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High-Growth Diagnostic Testing 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 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 examination 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.Overview8
  • 1.1Statement of Report8
  • 1.2Scope of this Report9
  • 1.3Methodology9
  • 1.4Executive Summary11
• 2.Sector Overview 15
  • 2.1Global Diagnostic Products Industry15
• 3.High-Growth Testing Markets: Market Segment Analysis: Size, Growth and Share20
  • 3.1Global High-Growth Diagnostic Testing Markets20
    • 3.1.1Market Drivers in the High-Growth Diagnostics Testing Sector22
    • 3.1.2Market Segments for High-Growth Testing 22
    • 3.1.3Key Players in the High-Growth Diagnostics Testing Segment23
    • 3.1.4High-Growth Testing Sector Analysis24
  • 3.2U.S. High-Growth Testing Market 25
    • 3.2.1Market Overview 25
    • 3.2.2Diagnostic Test Categories26
  • 3.3European High-Growth Diagnostic Test Market27
    • 3.3.1German Diagnostic Markets29
    • 3.3.2U.K. Testing Diagnostic Market31
      • 3.3.2.1U.K. Market Statistics32
      • 3.3.2.2U.K. Competitive Analysis36
      • 3.3.2.3U.K. Market Access38
  • 3.4Japanese Diagnostic Testing Market38
  • 3.5Chinese Diagnostic Testing Market41
• 4.High-Growth Testing Individual Markets45
  • 4.1Hepatitis Serologic Markers and Nucleic Acid Testing45
    • 4.1.1Hepatitis B Virus (HBV)45
    • 4.1.2Hepatitis C Virus (HCV) Testing54
    • 4.1.3Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance61
• 5.Cardiac Markers 64
  • 5.1Market Overview 64
    • 5.1.1American Market 69
    • 5.1.2European Market 72
  • 5.2Acute Myocardial Infarction74
  • 5.3Heart Failure (BNP)75
    • 5.3.1Market Overview 75
    • 5.3.2Commercial Assays for BNP and NT-proBNP77
    • 5.3.3Market Share78
  • 5.4CRP82
  • 5.5Pulmonary Embolism (D-dimer Test)83
  • 5.6Key Players84
• 6.Cytogenetic Testing93
  • 6.1Cancer Testing93
  • 6.2Prenatal Testing and Cytogenetics95
    • 6.2.1Cystic Fibrosis Testing98
      • 6.2.1.1CF Testing Methodology99
      • 6.2.1.2CF Screening Technology Summary101
  • 6.3Key Players in Segment101
• 7.Fertility Testing103
• 8.Clinical Laboratory Genomics106
  • 8.1Introduction106
  • 8.2Clinical Laboratory Genomics Testing107
  • 8.3Developments in Clinical Laboratory Genomics108
    • 8.3.1Nucleic Acid Amplification Techniques108
    • 8.3.2Chromosome Imaging109
    • 8.3.3Genomics Technologies109
    • 8.3.4Proteomics Technology110
    • 8.3.5Current Pharmacogenomic Tests110
    • 8.3.6Future Pharmacogenomic Testing111
• 9.Glucose Monitoring113
  • 9.1Overview of Market Segment117
  • 9.2Competitive Strategies118
  • 9.3Analyses of the Current Market Conditions, Competition and Product Mix118
    • 9.3.1First-Generation Monitors119
    • 9.3.2Second-Generation Monitors119
    • 9.3.3Third-Generation SMBG Technologies120
    • 9.3.4Other Monitoring Device Advancements123
• 10.Cancer Biomarker Testing124
  • 10.1Segment Overview124
  • 10.2The Cancer Testing Market125
  • 10.3Competition126
  • 10.4Individual Markets127
    • 10.4.1Cancer Pathology: Testing127
      • 10.4.1.1Rare Cell/Micro Metastasis Detection127
      • 10.4.1.2Cancer Pathology: High-Throughput Screening128
      • 10.4.1.3Competition130
      • 10.4.1.4Drivers 130
    • 10.4.2Breast Cancer131
      • 10.4.2.1CA 15-3 132
      • 10.4.2.2CA 27-29132
      • 10.4.2.3BRCA1 and BRCA2 Breast and Ovarian Cancer Genes 132
      • 10.4.2.4Estrogen and Progesterone Receptor (ER and PR)134
      • 10.4.2.5HER-2135
      • 10.4.2.6Herceptin135
      • 10.4.2.7p53135
      • 10.4.2.8NMP66136
      • 10.4.2.9Mammastatin136
      • 10.4.2.10Drivers for Breast Cancer Test Development136
    • 10.4.3Ovarian Cancer137
      • 10.4.3.1CA 125 II™137
      • 10.4.3.2BRCA1 and BRCA2 138
      • 10.4.3.3Steroid Hormone Receptors139
      • 10.4.3.4Epidermal Growth Factor Receptor (EGFR)139
      • 10.4.3.5Lysophospholipids141
    • 10.4.4Cervical Cancer141
    • 10.4.5Colon Cancer DNA Testing142
  • 10.5Pharmacogenomic Cancer Testing146
• 11.HPV Testing149
  • 11.1Overview149
  • 11.2U.S. Market151
  • 11.3European Market152
  • 11.4Other Markets154
  • 11.5The Association of HPV and Cervical Cancer155
  • 11.6Assays for HPV156
• 12.Biochips for Clinical Applications159
  • 12.1Roche AmpliChip 167
  • 12.2Amersham CodeLink168
  • 12.3Breast Cancer DNA Chips168
  • 12.4Osmetech eSensor169
  • 12.5Affymetrix GeneChip System 3000Dx v.2169
  • 12.6Caliper and Cepheid170
  • 12.7Agilent Technologies 2100 Lab-on-a-Chip170
• 13.HIV171
  • 13.1U.S. Testing Market171
  • 13.2World Testing Market175
    • 13.2.1Asia176
    • 13.2.2Japan178
    • 13.2.3Sub-Saharan Africa178
    • 13.2.4Rest of World178
  • 13.3Major Players179
• 14.Cellular Imaging Cytopathology and Histopathology181
  • 14.1Segment Overview181
  • 14.2The Market181
  • 14.3Market Drivers183
  • 14.4Market Restraints183
  • 14.5Cytology and Histology Technology Platforms183
    • 14.5.1Cytology Screening Procedures and Pap Smear Technology184
    • 14.5.2Histology189
    • 14.5.3Market Drivers190
    • 14.5.4ISH Staining190
    • 14.5.5Special-Stains Staining 191
  • 14.6Third-Party Reimbursement191
  • 14.7Competition191
• 15.Infectious Disease Testing196
  • 15.1Streptococcus Testing196
  • 15.2Chlamydia Testing201
  • 15.3Mononucleosis203
  • 15.4Gonorrhea204
  • 15.5Influenza206
  • 15.6Malaria207
  • 15.7Tuberculosis216
  • 15.8Methicillin-Resistant Staphylococcus aureus (MRSA)223
• 16.High-Growth Testing Diagnostic Trends226
  • 16.1Genetic Testing 226
  • 16.2Quality Measures226
  • 16.3Moderators of Growth226
    • 16.3.1Diagnostics and the Aging Population226
    • 16.3.2Individualized Medicine226
    • 16.3.3Genetic Testing 226
  • 16.4Workforce Issues228
  • 16.5Reimbursement228
    • 16.5.1Cardiovascular229
    • 16.5.2Screening for Diabetes230
    • 16.5.3CPT Test Codes and Payment Amounts230
  • 16.6Rapid Near-Patient Testing in Hospitals 233
  • 16.7Satellite Facilities233
  • 16.8Regionalization of Laboratory Care234
  • 16.9Requirements for High-Growth Testing235
  • 16.10Clinical Laboratory Improvement Act (CLIA)236
• 17.Business Trends in the Industry 239
  • 17.1Sector Consolidation239
  • 17.2Diagnostic Testing Growth Trends239
  • 17.3Acquisition, License Agreements, Internal Development, Partnerships240
  • 17.4Product Testing Depth in High-Growth Testing245
  • 17.5Government Regulation245
    • 17.5.1U.S. Regulations245
      • 17.5.1.1Importing Medical Devices into the U.S.247
      • 17.5.1.2Exporting Medical Devices from the U.S.247
    • 17.5.2U.K Regulations248
    • 17.5.3E.U. Regulations249
    • 17.5.4Japanese Regulations250
  • 17.6Increased Market Penetration in High-Growth Testing253
• 18.Important Technology Trends254
• 19.Company Profiles258
  • 19.1Accurex Biomedical, Pvt., Ltd.258
  • 19.2Adeza Biomedical Corporation (Hologic)258
  • 19.3Agilent Technologies, Inc.258
  • 19.4Ambri, Ltd.259
  • 19.5American Bio Medica Corp.259
  • 19.6Ani Biotech261
  • 19.7Applied Spectral Imaging262
  • 19.8Avitar, Inc.263
  • 19.9Axis-Shield264
  • 19.10Bayer Corporation265
  • 19.11Beckman Coulter 265
  • 19.12Becton Dickinson268
  • 19.13Biomerica268
  • 19.14Bio-Rad, Inc.269
  • 19.15Cozart Bioscience270
  • 19.16Denka Seiken Co., Ltd.270
  • 19.17diaDexus LLC270
  • 19.18Enterix, Inc. (Subsidiary of Quest Diagnostics) 271
  • 19.19Genetix 272
  • 19.20Genzyme Diagnostics272
  • 19.21Hologic, Inc.274
  • 19.22Iatron275
  • 19.23Inverness Medical Innovations275
  • 19.24Jiangnan Biotech277
  • 19.25Johnson & Johnson278
  • 19.26Kyowa Medex Co., Ltd.279
  • 19.27LifePoint, Inc.279
  • 19.28LifeScan 279
  • 19.29Matritech280
  • 19.30Medix Biochemica281
  • 19.31Myriad Genetics281
  • 19.32OraSure283
  • 19.33Pheromone Sciences284
  • 19.34Polymedco285
  • 19.35Procrea 286
  • 19.36QIAGEN286
  • 19.37Quidel286
  • 19.38Roche Diagnostics288
  • 19.39Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech)290
  • 19.40Shionogi & Co.290
  • 19.41Siemens 290
  • 19.42Spectral Diagnostics, Inc.291
  • 19.43Third Wave Technologies 293
• 20.Appendix 1: Opportunities in the Chinese Biotech Market 295
• 21.Appendix 2: Opportunities in the Indian Diagnostics Market306

INDEX OF TABLES

Table 1.1: Emerging Technology Platforms Driving High-Growth Diagnostics Market Segments12

Table 1.2: Market Trends in the High-Growth Diagnostics Space13

Table 2.1: U.S. Population Dynamics, 2005-2015 15

Table 2.2: World Population and Growth, 2000-202516

Table 2.3: Total Japanese Population and Aging Demographics Forecast16

Table 2.4: Worldwide Market Share In Vitro Diagnostic Companies, 200717

Table 2.5: Worldwide In Vitro Diagnostics Market Size, 2003-201217

Table 2.6: U.S. In Vitro Central Lab Diagnostic Testing, 2003-201217

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, 200726

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), 2002-201230

Table 3.7: The German Hospital Point of Care Market, 2002-2012 30

Table 3.8: German Clinical Diagnostic Rapid Test Market Segments31

Table 3.9: List of Diagnostics Companies in the U.K.37

Table 3.10: Major U.K. IVD Manufacturers37

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, 2000-201239

Table 3.14: Japan\'s Diagnostics Market Sales, 1997-2006 39

Table 3.15: Companies with Leading Market Share of Japanese Diagnostics, by Segment40

Table 3.16: Chinese Diagnostics Products Market Sales, 2000-201241

Table 3.17: Disease Burden in China: Urban and Rural42

Table 4.1: Global Market for HBV Diagnostic Testing, 2000-2012 46

Table 4.2: U.S. Market for HBV Diagnostic Testing, 2000-201246

Table 4.3: Serological Diagnosis of Hepatitis B Virus Infections48

Table 4.4: Lower Detection Limits of HBV DNA Assays49

Table 4.5: Summary of Hepatitis B Test Technology52

Table 4.6: Global Market for HCV Diagnostic Testing, 2000-200857

Table 4.7: U.S. Market for HCV Diagnostic Testing, 2000-200857

Table 4.8: Efficiency of Available HCV Screening Tests 58

Table 4.9: Recommendations for Diagnostic Testing for Hepatitis C60

Table 4.10: Hepatitis C Statistics60

Table 4.11: Gen-Probe Clinical Diagnostic Products Test for the Detection of HCV62

Table 5.1: Biomarkers in Heart Failure66

Table 5.2: Medication Chart for Cardiovascular Disease67

Table 5.3: Acute Myocardial Infarction Facts67

Table 5.4: Emergency Room Admissions in the U.S., 1997-200568

Table 5.5: Market Growth Drivers for Cardiac Markers68

Table 5.6: Market Barriers to Growth for Cardiac Markers68

Table 5.7: Specific Cardiac Markers69

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 Segment72

Table 5.11: U.S. Market for Point of Care Cardiac Marker Testing, 2000-201075

Table 5.12: BNP Characteristics77

Table 5.13: Global Sales of BNP Diagnostic Tests, 2000-201078

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 Level83

Table 5.17: Clinical Characteristics of D-dimer 83

Table 6.1: Global Market for Cancer Cytogenetic Diagnostic Testing, 2000-201296

Table 6.2: U.S. Market for Cancer Cytogenetic Diagnostic Testing, 2000-201297

Table 6.3: Genetic Testing: Consequences and Challenges 97

Table 6.4: CF Carrier Risk by Ethnic Group98

Table 6.5: Reasons for CF Testing98

Table 6.6: CF Gene Detection Rates Vary by Ethnic Background99

Table 6.7: Global Market for CF Diagnostic Testing, 2000-2010100

Table 6.8: U.S. Market for CF Diagnostic Testing, 2000-2010100

Table 6.9: Commercial CF Screening Products100

Table 6.10: Emerging CF Screening Products101

Table 7.1: The Fertility Testing Market in the U.S., 2000-2008103

Table 9.1: U.S. Population of Diabetics by Group113

Table 9.2: Percentage of U.S. Adults Using Diabetes Medication, by Age, 1997-2006114

Table 9.3: Health Care Utilization by the Diabetes Patient114

Table 9.4: The Global Population of Persons with Diabetes, 1995 and 2025116

Table 9.5: Market for Glucose Testing in the U.S., 2001-2012116

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 Meters117

Table 10.1: Women\'s Cancer Incidence Estimates in the U.S., 2008125

Table 10.2: Five-Year Disease-Free Survival by Stage at Diagnosis125

Table 10.3: TPA Marker Sensitivity134

Table 11.1: HPV Risk Factors149

Table 11.2: HPV and Cervical Carcinoma150

Table 11.3: Global HPV-Testing Market Size, 2003-2011150

Table 11.4: HPV and Cervical Carcinoma Risk151

Table 11.5: Reflex HPV Testing with Cytology156

Table 11.6: Predictability of HPV Test by Abnormal Pap Smear Type157

Table 11.7: Incidence of Cervical Cancer and Cytological Abnormalities157

Table 11.8: Long-Term Trends in HPV Testing158

Table 12.1: Biochip Revenues and Growth Rates by Application159

Table 12.2: Total Biochip Market: Worldwide Revenue Forecasts, 2000-2010163

Table 12.3: Total Biochip Market: U.S. Revenue Forecasts, 2000-2010164

Table 13.1: AIDS Statistics for the U.S.: Diagnoses, Deaths and Burden, 2002-2006171

Table 13.2: U.S. HIV Statistics, 2007171

Table 13.3: Births of HIV Infected Babies in U.S., 2000-2009172

Table 13.4: Rapid HIV Tests on the Market173

Table 13.5: U.S. High-Growth Testing Market for HIV, 2001-2012175

Table 13.6: Global HIV Statistics, 2007 176

Table 14.1: Estimated Cervical Cancer Cases/Deaths Worldwide187

Table 14.2: Medicare Reimbursement for Cervical Pathology Procedures191

Table 15.1: U.S. Strep Testing Market Size, 2000-2008197

Table 15.2: Rapid Strep Tests on the Market197

Table 15.3: U.S. Market for Rapid Point of Care Strep Tests198

Table 15.4: The U.S. Chlamydia Testing Market, 2001-2009201

Table 15.5: Rapid Tests for Chlamydia201

Table 15.6: Rapid Tests for Gonorrhea205

Table 15.7: Commercially-Available Rapid Tests for Malaria214

Table 15.8: FIND Partners221

Table 15.9: Global Market Potential for TB Diagnostic Testing, 2000-2010223

Table 15.10: MRSA Diagnostics Currently on the Market225

Table 16.1: New CPT Test Codes Introduced in 2008232

Table 18.1: Employment of Clinical Laboratory Workers, 2006-2016255

Table 20.1: China Biotech Reagents Market301

Table 20.2: Biotechnology Projects Between China and the West302

Table 21.1: Overview of Healthcare in India309

INDEX OF FIGURES

Figure 2.1: U.S. Lab Industry Market Share, 200718

Figure 2.2: Major Lab Testing Segments, U.S.19

Figure 3.1: Total Spending on Healthcare in the U.S., 200725

Figure 3.2: International Per Capita Spending on Healthcare, 200629

Figure 3.3: Japan IVD Sales by Segment, 200640

Figure 14.1: Worldwide Incidence Rates of Cervical Cancer Per 100,000 Females185

Figure 15.1: Global Incidence of Malaria208

Figure 15.2: Mode of Action of Common Malaria RDT Format211

Figure 15.3: FIND Pipeline for TB Diagnostics220

Figure 21.1: Indian Diagnostics Market Segments, 2007307

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