Digital therapeutics (DTx) is a segment of solutions within the wider digital health landscape that delivers evidence-based therapeutic interventions to prevent, treat, or manage disease. Subject to different degrees of clinical evaluation and regulatory oversight, DTx products are driven by software programs and delivered across a range of devices from smartphones to virtual reality (VR) headsets. DTx could be the future of patient-centric healthcare, able to provide personalized programs to patients anywhere and at any time, even removing the need for medications for some indications.
The report is designed to provide strategic planners, competitive intelligence professionals and key stakeholders in the pharmaceutical industry a clear view of the opportunities and risks over the foreseeable future for digital therapeutics.
DTx provides many benefits to both patients and providers
Digital therapeutics (DTx) is a segment of solutions within the wider digital health landscape that delivers evidence-based therapeutic interventions to prevent, treat, or manage disease. Subject to different degrees of clinical evaluation and regulatory oversight, DTx products are driven by software programs and delivered across a range of devices from smartphones to virtual reality (VR) headsets. DTx could be the future of patient-centric healthcare, able to provide personalized programs to patients anywhere and at any time, even removing the need for medications for some indications.Reimbursement is crucial for the widespread adoption of DTx
There is widespread uncertainty from both healthcare authorities and payors about the value of DTx, which is staunching the market. Lengthy processes and unclear requirements have made reimbursement difficult to navigate, limiting patient access. The most prominent example of the importance of reimbursement is the bankruptcy of Pear Therapeutics. The company was estimated to be worth of $1.6 billion in 2021, then fell to a total auction price of $6 million in 2023 as Pear Therapeutics failed to generate sufficient reimbursement for its products while also struggling with unstable market conditions and high R&D costs. The company’s bankruptcy proves that regulation is only the first challenge for DTx manufacturers, and without change, other players may also fail soon.Evolving regulatory and reimbursement pathways
Healthcare authorities worldwide are addressing the lack of regulatory and reimbursement pathways for digital health technologies such as DTx. Health authorities in Germany, Belgium, and France have established frameworks, that those in other countries, such as South Korea, are trying to emulate. In the US, progress in reimbursement through Medicaid and Medicare may improve depending on the success of newly introduced bills, while changing regulations in the UK following Brexit could lead to increased approvals. Although the regulatory landscape is currently divided, increasing international cooperation on the regulatory standards of digital health would improve patient access to safer and more effective DTx in the future.Key Highlights
This report consolidates the publisher's latest thinking and forecasts around how the healthcare, macroeconomic, technology, and regulatory trends will impact the digital therapeutics market, as well as providing insights into the leading players and future disruptors across the value chain.The report is designed to provide strategic planners, competitive intelligence professionals and key stakeholders in the pharmaceutical industry a clear view of the opportunities and risks over the foreseeable future for digital therapeutics.
Scope
- A focused chapter on the key healthcare, technology, macroeconomic, and regulatory trends impacting digital therapeutics, and a review of the ways in which these trends will accelerate or hinder the market.
- Market analysis of approved and reimbursed digital therapeutic products by region.
- Case studies providing in-depth insight into some of the most recent and most influential developments in digital therapeutics.
- Product profiles of disruptive digital therapeutic products across key therapeutic areas.
- Review of leaders and disruptors across the key therapeutic areas that digital therapeutics are indicated for.
Reasons to Buy
- Understand the key trends accelerating or hindering the digital therapeutics space.
- Review of leaders and disruptors across the digital therapeutics value chain.
- Understand recent and influential developments in digital therapeutics.
- View a regional analysis of the current digital therapeutics market and a breakdown of regulatory and reimbursement pathways for digital therapeutics worldwide.
Table of Contents
- Executive Summary
- Players
- Technology Briefing
- Trends
- Market analysis
- Product Profiles
- Signals
- Case Studies
- Value Chain
- Appendix
- About the Analyst
- Contact the Publisher
Table 1: Healthcare trends impacting the DTx space
Table 2: Key technology trends impacting the DTx space
Table 3: Key macroeconomic trends impacting the DTx space
Table 4: Key regulatory trends impacting the DTx space
Table 5: DTx available in the US
Table 6: Products currently included in, and products since removed from, the DiGA directory
Table 7: DTx available for reimbursement in Belgium, Denmark, Switzerland, France, Sweden, and the UK
Table 8: DTx available in APAC
Table 9: Examples of recent non-pharma DTx partnerships
Table 10: Examples of pharma DTx partnerships
Table 11: Examples of DTx financing deals
Table 12: Examples of DTx M&A transactions
Table 13: Public DTx companies
Table 14: Private DTx companies
Table 15: Analyst Reports
List of Figures
Figure 1: Examples of leading players in the DTx space
Figure 2: DTx are part of the wider digital health technology landscape
Figure 3: According to the DTA, products claiming to be a DTx must adhere to the following principles
Figure 4: Breakdown of DTx available in the US by therapy area
Figure 5: Reimbursed DTx in Europe
Figure 6: Breakdown of currently available DiGAs by therapy area
Figure 7: CureApp HT hypertension adjunctive treatment app
Figure 8: myCOPD app
Figure 9: EndeavorRx and EndeavorRx Insight apps
Figure 10: Sleepio app
Figure 11: Daylight app
Figure 12: Deprexis app
Figure 13: Vorvida
Figure 14: Sidekick health app
Figure 15: My IBD app
Figure 16: Dario blood glucose monitoring system connected to a smartphone
Figure 17: ApsyreRx app
Figure 18: The RelieVRx eight-week curriculum
Figure 19: ViViRA app
Figure 20: Cankado website
Figure 21: Oleena app
Figure 22: HelloBetter Vaginismus Plus
Figure 23: Natural Cycles app
Figure 24: M&A deals involving DTx companies, Q1 2021-Q2
Figure 25: DTx-related job trends by quarter, 2019-
Figure 26: DTx-related social media trends by quarter, 2019-
Figure 27: Word cloud with trends related to DTx from social media discussions
Figure 28: Examples of popular posts related to DTx by influencers
Figure 29: Pear Therapeutics’s reSET DTx
Figure 30: AmerisourceBergen’s DTx Connect platform
Figure 31: The Leva Pelvic Health System
Figure 32: Ampersand Health’s My IBD Care
Figure 33: DTx value chainFigure 34: Examples of DTx players in cardiovascular indications
Figure 35: Examples of DTx players in CNS indications
Figure 36: Examples of DTx players in immunology indications
Figure 37: Examples of DTx Players in metabolic disorders
Figure 38: Examples of DTx players in musculoskeletal disorders
Figure 39: Examples of DTx players in oncology indications
Figure 40: Examples of DTx players in women’s health
