Global Digital Therapeutics in Mental Health Market - 2025-2033

The global digital therapeutics in mental health market size reached US$ 3.07 billion in 2024 and is expected to reach US$ 15.16 billion by 2033, growing at a CAGR of 19.6% during the forecast period 2025-2033.

Digital therapeutics in mental health refers to evidence-based, software-driven therapeutic interventions designed to prevent, manage, or treat mental health disorders through digital technology. These solutions deliver personalized, clinically validated treatments via mobile apps, web-based platforms, AI-driven tools, virtual reality (VR), wearables, and connected devices to improve mental health outcomes. Unlike general wellness or mental health apps, digital therapeutics solutions undergo rigorous clinical validation, regulatory approvals, and real-world evidence trials to ensure efficacy and safety in treating conditions such as depression, anxiety, schizophrenia, substance use disorders, and other mental disorders.

Market Dynamics: Drivers & Restraints

The shift towards digital mental health solutions is significantly driving the digital therapeutics in the mental health market growth

The growing recognition of mental health issues, alongside the shortage of mental health professionals, is leading to an increased reliance on digital mental health solutions. These platforms provide a scalable way to address the rising demand for mental health services, particularly for populations that may not have easy access to traditional in-person therapy. As the demand for digital mental health solutions rises, the market players are focusing on the development of digital therapeutics for the treatment of mental disorders.

For instance, in August 2024, Otsuka Precision Health, Inc. and Click Therapeutics, Inc. commercially launched Rejoyn. Rejoyn was cleared by the U.S. Food and Drug Administration (FDA) in March 2024 and is the first and only prescription digital therapeutic for the treatment of major depressive disorder (MDD) symptoms as an adjunct to clinician-managed outpatient care for adult patients with MDD aged 22 years and older who are on antidepressant medication.

Additionally, in June 2024, DeepWell Digital Therapeutics (DTx), a maker of games to treat mental health, launched Zengence, its first action video game treating mental health. Launched in the Meta Game Store, DeepWell bills the game as the first therapeutic application released in the store for virtual reality applications. Zengence uses patent-pending technology for breath and sound mechanics to drive the first-of-its-kind action game, where players defeat Dark Wraiths and silence their inner anxieties.

Digital therapeutics solutions are built on evidence-based methodologies such as Cognitive Behavioral Therapy (CBT), Mindfulness-based Stress Reduction (MBSR), and Behavioral Activation (BA). These proven therapeutic models are delivered through apps and online platforms, offering patients an accessible, yet scientifically validated, way to manage and treat mental health conditions.

Data privacy & cybersecurity concerns hampering the market growth

Data privacy and cybersecurity concerns pose significant barriers to the growth of digital therapeutics in the mental health market, primarily due to the sensitive nature of mental health data and the increasing risks associated with cyberattacks and data breaches. The reliance on personalized data for treatment, along with the adoption of digital tools, raises security concerns among users, healthcare providers, and regulators.

With the increasing use of mobile apps and cloud storage to manage health-related data, digital mental health platforms are becoming prime targets for cyberattacks. A data breach could lead to identity theft, fraud, or reputational damage to the companies involved, causing a loss of consumer confidence and halting further adoption.

For instance, according to the HIPAA Journal, in August 2023, 23 million breached healthcare records were reported. Over the past 12 months, an average of 9,989,003 healthcare records were breached each month. In the year to August 31, 2024, there have been 491 data breaches of 500 or more records, and at least 58,668,002 records are known to have been breached. The average breach size in 2024 is currently 119,487 records, and the median breach size is 4,109 records.

Segment Analysis

The global digital therapeutics in mental health market is segmented based on type, application and region.

Type:

The software-based digital therapeutics segment is expected to dominate the digital therapeutics in mental health market with the highest market share

Software-based solutions, which include mobile apps, online platforms, and AI-driven interventions, have rapidly gained popularity because they can be widely adopted and personalized to cater to a large number of patients with mental health conditions. Software-based solutions are highly scalable, meaning they can reach large numbers of users simultaneously without the need for extensive physical infrastructure. These solutions are available 24/7, making mental health support more accessible for users around the globe. Thus, software solutions, especially mental health apps, are gaining traction.

For instance, in September 2024, Magellan Health, Inc., a leader in behavioral health and related services, launched a Teen Mental Wellbeing app to support the mental and emotional well-being of teenagers and young adults ages 13-22. Powered by BeMe Health's advanced digital health platform, the app helps promote self-understanding, builds resilience, and supports the journey to mental well-being through science-backed digital tools and evidence-based approaches.

Additionally, in June 2024, Talkspace, a leading online behavioral health care company, announced it will join forces with FitOn, the No. 1 fitness app and digital health and wellness platform, to provide a holistic mental health and fitness solution to employers, and showcase the power of bringing together physical and mental fitness into an everyday setting. Employers and organizations can now turn to Talkspace for its comprehensive suite of mental health services, including its core virtual therapy offering, and have the option to add FitOn within the same engagement.

Geographical Analysis

North America is expected to hold a significant position in the global digital therapeutics in mental health market with the highest market share

North America, particularly the U.S., has one of the most advanced healthcare systems globally. This includes widespread internet access, high smartphone penetration, and a tech-savvy population, all of which facilitate the adoption of digital health solutions, including digital therapeutics. The region has one of the highest adoption rates of smartphones and health-focused apps, which is a key factor in the dominance of software-based digital therapeutics in mental health.

North America is home to a large number of venture capital firms and private investors, and insurers who are actively funding and insuring digital health startups. This influx of investment has accelerated the growth of the digital therapeutics market in mental health by enabling research and development, clinical trials, and scaling of innovative solutions.

For instance, in October 2024, MassMutual announced it was the first insurer in the U.S. to offer eligible policy owners free access to Wysa Assure, an AI-powered conversational mental health app created by Wysa and Swiss Re. This offering is the latest addition to MassMutual's Health and Wellness Program, which provides policy owners with knowledge about their health, empowers them to seek out appropriate interventions, and motivates healthy behaviors and lifestyles.

Competitive Landscape

Top companies in the digital therapeutics in mental health market include BigHealth, Click Therapeutics, Inc., Welldoc, Inc., 2Morrow Inc., Mindscapes, Calm.com, Inc., MoodMission Pty Ltd, Boehringer Ingelheim Pharmaceuticals, Inc., Headspace Inc., and Happify, Inc., among others.

Why Purchase the Report?

• Pipeline & Innovations: Reviews ongoing clinical trials, product pipelines, and forecasts upcoming advancements in medical devices and pharmaceuticals.
• Product Performance & Market Positioning: Analyzes product performance, market positioning, and growth potential to optimize strategies.
• Real-World Evidence: Integrates patient feedback and data into product development for improved outcomes.
• Physician Preferences & Health System Impact: Examines healthcare provider behaviors and the impact of health system mergers on adoption strategies.
• Market Updates & Industry Changes: Covers recent regulatory changes, new policies, and emerging technologies.
• Competitive Strategies: Analyzes competitor strategies, market share, and emerging players.
• Pricing & Market Access: Reviews pricing models, reimbursement trends, and market access strategies.
• Market Entry & Expansion: Identifies optimal strategies for entering new markets and partnerships.
• Regional Growth & Investment: Highlights high-growth regions and investment opportunities.
• Supply Chain Optimization: Assesses supply chain risks and distribution strategies for efficient product delivery.
• Sustainability & Regulatory Impact: Focuses on eco-friendly practices and evolving regulations in healthcare.
• Post-market Surveillance: Uses post-market data to enhance product safety and access.
• Pharmacoeconomics & Value-Based Pricing: Analyzes the shift to value-based pricing and data-driven decision-making in R&D.

The global digital therapeutics in mental health market report delivers a detailed analysis with 54 key tables, more than 48 visually impactful figures, and 148 pages of expert insights, providing a complete view of the market landscape.

Target Audience 2024

• Manufacturers: Pharmaceutical, Medical Device, Biotech Companies, Contract Manufacturers, Distributors, Hospitals.
• Regulatory & Policy: Compliance Officers, Government, Health Economists, Market Access Specialists.
• Technology & Innovation: AI/Robotics Providers, R&D Professionals, Clinical Trial Managers, Pharmacovigilance Experts.
• Investors: Healthcare Investors, Venture Fund Investors, Pharma Marketing & Sales.
• Consulting & Advisory: Healthcare Consultants, Industry Associations, Analysts.
• Supply Chain: Distribution and Supply Chain Managers.
• Consumers & Advocacy: Patients, Advocacy Groups, Insurance Companies.
• Academic & Research: Academic Institutions.