Kalorama Information's "Global Market for Medical Devices, 14th Edition" provides the detailed market intelligence that industry leaders and investors need to be competitive. Purchase your copy today to stay informed and take advantage of the significant growth opportunities in the global medtech market with analysis from 2024-2029.
The medtech industry is at the forefront of life-changing advancements that enable patients to live longer and healthier lives. Whether you're interested in understanding the impact of new technologies, planning market entry strategies, or seeking investment opportunities, this report delivers the actionable data and market forecasts you need to thrive in the dynamic world of medical devices.
In the rapidly evolving landscape of healthcare, the medical device industry-also known as the medtech sector-plays an indispensable role. From everyday medical supplies like latex gloves to advanced devices such as cardiac defibrillators, medical devices are vital to diagnosing, treating, and managing diseases globally. Kalorama Information's "Global Market for Medical Devices, 14th Edition" is your definitive resource for understanding the current trends, challenges, and opportunities shaping medical devices from 2024-2029.
The 14th edition of "Global Market for Medical Devices" features new market trends and forecasts. Market share positions have changed for some companies as a result of the pandemic, and for some, mergers, restructurings, 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.
Report Features
Comprehensive Global Insights
Gain a deep understanding of the medical device market across 50 key regions, including the United States, China, Japan, and more. "Global Market for Medical Devices, 14th Edition" offers unparalleled insights into market size estimates for 2024 and forecasts through 2029.
Strategic Market Data
Uncover key market drivers, regulatory hurdles, and emerging opportunities in categories like cardiovascular, in vitro diagnostics (IVD), patient monitoring, and more. This report is your roadmap for making informed business decisions and capitalizing on high-growth segments.
Expert Analysis of Market Leaders
Stay ahead of the competition with profiles of bellwether companies leading the charge in medtech innovation. Understand the impact of mergers, acquisitions, and restructurings that have reshaped the industry in recent years.
Actionable Intelligence for Success
With insights on regulatory changes, reimbursement landscapes, and cost pressures, this report helps you navigate the complexities of the medtech market, ensuring your business stays agile and ready for future challenges.
25+ Medical Device Segments Covered
Market dynamics for more than two dozen selected device areas are analyzed, estimated, and discussed in the report. These include:
Blood Collection Supplies
Catheters
Contact Lenses
CPAP Devices
Critical Care Analysis - Blood Gas Analyzers
Defibrillators
Diabetes Management Devices
Dialysis Equipment & Supplies
Endoscopes
Gastric Banding and Bariatric Devices
Hernia Repair and Fixation Devices
Hip Implants
Infusion Pumps
Intraocular Lens Devices
Knee Implants
Medical Beds
Minimally Invasive Surgery (MIS)
MRI
Nasal Cannula
Ostomy Products
Pacemakers
Patient Monitoring
Personal Protective Equipment
Stents
Sterilization and Disinfection Equipment
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray
Research Parameters
"Global Market for Medical Devices, 14th Edition" was compiled using a combination of primary and secondary data sources. It builds on Kalorama Information's extensive medical device reports, along with insights from company annual reports, trade publications, government data, Ministries of Health, and medical literature. The authors, leveraging over two decades of experience, conducted personal interviews with medical device company executives to refine market estimates for specific devices. Statistical methods and analytical practices were used to assess market size and provide forecasts. Over 50 countries were analyzed through comprehensive processes, including interviews and published data. Kalorama Information emphasizes manufacturer revenue estimates for effective business planning, drawing on a history of numerous medical device market studies.
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.
Table of Contents
Chapter 1: Executive Summary
Overview
Size and Growth of the Market
Figure 1-1: Global Medical Device Market, CAGR, 2019-2029 (%) (Cardiac Rhythm Management; Catheters; Dental Equipment and Consumables; Dialysis Equipment & Supplies; Endoscopes; General Surgical; Glucose Management; Imaging Equipment; MIS Devices; Ophthalmic Equipment; Orthopedic Devices; Patient Monitoring; Respiratory Equipment; Wound Care; Other Device Segments)
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, Jan. 2020 - Oct. 2024 (Abbott Laboratories; Alcon; B. Braun; Baxter; Becton, Dickinson; Boston Scientific; Cardinal Health; Danaher Corporation; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens; Stryker)
Figure 2-4: FDA 510(k) Premarket Notifications, by Bellwether Company and Year, Jan. 2020 - Dec. 2023 and Jan. 2024 - Oct. 20, 2024 (Abbott Laboratories; Alcon; B. Braun; Baxter; Becton, Dickinson; Boston Scientific; Cardinal Health; Danaher Corporation; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens; Stryker)
Table 2-4: FDA Premarket Approval (PMA), by Bellwether Company and Year, Jan. 2020 - Oct. 2024 (Abbott Laboratories; Alcon; B. Braun; Baxter; Becton, Dickinson; Boston Scientific; Cardinal Health; Danaher Corporation; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens; Stryker)
Figure 2-5: FDA Premarket Approval (PMA), by Bellwether Company and Year, Jan. 2020 - Dec. 2023 and Jan. 2024 - Oct. 20, 2024 (Abbott Laboratories; Alcon; B. Braun; Baxter; Becton, Dickinson; Boston Scientific; Cardinal Health; Danaher Corporation; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens; Stryker)
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 2-5: EUA for Medical Devices - COVID-19 Related, 2020-2023 (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 2-6: EU Medical Device Classification Rules
Figure 2-6: EU Competent Authorities
United Kingdom - Brexit
European Economic Area
Figure 2-7: 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 (Blood circulation, Central circulation; Skin, cavity, and tract; Trauma tissue)
Table 2-9: China's Medical Device Classification Guide: Active Devices (Temporary Use, Short-Term Use, Long-Term Use)
Regulation in Canada
Regulation in Brazil
World Health Care Trends
Unique Device Identifier (UDI)
AI-Enabled Medical Devices
Table: 2-10: Selected FDA List of Approved AI/ML-Enabled Medical Devices, 2024
Chapter 3: Mergers and Acquisitions
Introduction
Figure 3-1: Top 10 Highest Valued Medical Device M&A Deals, 2015-2024 YTD ($ million)
Selected Recent Device Industry Mergers and Acquisitions
Boston Scientific Acquires Axonics
Medline Acquires Ecolab's Surgical Solutions
BD Acquires Edward LifeSciences' Critical Care
Boston Scientific Buys Silk Road Medical
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
Table 4-2: Endoscopes and Related Instrument Market Size by Subsegment, 2024
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 4-8: Pacemaker Device Sales, Distribution by Type, 2024 (%) (External, Implantable)
Patient Monitoring
Figure 4-9: Distribution of Patient Monitoring Technologies, by Type, 2024 (%) (Anesthesia Monitors, Blood Pressure Monitors, Cardiac Rhythm in Cardio, EKG/ECG Machines, Glucose Monitor Devices, All Others)
Personal Protective Equipment
Figure 4-10: Market Distribution of PPE, by Type, 2024 (%) (Gloves, Gowns, Shields, Masks, Others)
Medical Gloves Market Value (2024): $5.8 billion
Medical Mask/Face Protection Market Value (2024): $1.5 billion
Protective Clothing Market Value (2024): $1.3 billion
Respirators and PPE Kits Market Value (2024): $3.0 billion
Stents
Sterilization and Disinfection Equipment
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray
Figure 4-11: X-Ray Equipment Sales, Distribution by Type, 2024 (%) (Digital, Traditional)
Chapter 5: Market Analysis
Figure 5-1: Market Influence: Strength of Impact
Market Drivers
Aging Population
Figure 5-2: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
Increase in Chronic Disease
Figure 5-3: Global Prevalence of Disease, 2000, 2015, and Projected 2030 (in millions of population) (Alzheimer's Disease; Asthma; Depression; Diabetes Mellitus; Cancer; COPD; Coronary Heart Disease/Ischemic Heart Disease; Epilepsy; ESRD; HIV/AIDS; Hypertension; Parkinson's Disease; Stroke Survivors; Tuberculosis)
Market Constraints
Pressure on Prices
Figure 5-4: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2024 (%) (Australia; Brazil; Canada; China; France; Germany; India; Isreal; Italy; Japan; Mexico; the Netherlands; Poland; Spain; South Africa; South Arabia; South Korea; Sweden; Switzerland; Turkey; United States)
Group Purchasing Organization
Value Analysis Committees
Medical Device Size and Growth
Figure 5-5: Medical Device Market; 2023-2024 YOY Change; by Broad Segment (%) (Cardiac Rhythm Management; Catheters; Dental Equipment and Consumables; Dialysis Equipment & Supplies; Endoscopes; General Surgical; Glucose Management; Imaging Equipment; MIS Devices; Ophthalmic Equipment; Orthopedic Devices; Patient Monitoring; Respiratory Equipment; Wound Care [Advanced]; Other Device Segments)
Figure 5-6: Medical Device Market, 2019-2029 ($ billion)
Market by Region
Figure 5-7: Regional Medical Device Market Distribution
Figure 5-8: Medical Device Market Distribution, by Region, 2024 (%) (Asia Pacific, EMEA, Latin America, Northern America)
Market by Country: Top 20
Table 5-1: Top 20 Device Markets, by Country, 2024-2029 ($ billion) (Australia; Brazil; Canada; China; France; Germany; India; Italy; Japan; Mexico; The Netherlands; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey; United Kingdom; United States)
Figure 5-9: Top 20 Device Markets, by Country, 2024 ($ billion) (Australia; Brazil; Canada; China; France; Germany; India; Italy; Japan; Mexico; The Netherlands; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey; United Kingdom; United States)
Figure 5-10: Top 20 Device Markets, by Country, 2029 ($ billion) (Australia; Brazil; Canada; China; France; Germany; India; Italy; Japan; Mexico; The Netherlands; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey; United Kingdom; United States)
Figure 5-11: Medical Device Market Growth, CAGR 2024-2029 by Top 20 Country (Australia; Brazil; Canada; China; France; Germany; India; Italy; Japan; Mexico; The Netherlands; Russia; South Korea; Spain; Sweden; Switzerland; Taiwan; Turkey; United Kingdom; United States)
United States Medical Device Market
Table 5-2: United States Medical Device Market Indicators
Figure 5-12: United States Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
China Medical Device Market
Table 5-3: China Medical Device Market Indicators
Figure 5-13: China Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Japan Medical Device Market
Table 5-4: Japan Medical Device Market Indicators
Figure 5-14: Japan Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Germany Medical Device Market
Table 5-5: Germany Medical Device Market Indicators
Figure 5-15: Germany Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
France Medical Device Market
Table 5-6: France Medical Device Market Indicators
Figure 5-16: France Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
United Kingdom Medical Device Market
Table 5-7: United Kingdom Medical Device Market Indicators
Figure 5-17: United Kingdom Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Italy Medical Device Market
Table 5-8: Italy Medical Device Market Indicators
Figure 5-18: Italy Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Spain Medical Device Market
Table 5-9: Spain Medical Device Market Indicators
Figure 5-19: Spain Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Brazil Medical Device Market
Table 5-10: Brazil Medical Device Market Indicators
Figure 5-20: Brazil Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
India Medical Device Market
Table 5-11: India Medical Device Market Indicators
Figure 5-21: India Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Canada Medical Device Market
Table 5-12: Canada Medical Device Market Indicators
Figure 5-22: Canada Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Australia Medical Device Market
Table 5-13: Australia Medical Device Market Indicators
Figure 5-23: Australia Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Russia Medical Device Market
Table 5-14: Russia Medical Device Market Indicators
Figure 5-24: Russia Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Taiwan Medical Device Market
Table 5-15: Taiwan Medical Device Market Indicators
Figure 5-25: Taiwan Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
The Netherlands Medical Device Market
Table 5-16: The Netherlands Medical Device Market Indicators
Figure 5-26: The Netherlands Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
South Korea Medical Device Market
Table 5-17: South Korea Medical Device Market Indicators
Figure 5-27: South Korea Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Switzerland Medical Device Market
Table 5-18: Switzerland Medical Device Market Indicators
Figure 5-28: Switzerland Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Sweden Medical Device Market
Table 5-19: Sweden Medical Device Market Indicators
Figure 5-29: Sweden Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Mexico Medical Device Market
Table 5-20: Mexico Medical Device Market Indicators
Figure 5-30: Mexico Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Turkey Medical Device Market
Table 5-21: Turkey (Turkiye) Medical Device Market Indicators
Figure 5-31: Turkey Medical Device Market, Distribution of Revenues, 2024 (%) (Diagnostics, Orthopedics, Surgery, Others)
Second Tier: Market by Country
Table 5-22: Countries 21-50: Country Device Markets, 2024-2029 ($ billion) (Argentina; Bangladesh; Bulgaria; Chile; Croatia; Czech Republic; Egypt; Greece; Hungary; Indonesia; Iran; Iraq; Israel; Lithuania; Malaysia; New Zealand; Peru; Philippines; Poland; Romania; Saudi Arabia; Serbia; Singapore; Slovakia; Slovenia; South Africa; Thailand; UAE; Ukraine; Venezuela; Vietnam)
Chapter 6: Company Profiles: Bellwether
Overview
Table 6-1: Revenue Performance, Bellwether Companies, 2023 vs. 2024 ($ billion) (Abbott; Alcon; Baxter; B. Braun; Becton Dickinson; Boston Scientific; Cardinal Health; Danaher; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens Healthineers; Stryker)
Figure 6-1: Market Performance by Bellwether Company, 2023-2024 ($ million) (Abbott; Alcon; Baxter; B. Braun; Becton Dickinson; Boston Scientific; Cardinal Health; Danaher; GE Healthcare; Johnson & Johnson; Medtronic; Philips; Roche; Siemens Healthineers; Stryker)
Abbott Laboratories
Table 6-2: Abbott Corporate Summary
Company Overview
Products
Table 6-3: Abbott's Medical Device Premarket Approvals January 1, 2024 - October 1, 2024