Digital Therapeutics Today: Up Where We Belong
By Peter S. Kaplan, Founder and President, Synergy Search
Joe Cocker and Jennifer Warnes once sang, “The road is long, there are mountains in our way, but we climb a step every day.” This lyric aptly describes the digital therapeutics (DTx) industry’s journey—moving from turbulent beginnings to a period of validation and opportunity. Today, DTx stands as a credible pillar of modern healthcare, backed by expanding regulatory support, deepening pharmaceutical partnerships, and a wave of global case studies that reinforce both confidence and adoption.
DTx began as an uncertain niche, but now benefits from robust collaborations, real reimbursement pathways, and a growing library of clinical evidence. Prescription digital therapeutics is still early-stage and limited by the lack of an integrated digital health infrastructure. The real value appears when addressing unmet needs—places where molecular drugs fall short. In speaking to industry thought leaders, there is a need for ‘full-stack’ solutions, clinician-led care models where digital tools complement, not replace, traditional therapies. The field needs to prioritize broader systemic improvements such as care navigation, diagnostics, and equitable clinician access over digital therapeutics.
Andy Molnar, SVP Industry Affairs, American Telemedicine Association, champions the potential of digital therapeutics but tempers expectations: “Venture capitalists are only hesitant about the prescription DTx model because of inflated projections—seen particularly from Pear Therapeutics—rather than an inherent flaw in the model itself.” Charlie Hartwell, Managing Director, Bridge Builders Collective, is an early first-mover investor in the Digital Health space, for companies including Pear Therapeutics, and Twill/Happify Health concurs, “Digital as you know, it has a role. It’s not the cure all, it’s not the end all, though for populations it’s a great way to provide access that you can’t get in person, and for people who live in rural areas or in urban areas where it’s sometimes hard to find culturally appropriate care.”
The overhang from Pear Therapeutics’ high-profile bankruptcy has not dampened growth—rather, it has driven more rigorous, evidence-based product development, and encouraged the industry to clarify what real-world value DTx can deliver. Major pharma players like Novartis and Boehringer Ingelheim now invest heavily in “Prescription Drug Use-Related Software” (PDURS), launching products that integrate digital modules with standard therapies to improve adherence and deliver measurable health outcomes.
Europe leads in flexible regulation-Germany’s DiGA framework has already approved more than 60 digital therapeutics for insurance reimbursement, underscoring the region’s speed and adaptability. As Hannes Klöpper, CEO of HelloBetter, shares, “We can bring products to market much faster than drugs,” highlighting their portfolio of six reimbursable prescription products.
The power of digital-pharma partnerships is evident in projects like Otsuka and Click Therapeutics’ digital cognitive behavioral therapy (CBT) adjunct to Abilify MyCite for schizophrenia, which significantly reduced hospitalizations and secured formal label inclusion. In substance use disorders, Pear Therapeutics’ Reset/Reset-O products achieved Medicaid coverage in multiple states, showing clear clinical benefits and cost savings.
U.S. policymakers are paving the way for broader access and sustainable reimbursement of digital therapeutics (DTx) through initiatives like the “Access to Prescription Digital Therapeutics Act” and new CMS supply codes for Software as a Medical Device (SaMD). At the same time, DTx innovation in 2025 is being propelled by advances in artificial intelligence and virtual reality, allowing for real-time, hyper-personalized interventions that adapt to each patient’s unique journey. These data-driven solutions focus on patient engagement and seamless integration with traditional healthcare, helping to set a new standard of care. The sector’s momentum is clear, with North America leading the market—expected to grow from $9–10 billion in 2025 to $32–90 billion by 2035—driven by demand in diabetes, obesity, mental health, and neurological conditions, further fueled by investment and regulatory innovation.
As the song goes, for DTx and patients alike, “love lifts us up where we belong”, Digital therapeutics has evolved beyond its experimental roots to become a core component of modern, evidence-based healthcare, offering measurable benefits and broader accessibility. With the combined forces of continual innovation, strategic partnerships, and supportive policy, DTx is set to transition from a supplemental “add-on” to an indispensable part of patient care—delivering truly personalized, integrated solutions that realize the full promise of improved outcomes for diverse populations across healthcare.