The Global Market for Medical Devices, 10th Edition (45 Specific Device Markets and 50 Country Markets Forecasted to 2024)

Table of Contents

1: Executive Summary
Overview
Size and Growth of the Market

• • Figure 1-1: Global Medical Device Market, 2016-2024

Top Companies
Mergers and Acquisitions
Scope and Methodology
Conclusions

2: Introduction
Overview

• • Table 2-1: Summary: Global Atlas of Medical Devices, 2017 Update

Regulation in the United States

• Classification of Medical Devices
  • Table 2-2: Medical Device Reclassifications, 2013-2018 (Report February 14, 2019)
  • Figure 2-1: FDA Devices Cleared in 2018/2019 (August 2018 – August 2019), 510(k) Clearances by Month
  • Figure 2-2: FDA Devices Cleared in 2018/2019 (August 2018 – August 2019), 510(k) Clearances by Review Panel
  • Figure 2-3: FDA 510(k) Premarket Notifications by Bellwether Company and Year (January 2017 – August 2019)

Regulation in Europe

• European Union
  • Table 2-3: EU Medical Device Classification Rules
  • Table 2-4: EU Medical Device Directives by Device Type
  • Figure 2-4: EU Competent Authorities
  • Figure 2-5: EEA Competent Authorities

Regulation in Japan
Regulation in China

• • Table 2-5: China’s Medical Device Classification Guide: Passive Devices
• • Table 2-6: China’s Medical Device Classification Guide: Active Devices

Regulation in Canada
Regulation in Brazil
World Health Care Trends
Unique Device Identifier (UDI)

3: Mergers and Acquisitions
Introduction
Selected Significant Device Industry Mergers and Acquisitions

• • Figure 3-1: Top 10 Highest Valued Medical Device M&A Deals (2015-2019 YTD)
• Medtronic Acquires Covidien and Other Companies
• Abbott: Acquisitions, Divestures 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
• 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
  • Table 3-1: Mergers and Acquisitions in the Medical Device Market – Valued at $100 Million or More, 2015-2019 YTD
  • Figure 3-2: Medical Device M&A Combined Value by Year (2015-2019 YTD)
• Pending: AbbVie and Allergan – A $63 Billion Deal
• Pending: Genomic Health and Exact Sciences
• Pending: Siemens Healthineers and Corindus Vascular Robotics
• Pending: Stryker Corp. and Mobius Imaging

4: Specific Device Markets

• • Table 4-1: Global Markets for Specific Medical Devices, 2019-2024 ($ Billions) (3D Printing Equipment, Materials and Software; Anesthesia Monitors; Blood Collection; Blood Gas Analyzers; Blood Pressure Monitors; Cannual 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); Hip Implants; Hypodermic Syringe; Infusion Pumps; Intraocular Lenses; Knee Implants; Medical Beds; 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); Others)

Blood Collection Supplies
Catheters
CPAP Devices
Critical Care Analysis – Blood Gas Analyzers
Defibrillators

• • Figure 4-1: Defibrillation Device Sales, Distribution by Type, 2019 (%) (Implantable, External, AED)

Dialysis Equipment & Supplies

• • Figure 4-2: Patient Distribution, Hemodialysis vs. Peritoneal Dialysis, 2019 (%)

Endoscopes
Gastric Banding and Bariatric 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 Cannulae
Ostomy Products
Pacemakers

• • Figure 4-3: Pacemaker Device Sales, Distribution by Type, 2019 (%) (Implantable, External)

Patient Monitoring
Personal Protective Equipment

• Medical Gloves

Stents
Ultrasound
Wheelchairs
Wound Care Devices, Advanced Technologies
X-Ray and Digital X-Ray

• • Figure 4-4: X-Ray Equipment Sales, Distribution by Type, 2019 (%) (Traditional, Digital)

5: Bellwether Companies
Overview
Revenue Performance – 15 Bellwether Companies

• • Table 5-1: Revenue Performance, Bellwether Companies, 2018 vs. 2019 (US billions)

US Versus International Sales

• • Table 5-2: Percent of Sales from US, 2018 and 2019

Investment in Research and Development

• • Table 5-3: Research and Development Spending, Bellwether Companies, 2018 and Estimated 2019 (US billions)
• • Table 5-4: Research and Development Spending as a Percentage of Revenues, Bellwether Companies, 2018 and Estimated 2019

6: Market Analysis
Market Drivers

• Aging Population
  • Figure 6-1: Global Population Trends, Total Population vs. Age 65+ Population, 2000-2050
• Increase in Chronic Disease
  • Figure 6-2: Global Prevalence of Disease, 2000, 2015 and Projected 2030 (Hypertension, Diabetes Mellitus, Depression, Asthma, Coronary Heart Disease / Ischemic Heart Disease, COPD, Epilepsy, Alzheimer’s Disease, HIV/AIDS, Stroke Survivors, Cancer, Tuberculosis, Parkinson’s Disease, ESRD)
  • Figure 6-3: Mortality: Chronic vs. Acute, 2015

Market Constraints

• Pressure on Prices
  • Figure 6-4: Medical Device Spending as a Percentage of Total Health Spending, by Country, 2019 Estimates (United States, Canada, Germany, France, Italy, United Kingdom, Spain, Turkey, Poland, Romania, Sweden, Switzerland, Netherlands, Greece, Hungary, Russia, Bulgaria, Croatia, Czech. Rep., Serbia, Ukraine, Lithuania, Slovakia, Slovenia, South Africa, Saudi Arabia, Egypt, Israel, Iran, Iraq, UAE, Japan, China, Australia, Vietnam, S. Korea, Malaysia, India, Indonesia, Singapore, Brazil, Mexico, Chile, Argentina, Venezuela)
• Group Purchasing Organization
• Value Analysis Committees

State of the US Hospital Market

• • Figure 6-5: Major U.S. Hospital Chain 2015-2018 Results: Revenue (less doubtful accounts), Net Income, Salaries, Supply Spending

Medical Device Size and Growth

• • Figure 6-6: Medical Device Market, 2016-2024

Market by Region

• • Figure 6-7: Medical Device Market Distribution by Region, 2019 (Northern America, EMEA, Asia Pacific, Latin America)

Market by Country: Top 20

• • Table 6-1: Top 20 Country Device Markets, 2019-2024 ($ billions) (United States, Germany, Japan, China, France, United Kingdom, Italy, Spain, Brazil, Canada, India, Netherlands, Australia, Russia, Switzerland, Taiwan, Mexico, S. Korea, Sweden, Turkey)
• • Figure 6-8: Medical Device Ranking by Top 20 Countries, 2016, 2019, 2024 (United States, Germany, Japan, China, France, United Kingdom, Italy, Spain, Brazil, Canada, India, Netherlands, Australia, Russia, Switzerland, Taiwan, Mexico, S. Korea, Sweden, Turkey)
• United States Medical Device Market
  • Table 6-2: US Medical Device Market Indicators
• Germany Medical Device Market
  • Table 6-3: Germany Medical Device Market Indicators
• Japan Medical Device Market
  • Table 6-4: Japan Medical Device Market Indicators
• China Medical Device Market
  • Table 6-5: China Medical Device Market Indicators
• France Medical Device Market
  • Table 6-6: France Medical Device Market Indicators
• United Kingdom Medical Device Market
  • Table 6-7: United Kingdom Medical Device Market Indicators
• Italy Medical Device Market
  • Table 6-8: Italy Medical Device Market Indicators
• Spain Medical Device Market
  • Table 6-9: Spain Medical Device Market Indicators
• Brazil Medical Device Market
  • Table 6-10: Brazil Medical Device Market Indicators
• Canada Medical Device Market
  • Table 6-11: Canada Medical Device Market Indicators
• India Medical Device Market
  • Table 6-12: India Medical Device Market Indicators
• The Netherlands Medical Device Market
  • Table 6-13: The Netherlands Medical Device Market Indicators
• Australia Medical Device Market
  • Table 6-14: Australia Medical Device Market Indicators
• Russia Medical Device Market
  • Table 6-15: Russia Medical Device Market Indicators
• Switzerland Medical Device Market
  • Table 6-16: Switzerland Medical Device Market Indicators
• Taiwan Medical Device Market
  • Table 6-17: Taiwan Medical Device Market Indicators
• Mexico Medical Device Market
  • Table 6-18: Mexico Medical Device Market Indicators
• South Korea Medical Device Market
  • Table 6-19: South Korea Medical Device Market Indicators
• Sweden Medical Device Market
  • Table 6-20: Sweden Medical Device Market Indicators
• Turkey Medical Device Market
  • Table 6-21: Turkey Medical Device Market Indicators

Second Tier: Market by Country

• • Table 6-22: Countries 21-50: Country Device Markets, 2019-2024 ($ billions) (Poland, New Zealand, Saudi Arabia, Singapore, Egypt, Malaysia, Thailand, Philippines, Indonesia, Argentina, Greece, Chile, Romania, South Africa, Israel, Bangladesh, Vietnam, Czech Republic, Slovakia, Hungary, UAE, Iran, Venezuela, Croatia, Slovenia, Ukraine, Lithuania, Bulgaria, Iraq, Serbia)

7: Company Profiles: Bellwether
Medtronic

• • Table 7-1: Medtronic Corporate Summary
• Company Overview
• Products Highlights
• Company Financials
  • Table 7-2: Medtronic Financial Review, Fiscal 2017-2019 ($billions)

Johnson & Johnson

• • Table 7-3: Johnson & Johnson Corporate Summary
• Company Overview
• Product Overview
• Company Financials
  • Table 7-4: Johnson & Johnson Financial Review 2017-2019 ($ billions)

Abbott Laboratories

• • Table 7-5: Abbott Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-6: Abbott Financial Review, 2017-2019 ($billions)

Cardinal Health

• • Table 7-7: Cardinal Health Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-8: Cardinal Health Financial Review, 2017-2019 ($ billions)

Siemens Healthineers

• • Table 7-9: Siemens Healthineers Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-10: Siemens Healthineers Financial Review, 2017-2019 ($ billions)

Stryker Corporation

• • Table 7-11: Stryker Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-12: Stryker Corporation Financial Review, 2017-2019 ($ billions)

Becton Dickinson and Co. (BD)

• • Table 7-13: Becton Dickinson Corporate Summary
• Company Overview
• Mergers and Acquisitions
• Products
• Company Financials
  • Table 7-14: Becton Dickinson Financial Review, 2017-2019 ($ billions)

Roche

• • Table 7-15: Roche Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-16: Roche Financial Review, 2017-2019 ($billions)

Philips

• • Table 7-17: Royal Philips Corporate Summary
• Company Overview
• Mergers & Acquisitions
• Products
• Company Financials
  • Table 7-18: Philips Financial Review, 2017-2019 ($billions)

GE Healthcare

• • Table 7-19: GE Healthcare Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-20: GE Healthcare Financial Review, 2017-2019 ($ billions)

Boston Scientific Corp.

• • Table 7-21: Boston Scientific Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-22: Boston Scientific Financial Review, 2017-2019 ($billions)

Danaher Corp.

• • Table 7-23: Danaher Corporate Summary
• Company Overview
• Company Financials
  • Table 7-24: Danaher Financial Review, 2017-2019 ($billions)

Zimmer Biomet Holdings, Inc.

• • Table 7-25: Zimmer Biomet Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-26: Zimmer Biomet Financial Review, 2017-2019 ($ billions)

B. Braun Melsungen AG

• • Table 7-27: B. Braun Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-28: B. Braun Financial Review, 2017-2019 ($ billions)

Baxter International, Inc.

• • Table 7-29: Baxter Corporate Summary
• Company Overview
• Products
• Company Financials
  • Table 7-30: Baxter Financial Review, 2017-2019 ($ billions)

8: Company Profiles: Other Market Participants
3M Health Care

• • Table 8-1: 3M Corporate Summary
• Company Overview

Access Scientific, LLC

• • Table 8-2: Access Scientific Corporate Summary
• Company Overview

Acelity L.P. Inc.

• • Table 8-3: Acelity Corporate Summary
• Company Overview

Advanced Bionics AG

• • Table 8-4: Advanced Bionics Corporate Summary
• Company Overview

Alcon, Inc.

• • Table 8-5: Alcon Corporate Summary
• Company Summary

Angiodynamics

• • Table 8-6: Angiodynamics Corporate Summary
• Company Overview

Arjo AB

• • Table 8-7: Arjo Corporate Summary
• Company Overview

Arthrex, Inc.

• • Table 8-8: Arthrex Corporate Summary
• Company Overview

Asahi Kasei Corporation

• • Table 8-9: Asahi Kasei Corporate Summary
• Company Overview

BSN medical GmbH – Essity

• • Table 8-10: BSN medical Corporate Summary
• Company Overview

Canon Medical Systems

• • Table 8-11: Canon Medical Corporate Summary
• Company Summary

Coloplast A/S

• • Table 8-12: Coloplast Corporate Summary
• Company Overview

CONMED Corporation

• • Table 8-13: CONMED Corporate Summary
• Company Overview

ConvaTec

• • Table 8-14: ConvaTec Corporate Summary
• Company Overview
• Products

Cook Medical

• • Table 8-15: Cook Medical Corporate Summary
• Company Overview

Cooper Surgical, Inc.

• • Table 8-16: Cooper Surgical Corporate Summary
• Company Overview

Dentsply-Sirona

• • Table 8-17: Dentsply Sirona Corporate Summary
• Company Overview

Dr‰gerwerk AG & Co. KGaA

• • Table 8-18: Dr‰gerwerk Corporate Summary
• Company Overview

Drive DeVilbiss Healthcare

• • Table 8-19: Drive DeVilbiss Corporate Summary
• Company Overview

Edwards Lifesciences Corp.

• • Table 8-20: Edwards Lifesciences Corporate Summary
• Company Overview

Essilor Luxottica S.A.

• • Table 8-21: Essilor Luxottica Corporate Summary
• Company Summary

Fisher & Paykel Healthcare Limited

• • Table 8-22: Fisher & Paykel Corporate Summary
• Company Overview

Fresenius SE & Co. KGaA

• • Table 8-23: Fresenius Corporate Summary
• Company Overview

GF Health Products Inc.

• • Table 8-24: GF Health Products Corporate Summary
• Company Overview

Haemonetics

• • Table 8-25: Haemonetics Corporate Summary
• Company Overview

Hill-Rom

• • Table 8-26: Hill-Rom Corporate Summary
• Company Overview

Hollister Incorporated

• • Table 8-27: Hollister Inc. Corporate Summary
• Company Overview

Invacare Corporation

• • Table 8-28: Invacare Corporate Summary
• Company Overview

IRadimed Corporation

• • Table 8-29: IRadimed Corporate Summary
• Company Overview

Masimo Corporation

• • Table 8-30: Masimo Corporate Summary
• Company Overview

Mindray Bio-Medical Electronics Co., Ltd.

• • Table 8-31: Mindray Corporate Summary
• Company Overview

Mˆlnlycke Health Care AB

• • Table 8-32: Mˆlnlycke Corporate Summary
• Company Overview

Nova Biomedical

• • Table 8-33: Nova Biomedical Corporate Summary
• Company Overview

Olympus Corporation

• • Table 8-34: Olympus Corporate Summary
• Company Overview
• Products

Paul Hartmann AG

• • Table 8-35: Paul Hartmann Corporate Summary
• Company Overview

PerkinElmer, Inc

• • Table 8-36: PerkinElmer Corporate Summary
• Company Overview

ResMed

• • Table 8-37: ResMed Corporate Summary
• Company Overview

Smith & Nephew plc.

• • Table 8-38: Smith & Nephew Corporate Summary
• Company Overview
• Acquisitions
• Products

Teleflex Inc

• • Table 8-39: Teleflex Corporate Summary
• Company Overview
• Products

Terumo Corporation

• • Table 8-40: Terumo Corporate Summary
• Company Overview

Varian Medical Systems, Inc.

• • Table 8-41: Varian Medical Corporate Summary
• Company Overview
• Products

Vyaire Medical

• • Table 8-42: Vyaire Medical Corporate Summary
• Company Overview