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With digitization advancing at a rapid pace, the healthcare industry has seen significant transformation in recent years. Better treatment and health monitoring are now possible both inside and outside of clinics and hospitals thanks to the development of smart medical devices, software apps, cloud-based data platforms, and electronic health records. Recently, cutting-edge technological solutions falling under the category of digital therapeutics (DTx) have turned a new page.

The use of DTx in healthcare has expanded because of advancements in technology and the growing influence of AI and mobile devices in our daily lives. Big pharma has been interested in DTx because of its potential to improve health outcomes when used in conjunction with medications. As a result, these businesses have begun to make investments in DTx and form strategic collaborations with IT companies.  

Thanks to this new development, patients will have more opportunity to take an active role in managing their disease and become more conscious of their health.

According to a report by MarketsandMarkets, the market for DTx is predicted to reach a valuation of $21.9 billion (USD) by 2028 growing at a CAGR of 29.1 % from 2023 to 2028.

In this article, we will review the trends in the development of DTx over the past decade, the current emerging technologies, future prospects, and some of the challenges faced by companies looking to commercialize DTx applications.

Trends over the Past Decade and Future Predictions

In terms of therapeutic areas under examination, in the past decade, trials pertaining to psychiatric indications have accounted for the largest number (25%), and there is compelling evidence to support the efficacy of digital cognitive behavior therapy (DCBT) in this domain. Cardiovascular (11%), endocrine (10%), neurology (8%), addiction (10%), and respiratory (7%), in that order, come next. 

There has been minimal study to examine the efficacy of digital modalities in chronic nephrology and gastrointestinal reasons, despite the fact that traditional cognitive behavior therapy (CBT) has been successful in improving health outcomes in these domains.
The development of therapeutic applications for a wide range of neuroscience indications, including attention deficit hyperactivity disorder (ADHD), autism spectrum disorder (ASD), schizophrenia, depression, and bipolar disorder, dominates commercial research and development (R&D), according to a pipeline review of nine top DTx companies.

 Moreover, patterns observed in clinical trials during the previous 10 years are consistent with an emphasis on the development of treatments for cardiovascular disease (CVD), including hypertension, hyperlipidemia, and acute coronary syndrome (ACS).

Three Key Trends in Digital Therapeutics to Watch

As the market is growing, let’s see some of the key trends to watch for Dtx.

Direct to Consumer (DTC) 

Healthcare organizations have started taking this approach lately with their ADHD treatments. It is expected that others will follow suit, focusing on people with the financial means rather than requiring payer approval. It will rely on elements like the size of the addressable market and how well the therapy area fits within DTC.
Neurology and Mental Health will be important fields. The use of AI for behavioral support, therapy, and nudges in place of human interaction will increase the industry’s growth and profitability. This is what DTC models should use. 

Given that in-person therapists cost over $1000 per month and internet therapists charge about $300, why wouldn’t you spend at least $100 for an excellent AI program? On the plus side, prices will continue to decline due to competition and advancements in AI.

Growth in Integrated Ecosystems

Every facet of assisted living, including ambient and on-body sensors and communications through apps, tablets, and smart speakers, will be included into digital treatments for diseases like Alzheimer’s.
With advancements in wearables and CGMs that go beyond simple phone apps, such ecosystems are being seen in diabetes and mental health. The availability of standalone DTx apps will decline. 

Digital therapeutics startups and leading players have been using video interviews to treat ailments like Type 2 diabetes, enslavement, chemical imbalances, and external muscle wounds. They have also been distributing educational materials and online journals on their websites and utilizing applications to access medical services programs.

Prevention and Wellness Focus 

Those who can demonstrate that their products work in areas like diabetes prevention and weight loss and maintenance will emerge victorious. In the future, AI-driven behavior modification will be the main focus, with human coaches playing a smaller role in order to maximize profitability and scale.
Aversion to physical center visits in order to reduce the likelihood of disease, an increase in psychological wellness difficulties, and an increase in mindfulness with regard to wellbeing have all heightened interest in computerized treatments after the COVID-19 pandemic.

DTx’s success in healthcare: Examples to keep the pace going on

  • The Mayo Clinic and Healarium conducted a study that revealed a 40% decrease in three-month rehospitalizations and ER visits, a 4.0-kilogram weight loss, and a 10.8-millimeter drop in systolic blood pressure for patients with acute myocardial infarction. Tracking vital signs, food, and exercise was part of the trial, along with goal-setting and reminder-setting, providing information on patients’ current health, and patient education sessions.
  • Johns Hopkins and Corrie Health conducted a study in the US with over a thousand patients, and the results revealed a 50% decrease in the 30-day readmission rate for patients with AMI who received digital health-based therapies. The study included medication management through reminders and tracking adherence, mood tracking, connection with the care team, and continuous vitals monitoring with connected devices.
  • Patients with type 2 diabetes who took part in an online patient community as part of Virta Health’s ten-week nonrandomized parallel arm research involving 262 outpatients demonstrated a one-percentage-point decrease in HbA1c values. Through online medical counseling, continuous glucose monitoring kits, and specialized health coaches, the patients received personalized dietary advice.

Regulatory Challenges

The FDA’s Center for Devices and Radiological Health (CDRH) has stated, through its Digital Health Innovation Action Plan, that although the ultimate purpose of regulation is to guarantee that DTx applications are safe and effective, the regulatory landscape for DTx is still changing.

  • Revised FDA regulations on digital treatments, particularly with multifunctionality, software updates for current devices, and the clinical application of software as a medical device (SaMD).
    • The creation of the Software Precertification Program (Pre-Cert) was intended to eliminate the requirement for a premarket submission for specific goods, enabling a marketing submission to be reviewed more quickly and/or with less information.
    •To improve the quality, predictability, consistency, timeliness, and efficiency of decision-making for individual products and developers, the CDRH should hire more personnel with deep experience in software development and its application to medical devices or chemical and biological entities.

The Bottomline

Finally, the field of digital therapeutics (DTx) is changing, pointing to a time when artificial intelligence (AI) will power integrated digital ecosystems that can help both avoid actual disease. The competition will increase, while the difficulty of payer acceptance and reimbursement will lessen.
The potential of DTx to improve public health and save healthcare costs grows together with its therapeutic use and market penetration. Regulators, payers, and providers will be forced to reconsider their methods in order to make sure they are still appropriate for the job.

At Codewave EIT, there is the right tech for the right care. Our motto is maximizing patient centricity, and developing AI-assisted diagnosis, prognosis & predictions.

Codewave EIT works with hospitals, healthcare organizations, and connected industries (such as online pharmacy, telemedicine, in-house healthcare, fitness & wellness centers, biotech R&D, and smart medical devices) helping them reimagine their digital future with a unique data strategy driving high patient engagement and integrating technologies & tools into their organizational processes, to deliver maximum patient value.

To stay updated in the field of healthcare, feel free to speak to our team and explore our range of digital interventions.