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The Global Market for Point of Care Diagnostics - Major Players and Key Issues
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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.
Providing… - Extensive competitive comparison and evaluation of major and emerging companies - Market valuation and POC markets in context - Critical appraisal of research & innovation
Covering… - Blood Glucose - Cardiology - Coagulation - Blood Gas/Electrolytes - Infectious Diseases - Pregnancy/Fertility - Clinical Chemistry/Urinalysis - Haematology - Drugs of Abuse - Tumour Markers - Data Management - Emerging Research Trends
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.
A positive outlook for this rapidly growing sector Drivers of growth
Healthcare Trends Rising health costs have created new expectations in hospitals including shortened patient stays, and a movement from an inpatient to an outpatient or ambulatory setting.
As hospitals become treatment centres for the acutely ill and no longer serve primarily as diagnostic centres, the subsequent change in the patient's hospital stay and patient acuity have placed demands on the laboratory to deliver information in a manner which will facilitate rapid diagnosis and treatment. Because these demands have compressed the timeframe for performing testing, shorter turn around times and an increase in the volume of stat testing have become a necessity.
Social Pressure Many patients today have greater medical knowledge, more money and greater expectations of healthcare services. They are demanding faster, more effective treatment and want greater control of their health.
Industry Pressure Manufacturers are driving growth through the development of diagnostics instruments and tests that are simple and easy to use specifically for the POC environment. Many of the devices have data management capabilities to enable them to be linked to hospital information systems for the capture of patient data.
Technology Advancements - High-quality lab tests are now available at the point of care with smaller test systems suitable for POC environments and automated features of new POC instruments. - Wider test menus – a greater variety of tests have been developed for POC instruments. - Increase in the availability of home-testing devices. - Increased use of data management tools to handle POC test data and costs throughout the healthcare system. - Quality Control – advances in software to either automate quality control or alert operators to perform QC before a patient sample is analysed. - Future multiplex systems offering the promise of more cost-effective testing with several parameters measured from just one sample.
Future developments...
It is clear that technological advancements in POC equipment will be a future growth driver in the POC market. Various companies are developing multiplex assay systems which enable the simultaneous measurement of numerous analytes from one small sample. This represents a major advancement in POC testing and offers the opportunity of lower costs and a reduction in the number of tests performed.
Broad interest in pharmacogenetic testing is developing rapidly as clinical laboratories, physicians, payers, patients, and pharmaceutical companies seek to provide the most appropriate treatment for each patient, while mitigating the high costs of healthcare and drug development. Advances in nucleic acid testing technologies have contributed to this growing interest by enabling rapid, multiplex genotyping analysis, which is required for widespread adoption of pharmacogenetic testing by clinical laboratories. |
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Contents: |
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 TestsMeningitis 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
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
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 Tumou r 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 LaboratoryMenarini Diagnostics
References Table of Contents |
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Companies Mentioned |
- Abaxis
- Piccolo
- bioMérieux SA
- PSS World Medical
- Chatani
- Abbott Diagnostics
- i-STAT
- Axis-Shield
- OraSure
- Accumetrics
- ACON Laboratories
- MedSurge Medical
- SpotChem EZ
- Eli Lilly
- Roche Diagnostics
- Branan Medical
- Church & Dwight
- Quidel
- Vitalab Fibron
- Dade Behring
- ZyCare
- ABX Pentra
- Bayer Diagnostics
- Iris International
- ITI Scotland Limited
- Lifestream Technologies
- Omega Pharma |
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