Digital therapeutics (DTx) are a digital health category defined by the Digital Therapeutics Alliance as products that “deliver evidence-based therapeutic interventions to patients that are driven by high quality software programs to prevent, manage, or treat a medical disorder or disease.”1 DTx are distinct from digital medicines or “smart pills,” which combine a prescription medication with an ingestible sensor that is designed to communicate with a software application to track compliance.
Advances in and the increasingly dominant role of mobile technology and artificial intelligence (AI) in our everyday lives have broadened the role of DTx in healthcare. Although, historically, interest in developing DTx was mainly confined to academia and technology companies, the potential to use DTx in conjunction with medicines to improve health outcomes has sparked the interest of big pharma, who have started to venture into the DTx space through investments and strategic partnerships with tech companies.2 This exciting advancement will create opportunities to increase patients’ awareness of their health and their ability to play a more active role in managing their disease, thereby creating the potential to improve health outcomes and reduce the demands on healthcare systems compared to traditional pharmacological interventions alone.3,4 The DTx market is expected to grow tenfold in the next three to five years, with a projected market value of $9 billion (USD) by 2025.5 However, this presents challenges in terms of how the technology is regulated, how healthcare providers (HCP) respond to this paradigm shift, and how these technologies are reimbursed.
In this article, we will review the trends in the development of DTx over the past decade, the current landscape, future prospects, and some of the challenges faced by companies looking to commercialize DTx applications.
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