FREMONT, California, Dec. 17, 2019 /PRNewswire/ -- According to a new market intelligence report by BIS Research, "Global Digital Biomarkers Market – Analysis and Forecast, 2019-2025", the global digital biomarkers 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.
The surge in the demand for mobile health apps and consumer wearable technology, specifically for tracking health, is among the major factors that drive the growth of the global digital biomarkers market. For example, as of 2019, about 35% of the U.S. adult population (18-29 years age group) track their health with the help of mobile apps, while 27% of the adults own and use a wearable device for monitoring heart rate, blood pressure, physical activity, or similar other parameters of health.
A biomarker is an objective measure that captures physiologic, pathologic, or anatomic characteristics of an individual to understand the state of being and is more precisely a warning system of the body. With the recent technological advancements in the field of mobile and digitally connected technologies, the biomarkers have advanced into a new class, i.e., digital biomarkers. Digital biomarkers have found applications in clinical trials as well as clinical care. They also enable the collection of consumer-generated physiological and behavioral data with the help of digitally connected tools such as wearable, implantable, and ingestible devices and sensors.
Furthermore, the data generated from these devices is increasingly being validated through clinical trial programs. For instance, the number of clinical trials conducted using wearable devices was consistent during 2008 to 2018, i.e. 5-12 trials annually. However, the number surged significantly in 2016 and 2017, with 27 and 32 trials (using mobile devices) commencing each year respectively. The primary reason for this surge of clinical trials can be attributed to the increase in sponsorship for these studies.
Another major driver that is facilitating the need for validation of digital biomarkers is the high cost associated with drug development. The cost of drug development has increased by 145% over the past decade. As per a study conducted by the U.S-based Tufts Centers for the Study of Drug Development, Boston, Massachusetts, the average cost of drug development, as of now, is approximately $2.6 billion, which in 2003 was $802 million. However, the success rate of the drug transitioning from lab to the market (i.e., the number of drugs that are commercialized) is significantly low, currently. For instance, for every 25,000 compounds assessed in a laboratory, only 25 are tested on humans, and only five make it to the market.
According to Swarup Chakrabarty, Analyst at BIS Research, "The cardiovascular disease segment is currently the largest therapeutic segment for the global digital biomarkers market and holds a share of 31.75% of the market, followed by neurodegenerative diseases. Pain management, and mood and behavior segments are expected to witness the highest CAGR during the forecast period. The growth in the pain management segment is primarily due to the increasing development and adoption of augmented reality/virtual reality solutions for the detection and treatment of chronic pain."
Recent Developments in the Industry
In April 2019, FDA cleared two AI-enabled wearable devices, specifically designed to monitor patient's vital signs. KardiaMobile, by AliveCor, is the first device to have received FDA clearance. It detects three of the most common heart arrythmias. Another company, Current Health, received a clearance from the FDA in the same month for its remote patient-monitoring solution. Current Health is the first company to get a clearance from the FDA for its complete end-to-end passive RPM wearable and platform.
In October 2019, MC10, Inc., the developer of the innovative wearable device BioStamp nPoint, collaborated with the University of Rochester. The collaboration is aimed at application of FDA-approved BioStamp nPoint system for the continuous collection of movement-related data, for creation of algorithms to quantitatively assess the progression of diseases such as Huntington's and Parkinson's disease.
One of the latest developments in the digital biomarker space is the launch of Apple's Watch Series 4 in March 2019, with the addition of an ECG app and irregular rhythm notification. Both the software applications have received De Novo clearance in the U.S. from the FDA (in December 2018) and are now available in 19 European countries, including Hongkong. Furthermore, in September 2019, Apple activated its ECG app and irregular heart rhythm detection feature in India.
In August 2019, FDA also gave a clearance to the launch of Biobeat's patch and watch for the measurement of blood pressure, oxygenation, and heart rate, in the hospitals. The launch was aimed at remote monitoring of vital signs of patients, and the product is one of the first cuff-less blood pressure solutions to be cleared by the FDA.
This market intelligence report provides a multidimensional view of the global digital biomarkers market in terms of market size and growth potential. This research report aims at analyzing various aspects of the global digital biomarkers market such as the key factors driving the market, threats that challenge market growth, and the current growth opportunities that are expected to shape the future trajectory of the market. The study considers the growth-share matrix model for a comprehensive study of the global digital biomarkers market and assesses the factors governing the same.
Furthermore, the competitive landscape chapter in the report explicates the competitive nature of the global market and enables the reader to get acquainted with recent market activities such as product launches, regulatory clearance, and certifications, partnerships, collaborations, business expansion, as well as mergers and acquisitions. The research report provides a comprehensive analysis of product sales, manufacturers, and trend analysis by segments, and demand by regions.
This report is a meticulous compilation of research on more than 100 players in the market ecosystem and draws upon insights from in-depth interviews with key opinion leaders of more than 20 leading companies, market participants, end users, and vendors. The report also profiles 22 companies including several key players such as ActiGraph, LLC., Akili Interactive Labs, AliveCor, Inc., Fitbit, Inc., HumanAPI, Novartis, Pfizer Inc. F. Hoffmann-La Roche Ltd, Sanofi, Takeda Pharmaceuticals, and Verily Life Science LLC.
Key Questions Answered in the Report:
How did the global digital biomarkers market evolve over the years?
What is the total addressable market (TAM) and the potential market opportunity for the global digital biomarkers market?
What are the major market drivers and challenges of and the opportunities in the global digital biomarkers market?
What are the key developmental strategies implemented by the key players to stand out in this market?
What is the preferred business model used for building digital biomarkers?
How much revenue was generated by each segment of the global digital biomarkers market in 2018, and how are the segments expected to perform in the coming future on the basis of:
Applications, including sleep and movement, cardiovascular, mood and behavior, pain management, neurodegenerative disorders, and respiratory conditions.
End users, including biopharmaceutical companies, payers, and providers
Region, including North America, Europe, Asia-Pacific, and Rest-of-the-World (RoW)
What is the potential of the global digital biomarkers market in the emerging countries during the forecast period?
BIS Research is a global B2B market intelligence and advisory firm focusing on those emerging technological trends which are likely to disrupt the dynamics of the market.
With over 150 market research reports published annually, BIS Research focuses on high technology verticals such as 3D Printing, Advanced Materials and Chemicals, Aerospace and Defense, Automotive, Healthcare, Electronics and Semiconductors, Robotics and UAV, and other emerging technologies.
Our in-depth market intelligence reports focus on the market estimations, technology analysis, emerging high-growth applications, deeply segmented granular country-level market data, and other important market parameters useful in the strategic decision-making for senior management.
What distinguishes BIS Research from the rest of the players is that we don't simply provide data but also complement it with valuable insights and actionable inputs for the success of our clients.