The global digital therapeutics market size is predicted to increase from USD 9.73 billion in 2025 and is anticipated to be worth around USD 56.76 billion by 2034, expanding at a CAGR of 21.83% from 2025 to 2034. A study published by Statifacts a sister firm of Precedence Research.
Ottawa, Oct. 07, 2025 (GLOBE NEWSWIRE) -- According to Statifacts, the global digital therapeutics market size reached USD 7.88 billion in 2024 and is estimated to attain USD 56.76 billion by 2034, growing at a CAGR of 21.83% during the forecast period from 2025 to 2034. The rising popularity of digital therapeutics, the potential to increase the quality of care delivery, the increasing requirement for cost containment, and the rising prevalence of chronic diseases are driving the growth of the market.

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Digital Therapeutics Market Highlights
Digital Therapeutics Market Size, by Region, 2022 to 2026 (USD Million)
| Region | 2022 | 2023 | 2024 | 2025 | 2026 |
| North America | 2,261.07 | 2,800.82 | 3,459.24 | 4,259.88 | 5,230.32 |
| Europe | 1,451.43 | 1,791.02 | 2,203.49 | 2,702.87 | 3,305.53 |
| Asia Pacific | 1,025.79 | 1,294.17 | 1,627.60 | 2,040.45 | 2,549.90 |
| Latin America | 206.72 | 257.75 | 320.44 | 397.19 | 490.88 |
| Middle East & Africa | 177.10 | 217.89 | 267.26 | 326.83 | 398.47 |
Digital Therapeutics Market Size, by Product, 2022 to 2026 (USD Million)
| Product | 2022 | 2023 | 2024 | 2025 | 2026 |
| Devices | 4,489.00 | 5,558.35 | 6,862.23 | 8,447.04 | 10,367.15 |
| Softwares | 633.10 | 803.30 | 1,015.80 | 1,280.18 | 1,607.94 |
Digital Therapeutics Market Size, by Sales Channel, 2022 to 2026 (USD Million)
| Sales Channel | 2022 | 2023 | 2024 | 2025 | 2026 |
| Business-to-Consumer | 1,769.53 | 2,209.04 | 2,749.57 | 3,412.26 | 4,222.11 |
| Business-to-Business | 3,352.57 | 4,152.61 | 5,128.46 | 6,314.96 | 7,752.99 |
Digital Therapeutics Market Size, by Application, 2022 to 2026 (USD Million)
| Application | 2022 | 2023 | 2024 | 2025 | 2026 |
| Obesity | 909.72 | 1,145.21 | 1,437.19 | 1,797.98 | 2,242.35 |
| Diabetes | 1,361.66 | 1,683.53 | 2,075.35 | 2,550.80 | 3,125.86 |
| CNS Disorders | 623.75 | 776.32 | 963.39 | 1,192.01 | 1,470.53 |
| Gastrointestinal Disorders | 580.40 | 723.58 | 899.42 | 1,114.70 | 1,377.42 |
| CVD Disease | 685.62 | 847.22 | 1,043.81 | 1,282.22 | 1,570.39 |
| Smoking Cessation | 229.47 | 282.54 | 346.85 | 424.51 | 517.99 |
| Respiratory Diseases | 422.58 | 527.63 | 656.84 | 815.28 | 1,008.91 |
| Others | 308.91 | 375.61 | 455.19 | 549.73 | 661.64 |
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Market Challenges Facing Digital Therapeutics
Despite the rapid growth and potential of digital therapeutics, the industry faces several challenges. One of the primary hurdles is the complexity of regulatory approval. Regulatory bodies like the FDA and EMA are still developing frameworks for digital therapeutics, which can cause delays in market access. Furthermore, data privacy concerns remain significant, as digital therapeutics involve the collection and analysis of sensitive patient data. Ensuring that these products comply with strict data protection laws, like GDPR in Europe, is critical. Another challenge is the adoption rate among healthcare providers and patients. Although digital therapeutics offer convenience and personalized care, many patients are reluctant to rely on technology for their healthcare needs, especially in underserved or older demographics.
What is Digital Therapeutics?
The digital therapeutics market refers to the production, distribution, and use of digital therapeutics (DTx) that are evidence-based therapeutic interventions driven by software to prevent, manage, or treat a medical disorder or disease. Digital therapeutics (DTx) deliver medical interventions directly to patients using evidence-based, clinically evaluated software to treat, manage, and prevent a broad spectrum of disorders and diseases. Digital therapeutics are a part of digital health that deliver therapeutic interventions directly to patients through evidence-based, clinically evaluated software for disease management.
Digital therapeutics offers behavioral and cognitive interventions in place of specific conventional medicines, reducing drug toxicity. Therapy is delivered through wearable devices or smartphones, making it more accessible and mobile than traditional medicine and avoiding shortages of locations that offer therapy.
Key Government Initiatives for Digital Therapeutics:
Regulatory Advancements: FDA's Evaluation of AI-Enabled Digital Therapeutics for Mental Health
Background:
In September 2025, the U.S. Food and Drug Administration (FDA) held a critical meeting to evaluate the growing field of AI-enabled digital mental health devices. With the rising demand for mental health support, particularly in the wake of the COVID-19 pandemic, digital therapeutics have emerged as a scalable solution to address mental health conditions like anxiety, depression, and insomnia. The FDA's review focused on AI-based devices, such as virtual therapists and chatbots, that offer cognitive behavioral therapy (CBT) and other therapeutic interventions through digital platforms.

The Challenge:
Mental health disorders are a leading cause of disability globally, with limited access to care, particularly in underserved regions. Traditional therapy and medication-based approaches have limitations, including accessibility and cost. As the digital therapeutics space grows, so does the need for regulatory bodies to assess their efficacy and safety. The key challenge lies in establishing a comprehensive regulatory framework that ensures these AI-driven interventions are both effective and safe for patients.
The Solution:
The FDA's Digital Health Advisory Committee reviewed AI-enabled digital therapeutics, focusing on how these devices can serve as substitutes or complementary solutions to traditional treatments. The devices are designed to offer personalized, evidence-based interventions through the use of machine learning and behavioral health algorithms, improving patient outcomes without the need for in-person therapy sessions. These tools include virtual assistants that provide cognitive-behavioral therapy (CBT) for depression, AI-driven chatbots for anxiety management, and sleep therapy apps.
The committee's review sought to assess the following key aspects:
Outcome:
The FDA's review set the stage for clearer regulatory pathways for AI-enabled digital therapeutics in mental health. The meeting highlighted the need for continuous monitoring and post-market surveillance to ensure these devices maintain efficacy and safety over time. Following the evaluation, the FDA is expected to establish new guidelines for approving AI-based therapeutic devices, which will help drive the growth of digital therapeutics within the mental health industry.
Engagement Opportunity:
This case study is significant for stakeholders in digital therapeutics, AI, and mental health sectors. It addresses the regulatory challenges that could shape the future of AI-driven treatments. By focusing on regulatory approval and the use of AI for mental health management, this case study appeals to technology developers, healthcare providers, investors, and policymakers, encouraging conversations about the viability and oversight of digital therapeutics in mental healthcare.
Key Takeaways:
What are the Key Trends of the Digital Therapeutics Market?
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Market Dynamics
Driver
Chronic illness benefits include ensuring we are covered for specific life-threatening conditions like heart disease or diabetes that need ongoing treatment. When a chronic condition is managed effectively, it will likely result in fewer acute and long-term medical complications or side effects. Good management of chronic conditions can prevent or delay complications and slow the progression of our disease. In terms of chronic diseases, digital therapeutics are primarily designed for diabetes and cardiovascular diseases.
Restraint
Lack of skilled IT professionals may result in higher turnover rates, creating additional costs in recruitment, training, and the loss of valuable institutional knowledge. When employees feel unprepared or undervalued due to skill gaps, morale and job satisfaction plummet. The impact of skills shortage extends beyond operations; it profoundly affects workforce morale and employee retention. When companies lack skilled talent, existing employees may be burdened with extra workloads, leading to burnout, stress, and disengagement.
Opportunity
Digital health technologies have the potential to improve healthcare access and equity by providing remote care. The purpose of a global strategy on digital health is to promote healthy lives and well-being for everyone, everywhere, at all stages. Digital health technologies expanded access to healthcare for historically marginalized communities. Improving the use of digital technologies and data allows informed decision-making, providing people with better access to their health information when and where they need it, improved quality of care, and personalized health outcomes.
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Digital Therapeutics Market Scope
| Report Attribute | Key Statistics | |
| Market Size in 2024 | USD 7.88 Billion | |
| Market Size in 2025 | USD 9.73 Billion | |
| Market Size in 2031 | USD 32.39 Billion | |
| Market Size by 2034 | USD 56.76 Billion | |
| CAGR 2025-2034 | 21.83% | |
| Leading Region in 2024 | North America | |
| Fastest Growing Region | Asia Pacific | |
| Base Year | 2024 | |
| Forecast Period | 2025 to 2034 | |
| Segments Covered | By Product, By Sales Channel, By Application and By Region | |
| Regional analysis | North America, Europe, Asia-Pacific, Latin America, and Middle East & Africa | |
| Leading Players | Fitbit Health Solutions, 2MORROW Inc., Medtronic Plc., Livongo Health Inc., Pear Therapeutics Inc., Omada Health Inc., Resmed Inc . (Propeller Health), Proteus Digital Health Inc., Welldoc Inc., Voluntis Inc., Canary Health Inc, Noom Inc., Mango Health Inc., Dthera Sciences, and Others. | |
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Digital Therapeutics Market Segmentation
Product Insights
Why Does the Devices Segment Dominate the Digital Therapeutics Market?
The devices segment dominated the market in 2024. A digital therapy machine can work longer hours at less cost than human therapists. Digital technologies like wearable devices, health apps, and telemedicine facilitate continuous patient monitoring, personalized treatment plans, and enhanced engagement. Digital therapy machines use electrical impulses to stimulate nerves and muscles, which can help reduce pain, enhance blood circulation, and promote muscle relaxation. It generally offers multiple modes and intensity levels for customized therapy.
The software segment is projected to experience the highest growth rate in the market between 2025 and 2034. New digital therapy reduces anxiety and depression in people living with long-term physical health conditions. A new King’s College London study finds, a therapist's guided digital cognitive behavioral therapy reduced distress in 89% of participants living with long-term physical health conditions. Digital therapeutics (DXs) are patient-facing software applications that help patients treat, prevent, or manage a disease and that have proven clinical benefit.
Sales Channel Insights
Why Does the Business-to-Business (B2B) Segment Dominate the Digital Therapeutics Market?
The business-to-business (B2B) segment dominated the market share in 2024. The business-to-business (B2B) sales channel benefits include developing product and industry knowledge, convenient account management, competitive pricing, better customer service, wider market reach, offloading international distribution, lower customer acquisition costs, increased self-service, analytics, and cost reduction. The segment is experiencing further growth due to a complex buying process, B2B ecommerce, advanced marketing strategies, scalability, improved efficiency, and easier-to-scale business operations. The automated sales and business processes, reduced operational costs, higher order value and volume, and improved personalization & customer experience, further add to this growth.
The business-to-consumer (B2C) segment is projected to expand rapidly in the market in the coming years. The benefits of business to consumer include a stronger brand loyalty, a single catalog, personalization, making marketing easier, less technical overhead, increasing revenue, increasing prices, improving customer relationships, improving margins, and expanding business operations. The segment is maturing rapidly, with consumers preferring to buy direct, boosting innovation, a personalized shopping experience, improved customer experience, brand control, owning customer data, lower prices, increased reach, and more.
Application Insights
How does Diabetes Segment Lead the Digital Therapeutics Market?
The diabetes segment led the market in 2024. With digital therapeutics, patients can track their physical activity, blood glucose levels, and medication adherence in real-time. Digital therapeutics have improved patient compliance, therapeutic success, and economic outcomes in diabetes management. These enable active patient engagement, promoting lifestyle changes, providing comprehensive medical care, and facilitating periodic monitoring of glycemic status.
The obesity segment is expected to grow fastest over the forecast period. Digital therapeutics technologies allow us to monitor and manage our physical and mental health in our daily lives. Studies on digital therapeutic technologies for the self-management of obesity have found that they can enhance compliance and effectiveness in managing obesity. Digital technologies are transforming the management of obesity for patients and healthcare systems.
U.S. Digital Therapeutics Market Size and Growth 2025 to 2034
The U.S. digital therapeutics market size was estimated at USD 3,040 million in 2024 and is predicted to be worth around USD 21,140 million by 2034, registering a solid CAGR of 21.4% from 2024 to 2034.

Why is North America leading the global Digital Therapeutics Market?
North America maintained a leading position in the market in 2024 due to the rising demand for digital therapeutics, potential to improve the quality of care delivery, technological innovations, demand for personalized and remote care, increased digital adoption, prevalence of chronic diseases, increasing adoption of smartphones, and rising prevalence of chronic diseases like diabetes and mental health conditions in the region. Digital therapeutics provide innovative treatment options. In the United States, psychiatric disorders represent a major public health challenge and contribute to significant morbidity and healthcare costs.
The U.S. is a major player in the regional market, due to its well-established regulatory framework, robust healthcare infrastructure, and high adoption of digital health technologies. The U.S. Food and Drug Administration (FDA) has pioneered the approval of software-based medical treatments, enabling faster market access for digital therapeutics. Additionally, a strong ecosystem of innovation, fueled by venture capital, startups, and major tech players, supports rapid development. High prevalence of chronic diseases like diabetes, obesity, and mental health disorders drives demand, while increasing payer support and reimbursement pathways make digital therapeutics financially viable.

Asia Pacific Digital Therapeutics Market Trends
Asia Pacific is set to experience the fastest rate of market growth from 2025 to 2034 due to the growing investment in digital health technologies, supportive regulatory frameworks, need for remote and integrated healthcare systems, technological innovation, increased access to smartphones and internet penetration, growing health consciousness, demand for personalized & evidence-based therapies, and increasing chronic disease prevalence.
Country-Level Investments & Funding in the Digital Therapeutics Industry
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Top Companies in the Digital Therapeutics Market

The Digital Therapeutics (DTx) Market is characterized by a few high-revenue players integrated within large healthcare or tech ecosystems (like Alphabet , Medtronic , and Teladoc) and a long tail of smaller, niche-focused companies. The revenue data below represents estimated 2024 figures in USD millions (based on public filings, acquisition reports, and credible industry analyses).
Estimated 2024 Revenues by Company
| Rank | Company | 2024 Revenue (USD Million) | Notes / Highlights |
| 1 | Medtronic plc (Digital & Connected Care) | $1,200 M | Medtronic ’s digital platforms, CGMs, and connected insulin pumps dominate the DTx-linked medical devices space. The firm leverages clinical hardware with software integration technically broader than pure DTx, but included due to its algorithm-driven therapeutic delivery. |
| 2 | Noom, Inc. | $1,000 M | One of the largest consumer-facing behavioral DTx brands. Noom operates on a subscription-based weight management model, reporting nearly $1 B annual recurring revenue (ARR) by late 2023, driven by global app subscriptions. |
| 3 | Fitbit Health Solutions ( Alphabet ) | $700 M | Fitbit ’s health arm under Alphabet combines wellness and chronic care monitoring via wearable-integrated DTx platforms. It contributes meaningfully to Alphabet ’s Health and Fitbit revenue streams, particularly in cardiometabolic and lifestyle management. |
| 4 | Livongo Health (Teladoc Health) | $550 M | Now fully integrated into Teladoc Health, Livongo continues to serve chronic care management for diabetes and hypertension. Its DTx modules represent a significant share of Teladoc’s chronic condition revenue. |
| 5 | Omada Health, Inc. | $210 M | Among the few standalone DTx specialists with sustained revenue growth (~38% YoY). Omada’s platform spans diabetes prevention, MSK (musculoskeletal) care, and hypertension, with a strong payer/employer base. |
| 6 | ResMed (Propeller Health) | $200 M | Propeller Health, acquired by ResMed, dominates respiratory DTx (asthma, COPD). Its revenue reflects integration within ResMed’s connected solutions segment. |
| 7 | Welldoc, Inc. | $45 M | Known for its BlueStar diabetes management app, Welldoc partners with payers and pharma companies for digital chronic care, though its revenue scale remains moderate. |
| 8 | Voluntis (Aptar Group) | $35 M | Following its acquisition by Aptar, Voluntis contributes DTx solutions in oncology and diabetes, integrated into Aptar’s digital health ecosystem. |
| 9 | Mango Health (Mercalis / TrialCard) | $20 M | Focused on medication adherence DTx, operating under Mercalis since acquisition; small-scale, but growing in patient engagement programs. |
| 10 | Canary Health, Inc. | $15 M | Specializes in chronic disease self-management (especially arthritis, diabetes, and COPD) with partnerships in U.S. healthcare systems; niche presence. |
| 11 | 2MORROW, Inc. | $10 M | Focuses on behavioral change (smoking cessation, weight loss) through evidence-backed digital programs; operates primarily in employer and payer segments. |

Recent Developments
Segments Covered in the Report
By Product
By Sales Channel
By Application
By Region
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