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The Global Market for Medical Devices, 13th Edition
Publication Date: October 24, 2023
Tags: Cardiovascular Disease, Diagnostic Instruments, Imaging Instruments, In Vitro Diagnostics (IVD), Lab Equipment, Lab Instruments, Medical Devices, Respiratory Diseases
Pages: 310
SKU: 23-713
Discover the dynamic landscape of the medical device industry with Kalorama Information’s 13th edition of the Global Market for Medical Devices report. Gain valuable insights into market trends, competitive dynamics, and future forecasts in this ever-evolving sector.
Industry Overview:
The medical device industry, a cornerstone of healthcare, continues to evolve through technological advancements, impacting patient care and longevity. Despite challenges such as stringent regulations and pricing negotiations, this sector remains resilient and attractive to investors.
Key Highlights:
- Insights into regulations and market dynamics across 50 world markets.
- Market size estimates and forecasts up to 2028 for global and country-specific markets.
- Index of leading device companies and their market strategies.
- Analysis of specific device categories, including cardiovascular, dialysis, respiratory, and more.
- Examination of market drivers, limiters, and future growth opportunities.
Market Focus:
- Cardiovascular devices
- Dental equipment
- Dialysis equipment
- Imaging technologies
- In vitro diagnostics (IVD)
- Minimally invasive surgical instruments
- Orthopedic devices
- Patient monitoring devices
- Respiratory devices
- Wound care products
Competitive Landscape:
The market is highly fragmented, with top companies like Medtronic, J&J, Siemens Healthineers, Danaher, and Philips dominating. Rankings can shift due to acquisitions, and the top 15 companies continue to consolidate their market share. The industry is also characterized by thousands of smaller companies, particularly in the United States.
Table: Top 20 Device Markets, by Country, 2023-2028 ($ billions)
| Country | 2023 | 2028 | CAGR 2023-2028 |
| United States | $XX Billion | $XX Billion | XX% |
| China | $XX Billion | $XX Billion | XX% |
| Japan | $XX Billion | $XX Billion | XX% |
| Germany | $XX Billion | $XX Billion | XX% |
| France | $XX Billion | $XX Billion | XX% |
| United Kingdom | $XX Billion | $XX Billion | XX% |
| Italy | $XX Billion | $XX Billion | XX% |
| Spain | $XX Billion | $XX Billion | XX% |
| Brazil | $XX Billion | $XX Billion | XX% |
| India | $XX Billion | $XX Billion | XX% |
| Canada | $XX Billion | $XX Billion | XX% |
| Australia | $XX Billion | $XX Billion | XX% |
| Russia | $XX Billion | $XX Billion | XX% |
| Netherlands | $XX Billion | $XX Billion | XX% |
| Taiwan | $XX Billion | $XX Billion | XX% |
| South Korea | $XX Billion | $XX Billion | XX% |
| Switzerland | $XX Billion | $XX Billion | XX% |
| Sweden | $XX Billion | $XX Billion | XX% |
| Mexico | $XX Billion | $XX Billion | XX% |
| Turkey | $XX Billion | $XX Billion | XX% |
Source: Kalorama Information
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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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