The Medical Device Market: USA

NEW YORK, May 23, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

The Medical Device Market: USA

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Summary

Espicom's in-depth medical device market reports are ideal for executives wanting to understand the key drivers in medical markets and have access to a wealth of statistical data. Each report opens with an outlook section that provides analysis of the market, 5-year market forecasts, national data projections, market outlook and key developments such as regulation, health facilities and government policy. The report also provides extensive background information, population trends, health status, health expenditure, organisation & administration, hospital services, medical personnel, healthcare development, market access information, trade data and essential industry contacts. Included with the report are 3 free quarterly updated outlook reports, enabling you to keep up to date with market developments for a year.

Description

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.

In January 2012, the Obama administration said the bill is on track to being implemented, despite opposition from some States. The law requires all States to create new health insurance markets called exchanges, so that people who do not have insurance can buy tax-payer subsidised private cover. The law also expands eligibility for Medicaid so low-income adults who have no dependent children can get government insurance. Putting the two approaches together, more than 30 million Americans are expected to gain coverage by January 2014. Over 20 States are planning to overturn requirements of the law, and have made little progress in planning or creating these exchanges. If State plans are not approved by January 2013, one year before the exchanges are to be up and running, the Federal government can intervene and manage the process.

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 medical 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.

Imports grew by 8.9% to reach US$35.3 billion in 2011. All categories posted positive growth, with consumables recording the strongest rate of 12.1% for the period, reaching US$5.3 billion. The largest category, diagnostic imaging, rose by 7.4% during the period to reach US$8.3 million.

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.

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Key national data projections

Current market size

Unique 5-year market projections

Market outlook

Market structure; Including statistical data on imports and exports

Market access; Including distribution and medical device regulation

Healthcare analysis; Including demographics, healthcare system, health expenditure, healthcare infrastructure and personnel

HEALTHCARE DATA: A comprehensive tabula review of the market, including economic indicators, demographics, health expenditure, hospital and primary care data, and healthcare personnel.DISTRIBUTORSDetails of the medical equipment distributors held in Espicom's database at the time of publication.

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 23

Diagnostic Imaging 23

Dental Products . 23

Orthopaedic & Prosthetic Products . 23

Patient Aids . 23

Domestic Manufacturing . 41

Domestic Production . 41

Manufacturing by State, 2002 . 43

Trade Associations 44

Advanced Medical Technology Association (Advamed) . 44

Medical Device Manufacturers Association (MDMA) . 44

National Electrical Manufacturers Association (NEMA) 44

Local Manufacturers 44

Overview of the Top Ten Domestic Producers 45

1. Johnson & Johnson . 45

2. GE Healthcare . 46

3. Medtronic . 46

4. Baxter International . 47

5. Covidien (formerly Tyco Healthcare) 48

6. Boston Scientific 49

7. Becton Dickinson . 49

8. Stryker . 50

9. St. Jude Medical 50

10. Zimmer 50

Abbott to Split into Two Companies . 51

Exports 52

Consumables 53

Diagnostic Imaging 53

Dental Products . 53

Orthopaedic Products . 53

Patient Aids . 53

Monthly Exports Data 70

ACCESSING THE MARKET 72

Distribution 72

Health Industry Distributors Association (HIDA) . 72

Independent Medical Distributors Association (IMDA) . 72

Medical Device Regulations 72

Medical Device User Fee and Modernisation Act of 2002 . 73

Reprocessed Single-Use Devices 73

Third Party Reviews 73

FDA Modernisation Act of 1997 73

Pre-Marketing Requirements 74

510(k) Pre-Market Notification 75

510(k) Paradigm 75

Pre-Market Approval Application 75

510(k) Reform Plan . 76

Humanitarian Device Exemption . 76

Investigational Device Exemptions . 77

Third Party Review 77

Post-Marketing Requirements 78

GMP/QS Regulations 78

Compliance 79

Requirements for Record Keeping . 79

Product Liability . 80

Mutual Recognition Agreement with EU . 81

HEALTHCARE ANALYSIS 85

Demographics . 85

Population . 85

Birth Rate . 86

Death Rate 86

Infant Mortality . 86

Life Expectancy at Birth . 86

Public Health . 86

Causes of Death 86

Incidence of Communicable Diseases . 87

HIV/AIDS . 87

Healthcare System 87

Centers for Medicare & Medicaid Services (CMS) 88

Medicare 88

Medicaid 89

Children's Health Insurance Program Reauthorisation Act 90

Health Insurance Portaility and Accountability Act of 1996 90

Private Health Provision 90

Blue Cross and Blue Shield Association (BCBSA) . 90

Managed Care . 90

Patient Protection and Affordable Care Act HR 3590 (Healthcare Reform Bill) 91

Health Expenditure . 91

Healthcare Infrastructure 93

Inpatient Analysis 94

Healthcare Personnel . 94

DIRECTORY 96

Healthcare Organisations . 96

Health Care/Managed Care Systems 99

Trade Code Classifications 100

Methodology. 102

Sources . 102

Summary Key Data Projections, 2011-2016 2US Medical Device Market, Key Ratios, 2011 . 3Espicom Analysis of the US Medical Market, 2011 5SWOT Analysis of the US Medical Device Market, 2011 . 6Projected Medical Device Market, 2011-2016 . 9The US Medical Device Market, 2006-16 (US$ millions) 10The US Medical Device Market, 2006-16 (US$ per capita) . 10The US Medical Device Market, 2006-16 (% of Total) . 11The US Medical Device Market, 2006-16 (% Change) 11The US Consumables Market, 2006-16 (US$ millions) 12The US Diagnostic Imaging Market, 2006-16 (US$ millions) . 14The US Dental Products Market, 2006-16 (US$ millions). 16The US Orthopaedic & Prosthetic Devices Market, 2006-16 (US$ millions) 18The US Patient Aids Market, 2006-16 (US$ millions) . 20Summary Medical Imports by Product Area, 2007-11 (US$000s) . 24Summary Medical Imports by Product Area, 2007-11 (US$000s % Change) . 24CAGR of Medical Imports by Product Area, 2007-11 (%) 25Summary Medical Imports by Product Area, 2007-11 (% of Total) . 26Leading Medical Equipment Suppliers by Product Area, 2011 (US$000s) 27Top 20 Suppliers to the American Market, 2011 (US$000s) 28Detailed Imports of Medical Equipment, 2007-11 (US$000s) 29Detailed Imports of Medical Equipment, 2007-2011 (Growth Trends) 32Detailed Imports, Leading Suppliers, 2011 (US$000s) 35Monthly Imports Data to December 2011 (US$ millions) . 39Imports by Month, December 2009-December 2011 (US$ millions) . 39Import Growth by Sector, Latest Year and Quarter (%) . 40Summary Sector Trends, 1999-2007 (US$ Millions) . 41Medical Equipment Production by Category, 2007 (US$ Millions) . 42Establishments, Workers & Shipments by Top Five States & Industry Sector, 2002 . 43Top 10 US Manufacturers by Medical Device Revenue, 2006-10 (US$ millions) . 44Summary Medical Exports by Product Area, 2007-11 (US$000s) . 54Summary Medical Exports by Product Area, 2007-11 (US$000s % Change) . 54CAGR of Medical Exports by Product Area, 2007-11 (%) 55Summary Medical Exports by Product Area, 2007-11 (% of Total) . 56Leading Medical Equipment Destinations by Product Area, 2011 (US$000s) . 57Top 20 Destinations for American Exports, 2011 (US$000s) 58Detailed Exports of Medical Equipment, 2007-2011 (US$000s) 59Detailed Exports of Medical Equipment, 2007-2011 (Growth Trends) 62Detailed Exports, Leading Destinations, 2011 (US$000s) . 65Balance of Medical Trade, 2007-2011 (US$000s) . 68Monthly Exports Data to December 2011 (US$ millions). 70Exports by Month, December 2009-December 2011 (US$ millions) . 70Export Growth by Sector, Latest Year and Quarter (%). 71Medical Devices Cleared or Approved by the FDA in 2011 . 82Summary of Demographic Data 85Projected Population, 2011-16 . 85Reported AIDS Cases by Sex, 2003-08 . 87Largest Health Insurance & Managed Care Companies by Revenue and Profit, 2010 . 91Healthcare Expenditure 92Summary Health Expenditure by Type, 2007-09 (US$ billions) 92Projected Health Expenditure, 2011-16 . 93Hospitals & Beds . 93Hospital Bed Projections, 2011-16 93Projected Number of Physicians, 2011-16 94HS Trade Codes Used in This Report . 100HS Trade Codes, Rearranged 101

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, 1988-2011 (US$ Millions) . 22

Change in Imports of Medical Equipment & Supplies, 1989-2011 (%) . 22

Medical Equipment Imports by Product Area, 2011 (%) 26

Leading Medical Equipment Suppliers, 2011 (%) . 28

Exports of Medical Equipment & Supplies, 1988-2011 (US$ Millions) . 52

Change in Exports of Medical Equipment & Supplies, 1989-2011 (%) . 52

Medical Equipment Exports by Product Area, 2011 (%) 56

Leading Medical Equipment Destinations, 2011 (%) . 58

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