5 Trends In Digital Therapeutics For 2025

By Acacia Parks, Ph.D., MBA, CEO, Liquid Amber

Despite industry pitfalls we’ve seen in the past, digital therapeutics (DTx) are poised to gain momentum by showcasing their viability in addressing unmet healthcare needs, improving patient outcomes, and complementing traditional treatments over the next year.

Expansion In Mental Health And Other Therapeutic Areas

DTx has traditionally been rooted in areas like mental health and chronic disease management, and we’ll continue to see developers drive innovation in these areas — bringing new digital therapies to market and refining existing technologies, especially in new indications where there are no or limited existing digital health interventions.

For example, Pfizer recently released a new digital application for migraine management that helps patients better understand and manage their symptoms through personalized insights and education. Given the prevalence and global burden of migraines, it’s likely we’ll see more manufacturers homing in on this condition as well.

The digital health sector also will expand to new therapeutic domains, including:

• Oncology: Used to complement patients’ existing oncology care, DTx products are emerging as a valuable tool in addressing side effects such as pain, nausea, and fatigue, as well as anxiety and depression associated with cancer diagnoses.
• Women’s health: With helpful features such as symptom tracking, behavioral coaching, telehealth, and more, the women’s health sector will continue to see rapid adoption of digital therapeutics.
• Pediatric conditions: We’ve seen DTx interventions transform pediatric care by tackling ADHD, autism, and anxiety with engaging, interactive designs to address their symptoms.

Evolving Approaches To FDA Interactions

As the industry continues to mature, DTx companies need to continue engaging with the FDA early and often as they develop their products. This includes meeting with the Agency to gauge their thoughts on endpoints, study designs, and statistical approaches before conducting a trial, as well as at key milestones throughout development, such as the conclusion of a study.

Lack of robust clinical evidence, issues with data privacy, and regulatory missteps encompass the challenges developers face in obtaining FDA approval for their digital therapies. Many companies approach the FDA expecting to be guided on how to conduct their research or obtain clearance, which can delay the start of trials or market approval, especially if studies have already been conducted without a clear understanding of what’s needed for clinical validation. I’m hopeful that these companies will learn from their and others’ mistakes going into the next year.

The Future Of DTx And Healthcare Provider Partnerships

Seamless integration of DTx into clinical workflows will require stronger partnerships between DTx companies and healthcare providers. In 2025, these collaborations will be driven by co-design initiatives where providers play a central role in shaping the design and deployment of digital therapies. This will ensure that DTx tools address real-world challenges, such as fitting within the constraints of short appointment times or interfacing with existing electronic health records (EHRs).

Additionally, we’ll see a rise in clinical decision support (CDS) tools that integrate with DTx platforms, equipping providers with actionable insights to guide patient care. The success of these partnerships will hinge on DTx companies’ ability to demonstrate the simplicity, scalability, and tangible value of their solutions within the realities of modern clinical practice.

Predictions For Reimbursement Models

Reimbursement remains one of the greatest challenges for the DTx industry. However, in July of this year, the CMS introduced a potential new reimbursement pathway for "digital mental health treatment" (DMHT) devices and services in its 2025 Medicare Physician Fee Schedule Proposed Rule. This marks a monumental milestone for the DTx industry, where insurance companies have yet to offer reimbursement.

The introduction of three new codes anticipated for 2025 could pave the way for Medicare reimbursement frameworks for the treatment of chronic diseases and other therapeutic areas. This development has the potential to enhance the credibility of digital therapeutics by highlighting their ability to deliver measurable health outcomes. Ideally, it could also encourage the private insurance sector to adopt similar approaches.

The three proposed codes will reimburse physicians for:

• GMBT1: Prescribing FDA-approved DTx devices for mental health
• GMBT2: The first 20 minutes of managing a patient’s DTx device each month
• GMBT3: Each additional 20 minutes of management

AI-Driven Innovation

AI and ML will continue to redefine DTx development and delivery in 2025, accelerating innovation and transforming patient outcomes. AI-powered algorithms will enable hyper-personalized interventions in real time, adapting content and strategies based on user data. These advancements will enhance engagement and treatment efficacy, ensuring that patients receive the most effective therapy for their unique needs. At the same time, strong evidence-generation programs will help to differentiate science-backed products from the thousands of digital health products out there that are not based in, or tested by, science.

On the operational side, we’ll see more sponsors and CROs integrating AI within their everyday workflows. Companies will continue to leverage AI to streamline clinical trial design by identifying ideal patient populations and optimizing study endpoints through predictive analytics, reducing time and costs. AI also has untapped potential to improve diversity in trial populations with natural language processing (NLP) tools to provide translation services, remote monitoring to allow virtual participation, and data-driven site selection to identify sites with specific demographic populations. This sets the stage for developers to demonstrate value to payers by forecasting long-term outcomes and cost savings with greater precision.

A Call To Action For DTx Innovators

To thrive in 2025, DTx companies must prioritize collaboration with regulators, healthcare providers, and payers. Proactive engagement, combined with a relentless focus on evidence generation and user-centric design, will enable the industry to realize its full potential. By building trust and demonstrating value across stakeholders, DTx has the opportunity to not only transform individual patient care but also redefine how we deliver healthcare on a global scale. The steps we take today will determine how quickly and effectively these innovations can make a lasting impact on patients' lives.

About The Author:

Acacia Parks, Ph.D., MBA, who serves as an advisor to Lindus Health, is a digital health executive whose experience revolves around scientific, product, and regulatory strategy for digital therapeutics/software as medical device (SAMD). As chief science officer of Twill (fka Happify) for 10 years, she built evidence-generation strategies for direct-to-consumer, enterprise, healthcare, pharma, and FDA audiences. She then spent a year as chief behavioral health officer at Found, a telemedicine weight loss company, building its behavior change program, both digital product and coaching offerings. Now, she runs Liquid Amber, a consulting firm that delivers strategic advice to DTx companies and investors with a focus on products with high scientific and regulatory complexity, including novel mechanisms of action and delivery methods and combination drug/DTx products, across a variety of therapeutic areas (including cancer, obesity, treatment-resistant depression, Alzheimer's, social anxiety, ADHD, and chronic disease).