The Revolution of Digital Therapeutics (DTx) in the Pharmaceutical Industry and Their Quality Impacts.

An increasing number of developments and trends are driving the expansion of the digital therapeutics (DTx) market in the pharmaceutical industry. Digital therapeutics are therapies intended to treat, diagnose, and prevent diseases by using patient-directed clinically assessed software applications, which can optimize the effectiveness and delivery of healthcare. These digital innovations became important as the world changed, particularly during the coronavirus pandemic. Nowadays pharma companies are getting more comfortable with the idea of digital therapies. The majority of pharmaceutical companies are examining how to incorporate pharmaceuticals and digital therapies into their treatment regimens, leveraging digital tools to enhance patient outcomes and streamline healthcare delivery. A thorough overview of the most recent technological advancements in the creation of digital therapies shows particular technologies that are essential to the market's future growth. Moreover, the evaluation of digital therapeutics by clinical trial and real-world data is outlined. The critical quality attributes of DTx products and the challenges, including data management issues and regulatory obstacles, which make the creation, approval, and marketing of customized medicines more difficult, are covered in this review article. Overall, pharma companies are venturing into the world of digital therapeutics while acknowledging the limitations of the emerging field.