TABLE OF CONTENTS

1. Overview 8
1.1 Statement of Report 8
1.2 Scope of this Report 9
1.3 Methodology 9
1.4 Executive Summary 11
2. Sector Overview 15
2.1 Global Diagnostic Products Industry 15
3. High-Growth Testing Markets: Market Segment Analysis: Size, Growth and Share
20
3.1 Global High-Growth Diagnostic Testing Markets 20
3.1.1 Market Drivers in the High-Growth Diagnostics Testing Sector 22
3.1.2 Market Segments for High-Growth Testing 22
3.1.3 Key Players in the High-Growth Diagnostics Testing Segment 23
3.1.4 High-Growth Testing Sector Analysis 24
3.2 U.S. High-Growth Testing Market 25
3.2.1 Market Overview 25
3.2.2 Diagnostic Test Categories 26
3.3 European High-Growth Diagnostic Test Market 27
3.3.1 German Diagnostic Markets 29
3.3.2 U.K. Testing Diagnostic Market 31
3.3.2.1 U.K. Market Statistics 32
3.3.2.2 U.K. Competitive Analysis 36
3.3.2.3 U.K. Market Access 38
3.4 Japanese Diagnostic Testing Market 38
3.5 Chinese Diagnostic Testing Market 41
4. High-Growth Testing Individual Markets 45
4.1 Hepatitis Serologic Markers and Nucleic Acid Testing 45
4.1.1 Hepatitis B Virus (HBV) 45
4.1.2 Hepatitis C Virus (HCV) Testing 54
4.1.3 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance 61
5. Cardiac Markers 64
5.1 Market Overview 64
5.1.1 American Market 69
5.1.2 European Market 72
5.2 Acute Myocardial Infarction 74
5.3 Heart Failure (BNP) 75
5.3.1 Market Overview 75
5.3.2 Commercial Assays for BNP and NT-proBNP 77
5.3.3 Market Share 78
5.4 CRP 82
5.5 Pulmonary Embolism (D-dimer Test) 83
5.6 Key Players 84
6. Cytogenetic Testing 93
6.1 Cancer Testing 93
6.2 Prenatal Testing and Cytogenetics 95
6.2.1 Cystic Fibrosis Testing 98
6.2.1.1 CF Testing Methodology 99
6.2.1.2 CF Screening Technology Summary 101
6.3 Key Players in Segment 101
7. Fertility Testing 103
8. Clinical Laboratory Genomics 106
8.1 Introduction 106
8.2 Clinical Laboratory Genomics Testing 107
8.3 Developments in Clinical Laboratory Genomics 108
8.3.1 Nucleic Acid Amplification Techniques 108
8.3.2 Chromosome Imaging 109
8.3.3 Genomics Technologies 109
8.3.4 Proteomics Technology 110
8.3.5 Current Pharmacogenomic Tests 110
8.3.6 Future Pharmacogenomic Testing 111
9. Glucose Monitoring 113
9.1 Overview of Market Segment 117
9.2 Competitive Strategies 118
9.3 Analyses of the Current Market Conditions, Competition and Product Mix 118
9.3.1 First-Generation Monitors 119
9.3.2 Second-Generation Monitors 119
9.3.3 Third-Generation SMBG Technologies 120
9.3.4 Other Monitoring Device Advancements 123
10. Cancer Biomarker Testing 124
10.1 Segment Overview 124
10.2 The Cancer Testing Market 125
10.3 Competition 126
10.4 Individual Markets 127
10.4.1 Cancer Pathology: Testing 127
10.4.1.1 Rare Cell/Micro Metastasis Detection 127
10.4.1.2 Cancer Pathology: High-Throughput Screening 128
10.4.1.3 Competition 130
10.4.1.4 Drivers 130
10.4.2 Breast Cancer 131
10.4.2.1 CA 15-3 132
10.4.2.2 CA 27-29 132
10.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes 132
10.4.2.4 Estrogen and Progesterone Receptor (ER and PR) 134
10.4.2.5 HER-2 135
10.4.2.6 Herceptin 135
10.4.2.7 p53 135
10.4.2.8 NMP66 136
10.4.2.9 Mammastatin 136
10.4.2.10 Drivers for Breast Cancer Test Development 136
10.4.3 Ovarian Cancer 137
10.4.3.1 CA 125 II™ 137
10.4.3.2 BRCA1 and BRCA2 138
10.4.3.3 Steroid Hormone Receptors 139
10.4.3.4 Epidermal Growth Factor Receptor (EGFR) 139
10.4.3.5 Lysophospholipids 141
10.4.4 Cervical Cancer 141
10.4.5 Colon Cancer DNA Testing 142
10.5 Pharmacogenomic Cancer Testing 146
11. HPV Testing 149
11.1 Overview 149
11.2 U.S. Market 151
11.3 European Market 152
11.4 Other Markets 154
11.5 The Association of HPV and Cervical Cancer 155
11.6 Assays for HPV 156
12. Biochips for Clinical Applications 159
12.1 Roche AmpliChip 167
12.2 Amersham CodeLink 168
12.3 Breast Cancer DNA Chips 168
12.4 Osmetech eSensor 169
12.5 Affymetrix GeneChip System 3000Dx v.2 169
12.6 Caliper and Cepheid 170
12.7 Agilent Technologies 2100 Lab-on-a-Chip 170
13. HIV 171
13.1 U.S. Testing Market 171
13.2 World Testing Market 175
13.2.1 Asia 176
13.2.2 Japan 178
13.2.3 Sub-Saharan Africa 178
13.2.4 Rest of World 178
13.3 Major Players 179
14. Cellular Imaging Cytopathology and Histopathology 181
14.1 Segment Overview 181
14.2 The Market 181
14.3 Market Drivers 183
14.4 Market Restraints 183
14.5 Cytology and Histology Technology Platforms 183
14.5.1 Cytology Screening Procedures and Pap Smear Technology 184
14.5.2 Histology 189
14.5.3 Market Drivers 190
14.5.4 ISH Staining 190
14.5.5 Special-Stains Staining 191
14.6 Third-Party Reimbursement 191
14.7 Competition 191
15. Infectious Disease Testing 196
15.1 Streptococcus Testing 196
15.2 Chlamydia Testing 201
15.3 Mononucleosis 203
15.4 Gonorrhea 204
15.5 Influenza 206
15.6 Malaria 207
15.7 Tuberculosis 216
15.8 Methicillin-Resistant Staphylococcus aureus (MRSA) 223
16. High-Growth Testing Diagnostic Trends 226
16.1 Genetic Testing 226
16.2 Quality Measures 226
16.3 Moderators of Growth 226
16.3.1 Diagnostics and the Aging Population 226
16.3.2 Individualized Medicine 226
16.3.3 Genetic Testing 226
16.4 Workforce Issues 228
16.5 Reimbursement 228
16.5.1 Cardiovascular 229
16.5.2 Screening for Diabetes 230
16.5.3 CPT Test Codes and Payment Amounts 230
16.6 Rapid Near-Patient Testing in Hospitals 233
16.7 Satellite Facilities 233
16.8 Regionalization of Laboratory Care 234
16.9 Requirements for High-Growth Testing 235
16.10 Clinical Laboratory Improvement Act (CLIA) 236
17. Business Trends in the Industry 239
17.1 Sector Consolidation 239
17.2 Diagnostic Testing Growth Trends 239
17.3 Acquisition, License Agreements, Internal Development, Partnerships 240
17.4 Product Testing Depth in High-Growth Testing 245
17.5 Government Regulation 245
17.5.1 U.S. Regulations 245
17.5.1.1 Importing Medical Devices into the U.S. 247
17.5.1.2 Exporting Medical Devices from the U.S. 247
17.5.2 U.K Regulations 248
17.5.3 E.U. Regulations 249
17.5.4 Japanese Regulations 250
17.6 Increased Market Penetration in High-Growth Testing 253
18. Important Technology Trends 254
19. Company Profiles 258
19.1 Accurex Biomedical, Pvt., Ltd. 258
19.2 Adeza Biomedical Corporation (Hologic) 258
19.3 Agilent Technologies, Inc. 258
19.4 Ambri, Ltd. 259
19.5 American Bio Medica Corp. 259
19.6 Ani Biotech 261
19.7 Applied Spectral Imaging 262
19.8 Avitar, Inc. 263
19.9 Axis-Shield 264
19.10 Bayer Corporation 265
19.11 Beckman Coulter 265
19.12 Becton Dickinson 268
19.13 Biomerica 268
19.14 Bio-Rad, Inc. 269
19.15 Cozart Bioscience 270
19.16 Denka Seiken Co., Ltd. 270
19.17 diaDexus LLC 270
19.18 Enterix, Inc. (Subsidiary of Quest Diagnostics) 271
19.19 Genetix 272
19.20 Genzyme Diagnostics 272
19.21 Hologic, Inc. 274
19.22 Iatron 275
19.23 Inverness Medical Innovations 275
19.24 Jiangnan Biotech 277
19.25 Johnson & Johnson 278
19.26 Kyowa Medex Co., Ltd. 279
19.27 LifePoint, Inc. 279
19.28 LifeScan 279
19.29 Matritech 280
19.30 Medix Biochemica 281
19.31 Myriad Genetics 281
19.32 OraSure 283
19.33 Pheromone Sciences 284
19.34 Polymedco 285
19.35 Procrea 286
19.36 QIAGEN 286
19.37 Quidel 286
19.38 Roche Diagnostics 288
19.39 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 290
19.40 Shionogi & Co. 290
19.41 Siemens 290
19.42 Spectral Diagnostics, Inc. 291
19.43 Third Wave Technologies 293
20. Appendix 1: Opportunities in the Chinese Biotech Market 295
21. Appendix 2: Opportunities in the Indian Diagnostics Market 306



INDEX OF TABLES

Table 1.1: Emerging Technology Platforms Driving High-Growth Diagnostics Market
Segments 12
Table 1.2: Market Trends in the High-Growth Diagnostics Space 13
Table 2.1: U.S. Population Dynamics, 2005–2015 15
Table 2.2: World Population and Growth, 2000-2025 16
Table 2.3: Total Japanese Population and Aging Demographics Forecast 16
Table 2.4: Worldwide Market Share In Vitro Diagnostic Companies, 2007 17
Table 2.5: Worldwide In Vitro Diagnostics Market Size, 2003–2012 17
Table 2.6: U.S. In Vitro Central Lab Diagnostic Testing, 2003–2012 17
Table 2.7: Worldwide Near-Patient Diagnostic Testing, 2002–2012 17
Table 3.1: High-Growth Market Segments Overview, 2008 22
Table 3.2: U.S. High-Growth Diagnostic Testing Market Segments, 2007 26
Table 3.3: Regional Comparison of GDP, Healthcare and IVD, 2006 28
Table 3.4: German Diagnostics Products Market Sales, 2000-2008 29
Table 3.5: The German Patient Care Lab Test Market, 2002–2012 30
Table 3.6: The German Alternate Site Testing Market (POL), 2002–2012 30
Table 3.7: The German Hospital Point of Care Market, 2002–2012 30
Table 3.8: German Clinical Diagnostic Rapid Test Market Segments 31
Table 3.9: List of Diagnostics Companies in the U.K. 37
Table 3.10: Major U.K. IVD Manufacturers 37
Table 3.11: U.S. IVD Manufacturers Doing Business in the U.K. 37
Table 3.12: Other European Companies That Manufacture IVD Products in the U.K.
38
Table 3.13: Japanese In Vitro Diagnostic Testing Market, 2000-2012 39
Table 3.14: Japan’s Diagnostics Market Sales, 1997–2006 39
Table 3.15: Companies with Leading Market Share of Japanese Diagnostics, by
Segment 40
Table 3.16: Chinese Diagnostics Products Market Sales, 2000-2012 41
Table 3.17: Disease Burden in China: Urban and Rural 42
Table 4.1: Global Market for HBV Diagnostic Testing, 2000-2012 46
Table 4.2: U.S. Market for HBV Diagnostic Testing, 2000-2012 46
Table 4.3: Serological Diagnosis of Hepatitis B Virus Infections 48
Table 4.4: Lower Detection Limits of HBV DNA Assays 49
Table 4.5: Summary of Hepatitis B Test Technology 52
Table 4.6: Global Market for HCV Diagnostic Testing, 2000-2008 57
Table 4.7: U.S. Market for HCV Diagnostic Testing, 2000-2008 57
Table 4.8: Efficiency of Available HCV Screening Tests 58
Table 4.9: Recommendations for Diagnostic Testing for Hepatitis C 60
Table 4.10: Hepatitis C Statistics 60
Table 4.11: Gen-Probe Clinical Diagnostic Products Test for the Detection of HCV
62
Table 5.1: Biomarkers in Heart Failure 66
Table 5.2: Medication Chart for Cardiovascular Disease 67
Table 5.3: Acute Myocardial Infarction Facts 67
Table 5.4: Emergency Room Admissions in the U.S., 1997-2005 68
Table 5.5: Market Growth Drivers for Cardiac Markers 68
Table 5.6: Market Barriers to Growth for Cardiac Markers 68
Table 5.7: Specific Cardiac Markers 69
Table 5.8: Cardiac Markers after Onset of Myocardial Infarction 69
Table 5.9: The Cardiac Marker Market for Testing in the U.S., 2001-2010 72
Table 5.10: Market Share of Cardiac Marker Segment 72
Table 5.11: U.S. Market for Point of Care Cardiac Marker Testing, 2000-2010 75
Table 5.12: BNP Characteristics 77
Table 5.13: Global Sales of BNP Diagnostic Tests, 2000-2010 78
Table 5.14: Market Share of BNP Assays in the U.S. 78
Table 5.15: Market Share of NT-proBNP Assays in the U.S. 79
Table 5.16: Cardiovascular Risk Classification by CRP Level 83
Table 5.17: Clinical Characteristics of D-dimer 83
Table 6.1: Global Market for Cancer Cytogenetic Diagnostic Testing, 2000-2012 96
Table 6.2: U.S. Market for Cancer Cytogenetic Diagnostic Testing, 2000-2012 97
Table 6.3: Genetic Testing: Consequences and Challenges 97
Table 6.4: CF Carrier Risk by Ethnic Group 98
Table 6.5: Reasons for CF Testing 98
Table 6.6: CF Gene Detection Rates Vary by Ethnic Background 99
Table 6.7: Global Market for CF Diagnostic Testing, 2000-2010 100
Table 6.8: U.S. Market for CF Diagnostic Testing, 2000-2010 100
Table 6.9: Commercial CF Screening Products 100
Table 6.10: Emerging CF Screening Products 101
Table 7.1: The Fertility Testing Market in the U.S., 2000-2008 103
Table 9.1: U.S. Population of Diabetics by Group 113
Table 9.2: Percentage of U.S. Adults Using Diabetes Medication, by Age,
1997–2006 114
Table 9.3: Health Care Utilization by the Diabetes Patient 114
Table 9.4: The Global Population of Persons with Diabetes, 1995 and 2025 116
Table 9.5: Market for Glucose Testing in the U.S., 2001–2012 116
Table 9.6: The Worldwide Market for Glucose Testing, 2000-2012 117
Table 9.7: Major Players in Point of Care and Near-Patient Testing for OTC
Glucose Meters 117
Table 10.1: Women’s Cancer Incidence Estimates in the U.S., 2008 125
Table 10.2: Five-Year Disease-Free Survival by Stage at Diagnosis 125
Table 10.3: TPA Marker Sensitivity 134
Table 11.1: HPV Risk Factors 149
Table 11.2: HPV and Cervical Carcinoma 150
Table 11.3: Global HPV-Testing Market Size, 2003–2011 150
Table 11.4: HPV and Cervical Carcinoma Risk 151
Table 11.5: Reflex HPV Testing with Cytology 156
Table 11.6: Predictability of HPV Test by Abnormal Pap Smear Type 157
Table 11.7: Incidence of Cervical Cancer and Cytological Abnormalities 157
Table 11.8: Long-Term Trends in HPV Testing 158
Table 12.1: Biochip Revenues and Growth Rates by Application 159
Table 12.2: Total Biochip Market: Worldwide Revenue Forecasts, 2000-2010 163
Table 12.3: Total Biochip Market: U.S. Revenue Forecasts, 2000-2010 164
Table 13.1: AIDS Statistics for the U.S.: Diagnoses, Deaths and Burden,
2002–2006 171
Table 13.2: U.S. HIV Statistics, 2007 171
Table 13.3: Births of HIV Infected Babies in U.S., 2000-2009 172
Table 13.4: Rapid HIV Tests on the Market 173
Table 13.5: U.S. High-Growth Testing Market for HIV, 2001-2012 175
Table 13.6: Global HIV Statistics, 2007 176
Table 14.1: Estimated Cervical Cancer Cases/Deaths Worldwide 187
Table 14.2: Medicare Reimbursement for Cervical Pathology Procedures 191
Table 15.1: U.S. Strep Testing Market Size, 2000-2008 197
Table 15.2: Rapid Strep Tests on the Market 197
Table 15.3: U.S. Market for Rapid Point of Care Strep Tests 198
Table 15.4: The U.S. Chlamydia Testing Market, 2001-2009 201
Table 15.5: Rapid Tests for Chlamydia 201
Table 15.6: Rapid Tests for Gonorrhea 205
Table 15.7: Commercially-Available Rapid Tests for Malaria 214
Table 15.8: FIND Partners 221
Table 15.9: Global Market Potential for TB Diagnostic Testing, 2000-2010 223
Table 15.10: MRSA Diagnostics Currently on the Market 225
Table 16.1: New CPT Test Codes Introduced in 2008 232
Table 18.1: Employment of Clinical Laboratory Workers, 2006–2016 255
Table 20.1: China Biotech Reagents Market 301
Table 20.2: Biotechnology Projects Between China and the West 302
Table 21.1: Overview of Healthcare in India 309


INDEX OF FIGURES

Figure 2.1: U.S. Lab Industry Market Share, 2007 18
Figure 2.2: Major Lab Testing Segments, U.S. 19
Figure 3.1: Total Spending on Healthcare in the U.S., 2007 25
Figure 3.2: International Per Capita Spending on Healthcare, 2006 29
Figure 3.3: Japan IVD Sales by Segment, 2006 40
Figure 14.1: Worldwide Incidence Rates of Cervical Cancer Per 100,000 Females
185
Figure 15.1: Global Incidence of Malaria 208
Figure 15.2: Mode of Action of Common Malaria RDT Format 211
Figure 15.3: FIND Pipeline for TB Diagnostics 220
Figure 21.1: Indian Diagnostics Market Segments, 2007 307

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