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The Medical Device Market: USA

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OVERVIEW OF THE MEDICAL MARKET IN THE USA

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. http://www.bharatbook.com/market-research-reports/medical-devices-market-research-report/the-medical-device-market-usa.html

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.

PROVIDING STRATEGIC MARKET ANALYSIS EVERY MONTH
Espicom's highly-regarded world medical technology and device market research reports provide enhanced strategic intelligence in a user-friendly format. Each report provides in-depth information, setting the medical equipment market in context. The reports provide:

Unique projected estimates of market size and growth for 33 equipment categories
Five year statistical data for key economic and healthcare indicators
Information on regulation, distribution and market access, including Espicom’s unique distributor directory
Detailed Medical trade data
Data on leading local/multinational medical equipment players in the market

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 ... 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

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The Medical Device Market: USA

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