation

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The market is segmented based on various factors, including system components, type, application, end user, and region.

Segmentation by System Components
Data Collection Tools – Wearables, Implantable, and Mobile
Data Integration Software

Segmentation by Type
Clinical Trials
Clinical Settings

Segmentation by Application
Gastrointestinal Diseases
Sleep And Movement Disorders
Cardiovascular
Psychiatric Disorders (Mood and Behavior)
Neurodegenerative Diseases
Diabetes
Respiratory Diseases
Others

Segmentation by End User
Biopharmaceutical Companies
Providers
Payers

Segmentation by Region
North America
Europe
Asia-Pacific
Latin America
Rest-of-the-World

The global digital biomarkers market has been categorized into data collection tools and data integration software based on system components. Within the data collection tools segment, there are further subdivisions including wearable devices, implantable devices, and mobile applications. It is projected that the overall market size will experience a compounded annual growth rate (CAGR) of 36.06% from 2022 to 2028. This growth is attributed to technological advancements in digital biomarkers and their increasing adoption in various healthcare facilities.

The wearable devices segment is expected to reach a value of $16,174 million by the end of 2028. The introduction of connected digital technologies, such as wearable biosensors and mobile devices, allows for passive measurement of parameters like sleep, activity, and heart rate. This presents an opportunity to revolutionize data collection from clinical trial participants by enabling continuous collection and extraction of new digital biomarkers. These biomarkers offer more precise, patient-centric, clinically meaningful, and objective data compared to current research methods, such as subjective rating scales and patient diaries. This segment analyzes wearable devices like fitness bands and smartwatches, excluding other wearables such as smart glasses, smart video or photo devices, and smart clothing.

In the clinical settings segment, there is an expected incremental opportunity of $1,351 million between 2022-2028. The clinical trial segment has also experienced accelerated growth due to increased quality and compliance requirements. It is projected to register a CAGR of 38.07% during the forecast period. Clinical trials are a type of clinical research that evaluates and tests new interventions, including psychotherapy or drugs. These trials typically consist of four phases (Phase I, II, III, and IV) that serve different purposes and help scientists answer specific questions. The clinical trials segment focuses on the application of digital biomarkers in clinical trials, as they have emerged as a valuable tool for precision medicine and aiding in the trial process.

The psychiatric disorders (mood and behavior) segment has also witnessed accelerated growth due to the rising prevalence of cognitive and behavior disorders, along with advancements in digital biomarkers. It is projected to register a CAGR of 37.10% during the forecast period.

Cardiovascular diseases are responsible for 17.9 million deaths globally each year, according to the World Health Organization (WHO). Traditional assessment of cardiovascular health requires blood tests and various imaging modalities, which can be time-consuming and require trained personnel. Digital biomarkers offer an alternative approach, providing continuous monitoring and allowing for faster and more convenient assessment.

The biopharmaceutical companies segment has experienced accelerated growth due to the increasing demand for digital healthcare solutions. It is expected to register a CAGR of 34.98% during the forecast period. Pharmaceutical companies are transitioning from product-based corporations to service-oriented organizations to differentiate themselves from competitors. For example, Verily and Sanofi partnered to create Onduo, a disease management program focused on diabetes. Additionally, companies like Sanofi have developed mobile applications, such as MyDoseCoach, specifically designed for type-2 diabetic patients. Acquisition-based strategies are also being employed, such as Teva Pharmaceuticals acquiring Gecko Health Innovations to enhance medication adherence.

North America is expected to be the most lucrative region for the global digital biomarkers market, thanks to advanced healthcare infrastructure and a strong focus on research and development activities. The Asia-Pacific market shows great potential for expansion, driven by its large geriatric population base.

Overall, the global digital biomarkers market is poised for significant growth, fueled by technological advancements, increased adoption in healthcare settings, and the demand for innovative solutions in various sectors, such as clinical trials and biopharmaceutical companies.

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Competitive Landscape

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This segment encompasses various strategies including funding activities, mergers and acquisitions, partnerships, alliances, business expansions, regulatory and legal initiatives, as well as new product offerings and upgrades.

Some key players operating in the market include Alphabet Inc., AliveCor Inc., Akili Interactive Labs, Inc., Cambridge Cognition Ltd, Dassault Systèmes, IXICO plc, Koninklijke Philips N.V., Shimmer, Quanterix Corporation, Altoida AG, Evidation Health, Inc., Happify, Inc., Huma, Human API, Mindstrong Health, Neurotrack Technologies, Inc., Orikami, Winterlight Labs Inc.

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Key Questions Answered

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How has the COVID-19 pandemic affected the growth of the global digital biomarkers market?

What are the main regulatory frameworks governing the digital biomarkers market in key regions?

Which technological advancements are projected to exert the greatest influence on the global digital biomarkers market?

Who are the prominent players that hold significant market dominance in the global digital biomarkers market?

What are some of the growth opportunities that market players can leverage in the digital biomarkers market?

What are the drivers and constraints for the global digital biomarkers market?

Which region exhibits the highest growth rate in the digital biomarkers market?

Which countries are experiencing the fastest growth in the global digital biomarkers market?

What are the key strategies being adopted by market players in the global digital biomarkers market?