Table of Contents
1 Table of Contents 2
1.1 List of Tables 7
1.2 List of Figures 9
2
Introduction 11
2.1 What Is This Report About? 11
3 Definitions of
Markets Covered in the Report 12
3.1 In Vitro Diagnostics Devices 12
3.2 Clinical Chemistry Test Reagents 12
3.2.1 Laboratory Reagents 12
3.2.2 Clinical Chemistry Calibrators and Controls 12
3.2.3 Clinical
Chemistry Rapid Tests 12
3.3 Immunochemistry Test Reagents 12
3.3.1
Disease Specific Markers 12
3.3.2 Disease Specific Test Reagents 13
3.3.3 Drug Related Testing Reagents 13
3.3.4 Hormone Related Testing
Reagents 14
3.3.5 Immunochemistry Calibrators and Controls 14
3.3.6
Immunochemistry Rapid Tests 14
3.4 Blood Test Reagents 14
3.4.1
Hematology Test Reagents 14
3.4.2 Hemostasis Test Reagents 15
3.4.3
Tissue Typing Reagents 15
3.4.4 Monoclonal Antibodies 16
3.4.5
Cytokines and Immunomodulators 16
3.4.6 Histology and Cytology Reagents
16
3.5 Microbiology Test Reagents 16
3.5.1 Bacteriology Test Reagents
16
3.5.2 Microbiology Calibrators and Controls 16
3.5.3 Microbiology
Rapid Tests 17
3.6 Infectious Immunology Test Reagents 17
3.6.1
Bacteriology 17
3.6.2 Virology 17
3.6.3 Parasitology 17
3.6.4
Infectious Immunology Calibrators and Controls 17
3.6.5 Infectious
Immunology Rapid Tests 17
3.7 Genetic Test Reagents 17
3.8 Self
Testing 18
3.9 Instruments 18
4 Healthcare Sector Review 19
4.1
Healthcare Expenditure 19
4.2 Healthcare Infrastructure 20
4.3
Healthcare Policy 20
5 Regulation System 21
5.1 Medical Device
Registration Protocol 21
5.1.1 Registration Documentation 21
5.1.2
Registration Procedure 22
5.1.3 Medical Device Registration Fee 23
6
Pricing and Reimbursement 24
7 Distribution Structure 25
8 In Vitro
Diagnostics In Brazil 26
8.1 In Vitro Diagnostics, Brazil, Overall Revenue
($ mn), 2000-2015 26
8.2 In Vitro Diagnostics, Brazil Company Share
(2006-2007) 32
9 Blood Test Reagents In Brazil 33
9.1 Blood Test
Reagents Overall Revenue (2000-2015) 33
9.1.1 Haematology Test Reagents
Revenue (2000-2015) 37
9.1.2 Hemostasis Test Reagents Revenue (2000-2015)
39
9.2 Blood Test Reagents Distribution Share (2007-2008) 41
9.3 Blood
Test Reagents, Brazil, Company Share (2006-2007) 42
10 Clinical Chemistry
Test Reagents In Brazil 43
10.1 Clinical Chemistry Test Reagents Overall
Revenue (2000-2015) 43
10.2 Clinical Chemistry Test Reagents Distribution
Share (2007-2008) 45
10.3 Clinical Chemistry Test Reagents, Brazil,
Company Share (2006-2007) 46
11 Genetic Test Reagents In Brazil 47
11.1 Genetic Test Reagents Overall Revenue (2000-2015) 47
11.2 Genetic
Test Reagents Distribution Share (2007-2008) 49
11.3 Genetic Test
Reagents, Brazil, Company Share (2006-2007) 50
12 Immunochemistry Test
Reagents In Brazil 51
12.1 Immunochemistry Test Reagents Overall Revenue
(2000-2015) 51
12.1.1 Disease Specific Markers Revenue (2000-2015) 55
12.1.2 Disease Specific Test Reagents 57
12.1.3 Drug Related Testing
Reagents Revenue (2000-2015) 59
12.1.4 Hormone Related Testing Reagents
Revenue (2000-2015) 61
12.2 Immunochemistry Test Reagents Distribution
Share (2007-2008) 64
12.3 Immunochemistry Test Reagents, Brazil, Company
Share (2006-2007) 65
13 Infectious Immunology Test Reagents In Brazil
66
13.1 Infectious Immunology Test Reagents Overall Revenue (2000-2015)
66
13.1.1 Virology Revenue (2000-2015) 70
13.2 Infectious Immunology
Test Reagents Distribution Share (2007-2008) 72
13.3 Infectious Immunology
Test Reagents, Brazil, Company Share (2006-2007) 73
14 Instruments In
Brazil 74
14.1 Instruments Overall Revenue (2000-2015) 74
14.2
Instruments Distribution Share (2007-2008) 76
15 Microbiology Test
Reagents In Brazil 77
15.1 Microbiology Test Reagents Overall Revenue
(2000-2015) 77
15.1.1 Bacteriology Test Reagents Revenue (2000-2015)
79
15.2 Microbiology Test Reagents Distribution Share (2007-2008) 81
15.3 Microbiology Test Reagents, Brazil, Company Share (2006-2007) 82
16
Self Testing In Brazil 83
16.1 Self Testing Overall Revenue (2000-2015)
83
16.2 Self Testing Distribution Share (2007-2008) 85
16.3 Self
Testing, Brazil, Company Share (2006-2007) 86
17 Overview of Key Companies
in Brazil In Vitro Diagnostics Market 87
17.1 F. Hoffmann-La Roche Ltd.
Company Profile 87
17.1.1 Company Overview 87
17.1.2 Value Chain
Analysis 88
17.2 Abbott Laboratories Company Profile 91
17.2.1 Company
Overview 91
17.2.2 Value Chain Analysis 92
17.2.3 Abbott Laboratories
Pipeline Products 94
17.3 Ortho-Clinical Diagnostics Inc. Company Profile
96
17.3.1 Company Overview 96
17.3.2 Ortho-Clinical Diagnostics Inc.
Pipeline Products 96
17.4 Beckman Coulter, Inc. Company Profile 98
17.4.1 Company Overview 98
17.4.2 Value Chain Analysis 98
17.4.3
Beckman Coulter, Inc. Pipeline Products 100
17.5 bioMerieux S.A. Company
Profile 102
17.5.1 Company Overview 102
17.5.2 Value Chain Analysis
103
17.6 Dade Behring Holdings, Inc. Company Profile 106
17.6.1
Company Overview 106
17.7 Digene Corporation Company Profile 106
17.7.1 Company Overview 106
17.8 Siemens Healthcare Company Profile
107
17.8.1 Company Overview 107
17.8.2 Value Chain Analysis 107
17.9 Gen-Probe Incorporated Company Profile 110
17.9.1 Company Overview
110
17.9.2 Value Chain Analysis 111
17.9.3 Gen-Probe Incorporated
Pipeline Products 113
17.10 Becton, Dickinson and Company Company Profile
116
17.10.1 Company Overview 116
17.10.2 Value Chain Analysis 116
18 Financial Deals Landscape 118
18.1 Acquisition 118
18.1.1 FIR
Capital Partners Sells Stake In Prodimol Biotecnologia To Orgenics 118
19
Appendix 119
19.1 Global Markets Direct Research Methodology 119
19.2
Coverage 120
19.3 Secondary Research 120
19.4 Primary Research 121
19.5 Models 121
19.6 Forecasts 122
19.7 Expert Panel Validation
122
19.8 Currency Conversion 123
19.9 Contact Us 124
19.10
Disclaimer 124
1.1 List of Tables
Table 1: Medical Device
Registration Fee in Brazil, 2002 23
Table 2: In Vitro Diagnostics,
Brazil, Overall Revenue ($ mn), 2000-2015 26
Table 3: In Vitro
Diagnostics, Brazil, Cross-Category Analysis, 2000-2015 27
Table 4:
In Vitro Diagnostics, Brazil, Overall Revenue ($ mn), Historic, 2000-2008
29
Table 5: In Vitro Diagnostics, Brazil, Overall Revenue ($ mn),
Forecast, 2008-2015 31
Table 6: In Vitro Diagnostics, Brazil Company
Share by Revenue ($ mn), 2006-2007 32
Table 7: Blood Test Reagents,
Brazil, Revenue ($ mn) by Segment, Historic, 2000-2008 34
Table 8:
Blood Test Reagents, Brazil, Revenue ($ mn) by Segment, Forecast, 2008-2015
36
Table 9: Haematology Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 37
Table 10: Haematology Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 38
Table 11: Hemostasis Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 39
Table 12: Hemostasis Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 40
Table 13: Blood Test Reagents, Brazil, Distribution Share by Revenue
($mn), 2007-2008 41
Table 14: Blood Test Reagents, Brazil, Company
Share by Revenue ($ mn), 2006-2007 42
Table 15: Clinical Chemistry
Test Reagents, Brazil, Revenue ($ mn) by Segment, Historic, 2000-2008 43
Table 16: Clinical Chemistry Test Reagents, Brazil, Revenue ($ mn) by
Segment, Forecast, 2008-2015 44
Table 17: Clinical Chemistry Test
Reagents, Brazil, Distribution Share by Revenue ($mn), 2007-2008 45
Table
18: Clinical Chemistry Test Reagents, Brazil, Company Share by Revenue ($
mn), 2006-2007 46
Table 19: Genetic Test Reagents, Brazil, Revenue ($
mn), Historic, 2000-2008 47
Table 20: Genetic Test Reagents, Brazil,
Revenue ($ mn), Forecast, 2008-2015 48
Table 21: Genetic Test
Reagents, Brazil, Distribution Share by Revenue ($mn), 2007-2008 49
Table
22: Genetic Test Reagents, Brazil, Company Share by Revenue ($ mn),
2006-2007 50
Table 23: Immunochemistry Test Reagents, Brazil, Revenue
($ mn) by Segment, Historic, 2000-2008 52
Table 24: Immunochemistry
Test Reagents, Brazil, Revenue ($ mn) by Segment, Forecast, 2008-2015 54
Table 25: Disease Specific Markers, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 55
Table 26: Disease Specific
Markers, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 56
Table 27: Disease Specific Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 57
Table 28: Disease Specific Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 58
Table 29: Drug Related Testing Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 59
Table 30: Drug Related Testing
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 60
Table 31: Hormone Related Testing Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 62
Table 32: Hormone Related Testing
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 63
Table 33: Immunochemistry Test Reagents, Brazil, Distribution Share by
Revenue ($mn), 2007-2008 64
Table 34: Immunochemistry Test Reagents,
Brazil, Company Share by Revenue ($ mn), 2006-2007 65
Table 35:
Infectious Immunology Test Reagents, Brazil, Revenue ($ mn) by Segment,
Historic, 2000-2008 67
Table 36: Infectious Immunology Test Reagents,
Brazil, Revenue ($ mn) by Segment, Forecast, 2008-2015 69
Table 37:
Virology, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 70
Table 38: Virology, Brazil, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 71
Table 39: Infectious Immunology Test Reagents, Brazil,
Distribution Share by Revenue ($mn), 2007-2008 72
Table 40:
Infectious Immunology Test Reagents, Brazil, Company Share by Revenue ($ mn),
2006-2007 73
Table 41: Instruments, Brazil, Revenue ($ mn), Historic,
2000-2008 74
Table 42: Instruments, Brazil, Revenue ($ mn), Forecast,
2008-2015 75
Table 43: Instruments, Brazil, Distribution Share by
Revenue ($mn), 2007-2008 76
Table 44: Microbiology Test Reagents,
Brazil, Revenue ($ mn) by Segment, Historic, 2000-2008 77
Table 45:
Microbiology Test Reagents, Brazil, Revenue ($ mn) by Segment, Forecast,
2008-2015 78
Table 46: Bacteriology Test Reagents, Brazil, Revenue ($
mn) by Sub-Segment, Historic, 2000-2008 79
Table 47: Bacteriology
Test Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
80
Table 48: Microbiology Test Reagents, Brazil, Distribution Share
by Revenue ($mn), 2007-2008 81
Table 49: Microbiology Test Reagents,
Brazil, Company Share by Revenue ($ mn), 2006-2007 82
Table 50: Self
Testing, Brazil, Revenue ($ mn), Historic, 2000-2008 83
Table 51:
Self Testing, Brazil, Revenue ($ mn), Forecast, 2008-2015 84
Table 52:
Self Testing, Brazil, Distribution Share by Revenue ($mn), 2007-2008 85
Table 53: Self Testing, Brazil, Company Share by Revenue ($ mn),
2006-2007 86
Table 54: Abbott Laboratories Pipeline Products by
Equipment Type 94
Table 55: Abbott Laboratories Pipeline Products By
Development Stage 94
Table 56: Abbott Laboratories Pipeline Products
By Therapy Area 94
Table 57: Abbott Laboratories Pipeline Products
By Clinical Trials 95
Table 58: Abbott Laboratories Pipeline
Products By News Summary 95
Table 59: Ortho-Clinical Diagnostics Inc.
Pipeline Products by Equipment Type 96
Table 60: Ortho-Clinical
Diagnostics Inc. Pipeline Products By Development Stage 96
Table 61:
Ortho-Clinical Diagnostics Inc. Pipeline Products By Therapy Area 97
Table
62: Ortho-Clinical Diagnostics Inc. Pipeline Products By News Summary
97
Table 63: Beckman Coulter, Inc. Pipeline Products by Equipment
Type 100
Table 64: Beckman Coulter, Inc. Pipeline Products By
Development Stage 100
Table 65: Beckman Coulter, Inc. Pipeline
Products By Therapy Area 101
Table 66: Beckman Coulter, Inc. Pipeline
Products By News Summary 101
Table 67: Gen-Probe Incorporated
Pipeline Products by Equipment Type 113
Table 68: Gen-Probe
Incorporated Pipeline Products By Development Stage 113
Table 69:
Gen-Probe Incorporated Pipeline Products By Therapy Area 114
Table 70:
Gen-Probe Incorporated Pipeline Products By Clinical Trials 115
Table 71:
Gen-Probe Incorporated Pipeline Products By News Summary 115
Table
72: FIR Capital Partners Sells Stake In Prodimol Biotecnologia To
Orgenics 118
Table 73: USD to Local Currency, Average Exchange Rate 2008
123
1.2 List of Figures
Figure 1: Health Expenditure by Source in
Brazil 20
Figure 2: In Vitro Diagnostics, Brazil, Overall Revenue ($
mn), 2000-2015 26
Figure 3: In Vitro Diagnostics, Brazil,
Cross-Category Analysis, 2000-2015 27
Figure 4: In Vitro Diagnostics,
Brazil, Overall Revenue ($ mn), Historic, 2000-2008 28
Figure 5: In
Vitro Diagnostics, Brazil, Overall Revenue ($ mn), Forecast, 2008-2015 30
Figure 6: In Vitro Diagnostics, Brazil Company Share (%), 2007 32
Figure 7: Blood Test Reagents, Brazil, Revenue ($ mn) by Segment,
Historic, 2000-2008 33
Figure 8: Blood Test Reagents, Brazil, Revenue
($ mn) by Segment, Forecast, 2008-2015 35
Figure 9: Haematology Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 37
Figure 10: Haematology Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 38
Figure 11: Hemostasis Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 39
Figure 12: Hemostasis Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 40
Figure 13: Blood Test Reagents,
Brazil, Company Share (%), 2007 42
Figure 14: Clinical Chemistry Test
Reagents, Brazil, Revenue ($ mn) by Segment, Historic, 2000-2008 43
Figure
15: Clinical Chemistry Test Reagents, Brazil, Revenue ($ mn) by Segment,
Forecast, 2008-2015 44
Figure 16: Clinical Chemistry Test Reagents,
Brazil, Company Share (%), 2007 46
Figure 17: Genetic Test Reagents,
Brazil, Revenue ($ mn), Historic, 2000-2008 47
Figure 18: Genetic
Test Reagents, Brazil, Revenue ($ mn), Forecast, 2008-2015 48
Figure 19:
Genetic Test Reagents, Brazil, Company Share (%), 2007 50
Figure 20:
Immunochemistry Test Reagents, Brazil, Revenue ($ mn) by Segment, Historic,
2000-2008 51
Figure 21: Immunochemistry Test Reagents, Brazil,
Revenue ($ mn) by Segment, Forecast, 2008-2015 53
Figure 22: Disease
Specific Markers, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
55
Figure 23: Disease Specific Markers, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 56
Figure 24: Disease Specific Test
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 57
Figure 25: Disease Specific Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 58
Figure 26: Drug Related Testing
Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 59
Figure 27: Drug Related Testing Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 60
Figure 28: Hormone Related
Testing Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
61
Figure 29: Hormone Related Testing Reagents, Brazil, Revenue ($
mn) by Sub-Segment, Forecast, 2008-2015 63
Figure 30: Immunochemistry
Test Reagents, Brazil, Company Share (%), 2007 65
Figure 31:
Infectious Immunology Test Reagents, Brazil, Revenue ($ mn) by Segment,
Historic, 2000-2008 66
Figure 32: Infectious Immunology Test
Reagents, Brazil, Revenue ($ mn) by Segment, Forecast, 2008-2015 68
Figure
33: Virology, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
70
Figure 34: Virology, Brazil, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 71
Figure 35: Infectious Immunology Test
Reagents, Brazil, Company Share (%), 2007 73
Figure 36: Instruments,
Brazil, Revenue ($ mn), Historic, 2000-2008 74
Figure 37:
Instruments, Brazil, Revenue ($ mn), Forecast, 2008-2015 75
Figure 38:
Microbiology Test Reagents, Brazil, Revenue ($ mn) by Segment, Historic,
2000-2008 77
Figure 39: Microbiology Test Reagents, Brazil, Revenue
($ mn) by Segment, Forecast, 2008-2015 78
Figure 40: Bacteriology
Test Reagents, Brazil, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008
79
Figure 41: Bacteriology Test Reagents, Brazil, Revenue ($ mn) by
Sub-Segment, Forecast, 2008-2015 80
Figure 42: Microbiology Test
Reagents, Brazil, Company Share (%), 2007 82
Figure 43: Self Testing,
Brazil, Revenue ($ mn), Historic, 2000-2008 83
Figure 44: Self
Testing, Brazil, Revenue ($ mn), Forecast, 2008-2015 84
Figure 45:
Self Testing, Brazil, Company Share (%), 2007 86
Figure 46: F.
Hoffmann-La Roche Ltd Value Chain Analysis 88
Figure 47: Abbott
Laboratories Value Chain Analysis 92
Figure 48: Beckman Coulter, Inc.
Value Chain Analysis 98
Figure 49: Biomerieux Sa Value Chain Analysis
103
Figure 50: Siemens Medical Solutions Value Chain Analysis 107
Figure 51: Gen-Probe Incorporated Value Chain Analysis 111
Figure 52:
Becton, Dickinson and Company Value Chain Analysis 116
Figure 53:
Global Markets Direct Methodology 119
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