Digiceuticals: The Future of Digital Therapeutics in Healthcare
If you follow the recent trends in pharma and healthcare, you must’ve heard the term digiceuticals, which has become inescapable. To the ever-changing field of therapeutics, Digiceuticals may be recent additions, but they have managed to excite everyone with their potential. What makes digiceuticals stand out is their ability to weave together the threads of technology and healthcare to provide easier access and management to patients and provide data to the healthcare and pharma industry to continue the improvements. Digiceuticals represent an entirely new class of therapeutics in healthcare. Digiceuticals or Digital Therapeutics are software interventions that are clinically validated and are used to prevent, manage, or treat medical conditions. The primary goal of digiceuticals remains optimisation of patient care and healthcare outcomes, whether used independently or along with medications. Digiceuticals are often confused with wellness and health-related apps, though digiceuticals might seem to mimic these apps, digiceuticals far exceed them in terms of their usability. The emergence of digiceuticals promises a new era in the healthcare systems; to call them mere apps would be wrong. Digital therapeutics are diligently crafted tools purposefully designed to treat, manage, and even prevent various health conditions in their early stages. Digiceuticals go through rigorous clinical testing and real-world studies to get approved by regulatory bodies, unlike wellness or health-based apps.
Like every other machinery, digiceuticals also need regulation. Digiceuticals are regulated under the SaMD (Software as a Medical Device) framework, introduced by the International Medical Device Regulators Forum (IMDRF). Digiceuticals primarily works via data collection and provides real-time guidance to patients (done by using sensors or by asking patients for information) to provide specific therapeutic interventions. But the transformative power of digiceuticals lies in their ability to foster patient engagement and provide evidence-based, real-time interventions. The reported cases of chronic conditions like diabetes continue to rise, and the therapy for such chronic conditions often ends up being demanding and calls for regular monitoring and assistance. Unfortunately, regular access to healthcare systems and assistance is not a universal experience, and regular checkups can put strain on both time and finances for many patients. Digiceuticals offers a promising solution to this problem. In present times, over 60% of the global population are internet users, digiceuticals have become the go-to alternative as they are readily available, less time-consuming and economic too.
The market range of digiceutical products is broad enough to include compliance assistance tools to CBT, and neuromodulation devices. The current market players include Welldoc, which introduced the first ever FDA-approved smartphone prescription medication for Type-2 Diabetes known as BlueStarTM, Propeller Health, which is concerned with the management of respiratory disease and COPD, Voluntis, aimed to help patients self-manage, Akili Interactive Labs, Inc., operates as a digital medicine company that develops platform technology that tests and enhances cognitive abilities through video games. The Research and market analysis valued the global market for digiceuticals to reach $12.1 billion by 2026. According to Future Market Insights, the global market of digiceuticals will reach $101.66 billion by 2023. With such positive projections of growth, it’s no wonder that about 150 major pharma companies are all competing to launch their digiceuticals. To manage the surge of software and mobile applications offering clinical benefits, the FDA has introduced a “Precertification Program” for providers.
There is no doubt that digiceuticals will play a key role in the new chapter in healthcare. The data-driven therapeutic approach of digiceuticals gets the patients to become more active in managing their health and take charge of their health journeys. By reducing the need for hospital visits and expensive interventions, digiceuticals can alleviate some of the burdens on the healthcare systems, too. As we stand on the brink of this exciting frontier, we must acknowledge that the path ahead is not an easy one. The current world continues to get more complex for simple-minded beings; the fast-paced developments in pharma and therapeutics risk leaving a lot of patients behind. The widespread adoption of digiceuticals cannot become a possibility without some positive interventions. As exciting as the NEW is, it is also frightening because it is not known. Digiceuticals, even with all their merits, face scepticism due to a lack of general awareness. Privacy concerns are another thing that makes it hard for patients to fully embrace it. Education and awareness are the keys that can truly unlock the potential of digital therapies. By illuminating the benefits and addressing the concerns surrounding digiceuticals, we can help patients and providers alike embrace the unknown NEW, but this will not be possible without embracing the collaborative approach among technology developers, healthcare professionals, and regulatory bodies.
Author:
Jay Vishwakarma
Assistant Professor
NRI Institute of Pharmaceutical Sciences (NIPS)