Digital Therapeutics (DTx): The Emerging Digital Care Model Transforming Healthcare Delivery

Imagine a patient who is newly diagnosed with type 2 diabetes being prescribed medicine as well as an unspecified directive to "keep an eye on their diet," without any concrete intervention in between visits that can take place only after several months have passed. The purpose of digital therapeutics is to make up for precisely such voids: clinically validated and prescribed software-based treatments that provide patients with continuous monitoring and behavioural changes even after they have left the clinic. This article provides a brief overview of digital therapeutics, the level of their adoption in India at the moment, and the issues that need addressing.

What are Digital Therapeutics (DTx)?

Digital Therapeutics, also known as DTx, refers to technology interventions aimed at preventing, managing, or treating a certain medical disorder and delivered directly to patients in the form of applications or connected devices. Digital therapeutics products are distinguished from regular consumer apps since they must have clinical data showing their effectiveness; this means that, just like drugs and devices, a DTx solution must prove its usefulness before application.

In order for a product to be categorised in the DTx category, the industry association usually requires that the solution has a clearly defined clinical purpose, is created according to recognised standards of quality and safety management, and, what is more important, undergoes clinical validation and trials with published results. That means that a DTx solution has its own regulatory category which differs from that of the regular consumer health app.

As opposed to consumer health apps, DTx solutions are seen as medical solutions because of the therapeutic effect. That is why many international regulators consider DTx solutions to be the same as software-based medical devices.

Where India's Digital Therapeutics Market Stands Today

The Indian market of digital therapeutics is expected to amount to around USD 900 million by 2030, based on market research studies that have been made publicly available, which is, again, indicative of the specific portion of the global market of digital therapeutics, which is rapidly growing despite large differences in opinions of various global market research firms about its current size.

Indigenous companies form the mainstay of the activity in this regard in India rather than products imported from abroad. Indeed, one such Mumbai-based company created and validated a first-of-its-kind mobile app-based clinical trial in India for diabetes management, in cooperation with the leading Indian diabetes research body, and has already published several real-world evidence studies involving Indian and South Asian patient populations.

Commercial collaborations with well-established pharmaceutical firms are starting to introduce digital therapeutics products into mainstream healthcare system channels. In this respect, an Indian digital therapeutics firm joined hands with a top domestic pharmaceutical company to create a clinically validated digital disease management platform to be offered to patients via doctor clinics together with medication brands, instead of having patients download the product themselves.

The Conditions Where DTx is Already Being Used

Managing diabetes is now the most advanced example of digital therapeutics use in India due to the prevalence of type 2 diabetes in the country and the nature of the disease, which requires behavioural changes such as diet, exercise, and regular intake of medicine, which is something the software can do well.

Another related application of digital therapeutics is managing cardiovascular diseases, which can go hand-in-hand with the diabetes management platform because of the co-morbidity of the two diseases and the fact that lifestyle-based intervention applies to both diseases.

Mental health and disease management are the third type of applications of digital therapeutics. The software uses a programmatic approach and possibly an AI-driven coach or chatbot to help patients who require behaviour-related intervention when managing their diseases.

Why DTx is Gaining Traction

One obvious advantage of using DTx is that it extends the clinical intervention from the consulting room to the outside world. The patient with a chronic disease spends a negligible amount of time in consultations with their doctor during the year, but the DTx solution is meant to provide structured advice and oversight to the patient during all the other times when they manage the condition themselves.

Another advantage of using DTx is scalability, considering the lack of specialists in India. One DTx program that has been scientifically proven to work can be used to help many people at once, whereas the same thing cannot be done regarding specialist consultations, especially since specialists are concentrated in major Indian cities.

Thirdly, an emerging body of evidence is a major advantage of DTx solutions. Since DTx programs are supposed to publish their clinical results, there will be more data available for doctors and health organisations to consider when thinking about using the digital tool for patients' benefit.

Where DTx Adoption Still Faces Hurdles

Regulatory certainty continues to be an emerging area. India and other nations are increasingly seen as demanding local clinical data from their digital therapeutics even when they have already been validated and approved in other countries; in effect, the DTx has no option but to prove through its trials that it will behave in the same manner in India's patients as well.

Lack of awareness is another major issue. A lot of patients, along with many doctors, are not very familiar with the category of digital therapeutics, distinguishing it from generic health and wellness applications, delaying their prescription and adoption by the patients as an additional part of their medicine regimen.

Patient engagement is the third key challenge that pertains to this class of medical devices. For a DTx to work, the patient needs to continue to use it persistently, and developing such a piece of software that continues engaging the user for weeks or months at a time is a consistent challenge.

The Road Ahead for Digital Therapeutics

Considering consistently robust projections for growth across most of the market estimate numbers available, there is every indication that adoption of digital therapeutics will continue growing in India, especially for chronic diseases such as diabetes, which currently has the farthest developed evidence base and partnering with commercial entities.

Greater collaboration between DTx products and established drug distribution and health care networks, akin to what already exists in the doctor-clinic model and medicine co-packaging, will likely be one of the major factors driving the adoption moving forward, as it deals with the awareness and trust barriers that would be difficult for a stand-alone consumer application to achieve on its own.

It will come down to the speed at which regulatory clearance, physician readiness and continuous patient engagement are resolved collectively, not individually, whether digital therapeutics becomes an integral part of treatment in India, or remains known only among the first-adopter hospitals and specialist physicians.

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