Find out how diagnostic biomarkers will transform healthcare. We examine the current status of these digital health tools, the challenges and opportunities they offer, and envision three potential scenarios for their adoption.
The rise of digital health technologies
Five decades after the inception of the term “biomarker,” a new era dawns with the emergence of digital biomarkers.
Unlike traditional biomarkers (i.e., indicators of a biological state or medical condition, typically derived from bodily fluids or tissues), digital counterparts are recorded through digital health technologies, encompassing cognitive, physical, vocal, visual, and mood-based metrics. Digital biomarkers offer richer health data through continuous, real-time, and contextual information, surpassing the cumbersome sampling and lab testing methods of traditional biomarkers.
What is a digital biomarker? |
| A digital biomarker refers to measurable data about physiological functions or behaviors collected through digital devices and technologies, such as wearables, implants, ingestible sensors, smartphones, and mobile applications. These devices track aspects like heart rate, sleep patterns, or physical activity, providing objective insights into the health of individual persons. |
There are several benefits of these digital health tools, and their growth is expected to continue. Key macro drivers, such as increased data availability, higher usage of digital health devices, and improved connectivity, are likely to accelerate this growth. When leveraged correctly, these digital tools offer significant value across the patient journey and in critical support functions such as R&D. As shown in Exhibit 1, they offer several benefits, including accelerated drug development, earlier disease detection, and personalized treatment plans.
Exhibit 1. Benefits of digital biomarkers (not exhaustive)
Source: Simon-Kucher analysis
The growing adoption of diagnostic biomarkers and the push toward digitalizing healthcare are expected to drive demand for digital biomarker tools. The focus now is on real-world applications, where early successes highlight transformative potential. While commercialization challenges remain, some companies are already overcoming barriers and establishing successful business models.
The current state of the digital biomarker market
While clinical applications of user-generated health data remain relatively rare, early proof-of-concept examples like Fitbit have paved the way. However, we see that the landscape is changing, with projections suggesting that digital sensors could become a core component in 70 percent, or more, of clinical trials in the future.
There are multiple recent examples across various disease areas/indications which illustrate the growing clinical value of these digital health technologies. Advancements are particularly notable in fields like neurology where these tools are demonstrating significant promise, e.g., in Multiple Sclerosis and Alzheimer’s disease. On the other hand, oncology has been slower to adopt digital biomarkers. However, as they continue to evolve, their integration into oncology and other medical disciplines is anticipated to expand. Table 1 below highlights these developments by presenting specific use cases across various disease areas and linking them to distinct stages in the patient journey. This underscores how digital biomarkers are enhancing clinical practice and supporting strategic objectives for manufacturers.
Table 1: Examples of digital biomarker use cases
Disease group | Disease | Description | Stage in patient journey |
| Neurology | Multiple Sclerosis | Symptom characterization and assessment of disease burden via smartphone-based functional tests measuring cognition and motor activity (incl. finger-tapping, walk and balance, finger-to-nose) | (3) Treatment (4) Monitoring |
| Alzheimer’s disease | Prediction of disease progression from mild cognitive impairment to dementia via detection of subtle behavioral, cognitive, motor, and sensory changes in the early stages of Alzheimer’s Disease | (1) Screening | |
| Parkinson’s disease | Detection of intraday symptom fluctuations or response to dopaminergic medication via mobile Parkinson disease score (mPDS) derived from assessment of smartphone activity (voice, finger tapping, gait balance, and reaction time) | (2) Diagnosis (4) Monitoring | |
| Cardiovascular | Atrial fibrillation | Identification of disease via optical sensors and an irregular pulse notification algorithm | (2) Diagnosis |
| Heart failure | Detection of heart failure decompensation via ambient sensor systems tracking heart and respiration rate, physical activity, gait speed, night-time toilet use, and sleep quality | (1) Screening (3) Treatment (4) Monitoring | |
| Infectious diseases | COVID-19 | Prediction of COVID-19 by combination of informative acoustic features (voice/speech, cough, breathing) collected via web-based platform | (1) Screening |
… | … | … | … |
Source: Simon-Kucher analysis
Clearly, digital biomarkers hold transformative potential. However, due to the high development costs, successful commercialization is crucial for securing returns and ensuring continued future investments. Despite their potential, many companies face various challenges in effectively bringing digital health technologies to market.
Exhibit 2: Critical commercialization challenges for digital biomarkers
Source: Simon-Kucher analysis
The challenges outlined above are significant for any player looking to commercialize digital biomarkers. Nevertheless, many companies have overcome barriers and established successful business models with multiple customer groups/revenue streams.
Exhibit 3: Examples of successful digital biomarker companies
Source: Simon-Kucher analysis
In the next part of our article, we explore three potential scenarios for the future adoption of digital biomarkers. We will examine how key drivers and challenges could shape their trajectory in the coming years.
The road ahead: Scenarios for digital biomarkers adoption
Looking ahead, three potential scenarios illustrate how the adoption of digital biomarkers might develop over the next years, shaped by the drivers and challenges previously outlined. In the chart below, we have assessed the impact of each scenario on the future market size of digital biomarkers. Evidently, the market for digital biomarkers has the potential to grow robustly, but the pace of adoption will vary based on how effectively the existing challenges are managed. The scenarios indicate a dynamic landscape where actions by multiple key players could significantly influence the trajectory of digital biomarker integration into healthcare. The specifics of each scenario are outlined below.
Exhibit 4: Evolution of digital biomarker market size in different scenarios
Source: Simon-Kucher analysis
Scenario 1 – Slow adoption: Commercialization barriers remain
Investments in digital biomarker development continue, but significant breakthroughs remain elusive. Early-stage companies face challenges in validating their diagnostics biomarkers clinically, generating compelling evidence, and demonstrating commercial success, which deters larger players like pharmaceutical companies from investing substantially in this field. The absence of an international regulatory framework and guidelines, especially concerning data usage and AI, poses a significant barrier. Technological obstacles, including issues around interoperability and representativeness, data fragmentation, and algorithmic biases, further impede the development and deployment of digital biomarkers, constraining their efficacy. Moreover, healthcare practitioners and providers remain unconvinced about the clinical validity and utility of digital biomarkers due to insufficient evidence and a lack of compelling success stories.
Scenario 2 – Incremental adoption: Success cases setting the stage
The adoption of diagnostic biomarkers progresses steadily, marked by notable advancements in specific areas despite lingering barriers to widespread adoption. Pockets of innovation and success emerge in certain therapeutic domains and among individual players. Although progress on regulatory and technological fronts is sluggish, increasing recognition of the value of digital biomarkers drives incremental adoption, especially in areas with clear clinical needs such as Alzheimer's. Forward-thinking payer organizations or countries begin to reimburse selected digital biomarkers for a trial period, with the intent to evaluate and potentially grant permanent reimbursement. Collaborative efforts and evidence accumulation contribute to steady progress, laying the groundwork for deeper integration into clinical practice in the 2030s.
Scenario 3 – Accelerated adoption: Deep integration of digital biomarkers in healthcare
Key stakeholders and decision-makers swiftly recognize the transformative potential of digital biomarkers. Regulatory bodies collaborate to establish guidelines, creating a transparent environment for market players. Reduced uncertainty prompts increased investment, leading to a surge in the inclusion of digital endpoints in clinical trials. Rapid adoption of digital technologies in clinical practice demonstrates their value to patients, providers, and payers alike. Pharmaceutical companies reap tangible cost savings in drug development, while patients benefit from multiple types of data generated from different devices as tools for self-management and empowerment, resulting in improved health outcomes and satisfaction. Payers issue broad reimbursement for digital biomarkers, integrating them into healthcare delivery workflows for disease detection, monitoring, and treatment optimization. Sustained momentum, fueled by collaboration between technology firms, healthcare providers, and regulatory agencies, drives continued innovation in digital biomarker solutions across therapeutic domains.
Helping you improve your healthcare delivery
Irrespective of the scenario that unfolds, digital biomarkers should be a priority for all diagnostics and pharmaceutical companies. They are poised to become integral components of healthcare delivery, shaping the future of medicine, and revolutionizing patient care.
As seasoned commercial experts in the diagnostics and digital health space, we are committed to supporting clients at every stage of the product lifecycle, from initial clinical trials to post-launch strategies. We understand that each organization faces unique challenges and opportunities in implementing digital health technology strategies, and we are equipped to provide tailored support and guidance.
Let's connect to discuss how we can assist you in navigating the complexities of digital biomarkers and ensuring successful commercialization!
