Global Digital Biomarkers Market

The market size of global digital biomarkers market is valued at USD 1.02 billion in the year 2020. Its market value is expected to grow at the CAGR of 40.39% within the forecasted time horizon of 2020-2025 because of rising usage of smartphones & surge in the demand for mobile health apps, high prevalence of complex disease, increasing spending on research & development for digital biomarkers, and high cost associated with drug development.

However, increasing number of security breaches and high cost of the development of digital biomarkers might restrain the growth and development of this market. Its market value is expected to reach USD 5.52 billion by the year 2025.

Definition / Scope
Market Overview
Market Risks
Top Market Opportunities
Market Drivers
Market Restraints
Industry Challenges
Technology Trends
Pricing Trends
Regulatory Trends
Market Size and Forecast
Market Outlook
Technology Roadmap
Distribution Chain Analysis
Competitive Factors
Key Market Players
Strategic Conclusion
References
Appendix

Definition / Scope

The biomarkers are the objective measures that collects the physiological, anatomic, and pathological characteristics of individual to understand the health status of the people. Here, the digital biomarkers are concerned with the measurement of the biomarkers through the adoption of the digital devices.

At the present context, the most widely used digital devices used for the measurement of the biomarkers are wearables, digestible, implantable and portables. These digital biomarkers are majorly used by payers, providers and biopharmaceutical companies.

As per the system component of the global biomarkers market is concerned, it consists of data collection tools and data integration systems.

Based on the type of the technological platforms, the global digital biomarkers market is comprised of devices & platforms, mobile apps, desktop-based software, wearable and biosensors.

Based on the therapeutic application, the global digital biomarkers market consists of cardiovascular disease, neurodegenerative disease, respiratory disease, and others.

Market Overview

The total market size of the global digital biomarkers market is valued at USD 1.02 billion in the year 2020 and is expected to reach USD 1.43 billion in the year 2021. Its market value is expected to grow at a CAGR of 40.39 % within the forecasted time horizon of 2020-2025. Its market value is expected to reach USD 5.52 billion by the end of the year 2025.

Based on geography, the Asian Pacific region is leading the global market with a market share of almost 40.4.% of the total global digital biomarkers market because of the growing approval of smart devices in the region. The market size of this region is valued at USD 415.39 million in the year 2020.

Based on the therapeutic application, the cardiovascular disease segment is leading the market with a market share of almost 31.75% of the total global digital biomarkers market. The market size of this segment is valued at USD 326.45 million in the year 2020.

Based on technological platform type, the devices & platforms segment is leading the market with a market share of almost 43.75% of the total global digital biomarkers market. The market size of this segment is valued at USD 449.84 million in the year 2020.

As the system component of the digital biomarkers are considered, the data collection tools segment is leading the market with a market share of almost 63% of the total global digital biomarkers market. The market size of this segment is valued at USD 647.77 million in the year 2020.

Rising usage of smartphones & surge in the demand for mobile health apps, High prevalence of complex disease, increasing spending on research & development for digital biomarkers, and high cost associated with drug development are the factors responsible for the growth and development of the global digital biomarkers market. However, increasing number of security breaches and high cost of the development of digital biomarkers might restrain the growth and development of this market.

The key market players engaged in the operation of its global digital biomarkers through connected devices market are AliveCor Inc, Bayer AG, Evidation health Inc, Fitbit Inc, Happify health, Koninklijke Philips NV, Neurotrack Technologies Inc, Glaxosmithkline Inc, Novartis International AG and F Hoffmann-La Roche Ltd.

Market Risks

Increase number of security breaches

Globally the number of the cyber security and data breaches are in the rising trend along with the adoption of the advanced technological solutions. Here, the total number of the cyber-attack are rising at a rate of about 27% on annual basis. In the year 2020, the sensitive personal information of the staff, users and subscribers for Mashable.com are leaked by the hackers.

In accordance to the report from IBM and the Ponemon Institute, the average cost required to deal with the data breach is about USD 4.24 million per incident in the year 2021. After the pandemic outbreak of the COVID-19, the remote work is in rising trend and almost 192,000 corona viruses related cyberattacks per week in may 2020, which is almost 30% increase in comparison to the month April. The increasing number of the security breaches might create the significant risk for the growth and development of the global digital biomarkers market.

Top Market Opportunities

The opportunity favoring the growth and development of the global digital biomarkers market are increase in usage of connected digital devices, smart phones and health-related mobile applications, rise in focus of government on enhancing healthcare, high prevalence of complex diseases, and growing geriatric population & rising patient pool.

The major opportunity for the growth and development of the global digital biomarkers market are discussed as follows:

Rising usage of smartphones & surge in the demand for mobile health apps

Globally, the adoption of the smartphones and mobile health applications are in rising trend. In the year 2021, the number of the smartphone users is estimated at 6.4 billion and is rising at a rate of almost 11.84% annually.

Here, in the context of the United States, almost 35% of the adult population aged 18-29 years age group are tracking their health with the help of mobile apps and almost 27% of them use the wearable device for monitoring heart rate, blood pressure, physical activity and other characteristics of health.

The adoption of the high-speed networks is expected to increase up to 73% by the end of the year 2020. Thus, the rising usage of smartphones and demand for the mobile health application is creating a favorable environment for the growth and development of the global digital biomarkers market.

High prevalence of complex disease

Globally, the incidences and burden of chronic and complex non-communicable diseases are on increasing trend. The major chronic illnesses are diabetes, cancers, cardiovascular diseases, respiratory diseases, genetic diseases, etc. Globally, almost one in three adults has multiple chronic diseases.

According to the World Health Organization, the prevalence of chronic diseases is expected to increase by 57% and it accounts for about 75% of total global deaths. Here, almost 71% of the deaths will occur from ischemic heart disease, 75% from stroke, and 70% of the deaths from diabetes in developing countries. The rising incidences of chronic diseases are focused towards the adoption of digital devices to assess the biomarkers of the diseases at the earlier stage.

Along with this, the pandemic outbreak of the COVID-19 disease has enhanced the demand for the real-time monitoring of health & fitness in the healthcare market. For instance, artificial intelligence technologies have been used at field COVID-19 hospital of Wuhan, China to provide the constant monitoring of the vital diagnostic signs of COVID-19 such as temperature, heart rate, and blood oxygen levels.

So, the rising prevalence and incidences of the chronic complex diseases and the pandemic outbreak of the COVID-19 disease is creating a significant opportunity for the growth and development of the global digital biomarkers market.

Market Drivers

Increasing spending on research & development for digital biomarkers

The government and non-governmental organization are increasing their spending on the research and development activities related to the digital biomarkers. Here, the development of wearable sensors has raised almost USD 3 billion in the venture capital funding since the year 2013.

The market players engaged in the sector of digital biomarkers are also focused on the execution of the research & developmental activities on the digital biomarkers. For instance, Koneksa (organization engaged in the implementation of patient-specific digital biomarkers) has declared funding of almost USD 16 million for the integration of wearables and other patient-specific technologies into clinical research.

So, the rising spending of the organizations on the research and development for digital biomarkers is creating a significant opportunity for the growth and development of the global digital biomarkers market.

High cost associated with drug development

The high cost associated with drug development is facilitating the need for validation of digital biomarkers. Over the period of past one decade, the cost of the drug development has been increased by almost 145%.

According to the study of Drug Development conducted by the Tufts Centers, the average cost of the drug development is almost USD 2.6 billion, increased from USD 802 million in the year 2003. But the success rate of the drug is quite low as only five drugs are made to the market out of every 25,000-compound assessed in the laboratory.

Here, the digital biomarker can be an alternative for the neurodegenerative disorders and other disease management & control in the context of the failure of its drugs. So, the high failure rate of drugs is driving the growth and development of the global digital biomarkers market.

Market Restraints

The factors restraining the growth and development of the global digital biomarkers market are the high cost associated with digital biomarkers, clinical assessment of data platforms and addressing the bias & validation testing of the digital biomarker.

Here, the data collection from the digital biomarkers must be free from the data biases which can degrade the credibility of data analysis. However, the measurement of the biomarkers through the adoption of digital devices is subjected to bias.

Along with this, the cost of the development of the digital biomarkers is also quite high and the cost of the development of the new biomarker based on the diagnostic technology is about USD 100 million. These factors might restrain the growth and development of the global digital biomarkers market.

Industry Challenges

Highly fragmented market

In the context of the global digital biomarkers market, there are number of the key market players engaged in the operation of this market. The key market players engaged in the operation of its global digital biomarkers through connected devices market are AliveCor Inc, Bayer AG, Evidation health Inc, Fitbit Inc, Happify health, Koninklijke Philips NV, Neurotrack Technologies Inc, Glaxosmithkline Inc, Novartis International AG and F Hoffmann-La Roche Ltd. It is quite challenging for the key market players to establish their market value and portfolio in this context.

Technology Trends

Adoption of new and advanced technologies is creating a favorable environment for the growth and development of the global digital biomarkers market. Some of the key technological trends in this market are discussed as follows:

Artificial intelligence and machine learning: This technological approach creates the novel system to make the predictions based on the large and complex datasets in easy way. As a result, digital biomarkers can establish the correlation between the set of variables of interest.

Internet of things: This technological system is comprised of interrelated computing devices and digital machines with the capability to transfer the data over the network. Here, the sensors of heart monitor implant are an example of it.

Cloud storage: This model is used to store the data on the internet through cloud computing provider. It manages the capacity and durability to make data accessible to the application all over the world.

Pricing Trends

The price of the products of these digital biomarkers market depends upon the type of technology, platforms, system tools and end-users. For instance, the cost of the development of the new biomarker based on the diagnostic technology is about USD 100 million. Along with this, the cost of the digital biomarkers tests depends upon its therapeutic applications. Here, the cost of the biomarker testing of the lung cancer screening is about USD 300 per test.

Regulatory Trends

The regulatory framework for the research, development and approval of the digital biomarkers has been develop. The development and the approval of the digital biomarkers are undertaken by the FDA through the systematic process.

The major requirement for the approval of the digital biomarkers are establishment of the evidence, relevance and reliability of the data collected and analyzed from the wearable sensor devices in the regulatory decision-making process. Besides this, the key market players need to engage the FDA during the initial phase of development and research.

Market Size and Forecast

Based on geography

The Asian Pacific region is leading the global market with a market share of almost 40.4.% of the total global digital biomarkers market because of the growing approval of smart devices in the region. The market size of this region is valued at USD 415.39 million in the year 2020.
The North American region accounts for the market share of almost 19.44% of the total market value of the global digital biomarkers market. The market value of this region is valued at USD 199.93 million in the year 2020.
The European region accounts for the market share of almost 22.5% of the total market value of the global digital biomarkers market. The market value of this region is valued at USD 231.34 million in the year 2020.
ROW stands for the rest of the world, which includes the Middle East Africa and South America. The segment accounts for the market value of almost 17.65% of the total market size of the global digital biomarkers market. The market value of the segment is valued at USD 181.53 million in the year 2020.

Based on the therapeutic application

The cardiovascular disease segment is leading the market with a market share of almost 31.75% of the total global digital biomarkers market. The market size of this segment is valued at USD 326.45 million in the year 2020.
The Neurodegenerative disease segment accounts for the market share of almost 22% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 226.20 million in the year 2020.
The respiratory disease segment accounts for the market share of almost 17% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 174.79 million in the year 2020.

Based on technological platform type

The devices & platforms segment is leading the market with a market share of almost 43.75% of the total global digital biomarkers market. The market size of this segment is valued at USD 449.84 million in the year 2020.
The mobile apps segment accounts for the market share of almost 25% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 257.05 million in the year 2020.
The wearables segment accounts for the market share of almost 10% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 102.82 million in the year 2020.
The desktop-based software segment accounts for the market share of almost 12.5% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 128.52 million in the year 2020.
The biosensors segment accounts for the market share of almost 8.75% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 89.96 million in the year 2020.

Based on the type of the system component

The data collection tools segment is leading the market with a market share of almost 63% of the total global digital biomarkers market. The market size of this segment is valued at USD 647.77 million in the year 2020.
The data integration systems segment accounts for the market share of almost 37% of the total market value of the global digital biomarkers market. The market value of this segment is valued at USD 380.43 million in the year 2020.

Market Outlook

The global digital biomarkers market is expected to grow at the CAGR of 40.39% within the forecasted time horizon of 2020-2025 because of rising usage of smartphones & surge in the demand for mobile health apps, high prevalence of complex disease, increasing spending on research & development for digital biomarkers, and high cost associated with drug development. Its market value will reach USD 5.52 billion by the end of the year 2025.

Technology Roadmap

The adoption of the advanced technological platform for the assessment and measurement of the biomarkers are driving the growth and development of the global digital biomarkers market. The major technological changes occurring in this market are driving the growth and development of this market are artificial intelligence, machine learning, cloud-based technology, internet of things, etc. This technological approach creates the novel system to make the predictions based on the large and complex datasets in easy way.

Distribution Chain Analysis

The key stakeholders involved in the operation of this global digital biomarkers market are research & development organization, software vendors, digital equipment manufacturers, distribution, sales and end-users. Here, the research and development organizations are focused on the development of the innovative technological platforms and software vendors are responsible for the development of the software platform for it. The major end-users of this market are pharmaceutical company, payers and providers.

Competitive Factors

The key market players engaged in this market are competing for the product portfolio expansion, high investment in research and development activities, mergers & acquisitions, geographical expansion, and collaborations. For instance, KardiaMobile (AI-enabled wearable device) has been designed by the AliveCor to monitor the person’s vital signs.

The BioStamp nPoint (Developer of the innovative wearable device) has established collaborated with the University of Rochester for the development of the algorithms to ass the quantitative progression of disease such as Parkinson. The launch of the Apple Watch Series 4 has added the ECG application and irregular rhythm notification in 2019.

Key Market Players

Short profile of the key market players engaged in the global digital biomarkers market are discussed as follows:

AliveCor Inc: It is the US-based artificial intelligence and medical devices industry specialized in the production of the hardware and software for consumer mobile devices. Its major products are KardiaMobile, KardiaPro, KardiaBrand, KardiaMobile 6L, and veterinary heart monitor.

Bayer AG: It is the one of the largest German based multinational pharmaceutical company specialized in the sector of consumer healthcare products, agricultural chemicals, seeds, biotechnology products, and pharmaceuticals.

Evidation health Inc: It is the US-based company engaged in the measurement of the health in everyday life and enables the people to involve in the research and health programs.

Fitbit Inc: It is the US-based electronics and fitness company engaged in the production of the wireless-enabled wearable technology, activity trackers and physical fitness monitors. Its major products are smartwatches, pedometers and monitors for heart rate, quality of sleep and other health parameters.

Happify health: It is the US-based company engaged in the development of the highly engaging software for the improvement of the physical and mental health.

Koninklijke Philips NV: It is the Dutch multinational corporation engaged in the development of the medical equipment, home appliances, and intellectual property management & licensing.

Neurotrack Technologies Inc: It is the Us-based company engaged in the development of the digital cognitive health solutions to assess monitor and strengthen the brain health.

Glaxosmithkline Inc: It is the UK-based multinational pharmaceutical company specialized in the sector of pharmaceutical, biotechnology and consumer goods. Its major products pharmaceuticals, vaccines, oral healthcare, nutritional products, and over the counter medicines.

Strategic Conclusion

The global digital biomarkers market is growing at the CAGR of 40.39% within the forecasted time horizon of 2020-2025 because of rising usage of smartphones & surge in the demand for mobile health apps, high prevalence of complex disease, increasing spending on research & development for digital biomarkers, and high cost associated with drug development. However, increasing number of security breaches and high cost of the development of digital biomarkers might restrain the growth and development of this market.

References

Appendix

FDA= Food & Drug Administration
USD= United States Dollar
CAGR= Compound Annual Growth Rate