全球POC(重點照護)診斷市場：主要企業與主要課題-2007年

Abstract

The 2nd edition of this two volume guide from Espicom provides an extensive competitive comparison and evaluation of major and emerging companies, sets the POC markets in context and provides market valuations as well as critical appraisal of research & innovation.

The global point of care (POC) testing market is currently estimated to be worth US$11.3 billion in 2007 and is growing at 11% a year. POC testing accounts for approximately 34% of the US$33.6 billion global in-vitro diagnostic (IVD) testing market. Diagnostic testing accounts for only between 1-2% of government healthcare expenditures worldwide, yet influences between 60-70% of healthcare decisions.

The changing face of the POC industry

Double digit growth expectancy for POC testing has spurred considerable investment and interest from the industry. Although the POC sector is, in many respects, relatively immature it is already characterised by a great deal of M&A activity.

The most active acquirer at present is Inverness Medical Innovations which has made multiple acquisitions in recent years, buying up leading companies such as Biosite, Cholestech and Hemosense among others, and providing the company with a significant presence in cardiology and other segments.

Unsurprisingly, the POC market has also seen moves by large multinationals which previously had no presence in the IVD market. Siemens, for example, made major acquisitions to establish its diagnostics division, with Diagnostics Products Corporation and Bayer Diagnostics coming under the Siemens umbrella in 2006 at a cost of US$5.7 billion. The company has also just completed the acquisition of leading diagnostics company, Dade Behring, in a transaction valued at approximately US$7 billion.

3M Health Care also established a new medical diagnostics business in March 2007 and has already entered alliances with Response Biomedical and Gen-Probe in its aim to become a leader in screening for hospital and community-acquired infectious diseases. Strategic alliances such as this are a key feature of this rapidly evolving market, with many combining the innovations of smaller companies with the strong established distribution channels of large multinationals.

Table of Contents

Volume 1

POC MANUFACTURERS

• 3M Medical Diagnostics
  • Products
  • Agreements
• Abaxis
  • Clinical Chemistry Analyser
  • Agreements
  • Research and Development
  • Financials
    • Revenue by Geographic Region, Fiscal 2007
    • Revenue by Product Category, Fiscal 2007
• Abbott Diagnostics
  • i-STAT 1
  • Agreements
  • Financials
    • Abbott Diagnostics - Product Sales, 2004-2006
• Accumetrics
  • Platelet Function Analysers
• ACRONGENOMICS
  • BioLED Technology
  • Agreements
• Aerscher Diagnostics
  • HemaPrompt and HemaPrompt FG
• Alfa Scientific Designs
  • Instant-View Drug Screen Tests
  • Agreements
• AMDL
  • DR-70
  • Combination Immunogene Therapy (CIT)
• Amnisure International
  • AmniSure PROM Test
  • Litigation
• Analyte Works Ltd
  • POC Theranostics
• Arkray
  • POC Clinical Chemistry
  • Electrolyte Analyser
  • Blood Ammonia Meter
  • Urinalysis
• AT First Diagnostic
  • FirstVue
  • inSTIcheck
• Audit Diagnostics
  • Liqui-Stat Wet Chemistry POC System
  • Hb-Stat
• Axis-Shield
  • Instruments
  • Diabetes Tests
  • Inflammation Tests
  • Coagulation Tests
  • Afinion Pipeline Short-Term
  • Agreements
  • Financials
    • Point-of-Care Sales Analysis (£ thousand)
• British Biocell International
  • BBI Enzymes
  • Agreements
• BD Diagnostics
  • Flu Tests
  • Respiratory Syncytial Virus Tests
  • Meningitis Tests
  • Strep A Tests
  • H. pylori
  • C.difficile
  • Vaginitis Test
  • BD GeneOhm Products
  • Acquisitions
  • New Chinese Manufacturing Plant for Rapid Diagnostic Products
  • Financials
    • Operating Results by Division, 2003-2006 (US$ million)*
• Beckman Coulter
  • Physician Office Instruments
  • Rapid Test Kits for Primary Care
  • Pregnancy Tests
  • Infectious Disease Tests
  • Acquisitions
  • Financials
• bioLytical Laboratories
  • IDE Study for INSTI kit
    • Comparison of HIV-Test Products
• Biomerica
  • Home Diagnostic Products
  • Pregnancy Tests
  • Financials
• BioMérieux
  • Rapid Tests
  • Cardiovascular Critical Care
  • Agreements
  • Equity Investment
  • Divestments
  • Financials
  • Restructuring
  • Strategic Plan 2007-2012
    • Income Statement, 2005-2006
    • Breakdown of Sales, 2005-2006, EUR million
• Bio-Rad Laboratories
  • Diabetes Monitoring
  • Drugs-of-abuse Testing
  • HIV Tests
  • Acquisitions
  • Supply Agreement
  • Financials
• BioSafe
  • Self-Testing Kits
• Branan Medical
  • Drugs-of-Abuse Testing
  • Agreements
• CARE Products
  • Professional Tests
  • Home Use
• Chembio Diagnostics
  • HIV
  • Research and Development
  • Agreements
  • Financials
• CHEMPAQ
  • Chempaq XBC
• Church & Dwight
  • First Response Early Result Pregnancy Test
  • First Response Easy-Read Ovulation Predictor Test
  • Answer Pregnancy and Ovulation Tests
  • Agreements
• Clinical Data Inc
  • Clinical Chemistry
  • Coagulation Analyser
• Diagnostic Test Group (RAC Medical)
  • FOB Testing
  • Strep A
  • Pregnancy
  • H.pylori
  • Follicle Stimulating Hormone Urine Test
  • Infectious Mononucleosis Test
  • Glucose
  • Urine Strips
• EUMED Biotechnology
  • EUsure Blood Glucose Monitoring System
  • EUkare Blood Glucose Monitoring System
  • cHPV Detection System
• Fisher Healthcare
  • Own Brand Diagnostic Products
  • Agreements
  • Financials
• FlexSite diagnostics
  • HbA1c Test
  • Microalbumin Test
• Genzyme Diagnostics
  • Point of Care Tests
  • Development Projects
• Helena Laboratories Point of Care
  • Haemostasis
  • Coagulation
  • FOB Testing
• Hema Diagnostic Systems
• Home Access Health Corporation
  • Home Diagnostic Tests
• Horiba ABX
  • Medical Diagnostic Instruments and Systems - Major Products
  • New Reagent Plant
  • Agreements
  • Financials
• IND Diagnostic
  • Fertility Tests
  • Infectious Disease Tests (Hepatitis B, Hepatitis C and HIV)
  • Sexually Transmitted Disease Tests
  • Tumour Marker Tests
  • Cardiac Marker Tests
  • Drugs-of-Abuse Tests
  • Urinalysis Reagent Tests
  • Urine Analyser
• Instrumentation Laboratory
  • Blood Gas/CO-Oximetry/Electrolytes/Metabolites
  • Haemostasis
  • Coagulation
  • CO-Oximetry
  • Information Management
  • Agreements
  • Supply Agreement
• International Technidyne Corp
  • Hospital POC Coagulation
  • Hospital POC Blood Gas
  • Alternate Site Diagnostics
  • Haemoglobin Testing
  • Agreements
  • Financials
• Inverness Medical Innovations
  • Professional Diagnostic Products
    • Inverness Medical Professional Rapid Diagnostics - Product Revenue* 2002-2006 (US$ million)
  • Point-of-Care Tests
  • Consumer Diagnostics - Fertility/Pregnancy
    • IMA Pregnancy/Fertility Product Revenue*, 2002-2006, US$ million
  • Acquisitions
  • Equity Investments
  • Joint Venture
  • Agreements
  • Research and Development
  • Financials
    • Inverness Medical Financial Results - YTD Fiscal 2007
• Iris Diagnostics
  • Urine Chemistry Analyser for Physician Offices
  • Agreements
  • Financials
• Jant Pharmacal
  • Infectious Disease Tests
  • Pregnancy and Fertility
  • Cardiac Screening Products
  • Drugs-of-Abuse
  • Hypothyroidism Screening
  • Rapid UTI Screen
  • Sleep Apnoea Screen
• Lifestyle Choices Ltd
  • Triple Hormone Ovarian Reserve Test
• Matritech
  • Bladder Cancer Test
  • Agreements
  • Financials
    • Comparison of Revenue, 2005-2006
• Medical Automation Systems
  • RALS-Plus
  • Agreements
  • Acquisitions
• MedMira Laboratories
  • HIV and Hepatitis C Tests
  • HIV Tests
  • Hepatitis B Test
  • Hepatitis C Test
  • H. pylori Test
  • Acquisitions
  • Agreements
  • Patents
  • Financials
• Menarini Diagnostics
• Medtronic
  • ACT Plus Automated Coagulation Timer System
  • HMS PLUS Haemostasis Management System
  • Financials
• MCM Corporation
  • Cardiac Infarction Test
• Meridian Bioscience
  • E.coli Test
  • C.difficile Test
  • H. pylori Test
  • RSV Test
  • Strep A Test
  • Financials
• MYCROLAB
  • MycroCARD Miniaturised Diagnostic Testing System
• Nanogen
  • Test for CHF
  • Tests for ACS and AMI
  • Drugs-of-Abuse Test
  • In Development
  • Agreements
  • Acquisitions
  • Financials
• Nanosphere
  • Verigene System
  • Focus Areas
  • Agreements
• Nova Biomedical
  • Blood Gas Critical Care Analysers
  • Nova Electrolyte/Chemistry Analysers
  • Data Management
  • Supply Agreements
• Omega Pharma
  • Home Pregnancy Test
• OraSure Technologies
  • HIV Tests
  • Drugs of Abuse
  • Agreements
  • Supply Agreements
  • Research and Development
  • Financials
• Orion Diagnostica
  • Point-of-Care Tests
  • Financials
• OrSense
  • Haemoglobin Monitoring
• Ortho-Clinical Diagnostics
  • Clinical Chemistry Analyser
  • Financials
• OPTI Medical
  • Blood Gas Analysis
  • Point-Of-Care CO-Oximeter
  • Financials
• Polymedco
  • Point of Care/Rapid Diagnostics
• Polymer Technology Systems (PTS)
  • CardioChek P.A System (Professional System)
• Prima Biomedical
  • One Step Rapid Tests
  • Quantitative Rapid Tests
  • Urinalysis
  • Blood Glucose Rapid Tests
  • Instruments
• PreMD Inc
  • PREVU Point of Care Skin Sterol Test
  • Cancer Tests
  • Agreements
  • Financials
• Princeton BioMeditech
  • Home Pregnancy Tests
  • Infectious Disease Tests
  • Drugs of Abuse Tests
  • Tumour Marker Tests
  • Cardiac Marker Tests
  • Agreements
• Probe Scientific
  • MicroEye Blood Analysis Device
  • Agreements
• Proteome Systems
  • DiagnostIQ
  • Agreements
  • Diagnostic test for Ovarian Cancer
• Quest Diagnostics
  • HemoCue POC products
  • Focus Diagnostics' POC Products
  • Enterix' POC Products
  • Acquisitions
  • Agreements
• Quidel Corporation
  • Products
  • Research and Development
  • Agreements
  • Acquisitions
  • Financials
• Radiometer
  • Blood Gas Analysers
  • Quality Control
  • IT Systems
  • QA Support
  • Agreements
  • Group Purchasing Organisation (GPO) Partners
  • Financials
• Remel
  • Xpect Rapid Diagnostic Tests
  • Oxoid PBP2 Test
  • Financials
• Response Biomedical Corp
  • RAMP System
  • Cardiac Markers
  • Influenza
  • Agreements
  • Financials
• Roche Diagnostics
  • Coagulation Monitoring Systems
  • Cardiac Markers
  • Hospital Blood Gas/Electrolytes
  • Multi-parameter Clinical Chemistry Analysers
  • Urinalysis
  • Point of Care Data Management
  • Financials
    • Roche Point-of Care Diagnostics' Sales, 2004-2006 (SFr million)
    • Roche Point-of Care Diagnostics' Sales*, 2004-2006 (US$ million)
    • Roche Point-of Care Diagnostics' Sales*, 2004-2006 (US$ million)
    • Roche Diagnostics Division, 2006 Results
• Rohto Pharmaceutical
  • Pregnancy Test Kit
  • Ovulation Test Kit
• Runbio Biotech
  • Fertility Tests
  • Infectious Diseases
  • Tumour Marker Tests
  • Sexually-Transmitted Disease Tests
  • Drugs-of-abuse Tests
• SA Scientific
  • Fertility
  • Infectious Diseases
• Siemens Medical Solutions Diagnostics
  • POC Product Line
  • Dade Behring Products
  • Acquisitions
  • Agreements
  • Supply Agreements
  • Financials
• SIENCO
  • Platelet Function Analyser
  • Data Management
• Stanbio Laboratory
  • POC Haematology Analysers
  • Rapid Tests
  • Infectious Diseases
  • Agreements
• Syntron Bioresearch
  • Blood Glucose Testing
  • Drugs-of-abuse testing
  • Cholesterol Tests
  • Fertility Tests
• Sysmex
  • Haematology Analysers
  • Influenza Test
  • Coagulation Analyser
  • Agreements
  • Financials
• Telcor
  • Point Of Care Testing (POCT) Information System
• Tosoh Bioscience
  • Benchtop Immunoassay Analysers
  • AIA-600 II
• Trinity Biotech
  • POC Infectious Disease Tests
    • Comparison of POC HIV Tests
  • POC Pregnancy
  • Acquisitions
  • Agreements
  • Litigation Settlement
  • Financials
• Via Medical
  • VIA Blood Gas and Chemistry Monitor
  • VIA LVM Neonatal System
  • VIA Blood Glucose Monitoring System
• WayPoint Biomedical
  • OTC Market
  • Professional Point of Care Tests
  • International Products
  • Agreements
• References

Volume 2

POC Market Overview

• Executive Summary
  • IV D Market
    • Figure 1: Global IVD Market by Geographic Region 2007 US$33.6 Billion
    • Figure 2: IVD Market Leaders
    • Figure 3: EDMA 2006 IVD Market Estimates
    • Figure 4: POCT Relative to the Global IVD Market, 2007
    • Figure 5: Global POCT Market by Geographic Region 2007 US$11.32 billion
  • POC Market Sectors
    • Figure 6: POC Market by Segment, excluding Blood Glucose Testing, 2007, Total US$3.87 billion
  • POC Testing in the US
  • POC Testing in Europe
    • Figure 7: European Point of Care Market 2007 (US$3.44 billion)
• POC Growth Drivers
  • Healthcare Trends
  • Demographic Changes
  • Advantages of POC Testing
  • Social Pressure
  • Industry Pressure
  • Technology Advancements
• Challenges to POC
  • Cost Issues
  • Interfacing/Connectivity Issues
  • Regulatory Compliance and Quality Control
  • Central Laboratory Competition
  • Summary - Future Advances in POC
• Emerging POC Technologies
  • Nucleic Acid Lateral Flow (NALF)
  • Fluorescence Reader Systems
  • University of Illinois - DNA-Gold Nanoparticle Technology
  • Probe Scientific
  • Pharmacogenetic Testing
  • AMDL
• Blood Glucose Market
  • Table 1: WHO Diabetes Prevalence Estimates
  • Table 2: Prevalence of Diabetes in Selected Countries in the WHO European Region
  • Diabetes
  • BGM Technologies
    • Figure 8: Leading Manufacturers' Diabetes Care Revenues* 2004-2006 (US$ million)
    • Table 3: Leading Manufacturers' Diabetes Care Revenues 2004-2006 (US$ million)
    • Table 4: Leading Manufacturers' Diabetes Care Revenues - First Nine Months of Fiscal 2007 (US$ million)
  • BGM Market and Market Leaders
• Continuous Glucose Monitoring Systems
  • Medtronic
  • DexCom
  • Abbott Diabetes Care
  • Menarini Diagnostics
  • PreciSense
    • Summary of Performance of Precisense in 3 day trials - Comparison with Medtronic Needle Sensor
    • Summarised One Day Pilot - Clinical Results
    • Summarised Pre-clinical Results (2006)
  • Funding
• Long-Term Glucose Biosensors
  • Sensors for Medicine & Science (SMSI)
  • DexCom
  • Animas
• Non-Invasive BGM technologies
  • OrSense
  • AiMedics
  • Calisto Medical
  • GlucoLight Corporation
  • Glucon
  • GluMetrics
  • Integrity Applications
  • Kumetrix
  • Lein Applied Diagnostics
  • LighTouch Medical
  • Luminous Medical
  • iSense
  • NIR Diagnostics
  • NIBGM
  • Oculir
  • Pindi Products
  • Sensors for Medicine & Science
  • Echo Therapeutics (formerly Sontra Medical)
  • SpectRx
  • Synthetic Blood International (SYBD)
  • VeraLight
  • Freedom Meditech
  • Sensys Medical
  • Solianis Monitoring
• Current Blood Glucose Monitoring Systems
  • Roche Diabetes Care
    • Roche Diabetes Care Sales - First Nine Months of Fiscal 2007 (SFr million)
    • Roche Diabetes Care Sales 2005-2006 (SFr million)
  • LifeScan (J&J)
  • Abbott Diabetes Care
    • Abbott Diabetes Care - Product Sales, First Nine Months of Fiscal 2007
    • Abbott Diabetes Care - Product Sales, 2004-2006
  • Bayer Diabetes Care
    • Ascensia Sales - First Nine Months of Fiscal 2007 (EUR Million)
  • Arkray
  • Menarini Diagnostics
  • Home Glucose Testing
  • Home Diagnostics, Inc
  • Medtronic Diabetes
  • 77 Electronica Kft
  • Blood Glucose Meters
  • LiteLink Wireless Data Download Device
  • AgaMatrix
  • WaveSense Jazz
  • Apex Biotechnology
  • Diabetech
  • EUMED Biotechnology
  • Glucoplus
  • HMD Bio Medical
  • HemoCue AB
  • Nova Biomedical
  • TaiDoc Technology Corporation
  • US Diagnostics
• HbA1c Testing
  • Professional HbA1C Systems
  • Self-Testing HbA1c Systems

POC Cardiology Diagnos tics

• POC Coagulation Testing
  • PT/INR Testing in the US
  • PT/INR Testing in Europe
    • Table 5: Reimbursement for PT/INR Testing in Europe
  • PT/INR POC Market Leaders
  • PT/INR Analysers
• POC Cardiac Marker Market
  • Most Frequently Used Cardiac Markers
  • Cardiac Marker - Market Leaders
  • C-reactive protein (CRP)
• POC Blood Gas/Electrolytes Market
  • Radiometer
  • Siemens Medical Solutions Diagnostics
  • Roche Diagnostics
  • Nova Biomedical
  • Instrumentation Laboratory
  • International Technidyne Corporation
  • Abbott Diagnostics
  • OPTI Medical (formerly Osmetech)
  • Blood Gas and Chemistry Monitors
• POC Clinical Chemistry/Urinalysis
  • Blood Chemistry Analysers
  • Urinalysis
  • Iris International
  • Arkray
  • Hypoguard (Arkray)
  • POC Cholesterol Testing
    • Table 5: Initial classification based on total cholesterol and HDL cholesterol
• POC Haematology
  • POC Haematology Analysers
  • POC Haemoglobin Analysers
  • POC Platelet Function Analaysers
• POC Infectious Disease Test Market
  • HAI s
  • HIV
    • Table 6: Regional HIV/AIDS Statistics
    • Table 7: National Hospital Ambulatory Medical Survey 2002 Emergency Department Summary (USA)
    • Table 8: Comparison of POC HIV Tests
  • Currently Available HIV Tests for the POC Market
  • Tuberculosis
  • Hepatitis B
  • Hepatitis B Tests
  • Hepatitis C
  • Influenza
    • Table 9: Flu A & B Tests - Performance Comparison: Sensitivity and Specificity
  • Respiratory Syncytial Virus
    • Table 10: RSV Performance Comparison: Sensitivity and Specificity
  • S. aureus and MRSA
  • Streptococcal Infectious Disease tests
  • Strep B Tests
  • C.difficile Tests
  • Other Infectious Disease Tests
  • H. pylori
  • Mononucleosis Tests
  • Malaria Tests
• POC Drugs-of-Abuse Testing
  • Inverness Medical
  • Princeton BioMeditech
  • Dade Behring (Siemens)
  • Alfa Scientific
  • Bio-Rad
  • Branan Medical
  • IND Diagnostics
  • Instant Technologies
  • WayPoint Biomedical

POC Tumour Marker Tests

• FOB Testing
• PSA and Other Tumour Marker Tests

POC Pregn ancy /Fertility Market

• Figure 9: Global Pregnancy and Fertility Market
• Inverness Medical Pregnancy/Fertility Product Revenues **
• Home Pregnancy Tests
• Professional Pregnancy Tests
• Fertility Tests

POINT-OF-CARE DATA MANAGEMENT

• Medical Automation Systems
• Abbott Diagnostics
• Instrumentation Laboratory
• Menarini Diagnostics
• References