High-Growth Diagnostic Testing Markets

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High-Growth Diagnostic Testing Markets
Published on April 2012

Report Summary

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 Content

TABLE OF CONTENTS

1. Overview 11

1.1 Statement of Report 11

1.2 Scope of This Report 12

1.3 Methodology 13

1.4 Executive Summary 14

2. Introduction to the High-Growth Testing Market 23

2.1 Introduction to the Global Diagnostic Market 23

2.2 General Areas with Potential for High-Growth Testing 24

High-Growth Diagnostic Testing Markets (From Slideshare) Page 1/28


2.3 Market Drivers in the High-Growth Diagnostics Testing Sector 26

2.4 Market Segments for High-Growth Testing 26

2.5 Key Players in the High-Growth Diagnostics Testing Segment 26

2.6 High-Growth Testing Sector Analysis 28

3. Hepatitis Serologic Markers and Nucleic Acid Testing 29

3.1 Hepatitis B Virus (HBV) 29

3.2 Major Suppliers of Hepatitis B Virus (HBV) Testing Products 36

3.3 Market Revenue Analysis 39

3.4 Hepatitis C Virus (HCV) Testing 40


4. Human Papillomavirus (HPV) Testing 50

4.1 Overview 50

4.2 The Association of HPV and Cervical Cancer 52

4.3 The PAP Test 54

4.4 Current Laboratory Methods for HPV Detection 54

4.4.1 Direct-probe Methods 54

4.4.2 Signal Amplification 54

4.4.3 Target Amplification 54

4.5 Assays for HPV 55


4.7 Competitor Activity 58



5. HIV 61

5.1 Introduction to HIV/AIDS 61

5.2 Statistical Data Global HIV/AIDS Epidemic 61

5.3 HIV Prevention and Treatment 62

5.3.1 HIV Prevention 62

5.3.2 HIV Treatment 62

5.4 U.S. Testing Market 63

5.5 Market Dynamics 65

5.5.1 Market Drivers 65

5.5.2 Market Restraints 66

5.5.3 Market Trends 67

5.5.4 Technology Trends 69

5.6 Review of Selected HIV Testing Devices 69


5.8 Competitor Activity 73

5.9 HIV Market Challenges and Strategic Recommendations 75

5.10 Insurance Coverage and Reimbursement 76

5.11 Policies Affecting HIV Testing 76

5.12 Recent Industry Activity 77

6. Infectious Disease Testing 79

6.1 Introduction to Infectious Disease Testing 79

6.2 Types of Diagnosis for Infectious Diseases 80

6.2.1 Microbial Culture 80



6.2.2 Microscopy 80

6.2.3 Biochemical Tests 80

6.2.4 Molecular Diagnostics 80

6.3 Diagnostic Platforms for Infectious Diseases 81

6.3.1 Centralized Laboratory Testing for Infectious Diseases 81

6.3.2 POC Testing for Infectious Diseases 81

6.4 Emerging Technologies 82

6.5 Qualitative Analysis 82



6.6 Streptococcus Testing 83

6.7 Chlamydia Testing 88

6.8 Mononucleosis 89

6.9 Gonorrhea 91

6.10 Influenza 93

6.11 Malaria 95

6.12 Tuberculosis 104

6.13 Methicillin-Resistant Staphylococcus aureus (MRSA) 112


7. Cardiac Markers 116

7.1 Market Overview 116

7.2 Cardiac Marker Tests 116

7.2.1 Creatine Kinase (CK) 116



7.2.2 Myoglobin 117

7.2.3 Cardiac Troponins T (TnT), I (TnI) and C (TnC) 117

7.2.4 C-Reactive Protein (CRP) 117

7.2.5 Homocysteine 118

7.3 Emerging Markers 118

7.3.1 B-type Natriuretic Peptide (BNP) 118

7.3.2 Myeloperoxidase (MPO) 118

7.3.3 Ischemia Modified Albumin (IMA) 119

7.3.4 Glycogen Phosphorylase Isoenzyme BB (GPBB) 119

7.3.5 Fatty Acid-Binding Proteins (FABPs) 119




7.5 Specific Cardiac Conditions 121

7.5.1 Acute Myocardial Infarction 121

7.5.2 Heart Failure (BNP) 123

7.5.2.1 Market Overview 123

7.5.2.2 Commercial Assays for BNP and NT-proBNP 124

7.5.2.3 Clinical Applications of BNP 125

7.5.3 CRP 128

7.6 Pulmonary Embolism (D-dimer Test) 129

7.7 Key Players 130




8. Cytogenetic Testing 139

8.1 Cancer Testing 140

8.2 Prenatal Testing and Cytogenetics 142

8.2.1 Cystic Fibrosis Testing 143

8.2.1.1 CF Testing Methodology 144

8.2.1.2 CF Screening Technology Summary 147

8.3 Key Players in Segment 148

9. Fertility Testing 149

10. Cancer Biomarker Testing 153

10.1 Segment Overview 153

10.2 The Cancer Testing Market 154

10.3 Competition 156

10.4 Individual Markets 156

10.4.1 Cancer Pathology: Testing 156

10.4.1.1 Rare Cell/Micro Metastasis Detection 157

10.4.1.2 Cancer Pathology: High-Throughput Screening 158

10.4.1.3 Competition 159

10.4.1.4 Drivers 160

10.4.2 Breast Cancer 160

10.4.2.1 CA 15-3 161

10.4.2.2 CA 27-29 161

10.4.2.3 BRCA1 and BRCA2 Breast and Ovarian Cancer Genes 162



10.4.2.4 Estrogen and Progesterone Receptor (ER and PR) 164

10.4.2.5 HER-2 164

10.4.2.6 Herceptin 165

10.4.2.7 p53 165

10.4.2.8 NMP66 165

10.4.2.9 Mammastatin 166

10.4.2.10 Drivers for Breast Cancer Test Development 166

10.4.3 Ovarian Cancer 167

10.4.3.1 Cancer Antigen 125 (CA125) 167

10.4.3.2 BRCA1 and BRCA2 168

10.4.3.3 Steroid Hormone Receptors 169

10.4.3.4 Epidermal Growth Factor Receptor (EGFR) 169

10.4.3.5 Lysophospholipids 171

10.4.4 Cervical Cancer 171

10.4.4.1 Cervical Cancer Screening Tests 172

10.4.5 Colon Cancer DNA Testing 173

10.5 Pharmacogenomic Cancer Testing 175


11. Substance Abuse Testing 180

11.1 Background to POC Substance Abuse Testing 180

11.2 Substance Abuse Test Types 187

11.2.1 Urine Substance/Drug Screening 187

11.2.2 Hair Tests for Substance Abuse and Screening 187



11.2.3 Blood Tests for Substance Abuse and Screening 188

11.2.4 Saliva Tests for Substance Abuse and Screening 188

11.2.5 Sweat Tests for Substance Abuse and Screening 188

11.3 Alcohol Abuse and Screening 188

11.4 Saliva Testing 189




11.6 Review of Selected POC Substance Abuse Analyzers 190

11.7 Review of Company Products 192

11.7.1 Alere 192

11.7.2 Abbott Diagnostics 192

11.7.3 Roche Diagnostics 193

11.7.4 BioScan Screening Systems, Inc. 194

11.7.5 American Bio Medica Corp. 194

11.7.6 Phamatech, Inc. 197

11.7.7 First Check Medical 198

11.7.8 OraSure 198

11.7.9 Avitar, Inc. 199

11.7.10 Concateno 199

11.7.11 Pathtech 199

11.7.12 Alfa Scientific Designs, Inc. 200

11.7.13 TCPI, Inc. 201

11.7.14 Roche 201



11.7.15 Biophor Diagnostics 201

11.7.16 Randox Laboratories 201

11.7.17 Branan Medical 201

11.7.18 Concateno 202


12. Vitamin D Diagnostic Testing 204


13. Renal Dialysis Testing 209

14. Companion Diagnostics 210


15. Summary Analysis of the Global IVD High-Growth Market by Geographic Region
213

15.1 Summary Analysis of the Global IVD Market 213

15.2 Summary Analysis of the Global IVD High-Growth Market by Geographic Region
216

15.3 U.S.: Summary Analysis of the IVD High-Growth Market 217

15.3.1 U.S.: Summary of IVD High-Growth Market 218

15.3.2 Cardiac Markers 220

15.4 Europe: Summary Analysis of the IVD High-Growth Market 223

15.4.1 Summary of IVD High-Growth Market Europe 227

15.5 Brazil: Summary Analysis of the IVD High-Growth Market 230



15.5.1 Summary of IVD High-Growth Market Brazil 231

15.6 Russia: Summary Analysis of the IVD High-Growth Market 233

15.6.1 Summary of IVD High-Growth Market Russia 234

15.7 India: Summary Analysis of the IVD High-Growth Market 236

15.7.1 Summary of IVD High-Growth Market India 243

15.8 China: Summary Analysis of the IVD High-Growth Market 245

15.8.1 Summary of IVD High-Growth Market China 261

15.9 South-East Asia and Japan: Summary Analysis of the IVD High-Growth Market
263

15.9.1 Japan 264

15.9.2 South Korea 267

15.9.3 Rapid Growth Market of IVD HIV/AIDS Testing in Other Asia 269

15.9.4 Summary of IVD High-Growth Market Other Asia 271

16. Clinical Laboratory Genomics 273

16.1 Introduction 273

16.2 Clinical Laboratory Genomics Testing 274

16.3 Developments in Clinical Laboratory Genomics 275

16.3.1 Nucleic Acid Amplification Techniques 275

16.3.2 Chromosome Imaging 276

16.3.3 Genomics Technologies 276

16.3.4 Proteomics Technology 277

16.3.5 Current Pharmacogenomic Tests 277

16.3.6 Future Pharmacogenomic Testing 278



17. Cellular Imaging Cytopathology and Histopathology 280

17.1 Segment Overview 280

17.2 The Market 280

17.3 Market Drivers 282

17.4 Market Restraints 282

17.5 Cytology and Histology Technology Platforms 282

17.5.1 Cytology Screening Procedures and Pap Smear Technology 283

17.5.2 Histology 288


17.5.4 ISH Staining 290

17.5.5 Special-Stains Staining 290

17.6 Third-Party Reimbursement 290

17.7 Competition 291

18. High-Growth Testing Diagnostic Trends 295

18.1 Genetic Testing 295

18.2 Quality Measures 295

18.3 Moderators of Growth 295

18.3.1 Diagnostics and the Aging Population 295

18.3.2 Individualized Medicine 295

18.3.3 Genetic Testing 295

18.4 Workforce Issues 297

18.5 Reimbursement 297

18.5.1 Cardiovascular 298



18.5.2 Screening for Diabetes 299

18.5.3 CPT Test Codes and Payment Amounts 299

18.6 Rapid Near-Patient Testing in Hospitals 302

18.7 Satellite Facilities 302

18.8 Regionalization of Laboratory Care 303

18.9 Requirements for High-Growth Testing 304

18.10 Clinical Laboratory Improvement Act (CLIA) 305

19. Important Technology Trends 308

20. Molecular Diagnostics a Major Diagnostic Technological Advance 311

20.1 Polymerase Chain Reaction (PCR)-based Molecular Diagnostics 312

20.2 Micrarray Technologies and Molecular Diagnostics 313

20.3 Isothermal Amplification Technologies and Molecular Diagnostics 314

20.4 Miniaturization Technologies and Molecular Diagnostics (Biochips and Lab on
a Chip) 315

21. Technology Platform Innovations in POCT 317

21.1 Latest POCT Technological Platforms 317

21.1.1 Device Miniaturization and Microfluidic Technologies 317

21.1.2 Minimally Invasive and Non-invasive POCT Technologies 317

21.1.3 Advances in Wireless Technologies 318

21.1.4 Automation of POCT 318

21.1.5 Developments in New Genomic Technologies (Genotyping, Haplotyping and
Sequencing



Technologies) 318

21.1.6 Advances in Informatics Technologies 320

21.1.7 Pharmacogenetic Testing 321

21.1.8 Multi Assay Technologies in POCT 321

21.2 Developments in Key Technologies 321

21.2.1 Medical and Biological Sensors and Sensor Systems 321

21.2.2 Recent Biosensor Product Introductions and Latest Innovative Developments
323

21.2.2.1 Nanoscale Sensors for the Detection of Cancer Biomarkers 323

21.2.2.2 ForteBio Introduces Dip and Read Protein G Biosensor for Octet
Instruments 323

21.2.2.3 ForteBio Launches New Octet RED96 System and Dip and Read Protein L
Biosensor 323

21.2.2.4 AgaMatrix Europe Limited Introduces the New Jazz Blood Glucose Meter in
the U.K. 324

21.2.2.5 STMicroelectronics to Manufacture Worlds Smallest Biosensors 324

21.2.2.6 Universal Biosensors Advances Point of Care Molecular Diagnostic
Opportunity 324

21.2.2.7 Clinitek Advantus'A Semi Automated Urine Analyzer for Point of Care
Testing 324

21.2.2.8 The NOVA 16 STAT Chemistry Analyzer Offers the First
All-Electrode-based Seven Test Chemistry Profile 324

21.3 Sensor Systems for Diagnostic Applications 326

21.4 Nanogen (The ELITech Group) Third Generation Point of Care Analyzer 329

21.5 Philips Development of Magnotech Technology 329

21.6 Quidel Corporation MChip, AVR Chip and F Chip 329

21.7 Sanofi-Aventis 330



22. Data Management and Connectivity 331

22.1 Wireless LANs 331

22.2 Connectivity Platforms 334

22.2.1 DataLink Data Management System 334

22.2.2 RALS-Plus 335

22.2.2.1 International Technidyne Corporation HEMOCHRON Signature Elite 337

22.2.2.2 Siemens Diagnostics Rapidpoint Coag 337

22.2.2.3 Radiometer 337

22.2.2.4 HemoCue's DM Hemoglobin 337

22.2.2.5 Roche Diagnostics 337

22.2.3 BD.id 338

22.2.4 Medical Implant Communications Service (MICS) 338

22.2.5 Conworx Technology 338

22.2.6 Lab Data Systems 339

22.2.7 Medasys 339

22.2.8 NoemaLife 339

22.3 Advantages of POCT Connectivity 340

22.3.1 Cost Benefit of POCT and IT Connectivity 340

22.3.2 Hospital Network Issues 340

22.4 POCT Analyzer Connectivity Software Solutions 341

22.5 POCT2-P 343

23. Biochips for Clinical Applications 344

23.1 Roche AmpliChip 352



23.2 Amersham CodeLink 354

23.3 Breast Cancer DNA Chips 354

23.4 Osmetech eSensor 354

23.5 Affymetrix GeneChip System 3000Dx v.2 355

23.6 Caliper and Cepheid 355

23.7 Agilent Technologies 2100 Lab-on-a-Chip 355

24. Company Profiles 357

24.1 Abaxis, Inc. 357

24.2 Abbott Laboratories 359

24.3 Accurex Biomedical, Pvt. Ltd. 361

24.4 Adeza Biomedical Corporation (Hologic) 361

24.5 Agilent Technologies, Inc. 361

24.6 Alere, Inc. 363

24.7 Ambri Ltd. 365

24.8 American Bio Medica Corp. 365

24.9 Ani Biotech 367

24.10 Applied Spectral Imaging 368

24.11 Avitar, Inc. 369

24.12 Axis-Shield 370

24.13 Bayer Corporation 371

24.14 Beckman Coulter 372

24.15 Becton Dickinson 375

24.16 Biomerica 376



24.17 Bio-Rad, Inc. 377

24.18 Calypte Biomedical Corporation 378

24.19 Chembio Diagnostics, Inc. 379

24.20 Cozart Bioscience 380

24.21 Denka Seiken Co., Ltd. 380

24.22 diaDexus, LLC 381

24.23 Enterix, Inc. (Subsidiary of Quest Diagnostics) 382

24.24 EY Laboratories, Inc. 382

24.25 Genetix 383

24.26 Genzyme Diagnostics 384

24.27 Hologic, Inc. 384

24.28 Instrumentation Laboratory (IL)/Werfen Group 386

24.29 Jiangnan Biotech 386

24.30 Johnson & Johnson 387

24.31 Kyowa Medex Co., Ltd. 388

24.32 LifeAssays AB 388

24.33 LifeScan 389

24.34 Matritech 389

24.35 A Menarini Diagnostics 390

24.36 Meretek Diagnostics Group 390

24.37 Meridian Bioscience 391

24.38 Medix Biochemica 393

24.39 Myriad Genetics 393

24.40 NOVA Biomedical 395



24.41 OraSure 396

24.42 Pheromone Sciences 398

24.43 Polymedco 399

24.44 Polymer Technology Systems, Inc. 400

24.45 QIAGEN 400

24.46 Quest Diagnostics, Inc. 401

24.47 Quidel 402

24.48 Radiometer Medical 406

24.49 Roche Diagnostics 409

24.50 Shanghai Siic Kehua Biotech Co., Ltd. (Kehua Biotech) 412

24.51 Shionogi & Co. 412

24.52 Siemens 412

24.53 Spectral Diagnostics, Inc. 413

24.54 Trinity Biotech, Plc 413

24.55 Väsamed, Inc. 416

INDEX OF FIGURES

Figure 1.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2011
18

Figure 1.2: Top 13 Country IVD Testing Markets, 2011 19

Figure 1.3: Company Market Share for IVD Testing Markets, 2011 19

Figure 3.1: Evolution of HBV Markers in Acute and Chronic Infection 36

Figure 6.1: Global Incidence of Malaria 96



Figure 6.2: Mode of Action of Common Malaria RDT Format 99

Figure 6.3: FIND Pipeline for TB Diagnostics 109

Figure 15.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2011
214

Figure 15.2: Top 13 Country IVD Testing Markets, 2011 215

Figure 15.3: Company Market Share for IVD Testing Markets, 2011 215

Figure 15.4: Indian Diagnostics Market Segments, 2011 240

Figure 15.5: The Chinese Healthcare System 246

Figure 17.1: Worldwide Incidence Rates of Cervical Cancer Per 100,000 Females,
2011 284

INDEX OF TABLES

Table 1.1: Emerging Technology Platforms Driving High-Growth Diagnostics Market
Segments 14

Table 1.2: Market Trends in the High-Growth Diagnostics Space 16

Table 1.3: Worldwide Geographic Distribution of Total IVD Testing Market, 2011
18

Table 1.4: Top 13 Country IVD Testing Markets, 2011 18

Table 1.5: Company Market Share for IVD Testing Markets, 2011 19

Table 1.6: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing, 2008-2018 20

Table 1.7: Global IVD High-Growth Markets Revenues by Market Segment, 2008-2018
21

Table 1.8: Global IVD High-Growth Markets Percentage of Revenues by Geographic
Region, 2008-2018 21

Table 1.9: Global IVD High-Growth Markets Percentage of Revenues by Product



Type, 2008-2018 22

Table 3.1: Serological Diagnosis of Hepatitis B Virus Infections 32

Table 3.2: Lower Detection Limits of HBV DNA Assays 33

Table 3.3: Summary of Selected Suppliers of Hepatitis B Virus (HBV) Diagnostic
Products by Technology 37

Table 3.4: Global Revenue Forecasts for Hepatitis B Virus (HBV) and Hepatitis C
Virus (HCV) Diagnostic Testing, 2008-2018 39

Table 3.5: Global Revenue Forecasts for Hepatitis B Virus (HBV) Diagnostic
Testing, 2008-2018 40

Table 3.6: Efficiency of Available HCV Screening Tests 44

Table 3.7: Recommendations for Diagnostic Testing for Hepatitis C 45

Table 3.8: Hepatitis C Statistics 46

Table 3.9: Novartis Diagnostics Clinical Diagnostic Products Test for the
Detection of HCV 47

Table 3.10: Global Revenue Forecasts for Hepatitis C Virus (HCV) Diagnostic
Testing, 2008-2018 49

Table 4.1: HPV Risk Factors 50

Table 4.2: HPV and Cervical Carcinoma 51

Table 4.3: Key statistics on Cervical Cancer in the World, 2011 52

Table 4.4: Reflex HPV Testing with Cytology 57

Table 4.5: Predictability of HPV Test by Abnormal Pap Smear Type 57

Table 4.6: Long-Term Trends in HPV Testing 58

Table 4.7: Global Revenue Forecasts for Human Papillomavirus (HPV) Diagnostic
Testing, 2008-2018 58

Table 5.1: Global HIV Statistics, 2009 62

Table 5.2: Antiretroviral Therapy (ART) Coverage, 2008 63

Table 5.3: Estimated Number of HIV Infection, 2009 64



Table 5.4: Estimated Number of AIDS Infection, 2009 64

Table 5.5: Drivers of Demand for HIV Diagnostic Testing 65

Table 5.6: NAT HIV Monitoring Market: Market Drivers Ranked in Order of Impact
66

Table 5.7: Drivers of Demand for HIV Diagnostic Testing 66

Table 5.8: NAT HIV Monitoring Market: Market Restraints Ranked in Order of
Impact 66

Table 5.9: Selected POC Infectious Disease Testing Devices, 2011 70

Table 5.10: Global Revenue Forecasts for HIV and AIDS Diagnostic Testing,
2008-2018 72

Table 5.11: Competitive Factors Related to HIV Tests 74

Table 6.1: Rapid Strep Tests on the Market 84

Table 6.2: Rapid Tests for Chlamydia 88

Table 6.3: Rapid Tests for Gonorrhea 92

Table 6.4: Commercially-available Rapid Tests for Malaria 102

Table 6.5: Estimated TB Incidence, Prevalence and Mortality, 2009 105

Table 6.6: FIND Partners 110

Table 6.7: Global Market Potential for TB Diagnostic Testing, 2000-2010 112

Table 6.8: MRSA Diagnostics Currently on the Market 114

Table 6.9: Global Revenue Infectious Disease Revenue Analysis, 2008-2018 115

Table 7.1: Medication Chart for Cardiovascular Disease 120

Table 7.2: BNP Clinical Characteristics 124

Table 7.3: Cardiovascular Risk Classification by CRP Level 129

Table 7.4: Clinical Characteristics of D-dimer 129

Table 7.5: Global Revenue Forecasts for Cardiac Marker Testing, 2008-2018 138

Table 8.1: Genetic Testing: Consequences and Challenges 143



Table 8.2: CF Carrier Risk by Ethnic Group 143

Table 8.3: Reasons for CF Testing 144

Table 8.4: CF Gene Detection Rates Vary by Ethnic Background 145

Table 8.5: Global Market for CF Diagnostic Testing, 2008-2018 146

Table 8.6: U.S. Market for CF Diagnostic Testing, 2008-2018 146

Table 8.7: Commercial CF Screening Products 147

Table 8.8: Emerging CF Screening Products 147

Table 9.1: The Fertility Testing Market in the U.S., 2008-2018 149

Table 10.1: Estimated Numbers of New Cases for Selected Cancers in the U.S.,
2012 154

Table 10.2: Five-Year Disease-free Survival by Stage at Diagnosis 155

Table 10.3: TPA Marker Sensitivity 164

Table 10.4: INFINITI Applications 178

Table 10.5: Global Revenue Forecasts for Cancer Marker Testing, 2008-2018 179

Table 11.1: Drug Testing Needs Tier I for Rapid Serum POCT in the Emergency
Department 185

Table 11.2: Stat Urine Testing Drug Recommendations 186

Table 11.3: Selected POC Substance/Drug Abuse Testing Devices, 2011 190

Table 11.4: Selected POC Substance/Drug Abuse Testing Devices, OraSure, 2011 198

Table 11.5: Selected Target Substances and Drugs, 2011 199

Table 11.6: Global Revenue Forecasts for Substance Abuse Testing, 2008-2018 203

Table 12.1: Global Revenue Forecasts for Vitamin D Testing, 2008-2018 208

Table 14.1: Global Revenue Forecasts for Companion Diagnostics, 2008-2018 212

Table 15.1: Worldwide Geographic Distribution of Total IVD Testing Market, 2011
213

Table 15.2: Top 13 Country IVD Testing Markets, 2011 214



Table 15.3: Company Market Share for IVD Testing Markets, 2011 215

Table 15.4: Global Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing, 2008-2018 216

Table 15.5: Global IVD High-Growth Markets Percentage of Revenues by Geographic
Region, 2008-2018 216

Table 15.6: Global IVD High-Growth Markets Percentage of Revenues by Product
Type, 2008-2018 217

Table 15.7: Summary of IVD High-Growth Market U.S., 2011 218

Table 15.8: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic
Testing U.S.,

2008-2018 218

Table 15.9: U.S. Individual IVD High-Growth Markets Revenue Forecast, 2008-2018
219

Table 15.10: U.S. Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,

2008-2018 219

Table 15.11: Specific Cardiac Markers 220

Table 15.12: Cardiac Markers after Onset of Myocardial Infarction 221

Table 15.13: U.S. Cardiac Marker Revenue Forecasts, 2008-2018 223

Table 15.14: Market Share of Cardiac Marker Segment 223

Testing Europe,

2008-2018 227

Table 15.16: Europe: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 228

Table 15.17: Europe: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,

2008-2018 228




Testing Brazil,

2008-2018 232

Table 15.19: Brazil: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 232

Table 15.20: Brazil: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,

2008-2018 233

Testing Russia,

2008-2018 234

Table 15.22: Russia: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 235

Table 15.23: Russia: Individual IVD High-Growth Markets Percentage of Revenues
by Product Type,

2008-2018 235

Table 15.24: Overview of Healthcare in India 237

Table 15.25: Population Projections India 239

Table 15.26: Statistical Healthcare Data India 239

Testing India,

2008-2018 244

Table 15.28: India: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 244

Table 15.29: India: Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,

2008-2018 245

Table 15.30: Number of Healthcare Institutions According to Ownership China,
2010 247

Table 15.31: Total Number of Hospitals by Ranking China, 2010 248



Table 15.32: Disease Burden in China: Urban and Rural 249

Table 15.33: China Biotech Reagents Market 257

Table 15.34: Biotechnology Projects Between China and the West 258

Testing China,

2008-2018 262

Table 15.36: China: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 262

Table 15.37: China: Individual IVD High-Growth Markets Percentage of Revenues by
Product Type,

2008-2018 263

Testing Other Asia,

2008-2018 271

Table 15.39: Other Asia: Individual IVD High-Growth Markets Revenue Forecast,
2008-2018 272

Table 15.40: Other Asia: Individual IVD High-Growth Markets Percentage of
Revenues by Product Type,

2008-2018 272

Table 17.1: Estimated Cervical Cancer Cases/Deaths Worldwide, 2011 286

Table 17.2: Medicare Reimbursement for Cervical Pathology Procedures 290

Table 18.1: New CPT Test Codes Introduced in 2008 301

Table 19.1: Employment of Clinical Laboratory Workers, 2006-2016 309

Table 21.1: Common Genotype Techniques 319

Table 22.1: Applications for Wireless LAN Technology 331

Table 22.2: Customized Reports Must Support CAP and JCAHO Requirements 335

Table 22.3: RALS-Plus Point of Care Market Share 336



Table 22.4: Applications of RALS Connectivity with POCT Devices 336

Table 23.1: Biochip Revenues and Growth Rates by Application, 2003 and 2007 344

Table 23.2: Total Biochip Market: Worldwide Revenue Forecasts, 2008-2018 349

Table 23.3: Total Biochip Market: U.S. Revenue Forecasts, 2008-2018 349

Table 24.1: Abaxis, Inc. Financial Figures'Net Sales by Business Sector,
2008-2010 358

Table 24.2: Abaxis, Inc. Financial Figures'Net Sales by Geographic Region,
2008-2010 359

Table 24.3: Abbott Laboratories Financial Figures'Net Sales by Business Sector,
2008-2010 360

Table 24.4: Abbott Laboratories Financial Figures'Net Sales by Geographic
Region, 2008-2010 360

Table 24.5: Alere, Inc. Financial Figures'Net Sales by Business Sector,
2008-2010 364

Table 24.6: Alere, Inc. Financial Figures'Net Sales by Geographic Region,
2008-2010 365

Table 24.7: Bayer AG Financial Figures'Net Sales by Business Sector, 2008-2010
372

Table 24.8: Bayer AG Financial Figures'Net Sales by Geographic Region, 2008-2010
372

Table 24.9: Bio-Rad Laboratories, Inc. Financial Figures'Net Sales by Business
Sector, 2008-2010 377

Table 24.10: Bio-Rad Laboratories, Inc. Financial Figures'Net Sales by
Geographic Region, 2008-2010 378

Table 24.11: Johnson & Johnson Financial Figures'Net Sales by Major Medical and
Diagnostics Businesses,

2008-2010 388

Table 24.12: Quidel Product Sales Distribution and Sales, 2009 and 2010 403

Table 24.13: Danaher Corporation Financial Figures'Net Sales by Business Sector,
2008-2010 407



Table 24.14: Danaher Corporation Financial Figures'Net Sales by Geographic
Region, 2008-2010 407

Table 24.15: Roche Group Financial Figures'Net Sales by Business Sector,
2008-2010 411

Table 24.16: Roche Group Financial Figures'Net Sales by Geographic Region, 2009
and 2010 411

Table 24.17: Roche Group Financial Figures'Net Sales by Sub-Division, 2008-2010
411


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High-Growth Diagnostic Testing Markets

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