The medical device industry has unique challenges and opportunities. During 2020, many of these challenges, and opportunities, were highlighted even more so. It is a heavily regulated industry in most nations of the world. 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 capital interested in the field..
This eleventh edition of Kalorama Information’s The Global Market for Medical Devices consists of new market trends and forecasts based on events from the COVID-19 pandemic. Market share position has changed for some companies as a result of the pandemic and for some mergers, 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; however, the volume of acquisitions declined in 2020 due to uncertain market conditions.
Trends Affecting The Medical Device Market, Ranked
The US economy continues to recover from the setbacks in 2020; while Europe faced a second-round of lockdowns in Q4 2020, which slowed recovery for the region. In Europe as well as the United States, reimbursement challenges and the threat of new, and changing legislation looms. Emerging markets again helped to boost company revenues, but the double-digit growth of past years was not present for 2020 and forecasts are conservative going forward as continued recovery fosters.
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 2025 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.
Medical Device Categories
While there are hundreds of types of products that can be classified as medical devices, a few specific categories and products make up the bulk of the market and form the backbone of Kalorama’s analysis in this report. These 50+ categories include:
3D printing equipment, materials and software
Anesthesia Monitors
Blood Collection
Blood Gas Analyzers
Blood Pressure Monitors
Cannula Respiratory
Catheters
Computed Tomography
Continuous Glucose Monitors
Coronary Stents
Cosmetic surgery implants
CPAP Machines
Defibrillators
Dental Equipment/Devices (excluding x-ray)
Dental Implants/Components
Dental X-ray
Dialysis Equipment & Supplies
EKG/ECG Machines
Electrosurgical Devices
Endoscopes (excluding gastro)
Gastric Banding/Bariatric
Gastro Endoscopes
Glucose Monitors (excluding CGM)
Hernia Repair and Fixation Devices
Hip implants
Hypodermic Syringe
Infusion Pumps
Insulin Pumps
Intraocular Lenses
Knee implants
Medical Beds
Medical lasers
Minimally Invasive Surgical Instruments
MRI
Neurostimulation
Ostomy Care Devices
Oxygen Therapy Equip.
Pacemakers
Personal protective equipment (gloves, masks, gowns)
Spine implants
Sport, Extremity and Trauma
Sterilization/disinfection equipment
Stethoscopes
Surgical Guidance Devices
Surgical Robots
Sutures, Staples, Staplers
Traditional Surgical Instruments (scalpels, forceps, retractors, scissors)
Ultrasound
Vascular Closure Devices
Wheelchairs
Wound Care, Advanced
X-Ray (excluding dental)
Bellwether Companies
For the purposes of this study, Kalorama Information has identified 15 medical device companies with a diverse enough product range, significant revenues and performance to provide insight into the industry as a whole.
The following companies are included:
Abbott Laboratories
Braun
Baxter
Becton Dickinson
Boston Scientific
Cardinal Health
Danaher Corp.
GE Healthcare
Johnson & Johnson
Medtronic
Philips
Roche
Siemens Healthineers
Stryker
Zimmer Biomet
Table of Contents
Chapter 1: Executive Summary
Overview
Size and Growth of the Market
Figure 1-1: Global Medical Device Market, 2016-2025
Top Companies
Mergers and Acquisitions
Scope and Methodology
Conclusions
Chapter 2: Introduction
Overview
Table 2-1: Summary: Global Atlas of Medical Devices, 2017 Update
Regulation in the United States
Classification of Medical Devices
Class I Medical Devices
Limitations on Exemptions
Table 2-2: Regulations and Product Codes (same regulation number – 21 CFR 870.1875- four different product codes for specific device types with exempt status)
Table 2-3: Medical Device Reclassifications, 2013-2019 (Report December 20, 2019)
Class II Medical Devices
Class III Medical Devices
Device Classification Summary
Table 2-4: Medical Device Classification Summary (Class I, Class II, Class III)
Figure 2-1: FDA Devices Cleared in 2019/2020 (December 2019 – December 2020), 510(k) Clearances by Month
Figure 2-2: FDA Devices Cleared in 2019/2020 (December 2019 – December 2020), 510(k) Clearances by Review Panel
Table 2-3: FDA 510(k) Premarket Notifications by Bellwether Company and Year (January 2018 – December 2020)
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 (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
Table 2-7: EU Medical Device Directives by Device Type
Figure 2-4: EU Competent Authorities
United Kingdom – Brexit
European Economic Area
Figure 2-5: EEA Competent Authorities
Switzerland
Turkey
Regulation in Japan
Table 2-8: PMDA Review Categories
Regulation in China
Table 2-9: China’s Medical Device Classification Guide: Passive Devices
Table 2-10: 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
Selected Significant Device Industry Mergers and Acquisitions
Figure 3-1: Top 10 Highest Valued Medical Device M&A Deals (2015 – 2021 YTD)
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
Johnson & Johnson and Abbott Medical Optics: Combined #2 in Vision Care Industry; LifeScan Divesture
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
Hill-Rom Completes Acquisition of Welch Allyn
PerkinElmer and EUROIMMUN Medical Laboratory Diagnostics AG
Siemens Healthineers and Epocal Inc (Alere subsidiary)
Integra LifeSciences and Codman Neurosurgery from Johnson & Johnson
Fresenius Medical Care and NxStage Medical
AbbVie and Allergan – A $63 Billion Deal
Genomic Health and Exact Sciences
Siemens Healthineers and Corindus Vascular Robotics
3M buys Aceility for $6.7 Billion Expanding Wound Care Portfolio
Philips combined with BioTelemetry – Improves Cardiac Monitoring and Product Offerings
Closed April 15, 2021: Largest Announced Deal of 2020 – Siemens Healthineers grabs Varian Medical Systems
Table 3-1: Mergers and Acquisitions in the Medical Device Market – Valued at $100 Million or More, 2015-2020 and January-April 2021 (includes pending deals)
Figure 3-2: Medical Device M&A Combined Value by Year (2015-2020, January-April 2021 and Select Pending Deals)
Pending: Steris to Boost Infection Prevention Portfolio with Cantel Medical Acquisition
Pending with Opposition from FTC: Illumina Bids to Acquire GRAIL for $8 billion
Pending: Diagnostic Testing Leader Roche to Expand Capabilities with Acquisition of Gen Mark Diagnostics
Terminated: Thermo Fisher and Qiagen
Chapter 4: Specific Device Markets
Table 4-1: Global Markets for Specific Medical Devices, 2020-2025 ($ Billions)
Blood Collection Supplies
Catheters
CPAP Devices
Critical Care Analysis – Blood Gas Analyzers
Defibrillators
Figure 4-1: Defibrillation Device Sales, Distribution by Type, 2020 (%)
Diabetes Management Devices
Figure 4-2: Diabetes Management Device Market, Distribution by Segment, 2020
Glucose Monitor and Consumable Market Value (2020): $14.9 billion
Figure 4-4: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2020 (%)
Endoscopes
Table 4-2: Endoscopes and Related Instrument Market Size by Subsegment, 2020
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, 2020 (%)
Patient Monitoring
Figure 4-6: Distribution of Patient Monitoring Technologies by Type: 2020
Personal Protective Equipment
Figure 4-7: Market Distribution of PPE by Type, 2020
Figure 4-8: World Health Organization, Estimated Demand for PPE by Month, COVID-19 Impact (units in millions)
Medical Gloves Market Value (2020): $6.4 billion
Medical Mask/Face Protection Market Value (2020): $3 billion
Stents
Sterilization and Disinfection Equipment
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray and Digital X-Ray
Figure 4-9: X-Ray Equipment Sales, Distribution by Type, 2020 (%)
Table 7-30: B. Braun Financial Review, 2018-2020 ($ billions)
8: Other Market Participants
3M
Alcon
Asahi Kasei
Canon Medical Systems
Coloplast A/S
ConvaTec
Dentsply-Sirona
Drägerwerk AG & Co. KGaA
Fresenius SE & Co. KGaA
Hill-Rom
Masimo Corporation
Mindray Bio-Medical Electronics Co., Ltd.
Mölnlycke Health Care AB
Nova Biomedical
Olympus Corporation
PerkinElmer, Inc
ResMed
Smith & Nephew plc.
Smiths Group
Steris plc
Teleflex Inc
Terumo Corporation
Varian Medical Systems, Inc.
Vyaire Medical
