Table of Contents
ONE: EXECUTIVE SUMMARY
Overview
Size and Growth of the Market
Top Companies
Mergers and Acquisitions
Scope and Methodology
Conclusions
TWO: INTRODUCTION
Overview
Regulation in the US
Classification of Medical Devices
FDA Launches Early Approval Program (EAP)
Regulation in Europe
European Union
European Economic Area
Switzerland
Regulation in Japan
Regulation in China
Regulation in Canada
Regulation in Brazil
World Health Care Trends
Unique Device Identifier (UDI)
Hospital Market Update
Worldwide Hospital Bed Count
Medical Device Tax Suspension
THREE: MERGERS AND ACQUISITIONS
Introduction
Selected Significant Device Industry Mergers and Acquisitions
1Medtronic Acquires Covidien and Other Companies
Stryker Corporation Active in M&A
Abbott Acquires Alere
Smith & Nephew Remains Active in Acquisitions Despite Takeover Speculation
ResMed Acquires Brightree and Inova Labs
Dentsply-Sirona Merger
Tornier and Wright Medical Merger Finalized
Hill-Rom Completes Acquisition of Welch Allyn
Zimmer Finalizes Biomet Acquisition
BD Acquires CareFusion
FOUR: SPECIFIC DEVICE MARKETS
Wheelchairs
Defibrillators
Pacemakers
Medical Gloves
Advanced Wound Care Devices
Blood Collection Supplies
Catheters
Gastric Banding and Bariatric Devices
Minimally Invasive Surgery
Patient Monitoring
Dialysis
MRI
Ultrasound
Hip Implants
Metal-on-Metal
Ceramic
Plastic
Knee Implants
Posterior-Stabilized Knee Implants
Cruciate-Retaining Knee Implants
Unicompartmental Knee Implants
Medical Beds
X-Ray and Digital X-Ray
Intraocular Lens Devices
Infusion Pumps
Point of Care Tests
Stents
Respiratory Devices
Critical Care Analysis
Catheters
Nasal Cannulae
CPAP Devices
Wearable Devices
HealthPatch MD
E-4 WristBand
AliveCor Mobile ECG
Qardio Qardiocore
Heartview
Cardiovit, Medilog FD12Plus
SEER 100
Ostomy Products
FIVE: BELLWETHER COMPANIES
Revenue Performance – 15 Bellwether Companies
US versus International Sales
Investment in Research and Development
SIX: MARKET ANALYSIS
Market Drivers
Aging Population
Increase in Chronic Disease
Cardiovascular Disease
Diabetes
Cancer
Obesity
Market Constraints
Pressure on Prices
Group Purchasing Organization
Value Analysis Committees
Competitive Bidding
State of the US Hospital Market
Medical Device Size and Growth
Market by Region
Market by Country
SEVEN: COMPANY PROFILES
Medtronic
Covidien Merger
2015 Revenue Performance
New Products
Mergers and Acquisitions
Johnson & Johnson
2015 Revenue Performance
Cordis Divestiture
Coherex Medical, Inc.
NeuWave Medical
Boston Scientific
Mergers and Acquisitions
Stryker Corporation
Overview
Acquisitions
Product Launches
St. Jude Medical
Overview
Acquisitions
Product Launches
Becton Dickinson &Co. (BD)
Overview
Medical Segment
Molecular Instrumentation
Diagnostics Line
Product Launches and Approvals
Mergers and Acquisitions
GE Healthcare
Philips Healthcare
Mergers & Acquisitions
Siemens Healthcare
Overview
Product Launches
Smith & Nephew, Plc
Overview
Acquisitions
Product Launches
- Braun
ConvaTec
Overview
Wound Therapeutics Segment
Continence and Critical Care Segment
Infusion Devices Segment
Ostomy Care Segment
Global Operations
Baxter International
Cook Medical
Product Launches
Mindray medical
Hill-Rom
Overview
Advancing Mobility Products
Wound Care and Prevention Products
Clinical Workflow Products
Surgical Safety and Efficiency Products
Respiratory Health Products
Acquisitions
Product Launches
Research and Development
3M Health Care
Overview
Wound Management Products
Sterilization Assurance Products
Surgical Drapes & Masks
Electrodes, Thermometers, and Casting & Splinting Supplies
Drug Delivery Systems
Global Operations
Product Launches
Acquisitions
Toshiba Medical Systems (Canon)
Fresenius Medical Care
CR Bard
Acquisitions
Terumo Corporation
Cardinal Health
Acquisitions
Dentsply-Sirona
Coloplast
Paul Hartmann, AG
Teleflex Inc.
Haemonetics
Zimmer-Biomet
Acquisitions
Product Launches
Perkin Elmer, Inc.
Olympus Medical Systems
Wheelchairs of Kansas
GF Health Products, Inc.
Invacare
Overview
Existing Home Care Products
Hollister Incorporated
Overview
Existing Home Care Products
ArjoHuntleigh
History and Lines of Business
Launches and Existing Home Care Products
Corporate Strategies
Wright Medical Group N.V.
Overview
Products and Services
IRadimed Corporation
Zyno Medical, LLC
Nova Biomedical
Overview
Products
Access Scientific, LLC
Greatbatch, Inc.
Nevro Corporation
Edwards Lifesciences
Overview
Heart Valve Technologies
Critical Care Technologies
Product Launches
Drive Medical (Drive|DeVilbiss)
Overview
Acquisitions and Partnerships
New Products
DeVilbiss Healthcare (Drive|DeVilbiss)
Overview
Existing Respiratory Therapy Products
Fisher & Paykel Healthcare Limited
Overview
Products and Services
Product Launches
Research and Development
ResMed Corp.
Overview
Products and Services
Acquisitions
Masimo Corporation
Overview
Patents
AngioDynamics
Overview
Products
Advanced Bionics AG
Overview
Products
BSN Medical
Overview
Acquisitions
Joint Ventures
CooperSurgical
Overview
Products
Acquisitions
Vancive Medical Technologies
LIST OF EXHIBITS
ONE: EXECUTIVE SUMMARY
Figure 1-1: Global Medical Device Market, 2015-2020
Figure 1-2: Growth Rates of Companies Compared
TWO: INTRODUCTION
Table 2-1: Summary: Global Atlas of Medical Devices, 2014 Update
Table 2-2: Medical Device Reclassifications, 2013-2016
Figure 2-1: FDA Devices Cleared in 2015/2016 (January 2015 – February 2016), 510(k)Clearances by Month
Table 2-3: EU Medical Device Classification Rules
Figure 2-2: EU Competent Authorities
Figure 2-3: EEA Competent Authorities
Table 2-4: World Health Care Indicators
Figure 2-4: Number of Hospitals in the US, 2007-2015
Figure 2-5: Hospital Beds Worldwide by Market – Latin America, Japan, China, Europe, US –2003-2018
THREE: MERGERS AND ACQUISITIONS
Table 3-1: Mergers and Acquisitions in the Medical Device Market, 2015-2016
FOUR: SPECIFIC DEVICE MARKETS
Table 4-1: Global Markets for Specific Medical Devices, 2015-2020
Table 4-2: Selected Wheelchairs Available in the United States
Table 4-3: Selected Negative Pressure Wound Therapy Products Currently on the Market
FIVE: BELLWETHER COMPANIES
Table 5-1: Revenue Performance, Bellwether Companies, 2015 vs. 2014
Table 5-2: Percent of Sales from US, 2015 and 2014
Table 5-3: Research and Development Spending, Bellwether Companies, 2015 and 2014
Table 5-4: Research and Development Spending as a Percentage of Revenues, Bellwether Companies, 2015 and 2014
SIX: MARKET ANALYSIS
Figure 6-1: Persons Over 65+ Years of Age, by Region (US, Europe, Asia, LATAM),2003-2023
Figure 6-2: World Prevalence of Cardiovascular Disease by Type, 2013 Estimates (Hypertension,Myocardial Infarction, Coronary Heart Disease, Atrial fibrillation, Heart Failure)
Figure 6-3: Number of Diabetes Cases by Country, 2012 Estimates (India, Brazil, Mexico,Egypt, Pakistan, Germany, Philippines, Turkey, Thailand, Spain, Canada, Venezuela, Chile,Ukraine)
Figure 6-4: Cancer Incidence by Gender and Country, 2012 Estimates (United States, United
Kingdom, Turkey, Spain, Russia, Poland, Mexico, Korea, Japan, Italy, Israel, India, Germany,
France, China, Canada, Brazil, Australia)
Figure 6-5: Percent of the Population That Is Obese, 2013 Estimates (United States, UnitedKingdom, Iceland, Estonia, Brazil, Canada, Turkey, Israel, Finland, France, Denmark,
Netherlands, Italy, Norway, Korea)
Figure 6-6: Price Increase of Medical Devices Compared to Other Healthcare Expenditures,2006-2013 (CPI for Medical Care Services, CPI for Medical Care, CPI for All Items, MedicalDevice Prices)
Figure 6-7: Major U.S. Hospital Chain 2012-2015 Results: Revenue, Net Income, Debt, Supply Spending
Figure 6-8: Medical Device Market, 2015-2020
Figure 6-9: Medical Device Market by Region, 2015 (US, Europe, Asia, ROW)
Figure 6-10: US Market Forecast, 2015-2020
Table 6-1: Significant Country Device Markets (United States, Japan, Germany, China, France,Italy, United Kingdom, Spain, Canada, Australia, Vietnam, Brazil, Mexico, South Korea,Turkey, Chile, Malaysia, Poland, India, Indonesia, South Africa), 2015-2020
