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
