Digital Biomarkers Market Size, Share & Trends Analysis Report By Type (Wearable, Mobile based Applications, Sensors), By Clinical Practice, By Therapeutic Area, By End-use, By Region, And Segment - Global Industry Analysis, Size, Share, Growth, Trends, Regional Outlook, and Forecast 2024 – 2033

The global digital biomarkers market size was exhibited at USD 3.55 billion in 2023 and is projected to hit around USD 26.79 billion by 2033, growing at a CAGR of 22.4% during the forecast period 2024 to 2033.

Key Takeaways:

• North America dominated the market and accounted for a revenue share of more than 60% in 2023
• The Europe digital biomarker market is expected to witness the fastest growth, due to the market
• The wearables held the largest market share of 40.5% in 2023
• The market growth for digital biomarkers is predicted that mobile-based applications would rise at a CAGR of 24.4%.
• Diagnosis digital biomarkers held the largest market share of more than 33.9% in 2023
• Monitoring digital biomarkers had the fastest share during the forecast period.
• Healthcare companies held the largest market share of 51% in 2023.
• The payers segment is expected to grow at the fastest CAGR of 24.6% over the forecast period.

Digital Biomarkers Market Report Scope

The market is expected to grow due to the rapid adoption of health-related mobile applications and connected digital devices, rising usage of smartphones and the emergence of new wearables, and expanding therapeutic area applications.

In addition, it is projected that the market for digital biomarkers will expand as a result of new product releases and FDA approval, both of which will fuel market expansion. For instance, the U.S. FDA granted Kardia Mobile in April 2019, a grant for an AI-based wearable gadget made by AliveCor and intended to provide a patient with multidimensional insight into their heart.

This long-awaited permission will enable patients and their doctors to gain a more thorough understanding of their hearts, including awareness of specific arrhythmias that serve as early warning signs of cardiovascular disease. This trend will greatly accelerate the market expansion for digital biomarkers.

Due to the rise in investments and financing initiatives to speed up research on digital biomarkers, the healthcare companies segment is likely to experience market expansion during the forecast period. For instance, Altoida, Inc. received a USD 6.3 million Series A investment from Hikma Pharmaceuticals PLC in May 2020. In order to give healthcare professionals a new way to categorize patients' risk of moderate cognitive impairment and improve clinical outcomes for neurological conditions, Altoida's technology combines digital biomarkers with the most recent developments in artificial intelligence, virtual reality, and algorithms.

Medical professionals are searching for digital indicators that would make it simpler to remotely screen and diagnose COVID-19 patients in the current pandemic condition. This is expected to lead to market growth. For instance, The National Institutes of Health (NIH) and physIQ have a contract for the development of an AI-enabled COVID-19-associated de compensation Index in September 2020, along with the validation of an algorithm that can use the most recent wearable biosensor analytics created by the pinpointIQ cloud platform.

Additionally, a number of health tech firms have offered assistance to prevent the Covid-19 outbreak by contributing their digital biomarker technologies; with this investment, the market is anticipated to grow during the forecast period. For instance, Medopad is working with international partners to determine patients who are mostly at risk for COVID-19, speed up the validation process, and find digital biomarkers for data points like respiratory indicators. As a result, the market is expected to benefit from the COVID-19 situation.

As the prevalence of chronic and neurological disorders rise due to an aging population, there is a growing need for faster medication development to successfully combat these diseases, when compared with intermittently collected traditional endpoints. As a result, pharmaceutical firms are investing in a digital biomarker for decentralized clinical trials, which is anticipated to be a significant driver of market growth. 

Additionally, digital biomarkers go far beyond smartwatches and activity trackers. In order to speed up the adoption of this technology and enhance new solutions in the field of digital biomarkers, some large pharmaceutical companies have joined with ground-breaking digital health start-ups; this is expected to fuel market expansion.

Governmental organizations have expressed interest in creating digital biomarker-based medication due to the significant hardship brought on by the Covid-19 outbreak. For instance, in March 2022, AstraZeneca teamed up with UK-based medical technology company Huma Therapeutics to develop Software as a Medical Device (SaMD) companion applications for a range of therapeutic diseases. These applications combined predictive algorithms, digital biomarkers, and real-world data.

Although digital biomarkers have several benefits, some barriers to digital biomarker development and implementation are expected to hinder the market growth. These include concerns about data privacy, trustworthiness, data validation, and a lack of open-source data. However, growing competition and more use of these systems are anticipated to overcome this barrier during the forecast period.

Type Insights

The wearables held the largest market share of 40.5% in 2023. The development of remote data collecting technologies, the main technological component of the digital biomarker market is anticipated to have benefited from wearable technology improvements throughout the forecast period.

Due to the rising popularity of mobile applications, which is a major factor in the market growth for digital biomarkers is predicted that mobile-based applications would rise at a CAGR of 24.4%. Consequently, it is projected that there will be a rise in mobile phone usage to fuel market expansion in the coming years. Additionally, this market area is benefiting from the growing use of the internet. During the forecast period, the sensors section will compete with the wearable and mobile application categories.

Furthermore, market participants are establishing their market presence through the strategies like teaming up with regional players to broaden their customer and provide better solutions at a cheaper cost, which will ultimately boost overall market growth throughout the forecast period. For instance, in February 2021, Biogen and Apple collaborated to develop digital biomarkers for cognitive health by assessing the iPhone and Apple Watch's potential for conditions including moderate cognitive impairment (MCI).

Clinical Practice Insights

Diagnosis digital biomarkers held the largest market share of more than 33.9% in 2023, owing to the increasing use of the linked digital devices and health-related mobile applications for the diagnostic and monitoring of the measurements used for a variety of disease categories, including cardiovascular illnesses, mental health, neurological diseases, and diabetes. As a result, it is anticipated that digital biomarkers are expected to be an important device for future diagnostic and treatment meant for diverse disease areas.

Monitoring digital biomarkers had the fastest share during the forecast period. This growth was attributed to the rising investment in wearable technology and smartwatches, which will offer easier and more accurate access to health-related information. Additionally, wearables from biopharmaceutical companies are enhancing internal procedures by understanding patient biometrics and functionality from tracking, heart rate, sleep, and disease-specific biometrics like monitoring, electro-stimulation, and sweat analysis. This is anticipated to propel market expansion.

Therapeutic Area Insights

Due to the growing number of therapeutic applications and the fact that cardiovascular disease is the world's leading cause of death while being a perfectly preventable condition, the cardiovascular diseases category currently maintains the greatest market share in the global digital biomarker market. After receiving USD 300 million in series- D funding, Biofourmis, which is close to commercializing its BioVitalsHF digital treatment for heart failure, has attained unicorn status and is expected to benefit from the market's expansion.

Due to the rising number of investments and financing initiatives to speed up research on digital biomarkers, the healthcare companies segment is likely to experience dominant market growth during the forecast period. For instance, in May 2020, Hikma Pharmaceuticals PLC invested in Altoida, Inc. following the company's USD 6.3 million Series A investment in 2019. Altoida's technology combines digital biomarkers with the most recent advancements in artificial intelligence, virtual reality, and algorithms to provide healthcare professionals with a novel way to classify patients' risk of moderate cognitive impairment and drive improved clinical outcomes for neurological conditions.

End-use Insights

Based on end-use, the market is segmented into healthcare companies, healthcare providers, payers, and others, including patients and caregivers. Healthcare companies held the largest market share of 51% in 2023. This can be attributed to the fact that healthcare companies have been working toward integrating digital measurements across the spectrum of clinical care & research to ensure connected devices provide a comprehensive view of patient health.

Moreover, the payers segment is expected to grow at the fastest CAGR of 24.6% over the forecast period. The growth of the segment is attributed to the rising adoption of novel digital biomarkers in insurance firms and payers' ability to use these tools to satisfy patient needs further & develop individualized care plans with schedules for prior authorization.

Regional Insights

North America dominated the market and accounted for a revenue share of more than 60% in 2023, owing to the strong presence of leading market players, significant product launches, and increase in investments in R&D, growing approval of the smart devices, along with improved awareness of the digital biomarker effectiveness in the region.

Besides, the rising number of initiatives to promote healthcare IT and the presence of healthcare programs are some of the primary reasons for this region to anticipate market growth. In addition, the region's market participants' strategic initiatives and significant R&D expenditure are expected to drive the market in North America. For instance, in 2021, Med able formed a partnership with digital biomarker startup Aural Analytics to evaluate remote speech pattern recording in cancer patients to track patient deterioration and wellness.

The Europe digital biomarker market is expected to witness the fastest growth, due to the market being driven by an increasing number of chronically ill patients who require real-time monitoring and diagnostics of various diseases. Furthermore, advanced healthcare infrastructure in European nations, as well as a strong focus on R&D activities, is fueling market expansion during the forecast period, this is expected to drive the growth of the market.

Key Companies & Market Share Insights

Although North America holds the largest share, competition is growing in the future emerging market, where countries like Germany, the Netherlands, Italy, and others in Europe have developed healthcare systems that reflect U.S. practices.

Furthermore, in August 2021, the U.S.-based Alzheimer's Drug Discovery Foundation granted up to USD 2.0 million to the Early Detection of Neurodegenerative Diseases initiative for a collaborative research project headed by Alzheimer's Research UK with the aim of creating a digital biomarker to identify Alzheimer's disease at an early stage.

A well-known provider of digital biomarkers is attempting to enter the market through a strategic acquisition, which would give it access to a wider range of products and boost overall sales. For instance, Mitsubishi Tanabe Pharma America (MTHA) and Everything ALS, a nonprofit organization, devoted to bridging the gap between patients, technology, and research, teamed up in March 2022. This collaboration aims to hasten the development of digital biomarkers for amyotrophic lateral sclerosis (ALS).

Furthermore, players employ a range of strategies, such as increasing investment to provide additional stacks around profits. For instance, to accelerate the growth of its digital biomarkers platform, Koneksa, a company that designs and validates digital biomarkers, raised USD 45.0 million in Series C funding in February 2023, led by Ayur Maya with participation from Velosity Capital, Takeda Ventures, and existing investors Novartis, Merck Global Health Innovation Fund, McKesson Ventures, and others. Some of the prominent players in the global Digital Biomarkers Market include:

• ActiGraph LLC
• AliveCor Inc.
• Koneksa
• Altoida Inc.
• Amgen Inc.
• Biogen Inc.
• Empatica Inc.
• Vivo Sense
• IXICO plc
• Adherium Limited
• Neurotrack Technologies, Inc.
• Aural Analytic
• Huma
• Sonde Health, Inc.
• Clario
• Imagene AI
• Brainomix
• Kinsa Inc.
• Feel Therapeutics
• ResApp (Pfizer)

Segments Covered in the Report

This report forecasts revenue growth at global, regional, and country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2021 to 2033. For this study, Nova one advisor, Inc. has segmented the global Digital Biomarkers market.

By Type 

• Wearable
• Mobile based Applications
• Sensors
• Others

By Clinical Practice 

• Diagnostic digital biomarkers
• Monitoring digital biomarkers
• Predictive and Prognostic digital biomarkers
• Other's (Safety, Pharmaco dynamics/ Response, Susceptibility)

By Therapeutic Area 

• Cardiovascular and metabolic disorders (CVMD)
• Respiratory disorders
• Psychiatric disorders
• Sleep & Movement Disease
• Neurological disorders
• Musculoskeletal disorders
• Others (Diabetes, Pain Management)

By End-Use 

• Healthcare companies
• Healthcare Providers
• Payers
• Others (Patient, caregivers)

By Region

• North America
• Europe
• Asia-Pacific
• Latin America
• Middle East & Africa (MEA)