Key Diagnostic Testing Markets
This TriMark Publications report reviews the high-growth market segments for clinical laboratory testing equipment and supplies in the clinical hospital market, using screening reagents and instruments for analysis of individual components in blood, serum or plasma. Further, it examines the subsections of each market segment, including the clinical laboratory and research areas. Activity and trends in the clinical diagnostic market are discussed, including the numbers of institutions using this type of testing, and the factors that influence purchasing activity. Discussion details the trends that have developed that stimulate this market, and offers detailed comments on the patterns of information processing in point-of-care (POC) testing instruments. The study surveys most of the important companies known to be marketing, manufacturing or developing instruments and reagents in the areas selected as high-growth diagnostic markets in the U.S. and worldwide. Each company is discussed in depth, with a section on its history, product line, business and marketing analysis, and a subjective commentary on the company's position in its market and its strategic direction.
Table of Contents
- 1.Overview10
- 1.1Objectives10
- 1.2 Content and Scope10
- 1.3 Methodology11
- 1.4 Executive Summary12
- 1.4.1Glucose Monitoring13
- 1.4.2Coagulation13
- 1.4.3Rapid Cardiac Markers14
- 1.4.4 Drugs of Abuse Screening14
- 1.4.5 Infectious Disease Testing15
- 1.4.5.1Campylobacter15
- 1.4.5.2Chlamydia15
- 1.4.5.3Clostridium difficile15
- 1.4.5.4Cryptosporidium15
- 1.4.5.5 Dengue Fever15
- 1.4.5.6Entamoeba histolytica15
- 1.4.5.7 Giardia Species15
- 1.4.5.8 Helicobacter pylori15
- 1.4.5.9 Hepatitis Testing16
- 1.4.5.10HIV16
- 1.4.5.11Rapid Influenza Testing16
- 1.4.5.12Mononucleosis16
- 1.4.5.13Streptococcus Testing16
- 1.4.6Cholesterol Testing16
- 1.4.7Tumor Markers16
- 1.4.7.1 Prostate Specific Antigen (PSA) Testing17
- 2. Introduction18
- 2.1 Basic Structure and Perspectives18
- 2.2 Global Diagnostic Products Industry Status and Prognosis18
- 2.3 Size, Structure and Growth of the Industry19
- 2.3.1 Current Market Size19
- 2.3.2 Market Segments20
- 2.3.2.1 Clinical Chemistry20
- 2.3.2.2 Immunoassays21
- 2.3.2.3 Nucleic Acid Arrays22
- 2.3.2.4 Coagulation Tests23
- 2.3.2.5 Critical Care Testing24
- 2.4 Trends and Forces Driving the Industry24
- 2.4.1 Global Demographics24
- 2.4.2 Healthcare Delivery and Disease Management25
- 2.4.3 Technological Innovation26
- 2.5 Alternate Site Diagnostic Testing26
- 3. Market Analysis30
- 3.1 Glucose Monitoring30
- 3.1.1 Market Size30
- 3.1.2 Competitive Landscape31
- 3.1.2.1 LifeScan, Inc.31
- 3.1.2.2 Roche Diagnostics33
- 3.1.2.3 Bayer33
- 3.1.2.4 Abbott Diagnostics35
- 3.1.2.5 HemoCue35
- 3.1.2.6 Technical Chemicals & Products35
- 3.1.2.7 GDS Technology35
- 3.1.2.8 LXN Corp.35
- 3.1.2.9 Cholestech35
- 3.1.2.10Alternate Glucose Monitoring Products35
- 3.2 Rapid Coagulation Tests37
- 3.2.1 Roche Diagnostics39
- 3.2.2Avocet Medical40
- 3.2.3International Technidyne Corporation40
- 3.2.4Cardiovascular Diagnostics41
- 3.2.5Other Companies42
- 3.3 Rapid Cardiac Markers43
- 3.3.1The Companies44
- 3.3.1.1Spectral Diagnostics44
- 3.3.1.2Biosite Diagnostics44
- 3.3.1.3Roche Diagnostics45
- 3.3.1.4Beckman Coulter, Inc.46
- 3.3.1.5First Medical46
- 3.3.1.6 ANI Biotech46
- 3.3.1.7Chembio Diagnostics46
- 3.3.1.8Abbott Diagnostics46
- 3.3.1.9TOSOH Medics, Inc.47
- 3.3.1.10Roche Diagnostics47
- 3.3.1.11Bayer Diagnostics47
- 3.3.1.12Diagnostic Products47
- 3.3.1.13Dade Behring48
- 3.3.2BNP Testing and Congestive Heart Failure48
- 3.3.2.1Differential Diagnosis48
- 3.3.2.2Staging of Heart Failure48
- 3.3.2.3Circulating Marker of CHF49
- 3.3.2.4Commercial Assays for BNP and NT-proBNP49
- 3.3.2.5Clinical Applications of BNP50
- 3.3.2.6Correlation with NYHA Classifications50
- 3.3.2.7Correlation with LVSD50
- 3.3.2.8Prediction of Adverse Outcomes in Acute and Chronic Heart Disease51
- 3.3.2.9 Selection and Monitoring of Therapy51
- 3.3.2.10Summary52
- 3.3.1The Companies44
- 3.4 Drugs of Abuse Screening52
- 3.4.1Major Players57
- 3.4.1.1Bayer Diagnostics57
- 3.4.1.2Biosite Diagnostics57
- 3.4.1.3Dade Behring Syva (POC Technologies)58
- 3.4.1.4 Roche Diagnostics59
- 3.4.1.5 BioScan Screening Systems, Inc.60
- 3.4.1.6 American Bio Medica Corp.60
- 3.4.1.7 Instant Diagnostics, Inc.61
- 3.4.1.8Worldwide Medical62
- 3.4.1.9STC Diagnostics62
- 3.4.1.10DynaGen, Inc.63
- 3.4.1.11Avitar Technologies63
- 3.4.1.12Princeton BioMeditech63
- 3.4.1.13Abbott Diagnostics64
- 3.4.1.14Diagnostic Products64
- 3.4.1Major Players57
- 3.5 Infectious Disease Testing65
- 3.5.1Campylobacter65
- 3.5.2 Chlamydia66
- 3.5.3 Clostridium difficile66
- 3.5.4 Cryptosporidium67
- 3.5.5 Dengue Fever67
- 3.5.6 Entamoeba histolytica68
- 3.5.7 Giardia Species68
- 3.5.8 Helicobacter pylori69
- 3.5.9 Hepatitis Testing71
- 3.5.9.1 Overview71
- 3.5.9.2 Hepatitis Serologic Markers and Nucleic Acid Testing72
- 3.5.9.2.1 Hepatitis A Virus72
- 3.5.9.2.2Hepatitis B Virus72
- 3.5.9.2.3 Hepatitis C Virus75
- 3.5.9.2.4 Hepatitis D Virus77
- 3.5.9.2.5 Hepatitis E virus77
- 3.5.9.2.6 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance78
- 3.5.9.3Companies and Hepatitis Tests78
- 3.5.9.3.1Home Access Health78
- 3.5.9.3.2Orgenics78
- 3.5.9.3.3Princeton BioMeditech Corp.78
- 3.5.9.3.4Chembio Diagnostics78
- 3.5.9.3.5Abbott Diagnostics79
- 3.5.9.3.6Beckman Coulter79
- 3.5.9.2.7Roche Diagnostics79
- 3.5.9.3.8Bayer Diagnostics80
- 3.5.9.3.9Diagnostic Products Corp.80
- 3.5.9.3.10LabCorp80
- 3.5.10 HIV82
- 3.5.10.1 Blood Versus Oral Fluid/Urine Testing84
- 3.5.10.2 Life Insurance Companies and Urine Testing86
- 3.5.10.3HIV Outside the U.S.86
- 3.5.10.4Markets Analysis87
- 3.5.10.5Calypte Biomedical Corp.89
- 3.5.10.6Orgenics90
- 3.5.10.7Princeton BioMeditech Corp.90
- 3.5.10.8Chembio Diagnostics90
- 3.5.10.9OraSure Technologies90
- 3.5.10.10Ely Labs91
- 3.5.10.11Abbott Diagnostics91
- 3.5.10.12Beckman Coulter91
- 3.5.10.13Bayer Diagnostics92
- 3.5.10.14Celera Diagnostics92
- 3.5.10.15Roche Diagnostics92
- 3.5.10.16MedMira, Inc.93
- 3.5.10.17Summary and Recent Developments93
- 3.5.11 Rapid Influenza Testing94
- 3.5.12 Mononucleosis94
- 3.5.12.1Quidel95
- 3.5.12.2Worldwide Medical95
- 3.5.12.3Genzyme Diagnostics95
- 3.5.12.4Wyntek Diagnostics95
- 3.5.12.5Wampole Laboratories95
- 3.5.12.6GenBio95
- 3.5.12.7Other Companies in the Market95
- 3.5.13 Rubella96
- 3.5.14 Salmonella96
- 3.5.15 Shiga-Toxin E. coli96
- 3.5.16 Staphylococcus96
- 3.5.17 Streptococcus Testing97
- 3.5.17.1Quidel97
- 3.5.17.2Other Companies98
- 3.5.18 TB and Lyme Disease98
- 3.6 Cholesterol Testing98
- 3.6.1Consumer Market Disposable Testing (Single-Use)99
- 3.6.2Instrument/Disposable Strip (Multiple-Use Instruments)100
- 3.6.3Homocysteine100
- 3.6.4Companies in the Market100
- 3.6.4.1Cholestech100
- 3.6.4.2Lifestream Technologies100
- 3.6.4.3Actimed Laboratories101
- 3.6.4.4Drew Scientific101
- 3.6.4.5 International Medical Innovations101
- 3.7 Tumor Markers102
- 3.7.1 Market Description102
- 3.7.2 Clinical Diagnostic Serum-Based Cancer Markers103
- 3.7.2.1Beckman Coulter104
- 3.7.2.2Fujirebio, Inc.104
- 3.7.2.3Abbott Diagnostics104
- 3.7.2.4Beckman Coulter104
- 3.7.2.5Roche Diagnostics105
- 3.7.3 PSA Testing105
- 3.7.3.1 TOSOH Medics, Inc.105
- 3.7.3.2Bayer Diagnostics106
- 3.7.3.3Diagnostic Products106
- 3.7.4 Other Markers106
- 3.1 Glucose Monitoring30
- 4. Business Trends108
- 4.1 Industry Consolidation108
- 4.2 Breadth of Product Offering109
- 4.3 Government Regulation of Medical Devices109
- 4.3.1Importing/Exporting Medical Devices Into and Out of the U.S.111
- 4.3.2 U.K. Regulations112
- 4.3.3 EU Regulations113
- 4.3.4Japanese Regulations115
- 4.4 Clinical Laboratory Improvement Act (CLIA)115
- 5. Patient Management Trends117
- 5.1 Trends in Patient Care and Reimbursement117
- 5.1.1A Curious System118
- 5.1.2The Case of Tumor Markers119
- 5.1.3Other Federal Policy Considerations120
- 5.2 Alternate Site Testing120
- 5.3 Moderators of Growth120
- 5.3.1Quality Assurance Issues120
- 5.3.2Political Control121
- 5.3.3Regulatory Requirements121
- 5.3.4Record Keeping and Data Management121
- 5.3.5Finance121
- 5.3.6Emergency Room Admissions and Trends122
- 5.3.7 Attitudes of Critical Care Nurses and Physicians122
- 5.4 Personnel for POC Testing122
- 5.5 Locations of POC for Patient Care123
- 5.6 Focused Testing124
- 5.7 Satellite Facilities124
- 5.8 POC Testing124
- 5.9 Hospital Labs125
- 5.10 Doctor's Office Testing126
- 5.11 Home Care127
- 5.12 Non-traditional Collection for Sample Testing127
- 5.1 Trends in Patient Care and Reimbursement117
- 6. Technology Trends128
- 6.1 Sensor Systems for Diagnostic Applications128
- 6.2 Glucose Measurements129
- 6.2.1 Different Types of Diabetes130
- 6.2.2Public Health Impact of Diabetes130
- 6.2.3Diagnosis of Diabetes130
- 6.2.4Hypoglycemia131
- 6.2.5Glucose Test Methods131
- 6.3 Cholesterol Testing132
- 6.4 The New Paradigm132
- 6.5 Consolidated Workstations and Modularity133
- 6.6 Automation and Robotics133
- 6.7 Laboratory Information Systems (LIS)134
- 6.8 Biosensor Technology134
- 6.8.1Microfluidic and Biosensor Chip Technology135
- 6.9 Protein Sequencing136
- 6.10 DNA Sequencing136
- 6.11 The Human Genome Project137
- 6.12 Liquid Phase Chromatography138
- 6.13 Polymerase Chain Reaction138
- 6.14 Capillary Electrophoresis139
- 6.15 Proteomics139
- 7. Data Management Issues141
- 7.1 Wireless Local Area Networks141
- 7.2Wireless Technology141
- 7.3Wireless Devices142
- 7.4Considerations142
- 7.5Hospital Costs of Information Management143
- 7.6 Other Information Processing Capabilities143
- 8. Competitive Assessment of High-Growth Markets144
- 8.1 Glucose Monitoring144
- 8.1.1 Overview of Market Segment144
- 8.1.2Competitive Strategies145
- 8.1.3Analyses of the Current Market Conditions, Competition and Product Mix146
- 8.1.4 New Approaches to the Glucose Data Management Marketplace147
- 8.1.5 How Each Company is Losing/Gaining Market Share147
- 8.1.6Partnering Opportunities with Complementary Third-Party Products147
- 8.1.7 Adjacent Markets148
- 8.2 Tumor Markers148
- 8.2.1Overview of Market Segment148
- 8.2.2 Competitive Strategies148
- 8.2.3Analyses of the Current Market Conditions, Competition and Product Mix149
- 8.2.4Adjacent Markets152
- 8.3Cardiac Care152
- 8.4 Infectious Disease153
- 8.4.1 Overview of Market Segment153
- 8.4.2 Competitive Strategies153
- 8.4.3 Analyses of the Current Market Conditions, Competition and Product Mix154
- 8.4.4 New Approaches to the Infectious Disease Marketplace154
- 8.4.5 The Impact of Molecular Diagnostic Methods on the Diagnosis of Infectious Disease154
- 8.4.6Partnering Opportunities with Complementary Third-Party Products155
- 8.4.7 Emerging Viral Infections156
- 8.5 Coagulation156
- 8.6 Drugs of Abuse Testing/Therapeutic Drug Monitoring156
- 8.1 Glucose Monitoring144
- 9. Market Trends and Forecasts158
- 9.1Home Care Analysis158
- 9.2Non-traditional Collection for POC Testing158
- 9.3New Systems for Critical Care and Near-Patient Testing158
- 9.4Utility of Near-Patient Testing in Critical Care Settings158
- 9.5Mergers of Diagnostic Companies158
- 9.6Information Management Advances158
- 9.7Test Ordering Patterns158
- 9.8Patient Satisfaction158
- 9.9Move Away from Central Laboratory159
- 9.10Healthcare Cost Controls159
- 9.11Future of POC Testing159
- 9.12Biotechnology Industry Trends159
- 9.13Pharmaceutical Industry Trends160
- 9.14Acquisition, License Agreement, Partnerships160
- 10.Corporate Profiles161
- 10.1 LabCorp161
- 10.2 Lifescan, Inc.162
- 10.3 OraSure Technologies, Inc.162
- 10.3.1OraSure Collection Device162
- 10.3.2OraQuick Rapid Test162
- 10.3.3UPT162
- 10.3.4Histofreezer163
- 10.3.5Immunoassay Tests and Reagents163
- 10.4 Bayer Corp.163
- 10.4.1Background163
- 10.4.2Business Analysis164
- 10.5 MediSense166
- 10.6 i-STAT Corp.166
- 10.7 Nova Biomedical167
- 10.7.1Introduction167
- 10.7.2Electrolyte and Blood Gas Analyzers167
- 10.7.3Business Analysis168
- 10.8 Wyntek Diagnostics169
- 10.9Savyon Diagnostics169
- 10.10Spectral Diagnostics170
- 10.11Biosite Diagnostics170
- 10.12 Abbott Laboratories173
- 10.12.1Background173
- 10.12.2Key Opportunities in Rapid Tests173
- 10.12.3Business Analysis174
- 10.13Wampole Laboratories175
- 10.14Beckman Coulter Diagnostics Corp.175
- 10.15Instrumentation Laboratory176
- 10.16 MedMira Laboratories176
- 10.17Radiometer177
- 10.17.1Background177
- 10.17.2Instrumentation177
- 10.17.3Business Analysis178
- 10.18 GenBio178
- 10.19 Ely labs178
- 10.20Orgenics179
- 10.21bioMérieux Vitek, Inc.179
- 10.22 ANI Biotech179
- 10.23Sybron International Corp.180
- 10.24 Optical Sensors, Inc.180
- 10.25 Worldwide Medical Corp.181
- 10.26 International Medical Innovations (IMI)181
- 10.27 Cardiovascular Diagnostics181
- 10.28 Abaxis, Inc.181
- 10.29 Inverness Medical Innovations183
- 10.29.1Consumer Products183
- 10.29.2Clinical Diagnostic Products184
- 10.30 ChemTrak, Inc.184
- 10.30.1The AccuMeter Cassette System184
- 10.30.2The Home Test Service185
- 10.30.3Parent's Alert Home Drug Test Service185
- 10.30.4CholesTrak Home Cholesterol Test185
- 10.30.5Sales and Marketing185
- 10.30.6Competition186
- 10.31Cholestech187
- 10.31.1Diagnostic Products187
- 10.31.2WellCheck187
- 10.32 HemoCue, Inc.188
- 10.33Binax Corp.188
- 10.34 Selfcare188
- 10.35 Johnson & Johnson189
- 10.36 Accumetrics189
- 10.37 First Medical, Inc.189
- 10.38 Response Biomedical Corp.189
- 10.39 Compucyte Corp.190
- 10.40 Caliper Technologies190
- 10.41Princeton BioMeditech190
- 10.42 American Biogenics Sciences190
- 10.43 New Horizons Diagnostics191
- 10.44Beacon Diagnostics191
- 10.45Saliva Diagnostics191
- 10.46 Calypte Biomedical Corp.192
- 10.46.1The Calypte Urine-Based HIV-1 Screening and Supplemental Tests192
- 10.46.2The Cambridge Biotech Serum-Based HIV-1 Supplemental Test192
- 10.46.3The Sentinel Testing Service192
- 10.46.4HIV Viral Lysate Stock193
- 10.47 Meridian Diagnostic193
- 10.48Quidel195
- 10.49 Biomerica195
- 10.50 Diagnology, Inc.196
- 10.51 BioStar (Thermo Electron Corp.)196
- 10.52ActiMed Diagnostics196
- 10.53 Empyrean Diagnostics197
- 10.54 STC Technologies197
- 10.55 Trinity Diagnostics197
- 10.56 Genzyme Diagnostics198
- 10.57 ImmunoScience, Inc.198
- 10.58 Cygnus Therapeutic Systems199
- 10.58.1The GlucoWatch System199
- 10.58.2 GlucoWatch G2 Biographer199
- 10.58.3Partnerships200
- 10.59Seradyn Clinical Diagnostics/Apogent Technologies201
- 10.60 Adeza Biomedical Corp.201
- 10.61Array Medical202
- 10.62 Transmedica202
- 10.63BioScan Screening Systems, Inc.202
- 10.64American Bio Medica Corp.202
- 10.65GDS Technology203
- 10.66 Home Access Health Corp.203
- 10.67 Pharmatech Corp.204
- 10.68 Thoratec/International Technidyne Corp.204
- 10.69 SpectRx, Inc.204
- 10.70 Helena Laboratories205
- 10.71 Technical Chemicals & Products205
- 10.72 Roche Diagnostics206
- 10.73 Simplex Medical Systems208
- 10.74 Biex, Inc.208
- 10.75 POC Technologies208
- 10.76 LXN Corp. (Inverness Medical Technologies)209
- 10.77American Biogenetic Sciences, Inc.209
- 10.78Lifestream Technologies209
- 10.79 PanBio Corp.210
- 10.80 Phillips Medical Systems210
- 10.81 Jiangnan Biotech211
- 10.82 MiniMed211
- 10.83 Meretek Corp.212
- 10.84Avox Systems212
- 10.85 Dade Behring212
- 10.86 Chongqing Sungene Pharmaceutical Co., Ltd.213
- 10.87Medical Services International, Inc.213
- 10.88 Therasense, Inc.213
- 10.89PharmaNetics, Inc.213
- 10.90Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech)214
- 10.91LifePoint, Inc.214
- 10.92 Avitar, Inc.214
- 10.93Cozart Biosciences215
- 10.94 Enterix, Inc.215
- 10.95Kyowa Medex Co., Ltd.215
- 10.96 Iatron215
- 10.97 Denka Seiken Co., Ltd.215
- 10.98 Accurex Biomedical, Pvt., Ltd.215
- 11. Corporate Directory216
Other users found this report page using the following search terms: diagnostics point-of-care POC diagnostic market testing test poc share patient volume glucose keydiagnostictestingmarkets
If you can't find a report that meets your needs contact LeadDiscovery. We are one of the few report providers with extensive drug development experience and we frequently use this knowledge to help clients source the most appropriate reports or produce reports for them from scratch.