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United States In Vitro Diagnostics Investment Opportunities Analysis and Forecasts to 2012
Global Markets Direct, Sep 2008, Pages: 164
1 Table Of Contents
1 Table Of Contents 2
1.1 List of Tables 11
1.2 List of Figures 14
2 Introduction 16
2.1 What Is This Report About? 16
3 Definitions of Markets Covered in the Report 17
3.1 In Vitro Diagnostics Devices 17
3.2 Clinical Chemistry Test Reagents 17
3.2.1 Laboratory Reagents 17
3.2.2 Clinical Chemistry Calibrators and Controls 17
3.2.3 Clinical Chemistry Rapid Tests 17
3.3 Immunochemistry Test Reagents 17
3.3.1 Disease Specific Markers 17
3.3.2 Disease Specific Test Reagents 18
3.3.3 Drug Related Testing Reagents 18
3.3.4 Hormone Related Testing Reagents 19
3.3.5 Immunochemistry Calibrators and Controls 19
3.3.6 Immunochemistry Rapid Tests 19
3.4 Blood Test Reagents 19
3.4.1 Hematology Test Reagents 20
3.4.2 Hemostasis Test Reagents 20
3.4.3 Tissue Typing Reagents 21
3.4.4 Monoclonal Antibodies 21
3.4.5 Cytokines and Immunomodulators 21
3.4.6 Histology and Cytology Reagents 21
3.5 Microbiology Test Reagents 21
3.5.1 Bacteriology Test Reagents 21
3.5.2 Microbiology Calibrators and Controls 22
3.5.3 Microbiology Rapid Tests 22
3.6 Infectious Immunology Test Reagents 22
3.6.1 Bacteriology 22
3.6.2 Virology 22
3.6.3 Parasitology 22
3.6.4 Infectious Immunology Calibrators and Controls 23
3.6.5 Infectious Immunology Rapid Tests 23
3.7 Genetic Test Reagents 23
3.8 Self Testing 23
3.9 Instruments 23
4 Healthcare Sector Review 24
4.1 Healthcare Expenditure 24
4.2 Healthcare Infrastructure 29
4.2.1 Healthcare Personnel Data 30
4.2.2 Healthcare Facilities Data 33
4.3 United States Healthcare Trade Statistics 35
5 Regulation System 36
5.1 Regulation System 36
5.2 Medical Equipment Approval Process 36
5.2.1 Pre-market Approval Process 37
5.2.2 Intended use and Indications for use 37
5.2.3 Predicate Device 38
5.2.4 Safe and Effective 38
5.2.5 Other Category Devices 40
5.2.6 Post-Market Approval Process 41
5.2.7 Compliance and Enforcement 41
5.2.8 Registration Fee 43
5.2.9 Approval Time 43
6 Pricing and Reimbursement 44
6.1 Government Policies 44
6.2 Private Insurance 45
6.3 Diagnosis Related Groups (DRG) 46
7 Distribution Structure 47
7.1 Distribution Structure 47
8 United States Medical Equipment Cross Market Comparison 48
9 In Vitro Diagnostics In United States 50
9.1 In Vitro Diagnostics Cross Country Comparison (2000-2012) 50
9.2 In Vitro Diagnostics, United States, Overall Revenues, 2000-2012 51
9.3 In Vitro Diagnostics, United States, Company Share (2006-2007) 57
10 Blood Test Reagents In United States 58
10.1 Blood Test Reagents Overall Revenue (2000-2012) 58
10.1.1 Haematology Test Reagents Revenue (2000-2012) 60
10.1.2 Hemostasis Test Reagents Revenue (2000-2012) 62
10.2 Blood Test Reagents Distribution Share (2006-2007) 64
10.3 Blood Test Reagents, United States, Company Share (2006-2007) 65
11 Clinical Chemistry Test Reagents In United States 66
11.1 Clinical Chemistry Test Reagents Overall Revenue (2000-2012) 66
11.2 Clinical Chemistry Test Reagents Distribution Share (2006-2007) 68
11.3 Clinical Chemistry Test Reagents, United States, Company Share (2006-2007) 69
12 Genetic Test Reagents In United States 70
12.1 Genetic Test Reagents Overall Revenue (2000-2012) 70
12.2 Genetic Test Reagents Distribution Share (2006-2007) 72
12.3 Genetic Test Reagents, United States, Company Share (2006-2007) 73
13 Immunochemistry Test Reagents In United States 74
13.1 Immunochemistry Test Reagents Overall Revenue (2000-2012) 74
13.1.1 Disease Specific Markers Revenue (2000-2012) 77
13.1.2 Disease Specific Test Reagents Revenue (2000-2012) 79
13.1.3 Drug Related Testing Reagents Revenue (2000-2012) 81
13.1.4 Hormone Related Testing Reagents Revenue (2000-2012) 83
13.2 Immunochemistry Test Reagents Distribution Share (2006-2007) 85
13.3 Immunochemistry Test Reagents, United States, Company Share (2006-2007) 86
14 Infectious Immunology Test Reagents In United States 87
14.1 Infectious Immunology Test Reagents Overall Revenue (2000-2012) 87
14.1.1 Virology Revenue (2000-2012) 90
14.2 Infectious Immunology Test Reagents Distribution Share (2006-2007) 92
14.3 Infectious Immunology Test Reagents, United States, Company Share (2006-2007) 93
15 Instruments In United States 94
15.1 Instruments Overall Revenue (2000-2012) 94
15.2 Instruments Distribution Share (2006-2007) 96
15.3 Instruments, United States, Company Share (2006-2007) 97
16 Microbiology Test Reagents In United States 98
16.1 Microbiology Test Reagents Overall Revenue (2000-2012) 98
16.1.1 Bacteriology Test Reagents Revenue (2000-2012) 99
16.2 Microbiology Test Reagents Distribution Share (2006-2007) 101
16.3 Microbiology Test Reagents, United States, Company Share (2006-2007) 102
17 Self Testing In United States 103
17.1 Self Testing Overall Revenue (2000-2012) 103
17.2 Self Testing Distribution Share (2006-2007) 105
17.3 Self Testing, United States, Company Share (2006-2007) 106
18 F. Hoffmann-La Roche Ltd. Company Profile 107
18.1 Company Overview 107
18.2 Value Chain Analysis 107
18.2.1 Manufacturing 107
18.2.2 Product Development 108
18.2.3 Sales and Marketing 109
19 Beckman Coulter, Inc. Company Profile 110
19.1 Company Overview 110
19.2 Value Chain Analysis 110
19.2.1 Manufacturing 111
19.2.2 Product Development 111
19.2.3 Sales and Marketing 111
19.3 Beckman Coulter, Inc. Pipeline Products 112
19.3.1 Beckman Coulter, Inc. Pipeline Products by Equipment Type 112
19.3.2 Beckman Coulter, Inc. Pipeline Products by Development Stage 113
19.3.3 Beckman Coulter, Inc. Pipeline Products by Therapy Area 114
19.3.4 Beckman Coulter, Inc. Pipeline Products by News Summary 114
20 Dade Behring Holdings, Inc. Company Profile 115
20.1 Company Overview 115
20.2 Dade Behring Holdings, Inc. Pipeline Products 115
20.2.1 Dade Behring Holdings, Inc. Pipeline Products by Equipment Type 115
20.2.2 Dade Behring Holdings, Inc. Pipeline Products by Development Stage 115
20.2.3 Dade Behring Holdings, Inc. Pipeline Products by Therapy Area 115
20.2.4 Dade Behring Holdings, Inc. Pipeline Products by News Summary 116
21 Abbott Laboratories Company Profile 117
21.1 Company Overview 117
21.2 Value Chain Analysis 117
21.2.1 Manufacturing 118
21.2.2 Product Development 118
21.2.3 Sales and Marketing 119
21.3 Abbott Laboratories Pipeline Products 119
21.3.1 Abbott Laboratories Pipeline Products by Equipment Type 119
21.3.2 Abbott Laboratories Pipeline Products by Development Stage 119
21.3.3 Abbott Laboratories Pipeline Products by Therapy Area 120
21.3.4 Abbott Laboratories Pipeline Products by Clinical Trials 120
21.3.5 Abbott Laboratories Pipeline Products by News Summary 120
22 Siemens Medical Solutions Company Profile 121
22.1 Company Overview 121
22.2 Value Chain Analysis 121
22.2.1 Manufacturing 122
22.2.2 Product Development 122
22.2.3 Sales and Marketing 122
22.3 Siemens Medical Solutions Pipeline Products 123
22.3.1 Siemens Medical Solutions Pipeline Products by Equipment Type 123
22.3.2 Siemens Medical Solutions Pipeline Products by Development Stage 123
22.3.3 Siemens Medical Solutions Pipeline Products by Therapy Area 124
22.3.4 Siemens Medical Solutions Pipeline Products by News Summary 124
23 Gen-Probe Incorporated Company Profile 125
23.1 Company Overview 125
23.2 Value Chain Analysis 125
23.2.1 Manufacturing 126
23.2.2 Product Development 126
23.2.3 Sales and Marketing 127
23.3 Gen-Probe Incorporated Pipeline Products 127
23.3.1 Gen-Probe Incorporated Pipeline Products by Equipment Type 127
23.3.2 Gen-Probe Incorporated Pipeline Products by Development Stage 128
23.3.3 Gen-Probe Incorporated Pipeline Products by Therapy Area 128
23.3.4 Gen-Probe Incorporated Pipeline Products by Clinical Trials 128
23.3.5 Gen-Probe Incorporated Pipeline Products by News Summary 129
24 A&G Pharmaceutical, Inc. Company Profile 130
24.1 Company Overview 130
24.2 A&G Pharmaceutical, Inc. Pipeline Products 130
24.2.1 A&G Pharmaceutical, Inc. Pipeline Products by Equipment Type 130
24.2.2 A&G Pharmaceutical, Inc. Pipeline Products by Development Stage 130
24.2.3 A&G Pharmaceutical, Inc. Pipeline Products by Therapy Area 130
24.2.4 A&G Pharmaceutical, Inc. Pipeline Products by News Summary 131
25 Applied NeuroSolutions, Inc. Company Profile 132
25.1 Company Overview 132
26 Baxter International Inc. Company Profile 133
26.1 Company Overview 133
26.2 Value Chain Analysis 133
26.2.1 Manufacturing 134
26.2.2 Product Development 134
26.2.3 Sales and Marketing 135
27 Biovest International, Inc. Company Profile 136
27.1 Company Overview 136
28 BioVision, Inc. Company Profile 137
28.1 Company Overview 137
29 Egenix, Inc. Company Profile 138
29.1 Company Overview 138
30 Express Biotech International Company Profile 139
30.1 Company Overview 139
31 Genomic Health, Inc. Company Profile 140
31.1 Company Overview 140
32 Genzyme Corporation Company Profile 141
32.1 Company Overview 141
33 Haemonetics Corporation Company Profile 142
33.1 Company Overview 142
33.2 Value Chain Analysis 142
33.2.1 Manufacturing 143
33.2.2 Product Development 143
33.2.3 Sales and Marketing 144
34 ImmTech, Inc Company Profile 146
34.1 Company Overview 146
35 ImmunoVision, Inc. Company Profile 147
35.1 Company Overview 147
36 Financial Deals Landscape 148
36.1 Acquisition 148
36.1.1 Paul Kennedy And Patrice Debregeas Acquires 72% Stakes In IVAX Diagnostics From Teva Pharmaceutical Industries 148
36.1.2 Immucor Acquires BioArray Solutions 150
36.1.3 The Elitech To Acquire Nanogen 151
36.2 Venture Financing 153
36.2.1 Molecular Biometrics Secures $12 Million In Series A Financing 153
36.2.2 BioImagene Secures $26 Million In Series D Financing 155
36.2.3 Chronix Biomedical Secures $2.27 Million In Second Round Of Financing 156
37 Recent Developments 158
37.1 Product Annoucements 158
37.1.1 Aug 18, 2008: Biotest Receives FDA Approval To Market Its Full Line of Traditional Blood Bank Reagents 158
38 APPENDIX 159
38.1 Global Markets Direct Research Methodology 159
38.2 Coverage 160
38.3 Secondary Research 160
38.4 Primary Research 161
38.5 Models 161
38.6 Forecasts 162
38.7 Expert Panels 162
38.8 Currency Conversion 163
38.9 Contact Us 164
38.10 Disclaimer 164
Executive Summary
1.1 List of Tables
Table 1: United States Healthcare Expenditure, 2003-2010 25
Table 2: United States Healthcare Expenditure by Age (per person), 2000-2003 26
Table 3: United States Healthcare Expenditure by Sex (per person), 2000-2003 26
Table 4: United States Healthcare Expenditure by Race (per person), 2000-2003 26
Table 5: United States Personal Healthcare Expenditure by Type, 2000-2004 27
Table 6: United States Personal Healthcare Expenditure by Source, 2000-2004 28
Table 7: Total Number of Doctors in the United States, 2003-2010 30
Table 8: Number of Doctors by Specialty in the United States, 2003-2010 31
Table 9: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 32
Table 10: Doctors by Region (Number per 10,000 Civilian Population), 2002-2004 (Cont.) 33
Table 11: Total Hospitals in the United States, 2000-2004 33
Table 12: Community Hospitals by Number of Beds in the United States, 2000-2004 34
Table 13: Number of Hospital Beds in the United States, 2000-2004 34
Table 14: Number of Hospital Beds by Range in the United States, 2000-2004 34
Table 15: United States Healthcare Trade Statistics, 2001-2006 35
Table 16: Medical Equipment Registration Fee in United States, 2007 43
Table 17: Medical Device Approval Time in United States, 2004 43
Table 18: United States, Medical Equipment Market Comparison 49
Table 19: In Vitro Diagnostics Cross Country Comparison (2000-2012) 50
Table 20: In Vitro Diagnostics, United States, Overall Revenues ($ mn), 2000-2012 51
Table 21: In Vitro Diagnostics Market, United States, Portfolio Analysis 52
Table 22: In Vitro Diagnostics, United States, Overall Revenues ($ mn), Historic, 2000-2007 54
Table 23: In Vitro Diagnostics, United States, Overall Revenues ($ mn), Forecast, 2007-2012 56
Table 24: In Vitro Diagnostics, United States, Company Share by Revenue ($ mn), 2006-2007 57
Table 25: Blood Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 58
Table 26: Blood Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 59
Table 27: Haematology Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 60
Table 28: Haematology Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 61
Table 29: Hemostasis Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 62
Table 30: Hemostasis Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 63
Table 31: Blood Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 64
Table 32: Blood Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 65
Table 33: Clinical Chemistry Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 66
Table 34: Clinical Chemistry Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 67
Table 35: Clinical Chemistry Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 68
Table 36: Clinical Chemistry Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 69
Table 37: Genetic Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 70
Table 38: Genetic Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 71
Table 39: Genetic Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 72
Table 40: Genetic Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 73
Table 41: Immunochemistry Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 75
Table 42: Immunochemistry Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 76
Table 43: Disease Specific Markers, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 77
Table 44: Disease Specific Markers, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 78
Table 45: Disease Specific Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 79
Table 46: Disease Specific Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 80
Table 47: Drug Related Testing Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 81
Table 48: Drug Related Testing Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 82
Table 49: Hormone Related Testing Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 83
Table 50: Hormone Related Testing Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 84
Table 51: Immunochemistry Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 85
Table 52: Immunochemistry Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 86
Table 53: Infectious Immunology Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 88
Table 54: Infectious Immunology Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 89
Table 55: Virology, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 90
Table 56: Virology, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 91
Table 57: Infectious Immunology Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 92
Table 58: Infectious Immunology Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 93
Table 59: Instruments, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 94
Table 60: Instruments, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 95
Table 61: Instruments, United States, Distribution Share by Revenue ($ mn), 2006-2007 96
Table 62: Instruments, United States, Company Share by Revenue ($ mn), 2006-2007 97
Table 63: Microbiology Test Reagents, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 98
Table 64: Microbiology Test Reagents, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 98
Table 65: Bacteriology Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Historic, 2000-2007 99
Table 66: Bacteriology Test Reagents, United States, Revenues ($ mn) by Sub-Segment, Forecast, 2007-2012 100
Table 67: Microbiology Test Reagents, United States, Distribution Share by Revenue ($ mn), 2006-2007 101
Table 68: Microbiology Test Reagents, United States, Company Share by Revenue ($ mn), 2006-2007 102
Table 69: Self Testing, United States, Revenue ($ mn) by Segment, Historic, 2000-2007 103
Table 70: Self Testing, United States, Revenue ($ mn) by Segment, Forecast, 2007-2012 104
Table 71: Self Testing, United States, Distribution Share by Revenue ($ mn), 2006-2007 105
Table 72: Self Testing, United States, Company Share by Revenue ($ mn), 2006-2007 106
Table 73: Beckman Coulter, Inc. Pipeline Products by Equipment Type 112
Table 74: Beckman Coulter, Inc. Pipeline Products By Development Stage 113
Table 75: Beckman Coulter, Inc. Pipeline Products By Therapy Area 114
Table 76: Beckman Coulter, Inc. Pipeline Products By News Summaries 114
Table 77: Dade Behring Holdings, Inc. Pipeline Products by Equipment Type 115
Table 78: Dade Behring Holdings, Inc. Pipeline Products By Development Stage 115
Table 79: Dade Behring Holdings, Inc. Pipeline Products By Therapy Area 115
Table 80: Dade Behring Holdings, Inc. Pipeline Products By News Summaries 116
Table 81: Abbott Laboratories Pipeline Products by Equipment Type 119
Table 82: Abbott Laboratories Pipeline Products By Development Stage 119
Table 83: Abbott Laboratories Pipeline Products By Therapy Area 120
Table 84: Abbott Laboratories Pipeline Products By Clinical Trials 120
Table 85: Abbott Laboratories Pipeline Products By News Summaries 120
Table 86: Siemens Medical Solutions Pipeline Products by Equipment Type 123
Table 87: Siemens Medical Solutions Pipeline Products By Development Stage 123
Table 88: Siemens Medical Solutions Pipeline Products By Therapy Area 124
Table 89: Siemens Medical Solutions Pipeline Products By News Summaries 124
Table 90: Gen-Probe Incorporated Pipeline Products by Equipment Type 127
Table 91: Gen-Probe Incorporated Pipeline Products By Development Stage 128
Table 92: Gen-Probe Incorporated Pipeline Products By Therapy Area 128
Table 93: Gen-Probe Incorporated Pipeline Products By Clinical Trials 128
Table 94: Gen-Probe Incorporated Pipeline Products By News Summaries 129
Table 95: A&G Pharmaceutical, Inc. Pipeline Products by Equipment Type 130
Table 96: A&G Pharmaceutical, Inc. Pipeline Products By Development Stage 130
Table 97: A&G Pharmaceutical, Inc. Pipeline Products By Therapy Area 130
Table 98: A&G Pharmaceutical, Inc. Pipeline Products By News Summaries 131
Table 99: Currency Conversion from USD to Local Currency at 2007 Constant Rate 163
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