Medical Devices Market Size Worth USD 1,209.42 Bn by 2035 Fueled by Advances in Diagnostic Technologies

According to Precedence Research, the global medical devices market size will grow from USD 678.88 billion in 2025 to nearly USD 1,209.42 billion by 2035, with an expected CAGR of 5.94% from 2026 to 2035.

Ottawa, Dec. 10, 2025 (GLOBE NEWSWIRE) -- The global medical devices market size is expected to be worth over USD 1,209.42 billion by 2035, increasing from USD 719.61 billion in 2026, growing at a strong CAGR of 5.94% between 2026 and 2035. The growing expansion of digital health, the rising prevalence of chronic diseases, and technological advancements drive the market growth.

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Medical Devices Market Key Highlights:

• Market Value Outlook:
  The global medical devices market is estimated at USD 678.88 billion in 2025, with strong momentum toward USD 1.20 trillion by 2035.
  
• Growth Trajectory:
  The industry is set to expand steadily at a 6% CAGR throughout 2026–2035, driven by advanced diagnostics, minimally invasive procedures, and the rising demand for connected healthcare devices.
  
• Regional Leadership:
  North America led the global market in 2024, capturing nearly 40% of total revenue, supported by advanced healthcare infrastructure and early technology adoption.
  
• End-User Dominance:
  Hospitals & Clinics represented the largest share of device adoption in 2024, owing to high patient inflow, surgical volumes, and demand for high-precision diagnostic and therapeutic equipment.
  
• Fastest-Growing End-User Segment:
  Diagnostic Centers are projected to witness the highest growth rate between 2025 and 2034, fueled by the rising emphasis on early disease detection and advancements in imaging technologies.
  

What are Medical Devices?

The medical devices market growth is driven by the growing prevalence of chronic diseases, the adoption of minimally invasive procedures, increasing remote patient monitoring, and the growing development of wearable technology.

A medical device is a software app, instrument, or appliance used for treating, diagnosing, and preventing diseases. They are used on the human body and improve health by monitoring symptoms. The medical device is available in various forms, like diagnostic testing, assistive tools, software, implants, and surgical tools. Medical devices offer benefits like increasing patient safety, enhancing the management of diseases, early diagnosis, supporting remote monitoring, and better patient outcomes.

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Major Private Industry Investments in Medical Devices:

1. KKR acquired Healthium Medtech: KKR completed the acquisition of a majority stake in Healthium Medtech (formerly Sutures India) in a deal valued at approximately ₹7,000 crore (around $840 million USD) to expand its presence in the Indian medtech market.
2. GTCR acquired Surmodics: The private equity firm GTCR is planning to acquire Surmodics, a leading provider of medical device coatings and specialized intravascular catheters, in a deal valued at $627 million.
3. ADIA invested in Meril: The UAE sovereign wealth fund Abu Dhabi Investment Authority (ADIA) acquired a minority stake for $200 million in Micro Life Sciences (Meril), a Warburg Pincus-backed firm that develops and manufactures a wide range of medical devices.
4. Boston Scientific acquired Silk Road Medical: Boston Scientific plans to acquire Silk Road Medical for $1.16 billion to expand its portfolio in the vascular intervention segment.
5. Carl Zeiss acquired Dutch Ophthalmic Research Center (DORC): Carl Zeiss acquired DORC for $1.07 billion to strengthen its position in the field of ophthalmic surgery devices and equipment. 
   

Role of Artificial Intelligence in Medical Devices

Artificial intelligence (AI) is rapidly integrating with medical devices. AI enhances the diagnosis of diseases like diabetic retinopathy, heart disease, and cancer by analyzing MRIs & X-rays. AI accelerates the diagnostic process and improves rates of survival. It creates personalised treatment plans and predicts the progression of disease.

AI enhances the robotic surgery process and potentially minimizes invasiveness. AI speeds up the development of new medical devices and assists trial simulations. It assists with simulation and streamlines clinical trials. AI supports continuous monitoring of patients and assists healthcare professionals. Overall, AI-powered medical devices streamline workflow, enable remote monitoring, assist clinicians, and automate administrative tasks.

For instance, GE HealthCare uses AI in its imaging machines to accelerate scanning time and enhance the quality of the image.

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Trade Analysis of Medical Devices Market: Import & Export Statistics

• Costa Rica is the leading exporter of medical devices. The country exported 412305 shipments of medical devices. (Source: https://www.volza.com/p/medical-devices/export/)
• Israel exported $115M of scintigraphy medical devices in 2023. The country imported $11.1M of scintigraphy medical devices in the same year. (Source:https://oec.world/en/profile/bilateral-product/scintigraphy-medical-devices/reporter/isr)
• The leading exporter of cardiac pacemakers is Ireland. The country exported 14262 shipments of cardiac pacemakers. (Source:https://www.volza.com/p/cardiac-pacemaker/export/export-from-india/)
• In the World United States is the leading exporter of surgical devices. The United States exported 10877 shipments of surgical devices. (Source:https://www.volza.com/p/surgical-device/export/export-from-india/)
• China, Guatemala, and Panama are the top three exporters of ventilators. China exported 17692 shipments of ventilators. (Source: https://www.volza.com/p/ventilators/export/)
• Germany exported $1.79B of MRI machines in 2023. The country imported $762M of MRI machines. (Source: https://oec.world/en/profile/hs/mri-machines)

Medical Devices Market-Value Chain Analysis

1) Feedstock Procurement

The feedstock procurement is the sourcing of raw materials like metals, sterile packaging materials, medical-grade plastics, and electronic components.

• Key Players: - Johnson & Johnson, Siemens Healthineers, Philips, Medtronic, Abbott Laboratories, Stryker Corporation.
  

2) Quality Testing and Certifications

Quality testing is testing of properties like sterilization validation, software verification, biocompatibility, durability, & electrical safety, and certifications like ICMED, MDSAP, ISO 13485, CE Marking, & ISO 14971.

• Key Players:- Intertek, SGS, DEKRA, NAMSA, TÜV SÜD, Eurofins Scientific, UL Solutions
  

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What are the Types of Medical Devices?

Types	Description	Examples
Diagnostic Devices	Diagnostic devices are medical devices used to diagnose various conditions.	Contact Lenses X-ray Stethoscopes Ultrasound Machines Blood Glucose Meters Ultrasound Machines
Treatment Devices	A treatment device is a device used to treat injuries, diseases, and other health problems.	Artificial Hip Joints Ventilators Surgical Lasers Infusion Pumps Pacemakers Antibiotic syringes Dental Unit Waterlines
Monitoring Devices	Monitoring devices are used to monitor and track the health records of persons.	Pulse Oximeters ECG Monitors Thermometers Fetal Monitors Glucose Monitors BP Monitors
Assistive & Rehabilitation Devices	These kinds of devices are used to recover from injuries and perform daily tasks.	Prosthetics Wheelchairs Hearing Aids

Medical Devices Market Opportunity

Growing Prevalence of Chronic Disease Unlocks Market Opportunity

The growing prevalence of chronic disease and an aging population increases demand for various medical devices. The growing adoption of an unhealthy lifestyle increases the prevalence of chronic diseases. The growing rate of chronic diseases like cancer, diabetes, and heart disease increases demand for medical devices. The strong focus on the accurate diagnosis of chronic diseases requires a medical device.

The need for monitoring chronic conditions increases the adoption of monitoring devices like wearable sensors, CGMs, and smart inhalers. The growing demand for devices like pacemakers, nebulizers, insulin pumps, and stents helps the market growth. The strong focus on personalised medicines and the need for continuous monitoring increases the adoption of medical devices. The growing prevalence of chronic disease creates an opportunity for the growth of the medical devices market.

Medical Devices Market Limitations and Challenges

What is the Limitation for the Medical Devices Market?

High Development Costs Limit the Expansion of the Market

With several benefits of the medical devices in healthcare systems, the high development cost restricts the market growth. Factors like complex design, stricter regulatory requirements, need for specialized materials, need for high-quality, and high-precision engineering are responsible for the high development cost.

The complex design and need for specialized tooling increase the cost. The advanced manufacturing techniques and the need for skilled labor increase the cost. The need for raw materials like biocompatible materials, polymer, plastics, surgical-grade alloys, and other materials increases the cost. The stringent regulations and high investment in quality testing increase the cost. The high development cost hampers the growth of the medical devices market.

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Medical Devices Market Report Coverage

Report Attribute	Key Details
Market Size in 2025	USD 678.88 Billion
Market Size in 2026	USD 719.61 Billion
Forecast Market Size by 2035	USD 1,209.42 Billion
CAGR (2026–2035)	5.94%
Largest Market	Asia Pacific
Dominated Region (2024)	North America (approx. 40% share in 2024)
Base Year	2025
Forecast Period	2026 to 2035
Segments Covered	Product, Therapeutic Application, End User, Region
Regional Scope	Asia Pacific, North America, Europe, Latin America, Middle East & Africa
Major End-User Segment (2024)	Hospitals & Clinics – largest share (approx. 41.60%)
Fastest-Growing End-User (2025–2034)	Diagnostic Centers
Dominant Product Segment (2024)	Therapeutic Devices (~49.20% share), including: • Surgical devices • Cardiovascular devices • Orthopedic devices • Respiratory devices • Insulin delivery & infusion systems
High-Growth Product Sub-Segment	Assistive & Rehabilitation Devices – estimated CAGR of about 8.9%
Key Market Drivers	• Rising adoption of 3D-printed and robotic surgical devices • Increasing prevalence of chronic diseases (CVD, diabetes, respiratory disorders) • Expansion of home healthcare and connected/remote patient monitoring devices • Aging population driving demand for orthopedic, cardiovascular, and mobility devices
Market Challenges	• Cybersecurity and data protection risks for IoT-enabled devices • Regulatory complexities and compliance requirements • High cost of advanced medical equipment
Key Players (Representative List)	GE Healthcare, Siemens Healthineers, Philips Healthcare, Stryker, Medtronic, Baxter, Cardinal Health, BD, among others

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Case Study: How Medtronic Transformed Diabetes Care Through Smart, Connected Medical Devices

Background

Diabetes is one of the fastest-growing chronic diseases worldwide, increasing demand for advanced monitoring and insulin-delivery devices. Traditional glucose monitoring methods were painful, inconsistent, and provided limited real-time insights.

Recognizing this need, Medtronic invested in smart insulin pumps, continuous glucose monitoring systems, and AI-driven predictive technologies.

Challenge

Patients faced:

• Frequent finger-prick tests
• Fluctuating glucose levels
• Delayed detection of hypoglycemia
• Limited visibility into daily glucose patterns
• Elevated risk of complications
  

Healthcare providers faced:

• Difficulty tracking patient data continuously
• Challenges in personalizing treatment
• Higher rates of hospital visits and emergencies
  

Solution

Medtronic developed an interconnected diabetes management platform that includes:

1. MiniMed 780G Smart Insulin Pump
   • Automated insulin delivery driven by a predictive algorithm
   • Reduces extreme highs and lows
2. Guardian 4 Continuous Glucose Monitoring (CGM) System
   • Real-time glucose readings every five minutes
   • No finger-prick calibration required
   • Early warning alerts for dangerous glucose trends
3. Remote Monitoring Tools
   • Cloud connectivity for clinicians
   • Smartphone integration for patients
   • Telehealth support and remote adjustments
     

Market and Clinical Impact

• Rapid adoption among patients with Type 1 diabetes, pediatric users, and home-care patients
• Reinforced trends in the medical devices market: connected wearables, home-based care, and AI-enabled monitoring
• Improved patient outcomes, including increased time-in-range and fewer hypoglycemic events
• Higher adherence to treatment plans and reduced emergency visits
• Significant revenue contribution to Medtronic’s therapeutic devices and remote monitoring segments
  

Why This Case Matters

The Medtronic example demonstrates:

• How chronic disease prevalence drives medical device innovation
• The practical role of AI, IoT, and remote monitoring in patient care
• Tangible improvements in clinical outcomes and health-system efficiency
• How major device manufacturers influence broader market growth

Short Takeaway

Medtronic’s AI-enabled insulin delivery ecosystem exemplifies the future of medical devices: connected, personalized, minimally invasive, and focused on continuous monitoring — trends that are contributing to sustained global market growth.

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Medical Devices Market Regional Insights

How North America Dominated the Medical Devices Market?

North America dominated the market in 2024. The well-established healthcare infrastructure and advancement in medical technologies increase the production of medical devices. The growing government investment in medical devices and supportive regulatory frameworks helps market growth.

The strong focus on home care and increasing demand for remote patient monitoring increases the adoption of medical devices. The aging population and growth in chronic diseases increase demand for medical devices. The presence of key players like Abbott, Medtronic, and Johnson & Johnson drives the overall growth of the market.

What is the U.S. Medical Devices Market Size and Growth?

The U.S. medical devices market size is valued at USD 191.20 billion in 2025 and is expected to grow from USD 203.06 billion in 2026 to USD 346.19 billion by 2035, with a CAGR of 6.2% from 2026 to 2035.

United States Medical Devices Market Trends

The United States is a key contributor to the market. The strong presence of advanced healthcare infrastructure like clinics, hospitals, & ASCs, and a robust regulatory environment, increases the development of medical devices.

The growing prevalence of diseases like diabetes & heart disease, and increasing spending on healthcare infrastructure, increases demand for medical devices. The strong presence of key players like Abbott Laboratories, Medtronic, and Johnson & Johnson supports the overall market growth.

Why is Asia Pacific Experiencing the Fastest Growth in the Medical Devices Market?

Asia Pacific is experiencing the fastest growth in the market during the forecast period. The aging population and the rise of chronic conditions increase demand for medical devices. The growing healthcare spending and strong focus on telehealth services increase demand for medical devices.

The increasing awareness about healthcare and high investment in healthcare infrastructure increase the development of medical devices. The well-established medical device manufacturing and the rise in MedTech startups support the overall growth of the market.

China Medical Devices Market Trends

China is a major contributor to the market. The high prevalence of chronic diseases and the rising elderly population increase demand for medical devices. The healthcare initiatives, like Healthy China 2030 and favorable government policies, increase the production of medical devices. The presence of raw materials like specialized sensors, electronic components, and semiconductors increases the development of medical devices, driving the overall market growth.

India Market Trends

India is growing in the medical devices market. The growing health concerns and strong focus on preventive healthcare increase demand for medical devices. The rise in medical tourism and the expansion of healthcare infrastructure increase the adoption of medical devices. The strong government support for domestic manufacturing through policies like Aatmanirbhar Bharat & Make in India, and increased use of telehealth & wearable devices, support the overall market growth.

Medical Devices Market Segmentation Insights

Product Type Insights

Why did the Therapeutic Devices Segment Dominate the Medical Devices Market?

The therapeutic devices segment dominated the market in 2025. The growing prevalence of chronic diseases increases demand for therapeutic devices. The growth in personalised medicine and focus on minimally invasive treatments increases the adoption of therapeutic devices. The growing remote monitoring and focus on improving patient outcomes increase demand for therapeutic devices. The growing adoption of therapeutic devices like insulin pumps, smart glucose monitors, and wearable pain management drives the overall growth of the market.

The assistive and rehabilitation devices segment is the fastest-growing in the market during the forecast period. The aging population and growing age-related disorders like heart disease & arthritis increase demand for assistive and rehabilitation devices. The ongoing technological advancements in devices like augmented reality (AR) and virtual reality (VR), internet of things (IOT), AI, wearables, and robotics help the market growth. The growing shift towards home-based care and a strong government focus on the development of device support the overall market growth.

End User Insights

Which End User Held the Largest Share in the Medical Devices Market?

The hospitals segment held the largest share in the market in 2025. The growing number of patients and increasing diagnosis of various diseases increases demand for medical devices. The strong presence of advanced healthcare infrastructure and favorable reimbursement policies increases demand for medical devices. The availability of surgical instruments, specialized diagnostic tools, and monitoring systems in hospitals drives the overall growth of the market.

The home healthcare settings segment is experiencing the fastest growth in the market during the forecast period. The aging population and growing prevalence of chronic diseases increase demand for home healthcare. The growing preference for remote monitoring and the adoption of telehealth services help the market growth. The strong focus on convenience and focus on minimizing hospital admissions increases demand for home healthcare, supporting the overall growth of the market.

Sales Channel Insights

How the Direct Sales Segment Dominated the Medical Devices Market?

The direct sales segment dominated the market in 2025. The focus on maintaining strong relationships and building personal connections increases demand for direct sales. The need to control customer experience and focus on customization increases demand for direct sales. The extensive product education and availability of deep technical expertise increase demand for direct sales, driving the overall growth of the market.

The online sales segment is the fastest-growing in the market during the forecast period. The strong focus on convenience and easy accessibility for a wider range of products increases the adoption of online sales. The focus on enhancing customer experience, like secure payment & customized orders, increases demand for online sales. The easy availability of product information and the need for building a superior buying experience increase demand for online sales, supporting the overall growth of the market.

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Top Companies in the Medical Devices Market & Their Offerings:

• DePuy Synthes: Offers comprehensive orthopaedic products for joint reconstruction, trauma, spine, and sports medicine.
• Medtronic Plc: Develops a broad range of devices and therapies across cardiovascular, restorative, diabetes, and surgical technologies.
• Fresenius Medical Care: World's leading provider of products and services, including machines and disposables, for chronic kidney failure treatment.
• GE Healthcare: Specializes in medical imaging and diagnostic technologies, including MRI, CT, ultrasound scanners, and patient monitoring solutions.
• Philips Healthcare: Provides integrated health technology solutions, spanning diagnostic imaging systems, image-guided therapy, and patient monitoring.
• Ethicon LLC: Develops and markets surgical instruments and devices for both open and minimally invasive procedures.
• Siemens Healthineers: Offers a broad portfolio of diagnostic and therapeutic products, including medical imaging systems and laboratory diagnostics.
• Stryker: Provides products and services in MedSurg, Neurotechnology, and Orthopaedics, including implants, surgical equipment, and patient handling systems.
• Cardinal Health: Manufactures a private-brand portfolio of medical and surgical products, such as gloves, surgical apparel, and patient care items.
• Baxter International Inc.: Focuses on products to treat chronic and acute conditions, including IV solutions, infusion systems, renal care products, and surgical equipment.
• BD (Becton, Dickinson and Company): Manufactures and sells a vast array of medical supplies, devices, and diagnostic products like syringes, needles, and blood collection systems.
  

Recent Developments in the Medical Devices Industry:

• In January 2025, Stryker launched the Insignia Hip Stem device in India. The device uses Total Hip 4.1 software and captures patients' unique anatomy. The device is easy to implant for hemiarthroplasty and total hip procedures. (Source: https://health.economictimes.indiatimes.com)
  

• In June 2025, Tracky launched India’s first Bluetooth-connected continuous glucose monitor. The device supports iOS & Android and is available at Rs. 5999. The device consists of transmitters & sensors and helps in transforming diabetes care. (Source: https://www.biospectrumindia.com)
  

• In January 2025, ResMed launched the AirSense 11 device for sleep apnea in India. The features of the device include remote software update, care check-in, and a personal therapy assistant. The device has the AirView, a remote monitoring platform, and the myAir app. (Source: https://www.financialexpress.com)
  

Segments Covered in the Report

By Product Type

• Diagnostic Devices
  
  • Imaging Devices
    
    • X-ray
    • MRI (Magnetic Resonance Imaging)
    • CT (Computed Tomography)
    • Ultrasound
    • Nuclear Imaging (PET/SPECT)
  • In-vitro Diagnostic (IVD) Devices
    
    • Immunoassay Analyzers
    • Clinical Chemistry Analyzers
    • Hematology Analyzers
    • Molecular Diagnostics
    • Coagulation Analyzers
  • Endoscopy Devices
  • ECG/EKG Machines
  • Patient Monitoring Devices
  • Others
• Therapeutic Devices
  • Surgical Devices
    • Electrosurgical Devices
    • Powered Surgical Instruments
    • Minimally Invasive Surgical Instruments
  • Cardiovascular Devices
    • Pacemakers
    • Defibrillators
    • Stents
    • Catheters
  • Orthopedic Devices
    • Joint Reconstruction
    • Trauma Fixation Devices
    • Arthroscopy Devices
    • Spinal Devices
  • Respiratory Devices
    • Ventilators
    • Nebulizers
    • CPAP/BiPAP Devices
  • Dialysis Equipment
  • Infusion Pumps
  • Insulin Delivery Devices
  • Others
• Assistive and Rehabilitation Devices
  • Hearing Aids
  • Mobility Aids (Wheelchairs, Walkers, Prosthetics)
  • Exoskeletons
  • Robotic Rehabilitation Devices
  • Others
• Others
  • Disposable Medical Supplies (Syringes, Gloves, Bandages)
  • Wearable Devices
  • Smart Health Devices (IoT-enabled devices)
  • Implantable Devices (Cochlear implants, Neurostimulators)
    

By End User

• Hospitals
• Ambulatory Surgical Centers (ASCs)
• Diagnostic Centers
• Home Healthcare Settings
• Clinics
• Long-term Care Facilities
• Research and Academic Institutes
  

By Sales Channel

• Direct Sales (Distributors & Dealers)
• Indirect Sales
  • Third Party Distributors
  • Retail Pharmacies
• Online Sales
  • Direct to Consumer Sales
  • B2B E-commerce Platforms
  • Others

By Region

• North America: 
  • U.S. 
  • Canada 
  • Mexico 
  • Rest of North America 
• South America:  
  • Brazil 
  • Argentina 
  • Rest of South America 
• Europe: 
  • Western Europe  
    • Germany 
    • Italy 
    • France 
    • Netherlands 
    • Spain 
    • Portugal 
    • Belgium 
    • Ireland 
    • UK 
    • Iceland 
    • Switzerland 
    • Poland 
    • Rest of Western Europe 
• Eastern Europe  
  • Austria 
  • Russia & Belarus 
  • Türkiye 
  • Albania 
  • Rest of Eastern Europe 
• Asia Pacific:  
  • China 
  • Taiwan 
  • India 
  • Japan 
  • Australia and New Zealand,  
  • ASEAN Countries (Singapore, Malaysia) 
  • South Korea 
  • Rest of APAC 
• MEA:  
  • GCC Countries 
  • Saudi Arabia 
  • United Arab Emirates (UAE) 
  • Qatar 
  • Kuwait 
  • Oman 
  • Bahrain 
  • South Africa 
  • Egypt 
  • Rest of MEA

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