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High-Growth Diagnostic Testing Markets

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SOURCE ReportBuyer

LONDON, May 5, 2014 /PRNewswire/ -- Reportbuyer.com has added a new market research report:

High-Growth Diagnostic Testing Markets

http://www.reportbuyer.com/pharma_healthcare/diagnostics/high_growth_diagnostic_testing_markets.html

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 12
1.1 Statement of Report 12
1.2 Scope of This Report 13
1.3 Methodology 14
1.4 Executive Summary 15

2. Introduction to the High-Growth Testing Market 25
2.1 Introduction to the Global Diagnostic Market 25
2.2 General Areas with Potential for High-Growth Testing 26
2.3 Market Drivers in the High-Growth Diagnostics Testing Sector 28
2.4 Market Segments for High-Growth Testing 28
2.5 Key Players in the High-Growth Diagnostics Testing Segment 28
2.6 High-Growth Testing Sector Analysis 30

3. Hepatitis Serologic Markers and Nucleic Acid Testing 31
3.1 Hepatitis B Virus (HBV) 31
3.2 Major Suppliers of Hepatitis B Virus (HBV) Testing Products 39
3.3 Market Revenue Analysis 42
3.4 Hepatitis C Virus (HCV) Testing 43
3.5 Market Revenue Analysis 52
3.6 Market Share Analysis 52

4. Human Papillomavirus (HPV) Testing 54
4.1 Overview 54
4.2 The Association of HPV and Cervical Cancer 57
4.3 The PAP Test 59
4.4 Current Laboratory Methods for HPV Detection 59
4.4.1 Direct-Probe Methods 59
4.4.2 Signal Amplification 59
4.4.3 Target Amplification 59
4.5 Assays for HPV 60
4.6 Market Revenue Analysis 68
4.7 Competitor Activity 69
4.8 Market and Technology Trends 71
4.8.1 Market Trends 71
4.8.2 Technology Trends 72

5. HIV 75
5.1 Introduction to HIV/AIDS 75
5.2 Statistical Data Global HIV/AIDS Epidemic 75
5.3 HIV Prevention and Treatment 78
5.3.1 HIV Prevention 78
5.3.2 HIV Treatment 78
5.4 U.S. Testing Market 79
5.5 Market Dynamics 81
5.5.1 Market Drivers 81
5.5.2 Market Restraints 82
5.5.3 Market Trends 83
5.5.4 Technology Trends 85
5.6 Review of Selected HIV Testing Devices 86
5.7 Market Revenue Analysis 92
5.8 Competitor Activity 93
5.9 HIV Market Challenges and Strategic Recommendations 95
5.10 Insurance Coverage and Reimbursement 96
5.11 Policies Affecting HIV Testing 97
5.12 Recent Industry Activity 97

6. Infectious Disease Testing 100
6.1 Introduction to Infectious Disease Testing 100
6.2 Types of Diagnosis for Infectious Diseases 101
6.2.1 Microbial Culture 101
6.2.2 Microscopy 101
6.2.3 Biochemical Tests 101
6.2.4 Molecular Diagnostics 101
6.3 Diagnostic Platforms for Infectious Diseases 102
6.3.1 Centralized Laboratory Testing for Infectious Diseases 102
6.3.2 POC Testing for Infectious Diseases 102
6.4 Emerging Technologies 103
6.5 Qualitative Analysis 103
6.5.1 Market Drivers 103
6.5.2 Market Restraints 104
6.6 Streptococcus Testing 104
6.7 Chlamydia Testing 109
6.8 Mononucleosis 114
6.9 Gonorrhea 116
6.10 Influenza 120
6.11 Malaria 122
6.12 Tuberculosis 131
6.13 Methicillin-Resistant Staphylococcus Aureus (MRSA) 143
6.14 Market Revenue Analysis 146

7. Cardiac Markers 147
7.1 Market Overview 147
7.2 Cardiac Marker Tests 147
7.2.1 Creatine Kinase (CK) 147
7.2.2 Myoglobin 148
7.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 148
7.2.4 C-Reactive Protein (CRP) 148
7.2.5 Homocysteine 149
7.3 Emerging Markers 149
7.3.1 B-type Natriuretic Peptide (BNP) 149
7.3.2 Myeloperoxidase (MPO) 149
7.3.3 Ischemia Modified Albumin (IMA) 150
7.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 150
7.3.5 Fatty Acid-Binding Proteins (FABPs) 150
7.4 Qualitative Analysis 151
7.4.1 Market Drivers 151
7.4.2 Market Restraints 152
7.5 Specific Cardiac Conditions 152
7.5.1 Acute Myocardial Infarction 152
7.5.2 Heart Failure (BNP) 154
7.5.2.1 Market Overview 154
7.5.2.2 Commercial Assays for BNP and NT-proBNP 155
7.5.2.3 Clinical Applications of BNP 156
7.5.3 CRP 159
7.6 Pulmonary Embolism (D-dimer Test) 160
7.7 Key Players 161
7.8 Market Revenue Analysis 168

8. Cytogenetic Testing 170
8.1 Cancer Testing 171
8.2 Prenatal Testing and Cytogenetics 173
8.2.1 Cystic Fibrosis Testing 174
8.2.1.1 CF Testing Methodology 175
8.2.1.2 CF Screening Technology Summary 178
8.3 Key Players in Segment 179

9. Fertility Testing 180

10. Cancer Biomarker Testing 184
10.1 Segment Overview 184
10.2 The Cancer Testing Market 185
10.3 Competition 190
10.4 Individual Markets 190
10.4.1 Cancer Pathology: Testing 190
10.4.1.1 Rare Cell/Micro Metastasis Detection 191
10.4.1.2 Cancer Pathology: High-Throughput Screening 192
10.4.1.3 Competition 193
10.4.1.4 Drivers 194
10.4.2 Breast Cancer 194
10.4.2.1 CA 15-3 196
10.4.2.2 CA 27-29 196
10.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes 197
10.4.2.4 Estrogen and Progesterone Receptor (ER and PR) 199
10.4.2.5 Human Epidermal Growth Factor Receptor 2 (HER-2) 199
10.4.2.6 Herceptin 200
10.4.2.7 p53 200
10.4.2.8 Nuclear Matrix Protein 66 (NMP66) 200
10.4.2.9 Mammastatin 201
10.4.2.10 Drivers for Breast Cancer Test Development 201
10.4.3 Ovarian Cancer 202
10.4.3.1 Cancer Antigen 125 (CA 125) 203
10.4.3.2 BRCA1 and BRCA2 203
10.4.3.3 Steroid Hormone Receptors 204
10.4.3.4 Epidermal Growth Factor Receptor (EGFR) 204
10.4.3.5 Lysophospholipids 206
10.4.4 Cervical Cancer 206
10.4.4.1 Cervical Cancer Screening Tests 208
10.4.5 Colon Cancer DNA Testing 209
10.5 Pharmacogenomic Cancer Testing 211
10.6 Market Revenue Analysis 214

11. Substance Abuse Testing 216
11.1 Background to POC Substance Abuse Testing 216
11.2 Substance Abuse Test Types 223
11.2.1 Urine Substance/Drug Screening 223
11.2.2 Hair Tests for Substance Abuse and Screening 223
11.2.3 Blood Tests for Substance Abuse and Screening 224
11.2.4 Saliva Tests for Substance Abuse and Screening 224
11.2.5 Sweat Tests for Substance Abuse and Screening 224
11.3 Alcohol Abuse and Screening 224
11.4 Saliva Testing 225
11.5 Qualitative Analysis 225
11.5.1 Market Drivers 225
11.5.2 Market Restraints 226
11.6 Review of Selected POC Substance Abuse Analyzers 226
11.7 Review of Company Products 228
11.7.1 Alere 228
11.7.2 Abbott Diagnostics 228
11.7.3 Roche Diagnostics 229
11.7.4 BioScan Screening Systems, Inc. 230
11.7.5 American Bio Medica Corp. 230
11.7.6 Phamatech, Inc. 233
11.7.7 First Check Medical 234
11.7.8 OraSure 234
11.7.9 Avitar, Inc. 235
11.7.10 Concateno (Alere, Inc.) 235
11.7.11 Pathtech 235
11.7.12 Alfa Scientific Designs, Inc. 236
11.7.13 TCPI, Inc. 237
11.7.14 Roche 237
11.7.15 Biophor Diagnostics 237
11.7.16 Randox Laboratories 237
11.7.17 Branan Medical 238
11.7.18 Concateno 238
11.8 Market Revenue Analysis 239

12. Vitamin D Diagnostic Testing 240
12.1 Market Revenue Analysis 244

13. Renal Dialysis Testing 245

14. Companion Diagnostics 246
14.1 Market Revenue Analysis 247

15. Summary Analysis of the Global IVD High-Growth Market by Geographic Region
249
15.1 Summary Analysis of the Global IVD Market 249
15.2 Summary Analysis of the Global IVD High-Growth Market by Geographic Region
252
15.3 U.S.: Summary Analysis of the IVD High-Growth Market 253
15.3.1 U.S.: Summary of IVD High-Growth Market 254
15.3.2 Cardiac Markers 256
15.4 Europe: Summary Analysis of the IVD High-Growth Market 259
15.4.1 Summary of IVD High-Growth Market Europe 263
15.5 Brazil: Summary Analysis of the IVD High-Growth Market 266
15.5.1 Summary of IVD High-Growth Market Brazil 267
15.6 Russia: Summary Analysis of the IVD High-Growth Market 269
15.6.1 Summary of IVD High-Growth Market Russia 270
15.7 India: Summary Analysis of the IVD High-Growth Market 272
15.7.1 Summary of IVD High-Growth Market India 279
15.8 China: Summary Analysis of the IVD High-Growth Market 281
15.8.1 Summary of IVD High-Growth Market China 297
15.9 South-East Asia and Japan: Summary Analysis of the IVD High-Growth Market
299
15.9.1 Japan 300
15.9.2 South Korea 303
15.9.3 Rapid Growth Market of IVD HIV/AIDS Testing in Other Asia 305
15.9.4 Summary of IVD High-Growth Market Other Asia 307

16. Clinical Laboratory Genomics 309
16.1 Introduction 309
16.2 Clinical Laboratory Genomics Testing 310
16.3 Developments in Clinical Laboratory Genomics 311
16.3.1 Nucleic Acid Amplification Techniques 311
16.3.2 Chromosome Imaging 312
16.3.3 Genomics Technologies 312
16.3.4 Proteomics Technology 313
16.3.5 Current Pharmacogenomic Tests 313
16.3.6 Future Pharmacogenomic Testing 314

17. Cellular Imaging Cytopathology and Histopathology 316
17.1 Segment Overview 316
17.2 The Market 316
17.3 Market Drivers 318
17.4 Market Restraints 318
17.5 Cytology and Histology Technology Platforms 318
17.5.1 Cytology Screening Procedures and Pap Smear Technology 319
17.5.2 Histology 324
17.5.3 Market Drivers 326
17.5.4 ISH Staining 326
17.5.5 Special-Stains Staining 326
17.6 Third-Party Reimbursement 326
17.7 Competition 327

18. High-Growth Testing Diagnostic Trends 332
18.1 Genetic Testing 332
18.2 Quality Measures 332
18.3 Moderators of Growth 332
18.3.1 Diagnostics and the Aging Population 332
18.3.2 Individualized Medicine 332
18.3.3 Genetic Testing 332
18.4 Workforce Issues 334
18.5 Reimbursement 334
18.5.1 Cardiovascular 335
18.5.2 Screening for Diabetes 336
18.5.3 CPT Test Codes and Payment Amounts 336
18.6 Rapid Near-Patient Testing in Hospitals 339
18.7 Satellite Facilities 339
18.8 Regionalization of Laboratory Care 340
18.9 Requirements for High-Growth Testing 341
18.10 Clinical Laboratory Improvement Act (CLIA) 342

19. Important Technology Trends 345

20. Molecular Diagnostics a Major Diagnostic Technological Advance 348
20.1 Polymerase Chain Reaction (PCR)-based Molecular Diagnostics 349
20.2 Micrarray Technologies and Molecular Diagnostics 350
20.3 Isothermal Amplification Technologies and Molecular Diagnostics 351
20.4 Miniaturization Technologies and Molecular Diagnostics (Biochips and Lab on
a Chip) 352

21. Technology Platform Innovations in POCT 354
21.1 Latest POCT Technological Platforms 354
21.1.1 Device Miniaturization and Microfluidic Technologies 354
21.1.2 Minimally-Invasive and Non-Invasive POCT Technologies 354
21.1.3 Advances in Wireless Technologies 355
21.1.4 Automation of POCT 355
21.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and
Sequencing
Technologies) 355
21.1.6 Advances in Informatics Technologies 357
21.1.7 Pharmacogenetic Testing 358
21.1.8 Multi Assay Technologies in POCT 358
21.2 Developments in Key Technologies 358
21.2.1 Medical and Biological Sensors and Sensor Systems 358
21.2.2 Recent Biosensor Product Introductions and Latest Innovative Developments
360
21.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 360
21.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet
Instruments 360
21.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L
Biosensor 360
21.2.2.4 AgaMatrix Europe Limited Introduces the New Jazz Blood Glucose Meter in
the U.K. 361
21.2.2.5 STMicroelectronics to Manufacture Worlds Smallest Biosensors 361
21.2.2.6 Universal Biosensors Advances Point of Care Molecular Diagnostic
Opportunity 361
21.2.2.7 Clinitek Advantus-A Semi Automated Urine Analyzer for Point of Care
Testing 361
21.2.2.8 The NOVA 16 STAT Chemistry Analyzer Offers the First
All-Electrode-Based Seven Test Chemistry Profile 361
21.3 Sensor Systems for Diagnostic Applications 363
21.4 Nanogen (The ELITech Group) Third Generation Point of Care Analyzer 366
21.5 Philips Development of Magnotech Technology 366
21.6 Quidel Corporation MChip, AVR Chip and F Chip 366
21.7 Sanofi-Aventis 367

22. Data Management and Connectivity 368
22.1 Wireless LANs 368
22.2 Connectivity Platforms 371
22.2.1 DataLink Data Management System 371
22.2.2 RALS-Plus 372
22.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 374
22.2.2.2 Siemens Diagnostics Rapidpoint Coag 374
22.2.2.3 Radiometer 374
22.2.2.4 HemoCue's DM Hemoglobin 374
22.2.2.5 Roche Diagnostics 374
22.2.3 BD.id 375
22.2.4 Medical Implant Communications Service (MICS) 375
22.2.5 Conworx Technology 375
22.2.6 Lab Data Systems 376
22.2.7 Medasys 376
22.2.8 NoemaLife 376
22.3 Advantages of POCT Connectivity 377
22.3.1 Cost Benefit of POCT and IT Connectivity 377
22.3.2 Hospital Network Issues 377
22.4 POCT Analyzer Connectivity Software Solutions 378
22.5 POCT2-P 380

23. Biochips for Clinical Applications 381
23.1 Roche AmpliChip 389
23.2 Amersham CodeLink 391
23.3 Breast Cancer DNA Chips 391
23.4 Osmetech eSensor 391
23.5 Affymetrix GeneChip System 3000Dx v.2 392
23.6 Caliper and Cepheid 392
23.7 Agilent Technologies 2100 Lab-on-a-Chip 392

24. Company Profiles 394
24.1 Abaxis, Inc. 394
24.2 Abbott Laboratories 396
24.3 Accurex Biomedical Pvt. Ltd. 401
24.4 Adeza Biomedical Corporation (Hologic) 401
24.5 Agilent Technologies, Inc. 401
24.6 Alere, Inc. 403
24.7 Ambri Ltd. 405
24.8 American Bio Medica Corporation 406
24.9 Ani Biotech Oy Ltd. 409
24.10 Applied Spectral Imaging 410
24.11 Avitar, Inc. 411
24.12 Axis-Shield Plc 412
24.13 Bayer Corporation 413
24.14 Beckman Coulter (now part of Danaher) 414
24.15 Becton, Dickinson and Company 418
24.16 Biomerica, Inc. 419
24.17 Bio-Rad Laboratories, Inc. 420
24.18 Calypte Biomedical Corporation 422
24.19 Chembio Diagnostics, Inc. 423
24.20 Cozart Bioscience Ltd. 423
24.21 Denka Seiken Co., Ltd. 424
24.22 diaDexus, LLC 424
24.23 Enterix, Inc. (Subsidiary of Quest Diagnostics) 425
24.24 EY Laboratories, Inc. 426
24.25 Genetix (Molecular Devices) 426
24.26 Genzyme Diagnostics 427
24.27 Hologic Gen Probe 428
24.28 Instrumentation Laboratory (IL)/Werfen Group 433
24.29 Jiangnan Biotech 433
24.30 Johnson & Johnson 434
24.31 Kyowa Medex Co., Ltd. 435
24.32 LifeAssays AB 435
24.33 LifeScan 435
24.34 Matritech 436
24.35 A Menarini Diagnostics 437
24.36 Meretek Diagnostics Group (Otsuka Pharmaceutical, Inc.) 437
24.37 Meridian Bioscience 438
24.38 Medix Biochemica 438
24.39 Myriad Genetics, Inc. 439
24.40 NOVA Biomedical 441
24.41 OraSure 442
24.42 Pheromone Sciences Corporation 444
24.43 Polymedco, Inc. 444
24.44 Polymer Technology Systems, Inc. 446
24.45 QIAGEN N.V. 446
24.46 Quest Diagnostics, Inc. 449
24.47 Quidel Corporation 450
24.48 Radiometer Medical 455
24.49 Roche Diagnostics 458
24.50 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech) 461
24.51 Shionogi & Co., Ltd. 461
24.52 Siemens Healthcare Diagnostics 462
24.53 Spectral Diagnostics, Inc. 463
24.54 Trinity Biotech Plc 464
24.55 Väsamed, Inc. 466


INDEX OF FIGURES

Figure 1.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2012
20
Figure 1.2: Top 13 Country IVD Testing Markets, 2012 21
Figure 1.3: Company Market Share for IVD Testing Markets, 2012 21
Figure 3.1: Geographic Distribution of Chronic HBV Infection 32
Figure 3.2: Evolution of HBV Markers in Acute and Chronic Infection 39
Figure 3.3: U.S. Market Share of HCV Molecular Diagnostic Market, 2012 53
Figure 3.4: Global Market Share (Excluding U.S.) of HCV Molecular Diagnostic
Market, 2012 53
Figure 4.1: PCR Analytical Sensitivity Detection Limits 64
Figure 4.2: The Basic Steps of Hybrid Capture 2 Technology 65
Figure 4.3: Diagram of Qiagen QIAsymphony SP/AS instrument 66
Figure 5.1: Global View of HIV Infection, 2009 76
Figure 5.2: Global Trend of HIV Infection, 1991-2011 77
Figure 5.3: Number of People Living with HIV, Newly Infected with HIV and Number
of AIDS Deaths in the World, 1990-2011 77
Figure 5.4: Worldwide Rate of New HIV Cases, 1990-2011 78
Figure 5.5: Number of People Receiving Antiretroviral Therapy in Low- and
Middle-Income Countries, by Region, 2003-2012 (with Projection) 79
Figure 6.1: U.S. and Outlying Areas Gonorrhea Infection Rates, 1941-2011 117
Figure 6.2: Global Incidence of Malaria 123
Figure 6.3: Mode of Action of Common Malaria RDT Format 126
Figure 6.4: Rate of Tuberculosis (TB) Cases by State/Area in the U.S., 2011 135
Figure 6.5: FIND Pipeline for TB Diagnostics 139
Figure 10.1: Cervical Cancer: 2008 Estimates: World Age-Standardized Incidence
Rates per 100,000 Population, Females, World Regions 207
Figure 15.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2012
250
Figure 15.2: Top 13 Country IVD Testing Markets, 2012 251
Figure 15.3: Company Market Share for IVD Testing Markets, 2012 251
Figure 15.4: Indian Diagnostics Market Segments, 2011 276
Figure 15.5: The Chinese Healthcare System 282
Figure 17.1: Worldwide Incidence Rates of Cervical Cancer Per 100,000 Females,
2011 320
Figure 17.2: Cervical Cancer: 2008 Estimates: World Age-Standardized Incidence
Rates per 100,000 Population, Females, World Regions 322


INDEX OF TABLES

Table 1.1: Emerging Technology Platforms Driving High-Growth Diagnostics Market
Segments 15
Table 1.2: Market Trends in the High-Growth Diagnostics Space 17
Table 1.3: Worldwide Geographic Distribution of Total IVD Testing Market, 2012
20
Table 1.4: Top 13 Country IVD Testing Markets, 2012 20
Table 1.5: Company Market Share for IVD Testing Markets, 2012 21
Table 1.6: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing, 2008-2018 22
Table 1.7: Global IVD High-Growth Markets Revenues by Market Segment, 2008-2018
22
Table 1.8: Global IVD High-Growth Markets Percentage of Revenues by Geographic
Region, 2008-2018 23
Table 1.9: Global IVD High-Growth Markets Percentage of Revenues by Product
Type, 2008-2018 23
Table 3.1: Serological Diagnosis of Hepatitis B Virus Infections 35
Table 3.2: Lower Detection Limits of HBV DNA Assays 36
Table 3.3: Summary of Selected Suppliers of Hepatitis B Virus (HBV) Diagnostic
Products by
Technology 40
Table 3.4: Global Revenue Forecasts for Hepatitis B Virus (HBV) and Hepatitis C
Virus (HCV) Diagnostic Testing, 2008-2018 42
Table 3.5: Global Revenue Forecasts for Hepatitis B Virus (HBV) Diagnostic
Testing, 2008-2018 43
Table 3.6: Efficiency of Available HCV Screening Tests 47
Table 3.7: Recommendations for Diagnostic Testing for Hepatitis C 48
Table 3.8: Hepatitis C Statistics 49
Table 3.9: Novartis Diagnostics Clinical Diagnostic Products Test for the
Detection of HCV 51
Table 3.10: Global Revenue Forecasts for Hepatitis C Virus (HCV) Diagnostic
Testing, 2008-2018 52
Table 3.11: Major Companies Marketing HCV Molecular Diagnostic Tests: Market
Size and Share, 2012 52
Table 4.1: HPV Risk Factors 55
Table 4.2: HPV and Cervical Carcinoma 55
Table 4.3: Key Statistics on Cervical Cancer in the World, 2011 56
Table 4.4: Deaths in Thousands from Cervical Cancer by Region and by Age Group
in 2011 57
Table 4.5: Reflex HPV Testing with Cytology 62
Table 4.6: Predictability of HPV Test by Abnormal Pap Smear Type 62
Table 4.7: Qiagen's Digene HC2 High-Risk HPV DNA Test 63
Table 4.8: Commercially Available Molecular Diagnostic Products for HPV Assay 68
Table 4.9: Long-Term Trends in HPV Testing 68
Table 4.10: Global Revenue Forecasts for Human Papillomavirus (HPV) Diagnostic
Testing, 2008-2018 69
Table 5.1: Global HIV Statistics, 2011 76
Table 5.2: Antiretroviral Therapy in Low- and Middle-Income Countries by Region,
December 2011 79
Table 5.3: Diagnosis of HIV Infection in 2011 for the U.S. and Six Dependent
Areas 80
Table 5.4: Estimated Number of AIDS Infection, 2011 81
Table 5.5: Drivers of Demand for HIV Diagnostic Testing 82
Table 5.6: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact
82
Table 5.7: Drivers of Demand for HIV Diagnostic Testing 83
Table 5.8: NAT HIV Monitoring Market: Market Restraints Ranked in Order of
Impact 83
Table 5.9: Selected POC Infectious Disease Testing Devices, 2011 86
Table 5.10: Commercially Available Molecular Diagnostic Products for HIV Assay
92
Table 5.11: Global Revenue Forecasts for HIV and AIDS Diagnostic Testing,
2008-2018 92
Table 5.12: Competitive Factors Related to HIV Tests 94
Table 6.1: Rapid Strep Tests on the Market 105
Table 6.2: U.S. Chlamydia Infection Rates, 1985-2011 110
Table 6.3: Rapid Tests for Chlamydia 111
Table 6.4: Rapid Tests for Gonorrhea 117
Table 6.5: Commercially-available Rapid Tests for Malaria 129
Table 6.6: Estimated TB Incidence, Prevalence and Mortality, 2011 136
Table 6.7: FIND Partners 140
Table 6.8: Global Market Potential for TB Diagnostic Testing, 2000-2012 143
Table 6.9: MRSA Diagnostics Currently on the Market 145
Table 6.10: Global Revenue Infectious Disease Revenue Analysis, 2008-2018 146
Table 7.1: Medication Chart for Cardiovascular Disease 151
Table 7.2: BNP Clinical Characteristics 155
Table 7.3: Cardiovascular Risk Classification by CRP Level 160
Table 7.4: Clinical Characteristics of D-dimer 160
Table 7.5: Global Revenue Forecasts for Cardiac Marker Testing, 2008-2018 169
Table 8.1: Genetic Testing: Consequences and Challenges 174
Table 8.2: CF Carrier Risk by Ethnic Group 174
Table 8.3: Reasons for CF Testing 175
Table 8.4: CF Gene Detection Rates Vary by Ethnic Background 176
Table 8.5: Global Market for CF Diagnostic Testing, 2008-2018 177
Table 8.6: U.S. Market for CF Diagnostic Testing, 2008-2018 177
Table 8.7: Commercial CF Screening Products 178
Table 8.8: Emerging CF Screening Products 178
Table 9.1: The Fertility Testing Market in the U.S., 2008-2018 180
Table 10.1: Organ-Specific Medicines in Development for Cancer 186
Table 10.2: Estimates for the Leading Sites of New Cancer Cases in the U.S. by
Gender, 2013 187
Table 10.3: Estimates for the Leading Sites of Cancer Deaths in the U.S. by
Gender, 2013 187
Table 10.4: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer in
Men 187
Table 10.5: Worldwide Number of New Cancer Cases and Deaths by Type of Cancer in
Women 188
Table 10.6: Estimated Age-Standardized Incidence and Mortality Rates Per 100,000
by World Area, 2008 189
Table 10.7: Worldwide CA 15-3 Sales, 2009-2019 196
Table 10.8: TPA Marker Sensitivity 199
Table 10.9: Worldwide CA 125 Sales, 2009-2019 202
Table 10.10: INFINITI Applications 214
Table 10.11: Global Revenue Forecasts for Cancer Marker Testing, 2008-2018 215
Table 11.1: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency
Department 221
Table 11.2: Stat Urine Testing Drug Recommendations 222
Table 11.3: Selected POC Substance/Drug Abuse Testing Devices, 2011 226
Table 11.4: Selected POC Substance/Drug Abuse Testing Devices, OraSure, 2011 234
Table 11.5: Selected Target Substances and Drugs, 2011 235
Table 11.6: Global Revenue Forecasts for Substance Abuse Testing, 2008-2018 239
Table 12.1: Global Revenue Forecasts for Vitamin D Testing, 2008-2018 244
Table 14.1: Companion Biomarker Market Size, 2008-2018 248
Table 15.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2012
249
Table 15.2: Top 13 Country IVD Testing Markets, 2012 250
Table 15.3: Company Market Share for IVD Testing Markets, 2012 251
Table 15.4: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing, 2008-2018 252
Table 15.5: Global IVD High-Growth Markets Percentage of Revenues by Geographic
Region, 2008-2018 252
Table 15.6: Global IVD High-Growth Markets Percentage of Revenues by Product
Type, 2008-2018 253
Table 15.7: Summary of IVD High-Growth Market U.S., 2011 254
Table 15.8: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing U.S.,
2008-2018 254
Table 15.9: U.S. Individual IVD High-Growth Markets Revenue Forecast, 2008-2018
255
Table 15.10: U.S. Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,
2008-2018 255
Table 15.11: Specific Cardiac Markers 256
Table 15.12: Cardiac Markers after Onset of Myocardial Infarction 257
Table 15.13: U.S. Cardiac Marker Revenue Forecasts, 2008-2018 259
Table 15.14: Market Share of Cardiac Marker Segment 259
Table 15.15: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Europe,
2008-2018 263
Table 15.16: Europe: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 264
Table 15.17: Europe: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,
2008-2018 264
Table 15.18: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Brazil,
2008-2018 268
Table 15.19: Brazil: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 268
Table 15.20: Brazil: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,
2008-2018 269
Table 15.21: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Russia,
2008-2018 270
Table 15.22: Russia: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 271
Table 15.23: Russia: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,
2008-2018 271
Table 15.24: Overview of Healthcare in India 273
Table 15.25: Population Projections India, 2000-2020 275
Table 15.26: Statistical Healthcare Data India 275
Table 15.27: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing India,
2008-2018 280
Table 15.28: India: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 280
Table 15.29: India: Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,
2008-2018 281
Table 15.30: Number of Healthcare Institutions According to Ownership China,
2010 283
Table 15.31: Total Number of Hospitals by Ranking China, 2010 284
Table 15.32: Disease Burden in China: Urban and Rural 285
Table 15.33: China Biotech Reagents Market 293
Table 15.34: Biotechnology Projects Between China and the West 294
Table 15.35: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing China,
2008-2018 298
Table 15.36: China: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 298
Table 15.37: China: Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,
2008-2018 299
Table 15.38: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing Other Asia,
2008-2018 307
Table 15.39: Other Asia: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 308
Table 15.40: Other Asia: Individual IVD High-Growth Markets Percentage of
Revenues by Product Type,
2008-2018 308
Table 17.1: Medicare National Minimum Payment Amounts for Cervical Pathology
Procedures 327
Table 18.1: New CPT Test Codes Introduced in 2008 338
Table 19.1: Employment of Clinical Laboratory Workers, 2006-2016 346
Table 21.1: Common Genotype Techniques 356
Table 22.1: Applications for Wireless LAN Technology 368
Table 22.2: Customized Reports Must Support CAP and JCAHO Requirements 372
Table 22.3: RALS-Plus Point of Care Market Share 373
Table 22.4: Applications of RALS Connectivity with POCT Devices 373
Table 23.1: Biochip Revenues and Growth Rates by Application, 2012 and 2018 381
Table 23.2: Total Biochip Market: Worldwide Revenue Forecasts, 2008-2018 386
Table 23.3: Total Biochip Market: U.S. Revenue Forecasts, 2008-2018 386
Table 24.1: Abaxis, Inc. Financial Figures-Net Sales by Business Sector,
2011-2013 395
Table 24.2: Abaxis, Inc. Financial Figures-Net Sales by Geographic Region,
2011-2013 396
Table 24.3: Abbott Laboratories Financial Figures-Net Sales by Business Sector,
2010-2012 400
Table 24.4: Abbott Laboratories Financial Figures-Net Sales by Geographic
Region, 2010-2012 400
Table 24.5: Alere, Inc. Financial Figures-Net Sales by Business Sector,
2008-2012 405
Table 24.6: Alere, Inc. Financial Figures-Net Sales by Geographic Region,
2008-2012 405
Table 24.7: Bayer AG Financial Figures-Net Sales by Business Sector, 2009-2012
413
Table 24.8: Bayer AG Financial Figures-Net Sales by Geographic Region, 2009-2012
414
Table 24.9: Bio-Rad Laboratories, Inc. Financial Figures-Net Sales by Business
Sector, 2009-2012 421
Table 24.10: Bio-Rad Laboratories, Inc. Financial Figures-Net Sales by
Geographic Region, 2009-2010 421
Table 24.11: Johnson & Johnson Financial Figures-Net Sales by Major Medical and
Diagnostics Businesses,
2010-2012 435
Table 24.12: Quidel Product Sales Distribution and Sales, 2010-2012 452
Table 24.13: Danaher Corporation Financial Figures-Net Sales by Business Sector,
2009-2012 456
Table 24.14: Danaher Corporation Financial Figures-Net Sales by Geographic
Region, 2010-2012 456
Table 24.15: Roche Group Financial Figures-Net Sales by Business Sector,
2009-2012 460
Table 24.16: Roche Group Financial Figures-Net Sales by Geographic Region,
2010-2012 460
Table 24.17: Roche Group Financial Figures-Net Sales by Sub-Division, 2011 and
2012 461


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High-Growth Diagnostic Testing Markets

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