Republic of Korea In Vitro Diagnostics Market Outlook to ... · 10.4 Microbiology Culture Overall Revenue, (2004-2018) 150 10.4.1 Microbiology Analyzers, Revenue (2004-2018) 154 10.5

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Republic of Korea In Vitro Diagnostics Market Outlook to 2018- Clinical Chemistry Genetic Testing, Haematology, Histology

and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture

GDME1185IDB/ Published December 2012

© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form Page 1

Republic of Korea In Vitro Diagnostics Market Outlook to 2018 - Clinical Chemistry Genetic Testing, Haematology, Histology and Cytology, Immuno Chemistry, Infectious Immunology and Microbiology Culture

Reference Code: GDME1185IDB

Publication Date: December 2012

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1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 10

1.2 List of Figures 14

2 Introduction 17

2.1 What is This Report About? 17

3 In Vitro Diagnostics In Republic of Korea 18

3.1 In Vitro Diagnostics, Market Segmentation 18

3.2 In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018 19

3.3 In Vitro Diagnostics Market, Republic of Korea, Revenue Mix ($m), 2011 21

3.4 In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011 22

3.5 In Vitro Diagnostics, Republic of Korea, Company Share (2010-2011) 29

4 Clinical Chemistry In Republic of Korea 31

4.1 Clinical Chemistry, Market Segmentation 31

4.2 Clinical Chemistry Market, Republic of Korea, Revenue Mix ($m), 2011 32

4.3 Clinical Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 33

4.4 Clinical Chemistry Overall Revenue, (2004-2018) 34

4.4.1 Clinical Chemisty Analyzers, Revenue (2004-2018) 38

4.4.2 Urine Analysis, Revenue (2004-2018) 42

4.5 Clinical Chemistry Distribution Share (2010-2011) 46

4.6 Clinical Chemistry, Republic of Korea, Company Share (2010-2011) 47

5 Genetic Testing In Republic of Korea 49

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5.1 Genetic Testing, Market Segmentation 49

5.2 Genetic Testing Market, Republic of Korea, Revenue Mix ($m), 2011 50

5.3 Genetic Testing Market, Republic of Korea, Segment Contribution (%), 2011 51

5.4 Genetic Testing Overall Revenue, (2004-2018) 52

5.5 Genetic Testing Distribution Share (2010-2011) 56

5.6 Genetic Testing, Republic of Korea, Company Share (2010-2011) 57

6 Haematology In Republic of Korea 59

6.1 Haematology Market, Market Segmentation 59

6.2 Haematology Market, Republic of Korea, Revenue Mix ($m), 2011 60

6.3 Haematology Market, Republic of Korea, Segment Contribution (%), 2011 61

6.4 Haematology Overall Revenue, (2004-2018) 62

6.4.1 Haematology Reagents, Revenue (2004-2018) 66

6.4.2 Immunohaematology, Revenue (2004-2018) 70

6.4.3 Haemostasis, Revenue (2004-2018) 74

6.4.4 Haematology Rapid Tests, Revenue (2004-2018) 78

6.4.5 Haematology Cell Counters, Revenue (2004-2018) 82

6.5 Haematology Distribution Share (2010-2011) 86

6.6 Haematology, Republic of Korea, Company Share (2010-2011) 87

7 Histology And Cytology In Republic of Korea 89

7.1 Histology and Cytology Market, Market Segmentation 89

7.2 Histology And Cytology Market, Republic of Korea, Revenue Mix ($m), 2011 90

7.3 Histology And Cytology Market, Republic of Korea, Segment Contribution (%), 2011 91

7.4 Histology And Cytology Overall Revenue, (2004-2018) 92

7.5 Histology And Cytology Distribution Share (2010-2011) 96

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7.6 Histology And Cytology, Republic of Korea, Company Share (2010-2011) 97

8 Immuno Chemistry In Republic of Korea 99

8.1 Immuno Chemistry Market, Republic of Korea, Revenue Mix ($m), 2011 99

8.2 Immuno Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 100

8.3 Immuno Chemistry Overall Revenue, (2004-2018) 102

8.3.1 Disease Specific Immunochemistry, Revenue (2004-2018) 106

8.3.2 Drugs of Abuse / Toxicology, Revenue (2004-2018) 110

8.3.3 Endocrinology Tests, Revenue (2004-2018) 114

8.3.4 Immunochemistry Rapid Tests, Revenue (2004-2018) 118

8.3.5 Therapeutic Drug Monitoring, Revenue (2004-2018) 122

8.3.6 Immunochemistry Analyzers, Revenue (2004-2018) 126

8.4 Immuno Chemistry Distribution Share (2010-2011) 130

8.5 Immuno Chemistry, Republic of Korea, Company Share (2010-2011) 131

9 Infectious Immunology In Republic of Korea 133

9.1 Infectious Immunology, Market Segmentation 133

9.2 Infectious Immunology Market, Republic of Korea, Revenue Mix ($m), 2011 134

9.3 Infectious Immunology Market, Republic of Korea, Segment Contribution (%), 2011 135

9.4 Infectious Immunology Overall Revenue, (2004-2018) 136

9.4.1 Infectious Immunology Rapid Tests, Revenue (2004-2018) 140

9.5 Infectious Immunology Distribution Share (2010-2011) 144

9.6 Infectious Immunology, Republic of Korea, Company Share (2010-2011) 145

10 Microbiology Culture In Republic of Korea 147

10.1 Microbiology Culture, Market Segmentation 147

10.2 Microbiology Culture Market, Republic of Korea, Revenue Mix ($m), 2011 148

10.3 Microbiology Culture Market, Republic of Korea, Segment Contribution (%), 2011 149

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10.4 Microbiology Culture Overall Revenue, (2004-2018) 150

10.4.1 Microbiology Analyzers, Revenue (2004-2018) 154

10.5 Microbiology Culture Distribution Share (2010-2011) 158

10.6 Microbiology Culture, Republic of Korea, Company Share (2010-2011) 159

11 Overview of Key Companies in Republic of Korea In Vitro Diagnostics Market

161

11.1 F. Hoffmann-La Roche Ltd. 161

11.1.1 Company Overview 161

11.1.2 Share in the Republic of Korea In Vitro Diagnostics Market 161

11.2 Abbott Laboratories 162



11.3 Siemens Healthcare 163



11.4 Beckman Coulter, Inc. 164



11.5 Sysmex Corporation 165



11.6 Alere Inc. 166



11.7 bioMerieux S.A. 167


11.8 Ortho-Clinical Diagnostics Inc. 167


11.9 Bio-Rad Laboratories, Inc. 168


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11.10 Hitachi Medical Corporation 168


11.11 Becton, Dickinson and Company 169


11.12 Toshiba Medical Systems Corporation 169


11.13 DiaSorin S.p.A 170


11.14 Qiagen N.V. 170


11.15 PerkinElmer, Inc. 171


11.16 Danaher Corporation 171


11.17 Mindray Medical International Limited 172


11.18 Thermo Fisher Scientific Inc. 172


11.19 Gen-Probe Incorporated 173


11.20 Nihon Kohden Corporation 173


11.21 Horiba, Ltd. 174


11.22 Life Technologies Corporation 174


11.23 Phadia AB 175


12 In Vitro Diagnostics Market Pipeline Products 176

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12.1 Clinical Chemisty Market Pipeline Products 176

12.2 Immuno Chemistry Market Pipeline Products 179

12.3 Haematology Market Pipeline Products 190

12.4 Infectious Immunology Market Pipeline Products 192

12.5 Microbiology Culture Market Pipeline Products 199

12.6 Histology And Cytology Market Pipeline Products 200

12.7 Genetic Testing Market Pipeline Products 201

13 Financial Deals Landscape 206

13.1 Acquisition 206

13.1.1 Shanghai Fosun Pharma Acquires 17.65% Stake In SD Biosensor, In Vitro Diagnostics Company 206

13.2 Partnerships 207

13.2.1 bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology 207

13.2.2 Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes Particle Metrology System 209

13.2.3 Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ 210

13.2.4 BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays 211

13.2.5 CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions 212

13.2.6 Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test 214

13.2.7 Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology 216

13.2.8 CML HealthCare Enters Into Agreement With MaRS Innovation 217

13.2.9 Akrivis Technologies Enters Into Co-Development Agreement With United States Biological 218

13.2.10 Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test 219

13.2.11 Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products 220

13.2.12 GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina 221

13.2.13 Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test 222

13.2.14 Agilent Enters Into Co-Development Agreement With Gachon University For Biomarkers 223

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13.2.15 SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor 224

13.2.16 Sysmex Asia Pacific Enters Into Distribution Agreement With DiaSys Diagnostic Systems 225

13.2.17 Immuno-Biological Labs Enters Into Licensing Agreement With IBL International 226

13.2.18 MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test 227

13.2.19 NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus 228

13.2.20 Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis 230

13.2.21 Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test 232

13.2.22 One Lambda Enters Into Co-Marketing Agreement With CellTrend 233

13.2.23 Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK Cancer Biomarker 234

13.2.24 Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems 235

13.2.25 Seegene Enters Into Co-Development Agreement With DuPont Nutrition & Health To Develop Multiplexed Assays For Food Safety Testing 236

13.2.26 Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker 237

13.2.27 Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell Technology 238

13.2.28 Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA 239

13.2.29 Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR Kit 240

13.2.30 Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo 241

13.2.31 Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure Cycling Technology 242

13.2.32 LipoScience Enters Into Licensing Agreement With Cleveland Clinic 244

13.2.33 GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron And PET Tracer System 245

13.2.34 NexDx Enters Into Licensing Agreement With University of California For Epigenetic Biomarkers 246

13.2.35 Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX 247

14 Appendix 248

14.1 Definitions of Markets Covered in the Report 249

14.1.1 In Vitro Diagnostics 249

14.2 Research Methodology 260

14.3 Secondary Research 260

14.4 Primary Research 261

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14.5 Models 261

14.6 Forecasts 262

14.7 Expert Panels 262

14.8 GlobalData Consulting 262

14.9 Currency Conversion 262

14.10 Disclaimer 262

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1.1 List of Tables

Table 1: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018 ............................. 20

Table 2: In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011 .............................................. 22

Table 3: In Vitro Diagnostics Market, Republic of Korea, Cross-Category Analysis, 2004-2018 ...................................... 24

Table 4: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, Historic, 2004-2011 .............. 26

Table 5: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 ........... 28

Table 6: In Vitro Diagnostics, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 ........ 30

Table 7: Clinical Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 ................................................. 33

Table 8: Clinical Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ....... 35

Table 9: Clinical Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ..... 37

Table 10: Clinical Chemisty Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 39

Table 11: Clinical Chemisty Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 41

Table 12: Urine Analysis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ... 43

Table 13: Urine Analysis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 . 45

Table 14: Clinical Chemistry, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ..... 46

Table 15: Clinical Chemistry, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 ........ 48

Table 16: Genetic Testing Market, Republic of Korea, Segment Contribution (%), 2011 ................................................... 51

Table 17: Genetic Testing, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ......... 53

Table 18: Genetic Testing, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ....... 55

Table 19: Genetic Testing, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ......... 56

Table 20: Genetic Testing, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 ............ 58

Table 21: Haematology Market, Republic of Korea, Segment Contribution (%), 2011 ....................................................... 61

Table 22: Haematology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .............. 63

Table 23: Haematology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ........... 65

Table 24: Haematology Reagents, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............................................................................................................................................................................................. 67

Table 25: Haematology Reagents, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 69

Table 26: Immunohaematology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............................................................................................................................................................................................. 71

Table 27: Immunohaematology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................................................. 73

Table 28: Haemostasis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ...... 75

Table 29: Haemostasis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018.... 77

Table 30: Haematology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 79

Table 31: Haematology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 81

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Table 32: Haematology Cell Counters, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 83

Table 33: Haematology Cell Counters, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 85

Table 34: Haematology, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ............. 86

Table 35: Haematology, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 ................ 88

Table 36: Histology And Cytology Market, Republic of Korea, Segment Contribution (%), 2011 ..................................... 91

Table 37: Histology And Cytology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ...................................................................................................................................................................................................... 93

Table 38: Histology And Cytology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............................................................................................................................................................................................. 95

Table 39: Histology And Cytology, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 ...................................................................................................................................................................................................... 96

Table 40: Histology And Cytology, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 ...................................................................................................................................................................................................... 98

Table 41: Immuno Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 ........................................... 101

Table 42: Immuno Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .. 103

Table 43: Immuno Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 105

Table 44: Disease Specific Immunochemistry, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 107

Table 45: Disease Specific Immunochemistry, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 109

Table 46: Drugs of Abuse / Toxicology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 111

Table 47: Drugs of Abuse / Toxicology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 113

Table 48: Endocrinology Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................... 115

Table 49: Endocrinology Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................... 117

Table 50: Immunochemistry Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 119

Table 51: Immunochemistry Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 121

Table 52: Therapeutic Drug Monitoring, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 123

Table 53: Therapeutic Drug Monitoring, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 125

Table 54: Immunochemistry Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 127

Table 55: Immunochemistry Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 129

Table 56: Immuno Chemistry, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 . 130

Table 57: Immuno Chemistry, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 .... 132

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Table 58: Infectious Immunology Market, Republic of Korea, Segment Contribution (%), 2011 ..................................... 135

Table 59: Infectious Immunology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................................................................................................................................................................................................... 137

Table 60: Infectious Immunology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ........................................................................................................................................................................................... 139

Table 61: Infectious Immunology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 141

Table 62: Infectious Immunology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 143

Table 63: Infectious Immunology, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 .................................................................................................................................................................................................... 144

Table 64: Infectious Immunology, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 .................................................................................................................................................................................................... 146

Table 65: Microbiology Culture Market, Republic of Korea, Segment Contribution (%), 2011 ........................................ 149

Table 66: Microbiology Culture, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................................................................................................................................................................................................... 151

Table 67: Microbiology Culture, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .................................................................................................................................................................................................... 153

Table 68: Microbiology Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................... 155

Table 69: Microbiology Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 157

Table 70: Microbiology Culture, Republic of Korea, Distribution Share by Revenue ($m), USD Constant, 2010-2011 .................................................................................................................................................................................................... 158

Table 71: Microbiology Culture, Republic of Korea, Company Share by Revenue ($m), USD Constant, 2010-2011 . 160

Table 72: Clinical Chemisty Market Pipeline Products ........................................................................................................... 176

Table 73: Immuno Chemistry Market Pipeline Products ......................................................................................................... 179

Table 74: Haematology Market Pipeline Products .................................................................................................................. 190

Table 75: Infectious Immunology Market Pipeline Products .................................................................................................. 192

Table 76: Microbiology Culture Market Pipeline Products ...................................................................................................... 199

Table 77: Histology And Cytology Market Pipeline Products ................................................................................................. 200

Table 78: Genetic Testing Market Pipeline Products .............................................................................................................. 201

Table 79: Shanghai Fosun Pharma Acquires 17.65% Stake In SD Biosensor, In Vitro Diagnostics Company ............ 206

Table 80: bioMerieux Enters Into Licensing Agreement With Quanterix For Simoa Technology .................................... 207

Table 81: Affinity Biosensors Enters Into Distribution Agreement With Malvern Instruments For Archimedes Particle Metrology System .................................................................................................................................................................... 209

Table 82: Agenix Enters Into Licensing Agreement With Tyrian Diagnostics For DiagnostIQ ......................................... 210

Table 83: BD Diagnostic Systems Enters Into Agreement With Lab21 To Develop New Oncology Assays ................. 211

Table 84: CellaVision Enters Into Distribution Agreement With Siemens Healthcare For Digital Microscopy Hematology Solutions ............................................................................................................................................................. 212

Table 85: Med BioGene Amends Licensing Agreement With Precision Therapeutics For LungExpress Dx Test ........ 214

Table 86: Ovizio Imaging Systems Enters Into Distribution Agreement With Applikon Biotechnology ........................... 216

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Table 87: CML HealthCare Enters Into Agreement With MaRS Innovation ....................................................................... 217

Table 88: Akrivis Technologies Enters Into Co-Development Agreement With United States Biological ...................... 218

Table 89: Castle Biosciences Enters Into Licensing Agreement With Brigham and Women's Hospital For Mesothelioma Test .................................................................................................................................................................. 219

Table 90: Scienion Enters Into Co-Marketing Agreement With Maine Manufacturing For Protein Array Products ...... 220

Table 91: GeneCentric Diagnostics Enters Into Licensing Agreement With University of North Carolina ..................... 221

Table 92: Epistem Enters Into Distribution Agreement With Becton Dickinson For Mycobacterium TB Test ................ 222

Table 93: Agilent Enters Into Co-Development Agreement With Gachon University For Biomarkers ............................ 223

Table 94: SciFluor Life Sciences Enters Into Distribution Agreement With Sigma-Aldrich For PhenoFluor .................. 224

Table 95: Sysmex Asia Pacific Enters Into Distribution Agreement With DiaSys Diagnostic Systems .......................... 225

Table 96: Immuno-Biological Labs Enters Into Licensing Agreement With IBL International .......................................... 226

Table 97: MDxHealth Enters Into Licensing Agreement With Merck For MGMT Diagnostic Test .................................. 227

Table 98: NicOx Enters Into Licensing Agreement With Rapid Pathogen Screening For AdenoPlus ............................ 228

Table 99: Immunexpress Enters Into Licensing Agreement With Debiopharm And Biocartis ......................................... 230

Table 100: Omega Diagnostics Enters Into Licensing Agreement With Burnet Institute For CD4 POC Test ................ 232

Table 101: One Lambda Enters Into Co-Marketing Agreement With CellTrend ................................................................ 233

Table 102: Clarient Diagnostic Services Enters Into Licensing Agreement With Insight Genetics For ALK Cancer Biomarker .................................................................................................................................................................................. 234

Table 103: Affymetrix Enters Into Technology Integration Agreement With Leica Microsystems ................................... 235

Table 104: Seegene Enters Into Co-Development Agreement With DuPont Nutrition & Health To Develop Multiplexed Assays For Food Safety Testing ............................................................................................................................................ 236

Table 105: Ventana Medical Enters Into Licensing Agreement With Gen-Probe For IP Of ERG Marker ...................... 237

Table 106: Affymetrix Enters Into Distribution Agreement With ScreenCell For Circulating Tumor Cell Technology .. 238

Table 107: Hycor Biomedical Enters Into Distribution Agreement With Roche For KOVA ............................................... 239

Table 108: Genome Diagnostics Enters Into Co-Marketing Agreement With Qiagen For LongRange PCR Kit ........... 240

Table 109: Biofortuna Extends Co-Marketing Agreement With Abbott Labs For SSPGo ................................................ 241

Table 110: Pressure BioSciences Enters Into Licensing Agreement With Target Discovery For Pressure Cycling Technology ............................................................................................................................................................................... 242

Table 111: LipoScience Enters Into Licensing Agreement With Cleveland Clinic ............................................................. 244

Table 112: GE Healthcare Enters Into Co-Development Agreement With NXT2B For Compact Cyclotron And PET Tracer System .......................................................................................................................................................................... 245

Table 113: NexDx Enters Into Licensing Agreement With University of California For Epigenetic Biomarkers ............ 246

Table 114: Bio-Rad Labs Extends Distribution Agreement With Luminex For MAGPIX .................................................. 247

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1.2 List of Figures

Figure 1: In Vitro Diagnostics, Market Segmentation ............................................................................................................... 18

Figure 2: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018 ............................ 19

Figure 3: In Vitro Diagnostics Market, Republic of Korea, Revenue Mix ($m), 2011 .......................................................... 21

Figure 4: In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011 ............................................. 22

Figure 5: In Vitro Diagnostics Market, Republic of Korea, Cross-Category Analysis, 2004-2018 ..................................... 23

Figure 6: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, Historic, 2004-2011 ............ 25

Figure 7: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, Forecast, 2011-2018 .......... 27

Figure 8: In Vitro Diagnostics, Republic of Korea, Company Share (%), 2011 .................................................................... 29

Figure 9: Clinical Chemistry, Market Segmentation ................................................................................................................. 31

Figure 10: Clinical Chemistry Market, Republic of Korea, Revenue Mix ($m), 2011 ........................................................... 32

Figure 11: Clinical Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 ............................................. 33

Figure 12: Clinical Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .... 34

Figure 13: Clinical Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .. 36

Figure 14: Clinical Chemisty Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 38

Figure 15: Clinical Chemisty Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 40

Figure 16: Urine Analysis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .. 42

Figure 17: Urine Analysis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 44

Figure 18: Clinical Chemistry, Republic of Korea, Company Share (%), 2011 .................................................................... 47

Figure 19: Genetic Testing, Market Segmentation ................................................................................................................... 49

Figure 20: Genetic Testing Market, Republic of Korea, Revenue Mix ($m), 2011............................................................... 50

Figure 21: Genetic Testing Market, Republic of Korea, Segment Contribution (%), 2011 ................................................. 51

Figure 22: Genetic Testing, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ........ 52

Figure 23: Genetic Testing, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ...... 54

Figure 24: Genetic Testing, Republic of Korea, Company Share (%), 2011 ........................................................................ 57

Figure 25: Haematology Market, Market Segmentation .......................................................................................................... 59

Figure 26: Haematology Market, Republic of Korea, Revenue Mix ($m), 2011 ................................................................... 60

Figure 27: Haematology Market, Republic of Korea, Segment Contribution (%), 2011 ...................................................... 61

Figure 28: Haematology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............ 62

Figure 29: Haematology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .......... 64

Figure 30: Haematology Reagents, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 66

Figure 31: Haematology Reagents, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 68

Figure 32: Immunohaematology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ............................................................................................................................................................................................. 70

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Figure 33: Immunohaematology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................................................. 72

Figure 34: Haemostasis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .... 74

Figure 35: Haemostasis, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 .. 76

Figure 36: Haematology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 78

Figure 37: Haematology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 80

Figure 38: Haematology Cell Counters, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................... 82

Figure 39: Haematology Cell Counters, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................... 84

Figure 40: Haematology, Republic of Korea, Company Share (%), 2011 ............................................................................. 87

Figure 41: Histology and Cytology Market, Market Segmentation ......................................................................................... 89

Figure 42: Histology And Cytology Market, Republic of Korea, Revenue Mix ($m), 2011 ................................................. 90

Figure 43: Histology And Cytology Market, Republic of Korea, Segment Contribution (%), 2011 .................................... 91

Figure 44: Histology And Cytology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 ............................................................................................................................................................................................. 92

Figure 45: Histology And Cytology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ............................................................................................................................................................................................. 94

Figure 46: Histology And Cytology, Republic of Korea, Company Share (%), 2011 ........................................................... 97

Figure 47: Immuno Chemistry Market, Republic of Korea, Revenue Mix ($m), 2011 ......................................................... 99

Figure 48: Immuno Chemistry Market, Republic of Korea, Segment Contribution (%), 2011 .......................................... 100

Figure 49: Immuno Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 102

Figure 50: Immuno Chemistry, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .................................................................................................................................................................................................... 104

Figure 51: Disease Specific Immunochemistry, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 106

Figure 52: Disease Specific Immunochemistry, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 108

Figure 53: Drugs of Abuse / Toxicology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 110

Figure 54: Drugs of Abuse / Toxicology, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 112

Figure 55: Endocrinology Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................... 114

Figure 56: Endocrinology Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ........................................................................................................................................................................................... 116

Figure 57: Immunochemistry Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 118

Figure 58: Immunochemistry Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 120

Figure 59: Therapeutic Drug Monitoring, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 122

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Figure 60: Therapeutic Drug Monitoring, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 124

Figure 61: Immunochemistry Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ................................................................................................................................................................................. 126

Figure 62: Immunochemistry Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 128

Figure 63: Immuno Chemistry, Republic of Korea, Company Share (%), 2011 ................................................................. 131

Figure 64: Infectious Immunology, Market Segmentation ..................................................................................................... 133

Figure 65: Infectious Immunology Market, Republic of Korea, Revenue Mix ($m), 2011 ................................................. 134

Figure 66: Infectious Immunology Market, Republic of Korea, Segment Contribution (%), 2011 ................................... 135

Figure 67: Infectious Immunology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................................................................................................................................................................................................... 136

Figure 68: Infectious Immunology, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 ........................................................................................................................................................................................... 138

Figure 69: Infectious Immunology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 .................................................................................................................................................................. 140

Figure 70: Infectious Immunology Rapid Tests, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ............................................................................................................................................................... 142

Figure 71: Infectious Immunology, Republic of Korea, Company Share (%), 2011 .......................................................... 145

Figure 72: Microbiology Culture, Market Segmentation ......................................................................................................... 147

Figure 73: Microbiology Culture Market, Republic of Korea, Revenue Mix ($m), 2011 .................................................... 148

Figure 74: Microbiology Culture Market, Republic of Korea, Segment Contribution (%), 2011 ....................................... 149

Figure 75: Microbiology Culture, Republic of Korea, Revenue ($m) USD Constant, by Segment, Historic, 2004-2011 .................................................................................................................................................................................................... 150

Figure 76: Microbiology Culture, Republic of Korea, Revenue ($m) USD Constant, by Segment, Forecast, 2011-2018 .................................................................................................................................................................................................... 152

Figure 77: Microbiology Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Historic, 2004-2011 ........................................................................................................................................................................................... 154

Figure 78: Microbiology Analyzers, Republic of Korea, Revenue ($m) USD Constant, by Sub-Segment, Forecast, 2011-2018 ................................................................................................................................................................................. 156

Figure 79: Microbiology Culture, Republic of Korea, Company Share (%), 2011 .............................................................. 159

Figure 80: F. Hoffmann-La Roche Ltd., Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 ... 161

Figure 81: Abbott Laboratories, Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 ................ 162

Figure 82: Siemens Healthcare, Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 ............... 163

Figure 83: Beckman Coulter, Inc., Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 ............ 164

Figure 84: Sysmex Corporation, Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 ............... 165

Figure 85: Alere Inc., Company Share (%),Republic of Korea In Vitro Diagnostics Market, 2011 .................................. 166

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Introduction





2 Introduction

GlobalData‟s medical equipment market reports are the ideal guide for anyone wishing to understand the market better in terms of revenue, distribution shares and company shares.

2.1 What is This Report About?

Republic of Korea in vitro diagnostics market report provides the following information:

1. Comprehensive data related to the market revenue, company share and distribution share. 2. Global corporate-level profiles of key companies operating in the in vitro diagnostics

market in Republic of Korea, which includes a brief overview of the company. The selection of the companies is based on their operational presence in Republic of Korea. It includes key multinationals as well as key local players.

3. A list of key products under development by different companies. The selection of this list is based on the territory in which these products are being clinically investigated.

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In Vitro Diagnostics in Republic of Korea





In Vitro Diagnostics

Monoclonal

Antibodies

Genetic

Testing

Clinical

ChemistryHistology And

Cytology

Microbiology

CultureHaematology

Immuno

Chemistry

Infectious

Immunology

Clinical

Chemisty

Analyzers

Urine

Analysis

Electrolyte

Chemistry

Reagents

Metabolite

Chemistry

Reagents

Enzyme

Chemistry

Reagents

Clinical

Chemistry

Rapid Tests

& POC

Haematology

Reagents

Haemostasis

Haematology

Analyzers

Immuno

haematology

Haematology

Rapid Tests

Haematology

Cell Counters

Immunochemistry

Analyzers

Endocrinology

Tests

Organ Function

Assays

Immunochemistry

Rapid Tests

Anemia / Vitamin

Tests

Specific Proteins

Disease Specific

Immunochemistry

Microbiology

Analyzers

Blood Culture

Mycobacteria

Culture

Parasitology

Culture

Mycology

Culture

Immunological

Culture

Identification

Bacterial

Identification &

Susceptibility

Testing

Tissue

Typing

Reagents

Other

Genetic

Tests

Acquired

Gene or

Chromosome

Alterations

Inborn Gene

or

Chromosome

Alterations

Therapeutic Drug

Monitoring

Drugs of Abuse /

Toxicology

Flow

Cytometers

Retroviruses

Hepatitis

Viruses

Bacteriology

Other

Virology

Infectious

Immunology

Rapid Tests

In Vitro Diagnostics

Monoclonal

Antibodies

Genetic

Testing

Clinical

ChemistryHistology And

Cytology

Microbiology

CultureHaematology

Immuno

Chemistry

Infectious

Immunology

Clinical

Chemisty

Analyzers

Urine

Analysis

Electrolyte

Chemistry

Reagents

Metabolite

Chemistry

Reagents

Enzyme

Chemistry

Reagents

Clinical

Chemistry

Rapid Tests

& POC

Haematology

Reagents

Haemostasis

Haematology

Analyzers

Immuno

haematology

Haematology

Rapid Tests

Haematology

Cell Counters

Immunochemistry

Analyzers

Endocrinology

Tests

Organ Function

Assays

Immunochemistry

Rapid Tests

Anemia / Vitamin

Tests

Specific Proteins

Disease Specific

Immunochemistry

Microbiology

Analyzers

Blood Culture

Mycobacteria

Culture

Parasitology

Culture

Mycology

Culture

Immunological

Culture

Identification

Bacterial

Identification &

Susceptibility

Testing

Tissue

Typing

Reagents

Other

Genetic

Tests

Acquired

Gene or

Chromosome

Alterations

Inborn Gene

or

Chromosome

Alterations

Therapeutic Drug

Monitoring

Drugs of Abuse /

Toxicology

Flow

Cytometers

Retroviruses

Hepatitis

Viruses

Bacteriology

Other

Virology

Infectious

Immunology

Rapid Tests

Retroviruses

Hepatitis

Viruses

Bacteriology

Other

Virology

Infectious

Immunology

Rapid Tests

3 In Vitro Diagnostics In Republic of Korea

3.1 In Vitro Diagnostics, Market Segmentation

Figure 1: In Vitro Diagnostics, Market Segmentation

Source: GlobalData

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3.2 In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018

Figure 2: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018

Source: GlobalData

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Table 1: In Vitro Diagnostics, Republic of Korea, Overall Revenue ($m), USD Constant, 2004-2018

Category 2004 2011 2018 CAGR 04-11 CAGR 11-18 CAGR 04-18

Source: GlobalData

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3.3 In Vitro Diagnostics Market, Republic of Korea, Revenue Mix ($m), 2011

Figure 3: In Vitro Diagnostics Market, Republic of Korea, Revenue Mix ($m), 2011

Source: GlobalData

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3.4 In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011

Figure 4: In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011

Source: GlobalData

Table 2: In Vitro Diagnostics Market, Republic of Korea, Category Contribution (%), 2011

Category Revenue ($m) Contributon Revenue (%) Contributon

Source: GlobalData

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3.5 In Vitro Diagnostics, Republic of Korea, Company Share (2010-2011)

Figure 8: In Vitro Diagnostics, Republic of Korea, Company Share (%), 2011

Note: Company Share estimates are based on company reports, secondary research and primary research

Source: GlobalData

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Table 6: In Vitro Diagnostics, Republic of Korea, Company Share by Revenue ($m), USD Constant,

2010-2011

Company Name 2010 2011

Source: GlobalData

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Appendix





14 Appendix

The data and analysis within this report is driven by Medical eTrack

Medical eTrack gives you the key information to drive sales, investment and deal making activity in your business. It includes the following information:

15,000+ Market size data tables across 740 medical equipment segments and 39 countries with historic data from 2004 forecast to 2018

6,000+ Primary expert interviews conducted per annum for ensuring data and report quality

1,100+ Conferences on medical equipment covered

1,000+ Industry leading reports per annum covering growing sectors, market trends, investment opportunities and competitive landscape

600+ Analysis reports covering market and pipeline product analysis reports by indication, medical equipment trends and issue reports and investment and M&A trend reports worth over $3 Million

43,000+ Medical equipment companies profiled

1,500+ Private, emerging and technology start-up company profiles

1,500+ Medical equipment manufacturers in China and India

1,500+ Medical equipment companies in Japan

700+ Companies with revenue splits and market shares by category

1,500+ Quarterly and annual medical equipment company financials

700+ Medical equipment company SWOT‟s

9,000+ Pipeline product profiles

8,000+ Marketed product profiles

14,000+ Clinical trials

15,000+ Trial investigators

13,000+ New product patents

3,300+ Companies with products in development

17,000+ Deals in the medical equipment industry

1,100+ Surgical and diagnostic procedures by therapy area

40+ Key healthcare indicators by country

o For more information or to receive a free demo of the service visit

http://www.medicaletrack.com/contactus.aspx?RD=Demo=

http://www.medicaletrack.com/contactus.aspx?RD=Demo

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Appendix





14.1 Definitions of Markets Covered in the Report

14.1.1 In Vitro Diagnostics

In Vitro Diagnostics (IVD) include reagents, instruments and systems intended for use in the diagnosis of disease or other conditions, including the determination of the state of health, in order to treat or prevent disease. Such reagents, instruments and systems are intended for use in the collection, preparation and examination of specimens taken from the human body. The categories tracked under this market are clinical chemistry, immunochemistry, haematology, histology & cytology, infectious immunology, microbiology culture and genetic testing. In this market only values have been tracked.

14.1.1.1 Clinical Chemistry

Clinical chemistry includes reagents, test kits and devices that determine the concentration or activity of a protein, carbohydrate, lipid, electrolyte, enzyme or small molecules in easily-collected bodily fluids such as blood, serum, plasma or urine. Immuno chemical reagents are not included under this category and are tracked separately under Immuno chemistry. This category comprises of reagents for enzyme chemistry, metabolite chemistry and electrolyte chemistry. Rapid tests for all enzymes, metabolites and electrolyte analysis and instruments used for clinical chemistry diagnosis are also covered in this category.

Clinical Chemistry Rapid Tests & POC

Clinical chemistry rapid tests provide the test results immediately. These tests are used in low resource settings with the help of test strips, tablets and solutions. Clinical chemistry PoC diagnostics are used to determine the concentration or activity of blood gas, electrolytes, metabolites, enzymes, carbohydrates, proteins, lipids and small molecules. These tests are performed for the analysis of body fluids such as blood, serum, sputum, urine, feces and others. Blood glucose testing is not tracked in this segment.

Clinical Chemisty Analyzers

Clinical chemistry analyzers are instruments used to perform tests relating to enzyme chemistry, metabolite chemistry and electrolyte chemistry. Clinical chemistry analyzers can be fully automated or semi automated.

Automated Clinical Chemistry Analyzers

A fully automated clinical chemistry analyzer is connected to a software program that allows the user to feed in most test parameters. The tasks associated with performing the test like dispensing the reagents and incubation are automated and require minimum manual work.

Semi-Automated Clinical Chemistry Analyzers

A semi-automated clinical chemistry analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually.

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Appendix





Electrolyte Chemistry Reagents

Reagents used to quantify or detect electrolytes to detect bodily functions and disease states. Examples of electrolytes tracked include sodium, potassium, chloride, bicarbonate, magnesium, calcium etc from the extra cellular fluids of the body.

Enzyme Chemistry Reagents

Reagents and test kits used for quantification and detection of enzymes that act as a marker for identification and determination of disease states and bodily functions. Examples of enzymes tracked include acid phosphatase, alkaline phosphatase, creatine kinase lactate dehydrogenase etc.

Metabolite Chemistry Reagents

Reagents used for the quantification of metabolites for the assessment of bodily functions and disease states. Examples of metabolites tracked are creatinine, cholesterol, triglycerides, albumin, bilirubin etc.

Urine Analysis

Urine analysis is the analysis of urine to aid in the diagnosis of disease or to detect the presence of a specific substance.

Urine Analyzer Reagents

Urine analyzer reagents are the reagents used in urine analyzers.

Urine Analyzers

Urine analyzers are analytical laboratory equipment used in qualitative and semi-quantitative tests performed on a urine sample.

14.1.1.2 Genetic Testing

Genetic testing reagents are used for the identification of specific syndrome present in an individual and can improve the accuracy of the diagnostic tests leading to a better treatment. Reagents used to perform acquired gene or chromosome alterations, inborn gene or chromosome alterations and other genetic tests have been tracked under this category.

Acquired Gene or Chromosome Alterations

Reagents which are used in genetic tests to detect cancer causing genes/related alterations like p53, k-ras, BRCA 1+2 etc.

Inborn Gene or Chromosome Alterations

Genetic tests to detect monogenetic disorders (like Cystic Fibrosis, Haemochromatosis, Prothrombin Mutation etc), polygenetic disorders (like Asthma, Atherosclerosis, Diabetes, Hypertension, Osteoporosis, etc), chromosomal disorders (like Down's Syndrome, Edwards Syndrome etc), polymorphisms (like HLA-Typing etc).

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Appendix





Other Genetic Tests

Other genetic tests include pharmaco-genomics which include test related to cytochrome P450 (CYP 450). These tests can be by either individual tests or multiple tests which are conducted on micro-arrays.

14.1.1.3 Haematology

Haematology includes reagents, rapid tests and instruments used for determination and diagnosis of both physiological and pathological aspects of blood and its components. The category also includes immune related reagents used for analysis of blood and its components.

Haematology Analyzers

Analytical laboratory equipments which are used to perform tests related to blood and its components. These analyzers are also used to identify and determine morphology of blood and blood-forming cells such as white blood cells, lymphocytes, monocytes, neutrophils, eosinophils and basophils.

Haematology Cell Counters

These are blood counters used for complete blood count determination in routine examinations.

Differential Counters

These are instruments which are used in the measurement of the percentage of each type of white blood cell of an individual. It also detects if there are any abnormal or immature cells in an individual.

Hemoglobinometers

These are Instruments which are used for colorimetric representation of the percentage of haemoglobin in a blood sample.

Haematology Rapid Tests

These are spot tests that generate results immediately and can be done in low resource setting. These tests are performed to detect the Haemoglobin, Erythrocytes and Haematocrit etc

Erythrocytes (Ery)

Rapid test kits used for detecting the concentration of Erythrocytes in human blood are covered under Erythrocytes (Ery) rapid test kits.

Haematocrit (HCT)

Rapid test kits used for detecting the concentration of Haematocrit (HCT) in human blood are covered under Haematocrit (HCT) rapid test kits.

Haemoglobin (Hb)

Rapid test kits used for detecting the concentration of haemoglobin in human blood are covered under Haemoglobin (Hb) rapid test kits.

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Appendix





Haemostasis Rapid Tests (Home Monitoring)

These are spot tests to detect haemostasis. These include prothrombin time rapid test, D-Dimer rapid test, activated clotting time (ACT) rapid test etc

Haematology Reagents

These are reagents that are provided for substantially lysing the red blood cells in a whole blood sample prior to haematology analysis.

Haematology Analyzer Reagents

Haematology analyzer reagents are exclusively used in blood lysing techniques. These reagents generally contain tris-HCl, EDTA, EGTA, SDS, deoxycholate, tritonX, etc.

Slide Stainers

Slide stainers are reagents used in the staining of slides and smears. Reagents like crystal violet, safranin, etc have been tracked.

Haemostasis

These include test kits and reagents that are used to conduct blood coagulation related tests. Coagulation analyzers and reagents used to conduct various coagulation tests have been tracked under this segment.

Coagulation Analyzers

These are automated or semi automated laboratory equipments used in clotting assay, chromogenic assay, haemostasis profile etc.

Coagulation Factors

Reagents used in the detection of the coagulation factors are covered here. These coagulation factors such as Factor VII, VIII, IX, XII etc, are involved in the blood coagulation process.

General Coagulation Tests

Coagulation tests include INR/prothrombin time, activated partial thromboplastin time (APTT or PTT), bleeding time, plasma thrombin time etc. These tests are useful to diagnose disease condition such as Haemophilia, Uremia, Thrombocytopenia and Vitamin K deficiency.

Platelet Factors

These reagents are used to conduct tests in the determination of cytokines belonging to the chemokine family.

Special Coagulation Tests

These are reagents which are used to conduct special coagulation tests which provide quantitative determination of anticoagulant activities of heparin and thrombin formation.

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Appendix





Immunohaematology

Immuno haematology studies antigen-antibody reactions and analogous phenomena as they relate to the pathogenesis and clinical manifestations of blood disorders.

ABO Typing

These are the reagents used for detecting blood types into four categories: Type A, Type B, Type AB and Type O.

Antibody Detection

Antibody detection is done for the differential diagnosis of many different pathological conditions. These determinations of specific antibodies to bacterial and viral pathogens as well as to parasites enable the correct therapeutic measures to be taken.

Rhesus Typing

These are the tests which are used to detect Rh factor (antigen) on the surface of the red blood cells.

14.1.1.4 Histology And Cytology

These are reagent test kits and instruments used in tissue and cell typing techniques. Flow cytometers, monoclonal antibodies and tissue typing reagents have been tracked under this category.

Flow Cytometers

Flow cytometers are an electronic detection apparatus used in a technique for counting and examining microscopic particles, such as cells and chromosomes, by suspending them in a stream of fluid.

Monoclonal Antibodies

Monoclonal antibodies for cell surface antigen are antibodies from a single clone of hybridoma cells. These are used for specific target cells which identify the tissue by the cell surface antigen.

Tissue Typing Reagents

These are the reagents which are used to determine the compatibility of tissues between a prospective donor and a recipient prior to transplantation.

14.1.1.5 Immuno Chemistry

The immunochemistry category includes reagents, instruments and test kits used for the analysis of antigen-antibody interactions in any of the bodily fluids. The category includes both test kits and reagents for quantification and detection of specific proteins, hormones, drug moieties and non-infectious diseases. Reagents and kits used in the diagnosis of infectious disease are not included in this category.

Anemia / Vitamin Tests

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Appendix





Reagents used for estimation of anaemia and vitamin deficiency. These includes the reagents used for quantitative measurement of iron, ferritin, folate and vitamin B 1, 2, 6, 12, Vitamin-D

Disease Specific Immunochemistry

Disease specific immunochemistry is an assay of specific markers of a particular disease. These tests include assays of mostly antibodies released in response to a specific disease and also other disease-causing proteins.

Allergy Blood Tests

Allergy Blood test is allergen-specific IgE antibody test used to measure the amount of immunoglobulin (Ig) E antibodies to a specific allergen in the blood. A blood test tells a physician what type of antibodies your blood contains in order to provide information on what is causing your allergies. The test kits or reagents used to perform allergy blood test are covered under this sub segment.

Auto-Immune Diseases

This includes the reagents and kits used to perform tests for the diagnosis of immune system disorders and other disease states to detect auto-antibodies, which are antibodies produced against the body‟s own tissues. The tests are used for the diagnosis of certain autoimmune

disease such as Addison‟s disease, autoimmune pancreatitis, Celiac disease, Crohns Disease,

Diabetes mellitus type 1, etc. The kits in this sub-segment include anti-nuclear antibody (ANA) kits, etc.

Cardiac Markers

Cardiac marker tests function to identify blood chemicals associated with myocardial infarction and other acute coronary syndromes. The tests include assays for proteins and chemicals like Creatine Kinase-MB (CK-MB), myoglobin, homocysteine, C-Reactive Protein (CRP), troponin T (cTnT) and troponin I (cTnI), associated with heart diseases.

Rheumatoid - Inflammatory Diseases Markers

These are the reagents used to detect Rheumatoid – Inflammatory diseases markers. These markers are antigen/antibodies that detect specific antigen/antibodies produced by bone, cartilage or any other inflammatory disease activity.

Tumor markers

The reagents used in the tests that detect specific antibodies/antigen produced by the tumor itself or by the body in response to the tumor. Some commonly detected tumor markers include CA19-9, CA15-3, CA-125, AFP, etc. The tests can assay markers from samples of blood, urine or body tissue.

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Appendix





Drugs of Abuse / Toxicology

Test kits used to determine the type and approximate amount of legal and illegal drugs a person has taken are covered under Drugs of abuse/ Toxicology. Screening is most often done using a blood or urine sample. This segment includes drugs of abuse and toxicology.

Drugs of Abuse

Test kits for measurement of drugs of abuse from blood, serum or urine. These are the systems used for testing of depressants, narcotics, stimulants and hallucinogens.

Toxicology

These are test kits for measurement of toxic substances or drugs from the blood or urine sample. These are systems used for testing of drugs like Acetaminophene (Paracetamol), 5-Aminolevulinate Dehydratase, Desipramine, Hippuric Acid, Phenols, Ethanol (Alcohol), etc.

Endocrinology Tests

Reagents used for quantification and detection of endocrine hormones secreted in the human body. These include the thyroid function hormones, pregnancy hormones, individual and specified hormones.

Fertility or Pregnancy Hormones

Pregnancy test system intended for the early detection of pregnancy by the measurement of Human Chorionic Gonadotropin (HCG), a placental hormone, in plasma or urine.

Individual and Specified Hormones

Reagents used for a quantitative measurement of specific hormones for any purpose other than pregnancy and thyroidal hormones are included here. They include reagents for testing of hormones like Estrogen, Estradiol, Estriols, Adrenocorticotropic hormone, Aldosterone etc.

Thyroid Function Hormones

Reagents used for the quantification and detection of hormones secreted by the thyroid gland. Reagents used to test TSH, T3 and T4 are included in this segment.

Immunochemistry Analyzers

Immunochemistry analyzers are analytical laboratory equipments used to perform tests for specific proteins and therapeutic drugs. These analyzers are typically offered in modular increments, which can operate independently or simultaneously as a unit. Analyzers covered under this category include Chemiluminescence Analyzers, Radioimmunoassay Analyzers, Immunofluorescence Analyzers and ELISA Instruments. Analyzers used to perform chemical analysis (enzyme, electrolyte, metabolic or urine analysis are excluded and are covered under clinical chemistry.

Chemiluminescence Analyzers

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Appendix





Chemiluminescence analyzers are analytical laboratory equipments used to detect glow-based chemiluminescent reactions. These are used for the quantitative determination of bio-molecules such as hormones, antibodies to infectious diseases and other proteins in human serum and Plasma.

ELISA Instruments

ELISA Instruments are used in enzyme-linked immuno sorbent assays for the diagnostic analyses of antigens or antibodies in a solution using colorimetric signals. These instruments include micro plate readers, ELISA washers, ELISA reader, etc.

Immunofluorescence Analyzers

Immunofluorescence analyzers are analytical laboratory equipments used for the visualization of sub cellular distribution antibodies or antigens of interest. Using these analyzers the bio-molecules of interest are labelled with specific antibodies chemically conjugated with fluorescent dye.

Radioimmunoassay Analyzers

Radioimmunoassay analyzers are analytical laboratory equipments used to measure concentrations of antigens (for example, hormone levels in the blood) using radioactive substances without the need to use a bioassay.

Immunochemistry Rapid Tests

Spot test kits intended generally for rapid diagnosis with immediate results, through immuno assays. Some of the tests carried out using immunochemistry rapid test include rabies virus test, allergenic food proteins and enteric infection

Drugs of Abuse / Toxicology Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection and measurement of illegal and legal drugs a person has taken. These tests detects and measures Amphetamines, Amphetamine/Methamphetamine Specific (+Ecstasy), Barbiturates, Benzodiazepines, Cannabinoids, Cocaine, Methadone, Opiates, Phencyclidine, Tricyclic Antidepressants, etc in blood, serum and urine samples.

Fertility / Pregnancy Rapid Tests

Rapid immunodiagnostic tests intended for immediate detection of fertility / pregnancy by measurement of Follicle-stimulating hormone (FSH), Human placental lactogen (HPL), Human luteinizing hormone (LH) and Human chorionic gonadotropin (HCG) hormone in plasma, serum and urine samples.

Other Immunochemistry Rapid Tests

Immunodiagnostic tests intended for the immediate detection of Individual and Specified Hormones/Proteins, Albumin, uAlbumin, Glycosylated/Glycated Haemoglobin, Prostate-specific antigen (PSA), Bladder tumor antigen (BTA stat), C - Reactive protein, Rheumatoid / Inflammatory

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Appendix





Disease protein, Creatine Kinase, Myoglobin, Troponin, BNP / proBNP, Heart-Type Fatty Acid-Binding Protein, etc. in plasma, serum and urine samples.

Organ Function Assays

These include test systems usually carried out through blood or urine test, for evaluating the wellness of a specific organ through an assay of the organ metabolites. These include liver function tests, kidney function tests etc.

Specific Proteins

These are reagents and test kits which are used to quantify and detect protein molecules from bodily fluids. Immunoglobulins (without IgE), HAMA, Immunoelectrophoresis & ImmunoFixation Kits, Complement Components, Transport Proteins, Lipoproteins, AGP, AAT, Micro and Macro G etc. have been tracked under this segment.

Therapeutic Drug Monitoring

Therapeutic drug monitoring include reagents and test kits intended to measure different types of therapeutic drugs from samples ranging from serum/blood, urine, hair and sweat. Test kits for measurement of both proteins based and chemical based therapeutic drugs are covered. This include tests for antibiotics, anti analgesics, anti-inflammatory, antipyretic and menstrual drugs.

Antibiotic TDM / Antivirus TDM

Therapeutic drug monitoring reagents used for the measurement of antibiotics or antivirus are covered under antibiotic/antivirus TDM. Reagents used for detection of antibiotics like Gentamicin, Sisomycin, Streptomycin, Netilmycin etc are covered here.

Cardiovascular TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for cardiovascular diseases at timed intervals in order to maintain a relatively constant concentration of the medication in the bloodstream are covered under Cardiovascular TDM. Reagents used for detection of cardiovascular drugs like Digoxin, Procainamide, Propranolol, Quinidine, etc are covered here.

Central Nervous Systems TDM

Therapeutic drug monitoring reagents used for the measurement of drugs specific for central nervous system are covered under central nervous systems TDM. Reagents used for detection of central nervous systems drugs like Carbamazepine, Ethosuximide, Free Primodine, Valproic Acid etc are covered here.

Immunosuppressant TDM

Therapeutic drug monitoring reagents used for the detection of immunosuppressant concentration in human body are covered under immunosuppressant TDM. This includes reagents used for detection of Immunosuppressant like Cyclosporin, Mycophenolate, Tacrolimus, etc.

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Appendix





14.1.1.6 Infectious Immunology

This category includes reagents and test kits used for the detection or quantification of infectious agents like bacteria and viruses by using antigen-antibody (Ag – Ab) and nucleic acid tests.

Bacteriology

Reagents and test kits to detect the pathogenicity of bacteria such as chlamydia, gonococci, syphilis, helicobacter pylori, salmonella and so on.

Hepatitis Viruses

These are diagnostic test kits which are used to detect the hepatitis virus such as HAV, HBV, HCV, HbsAg and HXV.

Infectious Immunology Rapid Tests

Spot test kits intended generally for rapid diagnosis with immediate results, through immuno assays. Tests carried out using Infectious Immunology rapid test include Hepatitis Virus, Retrovirus and Other Virology Rapid Tests.

Hepatitis Viruses Rapid Tests

Immunodiagnostic tests intended for immediate detection of HBsAg, HCV Antibody and other Hepatitis Viruses.

Other Infectious Immunology Rapid Tests

Immunodiagnostic tests intended for immediate detection of Chlamydia Ag, H. pylori, Strep. A, Strep. B, Syphilis, Clost. diff. including Toxin A and B, Meningitis causitive agents, Legionella, Strep. Pneumoniae, CMV, RSV, Mononucleosis (EBV), Influenza A and/or B, VZV, Dengue, Plasmodium (Malaria), etc.

Retroviruses Rapid Tests

Immunodiagnostic rapid tests intended for immediate detection of HIV 1, HIV 1 / 2, HIV Ag/Ab Combi and other Retroviruses.

Other Virology

These are diagnostic test kits which are used to confirm the antigen/antibody of rubella, cytomegalovirus, the herpes simplex virus and the Epstein Barr Virus.

Retroviruses

These are diagnostic test kits which are used to detect the antigen/antibody of HIV1, HIV 2 and HTLV I, HTLVII.

14.1.1.7 Microbiology Culture

This category includes reagents used for the preparation of growth medium for microbial organisms. This category also includes dehydrated and prepared culture media for micro organism growth.

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Bacterial Identification & Susceptibility Testing

This includes the reagents and test kits (manual and automated) used to identify and test the sensitivity of bacteria towards an antimicrobial substance.

Blood Culture

Culture media used for the preparation of medium capable of supporting the growth of bacteria and other micro organisms. It is a culture of blood, used to identify the infection of blood stream like bacteremia, septicaemia, etc. They are generally in solid/liquid forms or only solid and liquid forms with constituents specific to the bacteria.

Immunological Culture Identification

Reagents used to test the streptococci grouping, meningitis, staphylococci and serotyping.

Microbiology Analyzers

These are analytical laboratory equipments used to perform routine and special microbiology tests. These include fully automated or semi automated microbiology analyzers.

Automated Microbiology Analyzers

A fully automated analyzer is connected to a software program that allows the user to feed in most test parameters. The tasks associated with performing the test like dispensing the reagents, incubation etc are automated and require minimum manual work.

Semi-Automated Microbiology Analyzers

A semi-automated analyzer requires an operator to perform the reagent dispensing, incubation and other tasks manually.

Mycobacteria Culture

It includes the culture media used for the preparation of medium capable of supporting the growth of mycobacterium.

Mycology Culture

It includes culture media and reagents for the preparation of culture medium that is capable of supporting the growth of fungi. These cultures are used to detect infection like dermatophyte infections, etc

Parasitology Culture

Culture media used for the preparation of medium capable of supporting the growth of blood parasites like plasmodium, pneumocystis etc.

Note: 1). Value, distribution and company shares figures reflect annual gross sales of in vitro diagnostics in local currency converted to $ at constant rate. The annual growth (year on year

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growth) and compounded annual growth rate (CAGR) in tables is rounded off to one decimal place.

2). Company share data represents market share (in revenues and as percentage to total market) of companies in market categories and geographies tracked. The data is rounded off to the nearest decimal places.

14.2 Research Methodology

GlobalData‟s dedicated research and analysis teams consists of qualified professionals with

experience in marketing, market research, consulting background in the medical devices industry and advanced statistical expertise.

GlobalData adheres to the codes of practice of the Market Research Society (www.mrs.org.uk) and the Strategic and Competitive Intelligence Professionals (www.scip.org).

All GlobalData databases are continuously updated and revised. The following research methodology is followed for all databases and reports.

14.3 Secondary Research

The research process begins with exhaustive secondary research on internal and external sources being carried out to source qualitative and quantitative information relating to each market.

The secondary research sources that are typically referred to include, but are not limited to:

Company websites, annual reports, financial reports, broker reports, investor presentations and SEC filings;

Industry trade journals, scientific journals and other technical literature;

Internal and external proprietary databases;

Relevant patent and regulatory databases;

National government documents, statistical databases and market reports;

Procedure registries; and

News articles, press releases and web-casts specific to the companies operating in the market.

http://www.mrs.org.uk/

http://www.scip.org/

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14.4 Primary Research

GlobalData conducts thousands of interviews a year with industry participants and commentators in order to validate its data and analysis. A typical research interview fulfills the following functions:

It provides first-hand information on market size, market trends, growth trends, competitive landscape and future outlook;

Helps in validating and strengthening the secondary research findings; and

Further develops the analysis team‟s expertise and market understanding.

Primary research involves e-mail interactions and telephonic interviews for each market, category, segment and sub-segment across geographies.

The participants who typically take part in such a process include, but are not limited to:

Industry participants: CEOs, VPs, marketing/product managers, market intelligence managers and national sales managers;

Hospital stores, laboratories, pharmacies, distributors and paramedics;

Outside experts: investment bankers, valuation experts, research analysts specializing in specific medical equipment markets; and

Key opinion leaders: physicians and surgeons specializing in different therapeutic areas corresponding to different kinds of medical equipment.

14.5 Models

Where no hard data is available, GlobalData uses modeling and estimates in order to produce comprehensive data sets. The following rigorous methodology is adopted:

Available hard data is cross-referenced with the following data types to produce estimates:

Demographic data on population segments;

Macro-economic indicators such as GDP, inflation rate;

Healthcare indicators such as health expenditure, physician base, healthcare infrastructure and facilities; and

Selected epidemiological and procedure statistics.

Data is then cross-checked by the expert panel. All data and assumptions related to modeling are stored and are made available to clients on request.

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14.6 Forecasts

GlobalData uses proprietary forecast models. The following four factors are utilized in the forecast models:

Historic growth rates;

Macro-indicators such as population trends and healthcare spending;

Forecast epidemiological data; and

Qualitative trend information and assumptions.

The data is then cross-checked by the expert panel.

14.7 Expert Panels

GlobalData uses a panel of experts to cross-verify its databases and forecasts.

GlobalData‟s expert panel comprises marketing managers, product specialists, international sales

managers from medical device companies; academics from research universities, KOLs from hospitals, consultants from venture capital funds and distributors/suppliers of medical equipment and supplies etc.

Historic data and forecasts are relayed to GlobalData‟s expert panel for feedback and adjusted in

accordance with their feedback.

14.8 GlobalData Consulting

We hope that the data and analysis in this brief will help you make informed and imaginative business decisions. If you have further requirements, GlobalData‟s consulting team may be able to

help you. GlobalData offers tailor-made analytical and advisory services to drive your key strategic decisions

14.9 Currency Conversion

The Currency Conversion rate is based on 2011 average rate 1 USD = 1,107.542 KRW

14.10 Disclaimer

All Rights Reserved.

No part of this publication may be reproduced, stored in a retrieval system or transmitted in any form by any means, electronic, mechanical, photocopying, recording or otherwise without the prior permission of the publisher, GlobalData.

Documents

Republic of Korea In Vitro Diagnostics Market Outlook to ... · 10.4 Microbiology Culture Overall Revenue, (2004-2018) 150 10.4.1 Microbiology Analyzers, Revenue (2004-2018) 154 10.5