TABLE OF CONTENTS
1. Overview 10
1.1 Objectives 10
1.2 Content and Scope 10
1.3 Methodology 11
1.4 Executive Summary 12
1.4.1 Glucose Monitoring 13
1.4.2 Coagulation 13
1.4.3 Rapid Cardiac Markers 14
1.4.4 Drugs of Abuse Screening 14
1.4.5 Infectious Disease Testing 15
1.4.5.1 Campylobacter 15
1.4.5.2 Chlamydia 15
1.4.5.3 Clostridium difficile 15
1.4.5.4 Cryptosporidium 15
1.4.5.5 Dengue Fever 15
1.4.5.6 Entamoeba histolytica 15
1.4.5.7 Giardia Species 15
1.4.5.8 Helicobacter pylori 15
1.4.5.9 Hepatitis Testing 16
1.4.5.10 HIV 16
1.4.5.11 Rapid Influenza Testing 16
1.4.5.12 Mononucleosis 16
1.4.5.13 Streptococcus Testing 16
1.4.6 Cholesterol Testing 16
1.4.7 Tumor Markers 16
1.4.7.1 Prostate Specific Antigen (PSA) Testing 17
2. Introduction 18
2.1 Basic Structure and Perspectives 18
2.2 Global Diagnostic Products Industry Status and Prognosis 18
2.3 Size, Structure and Growth of the Industry 19
2.3.1 Current Market Size 19
2.3.2 Market Segments 20
2.3.2.1 Clinical Chemistry 20
2.3.2.2 Immunoassays 21
2.3.2.3 Nucleic Acid Arrays 22
2.3.2.4 Coagulation Tests 23
2.3.2.5 Critical Care Testing 24
2.4 Trends and Forces Driving the Industry 24
2.4.1 Global Demographics 24
2.4.2 Healthcare Delivery and Disease Management 25
2.4.3 Technological Innovation 26
2.5 Alternate Site Diagnostic Testing 26
3. Market Analysis 30
3.1 Glucose Monitoring 30
3.1.1 Market Size 30
3.1.2 Competitive Landscape 31
3.1.2.1 LifeScan, Inc. 31
3.1.2.2 Roche Diagnostics 33
3.1.2.3 Bayer 33
3.1.2.4 Abbott Diagnostics 35
3.1.2.5 HemoCue 35
3.1.2.6 Technical Chemicals & Products 35
3.1.2.7 GDS Technology 35
3.1.2.8 LXN Corp. 35
3.1.2.9 Cholestech 35
3.1.2.10 Alternate Glucose Monitoring Products 35
3.2 Rapid Coagulation Tests 37
3.2.1 Roche Diagnostics 39
3.2.2 Avocet Medical 40
3.2.3 International Technidyne Corporation 40
3.2.4 Cardiovascular Diagnostics 41
3.2.5 Other Companies 42
3.3 Rapid Cardiac Markers 43
3.3.1 The Companies 44
3.3.1.1 Spectral Diagnostics 44
3.3.1.2 Biosite Diagnostics 44
3.3.1.3 Roche Diagnostics 45
3.3.1.4 Beckman Coulter, Inc. 46
3.3.1.5 First Medical 46
3.3.1.6 ANI Biotech 46
3.3.1.7 Chembio Diagnostics 46
3.3.1.8 Abbott Diagnostics 46
3.3.1.9 TOSOH Medics, Inc. 47
3.3.1.10 Roche Diagnostics 47
3.3.1.11 Bayer Diagnostics 47
3.3.1.12 Diagnostic Products 47
3.3.1.13 Dade Behring 48
3.3.2 BNP Testing and Congestive Heart Failure 48
3.3.2.1 Differential Diagnosis 48
3.3.2.2 Staging of Heart Failure 48
3.3.2.3 Circulating Marker of CHF 49
3.3.2.4 Commercial Assays for BNP and NT-proBNP 49
3.3.2.5 Clinical Applications of BNP 50
3.3.2.6 Correlation with NYHA Classifications 50
3.3.2.7 Correlation with LVSD 50
3.3.2.8 Prediction of Adverse Outcomes in Acute and Chronic Heart Disease 51
3.3.2.9 Selection and Monitoring of Therapy 51
3.3.2.10 Summary 52
3.4 Drugs of Abuse Screening 52
3.4.1 Major Players 57
3.4.1.1 Bayer Diagnostics 57
3.4.1.2 Biosite Diagnostics 57
3.4.1.3 Dade Behring Syva (POC Technologies) 58
3.4.1.4 Roche Diagnostics 59
3.4.1.5 BioScan Screening Systems, Inc. 60
3.4.1.6 American Bio Medica Corp. 60
3.4.1.7 Instant Diagnostics, Inc. 61
3.4.1.8 Worldwide Medical 62
3.4.1.9 STC Diagnostics 62
3.4.1.10 DynaGen, Inc. 63
3.4.1.11 Avitar Technologies 63
3.4.1.12 Princeton BioMeditech 63
3.4.1.13 Abbott Diagnostics 64
3.4.1.14 Diagnostic Products 64
3.5 Infectious Disease Testing 65
3.5.1 Campylobacter 65
3.5.2 Chlamydia 66
3.5.3 Clostridium difficile 66
3.5.4 Cryptosporidium 67
3.5.5 Dengue Fever 67
3.5.6 Entamoeba histolytica 68
3.5.7 Giardia Species 68
3.5.8 Helicobacter pylori 69
3.5.9 Hepatitis Testing 71
3.5.9.1 Overview 71
3.5.9.2 Hepatitis Serologic Markers and Nucleic Acid Testing 72
3.5.9.2.1 Hepatitis A Virus 72
3.5.9.2.2 Hepatitis B Virus 72
3.5.9.2.3 Hepatitis C Virus 75
3.5.9.2.4 Hepatitis D Virus 77
3.5.9.2.5 Hepatitis E virus 77
3.5.9.2.6 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance 78
3.5.9.3 Companies and Hepatitis Tests 78
3.5.9.3.1 Home Access Health 78
3.5.9.3.2 Orgenics 78
3.5.9.3.3 Princeton BioMeditech Corp. 78
3.5.9.3.4 Chembio Diagnostics 78
3.5.9.3.5 Abbott Diagnostics 79
3.5.9.3.6 Beckman Coulter 79
3.5.9.2.7 Roche Diagnostics 79
3.5.9.3.8 Bayer Diagnostics 80
3.5.9.3.9 Diagnostic Products Corp. 80
3.5.9.3.10 LabCorp 80
3.5.10 HIV 82
3.5.10.1 Blood Versus Oral Fluid/Urine Testing 84
3.5.10.2 Life Insurance Companies and Urine Testing 86
3.5.10.3 HIV Outside the U.S. 86
3.5.10.4 Markets Analysis 87
3.5.10.5 Calypte Biomedical Corp. 89
3.5.10.6 Orgenics 90
3.5.10.7 Princeton BioMeditech Corp. 90
3.5.10.8 Chembio Diagnostics 90
3.5.10.9 OraSure Technologies 90
3.5.10.10 Ely Labs 91
3.5.10.11 Abbott Diagnostics 91
3.5.10.12 Beckman Coulter 91
3.5.10.13 Bayer Diagnostics 92
3.5.10.14 Celera Diagnostics 92
3.5.10.15 Roche Diagnostics 92
3.5.10.16 MedMira, Inc. 93
3.5.10.17 Summary and Recent Developments 93
3.5.11 Rapid Influenza Testing 94
3.5.12 Mononucleosis 94
3.5.12.1 Quidel 95
3.5.12.2 Worldwide Medical 95
3.5.12.3 Genzyme Diagnostics 95
3.5.12.4 Wyntek Diagnostics 95
3.5.12.5 Wampole Laboratories 95
3.5.12.6 GenBio 95
3.5.12.7 Other Companies in the Market 95
3.5.13 Rubella 96
3.5.14 Salmonella 96
3.5.15 Shiga-Toxin E. coli 96
3.5.16 Staphylococcus 96
3.5.17 Streptococcus Testing 97
3.5.17.1 Quidel 97
3.5.17.2 Other Companies 98
3.5.18 TB and Lyme Disease 98
3.6 Cholesterol Testing 98
3.6.1 Consumer Market Disposable Testing (Single-Use) 99
3.6.2 Instrument/Disposable Strip (Multiple-Use Instruments) 100
3.6.3 Homocysteine 100
3.6.4 Companies in the Market 100
3.6.4.1 Cholestech 100
3.6.4.2 Lifestream Technologies 100
3.6.4.3 Actimed Laboratories 101
3.6.4.4 Drew Scientific 101
3.6.4.5 International Medical Innovations 101
3.7 Tumor Markers 102
3.7.1 Market Description 102
3.7.2 Clinical Diagnostic Serum-Based Cancer Markers 103
3.7.2.1 Beckman Coulter 104
3.7.2.2 Fujirebio, Inc. 104
3.7.2.3 Abbott Diagnostics 104
3.7.2.4 Beckman Coulter 104
3.7.2.5 Roche Diagnostics 105
3.7.3 PSA Testing 105
3.7.3.1 TOSOH Medics, Inc. 105
3.7.3.2 Bayer Diagnostics 106
3.7.3.3 Diagnostic Products 106
3.7.4 Other Markers 106
4. Business Trends 108
4.1 Industry Consolidation 108
4.2 Breadth of Product Offering 109
4.3 Government Regulation of Medical Devices 109
4.3.1 Importing/Exporting Medical Devices Into and Out of the U.S. 111
4.3.2 U.K. Regulations 112
4.3.3 EU Regulations 113
4.3.4 Japanese Regulations 115
4.4 Clinical Laboratory Improvement Act (CLIA) 115
5. Patient Management Trends 117
5.1 Trends in Patient Care and Reimbursement 117
5.1.1 A Curious System 118
5.1.2 The Case of Tumor Markers 119
5.1.3 Other Federal Policy Considerations 120
5.2 Alternate Site Testing 120
5.3 Moderators of Growth 120
5.3.1 Quality Assurance Issues 120
5.3.2 Political Control 121
5.3.3 Regulatory Requirements 121
5.3.4 Record Keeping and Data Management 121
5.3.5 Finance 121
5.3.6 Emergency Room Admissions and Trends 122
5.3.7 Attitudes of Critical Care Nurses and Physicians 122
5.4 Personnel for POC Testing 122
5.5 Locations of POC for Patient Care 123
5.6 Focused Testing 124
5.7 Satellite Facilities 124
5.8 POC Testing 124
5.9 Hospital Labs 125
5.10 Doctor’s Office Testing 126
5.11 Home Care 127
5.12 Non-traditional Collection for Sample Testing 127
6. Technology Trends 128
6.1 Sensor Systems for Diagnostic Applications 128
6.2 Glucose Measurements 129
6.2.1 Different Types of Diabetes 130
6.2.2 Public Health Impact of Diabetes 130
6.2.3 Diagnosis of Diabetes 130
6.2.4 Hypoglycemia 131
6.2.5 Glucose Test Methods 131
6.3 Cholesterol Testing 132
6.4 The New Paradigm 132
6.5 Consolidated Workstations and Modularity 133
6.6 Automation and Robotics 133
6.7 Laboratory Information Systems (LIS) 134
6.8 Biosensor Technology 134
6.8.1 Microfluidic and Biosensor Chip Technology 135
6.9 Protein Sequencing 136
6.10 DNA Sequencing 136
6.11 The Human Genome Project 137
6.12 Liquid Phase Chromatography 138
6.13 Polymerase Chain Reaction 138
6.14 Capillary Electrophoresis 139
6.15 Proteomics 139
7. Data Management Issues 141
7.1 Wireless Local Area Networks 141
7.2 Wireless Technology 141
7.3 Wireless Devices 142
7.4 Considerations 142
7.5 Hospital Costs of Information Management 143
7.6 Other Information Processing Capabilities 143
8. Competitive Assessment of High-Growth Markets 144
8.1 Glucose Monitoring 144
8.1.1 Overview of Market Segment 144
8.1.2 Competitive Strategies 145
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix 146
8.1.4 New Approaches to the Glucose Data Management Marketplace 147
8.1.5 How Each Company is Losing/Gaining Market Share 147
8.1.6 Partnering Opportunities with Complementary Third-Party Products 147
8.1.7 Adjacent Markets 148
8.2 Tumor Markers 148
8.2.1 Overview of Market Segment 148
8.2.2 Competitive Strategies 148
8.2.3 Analyses of the Current Market Conditions, Competition and Product Mix 149
8.2.4 Adjacent Markets 152
8.3 Cardiac Care 152
8.4 Infectious Disease 153
8.4.1 Overview of Market Segment 153
8.4.2 Competitive Strategies 153
8.4.3 Analyses of the Current Market Conditions, Competition and Product Mix 154
8.4.4 New Approaches to the Infectious Disease Marketplace 154
8.4.5 The Impact of Molecular Diagnostic Methods on the Diagnosis of Infectious Disease 154
8.4.6 Partnering Opportunities with Complementary Third-Party Products 155
8.4.7 Emerging Viral Infections 156
8.5 Coagulation 156
8.6 Drugs of Abuse Testing/Therapeutic Drug Monitoring 156
9. Market Trends and Forecasts 158
9.1 Home Care Analysis 158
9.2 Non-traditional Collection for POC Testing 158
9.3 New Systems for Critical Care and Near-Patient Testing 158
9.4 Utility of Near-Patient Testing in Critical Care Settings 158
9.5 Mergers of Diagnostic Companies 158
9.6 Information Management Advances 158
9.7 Test Ordering Patterns 158
9.8 Patient Satisfaction 158
9.9 Move Away from Central Laboratory 159
9.10 Healthcare Cost Controls 159
9.11 Future of POC Testing 159
9.12 Biotechnology Industry Trends 159
9.13 Pharmaceutical Industry Trends 160
9.14 Acquisition, License Agreement, Partnerships 160
10. Corporate Profiles 161
10.1 LabCorp 161
10.2 Lifescan, Inc. 162
10.3 OraSure Technologies, Inc. 162
10.3.1 OraSure Collection Device 162
10.3.2 OraQuick Rapid Test 162
10.3.3 UPT 162
10.3.4 Histofreezer 163
10.3.5 Immunoassay Tests and Reagents 163
10.4 Bayer Corp. 163
10.4.1 Background 163
10.4.2 Business Analysis 164
10.5 MediSense 166
10.6 i-STAT Corp. 166
10.7 Nova Biomedical 167
10.7.1 Introduction 167
10.7.2 Electrolyte and Blood Gas Analyzers 167
10.7.3 Business Analysis 168
10.8 Wyntek Diagnostics 169
10.9 Savyon Diagnostics 169
10.10 Spectral Diagnostics 170
10.11 Biosite Diagnostics 170
10.12 Abbott Laboratories 173
10.12.1 Background 173
10.12.2 Key Opportunities in Rapid Tests 173
10.12.3 Business Analysis 174
10.13 Wampole Laboratories 175
10.14 Beckman Coulter Diagnostics Corp. 175
10.15 Instrumentation Laboratory 176
10.16 MedMira Laboratories 176
10.17 Radiometer 177
10.17.1 Background 177
10.17.2 Instrumentation 177
10.17.3 Business Analysis 178
10.18 GenBio 178
10.19 Ely labs 178
10.20 Orgenics 179
10.21 bioMérieux Vitek, Inc. 179
10.22 ANI Biotech 179
10.23 Sybron International Corp. 180
10.24 Optical Sensors, Inc. 180
10.25 Worldwide Medical Corp. 181
10.26 International Medical Innovations (IMI) 181
10.27 Cardiovascular Diagnostics 181
10.28 Abaxis, Inc. 181
10.29 Inverness Medical Innovations 183
10.29.1 Consumer Products 183
10.29.2 Clinical Diagnostic Products 184
10.30 ChemTrak, Inc. 184
10.30.1 The AccuMeter Cassette System 184
10.30.2 The Home Test Service 185
10.30.3 Parent’s Alert Home Drug Test Service 185
10.30.4 CholesTrak Home Cholesterol Test 185
10.30.5 Sales and Marketing 185
10.30.6 Competition 186
10.31 Cholestech 187
10.31.1 Diagnostic Products 187
10.31.2 WellCheck 187
10.32 HemoCue, Inc. 188
10.33 Binax Corp. 188
10.34 Selfcare 188
10.35 Johnson & Johnson 189
10.36 Accumetrics 189
10.37 First Medical, Inc. 189
10.38 Response Biomedical Corp. 189
10.39 Compucyte Corp. 190
10.40 Caliper Technologies 190
10.41 Princeton BioMeditech 190
10.42 American Biogenics Sciences 190
10.43 New Horizons Diagnostics 191
10.44 Beacon Diagnostics 191
10.45 Saliva Diagnostics 191
10.46 Calypte Biomedical Corp. 192
10.46.1 The Calypte Urine-Based HIV-1 Screening and Supplemental Tests 192
10.46.2 The Cambridge Biotech Serum-Based HIV-1 Supplemental Test 192
10.46.3 The Sentinel Testing Service 192
10.46.4 HIV Viral Lysate Stock 193
10.47 Meridian Diagnostic 193
10.48 Quidel 195
10.49 Biomerica 195
10.50 Diagnology, Inc. 196
10.51 BioStar (Thermo Electron Corp.) 196
10.52 ActiMed Diagnostics 196
10.53 Empyrean Diagnostics 197
10.54 STC Technologies 197
10.55 Trinity Diagnostics 197
10.56 Genzyme Diagnostics 198
10.57 ImmunoScience, Inc. 198
10.58 Cygnus Therapeutic Systems 199
10.58.1 The GlucoWatch System 199
10.58.2 GlucoWatch G2 Biographer 199
10.58.3 Partnerships 200
10.59 Seradyn Clinical Diagnostics/Apogent Technologies 201
10.60 Adeza Biomedical Corp. 201
10.61 Array Medical 202
10.62 Transmedica 202
10.63 BioScan Screening Systems, Inc. 202
10.64 American Bio Medica Corp. 202
10.65 GDS Technology 203
10.66 Home Access Health Corp. 203
10.67 Pharmatech Corp. 204
10.68 Thoratec/International Technidyne Corp. 204
10.69 SpectRx, Inc. 204
10.70 Helena Laboratories 205
10.71 Technical Chemicals & Products 205
10.72 Roche Diagnostics 206
10.73 Simplex Medical Systems 208
10.74 Biex, Inc. 208
10.75 POC Technologies 208
10.76 LXN Corp. (Inverness Medical Technologies) 209
10.77 American Biogenetic Sciences, Inc. 209
10.78 Lifestream Technologies 209
10.79 PanBio Corp. 210
10.80 Phillips Medical Systems 210
10.81 Jiangnan Biotech 211
10.82 MiniMed 211
10.83 Meretek Corp. 212
10.84 Avox Systems 212
10.85 Dade Behring 212
10.86 Chongqing Sungene Pharmaceutical Co., Ltd. 213
10.87 Medical Services International, Inc. 213
10.88 Therasense, Inc. 213
10.89 PharmaNetics, Inc. 213
10.90 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech) 214
10.91 LifePoint, Inc. 214
10.92 Avitar, Inc. 214
10.93 Cozart Biosciences 215
10.94 Enterix, Inc. 215
10.95 Kyowa Medex Co., Ltd. 215
10.96 Iatron 215
10.97 Denka Seiken Co., Ltd. 215
10.98 Accurex Biomedical, Pvt., Ltd. 215
11. Corporate Directory 216
INDEX OF FIGURES
Figure 1: Serological and Clinical Course of Acute HBV Infection 73
Figure 2: Time Course of Serologic Markers in Acute Hepatitis C Infection 76
INDEX OF TABLES
Table 1: Ten Largest Diagnostic Companies Worldwide Revenues and Market Share 2000 19
Table 2: Total Clinical Diagnostics Dollar Volume by Market Segment 2000 20
Table 3: U.S. Market for Clinical Chemistry Dollar Volume by Analyte 2000
21
Table 4: Worldwide Market for Clinical Chemistry Dollar Volume by Analyte 2000
22
Table 5: Worldwide Market for Other Immunoassays Dollar Volume by Analyte 2000
22
Table 6: Worldwide Market for Nucleic Acid Assays for Infectious Disease Dollar Volume by Analyte 2000
23
Table 7: Worldwide Market for Other Nucleic Acid Arrays Dollar Volume by Analyte 2000
23
Table 8: Market for Coagulation Tests Dollar Volume by Region 2000 24
Table 9: Market for Critical Care Tests Dollar Volume by Region 2000
24
Table 10: U.S. Alternate Site Diagnostic Test Dollar Volume by Sector
26
Table 11: U.S. Clinical Diagnostic POC Testing and Rapid Test Market Segments Dollar
Volume 27
Table 12: Number of Sites by Type Doing In Vitro Diagnostic Testing in the U.S. 27
Table 13: U.S. Clinical Laboratory Testing Services Revenue and Growth Rates by Segment
28
Table 14: U.S. Doctor’s Office Test Market Revenue and Growth Rate by Segment
28
Table 15: U.S. Clinical Diagnostic Home Test Market Revenue and Growth Rates by Segments 1999
28
Table 16: U.S. In Vitro Diagnostic Testing Including Reagents, Instruments, Consumables and Controls Total Sales by Segments 1999
29
Table 17: Global Diabetic Population 1995 and 2025 30
Table 18: Worldwide POC Glucose Testing Market Dollar Volume and Growth Rate
31
Table 19: U.S. Market for POC and Near-Patient Blood Glucose Testing Market Share by Company
31
Table 20: World Market Share of POC Glucose Monitoring Marketers 31
Table 21a: Worldwide Market for Rapid Coagulation Testing Dollar Volume 2000-2008
38
Table 21b: U.S. Market for Rapid Coagulation Testing Dollar Volume 2000-2008 38
Table 21c: U.S. Market for Rapid Coagulation POC Testing Dollar Volume 1996-2007 38
Table 22: U.S. Market for POC Cardiac Marker Testing Dollar Volume and Growth Rate 1999–2007 44
Table 23: Drugs of Abuse Screening U.S. Market Size 1998-2007 53
Table 24: National Institute on Drug Abuse Screening Standards Cutoff Levels by Drug and Test Method 55
Table 25: U.S. POC Drugs of Abuse Testing Market 2001-2007 56
Table 26: Serological Diagnosis of Hepatitis B Virus Infections 74
Table 27: Lower Detection Limits of HBV DNA Assays 75
Table 28: U.S. and Global Market for HAV Diagnostic Testing 81
Table 29: U.S. and Global Market for HBV Diagnostic Testing 81
Table 30: U.S. and Global Market for HCV Diagnostic Testing 82
Table 31: Current Assays for HIV Viral Load Testing 93
Table 32: U.S. and World Markets for HIV Diagnostic Testing 94
Table 33: U.S. Cholesterol Testing Volume 2000-2007 99
Table 34: Worldwide Market for In Vitro Cancer Marker Products Dollar Volume in 1999 and 2007 102
Table 35: U.S. Market for Tumor Marker Assays Dollar Volume by Marker 1998-2002 103
Table 36: Comparison of Costs at "Moderately Complex" and "Waived" CLIA Labs 115
Table 37: CPT Codes and Reimbursement Amount for Selected Tumor Markers New York and California 119
Table 38a: POC Testing Versus Laboratory Testing Clinical Outcomes in Diabetic Ketoacidosis 121
Table 38b: POC Testing Versus Laboratory Testing Clinical Outcomes in ABG Measurements 121
Table 39: Emergency Room Admissions in the U.S. 122
Table 40: POC Testing Cost Analysis with Labor Included 123
Table 41: Cost Analysis for Glucose Testing: POCT versus Central Lab 123
Table 42: Normal Blood Glucose Values in Fasting State and Two Hours Postprandially 131
Table 43: Applications for Wireless LAN Technology Present and Future 141
Table 44: Wireless Hospital Network Access Points Technology Prices Access Points 143
Table 45: Wireless Hospital Network Access Points Technology Prices Desktop Adapters (One Computer) 143
Table 46: Wireless Hospital Network Access Points Technology Prices PCMCIA Adapters 143
