Japan Digital Therapeutics Market, till 2035: Industry Trends and Forecasts - Distribution by Type of Solution, Type of Therapy, Purpose of Solution, Type of Business Model and Target Therapeutic Area

Description

JAPAN DIGITAL THERAPEUTICS MARKET: OVERVIEW

As per Roots Analysis, the Japan digital therapeutics market is estimated to grow from USD 0.15 billion in 2026 to USD 1.13 billion by 2035 at a CAGR of 23.6% during the forecast period, 2026-2035.

Japan Digital Therapeutics Market - IMG1

JAPAN DIGITAL THERAPEUTICS MARKET: GROWTH AND TRENDS

Digital therapeutics are software or mobile app-based solutions that have been clinically validated to help prevent, treat, or manage diseases or clinical conditions. They have shown to be effective in addressing a variety of disorders, including lifestyle-related diseases, mental health problems, neurological disorders, and substance use disorders. Interestingly, such solutions usually employ evidence based and clinically validated software or technologies, in order to capture real-time / real world patient data and provide improved curative response. Further, these real-world outcomes generated by digital therapeutics may be used to optimize outcomes at the individual patient and population levels.

Considering the ongoing digitization efforts and transformation of the healthcare sector, digital therapeutics have garnered significant attention from industry stakeholders and investors alike. Additionally, government organizations have actively undertaken initiatives, such as enactment of legislation, publishing laws and establishment of regulations in the digital therapeutics industry.

The rising recognition of the advantages of digital therapeutics among healthcare providers, payers, and employers, along with pharmaceutical companies' growing interest in investing in treatment and care-related applications, is driving the market expansion.

It is important to highlight that Japan's digital therapeutics (DTx) market is flourishing due to its rapidly aging population, supportive regulatory reforms, and expanding national health insurance coverage for approved products. This drives demand for innovative solutions to manage chronic diseases, such as diabetes, hypertension, and mental health disorders through remote monitoring and behavioral interventions. Thus, in the future, ongoing regulatory progress and technological developments enable Japan to be at the forefront of global DTx innovation.

Growth Drivers: Strategic Enablers of Market Expansion

Aging demographics, with over 20% of the population above 65, fuel demand for DTx in managing chronic conditions like diabetes, hypertension, mental health issues, and cardiovascular diseases. Regulatory easing for low-risk Software as a Medical Device (SaMD) accelerates approvals and market entry, while advancements in AI, machine learning, and wearables enable personalized interventions. Integration with national health insurance and electronic health records, plus partnerships among hospitals, insurers, and developers, boosts adoption across urban and rural areas.

Market Challenges: Critical Barriers Impeding Progress

Only a few DTx products highlight limited national health insurance coverage, slowing widespread use. Clinician and patient awareness remains low, requiring education to drive acceptance, alongside concerns over data privacy and skilled personnel shortages. Dependence on regulatory reforms and reimbursement pathways means growth hinges on synchronized policy advancements.

Metabolic Disorder: Leading Market Segment

In terms of type of therapeutic area, the Japan digital therapeutics market is segmented across cardiovascular disorders, chronic pain, mental health problems, metabolic disorders, neurological disorders, respiratory disorders, sleep disorders, substance use disorders, and other disorders. Currently, metabolic disorders segment captures around 25% of the overall market share, followed by mental health disorders. The higher share of XX can be attributed to a higher prevalence of the disease and favorable regulatory environments. The increasing elderly population and the rise in chronic diseases create a demand for digital therapeutics aimed at changing behavior and ensuring adherence.

B2B Business Model: Dominating Market Segment

In terms of business model adopted, the Japan digital therapeutics market is segmented across B2B and B2C business model. Currently, majority (~65%) of the market share is held by B2B business model. This is a result of strategic collaborations with healthcare facilities, insurance providers, and businesses that facilitate widespread implementation and integration of reimbursement.

JAPAN DIGITAL THERAPEUTICS MARKET: KEY SEGMENTS

Type of Solution

Software Solution
Gaming Solution
Combination Solution

Type of Therapy

Curative
Preventive

Purpose of Solution

Medication Replacement Solutions
Medication Augmentation Solutions

Type of Business Model

Target Therapeutic Area

Cardiovascular Disorders
Chronic Pain
Mental Health Problems
Metabolic Disorders
Neurological Disorders
Respiratory Disorders
Sleep Disorders
Substance use Disorders
Other Disorders

KEY QUESTIONS ANSWERED IN THIS REPORT

How many Japan digital therapeutics developers are currently engaged in this market?
Which are the leading companies in this market?
Which country dominates the Japan digital therapeutics market?
What are the key trends observed in the Japan digital therapeutics market?
What factors are likely to influence the evolution of this market?
What are the primary challenges faced by Japan digital therapeutics market?
What is the current and future Japan digital therapeutics market size?
What is the CAGR of Japan digital therapeutics market?
How is the current and future market opportunity likely to be distributed across key market segments?

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The report helps in identifying customer demand by understanding the needs, preferences, and behavior of the target audience in order to tailor products or services effectively.
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1. PREFACE

1.1. Introduction
1.2. Market Share Insights
1.3. Key Market Insights
1.4. Report Coverage
1.5. Key Questions Answered
1.6. Chapter Outlines

2. RESEARCH METHODOLOGY

2.1. Chapter Overview
2.2. Research Assumptions
- 2.2.1. Market Landscape and Market Trends
- 2.2.2. Market Forecast and Opportunity Analysis
- 2.2.3. Comparative Analysis
2.3. Database Building
- 2.3.1. Data Collection
- 2.3.2. Data Validation
- 2.3.3. Data Analysis
2.4. Project Methodology
- 2.4.1. Secondary Research
  - 2.4.1.1. Annual Reports
  - 2.4.1.2. Academic Research Papers
  - 2.4.1.3. Company Websites
  - 2.4.1.4. Investor Presentations
  - 2.4.1.5. Regulatory Filings
  - 2.4.1.6. White Papers
  - 2.4.1.7. Industry Publications
  - 2.4.1.8. Conferences and Seminars
  - 2.4.1.9. Government Portals
  - 2.4.1.10. Media and Press Releases
  - 2.4.1.11. Newsletters
  - 2.4.1.12. Industry Databases
  - 2.4.1.13. Roots Proprietary Databases
  - 2.4.1.14. Paid Databases and Sources
  - 2.4.1.15. Social Media Portals
  - 2.4.1.16. Other Secondary Sources
- 2.4.2. Primary Research
  - 2.4.2.1. Types of Primary Research
    - 2.4.2.1.1. Qualitative Research
    - 2.4.2.1.2. Quantitative Research
    - 2.4.2.1.3. Hybrid Approach
  - 2.4.2.2. Advantages of Primary Research
  - 2.4.2.3. Techniques for Primary Research
    - 2.4.2.3.1. Interviews
    - 2.4.2.3.2. Surveys
    - 2.4.2.3.3. Focus Groups
    - 2.4.2.3.4. Observational Research
    - 2.4.2.3.5. Social Media Interactions
  - 2.4.2.4. Key Opinion Leaders Considered in Primary Research
    - 2.4.2.4.1. Company Executives (CXOs)
    - 2.4.2.4.2. Board of Directors
    - 2.4.2.4.3. Company Presidents and Vice Presidents
    - 2.4.2.4.4. Research and Development Heads
    - 2.4.2.4.5. Technical Experts
    - 2.4.2.4.6. Subject Matter Experts
    - 2.4.2.4.7. Scientists
    - 2.4.2.4.8. Doctors and Other Healthcare Providers
  - 2.4.2.5. Ethics and Integrity
    - 2.4.2.5.1. Research Ethics
    - 2.4.2.5.2. Data Integrity
- 2.4.3. Analytical Tools and Databases
2.5. Robust Quality Control

3. MARKET DYNAMICS

3.1. Chapter Overview
3.2. Forecast Methodology
- 3.2.1. Top-down Approach
- 3.2.2. Bottom-up Approach
- 3.2.3. Hybrid Approach
3.3. Market Assessment Framework
- 3.3.1. Total Addressable Market (TAM)
- 3.3.2. Serviceable Addressable Market (SAM)
- 3.3.3. Serviceable Obtainable Market (SOM)
- 3.3.4. Currently Acquired Market (CAM)
3.4. Forecasting Tools and Techniques
- 3.4.1. Qualitative Forecasting
- 3.4.2. Correlation
- 3.4.3. Regression
- 3.4.4. Extrapolation
- 3.4.5. Convergence
- 3.4.6. Sensitivity Analysis
- 3.4.7. Scenario Planning
- 3.4.8. Data Visualization
- 3.4.9. Time Series Analysis
- 3.4.10. Forecast Error Analysis
3.5. Key Considerations
- 3.5.1. Demographics
- 3.5.2. Government Regulations
- 3.5.3. Reimbursement Scenarios
- 3.5.4. Market Access
- 3.5.5. Supply Chain
- 3.5.6. Industry Consolidation
- 3.5.7. Pandemic / Unforeseen Disruptions Impact
3.6. Limitations

4. MACRO-ECONOMIC INDICATORS

4.1. Chapter Overview
4.2. Market Dynamics
- 4.2.1. Time Period
  - 4.2.1.1. Historical Trends
  - 4.2.1.2. Current and Forecasted Estimates
- 4.2.2. Currency Coverage
  - 4.2.2.1. Major Currencies Affecting the Market
  - 4.2.2.2. Factors Affecting Currency Fluctuations on the Industry
  - 4.2.2.3. Impact of Currency Fluctuations on the Industry
- 4.2.3. Foreign Currency Exchange Rate
  - 4.2.3.1. Impact of Foreign Exchange Rate Volatility on the Market
  - 4.2.3.2. Strategies for Mitigating Foreign Exchange Risk
- 4.2.4. Recession
  - 4.2.4.1. Assessment of Current Economic Conditions and Potential Impact on the Market
  - 4.2.4.2. Historical Analysis of Past Recessions and Lessons Learnt
- 4.2.5. Inflation
  - 4.2.5.1. Measurement and Analysis of Inflationary Pressures in the Economy
  - 4.2.5.2. Potential Impact of Inflation on the Market Evolution
- 4.2.6. Interest Rates
  - 4.2.6.1. Interest Rates and Their Impact on the Market
  - 4.2.6.2. Strategies for Managing Interest Rate Risk
- 4.2.7. Commodity Flow Analysis
  - 4.2.7.1. Type of Commodity
  - 4.2.7.2. Origins and Destinations
  - 4.2.7.3. Value and Weights
  - 4.2.7.4. Modes of Transportation
- 4.2.8. Global Trade Dynamics
  - 4.2.8.1. Import Scenario
  - 4.2.8.2. Export Scenario
  - 4.2.8.3. Trade Policies
  - 4.2.8.4. Strategies for Mitigating the Risks Associated with Trade Barriers
  - 4.2.8.5. Impact of Trade Barriers on the Market
- 4.2.9. War Impact Analysis
  - 4.2.9.1. Russian-Ukraine War
  - 4.2.9.2. Israel-Hamas War
- 4.2.10. COVID Impact / Related Factors
  - 4.2.10.1. Global Economic Impact
  - 4.2.10.2. Industry-specific Impact
  - 4.2.10.3. Government Response and Stimulus Measures
  - 4.2.10.4. Future Outlook and Adaptation Strategies
- 4.2.11. Other Indicators
  - 4.2.11.1. Fiscal Policy
  - 4.2.11.2. Consumer Spending
  - 4.2.11.3. Gross Domestic Product (GDP)
  - 4.2.11.4. Employment
  - 4.2.11.5. Taxes
  - 4.2.11.6. Stock Market Performance
  - 4.2.11.7. Cross-Border Dynamics
4.3. Conclusion

5. EXECUTIVE SUMMARY

6. INTRODUCTION

6.1. Chapter Overview
6.2. Digitization in Healthcare Sector
6.3. Next-Generation Healthcare Solutions
6.4. Key Concepts Associated with Digital Health Solutions
- 6.4.1. Cognitive Behavioral Therapy (CBT)
- 6.4.2. Internet of Things (IoT)
- 6.4.3. Big Data
- 6.4.4. Artificial Intelligence (AI)
- 6.4.5. Gamification
6.5. Overview of Digital Therapeutics
- 6.5.1. Key Strategic Initiatives
  - 6.5.1.1. Digital Therapeutics Alliance (DTA)
  - 6.5.1.2. Personal Connected Health (PCH) Alliance
  - 6.5.1.3. Programs Initiated by The Centers for Disease Control and Prevention (CDC)
  - 6.5.1.4. Health Insurance Portability and Accountability Act (HIPAA)
  - 6.5.1.5. National Health Service (NHS) Guidelines
  - 6.5.1.6. United States Food and Drug Administration (USFDA) Regulations for Digital Therapeutics
- 6.5.2. Typical Development and Commercialization Path for Digital Therapeutics
  - 6.5.2.1. Discovery and Preclinical Phase
  - 6.5.2.2. Clinical Trials and Validation
  - 6.5.2.3. Negotiation Involving Insurance Providers / Payers
  - 6.5.2.4. Distribution and Marketing
6.6 Concluding Remarks

7. MARKET LANDSCAPE

7.1. Chapter Overview
7.2. Japan Digital Therapeutics Market: Overall Market Landscape
- 7.2.1. Analysis by Year of Establishment
- 7.2.2. Analysis by Company Size
- 7.2.3. Analysis by Location of Headquarters
- 7.2.4. Analysis by Type of Business Model
- 7.2.5. Analysis by Type of Technology
- 7.2.6. Analysis by Purpose of Solution
- 7.2.7. Analysis by Target Population

8. COMPANY COMPETITIVENESS ANALYSIS

8.1. Chapter Overview
8.2. Assumptions and Key Parameters
8.3. Methodology
8.4. Japan Digital Therapeutics Developers: Company Competitiveness Analysis
- 8.4.1. Small Japan Digital Therapeutics Developers (Peer Group I)
- 8.4.2. Mid-sized Japan Digital Therapeutics Developers (Peer Group II)
- 8.4.3. Large Japan Digital Therapeutics Developers (Peer Group III)
8.5. Capability Benchmarking of top Japan Digital Therapeutics Developers

9. COMPANY PROFILES: JAPAN DIGITAL THERAPEUTICS MARKET

9.1. Chapter Overview
9.2. Susmed
- 9.2.1. Company Overview
- 9.2.2. Product Portfolio
- 9.2.3. Financial Information
- 9.2.4. Recent Developments and Future Outlook
9.3. CureApp
9.4. Hacarus
9.5. Ubie

10. PARTNERSHIPS AND COLLABORATIONS

10.1. Chapter Overview
10.2. Partnership Models
10.3. Japan Digital Therapeutic Solution Providers: Partnerships and Collaborations
- 10.3.1. Analysis by Year of Partnership
- 10.3.2. Analysis by Type of Partnership
- 10.3.3. Most Active Players: Analysis by Number of Partnerships
- 10.3.4. Analysis by Geography
  - 10.3.4.1. Intercontinental and Intracontinental Agreements
  - 10.3.4.2. Local and International Agreements

11. MARKET IMPACT ANALYSIS

11.1. Chapter Overview
11.2. Market Drivers
11.3. Market Restraints
11.4. Market Opportunities
11.5. Market Challenges
11.6. Conclusion

12. JAPAN DIGITAL THERAPEUTICS MARKET

12.1. Chapter Overview
12.2. Key Assumptions and Methodology
12.3. Japan Digital Therapeutics Market: Historical Trends (Since 2022) and Forecasted Estimates (Till 2035)
12.4. Roots Analysis Perspective on Market Growth
12.5 Scenario Analysis
- 12.5.1. Conservative Scenario
- 12.5.2. Optimistic Scenario
12.6. Key Market Segmentations

13. JAPAN DIGITAL THERAPEUTICS MARKET, BY TYPE OF SOLUTION

13.1. Chapter Overview
13.2. Key Assumptions and Methodology
13.3. Japan Digital Therapeutics Market: Distribution by Type of Solution
- 13.3.1. Japan Digital Therapeutics Market for Standalone Software Applications: Historical Trends (Since 2020) and Forecasted Estimates (Till 2035)
- 13.3.2. Japan Digital Therapeutics Market for Combination Offerings focused on Software Application, Historical Trends (Since 2022) and Forecasted Estimates (Till 2025)
- 13.3.3. Digital Therapeutics Market for Combination Offerings focused on Software Application and Personal Coach Historical Trends (Since 2022) and Forecasted Estimates (Till 2025)
- 13.3.4. Digital Therapeutics Market for Combination Offerings focused on Software Application and AI Support, Historical Trends (Since 2022) and Forecasted Estimates (Till 2025)
- 13.3.5. Digital Therapeutics Market for Combination Offerings focused on Software Application and Device, Historical Trends (Since 2022) and Forecasted Estimates (Till 2025)
- 13.3.6. Digital Therapeutics Market for Combination Offerings focused on Software Application, Device and AI Support, Historical Trends (Since 2022) and Forecasted Estimates (Till 2025)
13.4. Data Triangulation and Validation

14. JAPAN DIGITAL THERAPEUTICS MARKET, BY PURPOSE OF SOLUTION

14.1. Chapter Overview
14.2. Key Assumptions and Methodology
14.3. Japan Digital Therapeutics Market: Distribution by Purpose of Solution
- 14.3.1. Japan Digital Therapeutics Market for Medication Replacement Solutions, Historical Trends (Since 2022) and Forecasted Estimates (Since 2022) and Forecasted Estimates (Till 2035)
- 14.3.2. Japan Digital Therapeutics Market for Medication Augmentation Solutions, Historical Trends (Since 2022) and Forecasted Estimates (Since 2022) and Forecasted Estimates (Till 2035)
14.4. Data Triangulation and Validation

15. JAPAN DIGITAL THERAPEUTICS MARKET, BY TYPE OF THERAPY

15.1. Chapter Overview
15.2. Key Assumptions and Methodology
15.3. Japan Digital Therapeutics Market: Distribution by Type of Therapy
- 15.3.1. Japan Digital Therapeutics Market for Curative Therapy, Historical Trends (Since 2022) and Forecasted Estimates (Since 2022) and Forecasted Estimates (Till 2035)
- 15.3.2. Japan Digital Therapeutics Market for Preventive Therapy, (Since 2022) and Forecasted Estimates (Till 2035)
15.4. Data Triangulation and Validation

16. JAPAN DIGITAL THERAPEUTICS MARKET, BY BUSINESS MODEL

16.1. Chapter Overview
16.2. Key Assumptions and Methodology
16.3. Japan Digital Therapeutics Market: Distribution by Business Model
- 16.3.1. Japan Digital Therapeutics Market for B2C Model, (Since 2022) and Forecasted Estimates (Since 2022) and Forecasted Estimates (Till 2035)
- 16.3.2. Japan Digital Therapeutics Market for B2B Model, (Since 2022) and Forecasted Estimates (Till 2035)
16.4. Data Triangulation and Validation

17. JAPAN DIGITAL THERAPEUTICS MARKET, BY THERAPEUTIC AREA

17.1. Chapter Overview
17.2. Key Assumptions and Methodology
17.3. Japan Digital Therapeutics Market: Distribution by Therapeutic Area
- 17.3.2. Japan Digital Therapeutics Market for Cardiovascular Disorders (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.3. Japan Digital Therapeutics Market for Chronic Pain, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.4. Japan Digital Therapeutics Market for Mental Health Problems, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.5. Japan Digital Therapeutics Market for Metabolic Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.6. Japan Digital Therapeutics Market for Neurological Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.7. Japan Digital Therapeutics Market for Respiratory Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.8. Japan Digital Therapeutics Market for Sleep Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.9. Japan Digital Therapeutics Market for Substance Use Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
- 17.3.10. Japan Digital Therapeutics Market for Other Disorders, (Since 2022) and Forecasted Estimates (Till 2035)
17.4. Data Triangulation and Validation