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The Global Market for Point of Care Diagnostics - Major Players and Key Issues


Description: 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.


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


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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