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United States Medical Equipment Market Analysis & Forecasts to 2015
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United States Medical Equipment Market Analysis & Forecasts to 2015
Summary
This report is an essential source for in-depth information and data relating to the US medical equipment market. The report provides an overview of the market structure, healthcare system, regulatory environment, reimbursement policies, distribution structure and trade associations for US medical equipment market. It also offers detailed and comprehensive coverage of market revenue and company share; and news, financial deals, pipeline products information by medical equipment sector.
Scope
-The report provides an overview of the medical equipment industry in the US and provides data and information on each of the key industries - cardiovascular devices, orthopedic devices, anesthesia and respiratory devices, patient monitoring devices, ophthalmic devices, hospital supplies, dental devices, diagnostic imaging devices, endoscopy devices, and in-vitro diagnostics. -It details the healthcare system, market structure, regulatory environment, reimbursement policies, distribution structure and trade associations for the US medical equipment market. It also provides detailed data on market size by value, key company share information for leading competitors in the market, revenues by distribution channel, and forecasts of market values.
-All figures are based on rigorous research methodologies including in-depth primary and secondary research.
Reasons to buy
-A single source to fulfill all of your business and competitor intelligence needs
-Gain a strong understanding of the country's medical industry and the 18 key sectors within it.
-Evaluate the attractiveness of the geography for medial equipment investment in the light of government policies and the reimbursement regime.
-Identify growth segments and opportunities in the industry.
-Analyze the competitiveness of the market and target the shares of key competitors.
-Develop strategies based on the latest product, brand, and regulatory events.
-Do deals with an understanding of how competitors are financed, and the mergers and partnerships that have shaped the market.
-Identify and analyze the strengths and weaknesses of the industry incumbents.
List of Tables
1 Table of Contents 2
1.1 List of Tables 10
1.2 List of Figures 12
2 Introduction 14
2.1 What Is This Report About? 14
3 Definitions of Markets Covered in This Report 15
3.1 Patient Monitoring 15
3.2 Wireless Ambulatory Telemetry Monitoring 15
3.2.1 Hospital Ambulatory 15
3.2.2 Cardiac Rehabilitation 15
3.3 Multiparameter Patient Monitoring 15
3.3.1 Critical Care Monitors 15
3.3.2 Perioperative Care Monitors 15
3.4 Remote Patient Monitoring 15
3.5 Non-Invasive Blood Pressure Monitors 16
3.5.1 Mercury Sphygmomanometer 16
3.5.2 Aneroid Sphygmomanometer 16
3.5.3 Automatic Sphygmomanometer 16
3.6 Micro- Electromechanical Systems (MEMS) 16
4 Healthcare Sector Review 17
4.1 Healthcare Expenditure 17
4.2 Healthcare Infrastructure 21
4.2.1 Healthcare Personnel Data 23
4.2.2 Healthcare Facilities Data 26
4.3 United States Healthcare Trade Statistics 28
4.4 Healthcare Statistics 29
5 Regulation System 30
5.1 Regulation System 30
5.2 Medical Equipment Approval Process 30
5.2.1 Pre-market Approval Process 31
5.2.2 Intended use and Indications for use 31
5.2.3 Predicate Device 32
5.2.4 Safe and Effective 32
5.2.5 Other Category Devices 34
5.2.6 Post-Market Approval Process 35
5.2.7 Compliance and Enforcement 35
5.2.8 Registration Fee 36
5.2.9 Approval Time 36
6 Pricing and Reimbursement 37
6.1 Government Policies 37
6.2 Private Insurance 38
6.3 Diagnosis Related Groups (DRG) 39
7 Distribution Structure 40
7.1 Distribution Structure 40
8 The US Medical Equipment Market Overview 41
8.1 US Medical Equipment Competitive Landscape 44
9 US Medical Equipment Market - Sector Insights and Trend Assessment 45
9.1 Regulatory Landscape 45
9.1.1 Ruling To Provide Immunity For Medical Equipment Manufacturers 45
9.1.2 Medical Device Safety Act of 2008 46
9.1.3 FDA's Stand on Off-Label Marketing 47
9.1.4 FDA To Update Standards 49
9.2 Demographic Scenario 50
9.2.1 Aging Population 50
9.2.2 Sex Ratio 50
9.3 Economic and political Factors 50
9.3.1 Wall Street Crisis - Medical Equipment Perspective 50
9.4 Industry Outlook 52
9.4.1 Ban of Gifts to Doctors 52
9.4.2 DTC Advertising 53
9.4.2.1 Cardiovascular And Orthopedic Devices Market Approach 53
10 Cardiovascular Devices in the US 55
10.1 Market Overview 55
10.2 US Cardiovascular Devices Market Dynamics 56
10.2.1 Market Drivers 56
10.2.2 Market Restraints 58
10.3 US Cardiovascular Devices Competitive Landscape 59
11 Orthopedic Devices in the US 60
11.1 Market Overview 60
11.2 US Orthopedic Devices Market Dynamics 61
11.2.1 Market Drivers 61
11.2.2 Market Restraints 62
11.3 US Orthopedic Devices Competitive Landscape 63
12 Diagnostic Imaging in the US 64
12.1 Market Overview 64
12.2 US Diagnostic Imaging Market Dynamics 65
12.2.1 Market Drivers 65
12.2.2 Market Restraints 65
12.3 US Diagnostic Imaging Competitive Landscape 66
13 Ophthalmic Devices in the US 67
13.1 Market Overview 67
13.2 US Ophthalmic Devices Market Dynamics 68
13.2.1 Market Drivers 68
13.2.2 Market Restraints 69
13.3 US Ophthalmic Devices Competitive Landscape 70
14 Patient Monitoring in the US 71
14.1 Market Overview 71
14.2 US Patient Monitoring Market Dynamics 72
14.2.1 Market Drivers 72
14.2.2 Market Restraints 73
14.3 US Patient Monitoring Competitive Landscape 74
15 Anesthesia and Respiratory Devices in the US 75
15.1 Market Overview 75
15.2 US Anesthesia and Respiratory Devices Market Dynamics 76
15.2.1 Market Drivers 76
15.2.2 Market Restraints 77
15.3 US Anesthesia and Respiratory Devices Competitive Landscape 78
16 Dental Devices in the US 79
16.1 Market Overview 79
16.2 US Dental Devices Market Dynamics 80
16.2.1 Market Drivers 80
16.2.2 Market Restraints 81
16.3 US Dental Devices Competitive Landscape 82
17 Diabetes Care Devices in the US 83
17.1 Market Overview 83
17.2 US Diabetes Care Devices Market Dynamics 84
17.2.1 Market Drivers 84
17.2.2 Market Restraints 84
17.3 US Diabetes Care Devices Competitive Landscape 85
18 Neurology Devices in the US 86
18.1 Market Overview 86
18.2 US Neurology Devices Market Dynamics 87
18.2.1 Market Drivers 87
18.2.2 Market Restraints 87
18.3 US Neurology Devices Competitive Landscape 88
19 Endoscopy Devices in the US 89
19.1 Market Overview 89
19.2 US Endoscopy Devices Market Dynamics 90
19.2.1 Market Drivers 90
19.2.2 Market Restraints 90
19.3 US Endoscopy Devices Competitive Landscape 91
20 ENT Devices in the US 92
20.1 Market Overview 92
20.2 US ENT Devices Market Dynamics 93
20.2.1 Market Drivers 93
20.2.2 Market Restraints 93
20.3 US ENT Devices Competitive Landscape 94
21 Nephrology and Urology Devices in the US 95
21.1 Market Overview 95
21.2 US Nephrology and Urology Devices Market Dynamics 96
21.2.1 Market Drivers 96
21.2.2 Market Restraints 96
21.3 US Nephrology and Urology Devices Competitive Landscape 98
22 Drug Delivery Devices in the US 99
22.1 US Drug Delivery Devices Market Dynamics 100
22.1.1 Market Drivers 100
22.1.2 Market Restraints 100
22.2 US Drug Delivery Devices Competitive Landscape 101
23 Healthcare IT in the US 102
23.1 Market Overview 102
23.2 US Healthcare IT Market Dynamics 103
23.2.1 Market Drivers 103
23.2.2 Market Restraints 103
23.3 US Healthcare IT Competitive Landscape 104
24 Hospital Supplies in the US 105
24.1 Market Overview 105
24.2 US Hospital Supplies Market Dynamics 106
24.2.1 Market Drivers 106
24.2.2 Market Restraints 106
24.3 US Hospital Supplies Competitive Landscape 107
25 In Vitro Diagnostics in the US 108
25.1 Market Overview 108
25.2 US In Vitro Diagnostics Market Dynamics 109
25.2.1 Market Drivers 109
25.2.2 Market Restraints 110
25.3 US In Vitro Diagnostics Competitive Landscape 111
26 Surgical Equipment in the US 112
26.1 Market Overview 112
26.2 US Surgical Equipment Market Dynamics 113
26.2.1 Market Drivers 113
26.2.2 Market Restraints 113
26.3 US Surgical Equipment Competitive Landscape 114
27 Wound Care Management in the US 115
27.1 Market Overview 115
27.2 US Wound Care Management Market Dynamics 116
27.2.1 Market Drivers 116
27.2.2 Market Restraints 117
27.3 US Wound Care Management Competitive Landscape 118
28 Medtronic Company Profile 119
28.1 Company Overview 119
28.2 Medtronic Pipeline Products 120
28.2.1 Medtronic Pipeline Products by Equipment Type 120
28.2.2 Medtronic Pipeline Products by Development Stage 121
28.2.3 Medtronic Pipeline Products by Therapy Area 121
28.2.4 Medtronic Pipeline Products by Clinical Trials 123
29 Boston Scientific Corporation Company Profile 124
29.1 Company Overview 124
29.2 Boston Scientific Pipeline Products 124
29.2.1 Boston Scientific Pipeline Products by Equipment Type 124
29.2.2 Boston Scientific Pipeline Products by Development Stage 125
29.2.3 Boston Scientific Pipeline Products by Therapy Area 126
29.2.4 Boston Scientific Pipeline Products by Clinical Trials 127
30 Philips Healthcare Company Profile 128
30.1 Company Overview 128
30.2 Philips Healthcare Scientific Pipeline Products 128
30.2.1 Philips Healthcare Pipeline Products by Equipment Type 128
30.2.2 Philips Healthcare Pipeline Products by Development Stage 129
30.2.3 Philips Healthcare Pipeline Products by Therapy Area 129
31 Siemens Medical Solutions Company Profile 130
31.1 Company Overview 130
31.2 Siemens Pipeline Products 130
31.2.1 Siemens Pipeline Products by Equipment Type 130
31.2.2 Siemens Pipeline Products by Development Stage 131
31.2.3 Siemens Pipeline Products by Therapy Area 131
32 Stryker Corporation Company Profile 132
32.1 Company Overview 132
32.2 Stryker Pipeline Products 132
32.2.1 Stryker Pipeline Products by Equipment Type 132
32.2.2 Stryker Pipeline Products by Development Stage 132
32.2.3 Stryker Pipeline Products by Therapy Area 133
32.2.4 Stryker Pipeline Products by Clinical Trials 133
33 APPENDIX 134
33.1 Associations 134
33.1.1 Medical Device Manufacturers Association (MDMA) 134
33.1.2 AdvaMed 134
33.1.3 American Association for Homecare (AAHomecare) 134
33.1.4 American National Standards Institute (ANSI) 134
33.2 GlobalData Research Methodology 135
33.3 Coverage 135
33.4 Secondary Research 136
33.5 Primary Research 136
33.6 Models 137
33.7 Forecasts 137
33.8 Expert Panels 138
33.9 Currency Conversion 139
33.10 Contact Us 140
33.11 Disclaimer 140
List of Tables
1.1 List of Tables
Table 1: United States, Healthcare Expenditure by Type, 2001 - 2008 18
Table 2: United States Healthcare Expenditure by Race (per person), 2000-2003 19
Table 3: United States Personal Healthcare Expenditure by Type, 2000-2004 19
Table 4: United States Personal Healthcare Expenditure by Source, 2000-2004 20
Table 5: Total Number of Doctors in the United States, 2003-2010 23
Table 6: Number of Doctors by Specialty in the United States, 2003-2010 23
Table 7: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 24
Table 8: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 25
Table 9: Total Hospitals in the United States, 2000-2004 26
Table 10: Community Hospitals by Number of Beds in the United States, 2000-2004 26
Table 11: Number of Hospital Beds in the United States, 2000-2004 26
Table 12: Number of Hospital Beds by Range in the United States, 2000-2004 27
Table 13: United States Healthcare Trade Statistics, 2001-2008 28
Table 14: Population Statistics, US, 2001 - 2008 29
Table 15: Healthcare Statistics, US, 2001 - 2008 29
Table 16: Medical Equipment Registration Fee in United States, 2007 36
Table 17: Medical Device Approval Time in United States, 2004 36
Table 18: US Medical Equipment, Revenue ($ m), Cross Market Analysis, 2000 - 2015 42
Table 19: Cardiovascular Devices Market, US, Revenue ($ m), 2000-2015 56
Table 20: Orthopedic Devices Market, US, Revenue ($m), 2000-2015 61
Table 21: Diagnostic Imaging Market, US, Revenue ($m), 2000-2015 65
Table 22: Ophthalmic Devices Market, US, Revenue ($m), 2000-2015 68
Table 23: Patient Monitoring Market, US, Revenue ($m), 2000-2015 72
Table 24: Anesthesia and Respiratory Devices Market, US, Revenue ($m), 2000-2015 76
Table 25: Dental Devices Market, US, Revenue ($m), 2000-2015 80
Table 26: Diabetes Care Devices Market, US, Revenue ($m), 2000-2015 83
Table 27: Neurology Devices Market, US, Revenue ($m), 2000-2015 87
Table 28: Endoscopy Devices Market, US, Revenue ($m), 2000-2015 89
Table 29: ENT Devices Market, US, Revenue ($m), 2000-2015 93
Table 30: Nephrology and Urology Devices Market, US, Revenue ($m), 2000-2015 95
Table 31: Drug Delivery Devices Market, US, Revenue ($m), 2000-2015 99
Table 32: Healthcare IT Market, US, Revenue ($m), 2000-2015 102
Table 33: Hospital Supplies Market, US, Revenue ($m), 2000-2015 106
Table 34: In Vitro Diagnostics Market, US, Revenue ($m), 2000-2015 109
Table 35: Surgical Equipment Market, US, Revenue ($m), 2000-2015 113
Table 36: Wound Care Management Market, US, Revenue ($m), 2000-2015 116
Table 37: Medtronic Pipeline Products by Equipment Type 120
Table 38: Medtronic Pipeline Products by Development Stage 121
Table 39: Medtronic Pipeline Products by Therapy Area 122
Table 40: Medtronic Pipeline Products by Clinical Trials 123
Table 41: Boston Scientific Pipeline Products by Equipment Type 124
Table 42: Boston Scientific Pipeline Products by Development Stage 125
Table 43: Boston Scientific Pipeline Products by Therapy Area 126
Table 44: Boston Scientific Pipeline Products by Clinical Trials 127
Table 45: Philips Healthcare Pipeline Products by Equipment Type 128
Table 46: Philips Healthcare Pipeline Products by Development Stage 129
Table 47: Philips Healthcare Pipeline Products by Therapy Area 129
Table 48: Siemens Pipeline Products by Equipment Type 130
Table 49: Siemens Pipeline Products by Development Stage 131
Table 50: Siemens Pipeline Products by Therapy Area 131
Table 51: Stryker Pipeline Products by Equipment Type 132
Table 52: Stryker Pipeline Products by Development Stage 132
Table 53: Stryker Pipeline Products by Therapy Area 133
Table 54: Stryker Pipeline Products by Clinical Trials 133
Table 55: Currency Conversion from USD to Local Currency at 2008 Constant Rate 139
List of Figures
1.2 List of Figures
Figure 1: United States, Healthcare Expenditure by Source, 2006 18
Figure 2: United States, Healthcare Infrastructure, Top Level View, 2007 22
Figure 3: Medical Equipment Approval Process in the United States, 2007 31
Figure 4: PMA Approval Process in the United States, 2007 33
Figure 5: The 510(k) Approval Process for Medical Devices in the United States, 2007 34
Figure 6: Reimbursement Structure in the United States, 2007 39
Figure 7: Distribution Structure of Medical Equipment in the United States, 2006 40
Figure 8: US Medical Equipment, Revenue, Cross Market Analysis, 2000 - 2015 41
Figure 9: Medical Equipment, US, Company Share, 2008 44
Figure 10: Cardiovascular Devices Market, US, Revenue ($m), 2000-2015 55
Figure 11: Cardiovascular Devices Market, US, Company Share (%), 2007 59
Figure 12: Orthopedic Devices Market, US, Revenue ($m), 2000-2015 60
Figure 13: Orthopedic Devices Market, US, Company Share (%), 2007 63
Figure 14: Diagnostic Imaging Market, US, Revenue ($m), 2000-2015 64
Figure 15: Diagnostic Imaging Market, US, Company Share (%), 2007 66
Figure 16: Ophthalmic Devices Market, US, Revenue ($m), 2000-2015 67
Figure 17: Ophthalmic Devices Market, US, Company Share (%), 2007 70
Figure 18: Patient Monitoring Market, US, Revenue ($m), 2000-2015 71
Figure 19: Patient Monitoring Market, US, Company Share (%), 2007 74
Figure 20: Anesthesia and Respiratory Devices Market, US, Revenue ($m), 2000-2015 75
Figure 21: Anesthesia and Respiratory Devices Market, US, Company Share (%), 2007 78
Figure 22: Dental Devices Market, US, Revenue ($m), 2000-2015 79
Figure 23: Dental Devices Market, US, Company Share (%), 2007 82
Figure 24: Diabetes Care Devices Market, US, Revenue ($m), 2000-2015 83
Figure 25: Diabetes Care Devices Market, US, Company Share (%), 2007 85
Figure 26: Neurology Devices Market, US, Revenue ($m), 2000-2015 86
Figure 27: Neurology Devices Market, US, Company Share (%), 2007 88
Figure 28: Endoscopy Devices Market, US, Revenue ($m), 2000-2015 89
Figure 29: Endoscopy Devices Market, US, Company Share (%), 2007 91
Figure 30: ENT Devices Market, US, Revenue ($m), 2000-2015 92
Figure 31: ENT Devices Market, US, Company Share (%), 2007 94
Figure 32: Nephrology and Urology Devices Market, US, Revenue ($m), 2000-2015 95
Figure 33: Nephrology and Urology Devices Market, US, Company Share (%), 2007 98
Figure 34: Drug Delivery Devices Market, US, Revenue ($m), 2000-2015 99
Figure 35: Drug Delivery Devices Market, US, Company Share (%), 2007 101
Figure 36: Healthcare IT Market, US, Revenue ($m), 2000-2015 102
Figure 37: Healthcare IT Market, US, Company Share (%), 2008 104
Figure 38: Hospital Supplies Market, US, Revenue ($m), 2000-2015 105
Figure 39: Hospital Supplies Market, US, Company Share (%), 2000-2015 107
Figure 40: In Vitro Diagnostics Market, US, Revenue ($m), 2000-2015 108
Figure 41: In Vitro Diagnostics Market, US, Company Share (%), 2000-2015 111
Figure 42: Surgical Equipment Market, US, Revenue ($m), 2000-2015 112
Figure 43: Surgical Equipment Market, US, Company Share (%), 2000-2015 114
Figure 44: Wound Care Management Market, US, Revenue ($m), 2000-2015 115
Figure 45: Wound Care Management Market, US, Company Share (%), 2000-2015 118
Figure 46: GlobalData Methodology 135
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United States Medical Equipment Market Analysis & Forecasts to 2015
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