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The Market for Medical Devices, 12th Edition

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SKU: 22-713 Category: Medical Devices Market Research Tags: Cardiovascular device market, Catheters market, Dental equipment/devices market, Dialysis equipment & supplies market, imaging, in vitro diagnostics, ivd, Medical device country markets, Medical device market, Minimally invasive surgical instruments market, Respiratory device market, wound care Pages: 313
  • Description
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  • Latest reports

Description

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
  • 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.

 

Table of Contents

Chapter 1: Executive Summary

Overview

Size and Growth of the Market

  • Figure 1-1: Global Medical Device Market, 2017-2027

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)
  • Figure 2-4: FDA Devices Cleared in 2021/2022 (October 2021 – October 2022*), 510(k) Clearances by Month
  • Figure 2-5: FDA Devices Cleared in 2021/2022 (October 2021 – October 2022*), 510(k) Clearances by Review Panel
  • Figure 2-6: FDA 510(k) Premarket Notifications by Bellwether Company and Year  (January 2019 – December 2021 and January 2022 – October 24, 2022)

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 2-3: 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 2-4: EU Medical Device Classification Rules
  • Table 2-5: EU Medical Device Directives by Device Type
  • Figure 2-7: EU Competent Authorities

United Kingdom – Brexit

European Economic Area

  • Figure 2-8: EEA Competent Authorities

Switzerland

Turkey

Regulation in Japan

  • Table 2-6: PMDA Review Categories
  • Regulation in China
  • Table 2-7: China’s Medical Device Classification Guide: Passive Devices
  • Table 2-8: 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 – 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

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

Wright Medical Stryker Corp. and Wright Medical: $4.7 Billion Opportunity

AbbVie and Allergan – A $63 Billion Deal

  • Table 3-1: Mergers and Acquisitions in the Medical Device Market – Valued at $100 Million or More, 2015-2021 and January-October 2022 (includes pending deals)
  • Figure 3-2: Medical Device M&A Combined Value by Year (2015-2021, January-October 2022 and Select Pending Deals)

 

Chapter 4: Specific Device Markets

  • Table 4-1: Global Markets for Specific Medical Devices, 2022-2027 ($ 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, 2022 (%)

Diabetes Management Devices

  • Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2022

Glucose Monitor and Consumable Market Value (2022): $ 10.9 billion

  • Figure 4-3: Glucose Monitoring Device Market Trend by Product Type, 2017-2027 ($ millions)

Insulin Delivery Pump Market Value (2022): $4.1 billion

Dialysis Equipment & Supplies

  • Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2022 (%)

Endoscopes

  • Table 4-2: 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

  • Figure 4-5: Pacemaker Device Sales, Distribution by Type, 2022 (%)

Patient Monitoring

  • Figure 4-6: Distribution of Patient Monitoring Technologies by Type: 2022

Personal Protective Equipment

  • Figure 4-7: Market Distribution of PPE by Type, 2022

Medical Gloves Market Value (2022): $5.8 billion

Medical Mask/Face Protection Market Value (2022): $2.3 billion

Protective Clothing Market Value (2022): $2.5 billion

Respirators and PPE Kits Market Value (2022): $3.6 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, 2022 (%)

 

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 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

  • Figure 5-6: Medical Device Market, 2021-2022 YOY Change by Broad Segment (%)
  • Figure 5-7: Medical Device Market, 2017-2027

Market by Region

  • Figure 5-8: Medical Device Market Distribution by Region, 2022 (Northern America, EMEA, Asia Pacific, Latin America)

Market by Country: Top 20

  • Table 5-1: Top 20 Device Markets by Country, 2022-2027 ($ billions)
  • Figure 5-9: Medical Device Market Growth, CAGR 2022-2027 by Top 20 Country

United States Medical Device Market

  • Table 5-2: United States Medical Device Market Indicators
  • Figure 5-10: United States Medical Device Market: Distribution of Revenues, 2022

Japan Medical Device Market

  • Table 5-3: Japan Medical Device Market Indicators
  • Figure 5-11: Japan Medical Device Market: Distribution of Revenues, 2022

China Medical Device Market

  • Table 5-4: China Medical Device Market Indicators
  • Figure 5-12: China Medical Device Market: Distribution of Revenues, 2022

Germany Medical Device Market

  • Table 5-5: Germany Medical Device Market Indicators
  • Figure 5-13: Germany Medical Device Market: Distribution of Revenues, 2022

France Medical Device Market

  • Table 5-6: France Medical Device Market Indicators
  • Figure 5-14: France Medical Device Market: Distribution of Revenues, 2022

United Kingdom Medical Device Market

  • Table 5-7: United Kingdom Medical Device Market Indicators
  • Figure 5-15: United Kingdom Medical Device Market: Distribution of Revenues, 2022

Italy Medical Device Market

  • Table 5-8: Italy Medical Device Market Indicators
  • Figure 5-16: Italy Medical Device Market: Distribution of Revenues, 2022

Spain Medical Device Market

  • Table 5-9: Spain Medical Device Market Indicators
  • Figure 5-17: Spain Medical Device Market: Distribution of Revenues, 2022

Brazil Medical Device Market

  • Table 5-10: Brazil Medical Device Market Indicators
  • Figure 5-18: Brazil Medical Device Market: Distribution of Revenues, 2022

India Medical Device Market

  • Table 5-11: India Medical Device Market Indicators
  • Figure 5-19: India Medical Device Market: Distribution of Revenues, 2022

Canada Medical Device Market

  • Table 5-12: Canada Medical Device Market Indicators
  • Figure 5-20: Canada Medical Device Market: Distribution of Revenues, 2022

Australia Medical Device Market

  • Table 5-13: Australia Medical Device Market Indicators
  • Figure 5-21: Australia Medical Device Market: Distribution of Revenues, 2022

The Netherlands Medical Device Market

  • Table 5-14: Netherlands Medical Device Market Indicators
  • Figure 5-22: Netherlands Medical Device Market: Distribution of Revenues, 2022

Russia Medical Device Market

  • Table 5-15: Russia Medical Device Market Indicators
  • Figure 5-23: Russia Medical Device Market: Distribution of Revenues, 2022

Taiwan Medical Device Market

  • Table 5-16: Taiwan Medical Device Market Indicators
  • Figure 5-24: Taiwan Medical Device Market: Distribution of Revenues, 2022

South Korea Medical Device Market

  • Table 5-17: South Korea Medical Device Market Indicators
  • Figure 5-25: South Korea Medical Device Market: Distribution of Revenues, 2022

Switzerland Medical Device Market

  • Table 5-18: Switzerland Medical Device Market Indicators
  • Figure 5-26: Switzerland Medical Device Market: Distribution of Revenues, 2022

Sweden Medical Device Market

  • Table 5-19: Sweden Medical Device Market Indicators
  • Figure 5-27: Sweden Medical Device Market: Distribution of Revenues, 2022

Mexico Medical Device Market

  • Table 5-20: Mexico Medical Device Market Indicators
  • Figure 5-28: Mexico Medical Device Market: Distribution of Revenues, 2022

Turkey Medical Device Market

  • Table 5-21: Turkey Medical Device Market Indicators
  • Figure 5-29: Turkey Medical Device Market: Distribution of Revenues, 2022

Second Tier: Market by Country

  • Table 5-22: Countries 21-50: Country Device Markets, 2022-2027 ($ billions)

 

Chapter 6: Company Profiles: Bellwether

Overview

  • Table 6-1: Revenue Performance, Bellwether Companies, 2021 vs. 2022 (US billions)
  • Figure 6-1:  Market Performance by Bellwether Company, 2021-2022

Medtronic

  • Table 6-2: Medtronic Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-3: Medtronic Financial Review, Fiscal 2020-2022($billions)

Johnson & Johnson

  • Table 6-4: Johnson & Johnson Corporate Summary

Company Overview

Product Overview

Company Financials

  • Table 6-5: Johnson & Johnson Financial Review 2019-2021 ($ billions)

Abbott Laboratories

  • Table 6-6: Abbott Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-7: Abbott Financial Review, 2019-2021($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, 2019-2021($ billions)

Siemens Healthineers

  • Table 6-10: Siemens Healthineers Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-11: Siemens Healthineers Financial Review, 2019-2021 ($ billions)

Cardinal Health

  • Table 6-12: Cardinal Health Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-13: Cardinal Health Financial Review, 2020-2022 ($ billions)

Royal Philips

  • Table 6-14: Royal Philips Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-15:  Philips Financial Review, 2019-2021 ($billions)

Roche

  • Table 6-16: Roche Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-17: Roche Financial Review, 2019-2021 ($billions)

Stryker Corporation

  • Table 6-18: Stryker Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-19: Stryker Corporation Financial Review, 2019-2021 ($ billions)

GE Healthcare

  • Table 6-20:  GE Healthcare Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-21: GE Healthcare Financial Review, 2019-2021 ($ billions)

Boston Scientific Corp.

  • Table 6-22: Boston Scientific Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-23: Boston Scientific Financial Review, 2019-2021 ($billions)

Danaher Corp.

  • Table 6-24: Danaher Corporate Summary

Company Overview

Company Financials

  • Table 6-25: Danaher Financial Review, 2019-2021 ($billions)

Baxter International, Inc.

  • Table 6-26: Baxter Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-27: Baxter Financial Review, 2019-2021($ billions)

Zimmer Biomet Holdings, Inc.

  • Table 6-28: Zimmer Biomet Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-29: Zimmer Biomet Financial Review, 2019-2021 ($ billions)

Braun Melsungen AG

  • Table 6-30: B. Braun Corporate Summary

Company Overview

Products

Company Financials

  • Table 6-31: B. Braun Financial Review, 2019-2021 ($ billions)

 

Chapter 7: 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

 

    Global Market for Medical Devices, 14th Edition
    October 31, 2024
    Remote Patient Monitoring and Telehealth Markets, 13th Edition
    November 27, 2023
    The Global Market for Medical Devices, 13th Edition
    October 25, 2023
    The Market for Medical Devices, 12th Edition
    November 9, 2022

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