The Digital Biomarkers Market: Key Drivers and Challenges

digital biomarkers market research reportAn increased usage of digital tools, including smartphones and wearables, among others, has led to an expansion in collected health information.

The health data gathered by these devices also includes biomarker-related data — objective signals that are medically relevant and can be highly insightful for formulating treatments for patients, especially those who are suffering from chronic diseases.

Digital biomarkers are a nascent field with significant room for growth. According to the market intelligence study published by BIS Research titled Global Digital Biomarkers Market - Analysis and Forecast, 2019-2025, the digital biomarker market generated revenue of $524.6 million in 2018 and is estimated to grow over $5.64 billion by the end of 2025. The market is projected to grow at a CAGR of 40.39% during the forecast period from 2019 to 2025.  

Factors Influencing the Digital Biomarkers Market

The digital biomarker market is influenced by several factors including market drivers, challenges, opportunities, and trends. Some of the market drivers responsible for the growth of the market are as follows:

  • Increasing cost of drug development: In the recent past, the cost of developing a drug has increased by almost 145%, and the success rate of drug development has reduced to half. Presently, the approval rate for drugs entering clinical development is less than 12%. A major reason behind the increasing cost is the extensive R&D involved in drug manufacturing. The study of biomarkers can help target the avenues where research should be focused. This can reduce the number of processes required for drug development, which, in turn, can reduce the overall cost.
  • Failed drugs for neurodegenerative disorders: Among the three most prevalent neurodegenerative diseases such as Alzheimer’s disease, Parkinson’s disease, and amyotrophic lateral sclerosis (ALS), the prevalence of Alzheimer’s is currently the highest. In the last decade, several drugs were tested, out of which, many were rejected, and only four were approved. Most of the drugs that failed targeted the wrong pathological substrate or had an absence of specificity during clinical trials. These failed tests caused companies to lose money and resulted in the cancellation of additional research and development activities. This has led to a need for other alternatives, of which digital biomarker is a significant one.
  • Regulatory flexibility toward digital health solutions: To simplify the entry process for companies in the field of digital biomarkers, the FDA has modified its guidelines regarding software-as-medical-device. The Pre-Cert model, a form of pre-certification, was launched by the FDA, which aims to streamline the regulatory review process and boost innovation of digital health technologies.

In addition, there are various opportunities that have the potential to further boost the growth of the market, which include:

  • Personalized medicine
  • Investment in voice-based digital biomarkers
  • Investment in wearable technology

However, there are multiple factors that are restraining the growth of the market, some of which are as follows:

  • Addressing biases: The platform developed for assessing the data must be free from data bias as this can degrade the credibility of the data analysis and might even lead to failure of the process. It is important that such biases are either removed from the data or are addressed before the data is analyzed.
  • Validation testing: The clinical assessment of data platforms and other digital biomarkers (such as wearables and apps) is of the utmost importance. This is to show that data collected can be aligned to a health-related outcome. The validation testing of the data must be performed in healthy individuals and the target population in a clinically relevant environment.
  • Integration: Two of the most important parameters to be considered while designing digital health services are interoperability and integration. It must be ensured by the service providers that the data collected can be shared across clinicians, labs, hospitals, pharmacies, and patients irrespective of application vendor.
  • Cost and usability: Considering that the market is at a very nascent stage, it is of vital importance that the cost versus benefit analysis of digital biomarkers solutions is done appropriately.

Segmentation of the Digital Biomarkers Market

The market intelligence published includes the detailed study of the market on the basis of application, end users, and region.

The application segment of the market is categorized into the following:

  • Sleep and movement
  • Cardiovascular
  • Mood and behaviour
  • Pain management
  • Neurodegenerative disorders
  • Respiratory conditions

Based on the data analysed, the therapeutic area where the study of biomarker data was used the most in 2018 was the cardiovascular application, and this segment is expected to maintain a lead by 2025 as well. However, segments such as pain management along with mood and behavior are expected to register the maximum growth during the forecast period from 2019 to 2025.

The end-user industry for the market is segmented into biopharmaceutical companies, payers, and providers. The biopharmaceutical market dominated the market in 2018 and is projected to lead the market in 2025 as well. However, it is the health insurance payers segment that is expected to grow at the highest rate, approximately 44% during the forecast period.

The regional segmentation of the market is done on the basis of North America, Europe, Asia-Pacific, Latin America, and Rest-of-the-World (ROW). Asia-Pacific is the largest market in the digital biomarkers space and is projected to remain the same during the forecast period. However, the region of Europe is expected to attract the highest CAGR during the forecast period. The growth is primarily due to increasing standardization and collaboration among key stakeholders in the industry.

Major Players in the Market with Financials

ActiGraph, LLC.

Akili Interactive Labs

Amgen Inc.

AliveCor Inc

Altoida Inc.

Bayer AG

Biogen Inc

Eli Lilly and Company

Evidation Health, Inc

Fitbit, Inc.

Glaxo Smith Kline Plc

Human API

Happify Health


Neurotrack Technology, Inc


Pfizer Inc.

F. Hoffmann-La Roche Ltd


Takeda Pharmaceuticals

Verily Life Science LLC


Global Digital Biomarker Research Report

For more information, see the full report Global Digital Biomarkers Market. This comprehensive report draws on research from a mix of primary interviews and secondary research, along with analytical tools that have been used to build forecasts and predictive models. You can view the report's abstract on, or download a sample here.

About the Publisher: BIS Research is a global market intelligence, research and advisory company that focuses on emerging technology trends that are likely to disrupt the market. Its team includes industry veterans, experts, and analysts with diverse backgrounds in consulting, investment banking, government, and academia.

Topics: Pharmaceuticals Industry Insights