The digital therapeutics (DTx) market is emerging as one of the fastest-growing sectors in healthcare, centered on the development and deployment of software and connected devices that deliver evidence-based interventions for managing a wide range of diseases.
Chicago, Jan. 21, 2026 (GLOBE NEWSWIRE) — According to recent data from Astute Analytica, the global digital therapeutics market was valued at US$ 7.07 billion in 2024 and is projected to surpass the market size of US$ 45.56 billion by 2033, exhibiting a CAGR of 23.0% during the forecast period of 2025-2033.
The rising prevalence of chronic diseases is a major catalyst propelling the growth of the mixed-signal wearable market, particularly those devices designed for continuous biometric monitoring. According to the Centers for Disease Control and Prevention (CDC)’s National Center for Chronic Disease Prevention and Health Promotion, six in ten American adults currently suffer from at least one chronic condition, while four in ten adults grapple with two or more chronic diseases simultaneously.
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Mixed-signal wearables, equipped with advanced sensors capable of capturing a wide range of physiological signals, have emerged as indispensable tools in this landscape. By continuously tracking vital signs such as heart rate, blood oxygen levels, glucose trends, and blood pressure, these devices empower patients and healthcare providers with actionable insights into disease progression and treatment efficacy.
The Convergence of PPG and ECG: A Technological Leap in Digital Therapeutics
A defining technological advancement in the digital therapeutics (DTx) market is the consolidation of photoplethysmography (PPG) and electrocardiography (ECG) analog front-end (AFE) blocks into a single, configurable application-specific integrated circuit (ASIC). This integration represents a major shift from the hardware architectures of just five years ago, when therapeutic wearables relied on separate discrete AFE chips—one dedicated to capturing optical pulse-wave signals (PPG) and another for electrical cardiac signals (ECG).
Today, this landscape has transformed dramatically. Approximately 65% of digital therapeutics-cleared wearable devices now incorporate multi-modal AFEs that combine PPG and ECG capabilities within a single chip. Leading examples include Maxim Integrated’s MAX86177, Texas Instruments’ AFE4950, and Infineon’s PSoC-based CYW20822. These integrated AFEs streamline device design by reducing component count, shrinking board footprint, and simplifying firmware development.
The consolidation of PPG and ECG functions onto configurable ASICs has far-reaching implications for the digital therapeutics market. Smaller, more efficient hardware enables longer battery life and more comfortable form factors, which improve user adherence and engagement—critical factors for therapeutic success. Moreover, the simplified hardware architecture reduces production costs, allowing manufacturers to scale and innovate more rapidly.
Treatment-Focused Applications Lead Digital Therapeutics Market with Immediate Impact
Treatment-oriented digital therapeutics have taken center stage in the market by targeting high-cost clinical episodes that payers and providers monitor closely through claims data. In 2024, nearly sixty million adults are enrolled in software-guided programs addressing chronic conditions such as diabetes, hypertension, and heart failure. These programs deliver clinically billable outcomes within a remarkably short 90-day window, making their impact both visible and financially compelling for healthcare stakeholders.
One of the most striking examples of this impact comes from U.S. integrated delivery networks (IDNs), where the introduction of continuous glucose monitor (CGM)-linked coaching apps has led to a reduction of forty-two thousand emergency admissions for uncontrolled diabetes. This significant decline not only improves patient health outcomes but also saves hospitals from costly readmission penalties and reduces drug wastage.
The success of treatment-oriented digital therapeutics extends beyond diabetes management. Similar acute savings have been documented in conditions such as chronic obstructive pulmonary disease (COPD), insomnia, and substance-use disorders. Validated therapeutic modules have contributed to a reduction of fifty-four million rescue-inhaler canisters used in COPD patients and cut opioid prescriptions by eleven million tablets for substance-use disorder treatment.
B2B Channel Dominates Digital Therapeutics Market with Scale and Strategic Control
In the digital therapeutics (DTx) market, the business-to-business (B2B) channel has decisively eclipsed consumer-driven sales due to the institutional buyers’ control over risk pools and budget allocation. Unlike individual consumers who typically download apps through public app stores, large organizations—such as health insurers, integrated healthcare systems, and employers—hold the purchasing power to secure substantial license volumes that provide predictable revenue streams for vendors. This dynamic became especially clear in 2024 when industry giants like UnitedHealth, Kaiser Permanente, and CVS Aetna signed multiyear contracts covering a combined total of ninety million lives.
The rise of employer self-insurance further accelerates the B2B dominance in digital therapeutics. Major corporations such as Amazon, Walmart, and Accenture have proactively deployed digital health programs targeting musculoskeletal and metabolic conditions across their U.S. employee populations. Collectively, these initiatives cover over one million enrollees, reflecting the growing recognition among employers of the value digital therapeutics bring in managing workforce health and reducing overall healthcare costs.
Bulk procurement through B2B contracts offers significant cost advantages, lowering per-member licensing fees by nearly 50%. This pricing power benefits both buyers and digital therapeutics vendors by enabling scalable deployments while preserving margin potential. Moreover, these contracts increasingly incorporate performance-based incentives, where vendors earn bonuses based on measurable improvements in clinical biomarkers rather than superficial metrics like advertising clicks or app downloads.
North America: The Powerhouse of Global Digital Therapeutics Growth
North America continues to dominate the global digital therapeutics (DTx) market, commanding approximately 38% of the total share due to its unique ability to translate policy into large-scale commercial success. This region’s regulatory and reimbursement frameworks create an environment where innovation can flourish and reach patients at scale. A key factor driving this leadership is the U.S. Centers for Medicare & Medicaid Services (CMS), which has expanded reimbursement to cover sixteen categories of remote-monitoring CPT codes.
The U.S. digital therapeutics market alone generated approximately USD 3 billion in revenue during 2024, significantly outpacing Europe’s largest single-country markets by more than threefold. This impressive market size is supported by a vibrant innovation ecosystem comprising around 450 venture-backed companies and eight publicly traded pure-play digital therapeutics firms.
End-user penetration in North America is equally remarkable. Surveys conducted by Rock Health reveal that nearly one in five insured Americans—about 55 million people—have engaged with at least one clinically validated therapeutic app within the past year. The most popular modules focus on managing prevalent chronic conditions such as diabetes, hypertension, and behavioral health, highlighting the alignment of digital therapeutics with pressing public health needs.
Regulatory Agencies Accelerate Digital Therapeutics Growth with Swift Actions
In 2023 and 2024, regulatory agencies worldwide demonstrated unprecedented agility in shaping the digital therapeutics market, creating clearer guidelines and faster pathways for commercialization. This rapid regulatory evolution reflects a recognition of the growing importance of software as a medical device (SaMD) in modern healthcare. The U.S. Food and Drug Administration (FDA) led the charge by granting 19 new De Novo or 510(k) clearances for SaMD products in 2024 alone—an impressive increase from 11 clearances in 2022.
Europe has kept pace with the U.S. through its stringent Medical Device Regulation (MDR) framework. By April 2024, the European Database on Medical Devices (EUDAMED) recorded 46 MDR-certified digital therapeutics, effectively doubling the number listed just one year earlier. This surge highlights the region’s commitment to fostering innovation while maintaining rigorous safety and efficacy standards.
In Asia, regulatory progress has been marked by strategic collaboration to accelerate market access. South Korea and Singapore, two regional hubs for digital health innovation, signed mutual-recognition agreements that have trimmed certification timelines by nearly 30%, according to the Asia eHealth Information Network. This streamlined process facilitates faster entry of digital therapeutics into both markets, encouraging innovation and cross-border adoption.
Top Companies in the Digital Therapeutics Market:
- 2MORROW, Inc.
- Akili Interactive Labs, Inc.
- Click Therapeutics, Inc.
- Fitbit, Inc. (Twine Health, Inc.)
- Happify, Inc.
- Kaia Health
- Livongo Health, Inc.
- Medtronic Plc.
- Omada Health, Inc.
- Pear Therapeutics, Inc.
- Proteus Digital Health, Inc.
- ResMed, Inc. (Propeller Health)
- Voluntis, Inc.
- Welldoc, Inc.
- Other Prominent Players
Market Segmentation Overview
By Component:
- Hardware
- Software
- Services
By Application:
- Preventive Applications
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- Prediabetes
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- Obesity
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- Nutrition
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- Lifestyle Management
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- Others
- Treatment/Care-related Applications
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- Diabetes
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- CNS Disorders
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- Mental Health Disorder
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- Other CNS Disorders
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- Chronic Respiratory Disorders
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- Musculoskeletal Disorders
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- Cardiovascular Diseases
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- Smoking Cessation
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- Medication Adherence
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- Gastrointestinal Disorders
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- Substance Use & Addiction Management
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- Rehabilitation & Patient Care
By Sales Channel:
- Business-to-business (B2B)
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- Employer
-
- Healthcare Provider
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- Payers
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- Pharmaceutical Companies
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- Others
- Business-to-consumer (B2C)
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- Patient
-
- Caregiver
By Region
- North America
- Europe
- Asia Pacific
- Middle East & Africa
- South America
For more information about this report visit: https://www.astuteanalytica.com/industry-report/digital-therapeutics-market
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CONTACT: Contact Us: Astute Analytica Phone: +1-888 429 6757 (US Toll Free); +91-0120- 4483891 (Rest of the World) For Sales Enquiries: sales@astuteanalytica.com Website: https://www.astuteanalytica.com/
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