The Market for Medical Devices, 12th Edition


Attention: There is an updated edition available for this report.

The Market for Medical Devices, 12th Edition

The medical device industry, often referred to as the medtech industry, is an important aspect of the entire healthcare industry. The medical device industry is constantly updating and changing through the continued development of new technologies, equipment, tests and devices. Advancements in the medical device markets are life-changing and are allowing patients to live longer, healthier and more productive lives. However, the medical device industry has unique challenges. It is a heavily regulated industry in most nations of the world, as the regulatory section of this report details. Devices need to be approved for reimbursement and prices are negotiated in many cases by group purchasing organizations and governments. Companies in the field must make constant research and development investments to produce the innovations that drive market success. Yet, despite these challenges, devices also benefit from servicing an enlarging elderly population around the world. Devices are also among the first priority of emerging market nations, as they increase the size of their economies and their healthcare spending. Therefore, there are a great many device competitors and continued investors and venture capitalists interested in the field.

The 12th edition of Kalorama Information’s Global Market for Medical Devices consists of new market trends and forecasts. Market share position has changed for some companies as a result of the pandemic and for some mergers, while restructuring and divestitures of certain medical device units have impacted results. With increasing growth in the market, companies are merging to build revenue growth and present combined offerings to hospital and physician customers.

As part of its coverage, this report contains:

  • an overview of medical devices and relevant regulation in 50 world markets;
  • market size estimate and forecast to 2027 for the global market, the United States market and several country markets, including China, Japan, India, Brazil, Germany, Canada and other nations;
  • an index of bellwether device companies;
  • markets for specific categories of medical devices;
  • a look at market drivers and limiters;
  • and company profiles of major device concerns.
The definition of a medical device is a broad one. A medical device is a product that is used in treatment, diagnosis, or injury repair in a patient that does not achieve its effect through chemical action or metabolism in the human body. Most importantly, they are devices that are regulated. Because of the broad definition, estimates of medical device markets vary, as any item from a nuclear camera or catheter to a latex glove can be considered a medical device. In consideration of the fragmentation of this market, several reports vary on the definition, scope and methodology in calculating the total medical device market. In this report, medical devices include those that are used to treat, diagnose or monitor a condition. Excluded are areas of medical IT, which because of the complex nature of these markets, have been reviewed separately by Kalorama Information in other reports, including Electronic Health Records (EHRs) and healthcare cloud products. Also, excluded are services associated with many devices including laboratory service fees and patient monitoring services. It is a scattered market in which hundreds of companies participate worldwide. Despite this, 15 companies earned almost half of the revenues in this market. In addition, much of the revenue is earned in a few discernible categories:
  • cardiovascular,
  • dialysis,
  • respiratory,
  • in vitro diagnostics (IVD),
  • patient monitoring,
  • wound care,
  • imaging
  • and orthopedics being top areas.
Top Companies Covered

Because of the variety of types of medical devices, there are several hundred competitors. There is a growing trend toward consolidation in the industry and as a result the top 15 companies are maintaining and/or gaining a growing percentage of the market with each year. Additionally, there is a great deal of shifting in ranking as a big acquisition could catapult a company several spots up the ladder. Most companies operate in just a few markets, though the top companies such as Medtronic, J&J, Siemens Healthineers, Danaher, and Philips are multi-billion-dollar companies that operate in several categories. There are thousands of companies making devices in the United States alone, most of these private, and many having less than 50 employees.

In each edition, Kalorama Information looks at 12-15 companies in the industry that are large, global and representative of different categories of medical devices. The companies' performance provides insight into the performance of the global device market and reveals trends in geographic sales distribution and research and development spending. The following companies make up Kalorama’s Index of Bellwether Device Companies.
  • Abbott Laboratories
  • B. Braun
  • 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 was assembled using both secondary and primary data. Data from Kalorama Information's previous medical device reports, in addition to company annual reports, trade publications, government, Ministries of Health and medical literature were used as a foundation for estimates. The authors draw on more than two decades of knowledge and experience and completed a range of personal interviews with executives at medical device companies to provide as a key source of estimates for specific device markets. Further analysis is derived from statistical methods and various analytical practices to evaluate indicators for market size and forecasting. More than 50 countries were analyzed with comprehensive processes including interviews and published documents. Kalorama Information focuses on estimates of manufacturer revenues for business planning. Kalorama Information has already conducted scores of studies in medical devices.


  • Executive Summary
    • Overview
    • Size and Growth of the Market
      • Table Global Medical Device Market, 2017-2027
    • 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 Devices Cleared in 2021/2022 (October 2021 - October 2022*), 510(k) Clearances by Month
        • Table FDA Devices Cleared in 2021/2022 (October 2021 - October 2022*), 510(k) Clearances by Review Panel
        • Table FDA 510(k) Premarket Notifications by Bellwether Company and Year (January 2019 - December 2021 and January 2022 - October 24, 2022)
      • 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 - 2022 YTD)
    • Selected Recent Device Industry Mergers and Acquisitions
      • Boston Scientific and Baylis Medical, Lumenis, Preventice Solutions, Farapulse and Devoro Medical
      • GE Healthcare Acquires BK Medical
      • Baxter Buys Hillrom
      • Cordis Purchased Med Alliance
      • Teleflex Snags Standard Bariatric
      • Medtronic Continues Acquisition of Medtech Companies
      • B. Braun Acquires Starboard Medical’s Cather Device Line
      • Johnson and Johnson/DePuy Synthes Acquire CrossRoads
      • Siemens Healthineers and Varian Medical Systems
    • Selected Large Historic Medical Device Acquisitions
      • Medtronic Acquires Covidien and Other Companies
      • Abbott: Acquisitions, Divestitures and the Alere Deal
      • BD Acquires CareFusion; Following with C.R. Bard
      • Pfizer and the $17 Billion Hospira Acquisition
      • Zimmer Finalizes Biomet Acquisition
      • Cardinal Health Strengthens Position in Medical Device Market with Medtronic Asset Acquisition
      • Canon Medical Increases Imaging Portfolio with Toshiba Medical Systems Acquisition
      • Dentsply-Sirona Merger
      • In October 2018, Johnson & Johnson announced the divesture of its LifeScan division to Platinum Equity for $2.1 billion. Thermo Fisher Scientific Completes Major Deals in 2016
      • Danaher and Cepheid: Expanding Access to Molecular Diagnostic Technologies
      • Tornier and Wright Medical Merger Finalized
      • Stryker Corporation Active in M&A - Integrating Wright Medical
      • AbbVie and Allergan - A $63 Billion Deal
        • Table Mergers and Acquisitions in the Medical Device Market - Valued at $100 Million or More, 2015-2021 and January-October 2022 (includes pending deals)
        • Table Medical Device M&A Combined Value by Year (2015-2021, January-October 2022 and Select Pending Deals)
  • Specific Device Markets
    • Table Global Markets for Specific Medical Devices, 2022-2027 ($ Billions)
    • Blood Collection Supplies
    • Catheters
    • Contact Lenses
    • CPAP Devices
    • Critical Care Analysis - Blood Gas Analyzers
    • Defibrillators
      • Table Defibrillation Device Sales, Distribution by Type, 2022 (%)
    • Diabetes Management Devices
      • Table Diabetes Management Device Market, Distribution by Segment, 2022
      • Glucose Monitor and Consumable Market Value (2022): $ 10.9 billion
        • Table Glucose Monitoring Device Market Trend by Product Type, 2017-2027 ($ millions)
      • Insulin Delivery Pump Market Value (2022): $4.1 billion
    • Dialysis Equipment & Supplies
      • Table Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2022 (%)
    • Endoscopes
      • Table Endoscopes and Related Instrument Market Size by Subsegment, 2022
    • 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
      • Table Pacemaker Device Sales, Distribution by Type, 2022 (%)
    • Patient Monitoring
      • Table Distribution of Patient Monitoring Technologies by Type: 2022
    • Personal Protective Equipment
      • Table Market Distribution of PPE by Type, 2022
    • Stents
    • Sterilization and Disinfection Equipment
    • Ultrasound
    • Wheelchairs
    • Wound Care Devices, Advanced Technologies
    • X-Ray
      • Table X-Ray Equipment Sales, Distribution by Type, 2022 (%)
  • 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 Estimates
      • Group Purchasing Organization
      • Value Analysis Committees
    • State of the US Hospital Market
      • Pricing Transparency in the Hospital
      • Interoperability and Exchange of Patient Health Information
    • Medical Device Size and Growth
      • Table Medical Device Market, 2021-2022 YOY Change by Broad Segment (%)
      • Table Medical Device Market, 2017-2027
    • Market by Region
      • Table Medical Device Market Distribution by Region, 2022 (Northern America, EMEA, Asia Pacific, Latin America)
    • Market by Country: Top 20
      • Table Top 20 Device Markets by Country, 2022-2027 ($ billions)
      • Table Medical Device Market Growth, CAGR 2022-2027 by Top 20 Country
      • United States Medical Device Market
        • Table United States Medical Device Market Indicators
        • Table United States Medical Device Market: Distribution of Revenues, 2022
      • Japan Medical Device Market
        • Table Japan Medical Device Market Indicators
        • Table Japan Medical Device Market: Distribution of Revenues, 2022
      • China Medical Device Market
        • Table China Medical Device Market Indicators
        • Table China Medical Device Market: Distribution of Revenues, 2022
      • Germany Medical Device Market
        • Table Germany Medical Device Market Indicators
        • Table Germany Medical Device Market: Distribution of Revenues, 2022
      • France Medical Device Market
        • Table France Medical Device Market Indicators
        • Table France Medical Device Market: Distribution of Revenues, 2022
      • United Kingdom Medical Device Market
        • Table United Kingdom Medical Device Market Indicators
        • Table United Kingdom Medical Device Market: Distribution of Revenues, 2022
      • Italy Medical Device Market
        • Table Italy Medical Device Market Indicators
        • Table Italy Medical Device Market: Distribution of Revenues, 2022
      • Spain Medical Device Market
        • Table Spain Medical Device Market Indicators
        • Table Spain Medical Device Market: Distribution of Revenues, 2022
      • Brazil Medical Device Market
        • Table Brazil Medical Device Market Indicators
        • Table Brazil Medical Device Market: Distribution of Revenues, 2022
      • India Medical Device Market
        • Table India Medical Device Market Indicators
        • Table India Medical Device Market: Distribution of Revenues, 2022
      • Canada Medical Device Market
        • Table Canada Medical Device Market Indicators
        • Table Canada Medical Device Market: Distribution of Revenues, 2022
      • Australia Medical Device Market
        • Table Australia Medical Device Market Indicators
        • Table Australia Medical Device Market: Distribution of Revenues, 2022
      • The Netherlands Medical Device Market
        • Table Netherlands Medical Device Market Indicators
        • Table Netherlands Medical Device Market: Distribution of Revenues, 2022
      • Russia Medical Device Market
        • Table Russia Medical Device Market Indicators
        • Table Russia Medical Device Market: Distribution of Revenues, 2022
      • Taiwan Medical Device Market
        • Table Taiwan Medical Device Market Indicators
        • Table Taiwan Medical Device Market: Distribution of Revenues, 2022
      • South Korea Medical Device Market
        • Table South Korea Medical Device Market Indicators
        • Table South Korea Medical Device Market: Distribution of Revenues, 2022
      • Switzerland Medical Device Market
        • Table Switzerland Medical Device Market Indicators
        • Table Switzerland Medical Device Market: Distribution of Revenues, 2022
      • Sweden Medical Device Market
        • Table Sweden Medical Device Market Indicators
        • Table Sweden Medical Device Market: Distribution of Revenues, 2022
      • Mexico Medical Device Market
        • Table Mexico Medical Device Market Indicators
        • Table Mexico Medical Device Market: Distribution of Revenues, 2022
      • Turkey Medical Device Market
        • Table Turkey Medical Device Market Indicators
        • Table Turkey Medical Device Market: Distribution of Revenues, 2022
    • Second Tier: Market by Country
      • Table Countries 21-50: Country Device Markets, 2022-2027 ($ billions)
  • Company Profiles: Bellwether
    • Overview
      • Table Revenue Performance, Bellwether Companies, 2021 vs. 2022 (US billions)
      • Table Market Performance by Bellwether Company, 2021-2022
    • Medtronic
      • Table Medtronic Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Medtronic Financial Review, Fiscal 2020-2022($billions)
    • Johnson & Johnson
      • Table Johnson & Johnson Corporate Summary
      • Company Overview
      • Product Overview
      • Company Financials
        • Table Johnson & Johnson Financial Review 2019-2021 ($ billions)
    • Abbott Laboratories
      • Table Abbott Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Abbott Financial Review, 2019-2021($billions)
    • Becton Dickinson and Co. (BD)
      • Table Becton Dickinson Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Becton Dickinson Financial Review, 2019-2021($ billions)
    • Siemens Healthineers
      • Table Siemens Healthineers Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Siemens Healthineers Financial Review, 2019-2021 ($ billions)
    • Cardinal Health
      • Table Cardinal Health Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Cardinal Health Financial Review, 2020-2022 ($ billions)
    • Royal Philips
      • Table Royal Philips Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Philips Financial Review, 2019-2021 ($billions)
    • Roche
      • Table Roche Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Roche Financial Review, 2019-2021 ($billions)
    • Stryker Corporation
      • Table Stryker Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Stryker Corporation Financial Review, 2019-2021 ($ billions)
    • GE Healthcare
      • Table GE Healthcare Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table GE Healthcare Financial Review, 2019-2021 ($ billions)
    • Boston Scientific Corp.
      • Table Boston Scientific Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Boston Scientific Financial Review, 2019-2021 ($billions)
    • Danaher Corp.
      • Table Danaher Corporate Summary
      • Company Overview
      • Company Financials
        • Table Danaher Financial Review, 2019-2021 ($billions)
    • Baxter International, Inc.
      • Table Baxter Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Baxter Financial Review, 2019-2021($ billions)
    • Zimmer Biomet Holdings, Inc.
      • Table Zimmer Biomet Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table Zimmer Biomet Financial Review, 2019-2021 ($ billions)
    • B. Braun Melsungen AG
      • Table B. Braun Corporate Summary
      • Company Overview
      • Products
      • Company Financials
        • Table B. Braun Financial Review, 2019-2021 ($ billions)
  • Other Market Participants
    • Participants
      • 3M
      • Alcon
      • Asahi Kasei
      • 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
      • PerkinElmer, Inc
      • ResMed
      • Smith & Nephew plc.
      • Steris plc
      • Teleflex Inc
      • Terumo Corporation
      • Vyaire Medical

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