The Global Market for Medical Devices, 13th Edition

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Description

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.

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

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