What's the latest news in digital therapeutics?

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2025 has emerged as a transformative year for digital therapeutics, marked by unprecedented partnerships, regulatory breakthroughs, and market expansion across mental health, diabetes, and oncology applications.

For entrepreneurs and investors entering this space, understanding the current landscape means recognizing that digital therapeutics are no longer experimental—they're becoming integral to healthcare delivery with clear reimbursement pathways and proven clinical outcomes.

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What are the most significant partnerships, acquisitions, and investments in digital therapeutics announced since January 2025?

The digital therapeutics industry witnessed three major acquisition deals in 2025, led by ATA Action's acquisition of the Digital Therapeutics Alliance in March to form the "Advancing Digital Health Coalition."

Click Therapeutics secured the largest funding round with a $48.5 million Series C led by Dassault Systèmes, featuring strategic participation from pharmaceutical giants Otsuka and Boehringer Ingelheim. This funding specifically targets their FDA-authorized depression and schizophrenia platforms, positioning Click as a leading DTx developer with validated clinical outcomes.

Pear Therapeutics raised $64 million in Series C funding led by Temasek, focusing on their FDA-authorized addiction treatment platforms. The Singapore sovereign wealth fund's investment signals strong international confidence in prescription digital therapeutics with proven regulatory clearance.

Strategic partnerships gained momentum with Noom integrating its weight-management DTx into Collective Health's employer health plans, and knownwell partnering with LillyDirect for metabolic-care DTx integration targeting diabetes and obesity management. These partnerships demonstrate the shift toward embedding DTx solutions directly into existing healthcare delivery systems rather than standalone offerings.

Looking ahead, mental-health DTx startups like MindShift and AI diagnostics companies such as ClarityDx are positioned as prime acquisition targets for Big Pharma in late 2025, driven by the industry's need for validated digital biomarkers and behavioral intervention platforms.

Which companies or startups have launched new digital therapeutic products in 2025, and what clinical indications do they target?

Seven major DTx products launched in 2025, with mental health and chronic disease management dominating the pipeline.

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What regulatory approvals or clearances have been granted by the FDA, EMA, or other major agencies for digital therapeutics in 2025?

The FDA granted significant clearances in 2025, including 510(k) clearance for EpiWatch's seizure-management app for Apple Watch and marketing authorization for Click Therapeutics' prescription DTx for migraine prevention.

Multiple behavioral-health and chronic-disease DTx technologies received Breakthrough Device Designations under the FDA's Digital Health Center of Excellence pathway, streamlining the approval process for innovative solutions with significant clinical benefits. This expedited pathway has become crucial for startups seeking faster market entry with validated clinical evidence.

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In Europe, Germany's DiGA (Digital Health Applications) fast-track program expanded to 68 listed applications by January 2025, covering hypertension, IBS, depression, multiple sclerosis, and chronic pain. The German statutory health insurance (GKV) system reimbursed €234 million for DiGAs in 2024 with 861,000 prescriptions, demonstrating substantial real-world adoption.

The European Medicines Agency (EMA) advanced its qualification framework for AI-enabled Software as Medical Device (SaMD) under the CHMP workplan, providing clearer regulatory pathways for AI-driven DTx solutions. EMA also granted orphan drug designation to Dyne Therapeutics' DYNE-251 for Duchenne muscular dystrophy, reflecting the agency's acceptance of digital endpoints in rare disease applications.

What reimbursement models are being adopted in key markets like the US, Germany, Japan, and South Korea for digital therapeutics in 2025?

The United States implemented groundbreaking reimbursement changes with the Prescription Digital Therapeutics (PDT) Act becoming effective January 2026, creating a dedicated benefit category for FDA-approved DTx under Medicare and Medicaid programs.

CMS introduced new Digital Mental Health Treatment Device (DMHT) codes specifically for FDA-cleared behavioral health applications, enabling direct billing for DTx services. This represents the first systematic approach to DTx reimbursement in the US healthcare system, moving beyond experimental coverage to standardized payment models.

Germany's DiGA fast-track system allows statutory insurers to reimburse both provisional and permanent DiGAs listed by BfArM (Federal Institute for Drugs and Medical Devices). Unlike the US model, German insurers negotiate prices from day one under GKV recommendations, creating immediate revenue opportunities for approved DTx developers.

Japan launched the "Digital Health Japan" pilot program providing limited reimbursement via National Health Insurance (NHI) for behavioral-health apps and remote monitoring solutions. The Ministry of Health is revising national guidelines for SaMD coverage, indicating broader reimbursement expansion in 2026.

South Korea's Health Insurance Review & Assessment Service (HIRA) initiated pilot DTx coverage for insomnia and diabetes applications under outcome-based reimbursement models. The Ministry of Health and Welfare (MOHW) requires demonstrated clinical outcomes and cost-effectiveness data for continued coverage, emphasizing value-based healthcare delivery.

What are the current revenue figures and projected market size for digital therapeutics globally and by region for 2025 through 2030?

The global digital therapeutics market reached $9.73 billion in 2025, representing a significant acceleration from $7.88 billion in 2024, driven by expanding reimbursement coverage and regulatory approvals.

Market projections indicate robust growth at 21.65% CAGR through 2034, reaching $56.76 billion by 2034. Alternative forecasts project even higher growth at 28.2% CAGR, reaching $78.9 billion by 2034, reflecting the uncertainty around adoption rates and reimbursement expansion.

North America dominates with 43.9% market share, equivalent to $3.02 billion in US market value for 2024. The region benefits from advanced regulatory frameworks, established reimbursement pathways, and high healthcare digitization rates among providers and patients.

Europe represents the fastest-growing regional market, driven primarily by Germany's DiGA framework success and expanding adoption across France, UK, and Nordic countries. The European market benefits from harmonized regulatory standards and growing government support for digital health initiatives.

Asia-Pacific remains nascent but shows strong potential, with China leading regional adoption and Japan-South Korea pilot programs indicating future expansion. The region's growth depends on regulatory framework development and reimbursement model establishment across diverse healthcare systems.

Which therapeutic areas—mental health, diabetes, oncology, pain management, etc.—are showing the strongest growth and adoption trends in 2025?

Mental health DTx applications experienced the strongest growth in 2025, driven by FDA-cleared CBT apps, outcome-based reimbursement models, and exceptionally high unmet clinical need in anxiety and depression treatment.

Diabetes and chronic disease management ranked second in adoption rates, fueled by continuous glucose monitoring integration, behavior-change coaching platforms, and comprehensive DiGA coverage in Germany. The therapeutic area benefits from measurable clinical outcomes and clear cost-effectiveness data for payers.

Oncology support platforms gained significant traction through home-based intervention solutions and real-time monitoring capabilities. Companies like Reimagine Care launched comprehensive cancer support platforms that reduce hospital visits while maintaining clinical oversight, appealing to both patients and healthcare systems facing capacity constraints.

Pain management DTx solutions, particularly musculoskeletal digital programs from Kaia Health and HelloBetter, demonstrated strong growth through AI-driven physiotherapy protocols and chronic pain CBT applications. These solutions address the opioid crisis by providing non-pharmacological intervention options with measurable outcomes.

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What evidence of clinical efficacy and real-world outcomes has been published or presented in 2025 for leading digital therapeutic solutions?

Click Therapeutics published randomized controlled trial data for their depression and schizophrenia DTx platforms, demonstrating statistically significant symptom improvement at 12 weeks compared to standard care controls.

Biolinq completed Phase 2 trials for their intradermal glucose sensor, showing accuracy comparable to established CGM devices while offering improved patient comfort and reduced skin irritation. The company's data supports regulatory submissions for broader diabetes management applications.

SPG302 from Spinogenix presented Phase 1/2 ALS trial data showing acceptable tolerability and biomarker alignment supporting expanded access programs. While not a traditional DTx, the trial demonstrates regulatory acceptance of digital endpoints in neurodegenerative diseases.

At the MDA Conference 2025, Dyne Therapeutics presented SV95C functional improvement data for DYNE-251 extending up to 18 months, showcasing digital outcome measures in rare disease applications. This evidence supports broader adoption of digital biomarkers across therapeutic areas.

The Digital Health Alliance published real-world evidence highlighting substantial cost savings, with Sword Health claiming $1 billion in healthcare cost reductions across 500,000 patients treated with their M-band wearable technology. These outcomes demonstrate measurable economic benefits driving payer adoption.

How are pharma companies integrating digital therapeutics into their care models or product pipelines in 2025, and what does that imply for future collaborations?

Pharmaceutical companies pursued two primary integration strategies in 2025: co-development partnerships and direct pipeline embedding of DTx solutions alongside traditional drug therapies.

Otsuka's $300 million partnership with Click Therapeutics for the Rejoyn depression platform exemplifies the co-development model, where pharma companies leverage established DTx platforms to enhance their existing therapeutic portfolios. Boehringer Ingelheim similarly partnered with Click for schizophrenia DTx development, indicating sustained pharmaceutical investment in validated digital platforms.

Johnson & Johnson and Novo Nordisk initiated exploratory programs for DTx add-ons to their obesity and diabetes portfolios, recognizing that behavioral interventions can significantly improve drug efficacy and patient adherence. These integrations position DTx as complementary rather than competitive technologies.

Roche's Genentech division began trialing digital adherence tools in oncology regimens, addressing the critical challenge of medication compliance in cancer treatment. The company's approach integrates real-time monitoring with clinical decision support systems.

The implications for future collaborations suggest pharmaceutical firms increasingly view DTx as value drivers rather than experimental technologies. This perspective likely accelerates equity investments and M&A activity as pharma companies seek to acquire digital capabilities rather than develop them internally.

What are the biggest barriers to scale—clinical adoption, regulatory complexity, patient engagement, data integration—in 2025 and how are companies addressing them?

Regulatory complexity remains the primary barrier to DTx scaling, despite improvements through FDA's Digital Health Center of Excellence and harmonized ISO/IEC SaMD standards.

• Regulatory Complexity: Companies address this through specialized regulatory consultancies and early FDA engagement via pre-submission meetings. The Digital Health Center of Excellence provides clearer pathways but requires substantial clinical evidence generation.
• Reimbursement Uncertainty: The PDT Act in the US and DiGA Fast-Track refinements in Germany provide framework solutions, while pilot reimbursements in Asia create precedents for broader coverage.
• Patient Engagement: Solutions include gamification approaches like EndeavorRx, AI-driven personalization engines, and wearables integration for seamless user experiences. Companies focus on reducing friction through intuitive interfaces and meaningful feedback loops.
• Data Integration: FHIR-based EHR interoperability efforts and industry APIs address technical integration challenges. The ONC Health IT Request for Information drives standardization across healthcare systems.

Companies increasingly adopt platform approaches rather than standalone applications, recognizing that integration with existing clinical workflows determines adoption success more than individual product features.

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What are the most active or promising digital therapeutic startups founded in the last 12–18 months and what funding rounds have they closed?

Three standout startups emerged in the 12-18 month period, each targeting underserved therapeutic areas with novel technological approaches.

CareLoop, founded in 2024, focuses on psychosis monitoring through advanced behavioral pattern recognition and closed an undisclosed growth round. The company's platform combines smartphone sensors with machine learning algorithms to detect early psychotic episode indicators, addressing a critical gap in mental health monitoring.

Minze Health completed a $5.3 million Series A round for their urology remote diagnostics platform, targeting men's health conditions through at-home testing and telehealth integration. The company addresses the significant underserved market in urological care, particularly in rural areas with limited specialist access.

Reimagine Care launched their home oncology platform in 2024 and closed a Series B round of undisclosed amount. Their solution provides comprehensive cancer support care through remote monitoring, symptom management, and real-time clinical intervention, reducing hospital visits while maintaining care quality.

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These startups demonstrate the market's evolution toward specialized therapeutic areas and technology-enabled care delivery models that address specific clinical gaps rather than broad wellness applications.

Which digital therapeutics platforms are gaining traction with providers and insurers in 2025, and what is driving adoption?

Four DTx platforms achieved significant traction with providers and insurers in 2025, driven by proven outcomes, seamless integration capabilities, and favorable reimbursement models.

What key policy shifts, regulatory frameworks, or health tech initiatives are expected in 2026 and beyond that could impact the digital therapeutics market?

The implementation of the Prescription Digital Therapeutics (PDT) Act in January 2026 will formalize Medicare and Medicaid DTx coverage in the United States, creating the first systematic federal reimbursement framework for digital therapeutics.

CMS plans to introduce National Technology Infrastructure (NTI) guidelines in 2026, establishing technical standards for DTx integration with federal healthcare systems. These guidelines will likely influence private payer requirements and accelerate industry standardization.

The European Union's AI Act enforcement beginning in 2025 will significantly impact AI-enabled DTx solutions, requiring conformity assessments and CE marking for high-risk AI systems in healthcare. The European Health Data Space expansion will enable improved real-world evidence generation across member states.

Germany's G-BA (Federal Joint Committee) assumes DiGA benefit-risk evaluations in 2026, potentially tightening evidence standards based on GKV recommendations. This shift may increase development costs but improve clinical validation requirements.

Global initiatives include OECD and WHO advancement of DTx standards and cross-border reimbursement pilots, facilitating international market expansion for established DTx companies with regulatory clearances in multiple jurisdictions.

Conclusion

Sources

1. American Telemedicine Association
2. DeciBio Digital Health Round-Up
3. Legacy PSCT Healthcare M&A
4. QuickMarketPitch Digital Therapeutics Funding
5. Clinical Leader Trends
6. DeciBio March Round-Up
7. FDA Digital Health Center
8. MTR Consult GKV Report
9. DaVinci DTx DiGA Update
10. EMA CHMP Work Plan
11. Dyne Therapeutics EMA
12. DLA Piper Digital Health
13. AAMI Reimbursement
14. Precedence Research
15. Expert Market Research
16. Neurology Live FDA Update
17. LinkedIn Digital Health Soars
18. LinkedIn Rise of Digital Therapeutics