디지털 치료 기기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the digital therapeutics device market size is expected to grow from USD 9.96 billion in 2025 to USD 12.46 billion in 2026 and is forecast to reach USD 38.19 billion by 2031 at 25.14% CAGR over 2026-2031.

This report is Segmented by Product Type (Software-Only Digital Therapeutics, Connected Devices and More), Therapeutic Area (Preventive [Pre-Diabetes, and More] and Treatment [Diabetes and More]), Modality (Standalone Prescription DTx, Dtx + Drug Combination, and More), End User (Patients, Providers / Hospitals and More) and Geography. The Market Forecasts are Provided in Terms of Value (USD).

Global Digital Therapeutics Device Market Trends and Insights

Rising Burden of Chronic Diseases

Escalating rates of diabetes, asthma, chronic obstructive pulmonary disease, and cardiovascular disorders sustain continuous-care requirements that episodic clinical visits cannot satisfy. AI-driven digital twins helped 89% of users lower HbA1c below 7% within 12 months, underscoring clinical effectiveness in diabetes management. Chronic diseases absorb roughly 90% of developed-market spending, sharpening the argument for cost-saving, always-on digital therapies that curb emergency visits and hospitalizations. Respiratory-care applications with smart inhalers improve adherence and trim exacerbations, as documented in real-world studies. Demographic aging further heightens demand for intuitive self-management tools that operate across smartphones, wearables, and connected sensors.

Rapid Mobile & Cloud Technology Maturation

The arrival of 5G, edge computing, and advanced mobile chipsets lets therapeutic algorithms run locally, erasing latency and guarding privacy. Wearable AI built on soft microelectronics now processes data on-device, making continuous therapy unobtrusive and responsive. Mature cloud architectures synchronize information across gadgets and electronic health-record platforms via standard FHIR-based APIs, yielding a single longitudinal patient view that refines decision support. App-store validation programs dedicated to health applications create vetted distribution routes that reassure clinicians and reassure patients.

Data-Security Concerns & Clinician Resistance

Rising cyber-incidents erode trust among physicians and patients, especially when therapies require constant behavioral and physiologic monitoring. European regulators caution that perpetual data flows create heightened breach risk. Liability worries persist because algorithmic suggestions influence medical decisions without clear fault lines when outcomes falter. Privacy-preserving encryption offers a path forward but is costly and computationally heavy, slowing deployment.

Other drivers and restraints analyzed in the detailed report include:

1. Reimbursement Expansion by Payers
2. AI-Driven Hyper-Personalization Boosting Engagement
3. High Development & Validation Costs

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Software-only solutions accounted for 70.68% of the digital therapeutics devices market revenue in 2025, reflecting the healthcare sector's inclination toward low-overhead deployments that integrate seamlessly with existing clinical infrastructure. The segment's lead also stems from rapid update cycles, enabling developers to push algorithm refinements without hardware recalls. Virtual-reality and gaming products hold the highest CAGR outlook at 27.92% to 2031, buoyed by immersive environments that elevate patient motivation and deliver exposure therapy with controlled stimuli. Connected peripherals-such as smart inhalers, glucose monitors, and VR headsets-anchor ecosystem convergence, as platform-as-a-service models provide unified data pipelines that simplify analytics. This progression suggests that sustained leadership will belong to vendors offering end-to-end frameworks, rather than individual point solutions.

The digital therapeutics devices market size for software platforms is projected to increase as electronic health record integration improves. At the same time, the hardware-linked segment commands a growing premium for conditions requiring biometric feedback. Interoperability, powered by open APIs, mitigates earlier fragmentation and encourages hospitals to consolidate multiple therapeutic lines on single dashboards, reducing vendor fatigue and improving clinician acceptance.

Treatment applications accounted for 72.88% of the digital therapeutics devices market share in 2025, thanks to established reimbursement routes and clear diagnostic triggers. Clinicians view treatment-oriented software as a direct substitute or adjunct for pharmaceuticals, expediting prescription within familiar workflows. Preventive solutions-ranging from diabetes risk programs to migraine prophylaxis-are advancing at a 27.11% CAGR, propelled by value-based care models that reward early intervention. FDA clearance of CT-132 marked the first preventive prescription digital therapeutic for episodic migraine, raising confidence among both payers and providers.

As health systems shift toward capitation and shared savings, preventive digital therapeutics become strategic levers for bending cost curves. Corporate wellness contracts further accelerate preventive care uptake, granting developers alternative revenue streams outside of insurer channels. The digital therapeutics devices market size for preventive programs is therefore poised to compound at a faster rate than the treatment segment beyond 2027, even though the absolute value remains smaller throughout the forecast horizon.

Complete Report Scope:

• By Product Type
  • Software-only Digital Therapeutics
  • Connected Devices (smart inhalers, CGMs, VR headsets)
  • Platform-as-a-Service / APIs
• By Therapeutic Area
  • Preventive
    • Pre-diabetes
    • Obesity
    • Smoking Cessation
    • Others
  • Treatment
    • Diabetes
    • Cardiovascular Diseases
    • Neurological Disorders
    • Respiratory Diseases
    • Oncology Support
    • Others
• By Modality
  • Standalone Prescription DTx
  • DTx + Drug Combination (e.g., inhaled therapies)
  • Virtual-Reality / Gaming-based DTx
• By End User
  • Patients (D2C)
  • Providers / Hospitals
  • Payers & Insurers
  • Employers & Corporate Wellness Programs
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America generated 46.31% of 2025 sales, with the U.S. leading the way, rooted in FDA clarity, CMS reimbursement, and an investment ecosystem willing to fund late-stage trials. The launch of three mental-health billing codes in 2025 vaulted digital interventions into mainstream benefit design, driving swift integration across health plans. Canada and Mexico contribute incremental growth as cross-border telehealth collaborations expand.

The Asia-Pacific region is projected to be the fastest-growing territory, advancing at a 27.18% CAGR through 2031. Japan pioneered regulatory models that recognize software as a therapy, prompting domestic pharmaceutical companies to co-develop digital interventions for neurological disorders. China leverages the expansive adoption of mobile payments and urban telehealth portals to scale its chronic disease management programs. In contrast, India's surge in smartphone adoption enables the delivery of low-cost behavioral health applications to remote populations. Australia and South Korea act as test beds for advanced VR and AI algorithms due to high broadband penetration.

Europe shows measured but steady progress under the Medical Device Regulation, which harmonizes classification and post-market vigilance requirements. Germany's DiGA pathway covers more than 74 million insured lives and provides a practical reimbursement precedent that other member states increasingly emulate. France, Italy, and Spain integrate national-health-service pilots, whereas the United Kingdom refines NICE appraisal processes for software therapies. Strict data-protection rules fuel innovation in privacy-preserving analytics, differentiating European vendors on security credentials.

1. 2Morrow Inc.
2. Akili Interactive Labs
3. Better Therapeutics
4. Big Health
5. Biofourmis
6. Canary Health
7. Click Therapeutics
8. Cognoa
9. DarioHealth
10. Happify Health
11. Kaia Health
12. Koninklijke Philips
13. Livongo (Teladoc Health)
14. MindMaze
15. Noom Inc.
16. Omada Health
17. Pear Therapeutics
18. Propeller Health
19. Sword Health
20. Twine Health
21. Virta Health
22. WellDoc

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions and Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Burden Of Chronic Diseases
  • 4.2.2 Rapid Mobile & Cloud Technology Maturation
  • 4.2.3 Government-Backed Preventive-Care Initiatives & VC Funding
  • 4.2.4 Reimbursement Expansion By Payers
  • 4.2.5 AI-Driven Hyper-Personalisation Boosting Engagement
  • 4.2.6 Corporate Well-Being Budgets Shifting To Prescription DTx
• 4.3 Market Restraints
  • 4.3.1 Data-Security Concerns & Clinician Resistance
  • 4.3.2 High Development & Validation Costs
  • 4.3.3 Limited Long-Term Clinical-Outcome Evidence
  • 4.3.4 Algorithmic Bias Triggering Regulatory Scrutiny
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technology Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Bargaining Power of Suppliers
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Threat of New Entrants
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 Market Size and Growth Forecasts (Value-USD)

• 5.1 By Product Type
  • 5.1.1 Software-only Digital Therapeutics
  • 5.1.2 Connected Devices (smart inhalers, CGMs, VR headsets)
  • 5.1.3 Platform-as-a-Service / APIs
• 5.2 By Therapeutic Area
  • 5.2.1 Preventive
    • 5.2.1.1 Pre-diabetes
    • 5.2.1.2 Obesity
    • 5.2.1.3 Smoking Cessation
    • 5.2.1.4 Others
  • 5.2.2 Treatment
    • 5.2.2.1 Diabetes
    • 5.2.2.2 Cardiovascular Diseases
    • 5.2.2.3 Neurological Disorders
    • 5.2.2.4 Respiratory Diseases
    • 5.2.2.5 Oncology Support
    • 5.2.2.6 Others
• 5.3 By Modality
  • 5.3.1 Standalone Prescription DTx
  • 5.3.2 DTx + Drug Combination (e.g., inhaled therapies)
  • 5.3.3 Virtual-Reality / Gaming-based DTx
• 5.4 By End User
  • 5.4.1 Patients (D2C)
  • 5.4.2 Providers / Hospitals
  • 5.4.3 Payers & Insurers
  • 5.4.4 Employers & Corporate Wellness Programs
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company profiles (includes Global level Overview, Market level overview, Core Segments, Financials as available, Strategic Information, Market Rank/Share for key companies, Products and Services, and Recent Developments)
  • 6.3.1 2Morrow Inc.
  • 6.3.2 Akili Interactive Labs
  • 6.3.3 Better Therapeutics
  • 6.3.4 Big Health
  • 6.3.5 Biofourmis
  • 6.3.6 Canary Health
  • 6.3.7 Click Therapeutics
  • 6.3.8 Cognoa
  • 6.3.9 DarioHealth
  • 6.3.10 Happify Health
  • 6.3.11 Kaia Health
  • 6.3.12 Koninklijke Philips NV
  • 6.3.13 Livongo (Teladoc Health)
  • 6.3.14 MindMaze
  • 6.3.15 Noom Inc.
  • 6.3.16 Omada Health
  • 6.3.17 Pear Therapeutics
  • 6.3.18 Propeller Health
  • 6.3.19 Sword Health
  • 6.3.20 Twine Health
  • 6.3.21 Virta Health
  • 6.3.22 WellDoc Inc.

7 Market Opportunities and Future Outlook

• 7.1 White-Space and Unmet-Need Assessment