According to the new report published by Industry Research Place Global Digital Biomarkers Market is valued at USD 985.91 Million in 2020 and is expected to reach USD 9840.2 Million by 2027 with the CAGR of 38.9 % over the forecast period

This report analyses the global market for Digital Biomarkers. The report will enable the user to understand and gain insights into the current and forecast market situation. The market is comprehensively analyzed by geography to give complete information on the global scenario. The qualitative and quantitative data provided in this study can help user understand which market segments, regions are expected to grow at higher rates, factors affecting the market and key opportunity areas. The report also includes competitive landscape of key players in the industry along with emerging trends in the market.

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Key Players
1.ActiGraph
2.Akili Interactive Labs
3.AliveCor
4.Fitbit
5.Koneksa Health
6.Fossil
7.WIWE
8.MocaCare
9.Novartis
10.Roche
11.Takeda Pharmaceuticals
12.Others
Above mentioned companies were scrutinized to assess competitive landscape of Global Digital Biomarkers Market. Report provides company profiles of each player. Each profile include company product portfolio, business overview, company governance, company financials, business strategies, manufacturing locations and production facilities, company sale, recent developments and strategic collaborations & partnerships, new product launch, company segments, application diversification and company strength and weakness analysis.

Global Digital Biomarkers Market COVID-19 impact Analysis
Given the present situation, a significant proportion of the healthcare budget is being allocated to develop and distribute digital health solutions, including digital biomarkers. Further, the ongoing pandemic has boosted the adoption of digital solutions (as the patients are not able to physically access their healthcare teams). This has enabled a majority of developers to develop / modify their offerings to be used remotely. Once digital biomarkers get adopted in mainstream healthcare, the demand for such solutions is likely to increase in near future as well.

This report highlights the impact of the Covid-19 pandemic on Global Digital Biomarkers Market. By combining data from a range of industry sources, as well as predictive modeling and market trend analysis, we provide an evidence-based set of projections that will allow organizations to plan their strategies more effectively. The report gives in depth analysis of short term and long term impacts of epidemic on the industry.

The COVID 19 impact assessment of Global Digital Biomarkers Market is divided into following sections:

Section1: Pre Lockdown
This part of the report looks at how market changed throughout early 2020, as the spread of COVID-19 intensified on different geographies.

Section2: During Lockdown
This part of the report collects data from across the sector to know how people have responded to lockdown. It analyses the impact of the epidemic on the workforce in the industry and disruption in various regions and countries

Section3: Post Lockdown
This part of the report project what sector recovery could look like and summarizes ways in which the business landscape could shift.

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Market Segmentation
• Component
o Data Collection Tools
o Data Integration Systems
• Application
o Sleep and Movement
o Cardiovascular
o Mood and Behavior
o Pain Management
o Respiratory Conditions
o Others
• End User
o Pharmaceutical Companies
o Providers
o Payers

Based on the product type, the Digital Biomarker is primarily split into Data Collection Tools and Data Integration Systems. In 2020, Data Collection Tools accounted for a share of 63.11% in the global Digital Biomarker market. And this product segment is poised to reach US$ 6313.77 million by 2027 from US$ 622.21 million in 2020.

Based on the end user, the Digital Biomarker is primarily split into Pharmaceutical Companies, Providers and Payers. In 2020, Pharmaceutical Companies accounted for a share of 45.33% in the global Digital Biomarker market. And this end user segment is poised to reach US$ 4528.39 million by 2027 from US$ 446.87 million in 2020. Providers segment was the fastest growing segment worth of USD 195.00 Million in 2019 and it is expected to reach USD 2722.99 Million in 2027.

Based on the Digital Biomarker application, the Digital Biomarker market is segmented into several major parts, like Sleep and Movement, Cardiovascular, Mood and Behavior, Pain Management, Respiratory Conditions and other. The Cardiovascular holds an important share in terms of Application, and it is expected to reach revenue of USD 1383.29 Million by 2025, at a CAGR of 38.97% during 2021 and 2027
Global Digital Biomarker Market in terms of revenue is dominated by North America with the highest market share of 43.12% in 2020 and projected to reach at revenue of USD 4329.62 Million in 2027 at CAGR of 39.35% in the forecast period 2021-2027.

Global Digital Biomarkers Market Trends
Digital biomarkers are providing Industries with enhanced understanding of individual’s health
Biopharma will need to pull digital biomarkers to demonstrate increased real-world value and advantage as the shift towards pay-for-performance surges. This stimulates biopharma to develop patient outcomes with enhanced stratification guidelines and improved surrogate endpoints using digital biomarkers. Having access to each distinct patient through the smartphone presents an prospect for unprecedented engagement and ability to monitor disease headway with novel digital biomarkers. With a better understanding of disease development, biopharma and providers can work together to arbitrate preferably at the inception of symptoms.

Data for mobile health apps and health tracking sensors are on the rise
The progression in healthcare data can be recognized to broader access to and adoption of digital tools as well as the ability for these tools to allow physicians to constantly monitor individuals. Consumer-facing digital tools expand the population that can generate health data. Individuals who were not “patients” or formally enrolled in clinical research were earlier excluded from the data collection processes, but digital tools provide all internet-connected individuals with the opportunity to monitor and track their health status outside the four walls of healthcare. For instance, while traditional blood pressure cuff monitors provide static, infrequent measurements, wrist-worn devices can continuously record vitals over time with minimal effort from any end-user.

Increased importance of digital biomarker in the precise monitoring of disease states
The most promising consequence of digital biomarkers is the ability to create digital biomarker panels. In medicine, single discrete measurements have limited clinical significance—10 year cardiovascular risk is best predicted by a set of measurements including age, gender, cholesterol levels, smoking and medication status, and blood pressure. Integrated panels of digital, and traditional, biomarkers offer an opportunity to better explain variance in human health and disease. A parallel can be seen in the advent of gene expression signatures that serve diagnostic, prognostic, and predictive roles—researchers are able to identify a set of genes that act together in disease states, producing a genetic biomarker. Similarly, phenotypic signatures can be developed by identifying a set of biomarkers that additively enable precise monitoring of disease states.
Digital biomarkers adoption for clinical practice

For academia and research institutions to examine data and classify relationships for new digital biomarkers, exploratory hypothesis testing must occur. Once a potential relationship is drawn, the majority of industry experts uphold that digital biomarkers will follow a similar approval path to traditional biomarkers. Thus, the adoption of digital biomarkers in clinical practice will be contingent upon rigorous validation and approval. If, and when, digital biomarkers are integrated and used in clinical practice, this will yield a new set of evidence to verify and validate conclusions drawn using data from controlled settings.

Market Challenges
User adoption and user experience
Excessive and continuos tracking may negatively impact user experience and result in lower engangement; prioritising the patient experience by measuring only what matters can help reduce the measurement burden.

Technological platforms
Consumer facing technology may be updated regularly, forcing revalidation studies; new hardware or use of case specific harware can help ensure technology consistency over time.

Data validation
Research must be done to validate digital biomarkers as accurate and reliable. Before regulatory approval, the digital biomarker will need to be supported by evidence that demonstrates its specificity, sensitivity, and positive and negative predictive values.

Furthermore, the digital biomarker will likely need to be evaluated head-to-head against the current gold standard to assess the noninferiority, equivalence or superiority of the digital biomarker.

Regulatory approval
Like traditional biomarkers, digital biomarkers face a long regulatory pathway to approval.
Regardless, the four types of digital biomarkers require some degree of validation. Best practice dictates that entrepreneurs and researchers should engage in conversations with the FDA earlier rather than later.
For known-measurement / known-insight digital biomarkers, the measurement method (i.e., specific device or sensor) will likely be the focus of an FDA review, as the biomarker itself, collected traditionally, has been
previously validated.
Digital biomarkers with novel measurements and novel insights will require the most rigorous qualification process as both the biomarker and the measurement method will need to be evaluated.

Infrastructure challenge
Infrastructure must bridge existing data silos and support the storage, analysis, and usage of digital biomarkers. While an interest in collecting digital health data may exist, a clear infrastructure challenge remains for how this data is collected and where it should be stored.
Current EMRs are not structured to store large amounts of continuous data, nor are they designed to process analytics in real-time.

Adoption of digital biomarkers
Uncertainties around stakeholder incentives and workflow integration are key hurdles to clinical adoption of digital biomarkers. At the end of the day, physicians want to do what’s best for their patients.
Recent Developments in the Global Digital Biomarkers Market

Jan. 19, 2021
VeraSci—a global clinical research company offering eClinical software, translation services, and expertise in endpoints and assessments—is announce a new partnership with ActiGraph, a leading provider of medical-grade wearable activity and sleep monitoring devices.

Feb. 16, 2021
AliveCor the leader in AI-based personal ECG technology and provider of enterprise cardiology solutions, announced a new collaboration with AstraZeneca, a global science-led biopharmaceutical company, to research new disease management solutions in cardiovascular, renal, and metabolism (CVRM) therapeutic areas. The collaboration will translate AliveCor’s potassium detection technology and science, which enables potassium measurement outside of blood draws, into real-world disease management applications and solutions.

Feb. 1, 2021
AliveCor the global leader in FDA-cleared personal electrocardiogram (ECG) technology, launched an expanded range of ECG determinations on its KardiaMobile devices. These new determinations are cleared by the U.S. Food and Drug Administration (FDA) as of November 2020 and include Sinus Rhythm with Supraventricular Ectopy (SVE), Sinus Rhythm with Premature Ventricular Contractions (PVCs), and Sinus Rhythm with Wide QRS.

14-Jan-2021
Fitbit, Inc. (NYSE: FIT) announced that it has entered into a definitive agreement to be acquired by Google LLC for $7.35 per share in cash, valuing the company at a fully diluted equity value of approximately $2.1 billion.
Sep. 28, 2020
Koneksa, the leader in developing and implementing patient-centric digital biomarkers for drug development, announced today the completion of a $16M Series B financing round. The company plans to use the investment to expand the development of its digital platform for integrating wearables, sensors, and other patient-facing technologies into clinical research.

6-Jan-2020
Novartis AG (Novartis) recently announced that it has completed the acquisition of The Medicines Company (the “Company”) through the consummation of a merger of its indirect wholly-owned subsidiary, Medusa Merger Corporation (“Purchaser”), with and into the Company, with the Company surviving the merger, without a vote of the Company’s stockholders in accordance with Section 251(h) of the Delaware General Corporation Law.

22-May-2020
Roche today announced that it has acquired Stratos Genomics, an early-stage sequencing technology company to advance the development of Roche’s nanopore sequencer. The acquisition provides Roche access to Stratos Genomics unique chemistry, Sequencing by Expansion (SBX™). The Roche nanopore sequencer, once developed, will utilise a novel approach that combines electronic and biological components to sequence DNA for fast, flexible and cost-effective clinical diagnostic testing.

11-Jan-2021
French drugmaker Sanofi has agreed to buy British immunotherapy firm Kymab for up to $1.45 billion, the latest in a string of deals as it belatedly expands in a fast-growing medical area. The deal, which will see Sanofi pay $1.1 billion upfront, will give it full rights to Kymab's KY1005, an antibody therapy viewed as having the potential to treat a wide range of inflammatory disorders and immune-related diseases.

17-Aug-2020
Sanofi and Principia Biopharma Inc., a late-stage biopharmaceutical company focused on developing treatments for immune-mediated diseases, entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Principia for $100 per share in cash, which represents an aggregate equity value of approximately $3.68 billion (on a fully diluted basis). The Sanofi and Principia Boards of Directors unanimously approved the transaction.

10-Mar-2021
Takeda Pharmaceutical Company Limited announced the exercise of its option to acquire Maverick Therapeutics, Inc. a private biopharmaceutical company pioneering conditionally active bispecific T-cell targeted immunotherapies. Under the agreement, Takeda will obtain Maverick’s T-cell engager COBRA™ platform and a broad development portfolio, including Maverick’s lead development candidate TAK-186 (MVC-101) currently in a Phase 1/2 study for the treatment of EGFR-expressing solid tumors, and TAK-280 (MVC-280), which is anticipated to enter the clinic in the second half of Takeda’s fiscal year 2021 for the treatment of patients with B7H3-expressing solid tumors. After closing of the transaction, Maverick employees, including its team of talented scientists, will join Takeda’s Research & Development organization.

15-Sep-2020
Takeda Pharmaceutical Company Limited announced the expansion of its cell therapy manufacturing capabilities with the opening of a new 24,000 square-foot R&D cell therapy manufacturing facility at its R&D headquarters in Boston, Massachusetts. The facility provides end-to-end research and development capabilities and will accelerate Takeda’s efforts to develop next-generation cell therapies, initially focused on oncology with potential to expand into other therapeutic areas.

8-Jan-19
Takeda Pharmaceutical Company Limited announced the completion of its acquisition of Shire plc (“Shire”), becoming a global, values-based, R&D-driven biopharmaceutical leader headquartered in Japan.

Report Coverage
• An overview of the Global Digital Biomarkers Market
• In depth analysis of market dynamics and major factors such as drivers, restraints, opportunities and trends influencing the global market
• Global Digital Biomarkers Market revenue data historic and forecast analysis (2016 to 2026)
• Characterization and quantification of the market segments for Digital Biomarkers Market
• Market share analysis of key market participants and their competitive landscape

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Important Questions Answered by Global Digital Biomarkers Market Report
• What is the impact of COVID 19 epidemic on the Global Digital Biomarkers Market?
• Which is mostly affected region, country?
• Which is the current largest and fastest-growing region?
• What is the market size and growth rate of the Global Digital Biomarkers Market?
• What are current factors affecting the growth of market?
• What are Key trends and opportunity areas?
• Within Digital Biomarkers Market, which segments are fastest growing & emerging strongly? What are the drivers and restraints for each segment? What are vendor competencies by segment?
• What are the major strategies adopted by leading market companies?
• What are company challenges and essential success factors by market segment?
• How company offerings and supply chain capabilities are shifting to meet emerging market needs?

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