Top 5 Digital Biomarker Companies

Digital biomarkers harness real-time behavioral patterns and physiological metrics, to unlock a new paradigm of personalized healthcare. We analyzed 130 companies that are actively engaged in offering digital biomarker solutions. In this article, discover the top 5 digital biomarker companies.

Digital biomarker industry is revolutionizing the healthcare sector by employing advanced technologies to collect and evaluate the health information of individuals, in real time. These solutions identify and interpret different indicators (such as behavioral digital biomarkers, digital biomarkers of cognitive function, vocal digital biomarkers and physiological digital biomarkers) for continuous and non-invasive monitoring; notably, digital biomarkers allow early detection of disorders, remote patient monitoring and effective management of diseases. The integration of artificial intelligence and machine learning algorithms with the digital biomarker data has enhanced the precision and diagnostic ability of health assessments. 

Further, the digital biomarkers market is driven by several key factors, such as rising prevalence of chronic indications (necessitating continuous monitoring of health data), rising adoption of telehealth and remote monitoring digital biomarkers, rapid technological advancements in biosensors, wearable technology and mobile applications (simplifying the collection and analysis of health information), and shift towards personalized medications (focusing on tailored treatments for different patients). 

Roots Analysis has conducted an exhaustive study on Digital Biomarkers Market featuring the current market landscape of digital biomarker companies and future opportunity associated with the digital biomarkers market, over the forecast period 2023-2035.

Table of Contents

Below, we have listed (in alphabetical order), the top 5 players developing digital biomarker solutions:

1. BioSensics
2. AliveCor
3. BACtrack
4. Eyenuk
5. Quibim

Interested in exploring all 125+ digital biomarker companies across various regions?

Discover Below the Details on Top 5 Digital Biomarker Companies

Let us deep dive to understand the activity of the top 5 digital biomarker companies (shortlisted based on number of products developed). It is essential to note that the selection of top players can differ substantially according to the defined criteria.

BioSensics Portfolio, Comprising of Comprehensive and Validated Technologies Focus on Digital Biomarker Collection and Outcome Assessment in Healthcare

BioSensics focuses on developing digital platforms for tracking decentralized clinical research, remote monitoring systems and wearable devices. The solutions offered by the firm are extensively used for outcome assessment of patients through the collection of numerous validated digital biomarkers. It is worth noting that the company’s product commercialization strategy involves collaborations with academic institutions, for expediting research and development of innovative solutions. In February 2024, the company published a research study highlighting the application of its proprietary device PAMSys for monitoring mobility of patients for detection of cancer-related fatigue.   

Digital Biomarker Solutions Portfolio:

The table below presents the various digital biomarker solutions offered by BioSensics.

Product / Solution Name	Type of Digital Biomarker Solution	Type of Biomarker	Purpose of Solution	Status of Development
BalanSens™	Data Collection / Analysis Tool	Cognitive	Monitoring	FDA Registered
LEGSys™	Data Collection / Analysis Tool	Cognitive	Early Detection / Screening, Monitoring	FDA Registered
BioDigit Home	Data Collection / Analysis Tool	Physiological, Cognitive, Vocal,Idiosyncratic	Monitoring	Research and Development
BioDigit Mobile	Data Collection / Analysis Tool	Cognitive, Vocal, Idiosyncratic	Monitoring	Research and Development
BioDigit Clinic	Data Collection / Analysis Tool	Cognitive, Vocal	Monitoring	Research and Development
BioDigit Cloud	Data Collection / Analysis Tool	Physiological, Cognitive, Vocal,Idiosyncratic	Monitoring	Research and Development
PAMSys™	Data Collection / Analysis Tool	Physiological, Cognitive	Monitoring	Research and Development

Recent Developments:

• In May 2024, BioSensics was granted a USD 2 million contract by the NIH to enhance and validate the company’s clinical trial products (including BioDigit Home and BioDigit Mobile), for use in trials targeting rare diseases (neurological disorders) and neuromuscular disorders.
• In May 2024, the company entered into an agreement with Hereditary Neuropathy Foundation (HNF) to advance digital tools and biomarkers for Charcot-Marie-Tooth (CMT) disease.  
• In April 2024, the company participated in 2024 AAN Annual Meeting, held in Denver, Colorado.
• In February 2024, the company participated in 2024 MDA Clinical & Scientific Conference, held in Orlando, Florida.

Further information related to digital biomarker solutions from BioSensics and other digital biomarker companies are available in the full report.

Alivecor’s Artificial Intelligence-driven, Machine Learning-enabled ECG Sensors Support the Collection of Medical-grade Heart Data for Improved Health Management

AliveCor focuses on providing intelligent, highly-personalized cardiac care solutions to empower patients as well as clinicians. It is noteworthy that the company’s Kardiamobile received MedTech Breakthrough Award for Best New Technology Solution in the Cardiology category. Additionally, the firm safeguards its customers with strict data security and compliance approaches, achieving ISO 27001 certification, SOC 2 Type 2 certification and HIPAA compliance attestation.

Digital Biomarker Solutions Portfolio:

The table below presents the various digital biomarker solutions offered by AliveCor.

Product / Solution Name	Type of Digital Biomarker Solution	Type of Biomarker	Purpose of Solution	Status of Development
KARDIACARE™ PLUS	Data Collection / Analysis Tool	Physiological	Disease Risk Assessment, Monitoring, Diagnosis	Approved
KardiaMobile®	Data Collection / Analysis Tool	Physiological	Monitoring, Diagnosis	Approved
KardiaMobile® 6L	Data Collection / Analysis Tool	Physiological	Early Detection / Screening,   Monitoring, Diagnosis	Approved
KardiaStation™	Data Integration Tool	Physiological	Diagnosis	Approved
KardiaMobile® Card	Data Collection / Analysis Tool	Physiological	Monitoring, Diagnosis	Approved
Data Integration Solutions	Data Integration Tool	Physiological	Monitoring	Approved

Recent Developments: 

• In June 2023, AliveCor entered into an agreement with Jefferson Narcotic Addiction Rehabilitation Program (NARP) and Thomas Jefferson University Hospital to analyze the advantages of QTc monitoring with KardiaMobile 6L for patients with opioid use disorder.
• In May 2023, the company participated and sponsored the Exploring The K’s First AF Virtual Ward: An Innovative Care Solution For Patients With Cardiovascular Disease webinar, held virtually.

Further information related to digital biomarker solutions from AliveCor and other digital biomarker companies are available in the full report.

For Over 20 Years, BACtrack has Been Specializing in Offering Breathalyzers for Accurate Testing of Blood Alcohol

BACtrack focuses on developing breathalyzers that enable cost effective and convenient blood alcohol testing for consumers, businesses, schools, clinics, hospitals, military as well as law enforcement. According to the company website, BACtrack became the first firm to obtain FDA approval to manufacture and market breathalyzers for consumer use (in 2004), to introduce a smartphone breathalyzer, namely BACtrack Mobile (in 2013), and to launch smartphone-based remote alcohol monitoring system, namely BACtrack View (in 2016). Notably, its breathalyzers are currently being sold in more than 25 countries.

Digital Biomarker Solutions Portfolio:

The table below presents the various digital biomarker solutions offered by BACtrack.

Product / Solution Name	Type of Digital Biomarker Solution	Type of Biomarker	Purpose of Solution	Status of Development
BACtrack Skyn	Data Collection / Analysis Tool	Physiological	Monitoring	Research and Development
BACtrack S80	Data Collection / Analysis Tool	Physiological	Early Detection / Screening	Marketed
BACtrack C8	Data Collection / Analysis Tool	Physiological	Early Detection / Screening,   Monitoring	Marketed
BACtrack C6	Data Collection / Analysis Tool	Physiological	Early Detection / Screening,   Monitoring	Marketed
BACtrack Trace	Data Collection / Analysis Tool	Physiological	Early Detection / Screening	Marketed
BACtrack Mobile	Data Collection / Analysis Tool	Physiological	Early Detection / Screening,   Monitoring	Marketed

Recent Developments: 

The company focuses on offering a comprehensive range of solutions to its clients, in order to help monitor their blood alcohol content (BAC) and facilitate informed decision-making. The firm received a USD 200,000 award for BACtrack Skyn from the National Institutes of Health (NIH). Further, it strives to provide reliable ways for people to understand how alcohol affects their bodies, and to raise awareness about the consequences of alcohol consumption and impaired driving The company is anticipated to continue to offer innovative solutions to its clients, leveraging its expertise in this domain.

Further information related to digital biomarker solutions from BACtrack and other digital biomarker companies are available in the full report.

Through its Predictive and Preventative Diagnostic Solutions, Eyenuk Aims to Transform Healthcare

Eyenuk is an artificial intelligence-driven medical technology company that focuses on autonomous disease detection and risk assessment. According to the company website, its EyeArt is the first FDA cleared AI technology for autonomous detection of mild and vision-threatening diabetic retinopathy; it is worth mentioning that the technology analyzes the patient's retinal images and returns an easy-to-read report in under 60 seconds. Further, the firms’ EyeArt AI Eye Screening System is approved for sale in the EU as a Class IIb medical device. The quality management system of the company has been successfully audited under the Medical Device Single Audit Program (MDSAP), and is compliant with GDPR, HIPAA, ISO 13485:2016 as well as regulations of Australia, Brazil, Canada and the US.

Digital Biomarker Solutions Portfolio:

The table below presents the various digital biomarker solutions offered by Eyenuk.

Product / Solution Name	Type of Digital Biomarker Solution	Type of Biomarker	Purpose of Solution	Status of Development
EyeArt® AI Eye Screening System	Data Collection / Analysis Tool	Imaging	Diagnosis	Approved
EyeScreen™ Human+AI Diagnostic Service	Data Collection / Analysis Tool	Imaging	Diagnosis	NA
EyeMark™	Data Collection / Analysis Tool	Imaging	Prognosis	Research and Development
EyeRead™ UWF	Data Collection / Analysis Tool	Imaging	Prognosis	Research and Development
EyeArt For AMD Detection	Data Collection / Analysis Tool	Imaging	Diagnosis	Research and Development
EyeArt for Glaucoma	Data Collection / Analysis Tool	Imaging	Diagnosis	Research and Development

Recent Developments: 

• In June 2023, Eyenuk received FDA clearance to use the Topcon NW400 retinal camera with its EyeArt AI system to automatically detect diabetic retinopathy (mild and vision-threatening).
• In January 2023, the company received marketing approval (in the European Union) for its EyeArt® AI eye screening system for use in age-related macular degeneration and glaucomatous optic nerve damage.

Further information related to digital biomarker solutions from Eyenuk and other digital biomarker companies are available in the full report.

Quibim (Quantitative Imaging Biomarkers in Medicine) Designs AI-guided Precision Tools to Analyze Imaging Data and Improve Patient Outcomes 

Quibim focuses on employing AI in medical imaging (from magnetic resonance imaging (MRI), computed tomography (CT) and positron emission tomography (PET)) and disclosing cutting-edge data to enable actionable predictions for healthcare providers. In addition, it is ISO27001 certified and compliant with HIPAA and GDPR. The company also claims that its software is being used at more than 125 sites, across the world and has over 350 publications in high impact factor journals.

Digital Biomarker Solutions Portfolio:

The table below presents the various digital biomarker solutions offered by Quibim.

Product / Solution Name	Type of Digital Biomarker Solution	Type of Biomarker	Purpose of Solution	Status of Development
QP-Insights®	Data Integration Tool	Imaging	Monitoring	Marketed
QP-Prostate®	Data Collection / Analysis Tool, Data Integration Tool	Imaging	Early Detection / Screening, Diagnosis	Approved
QP-Brain®	Data Collection / Analysis Tool, Data Integration Tool	Imaging	Early Detection / Screening, Diagnosis	Approved
QP-Liver®	Data Collection / Analysis Tool	Imaging	Diagnosis	Launched
QP-Breast	Data Collection / Analysis Tool	Imaging	Prognosis	Research and Development
QP-Lung	Data Collection / Analysis Tool	Imaging	Prognosis	Research and Development

Recent Developments: 

• In March 2024, Quibim launched QP-Liver, that allows precise quantification of tissue fat and iron, thereby enhancing the diagnosis of diffuse liver diseases.
• In February 2024, Quibim launched its novel product, namely QP-Insights, that allows researchers to store and analyze medical images and other multi-omics data.
• In January 2024, the company signed an agreement with Merck to develop novel precision medicine technologies for various oncological disorders; the companies aim to explore the potential of biomarkers and radiomics in predicting a cancer patient’s response to immunotherapy.

Further information related to digital biomarker solutions from Quibim and other digital biomarker companies are available in the full report.

What About the Other Digital Biomarker Companies?

The above presentation features the top 5 players offering digital biomarker solutions selected from a pool of 130 digital biomarker companies that we have compiled. If you're interested, you can download the Sample Report on this topic by Roots Analysis. For personalized assistance in identifying the most relevant solutions based on your specific criteria, please don't hesitate to reach out to us at sales@rootsanalysis.com. 

Sources:

1. “NIH Selected BioSensics Technology for Rare Disease Clinical Trials”

https://biosensics.com/news/nih-selected-biosensics-technology-for-rare-disease-clinical-trials

2. “Quibim launches a platform to deploy imaging-based algorithms to accelerate drug development programs”

https://quibim.com/newsroom/news-and-press-releases/quibim-launches-platform-to-deploy-imaging-based-algorithms-to-accelerate-drug-development-programs-qp-insights/

3. “New FDA Clearance Makes Eyenuk the First Company with Multiple Cameras for Autonomous AI Detection of Diabetic Retinopathy”

https://www.eyenuk.com/en/articles/press-releases/eyenuk-fda-multiple-cameras/