Digital Biomarkers: Areas of Application, Use Cases, and Market Overview

Do you know anyone who wants to write down health data by hand? Especially given a chance to have it all gathered, recorded, analyzed, and stored automatically? Probably not. And we don’t have to reinvent the wheel because digital biomarkers have been around for a while. These digital grains of information have worked wonders for research, digital healthcare businesses, and pharma companies.

Digital biomarkers are already used to personalize preventive care, evaluate risks, and manage mental health conditions and diseases. Specialists predict that by 2030, the global digital biomarkers market will be worth $23.86 billion . Mobile users are the major promoters of digital biomarkers adoption in healthcare.

Thinking about using digital biomarkers in healthcare solutions? Keep reading and learn how to yield benefits for your business through the application of digital biomarkers.

Digital biomarkers market size and trends

Sensors wearables and digital biomarkers work hand in glove and create rapid market growth. Strategic Market Research’s report predicts positive growth of the digital biomarkers market. Here are a couple of interesting facts and useful figures:

• In 2021, the digital biomarkers market was valued at $1.51 billion with CARG of 35.7%
• By 2030, the market worth will reach a high mark of $23.86 billion

• Currently, digital biomarkers generate the majority of big data available in the healthcare industry
• As of now, there are four groups of devices that gather digital biomarkers: wearables, portables, digestibles, and implantables
• Smartphones, smartwatches, and medical bracelets are driving the demand for digital biomarkers use
• Oxygen saturation and heart rate monitoring are the two most common features in consumer wearables

Is it possible, though, that the user adoption of wearables alone can be responsible for the rapid market growth? What does the report say about the other digital biomarkers drivers? On a larger scale, the digital biomarkers market is driven by four aspects:

1. Government investment

Telemedicine has become the only alternative to traditional inpatient care during the COVID-19 pandemic. In the aftermath, the US and the EU governments have decisively invested in the development of government frameworks that support the adoption of healthcare platforms. The latter gives a massive boost to the global digital biomarkers market growth.

2. Increased healthcare expenditure

The COVID-19 pandemic impacted the world economy and raised per capita health consumption expenditures from $12,592 in 2020 to $12,914 in 2021, in the US.

“On average, other large, wealthy countries spend about half as much per person on health as the US,” claims Peterson Center on Healthcare and KFF overview of health spending in the US as compared to other countries.

3. More people use smartphones and smartwatches for health tracking

People use smartwatches and smartphones to track physical activity and some basic digital biomarkers including heart rate. For instance, Apple Watch Series 4 has an electrical heart sensor implanted into the back of the sapphire crystal and digital crown. This sensor allows people to take an electrocardiogram (ECG). What’s more, the FDA cleared the feature. So, in theory, people can share data with connected physicians.

And Apple Watch is just one among a myriad of smartwatches people use these days. Here’s how a cardiogram from Apple Watch visualizes the heart's performance during different everyday activities.

4. Drug development is becoming a heavy capital expenditure

Pharma companies spend extremely large budgets on drug development because clinical trials are quite costly, time-consuming, and, quite often, unsuccessful. That’s why pharmaceutical companies see great potential in using digital biomarkers: they are consistent, unified, timely, precise, and can be gathered remotely.

To be concise, digital biomarkers accelerate clinical trials (including ECRF clinical trials ) and save budget.

Types and areas of application of digital biomarkers

In the last decade, the number of digital biomarkers has increased and now we can even divide them into categories depending on the clinical goal they serve. So far, there are seven categories of digital biomarkers: diagnostic, safety, response, monitoring, prognostic, risk, and predictive.

Here’s an example of monitoring digital biomarkers usage in disease management.

You may also be acquainted with the following examples of digital biomarkers:

1. Wearable heart monitor that can detect heart arrhythmia
2. Wearable sensor that predicts falls in patients with Parkinson’s disease
3. Smartwatch photoplethysmography sensor that identifies irregular pulse rate
4. Wearable digital technologies that track mood
5. Accelerometry that tracks and measures the duration of sleep

Well, can’t you measure the same biomarkers without wearables? What’s the difference between ordinary and digital biomarkers, you may ask?

‍✅Digital biomarkers offer a continuous and longitudinal view of the health condition

✅Digital biomarkers are less labor-intensive and cheaper than ordinary biomarkers

✅Digital biomarkers offer a view of patients in real-time in their natural environment

Digital biomarkers are further subdivided into active and passive biomarkers.

Passive digital biomarkers – digital biomarkers that are collected simply when you wear a wearable device during unnoticed actions.

Active digital biomarkers – gathered during prompted actions. They are captured and generated by smartphones, tablets, and other devices when a person interacts with the device in response to an active prompt.

Benefits and impact of digital biomarkers on healthcare

Digital biomarkers are so versatile that they generate various benefits to clinicians, researchers, pharma businesses, patients, and DTx companies. The most frequently mentioned benefits of digital biomarkers:

• Their ability to minimize expenses spent on clinical data collection
• Digital biomarkers allow for transforming the process of obtaining and verifying evidence into a closed loop
• They expand and strengthen the role of the consumers in their own health
• They help to detect signatures to better explain differences in human health and disease

There is more to the usefulness of digital biomarkers in multiple fields.

1. Digital biomarkers enable early diagnosis

Wearable devices and cell phones continually collect health data so digital biomarkers can detect problems far earlier than traditional biomarkers, allowing for early treatment. For example, Element Science's app-connected wearable defibrillator continually analyzes patients' cardiac activity.

When the software identifies potentially fatal arrhythmias, it administers an electrical shock to restore normal heart rhythm, therefore averting sudden cardiac death.

Another example is Clarigent Health's app, which analyzes voice features to detect early symptoms of suicidality and aggression, allowing patients and professionals to intervene early and avert tragic incidents.

2. Digital biomarkers reduce the cost of personalized remote patient care and allow for better self-management

The capacity of smartphones and wearable technology to continually assess health data and combine data from several sources allows patients to have a better understanding of their condition and make better health decisions.

Furthermore, by sending this data to the doctor, they may deliver individualized care remotely. The expense is reduced since all of these actions may be completed remotely without the need to visit a doctor or a hospital.

Glooko is a digital tool that syncs data from glucose meters, insulin pumps, and Continuous Glucose Monitoring (CGM) devices, as well as tracks meals and exercise. Patients may utilize this data to better self-manage their diabetes, and the healthcare team can analyze it to deliver individualized treatment to patients remotely.

3. Digital biomarkers leverage cutting-edge technology

People's lives are already transformed by smartphones, linked wearable gadgets, and mobile health applications. Because these devices are used on a regular basis and already feature sensors (e.g., a voice recorder and a camera) to monitor and record health data, digital biomarkers utilize these characteristics to improve clinical practice and patient care.

Bluestar by WellDoc is one bright example of a digital health application that collects data from blood glucose meters and activity trackers. It delivers real-time input to diabetic patients in order to enhance long-term disease management. Another example is FibriCheck, an app that identifies cardiac arrhythmias and communicates the data with the user and the healthcare team to allow for early diagnosis and treatment. It works with both Fitbit and smartwatches.

4. Digital biomarkers in clinical trials increase efficiency

Clinical trials and digital biomarkers are an extremely powerful duo. ‍Smartphones and wearable technology provide objective and continuous digital biomarkers that increase clinical trial efficiency in data collection and analysis for medication development and patient monitoring.

Koneksa Health is one of the illustrative examples – a digital biomarker startup that collaborated with Novartis and Merck to collect and analyze data for drug studies remotely. AiCure, an AI and data analytics firm, has also been working with Syneos Health to enhance adherence and patient engagement, hence increasing the effectiveness of clinical studies.

Who benefits from the application of digital biomarker solutions?

1. Pharma

With greater knowledge of disease development, biopharma, and physicians may collaborate to act earlier when symptoms appear. Clinical guidelines are used to guide treatment decisions in broad disease populations, but the introduction of digital biomarkers can aid in the transition to a more individualized approach.

2. Payers

Payers can employ digital biomarkers to further stratify patients and build personalized treatment plans, including prior authorization schedules. Digital biomarkers that are proven to be superior to conventional measurements will be more likely to secure reimbursement and promote provider adoption.

Healthcare professionals must be sufficiently encouraged to invest in appropriate infrastructure and workflow integration. The approval of reimbursement will be critical in the implementation of this freshly obtained data.

3. Providers

Healthcare providers apply digital biomarker data to offer the best therapy to each patient at the appropriate time, including better detecting and treating high-risk, high-cost patients. Digital biomarkers, for example, might be used to predict readmissions as well as identify the appropriate therapies for a given patient.

Furthermore, because digital biomarkers are created outside of the healthcare system's four walls, they give a window into a patient's day-to-day state in between physician appointments. Digital biomarkers may be used to capture real-world data, which can then be processed in conjunction with clinical and genomic data and provided to the healthcare professional in real-time allowing for accurate, patient-specific medical decision-making.

What technologies help in digital biomarkers development

Ultimately, developing digital biomarkers necessitates a multidisciplinary approach combining skills in technology, medicine, and data science.

Artificial intelligence and machine learning

You can operate on digital biomarkers using machine learning and AI algorithms and examine large chunks of data from diverse sources. These algorithms can detect patterns and correlations in data and utilize them to create prediction models.

Cloud computing

Large volumes of data may be stored and processed with cloud computing. It offers the computational capacity required to run complicated studies on digital biomarker data.

Blockchain

This technology may be used to store and exchange digital biomarker data in a safe way. It offers a secure, decentralized mechanism for managing data privacy and security.

Wearable devices

Wearables such as smartwatches, fitness trackers, and biosensors may capture real-time physiological data such as heart rate, blood pressure, and activity levels. These gadgets can also monitor sleep habits, emotions, and other behavioral data.

Mobile application

Self-reported data, including symptoms, medication adherence, and nutrition, may be collected via mobile applications. They can also collect information from wearable devices and other sensors.

Sensors, wearables, and digital biomarkers work hand in glove

IoT technologies have multiple applications in healthcare but gathering digital biomarkers is by far the most popular. You can gather such digital biomarkers as activity level, track sleep patterns, and measure heart rate, blood pressure, and body temperature.

Wearables can also measure environmental data like air quality, temperature, noise levels, and humidity. This data helps to monitor environmental factors affecting health and well-being.

Are there any barriers to using digital biomarkers?

IoT digital biomarkers have a real impact on healthcare quality. The question is: Are they easy to use? And while digital biomarker solutions are becoming more and more popular, they still have limitations.

1. Sensors wearables and digital biomarkers work restlessly catching every change in the body. Quite often, analytics and management find that the sensors, wearables, and digital biomarkers data they collect hard to analyze.
2. The way people wear and use wearables may impact the quality of digital biomarkers.
3. It’s complicated to standardize digital biomarkers due to variations in healthcare settings in different countries. Sometimes, standardization causes changes in digital biomarkers’ value.
4. In many cases, companies decode digital biomarkers using machine learning. And the changing nature of ML algorithms may complicate the data validation and interpretation.

How can Binariks help?

Want to gather, analyze, and store digital biomarkers? We can help you create a digital biomarker platform with a tailored set of functions that serves your business needs. We are an experienced tech company with deep expertise in building digital biomarkers platforms for global healthcare innovators.

Feel free to ask us any questions regarding digital biomarker solutions engineering. We will help you create digital solutions for biomarkers, improve the code and expand the functionality of your solution, and make it HIPAA-compliant.

Conclusion

A forecasted growth in the application of digital biomarkers in healthcare is about to bring significant improvements in care and treatment. Not to mention clinical trials and digital biomarkers that are already revolutionizing medically-assisted treatment practices.

And, despite the current barriers to digital biomarkers implementation, we’re expecting to see better, improved, and more efficient AI and ML algorithms. Searching for a tech partner for digital biomarker development? Leave your details and we’ll come back to you promptly.