세계의 의료기기 시장 : 제15판(2025-2030년)

In the rapidly evolving healthcare landscape, the medical device industry-also known as the medtech sector-remains indispensable. From essential supplies like gloves and syringes to advanced technologies such as surgical robots and imaging systems, medical devices are critical for diagnosing, treating, and managing disease worldwide. Kalorama Information's "Global Market for Medical Devices, 15th Edition (2025-2030)" is your definitive resource for understanding the trends, challenges, and opportunities shaping this dynamic market.

The 15th edition delivers updated market forecasts and insights into competitive shifts driven by mergers, restructurings, and portfolio realignments. As growth accelerates, companies are consolidating to strengthen revenue streams and offer integrated solutions to healthcare providers.

Report Features:

• Comprehensive Global Insights: Analyze market size estimates for 2025 and forecasts through 2030 across 50 countries, including the United States, China, Japan, and key emerging markets.
• Strategic Market Data: Explore drivers, regulatory hurdles, and opportunities across diverse device categories-from imaging and surgical instruments to consumer-driven technologies.
• Expert Analysis of Market Leaders: Gain perspective on leading medtech companies and the impact of mergers and acquisitions reshaping the competitive landscape.
• Actionable Intelligence for Success: Navigate regulatory complexity, reimbursement challenges, and cost pressures with insights designed to support strategic planning.

25+ Medical Device Segments Covered:

Includes market estimates, forecasts, and analysis of the following critical areas:

Research Parameters:

This report combines primary interviews with medical device executives and extensive secondary research from company reports, trade publications, government sources, and medical literature. Statistical methods and analytical practices underpin market size estimates and forecasts, ensuring accuracy and reliability.

Table of Contents

Chapter 1: Executive Summary

• About Kalorama Information
• Overview
  • Report Coverage
• Size and Growth of the Market
  • Figure 1-1: Global Medical Device Market, Compound Annual Growth Rate (CAGR), 2020-2025 (%) [Advanced Wound Care, Cardiac Rhythm Management, Catheters, Dental Equipment and Consumables, Dialysis Equipment and Supplies, Endoscopes, General Surgical, Glucose Management, Imaging Equipment, MIS Devices, Orthopedic Devices, Other Device Segments, Patient Monitoring (excluding CRM & Glucose), Respiratory Equipment]
• Top Companies
• Mergers and Acquisitions
• Scope and Methodology
• Conclusions

Chapter 2: Introduction

• Overview
  • Figure 2-1: Summary: Health Technology (Medical Device) National Policy, Latest Year Available
  • Figure 2-2: Summary: Type of Nomenclature System, Latest Year Available
  • Figure 2-3: Summary: Use of Nomenclature System, Latest Year Available
• Regulation in the United States
  • Classification of Medical Devices
  • Class I Medical Devices
  • Limitations on Exemptions
    • Table 2-1: Regulations and Product Codes (same regulation number - 21 CFR 870.1875- four different product codes for specific device types with exempt status)
  • Class II Medical Devices
  • Class III Medical Devices
  • Device Classification Summary
    • Table 2-2: Medical Device Classification Summary (Class I, Class II, Class III)
  • FDA Launches Early Approval Program (EAP)
  • Real-World Data and Real-World Evidence in the Device Approval Process
    • Table 2-3: Comparison of FDA Early Access and Expedited Approval Programs for Medical Devices
• Regulation in Europe
  • European Union
    • Table 2-4: EU Medical Device Classification Rules
    • Figure 2-4: EU Competent Authorities
  • United Kingdom
  • European Economic Area
    • Figure 2-5: EEA Competent Authorities
  • Switzerland
  • Turkey
• Regulation in Japan
  • Table 2-5: PMDA Review Categories
• Regulation in China
  • Table 2-6: China's Medical Device Classification Guide: Passive Devices
  • Table 2-7: China's Medical Device Classification Guide: Active Devices
• Regulation in Canada
• Regulation in Brazil
• World Health Care Trends
• Unique Device Identifier (UDI)
• AI-Enabled Medical Devices
  • Table: 2-8: Selected FDA List of Approved AI/ML-Enabled Medical Devices, HY 2025
• Regulatory Changes
• Nanotech Implants Changing Drug Delivery
• Tariff Effects on the Medical Device Industry

Chapter 3: Mergers and Acquisitions

• Introduction
• Selected Recent Device Industry Mergers and Acquisitions
  • Avanos Medical Acquires Nexus Medical
  • Braun Acquires True Digital Surgery
  • GE HealthCare Acquires icometrix
  • Alcon Acquires LumiThera
  • Boston Scientific Buys Elutia
  • Terumo Acquires OrganOx
  • Zimmer Biomet Acquires Paragon 28
  • Alcon to Acquire STAAR Surgical
  • Arterex Buys Xponent Global
  • Waters Agrees to Acquire Becton Dickinson's Biosciences & Diagnostic Business
  • TEAM Technologies Purchases Duke Empirical
  • Verge Medical Acquires 2MG Medical
  • EssilorLuxottica Buys Optegra Clinics
  • Merit Medical Scoops Up Biolife Delaware
  • Safe Life Buys AEDMAX.PL
  • ResMed Acquires VirtuOx
  • Alcon Acquires Lensar
  • Boston Scientific Grabs SoniVie
  • Teleflex Buys Biotronik
  • KARL STORZ Acquires T1V's Medical Business
  • Boston Scientific Acquires Bolt Medical
  • Philips Acquires Vectura
  • Stryker Buys Inari Medical
  • Glooko Buys Monarch Medical Technologies
  • Zimmer Biomet Acquires Monogram Technologies
  • Boston Scientific Agrees to Acquire Nalu Medical
    • Table 3-1: Selected Mergers and Acquisitions in the Medical Device Market, 2024 and 10 Months 2025

Chapter 4: Selected Specific Device Markets

• Table 4-1: Global Markets for Specific Medical Devices, 2025-2030 ($ billion) [3D Printing Equipment, Materials, and Software; Anesthesia Monitors; Blood Collection; Blood Gas Analyzers; Blood Pressure Monitors; CPAP Machines; Cannula Respiratory; Catheters; Computed Tomography; Contact Lenses; Continuous Glucose Monitors; Cosmetic Surgery Implants; Defibrillators; Dental Equipment/Devices (excluding X-ray); Dental Implants/Components; Dental X-ray; Dialysis Equipment & Supplies; EKG/ECG Machines; Electrosurgical Devices; Endoscopes (excluding gastro); Gastric Banding/Bariatric; Gastro Endoscopes; Glucose Monitors (excluding CGM); Hernia Repair and Fixation Devices; Hip Implants; Hypodermic Syringe; Infusion Pumps; Insulin Pumps; Intraocular Lenses; Knee Implants; MRI; Medical Beds; Minimally Invasive Surgical Instruments; Neurostimulation; Ophthalmic Imaging and Diagnostics; Ophthalmic Lasers; Ostomy Care Devices; Oxygen Therapy Equipment; Pacemakers; Personal Protective Equipment (gloves, masks, gowns); Spine Implants; Sport, Extremity and Trauma; Stents; Sterilization/Disinfection Equipment; Stethoscopes; Surgical Guidance Devices; Surgical Robots; Sutures, Staples, Staplers; Traditional Surgical Instruments (scalpels, forceps, retractors, scissors); Ultrasound; Vascular Closure Devices; Wheelchairs; Wound Care, Advanced; X-Ray (excluding dental); Others]
• Blood Collection Supplies
• Catheters
• Contact Lenses
• CPAP Devices
• Critical Care Analysis - Blood Gas Analyzers
• Defibrillators
  • Figure 4-1: Defibrillation Device Sales, Distribution by Type, 2025 (%) [AED, External, Implantable]
• Diabetes Management Devices
  • Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2025 (%)
  • Glucose Monitor and Consumable Market Value (2025)
    • Figure 4-3: Glucose Monitoring Device Market Trend by Product Type, 2020-2030 ($ million)
  • Insulin Delivery Pump Market Value (2025)
• Dialysis Equipment & Supplies
  • Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2025 (%)
• Endoscopes
  • Table 4-2: Endoscopes and Related Instrument Market Size, by Subsegment, 2025 (%)
• Gastric Banding and Bariatric Devices
• Hernia Repair and Fixation Devices
• Hip Implants
• Infusion Pumps
• Intraocular Lens Devices
• Knee Implants
  • Posterior-Stabilized Knee Implants
  • Cruciate-Retaining Knee Implants
  • Unicompartmental Knee Implants
• Medical Beds
• Minimally Invasive Surgery (MIS)
• Magnetic Resonance Imaging (MRI)
• Nasal Cannula (Cannula Respiratory)
• Ostomy Products
• Pacemakers
  • Figure 4-5: Pacemaker Device Sales, Distribution, by Type, 2025 (%) [External, Implantable]
• Patient Monitoring
  • Figure 4-6: Distribution of Patient Monitoring Technologies, by Type, 2025 (%) [Anesthesia Monitors, Blood Pressure Monitors, Cardiac Rhythm in Cardio, EKG/ECG Machines, Glucose Monitor Devices, All Others]
• Personal Protective Equipment (PPE)
  • Figure 4-7: Market Distribution of Personal Protective Equipment (PPE), by Type, 2025 (%) [Gloves, Gowns, Shields & Masks (General Eye and Face Protection), Others (Respirators, Kits)]
  • Medical Gloves Market Value (2025)
  • Medical Mask/Face Protection Market Value (2025)
  • Protective Clothing Market Value (2025)
  • Respirators and PPE Kits Market Value (2025)
• Stents
• Sterilization and Disinfection Equipment
• Ultrasound
• Wheelchairs
• Wound Care Devices, Advanced Technologies
• X-Ray (excluding dental)
  • Figure 4-8: X-Ray Equipment Sales, Distribution by Type, 2025 (%) [Digital, Traditional]

Chapter 5: Market Analysis

• Figure 5-1: Market Influence: Strength of Impact
• Market Drivers
  • Consumer-Driven Market
  • Aging Population
    • Figure 5-2: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050 (in millions)
  • Increase in Chronic Disease
    • Figure 5-3: Global Prevalence of Disease, 2000, 2015 and Projected 2030
• Market Constraints
  • Pressure on Prices
    • Figure 5-4: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2024 (%)
  • Competitive Bidding
  • Group Purchasing Organization
  • Value Analysis Committees
• Medical Device Size and Growth
  • Figure 5-5: Global Medical Device Market, Compound Annual Growth Rate (CAGR), 2020-2025 (%) [Advanced Wound Care, Cardiac Rhythm Management, Catheters, Dental Equipment and Consumables, Dialysis Equipment and Supplies, Endoscopes, General Surgical, Glucose Management, Imaging Equipment, MIS Devices, Orthopedic Devices, Other Device Segments, Patient Monitoring (excluding CRM & Glucose), Respiratory Equipment]
  • Figure 5-6: Global Medical Device Market, 2020-2030 ($ billion)
• Market by Region
  • Figure 5-7: Regional Medical Device Market Distribution
  • Figure 5-8: Global Medical Device Market, Distribution by Region, 2025 (%) [Asia Pacific, EMEA, Latin America, North America]
• Market by Country: Top 20
  • Table 5-1: Top 20 Device Markets by Country, 2025-2030 ($ billion) [Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States]
  • Figure 5-9: Global Medical Device Market Growth, by Top 20 Countries, CAGR 2025-2030 (%) [Australia, Brazil, Canada, China, France, Germany, India, Italy, Japan, Mexico, Netherlands, Russia, South Korea, Spain, Sweden, Switzerland, Taiwan, Turkey, United Kingdom, United States]
  • United States Medical Device Market
  • Germany Medical Device Market
  • China Medical Device Market
  • Japan Medical Device Market
  • France Medical Device Market
  • United Kingdom Medical Device Market
  • Italy Medical Device Market
  • Brazil Medical Device Market
  • Spain Medical Device Market
  • India Medical Device Market
  • Canada Medical Device Market
  • Australia Medical Device Market
  • Russia Medical Device Market
  • The Netherlands Medical Device Market
  • Taiwan Medical Device Market
  • South Korea Medical Device Market
  • Switzerland Medical Device Market
  • Sweden Medical Device Market
  • Turkey Medical Device Market
  • Mexico Medical Device Market
• Second Tier: Market by Country
  • Table 5-2: Top 21-50 Medical Device Markets, by Country, 2025-2030 ($ billion) [Argentina, Bangladesh, Bulgaria, Chile, Croatia, Czech Republic, Egypt, Greece, Hungary, Indonesia, Iran, Iraq, Israel, Lithuania, Malaysia, Mexico, New Zealand, Peru, Philippines, Poland, Romania, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Thailand, Turkey, UAE, Ukraine, Venezuela, Vietnam]

Chapter 6: Company Profiles: Bellwether

• Overview
  • Table 6-1: Estimated Medical Device Revenue Performance, Bellwether Companies, 2024 vs. 2025 (US $ million)
  • Figure 6-1: Market Performance by Bellwether Medical Device Company, 2024 vs. 2025 (US $ million)
• Abbott Laboratories
  • Table 6-2: Abbott Corporate Summary
  • Company Overview
  • Products
  • Abbott's 2025 Medical Device Offerings
    • Table 6-3: Abbott's Selected Medical Device Premarket Approvals - November 6, 2024-October 3, 2025
• Company Financials
  • Table 6-4: Abbott Financial Review, 2020-2025 est, ($ billion)
• Alcon
  • Table 6-5: Alcon Corporate Summary
  • Company Overview
  • Recent Acquisitions
  • Products
    • Table 6-6: Alcon's Selected Medical Device Premarket Approvals December 4, 2024-October 1, 2025
  • Company Financials
    • Table 6-7: Alcon Financial Review, 2020-2025 ($ billion)
• Baxter International, Inc.
  • Table 6-8: Baxter Corporate Summary
  • Company Overview
  • Strategic Acquisitions
  • Products
  • Recent Product Launches
    • Table 6-9: Baxter's Selected Medical Device Premarket Approvals September 5, 2024-October 1, 2025
  • Company Financials
    • Table 6-10: Baxter Financial Review, 2020-2025 est ($ billion)
• Becton Dickinson and Co. (BD)
  • Table 6-11: Becton Dickinson Corporate Summary
  • Company Overview
  • Business Structure
  • Recent Strategic Moves
  • Products
  • Notable Innovations
    • Table 6-12: BD's Selected Medical Device Premarket Approvals January 1, 2025-August 1, 2025
  • Company Financials
    • Table 6-13: Becton Dickinson Financial Review, 2020-2025 est ($ billion)
• Boston Scientific Corp.
  • Table 6-14: Boston Scientific Corporate Summary
  • Company Overview
  • Recent Acquisitions and Milestones
  • Products
  • MedSurg Products
  • Electrophysiology and Rhythm Management
  • Regulatory Milestones
    • Table 6-15: Boston Scientific's Selected Medical Device Premarket Approvals - October 18, 2024-September 26, 2025
  • Company Financials
    • Table 6-16: Boston Scientific Financial Review, 2020-2025 est ($ billion)
• Cardinal Health
  • Table 6-17: Cardinal Health Corporate Summary
  • Company Overview
  • Products
    • Table 6-18: Cardinal Health's Selected Medical Device Premarket Approvals - December 19, 2024- August 22, 2025
  • Company Financials
    • Table 6-19: Cardinal Health Financial Review, 2020-2025 ($ billion)
• Danaher Corp.
  • Table 6-20: Danaher Corporate Summary
  • Company Overview
  • Company Financials
    • Table 6-21: Danaher Financial Review, 2020-2025 ($ billion)
• GE Healthcare
  • Table 6-22: GE Healthcare Corporate Summary
  • Company Overview
  • Business Segments
  • Recent Transactions
  • Products
  • Select 2025 Launches
    • Table 6-23: GE Healthcare's Selected Medical Device Premarket Approvals - November 12, 2024- April 1, 2025
  • Company Financials
    • Table 6-24: GE Healthcare Financial Review, 2020-2025 ($ billion)
• Johnson & Johnson
  • Table 6-25: Johnson & Johnson Corporate Summary
  • Company Overview
  • Recent Acquisitions and Strategic Moves
  • Product Overview
    • Table 6-26: Johnson & Johnson's DePuy Selected Premarket Approvals November 1, 2024-June 1, 2025
    • Table 6-27: Johnson & Johnson's Biosense Webster Selected Premarket Approvals August 2025
    • Table 6-28: Johnson & Johnson Ethicon's Selected Premarket Approvals January 1, 2025-June 1, 2025
    • Table 6-29: Johnson & Johnson's Shockwave Medical Selected Premarket Approvals May 2025
  • Company Financials
    • Table 6-30: Johnson & Johnson Financial Review, 2020-2025 est ($ billion)
• Medline
  • Table 6-31: Medline Corporate Summary
  • Company Overview
  • Products
    • Table 6-32: Medline Selected Premarket Approvals November 1, 2024-October 1, 2025
• Medtronic
  • Table 6-33: Medtronic Corporate Summary
  • Company Overview
  • Products
  • Recent Product Launches and Approvals
  • 2024 Highlights
  • 2025 Highlights
    • Table 6-34: Medtronic Selected Premarket Approvals November 1, 2024-October 1, 2025
  • Company Financials
    • Table 6-35: Medtronic Financial Review, Fiscal 2020-2025 ($ billion)
• Roche
  • Table 6-36: Roche Corporate Summary
  • Company Overview
  • Products
  • Company Financials
    • Table 6-37: Roche Financial Review, 2020-2025 est (CHF billion)
• Royal Philips
  • Table 6-38: Royal Philips Corporate Summary
  • Company Overview
  • Products
    • Table 6-39: Royal Philips Selected Medical Device Premarket Approvals October 18, 2024-October 2, 2025
  • Company Financials
    • Table 6-40: Philips Financial Review, 2020-2025 est (Euro- billion)
• Siemens Healthineers
  • Table 6-41: Siemens Healthineers Corporate Summary
  • Company Overview
  • Products
    • Table 6-42: Siemens's Medical Selected Device Premarket Approvals November 15, 2024-October 1, 2025
  • Company Financials
    • Table 6-43: Siemens Healthineers Financial Review, 2020-2025 (Euro- billion)
• Stryker Corporation
  • Table 6-44: Stryker Corporate Summary
  • Company Overview
  • Products
    • Table 6-45: Stryker Medical Device Selected Premarket Approvals November 7, 2024-September 30, 2025
  • Company Financials
    • Table 6-46: Stryker Corporation Financial Review, 2020-2025 ($ billion)

Chapter 7: Other Selected Market Participants

• Companies
  • Braun
  • Bausch + Lomb
  • Canon Medical Systems
  • Coloplast A/S
  • ConvaTec
  • Dentsply Sirona
  • Dexcom
  • Dragerwerk AG & Co. KGaA
  • Edwards Lifesciences
  • Fresenius SE & Co. KGaA
  • HeartFlow
  • Intuitive Surgical
  • ICU Medical
  • Masimo Corporation
  • Medical Electronics Co., Ltd. (Mindray)
  • Mindray
  • Olympus Corporation
  • RDS Medical Equipment Manufacturing
  • ResMed
  • Smith & Nephew plc
  • Solventum
  • Steris plc
  • Teleflex Inc.
  • Terumo Corporation
  • Zimmer Biomet Holdings, Inc.