Diagnostic Testing Market Analysis 2013-2018 with Industry Chain Structure, Competitive Landscape

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 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.

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List 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

Table 15.15: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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

Table 15.18: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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

Table 15.21: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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

Table 15.27: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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

Table 15.35: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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

Table 15.38: Summary Revenue Forecasts for IVD High-Growth Markets Diagnostic 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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List 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

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