Point of Care Diagnostic Testing - World Markets

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Publication Date: 2008-04-01

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The purpose of this report is to describe the point of care testing (POCT) market. It examines clinical measurement devices and their reagents and supplies as utilized in hospitals, clinics and doctor\'s offices. An analysis of analytes that are related to the common chemical constituents of blood, plasma or serum at the point of care of the patient is addressed. Moreover, the study defines the dollar volume of sales, both worldwide and in the U.S., and analyzes the factors that influence the size and the growth of the market segments.

Also examined are the subsections of each market segment, including the research labs, hospital labs and commercial laboratories. Additionally, rapid detection of food pathogens and infectious pathogens (MRSA, herpes simplex, avian flu, West Nile virus and typhoid) are discussed.

The report surveys almost all of the companies known to be marketing, manufacturing or developing instruments and reagents for the point of care market in the U.S. Each company is discussed in extensive depth with a section on its history, product line, business and marketing analysis, and a subjective commentary of the company\'s market position.

Table of Contents

 

  • LIST OF FIGURES

  • Figure 3.1:Worldwide Distribution of IVD Testing in 200626
  • Figure 3.2:Global Point of Care Revenues, 1998 - 2008 29
  • Figure 3.3:Global Point of Care Testing Share of Total In Vitro Diagnostic Testing Market 30
  • Figure 4.1Number of HbA1c Tests Performed Globally as POCT (in Millions)85
  • Figure 6.1:Annual Rate of Emergency Room Visits By Primary Expected Source of Payment: U.S., 2004 232


  • INDEX OF TABLES

  • Table 2.1:POC Testing21
  • Table 3.1:Number of ER Visits in U.S. Hospitals, 1997-200423
  • Table 3.2:Number of Point of Care Tests in U.S., 2000-201224
  • Table 3.3:Global Clinical Laboratory Market Sales, 1998-201025
  • Table 3.4:The Overall In Vitro Diagnostic Testing Market Worldwide in 200626
  • Table 3.5:Worldwide Distribution of IVD Testing in 200626
  • Table 3.6:Top Twelve Country IVD Testing Markets, 200527
  • Table 3.7:Fifteen Largest Diagnostic Companies Worldwide, 200527
  • Table 3.8:Global Point of Care Revenues, 2000-201228
  • Table 3.9:Worldwide POCT Market Size by Geographic Location, 2000 - 201229
  • Table 3.10:Worldwide Distribution of POCT, 200729
  • Table 3.11:Worldwide POCT by Performance Location, 200730
  • Table 3.12:Worldwide Clinical Diagnostic POCT and Rapid Test Market Segments, 200730
  • Table 3.13:U.S. Clinical Laboratory Testing Market, 2003-201231
  • Table 3.14:U.S. Clinical Laboratory Diagnostic Test Market Segments by Location of Analysis, 2006 31
  • Table 3.15:U.S. POCT Market, 2000-201231
  • Table 3.16:U.S. POCT by Performance Location, 200732
  • Table 3.17:U.S. Clinical Diagnostic POCT and Rapid Test Market Segments, 200532
  • Table 3.18:European Clinical Laboratory Testing IVD Reagents and Instruments Market ($), 2000-2012 33
  • Table 3.19:European Clinical Laboratory Testing IVD Reagents and Instruments Market (€), 2000-2012 33
  • Table 3.20:European Clinical Laboratory Testing Diagnostics by Country Market Estimates, 200634
  • Table 3.21:European Rapid Point of Care Testing by Country Market Estimates, 200634
  • Table 3.22:Regional Comparison of Healthcare Spending for IVD for Eastern Europe37
  • Table 3.23:European POCT Market, 2000-201238
  • Table 3.24:Top Twelve Country IVD and POC Testing Markets, 200538
  • Table 3.25:German Clinical Laboratory Testing Diagnostics Products Market Sales, 2003-201239
  • Table 3.26:German POCT Diagnostics Products Market Sales, 2003-2012 39
  • Table 3.27:German Clinical Diagnostic Rapid Test Market Segments, 200640
  • Table 3.28:U.K. Clinical Laboratory Diagnostics Products Market Sales, 2003-201241
  • Table 3.29:U.K. POCT Diagnostics Products Market Sales, 2006-201242
  • Table 3.30:U.K. Clinical Diagnostic Rapid Test Market Segments, 200642
  • Table 3.31:Major U.K. IVD Manufacturers43
  • Table 3.32:U.S. IVD Manufacturers Doing Business in the U.K.43
  • Table 3.33:Other European Companies that Manufacture IVD Products in the U.K.43
  • Table 3.34:French Clinical IVD Testing Diagnostics Products Market Sales, 2003-201244
  • Table 3.35:French POC Diagnostics Products Market Sales, 2005-201245
  • Table 3.36:French Clinical Diagnostic Rapid Test Market Segments, 2006 45
  • Table 3.37:Italian Laboratory Diagnostics Products Market Sales, 2003-201246
  • Table 3.38:Italian POC Diagnostics Products Market Sales, 2005-201246
  • Table 3.39:Italian Clinical Diagnostic Rapid Test Market Segments, 200646
  • Table 3.40:Spanish Clinical Laboratory Diagnostics Products Market Sales, 2003-201247
  • Table 3.41:Spanish Clinical Diagnostic Rapid Test Market Segments, 200647
  • Table 3.42:Spanish POC Diagnostics Products Market Sales, 2005-201248
  • Table 3.43:Scandinavian POCT Diagnostics Products Market Sales, 2000-201248
  • Table 3.44:Swedish Clinical Laboratory Diagnostics Products Market Sales, 2003-201249
  • Table 3.45:Swedish POC Diagnostics Products Market Sales, 2005-201249
  • Table 3.46:Finnish Clinical Laboratory Diagnostics Products Market Sales, 2003-201249
  • Table 3.47:Finnish POC Diagnostics Products Market Sales, 2005-201250
  • Table 3.48:Norwegian Clinical Laboratory Diagnostics Products Market Sales, 2003-201250
  • Table 3.49:Norwegian POC Diagnostics Products Market Sales, 2005-201250
  • Table 3.50:Swiss Clinical Laboratory Diagnostics Products Market Sales, 2003-201251
  • Table 3.51:Swiss POCT Diagnostics Products Market Sales, 2005-201251
  • Table 3.52:Dutch Clinical Laboratory Diagnostics Products Market Sales, 2003-201252
  • Table 3.53:Dutch POC Diagnostics Products Market Sales, 2005-201252
  • Table 3.54:Belgium Clinical Laboratory Diagnostics Products Market Sales, 2003-201252
  • Table 3.55:Belgium POCT Diagnostics Products Market Sales, 2005-201253
  • Table 3.56:Portuguese Clinical Laboratory Diagnostics Products Market Sales, 2003-201253
  • Table 3.57:Portuguese POCT Diagnostics Products Market Sales, 2005-201253
  • Table 3.58:Austrian Clinical Laboratory Diagnostics Products Market Sales, 2003-201254
  • Table 3.59:Austrian POCT Diagnostics Products Market Sales, 2005-201254
  • Table 3.60:Greek Clinical Laboratory Diagnostics Products Market Sales, 2003-201255
  • Table 3.61:Greek POCT Diagnostics Products Market Sales, 2005-201255
  • Table 3.62:Polish Clinical Laboratory Diagnostics Products Market Sales, 2003-201255
  • Table 3.63:Polish POCT Diagnostics Products Market Sales, 2005-201256
  • Table 3.64:Czech Clinical Laboratory Diagnostics Products Market Sales, 2004-201256
  • Table 3.65:Czech POCT Diagnostics Products Market Sales, 2005-201256
  • Table 3.66:Turkish POCT Market, 2000-201257
  • Table 3.67:Japan Point of Care Testing Market, 2000-201258
  • Table 3.68:Japanese Population and Aging Demographics Forecast, 2000-205058
  • Table 3.69:Indian IVD Market for Instruments and Reagents, 2004-201259
  • Table 3.70:Number of Automated Clinical Labs in India, 2004-201259
  • Table 3.71:Indian IVD Market, 200660
  • Table 3.72:Indian Point of Care Diagnostics Products Market Sales, 2000-200864
  • Table 3.73:Chinese IVD Market, 2006-201264
  • Table 3.74:Number of Automated Clinical Labs in China, 2004-201265
  • Table 3.75:Chinese IVD Market, 200666
  • Table 3.76:Chinese Point of Care Diagnostics Products Market Sales, 2000-201271
  • Table 3.77:The Rest of the World POCT Market, 2000-201273
  • Table 3.78:Canadian POCT Market, 2000-201274
  • Table 3.79:Brazilian POCT Market, 2000-201274
  • Table 3.80:Australian POCT Market, 2000-201275
  • Table 4.1:World Market Share of Point of Care Glucose Monitoring Marketers80
  • Table 4.2:The Global Population of Persons with Diabetes, 1995 and 202581
  • Table 4.3:The Glucose Testing Market for POCT Worldwide, 2001-201281
  • Table 4.4:U.S. Point of Care Glucose Testing Market, 1997-201282
  • Table 4.5:Manufacturer Market Share U.S. POCT Market, 2007 82
  • Table 4.6:Rapid Testing U.S. Market Share for Blood Glucose Testing Segment83
  • Table 4.7:The HbA1c Testing Market for POCT Worldwide, 2006-201286
  • Table 4.8:The Critical Care Blood Gas Testing Market for POCT Worldwide, 2006-201286
  • Table 4.9:The Blood Gas and Electrolyte Market for POCT in the U.S., 2001-201287
  • Table 4.10:Location Market Share of Critical Care Blood Gas Testing87
  • Table 4.11:Manufacturer Market Share U.S. POCT Blood Gas and Electrolytes Market, 200588
  • Table 4.12:The Coagulation Testing Market for POCT Worldwide, 2006-201290
  • Table 4.13:The Hand-held Coagulation Testing Market for POCT Worldwide, 2006-201290
  • Table 4.14:The Coagulation Market for POCT in the U.S., 2001-201291
  • Table 4.15:The POC Prothrombin Market for POCT in the U.S., 2000-200791
  • Table 4.16:The Cardiac Marker Market for POCT in the U.S., 2001-201295
  • Table 4.17:The Cardiac Marker Market for POCT Worldwide, 2001-201295
  • Table 4.18:Manufacturer Market Share U.S. POCT Cardiac Marker Market, 200595
  • Table 4.19:The Cardiac Marker Market for POCT in Europe, 2001-201196
  • Table 4.20:Drugs of Abuse Testing Market for POCT Worldwide, 2006-2012101
  • Table 4.21:U.S. Point of Care Drugs of Abuse Testing Market, 2006-2012101
  • Table 4.22:Drug Testing Needs Tier 1 for Rapid Serum Point of Care Testing in the Emergency Department103
  • Table 4.23:Stat Urine Testing Drug Recommendations103
  • Table 4.24:Device Specifications for POC Breath Alcohol Analysis105
  • Table 4.25:Global Point of Care Urine Test Strip Testing Market, 2001-2007106
  • Table 4.26:Global Point of Care Urine Test Strip POCT Testing Market, 2006-2012106
  • Table 4.27:U.S. Point of Care Urine Test Strip Testing Market, 2001-2011106
  • Table 4.28:U.S. Point of Care Urine Test Strip Testing Market Share107
  • Table 4.29:Medicare Fee Schedule for Urine Chemistry Testing108
  • Table 4.30:Pregnancy Testing Market for POCT Worldwide, 2006-2012108
  • Table 4.31:U.S. Point of Care Pregnancy Testing Market, 2001-2012109
  • Table 4.32:International Point of Care Pregnancy Testing Markets, 2001-2007109
  • Table 4.33:U.S. Market Share for Rapid Point of Care Pregnancy Tests109
  • Table 4.34:Hemoglobin Testing Market for POCT Worldwide, 2006-2012110
  • Table 4.35:Worldwide POCT Market for HIV, 2001-2012115
  • Table 4.36:U.S. POCT Market for HIV, 2001-2012115
  • Table 4.37:Countries with the Highest Prevalence of HIV/AIDS117
  • Table 4.38:FDA-Approved Rapid HIV Antibody Screening Tests118
  • Table 4.39:OraSure OraQuick Rapid HIV Test Revenues, 2005119
  • Table 4.40:The Cholesterol Testing Market for POCT Worldwide, 2006-2012120
  • Table 4.41:The Infectious Disease Testing Market for POCT Worldwide, 2006-2012120
  • Table 4.42:Salmonella Testing Market, 2002-2007122
  • Table 4.43:Worldwide Point of Care Influenza Testing Market, 2002-2007124
  • Table 4.44:U.S. Point of Care Influenza Testing Market, 2002-2007125
  • Table 4.45:International Point of Care Influenza Testing Markets, 2002-2007125
  • Table 4.46:U.S. Market for Rapid Point of Care Influenza Tests, 2005125
  • Table 4.47:Worldwide Point of Care Strep A Testing Market, 2002-2007126
  • Table 4.48:U.S. Point of Care Strep A Testing Market, 2002-2007126
  • Table 4.49:International Point of Care Strep A Testing Markets, 2002-2007126
  • Table 4.50:U.S. Market for Rapid Point of Care for Group A Strep Tests126
  • Table 4.51:Global Market for Chlamydia Diagnostic Testing, 2000-2009127
  • Table 4.52:U.S. Market for Chlamydia Diagnostic Testing, 2000-2009127
  • Table 4.53:Global Market for Gonorrhea Diagnostic Testing, 2000-2009132
  • Table 4.54:Global Market for TB Diagnostic Testing, 2000-2008133
  • Table 4.55:U.S. Anthrax Test Market135
  • Table 5.1:Drug Test Sensitivity Cut-Off Levels Established as Standard by NIDA, WHO and SAMHSA for Drugs of Abuse174
  • Table 5.2:Major Competitors in the Drugs of Abuse Testing Market Segment174
  • Table 5.3:Major Competitors in the Drugs of Abuse Oral Testing Market Segment174
  • Table 5.4:Major Competitors in the Drugs of Abuse Urine Testing Market Segment175
  • Table 5.5:Major Competitors in the Drugs of Abuse Saliva Testing Market Segment175
  • Table 5.6Siemens Urinalysis Near-patient Devices185
  • Table 5.7:ColoCARE Fecal Occult Blood Test188
  • Table 5.8:Type of Hepatitis Test: Lateral Flow217
  • Table 5.9:Flow-Through218
  • Table 5.10:Agglutination218
  • Table 5.11:Immunoblot218
  • Table 5.12:AmniSure224
  • Table 6.1:Access Points226
  • Table 6.2:Desktop Adapters-One Computer226
  • Table 6.3:Desktop Adapters-Four Computers227
  • Table 6.4:PCMCIA Adapters227
  • Table 6.5: POCT1-Compliant Connectivity Point of Care Instruments229
  • Table 6.6:POCT Clinical Outcomes in Diabetic Ketoacidosis232
  • Table 6.7:POCT Clinical Outcomes in Arterial Blood Gas Measurements232
  • Table 6.8:POCT in Three Hospitals. Cost Analysis with Labor Included235
  • Table 6.9:Cost Analysis for Glucose Testing: POCT vs. Central Lab235
  • Table 6.10:Financial Comparison for Moderate and Waived CLIA Labs238
  • Table 7.1Key Changes in IVD Business Structure244
  • Table 7.2Business Trends in Point of Care Testing253
  • Table 7.3Key Players Bring Business Developments to Point of Care Diagnostic Testing253
  • Table 8.1:Normal Glucose Values-Fasting State258
  • Table 9.1:Applications for Wireless LAN Technology265
  • Table 9.2:Wireless LAN Technology Companies266
  • Table 9.3:Customized Reports Must Support CAP and JCAHO Requirements269
  • Table 9.4RALS-Plus Point of Care Market Share270
  • Table 9.5:Applications of RALS Connectivity with POCT Devices270
  • Table 10.1:Products Marketed by Abbott in the Diagnostic Market278
  • Table 10.2:Quidel Product Sales Distribution and Sales, 2006329
  • Table 11.1:Improvements in Achieving ED Operational Efficiency Using POCT347
  • Table 11.2:Test Menu and TAT for ED348
  • Table 11.3:Top Reasons Why POC Cardiac Marker Testing is Implemented in the ED348
  • Table 11.4:Key Areas and Metrics That Hospitals Measure To Assess Efficiency of ED349
  • Table 11.5:Estimates of Patient Costs by DRG350

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