The Global Market for Medical Devices, 13th Edition


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The Global Market for Medical Devices, 13th Edition



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 Kalorama Information’s 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, Kalorama Information 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 Kalorama Information, 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 Kalorama Information’s 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.


  • Executive Summary
    • Overview
    • Size and Growth of the Market
      • Table Global Medical Device Market, 2018-2028
    • Top Companies
    • Mergers and Acquisitions
    • Scope and Methodology
    • Conclusions
  • Introduction
    • Overview
      • Table Summary: Health Technology (Medical Device) National Policy, Latest Year Available
      • Table Summary: Type of Nomenclature System, Latest Year Available
      • Table Summary: Use of Nomenclature System, Latest Year Available
    • Regulation in the United States
      • Classification of Medical Devices
        • Table Regulations and Product Codes (same regulation number - 21 CFR 870.1875- four different product codes for specific device types with exempt status)
        • Table Medical Device Classification Summary (Class I, Class II, Class III)
        • Table FDA 510 (k) Premarket Notifications by Bellwether Company and Year (January 2017-October 2023)
        • Table FDA 510(k) Premarket Notifications by Bellwether Company and Year (January 2019 - December 2021 and January 2022 - October 24, 2023)
      • Emergency Use Authorizations for Medical Devices - COVID-19 Related
        • Table 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 EU Medical Device Classification Rules
        • Table EU Medical Device Directives by Device Type
        • Table EU Competent Authorities
        • Table EEA Competent Authorities
    • Regulation in Japan
      • Table PMDA Review Categories
    • Regulation in China
      • Table China's Medical Device Classification Guide: Passive Devices
      • Table China's Medical Device Classification Guide: Active Devices
    • Regulation in Canada
    • Regulation in Brazil
    • World Health Care Trends
    • Unique Device Identifier (UDI)
  • Mergers and Acquisitions
    • Introduction
      • Table 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
      • Wright Medical Stryker Corp. and Wright Medical: $4.7 Billion Opportunity
      • AbbVie and Allergan - A $63 Billion Deal
        • Table Selected Mergers and Acquisitions in the Medical Device Market First Nine Months 2023
        • Table Medical Device M&A Combined Value by Year (2018-2022, January-October 2023 and Select Pending Deals)
  • Selected Specific Device Markets
    • Table Global Markets for Specific Medical Devices, 2023-2028 ($ Billions)
    • Blood Collection Supplies
    • Catheters
    • Contact Lenses
    • CPAP Devices
    • Critical Care Analysis - Blood Gas Analyzers
    • Defibrillators
      • Table Defibrillation Device Sales, Distribution by Type, 2023 (%)
    • Diabetes Management Devices
      • Table Diabetes Management Device Market, Distribution by Segment, 2023
      • Table Glucose Monitoring Device Market Trend by Product Type, 2017-2028 ($ millions)
    • Dialysis Equipment & Supplies
      • Table Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2023 (%)
    • Endoscopes
      • Table 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
    • Medical Beds
    • Minimally Invasive Surgery (MIS)
    • MRI
    • Nasal Cannula
    • Ostomy Products
    • Pacemakers
      • Table Pacemaker Device Sales, Distribution, by Type, 2023 (%)
    • Patient Monitoring
      • Table Distribution of Patient Monitoring Technologies, by Type, 2023 (%)
    • Personal Protective Equipment
      • Table Market Distribution of PPE by Type, 2023
    • Stents
    • Sterilization and Disinfection Equipment
    • Ultrasound
    • Wheelchairs
    • Wound Care Devices, Advanced Technologies
    • X-Ray
      • Table X-Ray Equipment Sales, Distribution, by Type, 2023 (%)
  • Market Analysis
    • Table Market Influence: Strength of Impact
    • Market Drivers
      • Aging Population
        • Table Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
      • Increase in Chronic Disease
        • Table Global Prevalence of Disease, 2000, 2015 and Projected 2030
        • Table Mortality: Chronic vs. Acute, 2015
    • Market Constraints
      • Pressure on Prices
        • Table Medical Device Spending as a Percentage of Total Health Spending, by Country, 2022
      • Group Purchasing Organization
      • Value Analysis Committees
    • Medical Device Size and Growth
      • Table Medical Device Market, 2022-2023 YOY Change, by Broad Segment (%)
      • Table Medical Device Market, 2018-2028 ($ Billions)
    • Market by Region
      • Table Regional Medical Device Market Distribution
      • Table Medical Device Market Distribution, by Region, 2023 (Northern America, EMEA, Asia Pacific, Latin America) (%)
    • Market by Country: Top 20
      • Table Top 20 Device Markets by Country, 2023-2028 ($ billions)
      • Table Medical Device Market Growth, by Top 20 Country, CAGR 2023-2028 (%)
      • United States Medical Device Market
        • Table United States Medical Device Market Indicators
        • Table United States Medical Device Market: Distribution of Revenues, 2023 (%)
      • China Medical Device Market
        • Table China Medical Device Market Indicators
        • Table China Medical Device Market: Distribution of Revenues, 2023
      • Japan Medical Device Market
        • Table Japan Medical Device Market Indicators
        • Table Japan Medical Device Market: Distribution of Revenues, 2023
      • Germany Medical Device Market
        • Table Germany Medical Device Market Indicators
        • Table Germany Medical Device Market: Distribution of Revenues, 2023
      • France Medical Device Market
        • Table France Medical Device Market Indicators
        • Table France Medical Device Market: Distribution of Revenues, 2023
      • United Kingdom Medical Device Market
        • Table United Kingdom Medical Device Market Indicators
        • Table United Kingdom Medical Device Market: Distribution of Revenues, 2023
      • Italy Medical Device Market
        • Table Italy Medical Device Market Indicators
        • Table Italy Medical Device Market: Distribution of Revenues, 2023
      • Spain Medical Device Market
        • Table Spain Medical Device Market Indicators
        • Table Spain Medical Device Market: Distribution of Revenues, 2023
      • Brazil Medical Device Market
        • Table Brazil Medical Device Market Indicators
        • Table Brazil Medical Device Market: Distribution of Revenues, 2023
      • India Medical Device Market
        • Table India Medical Device Market Indicators
        • Table India Medical Device Market: Distribution of Revenues, 2023
      • Canada Medical Device Market
        • Table Canada Medical Device Market Indicators
        • Table Canada Medical Device Market: Distribution of Revenues, 2023
      • Australia Medical Device Market
        • Table Australia Medical Device Market Indicators
        • Table Australia Medical Device Market: Distribution of Revenues, 2023
      • Russia Medical Device Market
        • Table Russia Medical Device Market Indicators
        • Table Russia Medical Device Market: Distribution of Revenues, 2023
      • The Netherlands Medical Device Market
        • Table Netherlands Medical Device Market Indicators
        • Table Netherlands Medical Device Market: Distribution of Revenues, 2023
      • Taiwan Medical Device Market
        • Table Taiwan Medical Device Market Indicators
        • Table Taiwan Medical Device Market: Distribution of Revenues, 2023
      • South Korea Medical Device Market
        • Table South Korea Medical Device Market Indicators
        • Table South Korea Medical Device Market: Distribution of Revenues, 2023
      • Switzerland Medical Device Market
        • Table Switzerland Medical Device Market Indicators
        • Table Switzerland Medical Device Market: Distribution of Revenues, 2023
      • Sweden Medical Device Market
        • Table Sweden Medical Device Market Indicators
        • Table Sweden Medical Device Market: Distribution of Revenues, 2023
      • Mexico Medical Device Market
        • Table Mexico Medical Device Market Indicators
        • Table Mexico Medical Device Market: Distribution of Revenues, 2023
      • Turkey Medical Device Market
        • Table Turkey Medical Device Market Indicators
        • Table Turkey Medical Device Market: Distribution of Revenues, 2023
    • Second Tier: Market by Country
      • Table Countries 21-50: Country Device Markets, 2023-2028 ($ billions)
  • Company Profiles: Bellwether
    • Overview
      • Table Revenue Performance, Bellwether Companies, 2022 vs. 2023 (US billions)
      • Table Market Performance by Bellwether Company, 2022-2023
    • Medtronic
      • Table Medtronic Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Medtronic Financial Review, Fiscal 2020-2023 ($billions)
    • Johnson & Johnson
      • Table Johnson & Johnson Corporate Summary
      • Company Overview
      • Product Overview
      • Company Financials
        • Table Johnson & Johnson Financial Review 2019-2023 ($ billions)
    • Abbott Laboratories
      • Table Abbott Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Abbott Financial Review, 2019-2023 ($billions)
    • Becton Dickinson and Co. (BD)
      • Table Becton Dickinson Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Becton Dickinson Financial Review, 2019-2023 ($ billions)
    • Siemens Healthineers
      • Table Siemens Healthineers Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Siemens Healthineers Financial Review, 2019-2023 ($ billions)
    • Cardinal Health
      • Table Cardinal Health Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Cardinal Health Financial Review, 2020-2023 ($ billions)
    • Royal Philips
      • Table Royal Philips Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Philips Financial Review, 2019-2023 ($billions)
    • Roche
      • Table Roche Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Roche Financial Review, 2019-2023 ($billions)
    • Stryker Corporation
      • Table Stryker Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Stryker Corporation Financial Review, 2019-2023 ($ billions)
    • GE Healthcare
      • Table GE Healthcare Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table GE Healthcare Financial Review, 2019-2023 ($ billions)
    • Boston Scientific Corp.
      • Table Boston Scientific Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Boston Scientific Financial Review, 2019-2023 ($billions)
    • Danaher Corp.
      • Table Danaher Corporate Summary
      • Company Overview
      • Company Financials
        • Table Danaher Financial Review, 2019-2023 ($billions)
    • Baxter International, Inc.
      • Table Baxter Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Baxter Financial Review, 2019-2023 ($ billions)
    • Zimmer Biomet Holdings, Inc.
      • Table Zimmer Biomet Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Zimmer Biomet Financial Review, 2019-2023 ($ billions)
    • Alcon
      • Table Alcon Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Alcon Financial Review, 2019-2023 ($ billions)
  • Other Market Participants
    • Companies
      • 3M Health Care
      • Asahi Kasei
      • B. 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

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