Digital Therapeutics - Thematic Intelligence

Digital Therapeutics - Thematic Intelligence

Summary

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.

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 GlobalData’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.