의료기기 기술 시장 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the medical device technologies market size is projected to expand from USD 0.68 trillion in 2025 and USD 0.73 trillion in 2026 to USD 1.02 trillion by 2031, registering a CAGR of 6.99% between 2026 to 2031.

This report is Segmented by Device Type (Diagnostic (Diagnostic Imaging Devices (MRI Systems) and More), Therapeutic, Surgical, and More), Technology Platform (Conventional, Wearable, and More), Therapeutic Application (Cardiology, and More), End User (Hospitals, Clinics, and More), and Geography (North America, Europe, and More). Market Forecasts are Provided in Terms of Value (USD).

Global Medical Device Technologies Market Trends and Insights

Aging Population & Rise in Chronic Diseases

By 2030, 1.4 billion people worldwide will be aged 60 or older, up 40% versus 2020 . Chronic illnesses already drive 74% of all deaths, ensuring sustained need for cardiac monitors, continuous-glucose devices, and infusion technologies. Extended life expectancy no longer translates into shorter illness phases; instead, patients live longer with multiple comorbidities, multiplying device use per capita. A typical 75-year-old with heart failure, diabetes, and osteoarthritis may concurrently rely on a cardiac monitor, CGM, and orthopedic brace, tripling hardware requirements per person. Payers shifting toward capitated payments now reward manufacturers that bundle hardware with predictive-analytics software able to minimize readmissions.

Technological Convergence in Minimally-Invasive & AI-Enabled Devices

The FDA's 2025 draft guidance on Predetermined Change Control Plans lets firms update algorithms inside preset safety envelopes without refiling a 510(k), reducing update cycles by six to nine months . Robotic surgery consoles now layer real-time tissue classification on force-feedback instruments, ultrasound probes auto-generate cardiac views, and navigation systems overlay CT reconstructions with sub-millimeter accuracy. Intuitive Surgical's da Vinci 5 pulls procedure data from an installed base of 8,600 systems to refine motion algorithms, giving incumbents with large datasets a defensible moat versus later entrants.

Stringent & Fragmented Regulatory Pathways

EU MDR pushed legacy-device transition to 2028, yet only 34 notified bodies remain, down from 58, stretching recertification to 18-24 months. Small firms face EUR 50,000-200,000 per-device costs that often exceed remaining product revenue, prompting 30-40% of Class IIa/IIb SKUs toward withdrawal. China's priority track drops approval to nine months but forces parallel dossiers distinct from FDA or EU templates, increasing overhead 25-35%. Japan's PMDA now supports digital-health pathways, although local patient data are still required, delaying launches 12-18 months.

Other drivers and restraints analyzed in the detailed report include:

1. Healthcare Infrastructure Expansion in Emerging Markets
2. Rapid Uptake of Wearable & Remote-Monitoring Devices
3. Reimbursement Cuts & Pricing Pressure

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Diagnostic Devices accounted for 39.12% of the medical device technologies market share in 2025, supported by large installed bases of MRI, CT, and ultrasound, plus high-margin consumables. Monitoring Devices are forecast to grow at 7.23% annually, eclipsing overall market growth as hospital-at-home and remote-patient-monitoring programs proliferate. Therapeutic Devices ride aging demographics and minimally invasive trends; transcatheter valve procedures expanded 22% year-over-year in 2024. Surgical ecosystems revolve around Intuitive's da Vinci, Medtronic's Hugo, and J&J's forthcoming Ottava, each selling proprietary tooling that yields 40-50% margins.

Photon-counting CT reduces radiation significantly while capturing 0.2 mm resolution, letting radiologists replace multi-phase protocols with a single scan. AI-powered handheld ultrasound priced below USD 3,000 broadens use beyond imaging departments. In-vitro panels now detect up to 30 pathogens from a single sample, enabling same-visit treatment. Assistive devices remain regionally fragmented, though myoelectric prosthetics gain traction as reimbursement frameworks mature in Germany, Japan, and select U.S. states.

Conventional Electro-mechanical & Disposable systems held 55.9% of 2025 revenue, reflecting the entrenchment of pumps, ventilators, and single-use instruments purchased under five-year group-purchasing contracts. Nanotechnology & Smart Materials are climbing at an 8.11% CAGR, led by antimicrobial coatings that cut central-line infections significantly in trials and biosensors tracking glucose, lactate, and pH in vivo. Wearable ECG monitors cleared by the FDA reached 47 models in 2024, and consumer devices such as the Apple Watch achieved 98% specificity for atrial-fibrillation screening.

Robotic platforms bifurcate into multiport cancer systems and single-port urology rigs; Intuitive's SP gained approval for transoral oncology in 2024, unlocking a USD 2 billion sub-segment. 3-D printing has shifted from prototyping to serial production of porous titanium cages with 95% osseointegration at one year. AR/VR overlays now guide spine surgeons, trimming screw-placement errors by 40%. AI-as-a-Medical-Device surpassed 1,300 U.S. authorizations by end-2025, 74% in radiology, each carrying its own CPT code and recurring software revenue stream.

Complete Report Scope:

• By Device Type
  • Diagnostic Devices
    • Diagnostic Imaging Devices
      • MRI Systems
      • CT Scanners
      • Ultrasound
    • In-Vitro Diagnostics
  • Therapeutic Devices
    • Implants
    • Drug-Delivery Pumps
  • Surgical Devices
    • Robotics & Navigation
    • Energy-based Devices
  • Monitoring Devices
    • Multiparameter Monitors
    • Remote Patient Monitors
  • Others
• By Technology Platform
  • Conventional Electro-mechanical & Disposable
  • Wearable & Remote Monitoring
  • Telehealth & mHealth
  • Robotic Surgery
  • 3-D Printing
  • Augmented / Virtual Reality
  • Nanotechnology & Smart Materials
  • AI-as-a-Medical-Device (SaMD)
• By Therapeutic Application
  • Cardiology
  • Orthopedics & Sports Medicine
  • Neurology
  • Ophthalmology
  • General & Laparoscopic Surgery
  • Oncology
  • Others
• By End User
  • Hospitals
  • Clinics
  • Ambulatory Surgical Centers
  • Home Healthcare Settings
  • Diagnostic Laboratories
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • India
    • Japan
    • South Korea
    • Australia
    • Rest of Asia-Pacific
  • Middle East and Africa
    • GCC
    • South Africa
    • Rest of Middle East and Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 45.3% of 2025 revenue, supported by USD 4.5 trillion in U.S. health spend and an FDA framework that allows iterative AI updates without new 510(k) filings, slicing half a year off time-to-market. Medicare's RPM codes drove 71 million users, and private payers broadened CGM coverage to 8 million insulin-dependent type-2 diabetics. Canada's single-payer bargaining suppresses prices 10-15% but offers predictable access, while Mexico's nearshoring and new public-hospital spending push 8-10% annual growth despite 12-18-month approvals at COFEPRIS.

Asia-Pacific is forecast to grow at 7.56% CAGR, paced by China's nine-month priority pathway and India's INR 30 billion manufacturing incentive. Japan faces 29% of its population over 65, fueling demand for robotic exoskeletons and home ventilators; the PMDA's 2024 digital pathway clipped software approval to 12 months. South Korea invested KRW 500 billion in AI diagnostics and robotics; Australia harmonized pathways with the FDA and the EU, slashing duplicate costs by 30-40%. Southeast Asian nations attract contract manufacturing as Chinese wages rise, with Medtronic and Abbott opening a Vietnam assembly in 2024.

Europe generated significant share of global revenue in 2025, but MDR bottlenecks have created 18-24-month queues that threaten the legacy Class II devices. Germany's NUB pathway gives temporary reimbursement pending health-technology assessment, often ahead of France or the U.K. post-Brexit UKCA adds complexity despite an MHRA fast track shaving 3-6 months from approvals. The GCC funds medical-tourism hubs, with Saudi Arabia alone allocating SAR 100 billion to build 20 new hospitals. South Africa's private networks buy premium equipment, though public budgets lag. Brazil grows notablly annually via expedited reviews for maternal-health and tropical-disease tools.

1. Abbott Laboratories
2. Baxter
3. Beckton Dickinson
4. Boston Scientific
5. Canon
6. Cardinal Health
7. Danaher
8. Dexcom
9. Edward Lifesciences
10. FUJIFILM
11. GE HealthCare Technologies Inc.
12. Hologic
13. Intuitive Surgical
14. Johnson & Johnson
15. Medtronic
16. Olympus
17. Koninklijke Philips
18. Resmed
19. Roche
20. Siemens Healthineers
21. Smiths Group
22. Stryker
23. Terumo
24. Zimmer Biomet

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Overview
• 4.2 Market Drivers
  • 4.2.1 Aging Population & Rise in Chronic Diseases
  • 4.2.2 Technological Convergence in Minimally Invasive & AI-Enabled Devices
  • 4.2.3 Healthcare Infrastructure Expansion in Emerging Markets
  • 4.2.4 Rapid Uptake of Wearable & Remote-Monitoring Devices
  • 4.2.5 Digital Twins & In-Silico Trials Shortening R&D Cycles
  • 4.2.6 Point-Of-Care 3-D Printing Enabling Just-In-Time Implants
• 4.3 Market Restraints
  • 4.3.1 Stringent & Fragmented Regulatory Pathways
  • 4.3.2 Reimbursement Cuts & Pricing Pressure
  • 4.3.3 Cyber-Security Liability Shifts Raising Compliance Costs
  • 4.3.4 Rare-Earth Material Supply Constraints for Imaging Components
• 4.4 Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Suppliers
  • 4.7.3 Bargaining Power of Buyers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD)

• 5.1 By Device Type
  • 5.1.1 Diagnostic Devices
    • 5.1.1.1 Diagnostic Imaging Devices
      • 5.1.1.1.1 MRI Systems
      • 5.1.1.1.2 CT Scanners
      • 5.1.1.1.3 Ultrasound
    • 5.1.1.2 In-Vitro Diagnostics
  • 5.1.2 Therapeutic Devices
    • 5.1.2.1 Implants
    • 5.1.2.2 Drug-Delivery Pumps
  • 5.1.3 Surgical Devices
    • 5.1.3.1 Robotics & Navigation
    • 5.1.3.2 Energy-based Devices
  • 5.1.4 Monitoring Devices
    • 5.1.4.1 Multiparameter Monitors
    • 5.1.4.2 Remote Patient Monitors
  • 5.1.5 Others
• 5.2 By Technology Platform
  • 5.2.1 Conventional Electro-mechanical & Disposable
  • 5.2.2 Wearable & Remote Monitoring
  • 5.2.3 Telehealth & mHealth
  • 5.2.4 Robotic Surgery
  • 5.2.5 3-D Printing
  • 5.2.6 Augmented / Virtual Reality
  • 5.2.7 Nanotechnology & Smart Materials
  • 5.2.8 AI-as-a-Medical-Device (SaMD)
• 5.3 By Therapeutic Application
  • 5.3.1 Cardiology
  • 5.3.2 Orthopedics & Sports Medicine
  • 5.3.3 Neurology
  • 5.3.4 Ophthalmology
  • 5.3.5 General & Laparoscopic Surgery
  • 5.3.6 Oncology
  • 5.3.7 Others
• 5.4 By End User
  • 5.4.1 Hospitals
  • 5.4.2 Clinics
  • 5.4.3 Ambulatory Surgical Centers
  • 5.4.4 Home Healthcare Settings
  • 5.4.5 Diagnostic Laboratories
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 India
    • 5.5.3.3 Japan
    • 5.5.3.4 South Korea
    • 5.5.3.5 Australia
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East and Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East and Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global-level Overview, Market-level Overview, Core Segments, Financials, Strategic Information, Market Rank/Share, Products & Services, Recent Developments)
  • 6.3.1 Abbott Laboratories
  • 6.3.2 Baxter International Inc.
  • 6.3.3 Becton, Dickinson and Company
  • 6.3.4 Boston Scientific Corporation
  • 6.3.5 Canon Medical Systems Corporation
  • 6.3.6 Cardinal Health Inc.
  • 6.3.7 Danaher Corporation
  • 6.3.8 Dexcom Inc.
  • 6.3.9 Edwards Lifesciences Corporation
  • 6.3.10 Fujifilm Holdings Corporation
  • 6.3.11 GE HealthCare Technologies Inc.
  • 6.3.12 Hologic Inc.
  • 6.3.13 Intuitive Surgical Inc.
  • 6.3.14 Johnson & Johnson
  • 6.3.15 Medtronic plc
  • 6.3.16 Olympus Corporation
  • 6.3.17 Philips Healthcare
  • 6.3.18 ResMed Inc.
  • 6.3.19 Roche Diagnostics
  • 6.3.20 Siemens Healthineers AG
  • 6.3.21 Smith & Nephew plc
  • 6.3.22 Stryker Corporation
  • 6.3.23 Terumo Corporation
  • 6.3.24 Zimmer Biomet Holdings Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment