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Key diagnostic testing markets

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Aarkstore Enterprise specialize in providing online market business information on market research reports, books, magazines, conference booking at competitive prices, and strive to provide......

Aarkstore Enterprise specialize in providing online market business information on market research reports, books, magazines, conference booking at competitive prices, and strive to provide excellent and innovative service to our customers.

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  • 1. Key Diagnostic Testing Markets This 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. Overview 10 1.1 Objectives 10 1.2 Content and Scope 10 1.3 Methodology 11 1.4 Executive Summary 12 1.4.1 Glucose Monitoring 13 1.4.2 Coagulation 13 1.4.3 Rapid Cardiac Markers 14 1.4.4 Drugs of Abuse Screening 14 1.4.5 Infectious Disease Testing 15 1.4.5.1 Campylobacter 15 1.4.5.2 Chlamydia 15 1.4.5.3 Clostridium difficile 15 1.4.5.4 Cryptosporidium 15 1.4.5.5 Dengue Fever 15 1.4.5.6 Entamoeba histolytica 15 1.4.5.7 Giardia Species 15 1.4.5.8 Helicobacter pylori 15 1.4.5.9 Hepatitis Testing 16 1.4.5.10 HIV 16 1.4.5.11 Rapid Influenza Testing 16 1.4.5.12 Mononucleosis 16 1.4.5.13 Streptococcus Testing 16 1.4.6 Cholesterol Testing 16 1.4.7 Tumor Markers 16 1.4.7.1 Prostate Specific Antigen (PSA) Testing 17 2. Introduction 18
  • 2. 2.1 Basic Structure and Perspectives 18 2.2 Global Diagnostic Products Industry Status and Prognosis 18 2.3 Size, Structure and Growth of the Industry 19 2.3.1 Current Market Size 19 2.3.2 Market Segments 20 2.3.2.1 Clinical Chemistry 20 2.3.2.2 Immunoassays 21 2.3.2.3 Nucleic Acid Arrays 22 2.3.2.4 Coagulation Tests 23 2.3.2.5 Critical Care Testing 24 2.4 Trends and Forces Driving the Industry 24 2.4.1 Global Demographics 24 2.4.2 Healthcare Delivery and Disease Management 25 2.4.3 Technological Innovation 26 2.5 Alternate Site Diagnostic Testing 26 3. Market Analysis 30 3.1 Glucose Monitoring 30 3.1.1 Market Size 30 3.1.2 Competitive Landscape 31 3.1.2.1 LifeScan, Inc. 31 3.1.2.2 Roche Diagnostics 33 3.1.2.3 Bayer 33 3.1.2.4 Abbott Diagnostics 35 3.1.2.5 HemoCue 35 3.1.2.6 Technical Chemicals & Products 35 3.1.2.7 GDS Technology 35 3.1.2.8 LXN Corp. 35 3.1.2.9 Cholestech 35 3.1.2.10 Alternate Glucose Monitoring Products 35 3.2 Rapid Coagulation Tests 37 3.2.1 Roche Diagnostics 39 3.2.2 Avocet Medical 40 3.2.3 International Technidyne Corporation 40 3.2.4 Cardiovascular Diagnostics 41 3.2.5 Other Companies 42 3.3 Rapid Cardiac Markers 43 3.3.1 The Companies 44 3.3.1.1 Spectral Diagnostics 44 3.3.1.2 Biosite Diagnostics 44 3.3.1.3 Roche Diagnostics 45 3.3.1.4 Beckman Coulter, Inc. 46 3.3.1.5 First Medical 46 3.3.1.6 ANI Biotech 46 3.3.1.7 Chembio Diagnostics 46 3.3.1.8 Abbott Diagnostics 46
  • 3. 3.3.1.9 TOSOH Medics, Inc. 47 3.3.1.10 Roche Diagnostics 47 3.3.1.11 Bayer Diagnostics 47 3.3.1.12 Diagnostic Products 47 3.3.1.13 Dade Behring 48 3.3.2 BNP Testing and Congestive Heart Failure 48 3.3.2.1 Differential Diagnosis 48 3.3.2.2 Staging of Heart Failure 48 3.3.2.3 Circulating Marker of CHF 49 3.3.2.4 Commercial Assays for BNP and NT-proBNP 49 3.3.2.5 Clinical Applications of BNP 50 3.3.2.6 Correlation with NYHA Classifications 50 3.3.2.7 Correlation with LVSD 50 3.3.2.8 Prediction of Adverse Outcomes in Acute and Chronic Heart Disease 51 3.3.2.9 Selection and Monitoring of Therapy 51 3.3.2.10 Summary 52 3.4 Drugs of Abuse Screening 52 3.4.1 Major Players 57 3.4.1.1 Bayer Diagnostics 57 3.4.1.2 Biosite Diagnostics 57 3.4.1.3 Dade Behring Syva (POC Technologies) 58 3.4.1.4 Roche Diagnostics 59 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 3.4.1.8 Worldwide Medical 62 3.4.1.9 STC Diagnostics 62 3.4.1.10 DynaGen, Inc. 63 3.4.1.11 Avitar Technologies 63 3.4.1.12 Princeton BioMeditech 63 3.4.1.13 Abbott Diagnostics 64 3.4.1.14 Diagnostic Products 64 3.5 Infectious Disease Testing 65 3.5.1 Campylobacter 65 3.5.2 Chlamydia 66 3.5.3 Clostridium difficile 66 3.5.4 Cryptosporidium 67 3.5.5 Dengue Fever 67 3.5.6 Entamoeba histolytica 68 3.5.7 Giardia Species 68 3.5.8 Helicobacter pylori 69 3.5.9 Hepatitis Testing 71 3.5.9.1 Overview 71 3.5.9.2 Hepatitis Serologic Markers and Nucleic Acid Testing 72 3.5.9.2.1 Hepatitis A Virus 72 3.5.9.2.2 Hepatitis B Virus 72
  • 4. 3.5.9.2.3 Hepatitis C Virus 75 3.5.9.2.4 Hepatitis D Virus 77 3.5.9.2.5 Hepatitis E virus 77 3.5.9.2.6 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance 78 3.5.9.3 Companies and Hepatitis Tests 78 3.5.9.3.1 Home Access Health 78 3.5.9.3.2 Orgenics 78 3.5.9.3.3 Princeton BioMeditech Corp. 78 3.5.9.3.4 Chembio Diagnostics 78 3.5.9.3.5 Abbott Diagnostics 79 3.5.9.3.6 Beckman Coulter 79 3.5.9.2.7 Roche Diagnostics 79 3.5.9.3.8 Bayer Diagnostics 80 3.5.9.3.9 Diagnostic Products Corp. 80 3.5.9.3.10 LabCorp 80 3.5.10 HIV 82 3.5.10.1 Blood Versus Oral Fluid/Urine Testing 84 3.5.10.2 Life Insurance Companies and Urine Testing 86 3.5.10.3 HIV Outside the U.S. 86 3.5.10.4 Markets Analysis 87 3.5.10.5 Calypte Biomedical Corp. 89 3.5.10.6 Orgenics 90 3.5.10.7 Princeton BioMeditech Corp. 90 3.5.10.8 Chembio Diagnostics 90 3.5.10.9 OraSure Technologies 90 3.5.10.10 Ely Labs 91 3.5.10.11 Abbott Diagnostics 91 3.5.10.12 Beckman Coulter 91 3.5.10.13 Bayer Diagnostics 92 3.5.10.14 Celera Diagnostics 92 3.5.10.15 Roche Diagnostics 92 3.5.10.16 MedMira, Inc. 93 3.5.10.17 Summary and Recent Developments 93 3.5.11 Rapid Influenza Testing 94 3.5.12 Mononucleosis 94 3.5.12.1 Quidel 95 3.5.12.2 Worldwide Medical 95 3.5.12.3 Genzyme Diagnostics 95 3.5.12.4 Wyntek Diagnostics 95 3.5.12.5 Wampole Laboratories 95 3.5.12.6 GenBio 95 3.5.12.7 Other Companies in the Market 95 3.5.13 Rubella 96 3.5.14 Salmonella 96 3.5.15 Shiga-Toxin E. coli 96 3.5.16 Staphylococcus 96
  • 5. 3.5.17 Streptococcus Testing 97 3.5.17.1 Quidel 97 3.5.17.2 Other Companies 98 3.5.18 TB and Lyme Disease 98 3.6 Cholesterol Testing 98 3.6.1 Consumer Market Disposable Testing (Single-Use) 99 3.6.2 Instrument/Disposable Strip (Multiple-Use Instruments) 100 3.6.3 Homocysteine 100 3.6.4 Companies in the Market 100 3.6.4.1 Cholestech 100 3.6.4.2 Lifestream Technologies 100 3.6.4.3 Actimed Laboratories 101 3.6.4.4 Drew Scientific 101 3.6.4.5 International Medical Innovations 101 3.7 Tumor Markers 102 3.7.1 Market Description 102 3.7.2 Clinical Diagnostic Serum-Based Cancer Markers 103 3.7.2.1 Beckman Coulter 104 3.7.2.2 Fujirebio, Inc. 104 3.7.2.3 Abbott Diagnostics 104 3.7.2.4 Beckman Coulter 104 3.7.2.5 Roche Diagnostics 105 3.7.3 PSA Testing 105 3.7.3.1 TOSOH Medics, Inc. 105 3.7.3.2 Bayer Diagnostics 106 3.7.3.3 Diagnostic Products 106 3.7.4 Other Markers 106 4. Business Trends 108 4.1 Industry Consolidation 108 4.2 Breadth of Product Offering 109 4.3 Government Regulation of Medical Devices 109 4.3.1 Importing/Exporting Medical Devices Into and Out of the U.S. 111 4.3.2 U.K. Regulations 112 4.3.3 EU Regulations 113 4.3.4 Japanese Regulations 115 4.4 Clinical Laboratory Improvement Act (CLIA) 115 5. Patient Management Trends 117 5.1 Trends in Patient Care and Reimbursement 117 5.1.1 A Curious System 118 5.1.2 The Case of Tumor Markers 119 5.1.3 Other Federal Policy Considerations 120 5.2 Alternate Site Testing 120 5.3 Moderators of Growth 120 5.3.1 Quality Assurance Issues 120
  • 6. 5.3.2 Political Control 121 5.3.3 Regulatory Requirements 121 5.3.4 Record Keeping and Data Management 121 5.3.5 Finance 121 5.3.6 Emergency Room Admissions and Trends 122 5.3.7 Attitudes of Critical Care Nurses and Physicians 122 5.4 Personnel for POC Testing 122 5.5 Locations of POC for Patient Care 123 5.6 Focused Testing 124 5.7 Satellite Facilities 124 5.8 POC Testing 124 5.9 Hospital Labs 125 5.10 Doctor’s Office Testing 126 5.11 Home Care 127 5.12 Non-traditional Collection for Sample Testing 127 6. Technology Trends 128 6.1 Sensor Systems for Diagnostic Applica For more information, please visit :http://www.aarkstore.com/reports/Key-Diagnostic- Testing-Markets-1323.html Contact :Sanaa Aarkstore Enterprise Tel : +912227453309 Mobile No: +919272852585 Email : contact@aarkstore.com