Digital Therapeutics & Medical Devices Market to Reach USD 56.76 Billion by 2034, Growing at 21.65% CAGR | Exactitude Consultancy

GlobeNewswire | Exactitude Consultancy
Monday, May 26, 2025 at 10:39am UTC

Luton, Bedfordshire, United Kingdom, May 26, 2025 (GLOBE NEWSWIRE) -- Market Overview

Digital Therapeutics & Medical Devices Market Size and Growth

The global Digital Therapeutics & Medical Devices Market was valued at USD 7.88 billion in 2024 and is projected to reach USD 56.76 billion by 2034, growing at a CAGR of 21.65% during the forecast period.

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Digital Therapeutic Devices Market Insights

The digital therapeutic devices segment is also witnessing robust growth, with the market expected to expand from USD 4.86 billion in 2024 to USD 14.0 billion by 2035.

The Digital Therapeutics (DTx) market refers to the use of software-based interventions to prevent, manage, or treat medical disorders or diseases. These solutions are evidence-based, often prescribed by healthcare professionals, and delivered through apps, wearables, or connected platforms. DTx is distinct from general wellness apps due to its clinical validation and regulatory oversight.

The Medical Devices market includes all instruments, machines, implants, and software that are used for medical purposes, such as diagnosis, treatment, and patient monitoring. When merged with digital therapeutics, it creates a powerful ecosystem combining hardware, data analytics, AI, and user-centric care delivery.

Regional Analysis
North America

  • Market Share: Held the largest share at 43.91% in 2024, attributed to advanced healthcare infrastructure and supportive regulatory policies.

Europe

  • Market Dynamics: Countries like Germany, the UK, and France are leading due to robust healthcare systems and government initiatives promoting digital healthcare solutions.

Asia-Pacific

  • Growth Potential: Expected to witness the fastest growth, driven by increasing healthcare digitization and a rising prevalence of chronic diseases.

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 Key Therapeutic Areas
Diabetes Management

  • Market Share: Dominated the digital therapeutics market with a 29.75% revenue share in 2024.

Mental Health

  • Market Value: Valued at USD 1.5 billion in 2024, reflecting growing awareness and demand for digital interventions in mental health.

Cardiovascular Diseases

  • Market Value: Estimated at USD 1.0 billion in 2024, with digital solutions aiding in managing heart-related ailments.

Key Market Players

Digital Therapeutics Companies (2025)

No.Company NameHeadquartersFocus Areas
1Omada HealthUSAChronic disease management, AI-driven nutrition
2Hinge HealthUSAMusculoskeletal care, AI-powered physical therapy
3Sword HealthPortugalVirtual physical therapy, AI integration
4Click TherapeuticsUSAPrescription digital therapeutics for mental health
5Kaia HealthGermanyAI-driven chronic pain management
6DarioHealthUSADiabetes, hypertension, weight management
7Virta HealthUSAType 2 diabetes reversal
8Pear TherapeuticsUSADigital treatments for addiction and mental health
9Big HealthUSAMental health solutions, including insomnia and anxiety
10Teladoc HealthUSATelemedicine, chronic condition management
11Lark HealthUSAAI-based chronic disease management
12Maven ClinicUSAWomen's and family health
13TalkspaceUSAOnline therapy and mental health services
14CureApp, Inc.JapanMobile applications for chronic disease management
15GAIA AGGermanyEvidence-based therapeutic apps
16Welldoc, Inc.USADiabetes management through digital platforms
172Morrow Inc.USASmoking cessation and weight management
18Reperio HealthUSAAt-home health assessments
19Thirty MadisonUSASpecialized virtual care for chronic conditions
20Meru HealthUSADigital mental health programs

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Medical Device Companies (2025)

No.Company NameHeadquartersSpecialization
1MedtronicIrelandCardiovascular, diabetes, surgical devices
2Johnson & JohnsonUSASurgical instruments, implants, diagnostics
3Abbott LaboratoriesUSADiabetes care, diagnostics, vascular devices
4Siemens HealthineersGermanyImaging systems, laboratory diagnostics
5GE HealthcareUSAImaging systems, medical devices, IT solutions
6Philips HealthcareNetherlandsImaging systems, patient monitoring
7Stryker CorporationUSAOrthopedics, neurotechnology, surgical equipment
8Boston ScientificUSAInterventional cardiology, neuromodulation
9Becton Dickinson (BD)USAMedical diagnostics, IV sets, syringes
10Danaher CorporationUSADiagnostics, life sciences, dental equipment

Recent Developments

1. Hinge Health's Successful IPO and AI Integration

In May 2025, Hinge Health, a digital physical therapy company, went public with a strong debut, reaching a $2.6 billion valuation. The company reported an 81% gross margin and $17.1 million profit in Q1 2025. Hinge Health utilizes AI-powered tools for motion tracking and care coordination, significantly reducing clinician hours and enhancing care delivery. The company plans to expand into additional healthcare specialties, further automating care with technology.

2. Medtronic's Diabetes Division Spin-Off

Medtronic announced plans to spin off its diabetes division into a standalone company. The new entity will be led by Que Dallara, current head of the diabetes division, and will employ around 8,000 people. This move aims to allow Medtronic to concentrate on its more lucrative businesses, especially heart devices. The separation is expected to be completed within 18 months.

3. Siemens Healthineers Faces Tariff Challenges

Siemens Healthineers' photon-counting CT scanner, the Naeotom Alpha, has gained global acclaim, including FDA approval. However, new U.S.-EU tariffs threaten to raise costs across the supply chain, affecting both foreign and domestic manufacturers. Industry leaders warn that these tariffs could raise healthcare costs, disrupt maintenance and supply, and stifle innovation.

4. FDA Approval of Intuitive Surgical's da Vinci 5 System

Intuitive Surgical received FDA clearance for its da Vinci 5 surgical system, which can be used in most surgical specialties, excluding cardiac and pediatric indications. This system, expected to enter full market launch in 2025, brings new capabilities of visualization, precision, and efficiency to operating rooms. The surgical robotics market is valued at over $8 billion in 2025 and is growing at a double-digit rate.

5. Empatica's Advancements in Wearable Health Monitoring

Empatica, a company specializing in AI-enabled tools for health monitoring, has developed medical-grade wearables like Embrace2 and EmbracePlus. These devices track physiological signals such as heart rate variability and skin temperature. Embrace2 has been cleared by the FDA as a seizure alerting solution for epilepsy patients. EmbracePlus is used for continuous health monitoring and has received the European CE mark as a Class IIa medical device.

6. Samsung's Noninvasive Glucose Monitoring Technology

Samsung has been developing noninvasive glucose monitoring technology using Raman spectroscopy. The company announced plans to incorporate glucose monitoring into its smartwatch, with a targeted release year of 2025. This technology aims to provide continuous glucose monitoring without the need for invasive procedures.

Technological Advancements

  • Artificial Intelligence (AI): AI integration is enhancing personalization in digital therapeutics, enabling real-time feedback and tailored treatment plans.
  • Wearable Devices: The proliferation of wearable health devices is facilitating continuous monitoring and data collection, improving patient engagement and outcomes.

Market Segmentation
By Product Type

  • Software/Platforms: Expected to hold the largest market share due to increasing reliance on sophisticated solutions for therapeutic interventions.
  • Devices: Includes wearable and non-wearable devices aiding in monitoring and treatment.

By Sales Channel

  • Business-to-Business (B2B): Dominated the market with a 64.51% share in 2024, driven by adoption among healthcare providers and employers.
  • Business-to-Consumer (B2C): Growing segment with direct-to-consumer apps and platforms.

This report is also available in the following languages : Japanese (片頭痛市場向けデジタル治療・医療機器), Korean (편두통 시장을 위한 디지털 치료제 및 의료 기기), Chinese (偏头痛市场的数字治疗和医疗设备), French (Thérapies numériques et dispositifs médicaux pour le marché de la migraine), German (Digitale Therapeutika und medizinische Geräte für den Migränemarkt), and Italian (Dispositivi medici e terapeutici digitali per il mercato dell'emicrania), etc.

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