Digital Health Market: Focus on Digital Therapeutics (3rd Edition), 2023-2035

Digital Health Market: Focus on Digital Therapeutics (3rd Edition), 2023-2035

Digital Therapeutics, popularly known as DTx, represent a digital health solution which delivers medical interventions directly to the patients in order to treat, manage and prevent a disease. Such solutions usually employ evidence based and clinically validated software or technologies, in order to capture real-time patient data and provide improved curative response. Considering the ongoing digitization efforts and transformation of the healthcare sector, digital therapeutics have garnered significant attention from industry stakeholders and investors alike. Further, government organizations have actively undertaken initiatives, such as enactment of legislation, publishing laws and establishment of regulations, in the digital therapeutics domain. For instance, the USFDA sanctioned the Breakthrough Device Designation Program for granting approvals to digital therapeutics. It is worth mentioning that, till September 2022, around 730 digital health products (including digital therapeutics, wellness apps and digital biomarkers) had been approved by the USFDA. A similar trend was observed in other countries, such as the UK, Germany, Denmark and South Korea, where regulatory authorities have published regulations pertaining to digital therapeutics and digital health solutions. Given the current activity in this domain and the growing demand for such solutions, the digital therapeutics market is likely to grow at a healthy pace over the next decade.

KEY MARKET INSIGHTS

The Digital Health Market: Focus on Digital Therapeutics (3rd Edition), 2023-2035: Distribution by Type of Solution (Software Solution, Gaming Solution and Combination Solution), Type of Therapy (Curative and Preventive), Purpose of Solution (Medication Replacement and Medication Augmentation), Type of Business Model (B2B and B2C), Target Therapeutic Area (Cardiovascular Disorders, Chronic Pain, Mental Health Problems, Metabolic disorders, Neurological disorders Respiratory disorders, Sleep disorders, Substance use disorders and Other disorder) and Key Geographical Regions (North America, Europe, Asia, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current landscape and future opportunity, offering an informed opinion on the likely adoption of digital therapeutic solutions in the healthcare industry, over the next 12 years. The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. The reports answers following key questions related to this domain

Key Advantages and Growing Demand for Digital Therapeutics

Owing to their multiple benefits, including ease of access, shorter development timelines, versatile delivery platforms, decreased cost of treatment, personalized treatment options, enhanced medication adherence, promotion of healthy lifestyle and remote access to healthcare providers for patients and vice versa, digital therapeutics have emerged as a promising alternative to conventional medication. Given the benefits offered by these solutions and the growing demand for remote and digital solutions across the world, post the pandemic, the overall demand for digital therapeutics is expected to steadily rise in the long term.

Current Market Landscape of Digital Therapeutics

The digital therapeutics market landscape features an extensive list of more than 150 large, mid-sized, small and very small players. It is worth highlighting that over 400 digital therapeutic solutions are presently available in the market / being developed by several industry stakeholders for various target indications. It is also worth noting that majority (more than 100) of the approved / under development digital therapeutic solutions target mental health problems. This is followed by solutions targeting neurological and metabolic disorders.

Key Drivers Behind the Digital Therapeutics Market

The COVID-19 pandemic, coupled to the subsequent enforcement of mandatory social distancing measures, has created an enormous demand for remote patient engagement. Further, the evolving regulatory and clinical settings around the world have created an ample opportunity for industry stakeholders. In addition, regulatory authorities and government bodies have provided considerable support for digital therapeutics over the past few years. Moreover, the growing interest of investors in this market can be validated by the significant rise in funding activity in the recent past. Additionally, various big pharma players have undertaken several key initiatives, including strengthening their product portfolio, entering into strategic deals and making significant financial investments. Considering the active involvement of well-established industry players, the new entrants, as well as big pharma players and government organizations, the development pipeline of digital therapeutics is likely to grow further, over the coming years.

Overall Size of the Digital Therapeutics Market

Driven by the rising interest in digital and remote health solutions, the future opportunities and growth associated with the digital therapeutics market is anticipated to witness significant growth in the foreseen future. Specifically, in terms of type of product, this market is anticipated to be driven by standalone software applications based digital therapeutics, which target metabolic disorders. In addition to this, presently, close to 90% of the market is captured by players based in North America and Europe. However, in the long term, the digital therapeutics market in Asia is anticipated to grow at a relatively faster pace.

Leading Players in the Digital Therapeutics Market

Examples of key players engaged in this domain (which have also been profiled in this report) include (in alphabetical order) Ampersand Health, Akili Interactives, Better Therapeutics, Brain+, Click Therapeutics, CogniFit, GAIA, Healios, JOGO Health, Jolly Good, KORE Digital Health Therapeutics, Livongo Health, Lucid, MedRhythms, Pear Therapeutics, Redicare Control, Susmed, The Learning CorpVoluntis and WellDoc.

SCOPE OF THE REPORT

Global Digital Therapeutics Market: Market Segmentations

S. No.

Market Segments

Details

Forecast Period

2022 - 2035

Type of Solution

Standalone Software Application, Software Application + Device, Software Application + AI Support, Software Application + Personal Coach, Software Application + Device + AI Support, Software Application + Device + Personal Coach and Others

Type of Therapy

Curative Solutions, and Preventive Solutions

Purpose of Solution

Medication Replacement and Medication Augmentation

Type of Business Model

B2B and B2C

Therapeutic Area

Cardiovascular disorders, Chronic Pain, Mental Health Problems, Metabolic disorders, Neurological disorders, Respiratory disorders, Sleep disorders, Substance use disorders and Other disorders

Key Geographical Area

North America, Europe, Asia, Middle East and North Africa, Latin America and Rest of the World

Source: Roots Analysis

The report features an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Amongst other elements, the report includes:

An executive summary of the key insights captured during our research, offering a high-level view on the current state of the digital therapeutics market and its likely evolution in the short to mid and long term.

A brief introduction to important concepts related to digital therapeutics, featuring information on various types of digital therapeutics and its primary applications in the healthcare domain. Further, this chapter features details related to the recent advancements that have been reported in this market space.

An overview of the current market landscape of digital therapeutic solutions, including information on status of development, type of solution (combination offering of software application and device or AI or personal coach, and standalone software application), type of therapy (curative and preventive), purpose of solution (medication replacement and medication augmentation), target indication(s), therapeutic area and target population. In addition, it presents details related to the companies engaged in developing digital therapeutic solutions, highlighting their year of establishment, company size, type of business model (B2B and B2C) and location of their headquarters.

An in depth analysis, highlighting the contemporary market trends, using three schematic representation, including a 4-D bubble analysis for comparing the leading players engaged in the development of digital therapeutic solutions (based on the parameters, such as product portfolio strength, number of target indication(s) and company size), an insightful tree map representation of the digital therapeutic solutions (distributed on the basis of therapeutic area and company size), and a world map representation (highlighting the regional distribution of developer companies).

A detailed product competitiveness analysis of digital therapeutic solutions that are available / under development for the most popular therapeutic areas, taking into consideration strength of the product portfolio (based on the number of digital therapeutic solutions being developed for that therapeutic area) and key product specific parameters, such as status of development, type of solution, type of therapy, prescription requirement and purpose of solution.

Elaborate profiles of prominent large, mid-sized and small players that are either engaged in the development or have developed digital therapeutic solutions. Each company profile features a brief overview of the company (including information on year of establishment, number of employees, location of headquarters and key members of the executive team), details related to their respective product portfolio, recent developments and an informed future outlook.

An analysis of completed, ongoing and planned clinical studies of digital therapeutics, various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, study design, trial recruitment status and trial focus, type of organization, and regional distribution of trials. In addition, it features an insightful clinical end-points analysis (for top ten recent initiated trials for popular therapeutic areas).

An analysis of funding and investments received by players engaged in the digital therapeutics’ domain, during the period 2016-2022, including grants, debt financing, seed funding, venture series, initial public offering, secondary offerings, private placements and other equity.

An in-depth analysis of partnerships that have been inked between various stakeholders during the period 2016-2022, covering marketing and distribution agreements, mergers / acquisitions, pilot product offerings, product / technology integration agreements, product / technology licensing agreements, product development agreements, product evaluation agreements, product training agreements, product development agreements, research and development agreements, and commercialization agreements.

A detailed analysis of various business models and go-to-market strategies adopted by firms engaged in developing digital therapeutic solutions, highlighting details on various channels adopted by the stakeholders in order to raise awareness and offer access to their proprietary products.

A Bowman’s clock pricing strategy framework analyzes the competitive position of various companies engaged in this domain, taking into consideration the prices and different features of their products. In addition, it presents an equation devised to calculate the likely price of digital therapeutics based upon their characteristics.

A detailed market forecast analysis in order to estimate the existing market size and the future opportunity for digital therapeutics developers over the next decade. Based on multiple parameters, likely adoption trends and expected price variations of these products, we have provided an informed estimate of the evolution of the market for the period 2023-2035. The report also features the likely distribution of the current and forecasted opportunity within the digital therapeutics market across type of solution (combination offering of software application and device or AI or personal coach, and standalone software applications), purpose of solution (medication replacement and medication augmentation), type of therapy (curative and preventive), business models (B2C (patients) and B2B (healthcare providers, payers, employers and pharmaceutical companies)), therapeutic area (cardiovascular disorders, chronic pain, mental health problems, metabolic disorders, neurological disorders, respiratory disorders, sleep disorders, substance use disorders, and other disorders), and key geographical regions (North America, Europe, Asia, Middle East and North Africa, Latin America 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.

A detailed assessment of the overall market landscape of women’s digital health solution developers, along with information on their year of establishment, company size, location of headquarters, type of solution(s) offered (applications / software, devices and services), along with their current status of development, product ratings, application area, usage during different stages of pregnancy, purpose of solution and type of end-users.

A discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall digital therapeutic solutions industry.

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 (in alphabetical order of company name):

Radhika Kamalia (Chief of Staffs to CEO and Strategy Lead, Ampersand Health)

Adam Kaufman (Ex-Chief Executive Officer, Canary Health)

Cindy Zhang (Marketing Director, Dnurse Technology)

Healther Ritchie (Chief Strategy Officer, Embr Labs)

Hooman Lee (Founder and Chief Executive Officer, Exosystems)

Vijay Ravindran (Chief Executive Officer, Floreo)

Stan Sugarman (Chief Commercial Officer, GAIA)

Guilhem Dupnot (Chairman and Chief Executive Officer, Healios)

Siva Nadarajah (Co-Founder and President, JOGO Health)

Tim Rudolphi (Chief Executive Officer, metaMe Health)

Soren Kleberg (Chief Executive Officer, SelfBack)

Eran Ofir (Ex-Chief Executive Officer, Somatix)

Edouard Gasser (Chief Executive Officer, Tilak Healthcare)

Torin Block (Chief Executive Officer, Turnaround Health)

Stephanie Tilenius (Co-Founder and Chief Executive Officer, Vida Health)

Amelie Janson (Ex-Communication Manager, Voluntis)

Palakh R Sarogi (Ex-Vice President Marketing, Wellthy Therapeutics), Arani Sarkra (Ex-Senior Manager Consumer Marketing, Wellthy Therapeutics) and Yolande D’Mello (Ex-Marketing and Public Relations, Wellthy Therapeutics)

Anonymous (Founder and Chief Executive Officer, UK based Small Company)

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.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Where possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market over the coming 13 years, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

FREQUENTLY ASKED QUESTIONS

Question 1: What are digital therapeutics?

Answers: Digital therapeutics, also known as DTx, represent a type of digital health solution which delivers medical interventions directly to the patients, using an evidence based, clinically validated software or a combination of software, in order to treat, manage and prevent a disease or disorder.

Question 2: What are the most popular therapeutic areas being targeted by digital therapeutics?

Answers: Majority (close to 30%) of the marketed / under development digital therapeutic solutions target mental health disorders. This can be attributed to the steep rise observed in the incidence of mental health disorders, such as anxiety, depression and stress, during and post the pandemic, across the globe. It is also worth highlighting that neurological and metabolic disorders are other popular therapeutic areas targeted by the digital therapeutic solutions.

Question 3: What is the future of digital therapeutics in pharma?

Answers: The global digital therapeutics market is anticipated to grow at a compound annual growth rate of 20% over the next 13 years and is expected to be worth around USD 20 billion by 2035.

Question 3: Which region is leading in the digital therapeutics market?

Answers: Currently, North America and Europe collectively hold 80% of the market share. In the long run, the digital therapeutics market in Asia is likely to grow at a relatively faster pace.

Question 4: What are the key factors influencing the price of digital therapeutic solutions?

Answers: Digital therapeutic solutions are priced based on factors, such as complexity, target patient population, cost of development and delivery, competition, perceived value and regulatory settings. Complex solutions utilizing technologies, such as artificial intelligence or machine learning, may be more expensive.

Question 5: What is the trend of capital investments in the digital therapeutics market?

Answers: Owing to the lucrative market opportunity associated with digital therapeutics, several investors have collectively invested over USD 8.41 billion.

Question 6: Which types of partnerships are usually signed in the digital therapeutics industry?

Answers: Commercialization agreements, pilot product offerings and product / technology integration agreements are the most common type of partnership models adopted by stakeholders engaged in the digital therapeutics’ domain.

Question 7: Which marketing strategies are commonly adopted for digital therapeutics?

Answers: Most of the players involved in the digital therapeutics’ domain have adopted the in-bound marketing strategies in order to enhance their company and product visibility. It is worth highlighting that majority of the players have used Facebook, You-Tube and LinkedIn as the most preferred social media platforms for in-bound marketing.

CHAPTER OUTLINES

Chapter 2 is an executive summary of the key insights captured in our research. It offers a high-level view on the current state of digital therapeutic solutions market and its likely evolution in the short to mid and long term.

Chapter 3 provides a general overview of the digital health sector, covering details related to the current and future trends in the domain. It also features a discussion on strategic initiatives undertaken by several organizations to support the development of digital solutions for treatment of chronic disorders. The chapter also provides an overview of the various product development pathways adopted by the companies in this field.

Chapter 4 includes a detailed analysis of the current market landscape of over 415 digital therapeutic solutions, based on status of development, type of solution (combination offering of software application and device or AI or personal coach, and standalone software application), type of therapy (curative and preventive), purpose of solution (medication replacement and medication augmentation), target disease indication(s), therapeutic area, and target population. Further, the chapter provides an analysis of digital therapeutic solution developers, based on year of establishment, company size, type of business model (B2B and B2C) and location of headquarters. It also highlights the contemporary market trends, using three schematic representations, which include a 4-D bubble analysis comparing the leading players engaged in the development of digital therapeutic solutions (based on the parameters, such as product portfolio strength, number of target indication(s) and company size), an insightful tree map representation of the digital therapeutic solutions (distributed on the basis of therapeutic area and company size), and a world map representation (highlighting the regional distribution of developer companies).

Chapter 5 presents a detailed product competitiveness analysis of digital therapeutic solutions, while taking into consideration the strength of product portfolio (based on the total number of digital therapeutic solutions being developed for that therapeutics area) and key product specific parameters, such as status of development (approved, marketed, development/ research, discovery and proof of concept) type of solution (combination offering of software application and device or AI or personal coach, and standalone software applications), type of therapy (curative and preventive), purpose of solution (medication replacement and medication augmentation) and prescription requirement.

Chapter 6 features elaborate profiles of prominent large, mid-sized and small players that are either engaged in the development or have developed digital therapeutic solutions. Each company profile features a brief overview of the company (with information on year of establishment, number of employees, location of headquarters and key members of the executive team), details of their respective product portfolio, recent developments and an informed future outlook.

Chapter 7 provides a detailed analysis of more than 500 completed, ongoing and planned clinical studies of various digital therapeutic solutions, based on the various relevant parameters, such as trial registration year, trial phase, number of patients enrolled, study design, trial recruitment status and trial focus, type of organization, and regional distribution of trials. In addition, it features an insightful clinical end-points analysis (for top ten recent initiated trials for popular therapeutic areas).

Chapter 8 An analysis of funding and investments received by players engaged in the digital therapeutics’ domain, during the period 2016-2022, including grants, debt financing, seed funding, venture series, initial public offering, secondary offerings, private placements and other equity.

Chapter 9 features an in-depth analysis and discussion on the various partnerships inked between the players in this market, during the period, 2016-2022, covering marketing and distribution agreements, mergers / acquisitions, pilot product offerings, product / technology integration agreements, product / technology licensing agreements, product development agreements, product evaluation agreements, product training agreements, product development agreements, research and development agreements, and commercialization agreements.

Chapter 10 features a detailed analysis on the various business models and go-to-market strategies adopted by companies involved in this space. It also provides details on various channels adopted / being adopted by stakeholders in the industry to raise awareness and offer access to their proprietary products.

Chapter 11 presents a Bowman’s Clock Pricing Strategy framework in order to analyze the competitive position of various companies in the marketplace, taking into consideration the prices and different features such as type of solution, purpose of solution and type of therapy, of their products. In addition, it presents the equation devised to calculate the likely price of the digital therapeutics based upon its characteristics.

Chapter 12 presents an insightful market forecast analysis, highlighting the likely growth of digital therapeutic solutions market till 2035. We have segmented the market across type of solution (combination offering of software application and device or AI or personal coach, and standalone software applications), purpose of solution (medication replacement and medication augmentation), type of therapy (curative and preventive), distribution channels (B2C and B2B), therapeutic areas (cardiovascular disorders, chronic pain, mental health problems, metabolic disorders, neurological disorders, respiratory disorders, sleep disorders, substance use disorders, and other disorders), and key geographical regions (North America, Europe, Asia, Middle East and North Africa, Latin America and rest of the world).

Chapter 13 provides an overall market landscape of women’s digital health solution providers along with the information on their year of establishment, company size, location of headquarters, type of solution(s) offered (applications / software, devices and services). In addition to this, the chapter provides information on their current status of development, product ratings, application area, usage during different stages of pregnancy, purpose of solution and type of end-users.

Chapter 14 presents a discussion on affiliated trends, key drivers and challenges, under a SWOT framework, which are likely to impact the industry’s evolution, including a Harvey ball analysis, highlighting the relative effect of each SWOT parameter on the overall digital therapeutic solutions industry.

Chapter 15 is a collection of interview transcripts of discussions held with various key stakeholders in this market. The chapter provides a brief overview of the companies and details of interviews held with Radhika Kamalia (Chief of Staffs to CEO and Strategy Lead, Ampersand Health), Adam Kaufman (Ex-Chief Executive Officer, Canary Health), Cindy Zhang (Marketing Director, Dnurse Technology), Healther Ritchie (Chief Strategy Officer, Embr Labs), Hooman Lee (Founder and Chief Executive Officer, Exosystems), Vijay Ravindran (Chief Executive Officer, Floreo), Stan Sugarman (Chief Commercial Officer, GAIA), Guilhem Dupnot (Chairman and Chief Executive Officer, Healios), Siva Nadarajah (Co-Founder and President, Joggo Health), Tim Rudolphi (Chief Executive Officer, metaMe Health), Soren Kleberg (Chief Executive Officer, SelfBack), Eran Ofir (Ex-Chief Executive Officer, Somatix), Edouard Gasser (Chief Executive Officer, Tilak Healthcare), Torin Block (Chief Executive Officer, Turnaround Health), Stephanie Tilenius (Co-Founder and Chief Executive Officer, Vida Health), Amelie Janson (Ex-Communication Manager, Voluntis), Palakh R Sarogi (Ex-Vice President Marketing, Wellthy Therapeutics), Arani Sarkra (Ex-Senior Manager Consumer Marketing, Wellthy Therapeutics) and Yolande D’Mello (Ex-Marketing and Public Relations, Wellthy Therapeutics), Anonymous (Founder and Chief Executive Officer, UK based Small Company)

Chapter 16 summarizes the entire report, highlighting various facts related to contemporary market trends and the likely evolution of the digital therapeutics market.

Chapter 17 is an appendix, which provides tabulated data and numbers for all the figures provided in the report.

Chapter 18 is an appendix, which contains the list of companies and organizations mentioned in the report