Discussions

Digital therapeutics are clinically validated applications / software / online programs that have demonstrated the capability to facilitate positive outcomes when used in the prevention / treatment / management of diseases / clinical conditions. 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.

The global digital therapeutics market size is estimated to grow from USD 2.83 billion in 2024 to USD 19.76 billion by 2035, representing a CAGR of 19.32% during the forecast period till 2035.

The domain is currently dominated by small-sized and very small-sized players. This can be attributed to the fact that healthcare domain has seen a shift from traditional medicines to digital solutions in the recent years, especially with increase in cases where the patients are not able to frequently visit their healthcare professional. In fact, in the recent years, a number of digital therapeutics have received regulatory approval, which has spurred the establishment of many start-ups in this domain.

Even though efforts for development of digital therapeutic solutions have been undertaken by players based all across the globe, majority of the developers are headquartered in North America. It is worth mentioning that within North America, maximum number of players are headquartered in the US. Similarly, within Europe, more than players are based in UK, France, Germany and Switzerland. Further, Australia, Israel, Japan and South Korea are major hubs in Asia-Pacific regions.

Traversing a digital therapeutic from the R&D stage to the market is a long process. The various developmental stages involved in this process have been discussed in detail in the following sections.

Discovery and Preclinical Phase: The discovery phase involves the identification of a novel digital therapeutic intervention. At this stage, researchers publish their work in academic journals and continue to investigate the potential applications of their digital solutions in disease treatment / management.

Clinical Trials and Validation: This phase involves the conduct of proper clinical trials to validate the claims made by a digital therapeutic solution providers, and to evaluate its potential in a real-world setting. It includes testing of the software / hardware on a specific patient population. In case of clinical studies, health outcomes are measured and tracked through data driven insights provided by the software. Disease specific improvements (post application / implementation of the intervention) are also tracked to evaluate the performance of a product. There are multiple challenges associated with conducting clinical trials for digital therapeutics. Firstly, technologies are known to change rapidly and there is a very high probability for a software to undergo upgrades / improvements over the duration of a clinical trial. As a result, there are technical issues in storing and updating patient data. Secondly, digital interventions cannot be studied in a double-blind manner, because the investigator is always aware of whether a trial subject is in the control group or being treated with the intervention under evaluation. Finally, at present, there is less structure and guidelines available, and as a result meaningful and conclusive insights are difficult to be drawn from such trials.

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