NEW YORK, Nov. 28, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
The Medical Device Market: USA
http://www.reportlinker.com/p0203047/The-Medical-Device-Market-USA.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=Medical_Equipment_and_Supply
With a population over 300 million, the USA is the third largest country in the world, behind China and India. The largest state is California, with a population of 37 million.
At an estimated US$105.8 billion in 2011, the US medical device market is the world's largest. Per capita expenditure, at US$339, is the third highest in the world.
Much of the market is in private hands; there is no single health system. Public healthcare systems, known as Medicaid, for those on low incomes, are operated by each State. Since 1960, the Medicare system has provided hospital care for the elderly; this has also provided prescription drug coverage since 2006.
President Obama succeeded in signing his healthcare reform bill into law on 23nd March 2010. The bill, formally called the Patient Protection and Affordable Care Act HR 3590, will eventually extend health insurance cover to an estimated 32 million Americans who don't have any form of health insurance.
The USA is home to many of the world's leading medical device manufacturers, such as Johnson & Johnson, General Electric, Baxter, Covidien and Medtronic. Seven out of the world's top ten device manufacturers are US companies.
Imports are forming an increasingly significant part of the market, and now account for around 32% of the total. This growth is partly explained by US manufacturers using cheap locations abroad, such as Ireland or Mexico, in order to re-export to the US market.
The market is highly regulated, and can be an expensive one in which to operate. It is, however, transparent and 'rules-based'. The US is a major site for R&D and clinical trials.
Includes 3 quarterly updated outlook reports!
Please note: Report sections are periodically updated and some sections may have been updated more recently than the publication date given for the full report.
Table of Contents
EXECUTIVE SUMMARY 1
Introduction 2
MEDICAL DEVICE MARKET ANALYSIS 3
Overview 3
The Market in 2011 4
Past Performance 2006-10 7
Future Performance 2011-16 8
New Medical Device Tax under Healthcare Reform Plan 8
The US Market For Consumables 12
The US Market For Diagnostic Imaging Apparatus 14
The US Market For Dental Products 16
The US Market For Orthopaedic Products 18
The US Market For Patient Aids 20
Imports 22
Consumables 24
Diagnostic Imaging 24
Dental Products 24
Orthopaedic & Prosthetic Products 24
Patient Aids 24
Domestic Manufacturing 34
Domestic Production 34
Manufacturing by State, 2002 36
Trade Associations 37
Advanced Medical Technology Association (Advamed) 37
Medical Device Manufacturers Association (MDMA) 37
National Electrical Manufacturers Association (NEMA) 37
Local Manufacturers 37
Overview of the Top Ten Domestic Producers 38
1 Johnson & Johnson 38
2 GE Healthcare 39
3 Medtronic 39
4 Baxter International 40
5 Covidien (formerly Tyco Healthcare) 41
6 Boston Scientific 42
7 Becton Dickinson 42
8 Stryker 43
9 St Jude Medical 43
10 Zimmer 43
Abbott to Split into Two Companies 44
Exports 45
Consumables 46
Diagnostic Imaging 46
Dental Products 46
Orthopaedic Products 46
Patient Aids 46
ACCESSING THE MARKET 55
Distribution 55
Health Industry Distributors Association (HIDA) 55
Independent Medical Distributors Association (IMDA) 55
Medical Device Regulations 55
Medical Device User Fee and Modernisation Act of 2002 56
Reprocessed Single-Use Devices 56
Third Party Reviews 56
FDA Modernisation Act of 1997 56
Pre-Marketing Requirements 57
510(k) Pre-Market Notification 57
510(k) Paradigm 58
Pre-Market Approval Application 58
510(k) Reform Plan 59
Humanitarian Device Exemption 59
Investigational Device Exemptions 60
Third Party Review 60
Post-Marketing Requirements 61
GMP/QS Regulations 61
Compliance 62
Requirements for Record Keeping 62
Product Liability 63
Mutual Recognition Agreement with EU 64
HEALTHCARE ANALYSIS 68
Demographics 68
Population 68
Birth Rate 69
Death Rate 69
Infant Mortality 69
Life Expectancy at Birth 69
Public Health 69
Causes of Death 69
Incidence of Communicable Diseases 70
HIV/AIDS 70
Healthcare System 70
Centers for Medicare & Medicaid Services (CMS) 71
Medicare 71
Medicaid 72
Children's Health Insurance Program Reauthorisation Act 73
Health Insurance Portaility and Accountability Act of 1996 73
Private Health Provision 73
Blue Cross and Blue Shield Association (BCBSA) 73
Managed Care 73
Patient Protection and Affordable Care Act HR 3590 (Healthcare Reform Bill) 74
Health Expenditure 74
Healthcare Infrastructure 76
Inpatient Analysis 77
Healthcare Personnel 77
DIRECTORY 78
Healthcare Organisations 78
Health Care/Managed Care Systems 81
Trade Code Classifications 82
Methodology 84
Sources 84
List of Tables
Summary Key Data Projections, 2011-2016 2
US Medical Device Market, Key Ratios, 2011 3
Espicom Analysis of the US Medical Market, 2011 5
SWOT Analysis of the US Medical Device Market, 2011 6
Projected Medical Device Market, 2011-2016 9
The US Medical Device Market, 2006-16 (US$ millions) 10
The US Medical Device Market, 2006-16 (US$ per capita) 10
The US Medical Device Market, 2006-16 (% of Total) 11
The US Medical Device Market, 2006-16 (% Change) 11
The US Consumables Market, 2006-16 (US$ millions) 12
The US Diagnostic Imaging Market, 2006-16 (US$ millions) 14
The US Dental Products Market, 2006-16 (US$ millions) 16
The US Orthopaedic & Prosthetic Devices Market, 2006-16 (US$ millions) 18
The US Patient Aids Market, 2006-16 (US$ millions) 20
Medical Equipment Imports by Product Area, 2005-09 (US$000s) 25
Medical Equipment Imports by Product Area, 2005-09 (%) 25
Change in Medical Equipment Imports by Product Area, 2006-2009 (%) 27
Leading Medical Equipment Suppliers by Product Area, 2009 (US$000s) 28
Leading Medical Equipment Suppliers by Product Area, 2009 (%) 28
Top 20 Suppliers to the American Market, 2009 29
Imports of Medical Equipment, 2005-09 (US$000s) 30
Medical Equipment Import Trends, 2009 31
Leading Suppliers, 2009 32
Leading Suppliers by Category, 2009 33
Summary Sector Trends, 1999-2007 (US$ Millions) 34
Medical Equipment Production by Category, 2007 (US$ Millions) 35
Establishments, Workers & Shipments by Top Five States & Industry Sector, 2002 36
Top 10 US Manufacturers by Medical Device Revenue, 2006-10 (US$ millions) 37
Medical Equipment Exports by Product Area, 2005-09 (US$000s) 47
Medical Equipment Exports by Product Area, 2005-09 (%) 47
Medical Exports by Product Area, 2005-2009 (% of Total) 48
Change in Medical Equipment Exports by Product Area, 2006-09 (%) 49
Leading Medical Equipment Destinations by Product Area, 2009 (US$000s) 50
Leading Medical Equipment Destinations by Product Area, 2009 (%) 50
Exports of Medical Equipment, 2005-09 (US$000s) 51
Medical Equipment Export Trends 52
Leading Destinations, 2009 53
Balance of Medical Trade, 2005-2009 (US$000s) 54
Medical Devices Cleared or Approved by the FDA in 2011 65
Summary of Demographic Data 68
Projected Population, 2011-16 68
Reported AIDS Cases by Sex, 2003-08 70
Largest Health Insurance & Managed Care Companies by Revenue and Profit, 2010 74
Healthcare Expenditure 75
Summary Health Expenditure by Type, 2007-09 (US$ billions) 75
Projected Health Expenditure, 2011-16 76
Hospitals & Beds 76
Hospital Bed Projections, 2011-16 76
Projected Number of Physicians, 2011-16 77
HS Trade Codes Used in This Report 82
HS Trade Codes, Rearranged 83
List of Figures
US Medical Device Market by Category, 2011 (%) 4
Change in the US Medical Device Market, 2006-2010 (%) 7
CAGR of the US Medical Device Market by Product Area, 2006-2010 (%) 7
Market Projections, 2011-16 9
The US Market For Consumables, 2006-16 (US$ millions) 13
The US Market For Consumables, 2006-16 (CAGR) 13
The US Market For Diagnostic Imaging Apparatus, 2006-16 (US$ millions) 15
The US Market For Diagnostic Imaging Apparatus, 2006-16 (CAGR) 15
The US Market For Dental Products, 2006-16 (US$ millions) 17
The US Market For Dental Products, 2006-16 (CAGR) 17
The US Market For Orthopaedic Products, 2006-16 (US$ millions) 19
The US Market For Orthopaedic Products, 2006-16 (CAGR) 19
The US Market For Patient Aids, 2006-16 (US$ millions) 21
The US Market For Patient Aids, 2006-16 (CAGR) 21
Imports of Medical Equipment & Supplies, 1988-2009 (US$ Millions) 22
Change in Imports of Medical Equipment & Supplies, 1989-09 (%) 22
Imports as % of the US Market, 1994-2009 23
Medical Equipment Imports by Product Area, 2009 (%) 26
Medical Imports by Product Area, 2005-2009 (% of Total) 26
CAGR of Medical Imports by Product Area, 2005-09 (%) 27
Leading Medical Equipment Suppliers, 2009 (%) 29
Exports of Medical Equipment & Supplies, 1988-2009 (US$ Millions) 45
Change in Exports of Medical Equipment & Supplies, 1989-09 (%) 45
Medical Equipment Exports by Product Area, 2009 (%) 47
CAGR of Medical Exports by Product Area, 2005-09 (%) 49
Leading Medical Equipment Destinations, 2009 (%) 50
To order this report:
Medical_Equipment_and_Supply Industry: The Medical Device Market: USA
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