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Key Diagnostic Testing Markets

  • ID: 7671
  • December 2004
  • Region: Global
  • 222 Pages
  • TriMark Publications
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This 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 companys position in its market and its strategic direction.

Note: Product cover images may vary from those shown
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1. Overview
1.1 Objectives
1.2 Content and Scope
1.3 Methodology
1.4 Executive Summary
1.4.1 Glucose Monitoring
1.4.2 Coagulation
1.4.3 Rapid Cardiac Markers
1.4.4 Drugs of Abuse Screening
1.4.5 Infectious Disease Testing
1.4.5.1 Campylobacter
1.4.5.2 Chlamydia
1.4.5.3 Clostridium difficile
1.4.5.4 Cryptosporidium
1.4.5.5 Dengue Fever
1.4.5.6 Entamoeba histolytica
1.4.5.7 Giardia Species
1.4.5.8 Helicobacter pylori
1.4.5.9 Hepatitis Testing
1.4.5.10 HIV
1.4.5.11 Rapid Influenza Testing
1.4.5.12 Mononucleosis
1.4.5.13 Streptococcus Testing
1.4.6 Cholesterol Testing
1.4.7 Tumor Markers
1.4.7.1 Prostate Specific Antigen (PSA) Testing

2. Introduction
2.1 Basic Structure and Perspectives
2.2 Global Diagnostic Products Industry Status and Prognosis
2.3 Size, Structure and Growth of the Industry
2.3.1 Current Market Size
2.3.2 Market Segments
2.3.2.1 Clinical Chemistry
2.3.2.2 Immunoassays
2.3.2.3 Nucleic Acid Arrays
2.3.2.4 Coagulation Tests
2.3.2.5 Critical Care Testing
2.4 Trends and Forces Driving the Industry
2.4.1 Global Demographics
2.4.2 Healthcare Delivery and Disease Management
2.4.3 Technological Innovation
2.5 Alternate Site Diagnostic Testing

3. Market Analysis
3.1 Glucose Monitoring
3.1.1 Market Size
3.1.2 Competitive Landscape
3.1.2.1 LifeScan, Inc.
3.1.2.2 Roche Diagnostics
3.1.2.3 Bayer
3.1.2.4 Abbott Diagnostics
3.1.2.5 HemoCue
3.1.2.6 Technical Chemicals & Products
3.1.2.7 GDS Technology
3.1.2.8 LXN Corp.
3.1.2.9 Cholestech
3.1.2.10 Alternate Glucose Monitoring Products
3.2 Rapid Coagulation Tests
3.2.1 Roche Diagnostics
3.2.2 Avocet Medical
3.2.3 International Technidyne Corporation
3.2.4 Cardiovascular Diagnostics
3.2.5 Other Companies
3.3 Rapid Cardiac Markers
3.3.1 The Companies
3.3.1.1 Spectral Diagnostics
3.3.1.2 Biosite Diagnostics
3.3.1.3 Roche Diagnostics
3.3.1.4 Beckman Coulter, Inc.
3.3.1.5 First Medical
3.3.1.6 ANI Biotech
3.3.1.7 Chembio Diagnostics
3.3.1.8 Abbott Diagnostics
3.3.1.9 TOSOH Medics, Inc.
3.3.1.10 Roche Diagnostics
3.3.1.11 Bayer Diagnostics
3.3.1.12 Diagnostic Products
3.3.1.13 Dade Behring
3.3.2 BNP Testing and Congestive Heart Failure
3.3.2.1 Differential Diagnosis
3.3.2.2 Staging of Heart Failure
3.3.2.3 Circulating Marker of CHF
3.3.2.4 Commercial Assays for BNP and NT-proBNP
3.3.2.5 Clinical Applications of BNP
3.3.2.6 Correlation with NYHA Classifications
3.3.2.7 Correlation with LVSD
3.3.2.8 Prediction of Adverse Outcomes in Acute and Chronic Heart Disease
3.3.2.9 Selection and Monitoring of Therapy
3.3.2.10 Summary
3.4 Drugs of Abuse Screening
3.4.1 Major Players
3.4.1.1 Bayer Diagnostics
3.4.1.2 Biosite Diagnostics
3.4.1.3 Dade Behring Syva (POC Technologies)
3.4.1.4 Roche Diagnostics
3.4.1.5 BioScan Screening Systems, Inc.
3.4.1.6 American Bio Medica Corp.
3.4.1.7 Instant Diagnostics, Inc.
3.4.1.8 Worldwide Medical
3.4.1.9 STC Diagnostics
3.4.1.10 DynaGen, Inc.
3.4.1.11 Avitar Technologies
3.4.1.12 Princeton BioMeditech
3.4.1.13 Abbott Diagnostics
3.4.1.14 Diagnostic Products
3.5 Infectious Disease Testing
3.5.1 Campylobacter
3.5.2 Chlamydia
3.5.3 Clostridium difficile
3.5.4 Cryptosporidium
3.5.5 Dengue Fever
3.5.6 Entamoeba histolytica
3.5.7 Giardia Species
3.5.8 Helicobacter pylori
3.5.9 Hepatitis Testing
3.5.9.1 Overview
3.5.9.2 Hepatitis Serologic Markers and Nucleic Acid Testing
3.5.9.2.1 Hepatitis A Virus
3.5.9.2.2 Hepatitis B Virus
3.5.9.2.3 Hepatitis C Virus
3.5.9.2.4 Hepatitis D Virus
3.5.9.2.5 Hepatitis E virus
3.5.9.2.6 Hepatitis B Virus/Hepatitis C Virus Viral Load and Drug Resistance
3.5.9.3 Companies and Hepatitis Tests
3.5.9.3.1 Home Access Health
3.5.9.3.2 Orgenics
3.5.9.3.3 Princeton BioMeditech Corp.
3.5.9.3.4 Chembio Diagnostics
3.5.9.3.5 Abbott Diagnostics
3.5.9.3.6 Beckman Coulter
3.5.9.2.7 Roche Diagnostics
3.5.9.3.8 Bayer Diagnostics
3.5.9.3.9 Diagnostic Products Corp.
3.5.9.3.10 LabCorp
3.5.10 HIV
3.5.10.1 Blood Versus Oral Fluid/Urine Testing
3.5.10.2 Life Insurance Companies and Urine Testing
3.5.10.3 HIV Outside the U.S.
3.5.10.4 Markets Analysis
3.5.10.5 Calypte Biomedical Corp.
3.5.10.6 Orgenics
3.5.10.7 Princeton BioMeditech Corp.
3.5.10.8 Chembio Diagnostics
3.5.10.9 OraSure Technologies
3.5.10.10 Ely Labs
3.5.10.11 Abbott Diagnostics
3.5.10.12 Beckman Coulter
3.5.10.13 Bayer Diagnostics
3.5.10.14 Celera Diagnostics
3.5.10.15 Roche Diagnostics
3.5.10.16 MedMira, Inc.
3.5.10.17 Summary and Recent Developments
3.5.11 Rapid Influenza Testing
3.5.12 Mononucleosis
3.5.12.1 Quidel
3.5.12.2 Worldwide Medical
3.5.12.3 Genzyme Diagnostics
3.5.12.4 Wyntek Diagnostics
3.5.12.5 Wampole Laboratories
3.5.12.6 GenBio
3.5.12.7 Other Companies in the Market
3.5.13 Rubella
3.5.14 Salmonella
3.5.15 Shiga-Toxin E. coli
3.5.16 Staphylococcus
3.5.17 Streptococcus Testing
3.5.17.1 Quidel
3.5.17.2 Other Companies
3.5.18 TB and Lyme Disease
3.6 Cholesterol Testing
3.6.1 Consumer Market Disposable Testing (Single-Use)
3.6.2 Instrument/Disposable Strip (Multiple-Use Instruments)
3.6.3 Homocysteine
3.6.4 Companies in the Market
3.6.4.1 Cholestech
3.6.4.2 Lifestream Technologies
3.6.4.3 Actimed Laboratories
3.6.4.4 Drew Scientific
3.6.4.5 International Medical Innovations
3.7 Tumor Markers
3.7.1 Market Description
3.7.2 Clinical Diagnostic Serum-Based Cancer Markers
3.7.2.1 Beckman Coulter
3.7.2.2 Fujirebio, Inc.
3.7.2.3 Abbott Diagnostics
3.7.2.4 Beckman Coulter
3.7.2.5 Roche Diagnostics
3.7.3 PSA Testing
3.7.3.1 TOSOH Medics, Inc.
3.7.3.2 Bayer Diagnostics
3.7.3.3 Diagnostic Products
3.7.4 Other Markers

4. Business Trends
4.1 Industry Consolidation
4.2 Breadth of Product Offering
4.3 Government Regulation of Medical Devices
4.3.1 Importing/Exporting Medical Devices Into and Out of the U.S.
4.3.2 U.K. Regulations
4.3.3 EU Regulations
4.3.4 Japanese Regulations
4.4 Clinical Laboratory Improvement Act (CLIA)

5. Patient Management Trends
5.1 Trends in Patient Care and Reimbursement
5.1.1 A Curious System
5.1.2 The Case of Tumor Markers
5.1.3 Other Federal Policy Considerations
5.2 Alternate Site Testing
5.3 Moderators of Growth
5.3.1 Quality Assurance Issues
5.3.2 Political Control
5.3.3 Regulatory Requirements
5.3.4 Record Keeping and Data Management
5.3.5 Finance
5.3.6 Emergency Room Admissions and Trends
5.3.7 Attitudes of Critical Care Nurses and Physicians
5.4 Personnel for POC Testing
5.5 Locations of POC for Patient Care
5.6 Focused Testing
5.7 Satellite Facilities
5.8 POC Testing
5.9 Hospital Labs
5.10 Doctors Office Testing
5.11 Home Care
5.12 Non-traditional Collection for Sample Testing

6. Technology Trends
6.1 Sensor Systems for Diagnostic Applications
6.2 Glucose Measurements
6.2.1 Different Types of Diabetes
6.2.2 Public Health Impact of Diabetes
6.2.3 Diagnosis of Diabetes
6.2.4 Hypoglycemia
6.2.5 Glucose Test Methods
6.3 Cholesterol Testing
6.4 The New Paradigm
6.5 Consolidated Workstations and Modularity
6.6 Automation and Robotics
6.7 Laboratory Information Systems (LIS)
6.8 Biosensor Technology
6.8.1 Microfluidic and Biosensor Chip Technology
6.9 Protein Sequencing
6.10 DNA Sequencing
6.11 The Human Genome Project
6.12 Liquid Phase Chromatography
6.13 Polymerase Chain Reaction
6.14 Capillary Electrophoresis
6.15 Proteomics

7. Data Management Issues
7.1 Wireless Local Area Networks
7.2 Wireless Technology
7.3 Wireless Devices
7.4 Considerations
7.5 Hospital Costs of Information Management
7.6 Other Information Processing Capabilities

8. Competitive Assessment of High-Growth Markets
8.1 Glucose Monitoring
8.1.1 Overview of Market Segment
8.1.2 Competitive Strategies
8.1.3 Analyses of the Current Market Conditions, Competition and Product Mix
8.1.4 New Approaches to the Glucose Data Management Marketplace
8.1.5 How Each Company is Losing/Gaining Market Share
8.1.6 Partnering Opportunities with Complementary Third-Party Products
8.1.7 Adjacent Markets
8.2 Tumor Markers
8.2.1 Overview of Market Segment
8.2.2 Competitive Strategies
8.2.3 Analyses of the Current Market Conditions, Competition and Product Mix
8.2.4 Adjacent Markets
8.3 Cardiac Care
8.4 Infectious Disease
8.4.1 Overview of Market Segment
8.4.2 Competitive Strategies
8.4.3 Analyses of the Current Market Conditions, Competition and Product Mix
8.4.4 New Approaches to the Infectious Disease Marketplace
8.4.5 The Impact of Molecular Diagnostic Methods on the Diagnosis of Infectious Disease
8.4.6 Partnering Opportunities with Complementary Third-Party Products
8.4.7 Emerging Viral Infections
8.5 Coagulation
8.6 Drugs of Abuse Testing/Therapeutic Drug Monitoring

9. Market Trends and Forecasts
9.1 Home Care Analysis
9.2 Non-traditional Collection for POC Testing
9.3 New Systems for Critical Care and Near-Patient Testing
9.4 Utility of Near-Patient Testing in Critical Care Settings
9.5 Mergers of Diagnostic Companies
9.6 Information Management Advances
9.7 Test Ordering Patterns
9.8 Patient Satisfaction
9.9 Move Away from Central Laboratory
9.10 Healthcare Cost Controls
9.11 Future of POC Testing
9.12 Biotechnology Industry Trends
9.13 Pharmaceutical Industry Trends
9.14 Acquisition, License Agreement, Partnerships

10. Corporate Profiles
10.1 LabCorp
10.2 Lifescan, Inc.
10.3 OraSure Technologies, Inc.
10.3.1 OraSure Collection Device
10.3.2 OraQuick Rapid Test
10.3.3 UPT
10.3.4 Histofreezer
10.3.5 Immunoassay Tests and Reagents
10.4 Bayer Corp.
10.4.1 Background
10.4.2 Business Analysis
10.5 MediSense
10.6 i-STAT Corp.
10.7 Nova Biomedical
10.7.1 Introduction
10.7.2 Electrolyte and Blood Gas Analyzers
10.7.3 Business Analysis
10.8 Wyntek Diagnostics
10.9 Savyon Diagnostics
10.10 Spectral Diagnostics
10.11 Biosite Diagnostics
10.12 Abbott Laboratories
10.12.1 Background
10.12.2 Key Opportunities in Rapid Tests
10.12.3 Business Analysis
10.13 Wampole Laboratories
10.14 Beckman Coulter Diagnostics Corp.
10.15 Instrumentation Laboratory
10.16 MedMira Laboratories
10.17 Radiometer
10.17.1 Background
10.17.2 Instrumentation
10.17.3 Business Analysis
10.18 GenBio
10.19 Ely labs
10.20 Orgenics
10.21 bioMérieux Vitek, Inc.
10.22 ANI Biotech
10.23 Sybron International Corp.
10.24 Optical Sensors, Inc.
10.25 Worldwide Medical Corp.
10.26 International Medical Innovations (IMI)
10.27 Cardiovascular Diagnostics
10.28 Abaxis, Inc.
10.29 Inverness Medical Innovations
10.29.1 Consumer Products
10.29.2 Clinical Diagnostic Products
10.30 ChemTrak, Inc.
10.30.1 The AccuMeter Cassette System
10.30.2 The Home Test Service
10.30.3 Parents Alert Home Drug Test Service
10.30.4 CholesTrak Home Cholesterol Test
10.30.5 Sales and Marketing
10.30.6 Competition
10.31 Cholestech
10.31.1 Diagnostic Products
10.31.2 WellCheck
10.32 HemoCue, Inc.
10.33 Binax Corp.
10.34 Selfcare
10.35 Johnson & Johnson
10.36 Accumetrics
10.37 First Medical, Inc.
10.38 Response Biomedical Corp.
10.39 Compucyte Corp.
10.40 Caliper Technologies
10.41 Princeton BioMeditech
10.42 American Biogenics Sciences
10.43 New Horizons Diagnostics
10.44 Beacon Diagnostics
10.45 Saliva Diagnostics
10.46 Calypte Biomedical Corp.
10.46.1 The Calypte Urine-Based HIV-1 Screening and Supplemental Tests
10.46.2 The Cambridge Biotech Serum-Based HIV-1 Supplemental Test
10.46.3 The Sentinel Testing Service
10.46.4 HIV Viral Lysate Stock
10.47 Meridian Diagnostic
10.48 Quidel
10.49 Biomerica
10.50 Diagnology, Inc.
10.51 BioStar (Thermo Electron Corp.)
10.52 ActiMed Diagnostics
10.53 Empyrean Diagnostics
10.54 STC Technologies
10.55 Trinity Diagnostics
10.56 Genzyme Diagnostics
10.57 ImmunoScience, Inc.
10.58 Cygnus Therapeutic Systems
10.58.1 The GlucoWatch System
10.58.2 GlucoWatch G2 Biographer
10.58.3 Partnerships
10.59 Seradyn Clinical Diagnostics/Apogent Technologies
10.60 Adeza Biomedical Corp.
10.61 Array Medical
10.62 Transmedica
10.63 BioScan Screening Systems, Inc.
10.64 American Bio Medica Corp.
10.65 GDS Technology
10.66 Home Access Health Corp.
10.67 Pharmatech Corp.
10.68 Thoratec/International Technidyne Corp.
10.69 SpectRx, Inc.
10.70 Helena Laboratories
10.71 Technical Chemicals & Products
10.72 Roche Diagnostics
10.73 Simplex Medical Systems
10.74 Biex, Inc.
10.75 POC Technologies
10.76 LXN Corp. (Inverness Medical Technologies)
10.77 American Biogenetic Sciences, Inc.
10.78 Lifestream Technologies
10.79 PanBio Corp.
10.80 Phillips Medical Systems
10.81 Jiangnan Biotech
10.82 MiniMed
10.83 Meretek Corp.
10.84 Avox Systems
10.85 Dade Behring
10.86 Chongqing Sungene Pharmaceutical Co., Ltd.
10.87 Medical Services International, Inc.
10.88 Therasense, Inc.
10.89 PharmaNetics, Inc.
10.90 Shanghai SIIC Kehua Biotech Co., Ltd. (Kehua Biotech)
10.91 LifePoint, Inc.
10.92 Avitar, Inc.
10.93 Cozart Biosciences
10.94 Enterix, Inc.
10.95 Kyowa Medex Co., Ltd.
10.96 Iatron
10.97 Denka Seiken Co., Ltd.
10.98 Accurex Biomedical, Pvt., Ltd.

11. Corporate Directory

INDEX OF FIGURES

Figure 1: Serological and Clinical Course of Acute HBV Infection
Figure 2: Time Course of Serologic Markers in Acute Hepatitis C Infection

INDEX OF TABLES

Table 1: Ten Largest Diagnostic Companies Worldwide Revenues and Market Share 2000
Table 2: Total Clinical Diagnostics Dollar Volume by Market Segment 2000
Table 3: U.S. Market for Clinical Chemistry Dollar Volume by Analyte 2000
Table 4: Worldwide Market for Clinical Chemistry Dollar Volume by Analyte 2000
Table 5: Worldwide Market for Other Immunoassays Dollar Volume by Analyte 2000
Table 6: Worldwide Market for Nucleic Acid Assays for Infectious Disease Dollar Volume by Analyte 2000
Table 7: Worldwide Market for Other Nucleic Acid Arrays Dollar Volume by Analyte 2000
Table 8: Market for Coagulation Tests Dollar Volume by Region 2000
Table 9: Market for Critical Care Tests Dollar Volume by Region 2000
Table 10: U.S. Alternate Site Diagnostic Test Dollar Volume by Sector
Table 11: U.S. Clinical Diagnostic POC Testing and Rapid Test Market Segments Dollar Volume
Table 12: Number of Sites by Type Doing In Vitro Diagnostic Testing in the U.S.
Table 13: U.S. Clinical Laboratory Testing Services Revenue and Growth Rates by Segment
Table 14: U.S. Doctors Office Test Market Revenue and Growth Rate by Segment
Table 15: U.S. Clinical Diagnostic Home Test Market Revenue and Growth Rates by Segments 1999
Table 16: U.S. In Vitro Diagnostic Testing Including Reagents, Instruments, Consumables and Controls Total Sales by Segments 1999
Table 17: Global Diabetic Population 1995 and 2025
Table 18: Worldwide POC Glucose Testing Market Dollar Volume and Growth Rate
Table 19: U.S. Market for POC and Near-Patient Blood Glucose Testing Market Share by Company
Table 20: World Market Share of POC Glucose Monitoring Marketers
Table 21a: Worldwide Market for Rapid Coagulation Testing Dollar Volume 2000-2008
Table 21b: U.S. Market for Rapid Coagulation Testing Dollar Volume 2000-2008
Table 21c: U.S. Market for Rapid Coagulation POC Testing Dollar Volume 1996-2007
Table 22: U.S. Market for POC Cardiac Marker Testing Dollar Volume and Growth Rate 1999-2007
Table 23: Drugs of Abuse Screening U.S. Market Size 1998-2007
Table 24: National Institute on Drug Abuse Screening Standards Cutoff Levels by Drug and Test Method
Table 25: U.S. POC Drugs of Abuse Testing Market 2001-2007
Table 26: Serological Diagnosis of Hepatitis B Virus Infections
Table 27: Lower Detection Limits of HBV DNA Assays
Table 28: U.S. and Global Market for HAV Diagnostic Testing
Table 29: U.S. and Global Market for HBV Diagnostic Testing
Table 30: U.S. and Global Market for HCV Diagnostic Testing
Table 31: Current Assays for HIV Viral Load Testing
Table 32: U.S. and World Markets for HIV Diagnostic Testing
Table 33: U.S. Cholesterol Testing Volume 2000-2007
Table 34: Worldwide Market for In Vitro Cancer Marker Products Dollar Volume in 1999 and 2007
Table 35: U.S. Market for Tumor Marker Assays Dollar Volume by Marker 1998-2002
Table 36: Comparison of Costs at "Moderately Complex" and "Waived" CLIA Labs
Table 37: CPT Codes and Reimbursement Amount for Selected Tumor Markers New York and California
Table 38a: POC Testing Versus Laboratory Testing Clinical Outcomes in Diabetic Ketoacidosis
Table 38b: POC Testing Versus Laboratory Testing Clinical Outcomes in ABG Measurements
Table 39: Emergency Room Admissions in the U.S.
Table 40: POC Testing Cost Analysis with Labor Included
Table 41: Cost Analysis for Glucose Testing: POCT versus Central Lab
Table 42: Normal Blood Glucose Values in Fasting State and Two Hours Postprandially
Table 43: Applications for Wireless LAN Technology Present and Future
Table 44: Wireless Hospital Network Access Points Technology Prices Access Points
Table 45: Wireless Hospital Network Access Points Technology Prices Desktop Adapters (One Computer)
Table 46: Wireless Hospital Network Access Points Technology Prices PCMCIA Adapters

Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown

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