Digital Solutions for Biomarkers Market by Content, Purpose, Type of Biomarker, Therapeutic Area, Business Model, and by Key Geographical Regions: Industry Trends and Global Forecasts, 2021-2030

Overview

From periodically monitoring disease progression in patients to developing customized therapies based on genetic predisposition, biomarkers (which are specific indicators of biological events) have become an indispensable aspect of contemporary healthcare solutions/practices. Ongoing digitization efforts in the healthcare industry have led to the development of a number of digital solutions, which are capable of generating, collecting, and tracking medical data. From this data, details of anatomical, physiological, and molecular events, and even behavior-related patterns in humans, or digital biomarkers, have been acknowledged as viable inputs to explain, influence and/or predict health-related outcomes. Digital biomarkers are analyzed in silico, using advanced analytical algorithms and artificial intelligence (AI) enabled tools, and therefore, can be used to rapidly generate actionable insights and identify previously undetected biological events (obscured by the shortcomings of manual processes). In this context, regulatory bodies across the world have actually begun evaluating software as a medical device. Fundamentally, digital biomarkers are identified/measured using sensors and algorithms across the plethora of available connected medical devices and other health-focused software solutions. Moreover, the fact that the procurement/analysis of digital biomarkers are not limited to the physical confines of the clinical environment, presents new opportunities to revolutionize disease diagnosis, patient monitoring and clinical trial conduct. When combined with specific phenotypic signatures, digital biomarkers have demonstrated the potential to be used to generate insights related to esoteric medical fields, such as psychiatry and neurology. In fact, experts believe that future diagnostic/treatment protocols for certain mental health indications are likely to be underpinned by digital biomarkers, similar to how the management of diabetes and hypertension are underpinned by biochemical biomarkers.

In the current pandemic scenario, medical professionals are trying to identify digital biomarkers that can facilitate the successful screening/diagnosis of COVID-19 patients, remotely. For instance, the National Institutes of Health (NIH) has tasked physIQ with developing and validating an algorithm, which can use existing wearable biosensor-derived analytics (generated by the company’s pinpointIQ™ cloud platform) to discover a novel digital biomarker for COVID-19 associated decompensation. In this regard, it is worth noting that the development of tools to capture digital biomarkers and analyze them, requires multidisciplinary (including computer science and engineering, as well as neology and medicine) expertise. Currently, several successful start-ups claim to be involved in designing and developing the necessary software/hardware solutions for the abovementioned purposes. Most of these companies have also received significant capital investments to support their respective product development initiatives. One of the primary challenges encountered by innovators in this market is related to regulatory review. Digital biomarkers are subjected to the same level of regulatory scrutiny as their traditional counterparts. Moreover, there is an evident need for a systematic approach to assess the quality and utility of digitized renderings of biological events, in order to gauge their safety and efficacy in informing health-related decision making. Despite existing challenges, this niche, but emerging domain, is expected to evolve complementary to digital therapeutics, with pioneers in the field poised to benefit from the first-to-market advantage. Given the recent rise in partnership activity in this field, and the growing demand for remote diagnostic and therapeutic solutions (mostly influenced by the pandemic), we believe that the digital biomarkers market is likely to grow at a healthy pace over the next decade.

Scope of the Report

The “Digital Solutions for Biomarkers Market by Content of Solution (Standalone Software Solutions and Combination Offerings), Purpose of Solution (Diagnosis, Early Screening, Monitoring, and Predictive Insights), Type of Biomarker (Cognitive, Idiosyncratic, Physiological, Vocal, and Other Biomarkers), Therapeutic Area (Autoimmune Disorders, Cardiovascular Disorders, Infectious Disorders, Mental Health Problems, Neurological Disorders, Respiratory Disorders, Substance Use Disorders, and Other Disorders), Business Model (B2B and B2C), and by Key Geographical Regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2021-2030 ” report features an extensive study of the current landscape, offering an informed opinion on the likely adoption of digital solutions for biomarkers (either commercialized or under development) in the healthcare industry, over the next decade. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. 

Amongst other elements, the report includes:

• An overview of the current market landscape of digital solutions for biomarkers, including information on current status (approved, marketed, USFDA submission, research and development, proof-of-concept, and discovery), content of solution (combination offering of  software application/gaming solution + AI support or device or personal coach, and standalone software/gaming solution ), purpose of solution (diagnosis, early screening, monitoring and predictive insights), type of biomarker (cognitive, idiosyncratic, molecular, neurophysiological, physiological, respiratory, vocal, and others ), target indication(s), therapeutic area(s), target population, and prescription requirement. In addition, it highlights the companies engaged in developing digital solutions for biomarkers, along with information on their year of establishment, company size, type of business model used (B2B and B2C) and location of headquarters.
• An in depth analysis of the contemporary market trends, presented using five schematic representations, including [A] a bubble analysis comparing the leading players engaged in the development of digital solutions for biomarkers, based on various parameters (such as product portfolio strength, type of biomarker and company size), [B] a grid representation illustrating the distribution of digital solutions for biomarkers based on their current status, content of solution and target therapeutic area, [C] an insightful tree map representation of digital solutions for biomarkers based on their therapeutic area and company size, [D] a world map representation highlighting the regional distribution of developer companies, and [E] a comparative grid representation to highlight the current and likely future market landscape based on status of development, type of biomarker and therapeutic area.  
• Elaborate profiles of prominent players that are either currently engaged in developing or have developed digital solutions for biomarkers. Each company profile features a brief overview of the company (with information on its year of establishment, number of employees, location of headquarters and key members of the executive team), details related to their respective product portfolios, recent developments and an informed future outlook.
• A detailed product competitiveness analysis of digital solutions for biomarkers taking into consideration several relevant parameters, such as current status, content of solution, purpose of solution, therapeutic area, and prescription requirement.
• An analysis of the recent global events (summits/forums/conferences/annual meetings) that were organized for stakeholders engaged in this domain, highlighting the evolution of discussion topics related to digital solutions for biomarkers. The chapter also includes details on type of event, regional distribution, emerging agendas, popular organizers, and most active industry and non-industry players.
• An elaborate analysis of the investments, including seed financing, venture capital financing, debt financing, grants/awards, made at various stages of development in companies that are engaged in this field, during the period 2012-2020 (till September). 
• An analysis of the partnerships that have been inked by stakeholders in this domain, in the period between 2014 and 2020 (till September), covering marketing and distribution agreements, mergers/acquisitions, pilot programs, product/technology integration agreements, product/technology licensing agreements, product development agreements, product development and commercialization agreements, product evaluation agreements, and research and development agreements.
• An analysis of the various digital solutions for biomarkers focused initiatives carried out by big pharma players (out of top 25 established pharmaceutical players), featuring [A] an analysis highlighting information on clinical research activity, funding, partnership activity, research publications, and participation in conferences, and [B] a spider web representation of the individual competitiveness of the initiatives of big pharma players based on multiple relevant parameters.
• An insightful discussion on how the recent COVID-19 pandemic is likely to impact the overall digital solutions for biomarkers market, along with information on the key initiatives undertaken by big pharma players to overcome the challenges faced due to the pandemic.

One of the key objectives of the report was to estimate the existing market size and future opportunity for digital solutions for biomarkers developers over the next decade. Based on multiple parameters, likely adoption trends, and expected price variations for these products, we have provided an informed estimate of the evolution of the market for the period 2021-2030. The report also features the likely distribution of the current and forecasted opportunity within digital solutions for biomarkers market across [A] content of solution (combination offering of software application + device or AI, and standalone software applications), [B] purpose of solution (diagnosis, early screening, monitoring and predictive insights), [C] type of biomarker (cognitive, idiosyncratic, physiological, vocal, and other biomarkers), [D] therapeutic area (autoimmune disorders, cardiovascular disorders, infectious disorders, mental health problems, neurological disorders, respiratory disorders, substance use disorders, and other disorders), [E] business model (B2B (healthcare providers, payers, employers and pharmaceutical companies) and B2C (patients and caregivers)), and [F] key geographical regions (North America, Europe, Asia-Pacific, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and to add robustness to our model, we have provided three forecast scenarios, namely conservative, base and optimistic scenarios, representing different tracks of the industry’s growth.

The opinions and insights presented in the report were influenced by discussions held with senior stakeholders in the industry. 

The report features detailed transcripts of interviews held with the following industry stakeholders: 

• Edouard Gasser (Co-Founder and Chief Executive Officer, Tilak Healthcare)
• Michael Seggev (Chief Commercial Officer, Vocalis Health)

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

Key Questions Answered

• Who are the leading players engaged in digital solutions for biomarkers?
• Which popular therapeutic areas are being targeted by digital solutions for biomarkers?
• Which players are actively involved in organizing/participating in global events conducted within this domain?
• What is the trend for capital investments in the digital solutions for biomarkers market?
• Which partnership models are most commonly adopted by stakeholders engaged in this industry?
• What type of strategies are being adopted by big pharma players engaged in this domain?
• How is the recent COVID-19 pandemic likely to impact the overall digital solutions for biomarkers market?
• What are the opportunities available for digital solutions for biomarkers in emerging markets?
• How is the current and future opportunity likely to be distributed across key market segments?
• What are the anticipated future trends related to digital solutions for biomarkers market?