정신건강 분야 의료기기 소프트웨어(SaMD) 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the software as a medical device for mental health market size was valued at USD 10.26 billion in 2025 and is estimated to grow from USD 12.44 billion in 2026 to reach USD 27.40 billion by 2031, at a CAGR of 17.45% during the forecast period (2026-2031).

This report is Segmented by Type (PDTs, CDSS, Remote Monitoring, Companion Software), Therapeutic Area (Depression, Anxiety, Insomnia, Substance Use, and More), Delivery Mode (Mobile Apps, Web-Based, Hybrid, Wearable-Integrated), End User (Patients, Providers, and More), and Geography (North America, Europe, Asia-Pacific, MEA, South America). Forecasts in Value (USD).

Global Software As A Medical Device (SaMD) For Mental Health Market Trends and Insights

Rising FDA and Regulator-Backed Clinical Validation

The software as a medical device for mental health market is benefiting from a clearer regulatory pathway than it had a few years ago. A 2025 peer-reviewed review identified 19 FDA-authorized mental health SaMD products across digital therapeutics, biofeedback tools, remote monitoring systems, and software-based care support applications. This expanding base provides developers with visible product precedents and gives providers greater confidence in clinical adoption.

The same review noted that many later products relied on substantial equivalence to earlier De Novo predicates, giving established players an advantage as product lineages deepened. This trend is reshaping competition, as newer entrants must meet a higher evidence and compliance threshold to build trust. Over time, it should support higher-quality products, stronger clinical acceptance, and more durable commercial positions for companies with cleared assets.

Expansion of Reimbursement Pathways for Prescription Digital Therapeutics

Reimbursement remains one of the strongest growth levers in the software as a medical device for mental health market. CMS activated the G0552 to G0554 billing codes on January 1, 2025, allowing Medicare providers to bill for eligible digital mental health treatment devices and related clinical services. This policy shift turns clinical validation into a more viable revenue pathway, especially for products that require prescription oversight.

The Access to Prescription Digital Therapeutics Act of 2025 also indicated that federal policy was moving toward a more formal benefit structure for these tools, including manufacturer reporting obligations and pricing transparency. In Europe, Germany continued to serve as an important reference point through DiGA, and the 2026 update linked at least 20% of reimbursed pricing to outcomes performance. Together, these reimbursement changes improve buyer visibility and make the market more investable.

Slow and Uneven Payer Coverage for Novel Digital Therapeutics

The software as a medical device for mental health market continued to face uneven coverage even after the 2025 Medicare milestone. CMS opened an important route for eligible digital mental health treatments, but broader payer adoption across plans and care settings remained in progress. Provider willingness to prescribe and operationalize these tools varied widely depending on reimbursement clarity. This created a split commercial picture, with some employer-backed or provider-led programs moving ahead quickly while other parts of the care system remained cautious. This uneven pace slowed scale-up for products that required prescription support, workflow integration, and repeat provider engagement. Until coverage becomes more consistent, the market is expected to show stronger adoption in channels where payment visibility is better.

Other drivers and restraints analyzed in the detailed report include:

1. Employer and Payer Demand for Scalable Mental Health Solutions
2. AI-Enabled Personalization and Measurement-Based Care
3. High Clinical Evidence Burden and Long Reimbursement Timelines

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

Segment Analysis

Prescription digital therapeutics held 38.55% of the type segment in 2025, making them the largest revenue contributor in the software as a medical device for mental health market. Their lead reflected a stronger clinical identity, higher physician relevance, and better alignment with formal reimbursement pathways than lower-acuity companion applications. Rejoyn, cleared in 2024 as the first prescription digital therapeutic authorized for adjunctive treatment of major depressive disorder symptoms in adults, showed that smartphone-based interventions could meet FDA standards for clinical use. This milestone strengthened the business case for products that providers could prescribe, monitor, and bill within established workflows.

Remote patient monitoring and digital biomarker software is projected to grow at an 18.93% CAGR from 2026 to 2031, making it the fastest-moving type in the software as a medical device for mental health market. A 2025 review in JMIR found consistent support for passive sensing across 42 peer-reviewed studies, covering mobility, sleep, social activity, and voice-related patterns. This evidence base expanded mental health software from treatment delivery to continuous measurement and tracking. As products shift from symptom support to longitudinal monitoring, biomarker-driven tools are likely to play a larger role in relapse prevention, therapy adjustment, and clinical oversight.

Depression accounted for 34.22% of therapeutic area revenue in 2025, giving it the largest position in the software as a medical device for mental health market. The segment benefited from a large diagnosed population, a more established cognitive behavioral therapy evidence base, and clearer regulatory familiarity for digital treatment models. Product proof points, including Rejoyn for major depressive disorder and SleepioRx and DaylightRx in related reimbursable behavioral treatment pathways, supported commercial confidence. Anxiety, insomnia, and sleep disorders also remained attractive due to strong payer and employer demand and alignment with digital behavior-change models.

ADHD is projected to grow at a 19.67% CAGR from 2026 to 2031, making it the fastest-growing therapeutic area in the software as a medical device for mental health market. APA Services noted in 2025 that the 2026 Medicare Physician Fee Schedule proposal extended digital mental health treatment billing to ADHD devices under CFR § 882.5803, creating an important reimbursement signal. This policy direction built on the regulatory foundation established by EndeavorRx and supported follow-on products for structured attention-related interventions. Substance use disorder and PTSD remained active middle-tier categories, while severe mental illness presented white space due to limited cleared products and complex clinical measurement.

Complete Report Scope:

• By Type
  • Prescription Digital Therapeutics
  • Clinical Decision Support Software
  • Remote Patient Monitoring and Digital Biomarker Software
  • Companion and Adjunct Therapeutic Software
• By Therapeutic Area
  • Depression
  • Anxiety Disorders
  • Insomnia and Sleep Disorders
  • Substance Use Disorders
  • Attention-Deficit/Hyperactivity Disorder
  • Post-Traumatic Stress Disorder
  • Schizophrenia and Psychosis
  • Other Mental Health Indications
• By Delivery Mode
  • Mobile Applications
  • Web-Based Platforms
  • Hybrid App and Provider Workflow Platforms
  • Wearable-Integrated Software
• By End User
  • Patients and Consumers
  • Healthcare Providers
  • Payers and Employers
  • Behavioral Health Clinics and Telepsychiatry Networks
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • 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 held 40.56% of the software as a medical device for mental health market share in 2025 and remained the leading commercial region. The United States supported this position through strong FDA authorization pathways, improving reimbursement, and provider familiarity with digital mental health treatment categories. CMS billing codes for eligible devices created a clearer route for prescription-linked products, strengthening revenue conversion and product validation. The region also benefited from a deeper installed base of cleared products and strong employer interest in measurable mental health benefits.

Europe remained the second major regional pillar in the software as a medical device for mental health market. Germany stood out as its DiGA pathway remained one of the most developed national prescription routes for digital health applications. A 2024 review found that mental health applications formed the largest category in Germany's DiGA directory, with 25 listed applications. The 2026 DiGA update required outcomes monitoring and linked at least 20% of reimbursed pricing to performance, raising the standard for evidence-backed adoption.

Asia-Pacific is projected to grow at a CAGR of 19.56% from 2026 to 2031, making it the fastest-growing regional segment in the software as a medical device for mental health market. The region offers strong demand potential as care access gaps remain wider, and digital delivery can expand support without requiring every user to consult an in-person specialist. Japan remains strategically important as its PMDA framework provides a defined path for SaMD review and supports interest in reimbursable digital therapeutic use. South Korea and Australia have more structured digital health environments, while the Middle East and Africa remains early-stage and South America is building a stronger regulatory base.

1. AbleTo, Inc.
2. Akili Interactive Labs, Inc.
3. Behavioral Health Tech, LLC
4. BetterHelp, Inc.
5. Big Health, Inc.
6. Calm.com, Inc.
7. Curio Digital Therapeutics, Inc.
8. Headspace, Inc.
9. Headway, Inc.
10. Koa Health, S.L.
11. Limbix Health, Inc.
12. Lyra Health, Inc.
13. Otsuka
14. Qualifacts Systems, LLC
15. Quartet Health, Inc.
16. Rejoyn, Inc.
17. Spring Health, Inc.
18. Talkspace, Inc.
19. Teladoc Health
20. Wysa Ltd.

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 FDA and Regulator-Backed Clinical Validation for Digital Mental Health Treatments
  • 4.2.2 Expansion of Reimbursement Pathways for Prescription Digital Therapeutics
  • 4.2.3 Employer and Payer Demand for Scalable Mental Health Access
  • 4.2.4 AI-Enabled Personalization and Measurement-Based Care Workflows
  • 4.2.5 Under-Served Psychiatric Comorbidities with Low Therapy Adherence
  • 4.2.6 Post-Acute and Relapse-Prevention Use Cases That Extend Care Beyond Sessions
• 4.3 Market Restraints
  • 4.3.1 Slow and Uneven Payer Coverage for Novel Digital Therapeutics
  • 4.3.2 High Clinical Evidence Burden and Long Reimbursement Timelines
  • 4.3.3 Patient Retention and Engagement Decay After Initial Use
  • 4.3.4 Data Privacy, Cybersecurity, and Algorithm Transparency Concerns
• 4.4 Value/Supply Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Intensity of Competitive Rivalry

5 MARKET SIZE AND GROWTH FORECASTS (VALUE, USD)

• 5.1 By Type
  • 5.1.1 Prescription Digital Therapeutics
  • 5.1.2 Clinical Decision Support Software
  • 5.1.3 Remote Patient Monitoring and Digital Biomarker Software
  • 5.1.4 Companion and Adjunct Therapeutic Software
• 5.2 By Therapeutic Area
  • 5.2.1 Depression
  • 5.2.2 Anxiety Disorders
  • 5.2.3 Insomnia and Sleep Disorders
  • 5.2.4 Substance Use Disorders
  • 5.2.5 Attention-Deficit/Hyperactivity Disorder
  • 5.2.6 Post-Traumatic Stress Disorder
  • 5.2.7 Schizophrenia and Psychosis
  • 5.2.8 Other Mental Health Indications
• 5.3 By Delivery Mode
  • 5.3.1 Mobile Applications
  • 5.3.2 Web-Based Platforms
  • 5.3.3 Hybrid App and Provider Workflow Platforms
  • 5.3.4 Wearable-Integrated Software
• 5.4 By End User
  • 5.4.1 Patients and Consumers
  • 5.4.2 Healthcare Providers
  • 5.4.3 Payers and Employers
  • 5.4.4 Behavioral Health Clinics and Telepsychiatry Networks
• 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 India
    • 5.5.3.3 Japan
    • 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, Products and Services, Recent Developments)
  • 6.3.1 AbleTo, Inc.
  • 6.3.2 Akili Interactive Labs, Inc.
  • 6.3.3 Behavioral Health Tech, LLC
  • 6.3.4 BetterHelp, Inc.
  • 6.3.5 Big Health, Inc.
  • 6.3.6 Calm.com, Inc.
  • 6.3.7 Curio Digital Therapeutics, Inc.
  • 6.3.8 Headspace, Inc.
  • 6.3.9 Headway, Inc.
  • 6.3.10 Koa Health, S.L.
  • 6.3.11 Limbix Health, Inc.
  • 6.3.12 Lyra Health, Inc.
  • 6.3.13 Otsuka America Pharmaceutical, Inc.
  • 6.3.14 Qualifacts Systems, LLC
  • 6.3.15 Quartet Health, Inc.
  • 6.3.16 Rejoyn, Inc.
  • 6.3.17 Spring Health, Inc.
  • 6.3.18 Talkspace, Inc.
  • 6.3.19 Teladoc Health, Inc.
  • 6.3.20 Wysa Ltd.

7 MARKET OPPORTUNITIES AND FUTURE OUTLOOK

• 7.1 White-Space and Unmet-Need Assessment