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The Global Market for Medical Devices, 13th Edition

  • Report

  • 312 Pages
  • November 2023
  • Region: Global
  • Kalorama Information
  • ID: 5314777

The medical device industry, commonly referred to as the medtech industry, plays a pivotal role within the broader healthcare sector. This industry undergoes continuous evolution due to ongoing advancements in technology, equipment, diagnostic tools, and medical devices. These innovations have the profound impact of extending and enhancing the lives of patients, promoting longevity and well-being. However, the medical device industry faces distinctive challenges, primarily characterized by stringent regulations across the globe, as discussed in the regulatory section of this report. Devices must undergo approval for reimbursement, and pricing negotiations often involve group purchasing organizations and governments. Companies operating in this sector must consistently invest in research and development to drive market success through innovation.

Despite these challenges, medical devices stand to benefit from serving an aging global population. Emerging market nations also prioritize medical devices as they expand their economies and healthcare expenditures. This has attracted numerous competitors, investors, and venture capitalists to the field.

The 13th edition of the Global Market for Medical Devices report offers insights into the latest market trends and forecasts. The competitive landscape has shifted for some companies due to the pandemic and mergers, while restructuring and divestitures of medical device units have also influenced results.

This report includes:

  • An overview of medical devices and relevant regulations in 50 world markets.
  • Market size estimates and forecasts up to 2028 for the global market, the United States market, and various country markets, including Brazil, Canada, China, Germany, India, Japan, and more.
  • An index of leading device companies.
  • Market analysis for specific categories of medical devices.
  • Examination of market drivers and limiters.
  • Company profiles of major device manufacturers.

The definition of a medical device is broad, encompassing products used in the treatment, diagnosis, or injury repair in patients that do not achieve their effects through chemical action or metabolism in the human body. These devices are subject to regulation. The market encompasses a wide array of items, from nuclear cameras and catheters to latex gloves. This report focuses on medical devices used for treatment, diagnosis, or monitoring of medical conditions. It excludes medical IT and services associated with many devices, such as laboratory service fees and patient monitoring services. The market is highly fragmented, with hundreds of companies participating worldwide, although the bulk of revenues are generated in specific categories:

  • cardiovascular,
  • dialysis,
  • respiratory,
  • in vitro diagnostics (IVD),
  • patient monitoring,
  • wound care,
  • imaging
  • dental
  • minimally invasive surgical instruments
  • and orthopedics being top areas.

Top companies in the industry vary in terms of their specialization, and consolidation trends are increasingly apparent. The top 15 companies continue to capture a growing share of the market each year, and rankings may shift due to significant acquisitions. While most companies operate in specific markets, major players like Medtronic, J&J, Siemens Healthineers, Danaher, and Philips are multi-billion-dollar entities active in several categories. In the United States alone, there are thousands of companies manufacturing medical devices, with many being private and having fewer than 50 employees.

In each edition, the analyst examines 12-15 large, global companies that represent different categories of medical devices. The performance of these companies offers insights into the overall performance of the global device market, revealing trends in geographic sales distribution and research and development spending. The report features an Index of Bellwether Device Companies, including companies such as:

  • Abbott Laboratories
  • Alcon
  • Baxter
  • Becton Dickinson
  • Boston Scientific
  • Cardinal Health
  • Danaher Corp.
  • GE Healthcare
  • Johnson & Johnson
  • Medtronic
  • Philips
  • Roche
  • Siemens Healthineers
  • Stryker Corp.
  • Zimmer Biomet

Scope and Methodology

This report is based on a combination of secondary and primary data sources. Previous reports on medical devices by the analyst, as well as company annual reports, trade publications, government data, Ministries of Health, and medical literature, served as foundational sources for estimates. The authors conducted personal interviews with executives at medical device companies to derive estimates for specific device markets. Further analysis involved statistical methods and various analytical practices to assess indicators for market size and forecasting. Over 50 countries were analyzed through comprehensive processes, including interviews and published documents. The primary focus of this research is to estimate manufacturer revenues for business planning, building on more than two decades of experience and numerous studies in the medical device field.

Table of Contents

Chapter 1: Executive Summary
  • Overview
  • Size and Growth of the Market
  • Figure 1-1: Global Medical Device Market, 2018-2028
  • 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)
  • Table 2-3: FDA 510 (k) Premarket Notifications by Bellwether Company and Year (January 2017-October 2023)
  • Figure 2-4: FDA 510(k) Premarket Notifications by Bellwether Company and Year  (January 2019 - December 2021 and January 2022 - October 24, 2023)
  • FDA Launches Early Approval Program (EAP)
  • Real-World Data and Real-World Evidence in Device Approval Process
  • Emergency Use Authorizations for Medical Devices - COVID-19 Related
  • Table 2-4: EUA for Medical Devices - COVID-19 Related (blood purification devices, continuous renal replacement therapy devices, decontamination systems, infusion pumps, personal protective equipment, remote or wearable patient monitoring devices, respiratory assist devices, other medical devices)
  • Regulation in Europe
  • European Union
  • Table 2-5: EU Medical Device Classification Rules
  • Table 2-6: EU Medical Device Directives by Device Type
  • Figure 2-5: EU Competent Authorities
  • United Kingdom - Brexit
  • European Economic Area
  • Figure 2-6: EEA Competent Authorities
  • Switzerland
  • Turkey
  • Regulation in Japan
  • Table 2-7: PMDA Review Categories
  • Regulation in China
  • Table 2-8: China’s Medical Device Classification Guide: Passive Devices
  • Table 2-9: China’s Medical Device Classification Guide: Active Devices
  • Regulation in Canada
  • Regulation in Brazil
  • World Health Care Trends
  • Unique Device Identifier (UDI)
Chapter 3: Mergers and Acquisitions
  • Introduction
  • Figure 3-1: Top 10 Highest Valued Medical Device M&A Deals, 2015-2023 YTD (M&A Value in Millions)
  • Selected  Recent Device Industry Mergers and Acquisitions
  • Cordis Acquires MedAlliance
  • Abbott Completes Acquisition of Bigfoot Biomedical
  • Boston Scientific   Agrees to Acquire Relievant MedSystems
  • Inogen Completes Acquisition of Physio-Assist
  • Laborie Medical Technologies Agrees to Acquire Urotronic
  • Restor3d Completes Acquisition of Conformis
  • Amber Therapeutics Acquires Bioinduction Limited
  • STERIS Completes Acquisition of Assets from Beckton Dickinson
  • Globus Medical Completes Acquisition of NuVasive
  • Enovis Completes Acquisition of Novastep
  • Zavation Acquires CoreLink
  • Stryker Acquires Cerus Endovascular
  • Merit Medical Acquires Dialysis Portfolio from AngioDynamics
  • Abbott Signed Agreement to Acquire Cardiovascular Systems
  • Shockwave Acquires Neovasc
  • Bausch + Lomb Acquires AcuFocus
  • Laborie Acquires Novonate
  • Silony Medical  Agrees to Acquire Centinel Spine’s Business
  • Caldera Medical Acquires Atlantic Therapeutics
  • Siemens Healthineers’ Varian Acquires Aspekt Solutions
  • Envoy Medical Merges with Anzu Special Acquisition Corp
  • Ra Medical Systems Acquires Catheter Precision
  • Selected Large Historic Medical Device Acquisitions
  • Medtronic Acquires Covidien and Other Companies
  • Dentsply-Sirona Merger
  • Stryker Corporation Active in M&A - Integrating Wright Medical
  • Wright Medical Stryker Corp. and Wright Medical: $4.7 Billion Opportunity
  • AbbVie and Allergan - A $63 Billion Deal
  • Table 3-1: Selected Mergers and Acquisitions in the Medical Device Market  First Nine Months  2023
  • Figure 3-2: Medical Device M&A Combined Value by Year (2018-2022, January-October 2023 and Select Pending Deals)
Chapter 4: Selected Specific Device Markets
  • Table 4-1: Global Markets for Specific Medical Devices, 2023-2028 ($ 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, 2023 (%)
  • Diabetes Management Devices
  • Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2023
  • Glucose Monitor and Consumable Market Value (2023): $ 20.2 billion
  • Figure 4-3: Glucose Monitoring Device Market Trend by Product Type, 2017-2028 ($ millions)
  • Insulin Delivery Pump Market Value (2023): $4.1 billion
  • Dialysis Equipment & Supplies
  • Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2023 (%)
  • Endoscopes
  • Table 4-2: Endoscopes and Related Instrument Market Size, by Subsegment, 2023
  • 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, 2023 (%)
  • Patient Monitoring
  • Figure 4-6: Distribution of Patient Monitoring Technologies, by Type, 2023 (%)
  • Personal Protective Equipment
  • Figure 4-7: Market Distribution of PPE by Type, 2023
  • Medical Gloves Market Value (2023): $5.8 billion
  • Medical Mask/Face Protection Market Value (2023): $1.9 billion
  • Protective Clothing Market Value (2023): $1.9 billion
  • Respirators and PPE Kits Market Value (2023): $3.2 billion
  • Stents
  • Sterilization and Disinfection Equipment
  • Ultrasound
  • Wheelchairs
  • Wound Care Devices, Advanced Technologies
  • X-Ray
  • Figure 4-8: X-Ray Equipment Sales, Distribution, by Type, 2023 (%)
Chapter 5: Market Analysis
  • Figure 5-1: Market Influence: Strength of Impact
  • Market Drivers
  • Aging Population
  • Figure 5-2: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
  • Increase in Chronic Disease
  • Figure 5-3: Global Prevalence of Disease, 2000, 2015 and Projected 2030
  • Figure 5-4: Mortality: Chronic vs. Acute, 2015
  • Market Constraints
  • Pressure on Prices
  • Figure 5-5: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2022
  • Group Purchasing Organization
  • Value Analysis Committees
  • Medical Device Size and Growth
  • Figure 5-6: Medical Device Market, 2022-2023 YOY Change, by Broad Segment (%)
  • Figure 5-7: Medical Device Market, 2018-2028 ($ Billions)
  • Market by Region
  • Figure 5-8: Regional Medical Device Market Distribution
  • Figure 5-9: Medical Device Market Distribution, by Region, 2023 (Northern America, EMEA, Asia Pacific, Latin America) (%)
  • Market by Country: Top 20
  • Table 5-1: Top 20 Device Markets by Country, 2023-2028 ($ billions)
  • Figure 5-10: Medical Device Market Growth, by Top 20 Country, CAGR 2023-2028 (%)
  • United States Medical Device Market
  • Table 5-2: United States Medical Device Market Indicators
  • Figure 5-11: United States Medical Device Market: Distribution of Revenues, 2023 (%)
  • China Medical Device Market
  • Table 5-3: China Medical Device Market Indicators
  • Figure 5-12: China Medical Device Market: Distribution of Revenues, 2023
  • Japan Medical Device Market
  • Table 5-4: Japan Medical Device Market Indicators
  • Figure 5-13: Japan Medical Device Market: Distribution of Revenues, 2023
  • Germany Medical Device Market
  • Table 5-5: Germany Medical Device Market Indicators
  • Figure 5-14: Germany Medical Device Market: Distribution of Revenues, 2023
  • France Medical Device Market
  • Table 5-6: France Medical Device Market Indicators
  • Figure 5-15: France Medical Device Market: Distribution of Revenues, 2023
  • United Kingdom Medical Device Market
  • Table 5-7: United Kingdom Medical Device Market Indicators
  • Figure 5-16: United Kingdom Medical Device Market: Distribution of Revenues, 2023
  • Italy Medical Device Market
  • Table 5-8: Italy Medical Device Market Indicators
  • Figure 5-17: Italy Medical Device Market: Distribution of Revenues, 2023
  • Spain Medical Device Market
  • Table 5-9: Spain Medical Device Market Indicators
  • Figure 5-18: Spain Medical Device Market: Distribution of Revenues, 2023
  • Brazil Medical Device Market
  • Table 5-10: Brazil Medical Device Market Indicators
  • Figure 5-19: Brazil Medical Device Market: Distribution of Revenues, 2023
  • India Medical Device Market
  • Table 5-11: India Medical Device Market Indicators
  • Figure 5-20: India Medical Device Market: Distribution of Revenues, 2023
  • Canada Medical Device Market
  • Table 5-12: Canada Medical Device Market Indicators
  • Figure 5-21: Canada Medical Device Market: Distribution of Revenues, 2023
  • Australia Medical Device Market
  • Table 5-13: Australia Medical Device Market Indicators
  • Figure 5-22: Australia Medical Device Market: Distribution of Revenues, 2023
  • Russia Medical Device Market
  • Table 5-14: Russia Medical Device Market Indicators
  • Figure 5-23: Russia Medical Device Market: Distribution of Revenues, 2023
  • The Netherlands Medical Device Market
  • Table 5-15: Netherlands Medical Device Market Indicators
  • Figure 5-24: Netherlands Medical Device Market: Distribution of Revenues, 2023
  • Taiwan Medical Device Market
  • Table 5-16: Taiwan Medical Device Market Indicators
  • Figure 5-25: Taiwan Medical Device Market: Distribution of Revenues, 2023
  • South Korea Medical Device Market
  • Table 5-17: South Korea Medical Device Market Indicators
  • Figure 5-26: South Korea Medical Device Market: Distribution of Revenues, 2023
  • Switzerland Medical Device Market
  • Table 5-18: Switzerland Medical Device Market Indicators
  • Figure 5-27: Switzerland Medical Device Market: Distribution of Revenues, 2023
  • Sweden Medical Device Market
  • Table 5-19: Sweden Medical Device Market Indicators
  • Figure 5-28: Sweden Medical Device Market: Distribution of Revenues, 2023
  • Mexico Medical Device Market
  • Table 5-20: Mexico Medical Device Market Indicators
  • Figure 5-29: Mexico Medical Device Market: Distribution of Revenues, 2023
  • Turkey Medical Device Market
  • Table 5-21: Turkey Medical Device Market Indicators
  • Figure 5-30: Turkey Medical Device Market: Distribution of Revenues, 2023
  • Second Tier: Market by Country
  • Table 5-22: Countries 21-50: Country Device Markets, 2023-2028 ($ billions)
Chapter 6: Company Profiles: Bellwether
  • Overview
  • Table 6-1: Revenue Performance, Bellwether Companies, 2022 vs. 2023 (US billions)
  • Figure 6-1:  Market Performance by Bellwether Company, 2022-2023
  • Medtronic
  • Table 6-2: Medtronic Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-3: Medtronic Financial Review, Fiscal 2020-2023 ($billions)
  • Johnson & Johnson
  • Table 6-4: Johnson & Johnson Corporate Summary
  • Company Overview
  • Product Overview
  • Company Financials
  • Table 6-5: Johnson & Johnson Financial Review 2019-2023 ($ billions)
  • Abbott Laboratories
  • Table 6-6: Abbott Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-7: Abbott Financial Review, 2019-2023 ($billions)
  • Becton Dickinson and Co. (BD)
  • Table 6-8: Becton Dickinson Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-9: Becton Dickinson Financial Review, 2019-2023 ($ billions)
  • Siemens Healthineers
  • Table 6-10: Siemens Healthineers Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-11: Siemens Healthineers Financial Review, 2019-2023 ($ billions)
  • Cardinal Health
  • Table 6-12: Cardinal Health Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-13: Cardinal Health Financial Review, 2020-2023 ($ billions)
  • Royal Philips
  • Table 6-14: Royal Philips Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-15:  Philips Financial Review, 2019-2023 ($billions)
  • Roche
  • Table 6-16: Roche Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-17: Roche Financial Review, 2019-2023 ($billions)
  • Stryker Corporation
  • Table 6-18: Stryker Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-19: Stryker Corporation Financial Review, 2019-2023 ($ billions)
  • GE Healthcare
  • Table 6-20: GE Healthcare Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-21: GE Healthcare Financial Review, 2019-2023 ($ billions)
  • Boston Scientific Corp.
  • Table 6-22: Boston Scientific Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-23: Boston Scientific Financial Review, 2019-2023 ($billions)
  • Danaher Corp.
  • Table 6-24: Danaher Corporate Summary
  • Company Overview
  • Company Financials
  • Table 6-25: Danaher Financial Review, 2019-2023 ($billions)
  • Baxter International, Inc.
  • Table 6-26: Baxter Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-27: Baxter Financial Review, 2019-2023 ($ billions)
  • Zimmer Biomet Holdings, Inc.
  • Table 6-28: Zimmer Biomet Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-29: Zimmer Biomet Financial Review, 2019-2023 ($ billions)
  • Alcon
  • Table 6-30: Alcon Corporate Summary
  • Company Overview
  • Products
  • Company Financials
  • Table 6-31: Alcon Financial Review, 2019-2023 ($ billions)
Chapter 7: Other Market Participants
  • Companies
  • 3M Health Care
  • Asahi Kasei
  • Braun Melsungen AG
  • Canon Medical Systems
  • Coloplast A/S
  • ConvaTec
  • Dentsply-Sirona
  • Drägerwerk AG & Co. KGaA
  • Fresenius SE & Co. KGaA
  • ICU Medical
  • Masimo Corporation
  • Mindray Bio-Medical Electronics Co., Ltd.
  • Mölnlycke Health Care AB
  • Nova Biomedical
  • Olympus Corporation
  • ResMed
  • Smith & Nephew plc.
  • Steris plc
  • Teleflex Inc
  • Terumo Corporation
  • Vyaire Medical
  • ZimVie

Companies Mentioned

  • 3M Health Care
  • Abbott Laboratories
  • Alcon
  • Amber Therapeutics
  • Asahi Kasei
  • Bausch + Lomb
  • Baxter International, Inc.
  • Becton Dickinson and Co. (BD)
  • Boston Scientific Corp.
  • Braun Melsungen AG
  • Caldera Medical
  • Canon Medical Systems
  • Cardinal Health
  • Coloplast A/S
  • ConvaTec
  • Cordis
  • Danaher Corp.
  • Dentsply-Sirona
  • Drägerwerk AG & Co. KGaA
  • Enovis
  • Fresenius SE & Co. KGaA
  • GE Healthcare
  • Globus Medical
  • ICU Medical
  • Inogen
  • Johnson & Johnson
  • Laborie
  • Laborie Medical Technologies
  • Masimo Corporation
  • Medtronic
  • Merit Medical
  • Mindray Bio-Medical Electronics Co., Ltd.
  • Mölnlycke Health Care AB
  • Nova Biomedical
  • Olympus Corporation
  • ResMed
  • Restor3d
  • Roche
  • Royal Philips
  • Shockwave
  • Siemens Healthineers
  • Silony Medical
  • Smith & Nephew plc.
  • STERIS
  • Steris plc
  • Stryker
  • Stryker Corporation
  • Teleflex Inc
  • Terumo Corporation
  • Vyaire Medical
  • Zavation
  • Zimmer Biomet Holdings, Inc.
  • ZimVie