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Global Market for Medical Devices, 16th Edition (2026–2031)
Publication Date: October 29, 2026
Tags: Cardiovascular Disease, Computerized Tomography (CT), Diagnostic Instruments, Diagnostics, Glucose, HbA1c, Imaging Instruments, In Vitro Diagnostics (IVD), IVD, Lab Equipment, Lab Instruments, Magnetic Resonance Imaging (MRI), Medical Devices, MRI, Patient Monitoring and Telehealth, Respiratory Diseases, Telehealth, Ultrasound, X-ray
Pages: 296
SKU: 26-032KA
Medical devices are used at nearly every point of care, from gloves, syringes and wound dressings to imaging systems, cardiac implants and surgical robots. Demand continues to grow with aging populations, rising chronic disease and higher procedure volumes. At the same time, manufacturers face pricing pressure, reimbursement constraints, tariffs and tighter regulatory requirements. Kalorama Information’s Global Market for Medical Devices, 16th Edition provides market estimates for 2026 and forecasts through 2031, along with analysis of the companies, technologies and policies shaping the industry.
The 16th edition reflects a period of significant change in the competitive landscape. It covers major transactions announced or completed between January 2025 and August 2026, including Boston Scientific’s agreement to acquire Penumbra, Danaher’s acquisition of Masimo, the take-private of Hologic by Blackstone and TPG, and the separation of MiniMed from Medtronic. It also examines how companies are directing investment toward higher-growth areas such as cardiovascular intervention, neurovascular devices, neuromodulation, robotics and connected care while divesting slower-growing businesses.
What’s New in This Edition
- Market estimates for 2026 and forecasts through 2031 for more than 50 device segments and 50 countries
- A selected mergers and acquisitions table covering about 70 transactions from January 2025 through August 2026
- Coverage of new regulatory milestones, including the FDA’s Quality Management System Regulation and mandatory EUDAMED modules under the EU MDR
- Analysis of AI-enabled devices, medical device cybersecurity incidents, tariffs and supply-chain risk, and the restart of Medicare’s competitive bidding program
- Updated profiles of 15 bellwether companies, with financial reviews and recent FDA clearances and approvals
Report Features
- Global and country-level analysis: market size and growth for the 20 largest national markets, with additional estimates for markets ranked 21 through 50 and analysis by region (North America; Europe, the Middle East and Africa; Asia Pacific; and Latin America)
- Market drivers and constraints: aging populations, chronic disease, consumer-driven demand and home-based care, weighed against pricing pressure, value analysis, hospital cost controls and procurement policies
- Regulatory environment: device classification and approval pathways in the United States, the European Union, the United Kingdom, Switzerland, Japan, China, Canada, Brazil and other markets
- Competitive landscape: profiles of leading manufacturers and other market participants, covering products, strategy, acquisitions and financial performance
Bellwether Companies Profiled
Abbott Laboratories, Baxter, Becton Dickinson, Boston Scientific, Cardinal Health, Danaher, GE HealthCare, Intuitive Surgical, Johnson & Johnson, Medline Industries, Medtronic, Philips, Roche, Siemens Healthineers and Stryker, plus profiles of additional market participants.
Device Segments Covered
Includes market estimates, forecasts and analysis for:
- 3D Printing Equipment, Materials and Software
- Anesthesia Monitors
- Blood Collection
- Blood Gas Analyzers
- Blood Pressure Monitors
- Cannula Respiratory
- Catheters
- Computed Tomography
- Contact Lenses
- Continuous Glucose Monitors
- Cosmetic Surgery Implants
- CPAP Machines
- 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 Syringes
- Infusion Pumps
- Insulin Pumps
- Intraocular Lenses
- Knee Implants
- Medical Beds
- Minimally Invasive Surgical Instruments
- MRI
- 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)
- Other device segments
Research Parameters
This report combines primary interviews with medical device executives and extensive secondary research from company reports, government and regulatory sources, trade publications and medical literature. Market size estimates and forecasts are developed using established statistical and analytical methods.
Chapter 1: Executive Summary
About Kalorama Information
Overview
Size and Growth of the Market
- Figure 1-1: Global Medical Device Market, 2021-2031 (US$ billions)
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
Challenges in the Medical Device Market
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 product codes with differing class and exemption 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 Breakthrough Devices Program
- 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: Select 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
Global Health Care Trends
Unique Device Identifier (UDI)
AI-Enabled Medical Devices
- Table 2-8: Selected FDA List of Authorized AI/ML-Enabled Medical Devices
Regulatory Changes
Tariff Effects on the Medical Device Industry
Cybersecurity Concerns
Chapter 3: Mergers and Acquisitions
Introduction
Selected Recent Device Industry Mergers and Acquisitions
Blackstone and TPG Acquire Hologic
Boston Scientific Acquires Penumbra
Danaher Completes Acquisition of Masimo
KKR Buys Integer Holdings
Montagu/Kohlberg Acquire Teleflex Medical OEM
American Industrial Partners Acquires Avanos Medical
Teledyne to Acquire Varex Imaging
Stryker Adds Amplitude Vascular Systems
Medtronic Buys SPR Therapeutics
Medtronic Acquires CathWorks
Medtronic Completes Acquisition of Scientia Vascular
ResMed Acquires Noctrix Health
iRhythm Buys VitalConnect
Haemonetics Acquires Vivasure Medical
Stereotaxis Buys Robocath
Johnson & Johnson Acquires Atraverse Medical
Johnson & Johnson Buys Expanding Innovations
Stryker Adds ZuriMED
- Table 3-1: Selected Mergers and Acquisitions in the Medical Device Market, Jan. 2025 to Aug. 2026
Chapter 4: Selected Specific Device Markets
- Table 4-1: Global Markets for Specific Medical Devices, 2026-2031 (US$ billions)
Blood Collection Supplies
Catheters
Contact Lenses
CPAP Devices
Critical Care Analysis – Blood Gas Analyzers
Defibrillators
- Figure 4-1: Defibrillation Device Sales, Distribution by Type, 2026 (%)
Diabetes Management Devices
- Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2026 (%)
Glucose Monitor and Consumable Market Value, 2026 (including monitors, lancets, test strips, cartridges, and others)
- Figure 4-3: Glucose Monitoring Device Market Trend, by Product Type, 2021-2031 (US$ millions)
Insulin Delivery Pump Market Value (2026)
Dialysis Equipment & Supplies
- Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2026 (%)
Endoscopes
- Table 4-2: Endoscopes and Related Instruments, Distribution by Subsegment, 2026, and CAGR, 2026-2031 (%)
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)
MRI
Nasal Cannula
Ostomy Products
Pacemakers
- Figure 4-5: Pacemaker Device Sales, Distribution by Type, 2026 (%)
Patient Monitoring
- Figure 4-6: Distribution of Patient Monitoring Technologies, by Type, 2026 (%)
Personal Protective Equipment
- Figure 4-7: Market Distribution of Personal Protective Equipment (PPE), by Type, 2026 (%)
- Medical Gloves Market Value (2026)
- Medical Mask/Face Protection Market Value (2026)
- Protective Clothing Market Value (2026)
- Respirators and PPE Kits Market Value (2026)
Stents
Sterilization and Disinfection Equipment
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray
- Figure 4-8: X-Ray Equipment Sales, Distribution by Type, 2026 (%)
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 and Age 65+, 2000–2050 (population in millions)
Increase in Chronic Disease
- Figure 5-3: Global Prevalence of Selected Chronic Diseases, 2000, 2015 and 2030 Projected (Millions of People)
Market Constraints
Pressure on Prices
- Figure 5-4: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2025 (%)
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) by Broad Segment, 2021-2026 (%)
- Figure 5-6: Global Medical Device Market, 2021-2031 (US$ billions)
Market by Region
- Figure 5-7: Regional Medical Device Market Distribution
- Figure 5-8: Global Medical Device Market Distribution, by Region, 2026 (%)
Market by Country: Top 20
- Table 5-1: Top 20 Device Markets, by Country, 2026-2031 (US$ billions)
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
Canada Medical Device Market
India Medical Device Market
Australia Medical Device Market
Russia Medical Device Market
Netherlands Medical Device Market
Taiwan Medical Device Market
Switzerland Medical Device Market
South Korea 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 Device Markets, by Country, 2026-2031 (US$ billions)
Chapter 6: Company Profiles: Bellwether
Overview
- Table 6-1: Estimated Medical Device Revenue Performance, Bellwether Companies, 2026 vs. 2031 (US$ millions)
- Figure 6-1: Market Performance by Bellwether Company, 2025-2026 (US$ millions)
Abbott Laboratories
- Table 6-2: Abbott Corporate Summary
Company Overview
Products
- Diabetes Care
- Electrophysiology
- Rhythm Management
- Heart Failure
- Structural Heart
- Vascular Intervention
- Neuromodulation
- Recent Developments
- Table 6-3: Abbott’s Selected Medical Device Premarket Clearances and Approvals, Nov. 2024 – Aug. 2026
Company Financials
- Table 6-4: Abbott Financial Review, 2021-2026 est. (US$ billions)
Baxter International, Inc.
- Table 6-5: Baxter Corporate Summary
Company Overview
Products
- Table 6-6: Baxter’s Selected Medical Device Premarket Clearances and Approvals Sept. 2024 – July 2026
Company Financials
- Table 6-7: Baxter Financial Review, 2021-2026 est (US$ billions)
Becton Dickinson and Co. (BD)
- Table 6-8: Becton Dickinson Corporate Summary
Company Overview
Products
- Medical Essentials includes Medication Delivery Solutions and Specimen Management.
- Connected Care
- BioPharma Systems
- Interventional
- Recent Developments
- Table 6-9: BD’s Selected Medical Device Premarket Clearances and Approvals Jan. 2025 – Sept. 2026
Company Financials
- Table 6-10: BD’s Financial Review, 2021-2026 est (US$ billions)
Boston Scientific Corp.
- Table 6-11: Boston Scientific Corporate Summary
Company Overview
Products
- Cardiovascular
- Electrophysiology
- WATCHMAN Left Atrial Appendage Closure
- Cardiac Rhythm Management
- Interventional Cardiology and Vascular Therapies
- Interventional Oncology and Embolization
- MedSurg
- Endoscopy
- Urology
- Neuromodulation
- Recent Developments
- Table 6-12: Boston Scientific’s Selected Medical Device Premarket Clearances and Approvals, 2024 – Sept. 2026
Company Financials
- Table 6-13: Boston Scientific Financial Review, 2021- 2026 est. (US$ billions)
Cardinal Health
- Table 6-14: Cardinal Health Corporate Summary
Company Overview
Products
- Medical and Surgical Products
- Surgical Apparel and Infection Prevention
- Patient Monitoring and Electrodes
- Enteral Feeding
- Anesthesia and Respiratory Supplies
- Laboratory Products
- Fluid Management
- at-Home Solutions
- Supply Chain and Inventory Technology
- Recent Developments
- Table 6-15: Cardinal Health’s Selected Medical Device Premarket Clearances and Approvals, 2024 – Sept. 2026
Company Financials
- Table 6-16: Cardinal Health Financial Review, 2021-2026 (US$ billions)
Danaher Corp.
- Table 6-17: Danaher Corporate Summary
Company Overview
Products
- Patient Monitoring (Masimo)
- Surgical Microscopes (Leica Microsystems)
- Ophthalmic Surgical Microscopes
- Neurosurgical Visualization
- ENT and Reconstructive Surgery
- Recent Developments
Company Financials
- Table 6-18: Danaher Financial Review, 2021-2026 est (US$ billions)
GE HealthCare
- Table 6-19: GE HealthCare Corporate Summary
Company Overview
Products
- Magnetic Resonance Imaging
- Computed Tomography
- Molecular Imaging Equipment
- X-Ray and Mammography
- Ultrasound
- Surgical and Interventional Ultrasound
- Image-Guided Procedures
- Patient Monitoring
- Maternal and Infant Care
- Anesthesia and Respiratory Care
- Recent Developments
- Table 6-20: GE HealthCare’s Selected Medical Device Premarket Clearances and Approvals, 2024 – Sept. 2026
Company Financials
- Table 6-21: GE HealthCare Financial Review, 2021-2026 (US$ billions)
Intuitive Surgical
- Table 6-22: Intuitive Surgical Summary
Company Overview
Products
- Table 6-23: Intuitive Surgical Selected Medical Device Premarket Clearances and Approvals, 2025
Company Financials
- Table 6-24: Intuitive Surgical Financial Review, 2021-2026 est (US$ millions)
Johnson & Johnson
- Table 6-25: Johnson & Johnson Corporate Summary
Company Overview
Products
- Cardiovascular
- Surgery
- Orthopedics
- Vision
- Recent Developments
- Table 6-26: Johnson & Johnson’s DePuy Selected Premarket Clearances and Approvals, 2024 – June 2026
- Table 6-27: Johnson & Johnson’s Biosense Webster Selected Premarket Approvals Aug. 2025 – Sept. 2026
- Table 6-28: Johnson & Johnson Ethicon’s Selected Premarket Approvals, Jan. 2025 – May 2026
- Table 6-29: Johnson & Johnson’s Shockwave Medical Selected Premarket Clearances and Approvals, 2024 – July 2026
Company Financials
- Table 6-30: Johnson & Johnson Financial Review, 2021-2026 est (US$ billions)
Medline
- Table 6-31: Medline Corporate Summary
Company Overview
Products
- Wound Care
- Surgical Products
- Infection Prevention and Protective Apparel
- Patient Care Products
- Urology and Continence Care
- Respiratory and Anesthesia Products
- Enteral Nutrition
- Durable Medical Equipment
- Recent Developments
- Table 6-32: Medline Selected Premarket Clearances and Approvals, Nov. 2024 – July 2026
- Table 6-33: Medline Financial Review, 2023-2026 est (US$ millions)
Medtronic
- Table 6-34: Medtronic Corporate Summary
Company Overview
Products
- Cardiovascular
- Structural Heart and Aortic
- Coronary and Peripheral Vascular
- Neuroscience
- Spinal Cord and Peripheral Nerve Stimulation
- Pelvic Health
- Neurovascular
- Medical Surgical
- Robotic Surgery
- Surgical Products
- Endoscopy
- Acute Care and Monitoring
- Diabetes and MiniMed
- Recent Developments
- Table 6-35: Medtronic Selected Premarket Clearances and Approvals, November 2024 – September 2026
Company Financials
- Table 6-36: Medtronic Financial Review, Fiscal 2021-2026 (US$ billions)
Roche
- Table 6-37: Roche Corporate Summary
Company Overview
Products
- Continuous Glucose Monitoring
- Insulin Delivery
- Connected Diabetes Management
- Recent Developments
Company Financials
- Table 6-38: Roche Financial Review, 2021-2026 est (CHF millions)
Royal Philips
- Table 6-39: Royal Philips Corporate Summary
Company Overview
- Products
- Diagnostic Imaging
- Magnetic Resonance Imaging
- Computed Tomography
- Image-Guided Therapy
- Ultrasound
- Patient Monitoring
- Maternal and Fetal Monitoring
- Remote Cardiac Monitoring
- Respiratory and Sleep Care
- Recent Developments
- Table 6-40: Royal Philips Selected Medical Device Premarket Clearances and Approvals, Oct. 2024 – Aug. 2026
Company Financials
- Table 6-41: Philips Financial Review, 2021-2026 est (€ billions)
Siemens Healthineers
- Table 6-42: Siemens Healthineers Corporate Summary
Company Overview
Products
- Computed Tomography
- Magnetic Resonance Imaging
- Molecular Imaging Equipment
- X-Ray and Radiography
- Angiography and Image-Guided Therapy
- Ultrasound
- Radiation Oncology
- Recent Developments
- Table 6-43: Siemens Healthineers’ Selected Medical Device Premarket Clearances and Approvals, November 2024 – September 2026
Company Financials
- Table 6-44: Siemens Healthineers Financial Review, 2025-2026 (€ billions)
Stryker Corporation
- Table 6-45: Stryker Corporate Summary
Company Overview
Products
- Orthopedics
- Mako Robotic Surgery
- Trauma and Extremities
- Shoulder Reconstruction
- Neurotechnology
- Peripheral Vascular
- Interventional Pain
- Endoscopy and Surgical Visualization
- Emergency Care
- Patient Handling and Acute Care
- Recent Developments
- Table 6-46: Stryker Medical Device Selected Premarket Clearances and Approvals, Nov. 2024 – Aug. 2026
Company Financials
- Table 6-47: Stryker Corporation Financial Review, 2021-2026 (US$ billions)
Other Selected Market Participants
Alcon
Braun
Bausch + Lomb
Canon Medical Systems
Coloplast A/S
Dentsply Sirona
Dexcom
Drägerwerk AG & Co. KgaA
Edwards Lifesciences
Fresenius SE & Co. KGaA
Heartflow
ICU Medical
Masimo Corporation (a Danaher company)
Mindray
Olympus Corporation
RDS Medical Equipment Manufacturing
ResMed
Smith & Nephew plc
STERIS plc
Teleflex Inc
Terumo Corporation
Zimmer Biomet Holdings, Inc.
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