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High-Growth Diagnostic Tests Markets

There will be a steady increase in demand for new diagnostic testing services in the next five-year period, along with pressures to improve the quality of healthcare delivered in the clinic and also to lower its costs. Clinical labs experienced a substantial growth during the last decade. The emphasis in this TriMark Publications report is on those companies that are actively developing and marketing high-growth diagnostic testing technologies in the clinical hospital market. It defines the dollar volume of sales, both worldwide and in the U.S., of the market and analyzes the factors that influence the size and growth of market segments. The study goes on to discuss in detail trends that have developed which have stimulated this market, and also comments in detail patterns of information processing in the high-growth diagnostic testing technologies. Moreover, this exanimation provides an overview of the diagnostic testing market, including the latest information regarding exciting new products and industry trends. It will not only quantify but also qualify the market high-growth segments as an area of research and investment. Forecasts of the market and analyses of products in the worldwide prescriptions market will provide a basis for understanding the significance of past developments and future possibilities within this therapeutic category.

Table of Contents

• 1. Overview 7
  • 1.1 Statement of Report 7
  • 1.2 Objectives of this Report 7
  • 1.3 Scope of this Report 8
  • 1.4 Methodology 9
  • 1.5 Executive Summary 9
  
  
• 2. Sector Overview 12
  • 2.1 Global Diagnostic Products Industry 12
  
  
• 3. High-Growth Testing Markets: Market Segment Analysis: Size, Growth and Share 17
  • 3.1 Global High-Growth Diagnostic Testing Markets 17
    • 3.1.1 Market Drivers in the High-Growth Diagnostics Testing Sector - Overview 19
    • 3.1.2 Market Segments for High-Growth Testing 19
    • 3.1.3 Key Players in the High-Growth Diagnostics Testing Segment 20
    • 3.1.4 High-Growth Testing Sector Analysis 21
  • 3.2 U.S. High-Growth Testing Market 21
    • 3.2.1 Market Overview 21
    • 3.2.2 Diagnostic Test Categories 22
  • 3.3 European High-Growth Diagnostic Test Market 22
    • 3.3.1. German Diagnostic Markets 25
    • 3.3.2 U.K. Testing Diagnostic Market 27
      • 3.3.2.1 U.K. Market Statistics 28
      • 3.3.2.2 U.K. Competitive Analysis 28
      • 3.3.2.3 U.K. Market Access 29
  • 3.4. Japanese Diagnostic Testing Market 30
  • 3.5 Chinese Diagnostic Testing Market 30
  • 3.6 High-Growth Testing Individual Markets 32
    • 3.6.1 Hepatitis Serologic Markers and Nucleic Acid Testing 32
      • 3.6.1.1 Hepatitis B Virus (HBV) 32
      • 3.6.1.2 Hepatitis C Virus (HCV) Testing 42
      • 3.6.1.3 Hepatitis B virus/Hepatitis C Virus Viral Load and Drug Resistance 49
    • 3.6.2 Cardiac Markers 50
      • 3.6.2.1 Market Overview 50
        • 3.6.2.1.1 American Market 52
        • 3.6.2.1.2 European Market 54
      • 3.6.2.2 Acute Myocardial Infarction 55
      • 3.6.2.3 Heart Failure (BNP) 56
        • 3.6.2.3.1 Market Overview 56
        • 3.6.2.3.2 Commercial Assays for BNP and NT-proBNP 57
        • 3.6.2.3.3 Market Share 59
      • 3.6.2.4 Myoglobin 62
      • 3.6.2.5 Homocysteine 62
      • 3.6.2.6 CRP 62
      • 3.6.2.7 Pulmonary Embolism (D-Dimer Test) 63
      • 3.6.2.8 LDL and HDL 63
      • 3.6.2.9 Key Players 64
    • 3.6.3 Cytogenetic Testing 71
      • 3.6.3.1 Cancer Testing 71
      • 3.6.3.2 Pre-natal Testing and Cytogenetics 73
        • 3.6.3.2.1 Cystic Fibrosis Testing 74
      • 3.6.3.3 Key Players in Segment 78
    • 3.6.4 Fertility Testing 78
    • 3.6.5 Clinical Laboratory Genomics 82
      • 3.6.5.1 Introduction 82
      • 3.6.5.2 Clinical Laboratory Genomics Testing 83
      • 3.6.5.3 Developments in Clinical Laboratory Genomics 84
        • 3.6.5.3.1 Nucleic Acid Amplification Techniques 84
        • 3.6.5.3.2 Chromosome Imaging 84
        • 3.6.5.3.3 Genomics Technologies 85
        • 3.6.5.3.4 Proteomics Technology 85
        • 3.6.5.3.5 Current Pharmacogenomic Tests 86
        • 3.6.5.3.6 Future Pharmacogenomic Testing 87
    • 3.6.6 Glycosylated Hemoglobin Glucose Monitoring 88
      • 3.6.6.1 Overview of Market Segment 92
      • 3.6.6.2 Competitive Strategies 93
      • 3.6.6.3 Analyses of the Current Market Conditions, Competition and Product Mix 93
        • 3.6.6.3.1 First-Generation Monitors 93
        • 3.6.6.3.2 Second-Generation Monitors 94
        • 3.6.6.3.3 Third-Generation SMBG Technologies 95
        • 3.6.6.3.4 Other Monitoring Device Advancements 96
    • 3.6.7 Cancer BioMarker Testing 96
      • 3.6.7.1 Segment Overview 96
      • 3.6.7.2 The Cancer Testing Market 98
      • 3.6.7.3 Competition 99
      • 3.6.7.4 Individual Markets 100
        • 3.6.7.4.1 Cancer Pathology: Testing 100
          • 3.6.7.4.1.1 Rare Cell/Micro Metastasis Detection 100
          • 3.6.7.4.1.2 Cancer Pathology: High Throughput Screening 101
          • 3.6.7.4.1.3 Competition 102
          • 3.6.7.4.1.4 Drivers 102
        • 3.6.7.4.2 Breast Cancer 102
          • 3.6.7.4.2.1 CA 15-3 103
          • 3.6.7.4.2.2 CA 27-29 103
          • 3.6.7.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes 104
          • 3.6.7.4.2.4 Estrogen and Progesterone Receptor (ER and PR) 106
          • 3.6.7.4.2.5 HER-2 106
          • 3.6.7.4.2.6 Herceptin 106
          • 3.6.7.4.2.7 p53 106
          • 3.6.7.4.2.8 NMP66 107
          • 3.6.7.4.2.9 Mammastatin 107
          • 3.6.7.4.2.10 Drivers for Breast Cancer Test Development 107
        • 3.6.7.4.3 Ovarian Cancer 108
          • 3.6.7.4.3.1 CA 125 II™ 108
          • 3.6.7.4.3.2 BRCA1 and BRCA2 108
          • 3.6.7.4.3.3 Steroid Hormone Receptors 109
          • 3.6.7.4.3.4 Epidermal Growth Factor Receptor (EGF-R) 110
          • 3.6.7.4.3.5 Lysophospholipids 111
        • 3.6.7.4.4 Cervical Cancer 111
        • 3.6.7.4.5 Colon Cancer DNA Testing 112
      • 3.6.7.5 Pharmocogenomic Cancer Testing 115
    • 3.6.8 HPV Testing 117
      • 3.6.8.1 Overview 117
      • 3.6.8.2 U.S. Market 119
      • 3.6.8.3 European Market 119
      • 3.6.8.4 Other Markets 120
      • 3.6.8.5 The Association of HPV and Cervical Cancer 120
      • 3.6.8.6 Assays for HPV 121
    • 3.6.9 Biochips for Clinical Applications 123
      • 3.6.9.1 Roche AmpliChip 128
      • 3.6.9.2 Amersham CodeLink 130
      • 3.6.9.3 Breast Cancer DNA Chips 131
      • 3.6.9.4 Motorola eSensor 131
      • 3.6.9.5 Affymetrix GeneChip System 3000Dx 131
      • 3.6.9.6 Caliper and Cepheid 132
      • 3.6.9.7 Agilent Technologies 5100 Lab-on-a-Chip 132
    • 3.6.10 HIV 132
      • 3.6.10.1 U.S. Testing Market 132
      • 3.6.10.2 World Testing Market 134
        • 3.6.10.2.1 Asia 134
        • 3.6.10.2.2 Japan 136
        • 3.6.10.2.3 Sub-Saharan Africa 137
      • 3.6.10.3 Major Players 137
    • 3.6.11 Cellular Imaging Cytopathology and Histopathology 137
      • 3.6.11.1 Segment Overview 137
      • 3.6.11.2 The Market 138
      • 3.6.11.3 Market Drivers: 139
      • 3.6.11.4 Market Restraints 139
      • 3.6.11.5 Cytology and Histology Technology Platforms 139
        • 3.6.11.5.1 Cytology Screening Procedures and Pap Smear Technology 140
        • 3.6.11.5.2 Histology 148
        • 3.6.11.5.3 Market Drivers 149
        • 3.6.11.5.4 ISH Staining 149
        • 3.6.11.5.5 Special Stains Staining 149
      • 3.6.11.6 Third Party Reimbursement 149
      • 3.6.11.7 Competition 150
    • 3.6.12 Infectious Disease Testing 156
      • 3.6.12.1 Streptococcus Testing 156
      • 3.6.12.2 Chlamydia Testing 160
      • 3.6.12.3 Mononucleosis 161
      • 3.6.12.4 Gonorrhea 162
      • 3.6.12.5 Influenza 163
      
      
• 4. High-Growth Testing Diagnostic Trends 165
  • 4.1 Genetic Testing 165
  • 4.2 Quality measures 165
  • 4.3 Moderators of Growth 165
    • 4.3.1 Diagnostics and the Aging Population 165
    • 4.3.2 Individualized Medicine 165
    • 4.3.3 Patient Safety and Quality Measures 166
    • 4.3.4 Genetic Testing 166
    • 4.3.5 Preventive medicine 166
  • 4.4 Workforce Issues 167
  • 4.5 Reimbursement 167
    • 4.5.1 Cardiovascular 167
    • 4.5.2 Screening for Diabetes 168
    • 4.5.3 Other Reimbursement Concerns for 2005 168
    • 4.5.4 New CPT Test Codes and Payment Amounts for 2005 168
  • 4.6 Rapid Near Patient Testing In Hospitals 171
  • 4.7 Satellite Facilities 171
  • 4.8 Regionalization of Laboratory Care 172
  • 4.9 Requirements for High-Growth Testing 173
  • 4.10 Clinical Laboratory Improvement Act (CLIA) 174
  
  
• 5. Business Trends in the Industry 176
  • 5.1 Sector Consolidation 176
  • 5.2 Diagnostic Testing Growth Trends 176
  • 5.3 Acquisition, License Agreements, Internal Development, Partnerships 177
  • 5.4 Product Testing Depth in High-Growth Testing 178
  • 5.5 Government Regulation 179
    • 5.5.1 United States Regulations 179
      • 5.5.1.1 Importing Medical Devices into the U.S. 180
      • 5.5.1.2 Exporting Medical Devices from the U.S. 181
    • 5.5.2 U.K Regulations 181
    • 5.5.3 E.U. Regulations 183
    • 5.5.4 Japanese Regulations 184
  • 5.6 Increased Market Penetration in High-Growth Testing 185
  • 5.7 Legal Issues 185
  
  
• 6. Important Technology Trends 187


• 7. Company Profiles 190
  • 7.1 TriPath Imaging 190
  • 7.2 Lifescan Corporation 192
  • 7.3 OraSure 193
  • 7.4 Bayer Corporation 194
  • 7.5 Abbott Diagnostics 196
  • 7.6 Cytyc Corporation 200
  • 7.7 Inverness Medical Innovations 201
  • 7.8 Johnson & Johnson 202
  • 7.9 Quidel 203
  • 7.10 Biomerica 206
  • 7.11 Genzyme Diagnostics 206
  • 7.12 Adeza Biomedical Corporation 208
  • 7.13 Jiangnan Biotech 208
  • 7.14 diaDexus LLC 209
  • 7.15 Digene 209
  • 7.16 Matritech 210
  • 7.17 Roche Diagnostics 212
  • 7.18 Myraid Genetics 212
  • 7.19 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 213
  • 7.20 LifePoint, Inc. 213
  • 7.21 Avitar, Inc. 214
  • 7.22 Cozart Bioscience 214
  • 7.23 Enterix, Inc. 214
  • 7.24 Kyowa Medex Co., Ltd. 215
  • 7.25 Iatron 215
  • 7.26 Denka Seiken Co., Ltd. 215
  • 7.27 Accurex Biomedical, Pvt., Ltd. 215
  • 7.28 Ambri Ltd. 215
  • 7.29 Thermo Biostar 215
  • 7.30 Axis-Shield 216
  • 7.31 Polymedco 216
  • 7.32 Medix Biochemica 217
  • 7.33 Pheromone Sciences 218
  • 7.34 Ostex International, Inc. 218
  • 7.35 Procrea 218
  • 7.36 American Bio Medica Corp. 219
  • 7.37 Third Wave Technologies 220
  • 7.38 Biosite, Inc. 221
  • 7.39 Spectral Diagnostics, Inc. 223
  • 7.40 Dade Behring 224
  • 7.41 Beckman-Coulter 225
  • 7.42 Ani Biotech 227
  • 7.43 Applied Spectral Imaging 227
  • 7.44 Applied Imaging Corp. 228
  • 7.45 Shionogi & Co. 230
  • 7.46 Biorad, Inc. 230
  
  
• 8. Appendix 1 - Opportunities in the Chinese Biotech Market 232

 

INDEX OF TABLES

Table 1: U.S. Population Dynamics in Millions 13

Table 2: World Population and Growth Through 2024 14

Table 3: Total Japanese Population and Aging Demographics Forecast 14

Table 4: Worldwide Market Share In Vitro Diagnostic Companies 15

Table 5: Worldwide In Vitro Diagnostics Market Size 2001-2007 15

Table 6: U.S. In Vitro Central Lab Diagnostic Testing 2001-2007 15

Table 7: Worldwide Near Patient Diagnostic Testing 2001-2007 16

Table 8: High-Growth Market Segments Overview 20

Table 9: U.S. High-Growth Diagnostic Testing Market Segments 23

Table 10: Regional Comparison of 1999 GDP, Healthcare, and IVD 25

Table 11: German Diagnostics Products Market Sales 26

Table 12: The German Patient Care Lab Test Market 26

Table 13: The German Alternate Site Testing Market (POL) 27

Table 14: The German Hospital Point-of-Care Market 27

Table 15: German Clinical Diagnostic Rapid Test Market Segments 27

Table 16: The U.K. IVD Market ($ Millions) 29

Table 17: Major U.K. IVD Manufacturers 29

Table 18: U.S. IVD Manufacturers Doing Business in the U.K. 30

Table 19: Other European Companies that Manufacture IVD Products in the U.K. 30

Table 20: Japanese Diagnostic Testing Market 31

Table 21: Chinese Diagnostics Products Market Sales 31

Table 22: Global Market for HBV Diagnostic Testing 34

Table 23: U.S. Market for HBV Diagnostic Testing 34

Table 24: HBV Markers 35

Table 25: Serological Diagnosis of Hepatitis B Virus Infections 37

Table 26: Unusual Hepatitis B Serologic Profiles Requiring Further Evaluation 37

Table 27: Recommendations for Diagnostic Testing for Hepatitis B 37

Table 28: Lower Detection Limits of HBV DNA Assays 38

Table 29: Recommendations for Hepatitis B Testing 38

Table 30: Summary of Hepatitis Test Technology 41

Table 31: Global Market for HCV Diagnostic Testing 45

Table 32: U.S. Market for HCV Diagnostic Testing 45

Table 33: Recommendations for Diagnostic Testing for Hepatitis C 47

Table 34: Hepatitis C Statistics 48

Table 35: Gen-Probe Clinical Diagnostic Products Test for the Detection of HCV 51

Table 36: Acute Myocardial Infarction Facts 52

Table 37: Emergency Room Admissions in the U.S. 53

Table 38: Specific Cardiac Markers 53

Table 39: Cardiac Markers after Onset of Myocardial Infarction 54

Table 40: The Cardiac Marker Market for Testing in the U.S. 55

Table 41: Market Share of Cardiac Marker Segment 55

Table 42: U.S. Market for Point-of-Care Cardiac Marker Testing 57

Table 43: BNP Characteristics 58

Table 44: BNP Testing Dollar Volume 59

Table 45: Market Share of BNP Assays in the U.S. 60

Table 46: Market Share of NT-proBNP Assays in the U.S. 60

Table 47: Clinical Characteristics of D-Dimer 64

Table 48: Global Market for Cancer Cytogenetic Diagnostic Testing 74

Table 49: U.S. Market for Cancer Cytogenetic Diagnostic Testing 75

Table 50: CF Carrier Risk by Ethnic Group 75

Table 51: Reasons for CF Testing 76

Table 52: CF Testing Methodology 76

Table 53: CF Gene Detection Rates Vary by Ethnic Background 77

Table 54: Global Market for CF Diagnostic Testing 77

Table 55: U.S. Market for CF Diagnostic Testing 77

Table 56: Commercial CF Screening Products 78

Table 57: Emerging CF Screening Products 78

Table 58: CF Screening Technology Summary 78

Table 59: The Fertility Testing Market in the U.S. 80

Table 60: Rite Aid and other OEM Ovulation Predictors 82

Table 61: U.S. Population of Diabetics by Group 89

Table 62: Percentage of Adults with Diabetes Using Diabetes Medication, by Age, U.S., 1997-2002 Age Group 90

Table 63: Health Care Utilization by the Diabetes Patient 90

Table 64: The Global Population of Persons with Diabetes (in Millions) 92

Table 65: The Glucose Market for OTC Testing in the U.S. 92

Table 66: The Glucose Market for OTC Testing Worldwide 93

Table 67: Major Players in the Point-of-Care and Near Patient Testing for Glucose - OTC Glucose Meter U.S. Market Share for Blood Glucose Measurements 93

Table 68: Women's Cancers - 2004 Cancer Estimates (U.S.) Incidence 99

Table 69: Five Year Disease-Free Survival by Stage at Diagnosis 99

Table 70: TPA Marker Sensitivity 106

Table 71: Facts About HPV Risk Factors 119

Table 72: HPV and Cervical Carcinoma 119

Table 73: HPV and Cervical Carcinoma Risk 120

Table 74: Rationale for Reflex HPV Testing with Cytology 123

Table 75: Rationale against Reflex HPV Testing with Cytology 123

Table 76: Predictability of HPV Test by Abnormal Pap Smear Type 123

Table 77: Incidence of Cervical Cancer and Cytological Abnormalities 123

Table 78: Long Term Trends in HPV Testing 124

Table 79: Biochip Revenues and Growth Rates by Application 125

Table 80: Total Biochip Market: Revenue Forecasts by Segment (World) 126

Table 81: Total Biochip Market: Revenue Forecasts by Segment (U.S) 126

Table 82: U.S. HIV Positive Population 1998-2007 134

Table 83: U.S. High-Growth Testing Market for HIV 135

Table 84: Countries with the Highest Prevalence of HIV/AIDS 137

Table 85: Births of HIV Infected Babies in U.S. 137

Table 86: Number (Millions) of Pap Smears Performed by Country 143

Table 87: Estimated Cervical Cancer Cases/Deaths Worldwide 146

Table 88: Medicare Reimbursement for Cervical Pathology Procedures 151

Table 89: U.S. Strep Testing Market Size 158

Table 90: U.S. Market for Rapid Point of Care Strep Tests 158

Table 91: The U.S. Chlamydia Testing Market 161

Table 92: Products Marketed by Abbott in the Diagnostic Market 200

Table 93: China Biotech Reagents Market 235

Table 94: Biotechnology Projects between China and the West 236

INDEX OF FIGURES

Figure 1: Lab Industry Market Shares 2003 15

Figure 2: Major Lab Testing Segments 16

 

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