Navigating Regulatory Pathways For Digital Therapeutics

Accelerated by increasing acceptance of decentralized medicine ushered in by the pandemic, the digital therapeutics (DTx) market is rising exponentially. In January 2022, a Research And Markets analysis valued the 2021 global market for DTx at $3.35 billion and estimated it would reach $12.1 Billion by 2026.¹ In March 2022, Insider Intelligence revised its previous projection for the 2025 global DTx market value from $9 billion to $56 billion.² Though the predicted values show degrees of variability, the trend lines consistently point to continued rapid expansion.

For the purposes of early regulatory planning, the first question that must be answered is whether a device falls into this regulatory category at all. To avoid unnecessarily embarking on a regulatory pathway that may cost considerable time and money, sponsors must be certain of how their products will be identified by regulators. This blog post will help sponsors gain clarity regarding what is and what is not considered a DTx and how to ensure they are following the correct regulatory pathway for their device.