Prescription Digital Therapeutics: Advancing Access to the Digital Pills

As per United Nation’s report, the current global population stands at around 8 billion and expected to reach 9 billion by the end of 2030. This increase in population is accompanied with a rise in the incidence of several chronic disease indications. In fact, as per a report published by National Association of Chronic Disease Director, by 2030 this increase of the chronic condition would cost the US economy about USD 2 trillion. Furthermore, the lack of medical awareness and vulnerability in the medical infrastructure is believed to make the things more complicated in the coming future. Therefore, in order to cater this need, a number of stakeholders have come up with the innovative solution of digitizing the healthcare industry with next generation tools, such as artificial intelligence, telemedicine, electronic health records and digital therapies. As is the case with pharmaceutical industry, digital therapeutics can also be accessed through a prescription or without a prescription. It is worth noting that these next generation techniques, specifically prescription digital therapeutics have demonstrated significant potential to improve the quality of lives of individuals suffering from chronic conditions.

What is the Process of digital therapeutics - Roots Analysis

What are Prescription Digital Therapeutics?

Digital Therapeutics is one of the many new initiatives undertaken by the stakeholders to cater the growing need. As per Digital Therapeutics Alliance, digital therapeutics is a software-based intervention to patients to treat, manage or prevent a disease or disorder. These therapeutics are designed to engage patients in personalized treatment or disease prevention programs, through mediating behavioral or psychological modifications, providing motivational support and inculcating healthy lifestyle changes. Moreover, in order to be at par with the conventional medicines, several organizations have taken the initiative of validating their product in clinical trials for its safety and efficacy. In fact, the term “digital pills” has been coined due to its ability to compete against the conventional medicines/drugs.

Software flowchart of information for digital therapeutics - Roots Analysis

Prescription digital therapeutics are regulated by the FDA and are approved via 510(k) or de novo pathway, for prescription use to treat or manage a disease. Several digital therapeutics companies are focused on the development of prescription digital therapeutic solutions, wherein the product is prescribed by healthcare professionals or clinicians after confirmation of the eligibility of patients for using such solutions. In addition, to make digital therapeutics more engaging, these are currently being offered in a combination of software applications and others such as gaming solution, personal coach, and AI support.

Prescription digital therapeutic flow

In addition to prescription digital therapeutics, some non-prescription digital therapeutics have also received FDA approval, such as menstruation tracker Natural Cycles and Clue. The women’s digital health market is a more than $2 billion market within the femtech industry.

Prescription Digital Therapeutics for Metabolic Disorders are Gaining Interest

In terms of type of product, the global digital therapeutics market is anticipated to be driven by standalone software applications based digital therapeutics, which target metabolic disorders. Diabetes management through digital therapeutics has garnered a lot of attention, with more than 7 prescription digital therapeutics approved in the US. the most recent approval came in July 2023, when Better Therapeutics received approval for AspyreRx for use by adults with type 2 diabetes. Six products received 510(k) clearance, while the latest therapeutic received approval through de novo pathway.

Regulatory Landscape Will Play an Important Role to Drive the Adoption of Digital Therapeutics

It is worth mentioning that the ease of use, personalized experience, accessibility, and convenience coupled with the COVID-19 pandemic, has popularized the digital therapeutics among the general population. In fact, countries, such as United States, Germany, UK, and others now have come up with their own laws to regulate the digital therapeutics among its population. For instance, in United States, the USFDA has implemented “Breakthrough Device Designation Program” for regularizing digital therapies as a medical intervention / solution for various indication. Likewise, UK have NHS based digital therapeutics database, wherein clinicians can refer for prescribing products and Germany has “Digital Health Act-2019”, for regularization of digital therapeutics.

A bill “Access to Prescription Digital Therapeutics Act of 2023” was introduced in the Senate in March 2023; when passed, it will expand the coverage of prescription digital therapeutics and, hence, their adoption in the US. 


Amidst growing competition, the availability of cutting-edge tools and technologies have emerged as a differentiating factor. This has caused many big pharma companies to actively expand their service portfolios, either through strategic acquisitions or entering into alliances with other digital therapeutic developers. Prescription digital therapeutics adoption in the near future will be governed by their reimbursement status, making it imperative for the digital therapeutic developers to work collaboratively with the regulatory authorities.

You can access the Sample Pages for our market report on “Digital Therapeutics Market, 2023 – 2035”.