digital therapeutics marketdigital therapeutics market


Digital therapeutics is often known as software as a medicine is a popular alternative to traditional treatment. It comprises digital tools for the management, prevention, and treatment of the disease. Digital therapeutics also serve as a remote monitoring system, enabling healthcare experts to provide care to patients in their home settings. This type of digital therapeutics can be implemented independently and in combination with additional therapies for the treatment of behavioral and physical conditions including anxiety, diabetes, pain, and post-traumatic disorder.

Owing to its significance, digital therapeutics companies are adopting this holistic approach to track real-time data and finding new opportunities to provide sustainable options for healthcare. It is worth highlighting that the FDA has sanctioned the Breakthrough Device Designation Program to approve digital therapeutics. With ongoing efforts and approval from regulatory bodies, it is expected that the digital therapeutics market is expected to grow at a CAGR of 20% in the future.

Current Digital Therapeutics Market Landscape

At present, the digital therapeutic market is booming at a steady rate due to the increasing awareness of real time data monitoring for the treatment of the patients. Digital therapeutics uses an evidence-based approach to deliver medical interventions to patients for the treatment of a broad spectrum of diseases. Several government bodies, regulatory bodies, and digital therapeutics companies provide considerable support to upscale the production of digitized therapeutics.

It is worth noting that, recently, the FDA has approved ReSET™ and ReSET-O™, which Pear Therapeutic developed for the treatment of substance use disorders. The application has been used in combination with buprenorphine to enhance the retention of patients with drug addiction. Though the digital therapeutic market seems to hold a bright future, several challenges are yet to be overcome.

Common Challenges Faced by Digital Therapeutic Market Players

While the technology made it feasible to collect information for clinical trials, seeking FDA clearance is a big challenge. For instance, the lack of FDA clinical oversight is a major challenge for digital therapeutic companiesl. Therefore, the digital health market is accelerating its efforts to overcome those challenges and bring more solutions. As digital software proliferates, companies are focusing on fetching validated data to confirm clinical validity.

▪          Adoption of Digital Therapeutics

The adoption of digital therapeutics is a major challenge that companies have faced recently. For instance, if digital therapeutics do not provide immediate outcomes, it may create problems in the treatment of patients where it may require long-term use.

▪          Data Privacy and Management

Digital therapeutics uses the Internet of Things and cloud software to transmit data on different devices. There may be a risk of unauthorized access to the information of the patients, causing problems in patient care. Currently, the FDA does not mandate the completion of pre-market medical device safety evaluations. Device makers are responsible for determining the degree of cybersecurity risk attached to their goods and taking steps to reduce that risk. The FDA then assesses the manufacturer’s paperwork on design and risk management to determine if it provides a reasonable level of assurance of safety and effectiveness. Manufacturers may establish and distribute corporate and user data rights to track, assess, and share the gathered data by using the Terms of Service, End User License Agreements, and Privacy Policies.

▪          Regulatory Approval From the FDA

Digital therapeutics is an entirely new class of therapies and has unexplored broad applications. Therefore, no universal standards have been set for the evaluation and approval of therapeutics from the FDA and other regulatory bodies. The FDA is a global organizer for addressing the challenges companies face with manufacturing digital therapies, and today, it has become flexible in the approval of drugs. Currently, the FDA has two options to place a digital therapeutic in the market.

1.      FDA Approval: The approval for digital therapeutics from the FDA has been obtained if the product sophisticatedly passes the rigorous clinical trials for safety and efficacy.

2.      FDA Statement: The statement is granted to the digital therapeutics when it doesn’t pose a potential risk to the patient.

In addition, the Digital Health Software Pre-Certification Program by the FDA is specially designed for the validation of software-based therapeutic devices. Therefore, the digital therapeutic industry can harness the program to support research and development of unique solutions.

▪          Digital Therapeutic Cost Settlement

Setting the reimbursement value of the digital therapeutic depends on how much the client is willing to pay. Most of the payers choose a new therapeutic drug to reduce the cost of healthcare services and emergency calls by receiving treatment in remote settings. If digital therapeutics show effective results and minimizes the complications associated with treatment, payers are willing to pay reimbursement.

Since the digital therapeutics reimbursement policies have been designed by the regulatory bodies at the national level, the segmented policies may create challenges in digital therapeutics validation. The segmented reimbursement policies approval may increase the cost and cause delay in the marketing. If digital therapeutic companies successfully evaluate the cost-effectiveness and treatment efficacy, they are likely to settle reimbursement costs properly.

Digital Therapeutics Market: Future Outcomes

By focusing on all these potential challenges, digital therapeutic companies will implement development and curation platforms. The tech-enabled platforms enhance the speed of manufacturing and allow companies to emphasize the business. Furthermore, in the future, companies are likely to adopt innovative technology such as tactile sensation, computing, biochips, holographic displays, and volumetric and natural programming languages that help to reshape the digital therapeutic market. With ongoing adoption and increasing efforts, it is anticipated that market players will emerge with promising solutions and expand the production of digital therapeutics to uncover potential applications.

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