Table of Contents
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 In Vitro Diagnostics 15
3.2
Clinical Chemistry Test Reagents 15
3.2.1 Laboratory Reagents 15
3.2.2
Clinical Chemistry Calibrators and Controls 15
3.2.3 Clinical Chemistry
Rapid Tests 15
3.3 Immunochemistry Test Reagents 15
3.3.1 Disease
Specific Markers 15
3.3.1.1 Tumor Markers 15
3.3.1.2 Cardiac Markers
16
3.3.2 Disease Specific Test Reagents 16
3.3.2.1 Auto-Immune Disease
16
3.3.2.2 Rheumatoid Disease 16
3.3.2.3 Anemia/ Vitamins 16
3.3.2.4 Allergy 16
3.3.3 Drug Related Testing Reagents 16
3.3.3.1
Therapeutic Drugs 16
3.3.3.2 Drug of Abuse and Toxicology 17
3.3.4
Hormone Related Testing Reagents 17
3.3.4.1 Specific Proteins 17
3.3.4.2 Fertility and Pregnancy 17
3.3.4.3 Individual/Specified hormones
17
3.3.4.4 Specific Organ Function 17
3.3.5 Immunochemistry
Calibrators and Controls 17
3.3.6 Immunochemistry Rapid Tests 17
3.4
Blood Test Reagents 17
3.4.1 Hematology Test Reagents 17
3.4.1.1
Hematology 18
3.4.1.2 Immunohaematology 18
3.4.1.3 Hematology
Calibrators and Controls 18
3.4.1.4 Immunohaematology Controls 18
3.4.2 Hemostasis Test Reagents 18
3.4.2.1 Hemostasis 18
3.4.2.2
Hemostasis Calibrators and Controls 18
3.4.2.3 Hemostasis Rapid Tests
18
3.4.3 Tissue Typing Reagents 18
3.4.4 Monoclonal Antibodies 19
3.4.5 Cytokines and Immunomodulators 19
3.4.6 Histology and Cytology
Reagents 19
3.5 Microbiology Test Reagents 19
3.5.1 Bacteriology Test
Reagents 19
3.5.1.1 Bacteriology Culture 19
3.5.1.2 Blood Culture
19
3.5.1.3 Bacteriology Identification and Susceptibility 19
3.5.2
Microbiology Calibrators and Controls 19
3.5.3 Microbiology Rapid Tests
20
3.6 Infectious Immunology Test Reagents 20
3.6.1 Bacteriology
20
3.6.2 Virology 20
3.6.2.1 Hepatitis Viruses 20
3.6.2.2
Retroviruses 20
3.6.3 Parasitology 20
3.6.4 Infectious Immunology
Calibrators and Controls 20
3.6.5 Infectious Immunology Rapid Tests 20
3.7 Genetic Test Reagents 20
3.8 Instruments 21
4 Healthcare Sector
Review 22
4.1 Healthcare Expenditure 22
4.2 Healthcare Infrastructure
24
4.2.1 Healthcare Personnel Data 25
4.2.2 Healthcare Facilities Data
26
4.3 Healthcare Policy 27
5 Regulation System 28
5.1 Medical
Equipment Approval 28
5.2 Central Drugs Authority of India (CDAI) 29
5.3 Medical Device Regulatory Authority of India (MDRAI) 29
5.4
Classification of medical devices 29
5.4.1 Registration Period 30
6
Pricing and Reimbursement 31
6.1 Pricing and Reimbursement 31
7
Distribution Structure 32
7.1 Distribution Structure 32
8 In Vitro
Diagnostics In India 33
8.1 In Vitro Diagnostics Cross Country Comparison,
Revenue ($ mn), 2000-2015 33
8.2 In Vitro Diagnostics, India, Overall
Revenue ($ mn), 2000-2015 34
8.3 In Vitro Diagnostics, India, Company
Share (2006-2007) 38
9 Blood Test Reagents In India 39
9.1 Blood Test
Reagents Overall Revenue (2000-2015) 39
9.1.1 Haematology Test Reagents
Revenue (2000-2015) 41
9.1.2 Hemostasis Test Reagents (Hemostasis) Revenue
(2000-2015) 43
9.2 Blood Test Reagents Distribution Share (2007-2008)
45
9.3 Blood Test Reagents, India, Company Share (2006-2007) 46
10
Clinical Chemistry Test Reagents In India 47
10.1 Clinical Chemistry Test
Reagents Overall Revenue (2000-2015) 47
10.2 Clinical Chemistry Test
Reagents Distribution Share (2007-2008) 49
10.3 Clinical Chemistry Test
Reagents, India, Company Share (2006-2007) 50
11 Immunochemistry Test
Reagents In India 51
11.1 Immunochemistry Test Reagents Overall Revenue
(2000-2015) 51
11.1.1 Disease Specific Markers Revenue (2000-2015) 53
11.1.2 Disease Specific Test Reagents Revenue (2000-2015) 55
11.1.3
Hormone Related Testing Reagents Revenue (2000-2015) 57
11.2
Immunochemistry Test Reagents Distribution Share (2007-2008) 59
11.3
Immunochemistry Test Reagents, India, Company Share (2006-2007) 60
12
Infectious Immunology Test Reagents In India 61
12.1 Infectious Immunology
Test Reagents Overall Revenue (2000-2015) 61
12.2 Infectious Immunology
Test Reagents Distribution Share (2007-2008) 62
12.3 Infectious Immunology
Test Reagents, India, Company Share (2006-2007) 63
13 Instruments In India
64
13.1 Instruments Overall Revenue (2000-2015) 64
13.2 Instruments
Distribution Share (2007-2008) 66
13.3 Instruments, India, Company Share
(2006-2007) 67
14 Microbiology Test Reagents In India 68
14.1
Microbiology Test Reagents Overall Revenue (2000-2015) 68
14.1.1
Bacteriology Test Reagents Revenue (2000-2015) 70
14.2 Microbiology Test
Reagents Distribution Share (2007-2008) 72
14.3 Microbiology Test
Reagents, India, Company Share (2006-2007) 73
15 Overview of Key Companies
in India In Vitro Diagnostics Market 74
15.1 Transasia Bio-Medicals Ltd.
74
15.1.1 Company Overview 74
15.2 Abbott Laboratories 75
15.2.1
Company Overview 75
15.2.2 Value Chain Analysis 76
15.2.2.1
Manufacturing 76
15.2.2.2 Product Development 76
15.2.2.3 Sales and
Marketing 78
15.3 Ortho-Clinical Diagnostics Inc. 79
15.3.1 Company
Overview 79
15.3.2 Ortho-Clinical Diagnostics Inc. Pipeline Products
79
15.3.2.1 Ortho-Clinical Diagnostics Inc. Pipeline Products By Equipment
Type 79
15.3.2.2 Ortho-Clinical Diagnostics Inc. Pipeline Products By
Development Stage 79
15.3.2.3 Ortho-Clinical Diagnostics Inc. Pipeline
Products By Therapy Area 80
15.3.2.4 Ortho-Clinical Diagnostics Inc.
Pipeline Products By News Summary 80
15.4 F. Hoffmann-La Roche Ltd. 81
15.4.1 Company Overview 81
15.4.2 Value Chain Analysis 82
15.4.2.1
Manufacturing 82
15.4.2.2 Product Development 82
15.5 Beckman Coulter,
Inc. 84
15.5.1 Company Overview 84
15.5.2 Value Chain Analysis 84
15.5.2.1 Manufacturing 85
15.5.2.2 Product Development 85
15.5.2.3
Sales and Marketing 85
15.5.3 Beckman Coulter, Inc. Pipeline Products
86
15.5.3.1 Beckman Coulter, Inc. Pipeline Products By Equipment Type
86
15.5.3.2 Beckman Coulter, Inc. Pipeline Products By Development Stage
87
15.5.3.3 Beckman Coulter, Inc. Pipeline Products By Therapy Area 87
15.5.3.4 Beckman Coulter, Inc. Pipeline Products By News Summary 88
15.6
Siemens Healthcare 89
15.6.1 Company Overview 89
15.6.2 Value Chain
Analysis 90
15.6.2.1 Manufacturing 90
15.6.2.2 Product Development
90
15.6.2.3 Sales and Marketing 91
15.7 Dade Behring Holdings, Inc.
92
15.7.1 Company Overview 92
15.8 Gen-Probe Incorporated 93
15.8.1 Company Overview 93
15.8.2 Value Chain Analysis 94
15.8.2.1
Manufacturing 94
15.8.2.2 Product Development 95
15.8.2.3 Sales and
Marketing 95
15.8.3 Gen-Probe Incorporated Pipeline Products 96
15.8.3.1 Gen-Probe Incorporated Pipeline Products By Equipment Type 96
15.8.3.2 Gen-Probe Incorporated Pipeline Products By Development Stage 96
15.8.3.3 Gen-Probe Incorporated Pipeline Products By Therapy Area 97
15.8.3.4 Gen-Probe Incorporated Pipeline Products By Clinical Trials 97
15.8.3.5 Gen-Probe Incorporated Pipeline Products By News Summary 97
15.9
Becton, Dickinson and 98
15.9.1 Company Overview 98
15.9.2 Value Chain
Analysis 99
15.9.2.1 Manufacturing 99
15.9.2.2 Product Development
99
15.9.2.3 Sales and Marketing 100
15.10 bioMerieux S.A. 101
15.10.1 Company Overview 101
15.10.2 Value Chain Analysis 102
15.10.2.1 Manufacturing 102
15.10.2.2 Product Development 103
15.10.2.3 Sales and Marketing 103
15.11 OLYMPUS CORPORATION 105
15.11.1 Company Overview 105
15.11.2 Value Chain Analysis 106
15.11.2.1 Manufacturing 106
15.11.2.2 Product Development 106
15.11.2.3 Sales and Marketing 107
15.11.3 Olympus Medical Systems Corp.
Pipeline Products 107
15.11.3.1 Olympus Medical Systems Corp. Pipeline
Products by Equipment Type 107
15.11.3.2 Olympus Medical Systems Corp.
Pipeline Products by Development Stage 108
15.11.3.3 Olympus Medical
Systems Corp. Pipeline Products by Therapy Area 108
15.11.3.4 Olympus
Medical Systems Corp. Pipeline Products by Clinical Trials 108
15.11.3.5
Olympus Medical Systems Corp. Pipeline Products by News Summary 108
15.12
Agappe Diagnostics Ltd. 109
15.12.1 Company Overview 109
15.13
Transasia Bio-Medicals Ltd. 109
15.13.1 Company Overview 109
15.14
Narang Medical Limited 109
15.14.1 Company Overview 109
15.15 Bhat
Bio-tech India (P)Ltd 110
15.15.1 Company Overview 110
15.16
Professional Biotech Pvt. Ltd. 110
15.16.1 Company Overview 110
15.17
Span Diagnostics Ltd. 110
15.17.1 Company Overview 110
15.18 Accurex
Biomedical Pvt. Ltd. 111
15.18.1 Company Overview 111
15.19 Invitro
Biotech Ltd. 111
15.19.1 Company Overview 111
15.20 Medicare Products
Inc. 111
15.20.1 Company Overview 111
15.21 RFCL Limited 112
15.21.1 Company Overview 112
16 Recent Developments 113
16.1 Strategy
and Business Planning 113
16.1.1 Feb 04, 2009: Biofield Expands Arsenal of
Non-Invasive Diagnostic Devices 113
16.2 Government and Public Interest
114
16.2.1 Mar 26, 2009: Obama US Stem Cell Policy May Benefit India
114
16.2.2 Jan 27, 2009: Diagnostics and Laboratory Tests Outsourcing To
India Hindered By Regulations 114
16.3 Product News 115
16.3.1 Apr 01,
2009: Landmark Study Shows Significant Reduction in Death Rate from Cervical
Cancer with The Digene HPV Test Compared To Other Methods Including Pap
115
16.3.2 Feb 24, 2009: Zila Launches ViziLite Plus In India 116
16.3.3 Jan 06, 2009: Xenomics Presents HPV Test Based On Proprietary
Technology At 52nd All India Congress Of Obstetrics & Gynecology 116
16.3.4 Nov 10, 2008: Diagenic Announces Launch Of First Breast Cancer
Gene-Expression Blood Test 116
16.3.5 Nov 08, 2008: World Premiere Of A
Revolutionary Breast Cancer Test 117
17 Appendix 118
17.1 Global
Markets Direct Research Methodology 118
17.2 Coverage 119
17.3
Secondary Research 119
17.4 Primary Research 120
17.5 Models 120
17.6 Forecasts 121
17.7 Expert Panel Validation 121
17.8 Currency
Conversion 122
17.9 Contact Us 123
17.10 Disclaimer 123
1.1
List of Tables
Table 1: Number of Doctors by Specialty in India, 2000-2006
25
Table 2: Wards by Specialty in India, 2000-2006 26
Table 3: In
Vitro Diagnostics Cross Country Comparison, Revenue ($ mn), 2000-2015 33
Table 4: In Vitro Diagnostics, India, Overall Revenue ($ mn), 2000-2015
34
Table 5: In Vitro Diagnostics, India, Cross-Category Analysis,
2000-2015 35
Table 6: In Vitro Diagnostics, India, Overall Revenue ($
mn), Historic, 2000-2008 36
Table 7: In Vitro Diagnostics, India,
Overall Revenue ($ mn), Forecast, 2008-2015 37
Table 8: In Vitro
Diagnostics, India, Company Share by Revenue ($ mn), 2006-2007 38
Table 9:
Blood Test Reagents, India, Revenue ($ mn) by Segment, Historic,
2000-2008 39
Table 10: Blood Test Reagents, India, Revenue ($ mn) by
Segment, Forecast, 2008-2015 40
Table 11: Haematology Test Reagents,
India, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 41
Table 12:
Haematology Test Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 42
Table 13: Hemostasis Test Reagents (Hemostasis), India,
Revenue ($ mn), Historic, 2000-2008 43
Table 14: Hemostasis Test
Reagents (Hemostasis), India, Revenue ($ mn), Forecast, 2008-2015 44
Table
15: Blood Test Reagents, India, Distribution Share by Revenue ($mn),
2007-2008 45
Table 16: Blood Test Reagents, India, Company Share by
Revenue ($ mn), 2006-2007 46
Table 17: Clinical Chemistry Test
Reagents(Laboratory Reagents), India, Revenue ($ mn), Historic, 2000-2008
47
Table 18: Clinical Chemistry Test Reagents(Laboratory Reagents),
India, Revenue ($ mn), Forecast, 2008-2015 48
Table 19: Clinical
Chemistry Test Reagents, India, Distribution Share by Revenue ($mn), 2007-2008
49
Table 20: Clinical Chemistry Test Reagents, India, Company Share
by Revenue ($ mn), 2006-2007 50
Table 21: Immunochemistry Test
Reagents, India, Revenue ($ mn) by Segment, Historic, 2000-2008 51
Table
22: Immunochemistry Test Reagents, India, Revenue ($ mn) by Segment,
Forecast, 2008-2015 52
Table 23: Disease Specific Markers, India,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 53
Table 24:
Disease Specific Markers, India, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 54
Table 25: Disease Specific Test Reagents, India, Revenue
($ mn) by Sub-Segment, Historic, 2000-2008 55
Table 26: Disease
Specific Test Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 56
Table 27: Hormone Related Testing Reagents, India,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 57
Table 28:
Hormone Related Testing Reagents, India, Revenue ($ mn) by Sub-Segment,
Forecast, 2008-2015 58
Table 29: Immunochemistry Test Reagents,
India, Distribution Share by Revenue ($mn), 2007-2008 59
Table 30:
Immunochemistry Test Reagents, India, Company Share by Revenue ($ mn),
2006-2007 60
Table 31: Infectious Immunology Test Reagents, India,
Revenue ($ mn) by Segment, Historic, 2000-2008 61
Table 32:
Infectious Immunology Test Reagents, India, Revenue ($ mn) by Segment,
Forecast, 2008-2015 61
Table 33: Infectious Immunology Test Reagents,
India, Distribution Share by Revenue ($mn), 2007-2008 62
Table 34:
Infectious Immunology Test Reagents, India, Company Share by Revenue ($ mn),
2006-2007 63
Table 35: Instruments, India, Revenue ($ mn), Historic,
2000-2008 64
Table 36: Instruments, India, Revenue ($ mn), Forecast,
2008-2015 65
Table 37: Instruments, India, Distribution Share by
Revenue ($mn), 2007-2008 66
Table 38: Instruments, India, Company
Share by Revenue ($ mn), 2006-2007 67
Table 39: Microbiology Test
Reagents, India, Revenue ($ mn) by Segment, Historic, 2000-2008 68
Table
40: Microbiology Test Reagents, India, Revenue ($ mn) by Segment,
Forecast, 2008-2015 69
Table 41: Bacteriology Test Reagents, India,
Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 70
Table 42:
Bacteriology Test Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 71
Table 43: Microbiology Test Reagents, India,
Distribution Share by Revenue ($mn), 2007-2008 72
Table 44:
Microbiology Test Reagents, India, Company Share by Revenue ($ mn), 2006-2007
73
Table 45: Ortho-Clinical Diagnostics Inc. Pipeline Products by
Equipment Type 79
Table 46: Ortho-Clinical Diagnostics Inc. Pipeline
Products By Development Stage 79
Table 47: Ortho-Clinical Diagnostics
Inc. Pipeline Products By Therapy Area 80
Table 48: Ortho-Clinical
Diagnostics Inc. Pipeline Products By News Summary 80
Table 49:
Beckman Coulter, Inc. Pipeline Products by Equipment Type 86
Table 50:
Beckman Coulter, Inc. Pipeline Products By Development Stage 87
Table 51:
Beckman Coulter, Inc. Pipeline Products By Therapy Area 87
Table 52:
Beckman Coulter, Inc. Pipeline Products By News Summary 88
Table 53:
Gen-Probe Incorporated Pipeline Products by Equipment Type 96
Table 54:
Gen-Probe Incorporated Pipeline Products By Development Stage 96
Table 55: Gen-Probe Incorporated Pipeline Products By Therapy Area 97
Table 56: Gen-Probe Incorporated Pipeline Products By Clinical Trials
97
Table 57: Gen-Probe Incorporated Pipeline Products By News Summary
97
Table 58: Olympus Medical Systems Corp. Pipeline Products by
Equipment Type 107
Table 59: Olympus Medical Systems Corp. Pipeline
Products by Development Stage 108
Table 60: Olympus Medical Systems
Corp. Pipeline Products by Therapy Area 108
Table 61: Olympus Medical
Systems Corp. Pipeline Products by Clinical Trials 108
Table 62:
Olympus Medical Systems Corp. Pipeline Products by News Summary 108
Table
63: USD to Local Currency, Average Exchange Rate 2008 122
1.2 List
of Figures
Figure 1: Total Healthcare Expenditure in India, 2000-2005
23
Figure 2: Private Expenditure on Health by Source, 2005 24
Figure
3: Proposed Medical Equipment Classification in India, 2005 30
Figure 4:
In Vitro Diagnostics Cross Country Comparison, Revenue ($ mn), 2000-2015
33
Figure 5: In Vitro Diagnostics, India, Overall Revenue ($ mn),
2000-2015 34
Figure 6: In Vitro Diagnostics, India, Cross-Category
Analysis, 2000-2015 35
Figure 7: In Vitro Diagnostics, India, Overall
Revenue ($ mn), Historic, 2000-2008 36
Figure 8: In Vitro
Diagnostics, India, Overall Revenue ($ mn), Forecast, 2008-2015 37
Figure
9: In Vitro Diagnostics, India, Company Share (%), 2007 38
Figure 10:
Blood Test Reagents, India, Revenue ($ mn) by Segment, Historic,
2000-2008 39
Figure 11: Blood Test Reagents, India, Revenue ($ mn) by
Segment, Forecast, 2008-2015 40
Figure 12: Haematology Test Reagents,
India, Revenue ($ mn) by Sub-Segment, Historic, 2000-2008 41
Figure 13:
Haematology Test Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast,
2008-2015 42
Figure 14: Hemostasis Test Reagents (Hemostasis), India,
Revenue ($ mn), Historic, 2000-2008 43
Figure 15: Hemostasis Test
Reagents (Hemostasis), India, Revenue ($ mn), Forecast, 2008-2015 44
Figure 16: Blood Test Reagents, India, Company Share (%), 2007 46
Figure 17: Clinical Chemistry Test Reagents(Laboratory Reagents), India,
Revenue ($ mn), Historic, 2000-2008 47
Figure 18: Clinical Chemistry
Test Reagents(Laboratory Reagents), India, Revenue ($ mn), Forecast, 2008-2015
48
Figure 19: Clinical Chemistry Test Reagents, India, Company Share
(%), 2007 50
Figure 20: Immunochemistry Test Reagents, India, Revenue
($ mn) by Segment, Historic, 2000-2008 51
Figure 21: Immunochemistry
Test Reagents, India, Revenue ($ mn) by Segment, Forecast, 2008-2015 52
Figure 22: Disease Specific Markers, India, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 53
Figure 23: Disease Specific
Markers, India, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 54
Figure 24: Disease Specific Test Reagents, India, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 55
Figure 25: Disease Specific Test
Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015 56
Figure 26: Hormone Related Testing Reagents, India, Revenue ($ mn) by
Sub-Segment, Historic, 2000-2008 57
Figure 27: Hormone Related
Testing Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
58
Figure 28: Immunochemistry Test Reagents, India, Company Share
(%), 2007 60
Figure 29: Infectious Immunology Test Reagents, India,
Company Share (%), 2007 63
Figure 30: Instruments, India, Revenue ($
mn), Historic, 2000-2008 64
Figure 31: Instruments, India, Revenue ($
mn), Forecast, 2008-2015 65
Figure 32: Instruments, India, Company
Share (%), 2007 67
Figure 33: Microbiology Test Reagents, India,
Revenue ($ mn) by Segment, Historic, 2000-2008 68
Figure 34:
Microbiology Test Reagents, India, Revenue ($ mn) by Segment, Forecast,
2008-2015 69
Figure 35: Bacteriology Test Reagents, India, Revenue ($
mn) by Sub-Segment, Historic, 2000-2008 70
Figure 36: Bacteriology
Test Reagents, India, Revenue ($ mn) by Sub-Segment, Forecast, 2008-2015
71
Figure 37: Microbiology Test Reagents, India, Company Share (%),
2007 73
Figure 38: Abbott Laboratories Value Chain Analysis 76
Figure 39: F. Hoffmann-La Roche Ltd Value Chain Analysis 82
Figure
40: Beckman Coulter, Inc. Value Chain Analysis 84
Figure 41:
Siemens Medical Solutions Value Chain Analysis 90
Figure 42:
Gen-Probe Incorporated Value Chain Analysis 94
Figure 43: Becton,
Dickinson and Company Value Chain Analysis 99
Figure 44: Biomerieux
Sa Value Chain Analysis 102
Figure 45: Olympus Medical Systems Corp.
Value Chain Analysis 106
Figure 46: Global Markets Direct Methodology
118
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