Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads

Point of Care Diagnostics 2010 and Beyond: Rapid Testing at a Crossroads

As the author lead diagnostic analyst finds, the point of care concept is at a crossroads: the technologies needed to make rapid testing a reality are here. But is healthcare ready?

The drive for wellness and the attention surrounding healthcare reform will surely focus attention on rapid diagnostics. However, according to Shara Rosen, RT, M.B.A., there are many challenges which must be overcome for point of care solutions to fit, and those companies willing to pivot strategies and best adjust to changes in the healthcare marketplace may be rewarded.

This report, Point of Care Diagnostics 2010: Rapid Testing at a Crossroads represents the most current analysis of the role of Point of Care Diagnostics in today's in vitro industry. Other reports have looked at products, companies and market forecasts, as this report does. But in her analysis Shara Rosen takes a bold look into the markets, technologies, and trends in decentralized testing with a special focus on the economics of rapid test use in critical care and emergency medicine.

The report includes:

- Markets for POC Diagnostics (Diabetes, Cardiac markers, Clinical Chemistry/Critical Care, Hematology, Coagulation,
- Drugs of Abuse/Therapeutic Drug Monitoring, Infectious Diseases, Pharmacodiagnostics, Sepsis, Oncology, Women’s health / Pregnancy/Fertility)
- By Venue Revenue Estimates for Hospital POC, Physician POC and Other Venue
- Review of Products in the Market
- Forecasts to 2013
- Markets and Forecasts for Self-Testing (OTC)
- The role of EMR in the Point of Care Market
- Possible Effects of Healthcare Reform
- POLs, Home Monitoring, Alternate Samples and Other Trends
- Successful Strategies of POC Companies
- Profiles of Over 100 Companies Competing in this Market


There are many factors in the growth of POC testing- increasing numbers of diagnosed diabetics, people with cardiovascular disease, and other chronic conditions. It is also expected to play a role in a trend in health care to evaluate provider organizations for quality in care delivery. While this quality imperative is most apparent in pay-for-performance systems, it also provides a framework by which public funds can be used more rationally. This is an especially relevant technology given the U.S. healthcare reform efforts.

All countries are feeling the brunt of aging populations and an increased burden of chronic disease management. Employers and insurance companies are interested in improving the health of customers, and there are some innovative tactics developing in this area. The report is conservative in its predictions and offers a calculated look into the future, based on events currently taking place.

The report offers a quantitative assessment of specific markets in US dollars for 2008 and forecasted out to 2013. These data are provided in order to set the status quo of tests and technologies. However the report concentrates on how these will impact the economics of healthcare over the near term and longer when possible.


The following companies are discussed:

23andMe
3M Health Care
77 Elektronika
A. Menarini
A/C Diagnostics
Abaxis, Inc.
Abbott Diagnostics
ABTECH Scientific
Accumetrics
ACIST Medical
Acrongenomics Inc.
Adeza Biomedical
ADIATEC
Aerscher Diagnostics
AgaMetrix, Inc.
Alfa Scientific
Alfa Wassermann
Alverix Inc.
American Bio Medica
Amic/Ortho
Amnisure International
Animas/J&J
ANP Technologies
Antigen Discovery Inc.
Apollo Hospitals
Arkray
Arrayit Diagnostics
AspenBio Pharma
Astron Clinica
AT First Diagnostic
Audit Diagnostics
Axis-Shield plc
Bayer Diabetes Care
Beckman Coulter
Becton Dickinson
Bedfont Scientific
Biohit Oy
BioIQ
bioLytical Labs
Biomagnetics Diagnostics
Biomerica, Inc.
bioMérieux
Bionime Corp.
Bio-Rad Laboratories
BIOSAFE Medical Technologies
Biosite/Inverness
Boditech Med
BodyTel Scientific
Branan Medical Corp
Burnet Institute
Calypte Biomedical
Careside Medical
Carolina Liquid Chemistries
Celerus Diagnostics
Chelsea Technologies
Chembio Diagnostic
Chempaq A/S
Chemtron Biotech
Cholestech Corp.
Claros Diagnostics
CLX Medical, Inc.
Combimatrix
Common Sense, Ltd.
Commonwealth Labs
Connectyx Technologies
ContraVac, Inc.
Decision Biomarkers
DexCom, Inc.
Diabetech, LP
Diabetes Sentry
Diaglobal GmbH
Diagnostic Devices
Diagnostics for All
Diagnostics for the Real World
Diazyme Laboratories
Digital Bio Tech
Diversa Limited
DNA Direct, Inc.
DNAFORM
DxNA
Echo Therapeutics
EKF-diagnostic GmbH
Enfora
Enigma Diagnostics
Enterix Inc.
Entra Health
Epocal, Inc.
EPS Bio Technology
ESA Biosciences
eScreen, Inc.
ExpressMD Solutions
EyeMarker Systems
Flexsite Diagnostics
Focus Diagnostics
Fora Care
GE Healthcare
GenBio
Gene Smart Wellness
Genexel-Sein Inc.
Gentag Inc.
Genzyme Diagnostics
Global Detection & Reporting
Glucometrics, Inc.
Google, Inc.
Guided Therapeutics
Hai Kang Life Corp.
Hain Lifescience GmbH
HandyLab, Inc.
HealthPia America
HealthPort
Helena Laboratories
Hema Diagnostic Systems
Hema Metrics
HemoCue AB
Hero Network Network
HMM GmbH
Hoana Medical
Home Access Health
Home Diagnostics
Horiba ABX
Idaho Technology
IDenta Corp
Identigene
IDEXX Laboratories
incentaHEALTH LLC
Innovative Biosensors
Instrumentation Laboratory
Insulet Corporation
Integrity Applications
Intel Corporation
International Technidyne
Inverness Medical Innovations
Knome
Lab Express
LifeAssays AB
Lifescan
LifeSign LLC
LifeStat
Lifestream Technologies, Inc.
Lifestyle Choices
Luminex
Luminous Medical
MACHEREY-NAGEL
Masimo Corp
Matritech
M-Biotech
Medical Automation Systems
MedMira Inc.
Medtronic Inc.
Menssana Research, Inc.
Meretek Diagnostics Inc.
Meridian Bioscience
Micromem Technologies
Micronics Inc.
MicroPhage, Inc.
MinuteClinic
Mitsubishi Kagaku Iatron
MP Biomedicals
Multilyte Limited
MycroLab Pty
Nanogen
Nanomix, Inc.
Nanosphere, Inc.
National Jewish Health
Navigenics, Inc.
Network Biosystems
Neuroptix Corp
Nihon Kohden
Noninvasive Medical Tech
Nova Biomedical
OPTI Medical Systems
OraSure Technologies
Orion Diagnostica
OrSense Ltd.
Ortho Clinical Diagnostics
OvumOptics, Inc.
Oxford Biosensors
Oxonica Diagnostics
Phadia AB
Philips Handheld Immunoassays
PlaCor, Inc.
PointCare Technologies
Polymedco
Practice Fusion
PreMD Inc.
PrimeraDx
Probe Scientific Ltd
Prometheus Laboratories
Psynomics
QBC Diagnostics
Qiagen
Q-linea
Quadraspec
QualSec, Inc
QuantRx Biomedical Corporation
Quidel Corp
Quotient Diagnostics
Radiometer A/S
Raman spectroscopy
Rapid Pathogen Screening
Rennesens GmbH
Response Biomedical
Rite Aid
Roche Diagnostics
Royal Philips Electronics
Safeway, Inc.
Screening Devices Canada
SEMOFS
Sentinel Bioactive Paper Network
SeraCare Life Sciences
Serotec
Siemens Healthcare Diagnostics
SIENCO
Smiths Detection
Smiths Medical MD
Soar BioDynamics
Solei Systems, Inc
Solianis Monitoring
SpectraScience, Inc.
Sphere Medical Ltd.
SpheroSense Technologies
Stanbio Laboratory
StatSure Diagnostic Systems
STD Test Express
STMicroelectronics
Synova Healthcare
Sysmex Corp
T2 Biosystems
Taidoc Technology
TelCare
Telus Corporation
Textronics, Inc.
Thermo Fisher Scientific
Tosoh Corp
Trinity Biotech
TwistDx, Ltd.
Tyrian Diagnostics
UnitedHealth Group
Veralight, Inc.
Veredus Laboratories
VeriChip Corporation
Via Medical Corp
Vital Diagnostics
Vivacta Limited
Walgreens
Wal-Mart Stores
Webahn Inc.
Ypsomed

CHAPTER ONE: EXECUTIVE SUMMARY

Scope and Methodology

Size and Growth of the Market

Market Trends

CHAPTER TWO: INTRODUCTION

Miniaturization, Digitization and Informatics

The pros and cons of POC testing

Point of View

CHAPTER THREE: ECONOMICS, EMR AND HEALTHCARE REFORM

Healthcare Reform

POC and Clinical Outcomes Management

POC’s Unmet Need

CHAPTER FOUR: TECHNOLOGY AND INDUSTRY TRENDS

Background

The search for non-invasive tools

Saliva

Breath

Optical Techniques

Patch Technology

Wearable Sensors/Textiles

The Wireless Revolution

Connectivity Imperative

Lab-on-a chip

CHAPTER FIVE: VENUES FOR POC TESTING

POC Testing in the Hospital

POL and Clinic Testing

Retail Outlets

Other Professional POC Venues - Workplace Testing and Home Visits

Home Monitoring of Individuals with Chronic Diseases

Self-Test Sector - OTC Tests

CHAPTER SIX: MARKET ANALYSIS

Market Overview

Prognosis for POC growth

Technological Challenges

Market and Forecasts

Self Testing/OTC

Breakout of Non-Glucose Tests

Professional POC Testing

POC in world markets

Europe

Asia

Rest of World

United States

Physician Office Labs

United Kingdom

HIV/AID

Market for Rapid Flu Testin

The Major Players

Licenses and Distribution Agreements

Struggling Competitors

CHAPTER SEVEN: POC TEST SEGMENTS

Diabetes Testing - Blood Glucose Monitoring (BGM)

Blood Glucose Self-Testing

Blood Glucose Testing by Professionals

Diabetes Testing - Glycated Hemoglobin

Cardiovascular Diagnostics

Cardiac Markers (AMI enzymes)

Cholesterol/Lipid Panels

Clinical Chemistry/Critical Care

Hemoglobin Testing for Anemia

Hematology

Coagulation

Decentralized Coagulation testing - Professional Use

Decentralized Coagulation Testing - OTC

Drugs of Abuse/Therapeutic Drug Monitoring

Allergy

Infectious Diseases

OTC Tests for Infectious Diseases

Professional POC Tests for Infectious Diseases

Pharmacodiagnostics

Sepsis

Oncology

Bladder Cancer

Colon Cancer

Prostate Cancer

Cervical Cancer

Women’s Health / Pregnancy/Fertility

Emerging Tests and Technologies

Commercial Outlook

CHAPTER EIGHT: COMPANY PROFILES MAJOR COMPANIES

Abbott Diagnostics

Diabetes

Critical Care

Hematology

ARKRAY, Inc.

Distribution News

Product News

Bayer Diabetes Care

Beckman Coulter Inc.

Becton, Dickinson and Company (BD)

bioMerieux Inc.

Bio-Rad Laboratories Inc.

GE Healthcare

Instrumentation Laboratory

Inverness Medical Innovations

Lifescan Inc.

Nova Biomedical

Ortho Clinical Diagnostics (OCD)

Qiagen N.V.

Quidel Corporation

Radiometer A/S

Roche Diagnostics

Diabetes

Cardiac Markers

Clinical Chemistry

Critical Care

Siemens Healthcare Diagnostics

Cardiac Markers

Diabetes Care

Blood Gases

Urinalysis

Sysmex Corporation

TOSOH Corporation

‘New Frontier’ POC COMPANIES

3M Health Care

77 Elektronika Kft.

Abaxis, Inc.

A/C Diagnostics

Accumetrics

ACIST Medical Systems, Inc.

AgaMetrix, Inc.

Alfa Wassermann Diagnostic Technologies, LLC (AWDT)

American Bio Medica Corp

Audit Diagnostics

Axis-Shield plc

Biohit Oy

BioIQ

Biomerica, Inc.

Biosite Incorporated

B.R.A.H.M.S. AG

Calypte Biomedical Corporation

Chembio Diagnostic Systems, Inc.

Chempaq A/S

Cholestech Corporation

Concateno plc

DexCom, Inc.

Diabetech, LP

Diazyme Laboratories

EKF-diagnostic GmbH

ESA Biosciences Inc.

Hain Lifescience GmbH

HandyLab, Inc.

Helena Laboratories USA

Hema Diagnostic Systems (HDS)

HemoCue AB

HemoSense, Inc.

Home Diagnostics, Inc.

Horiba ABX S.A.

Insulet Corporation

International Technidyne Corp (ITC)

Masimo Corporation

Matritech

Medical Automation Systems, Inc.

MedMira Inc.

Medtronic Inc.

A. Menarini Diagnostics

Meridian Bioscience

MP Biomedicals LLC

Nanosphere, Inc.

OPTI Medical Systems, Inc.

OraSure Technologies, Inc.

Phadia AB

Philips Handheld Immunoassays

Polymedco, Inc.

QBC Diagnostics, Inc.

Response Biomedical Corp

Serotec (AbD Serot

Smiths Medical MD, Inc. (formerly Deltec, Inc.)

Stanbio Laboratory

Taidoc Technology Corp.

Trinity Biotech plc

Via Medical Corporation

Vital Diagnostics

Other Players

Acrongenomics Inc.

Alfa Scientific Designs, Inc.

Amic AB

Astron Clinica

AspenBio Pharma, Inc.

AT First Diagnostic, LLC

bioLytical Laboratories Inc.

Biomagnetics Diagnostics Corporation

Bionime Corporation

BodyTel Scientific, Inc.

Burnet Institute

Celerus Diagnostics

Chelsea Technologies Group Ltd

Claros Diagnostics

CLX Medical, Inc.

ContraVac, Inc.

Decision Biomarkers Inc.

Diabetes Sentry Products Inc.

Diaglobal GmbH

Diagnostic Devices, Inc.

Diagnostics for All (DFA)

Diagnostics for the Real World (DRW)

Digital Bio Technology/ InCyto

Diversa Limited (formerly Ambri Ltd.)

DNAFORM

DxNA

Echo Therapeutics, Inc. (previously Sontra Medical)

Enigma Diagnostics Limited

Enterix Inc.

Entra Health Systems

Epocal, Inc.

EUMED Biotechnology Co. Ltd.

eScreen, Inc.

EyeMarker Systems, Inc.

Flexsite Diagnostics, Inc.

Fora Care

GenBio

Gene Smart Wellness

Gentag Inc.

Glucometrics, Inc.

Guided Therapeutics, Inc.

Hai Kang Life Corporation

HealthPia America

Heidelberger-Medical-Marketing GmbH (HMM GmbH)

Hema Metrics

Hoana Medical, Inc.

Idaho Technology, Inc.

Identa Corporation

Identigene

Innovative Biosensors, Inc.

Integrity Applications Ltd.

Intel Corporation

LifeAssays AB

LifeSign LLC

Lifestyle Choices Ltd

Luminous Medical, Inc.:

M-Biotech

Menssana Research, Inc.

Micromem Technologies Inc.

Micronics Inc.

MicroPhage, Inc.

Multilyte Limited

MycroLab Pty Ltd.

Nanomix, Inc.

National Jewish Health

Network Biosystems

Neuroptix Corporation

Noninvasive Medical Technologies, Inc.

OrSense Ltd.

OvumOptics, Inc.

Oxonica Diagnostics

PlaCor, Inc.

PointCare Technologies

Probe Scientific Ltd

Prometheus Laboratories Inc.

Q-linea

Quadraspec

QualSec, Inc

QuantRx Biomedical Corporation

Quotient Diagnostics

Rapid Pathogen Screening

Rennesens GmbH

Screening Devices Canada, Inc.

Sentinel Bioactive Paper Network

Sphere Medical Ltd.

SIENCO

Smiths Detection

Solei Systems, Inc.

Solianis Monitoring AG

SpheroSense Technologies Inc.

STD Test Express

Surface Enhanced Micro Optical Fluidic Systems

T2 Biosystems, Inc.

TwistDx, Ltd.

Veralight, Inc.

Veredus Laboratories Pte

VeriChip Corporation

Vivacta Limited

LIST OF EXHIBITS

CHAPTER ONE: EXECUTIVE SUMMARY

Table 1-1: Exchange Rate Fluctuations, 2005-2008

Table 1-2: POC Sales by Test Category (OTC and POC), Worldwide 2008-2013

CHAPTER FOUR: TECHNOLOGY AND INDUSTRY TRENDS

Table 4-1: Selected Non-Invasive Testing Innovations

Table 4-2: Selected disease markers in exhaled breath

Table 4-3: Selected POC Wireless Innovations, 2008-2009

Table 4-4: RALS connected POC systems, 2009

Table 4-5: Selected biochip and biosensor innovations, 2009

CHAPTER FIVE: VENUES FOR POC TESTING

Figure 5-1: Venues for POC Testing (Hospital, Physician, Other)

Table 5-1: POC Test Sales in the Hospital Sector (Critical Care, Glucose, Cardiac Markers, Infectious Diseases, Coagulation, Hematology, Drugs of Abuse, Cholesterol, Pregnancy, Urinalysis), 2008

Table 5-2: POC Test Sales in the POL Sector (Glucose, Cholesterol, HbA1c, Coagulation, Hematology, Chemistry/Immunoassays, Infectious Diseases, Fecal Occult Blood, Pregnancy, Cardiac Markers, Oncology, Urinalysis, Drugs of Abuse), 2008

Table 5-3: Selected Small Footprint Chemistry Systems, 2009

Table 5-4: Selected Small Footprint Hematology Systems, 2009

Table 5-5: Selected New Small Footprint Immunoassay Systems, 2009

Table 5-6: POC Test Sales in Other Care Venues (Glucose, Cholesterol, Drugs of Abuse, Fecal Occult Blood, Infectious Diseases, Urinalysis, Coagulation), 2008

Table 5-7: Selected self-test innovations, 2008-2009

CHAPTER SIX: MARKET ANALYSIS

Table 6-1: OTC/Self Test Sales by Test Category (Glucose, Pregnancy, Coagulation, Fecal Occult Blood, Drugs of Abuse, HbA1c, HIV, Cholesterol, Other) Worldwide 2008 and 2013

Figure 6-1: Breakout of Non-Glucose Self-Testing

Figure 6-2: Professional POC Testing Market by Test Category

Table 6-2: Professional Point of Care Testing Market by Test Category (Glucose, Critical Care, Cardiac Markers, Infectious Diseases, Cholesterol/Lipids, Coagulation, Hematology, HbA1c, Chemistry/Immunoassays, Fecal Occult Blood, Drugs of Abuse, Pregnancy, Urinalysis, Onocology, Other) 2008 and 2013

Figure 6-3: Professional POC Testing Market by Test Category

Table 6-3: POC Test Sales by Region (US, Europe, Asia, ROW), 2008-2013

Table 6-4: POC Test Revenues of Selected IVD Companies, $ million, estimated

Table 6-5: Selected Market Expansion Deals in POC testing, 2008-2009

CHAPTER SEVEN: POC TEST SEGMENTS

Table 7-1: World Glucose Monitoring Sales, by Company, 2005 - 2008

Table 7-2: Selected Glucose Meter Innovations, 2008-2009

Table 7-3: Selected Wireless Enabled Blood Glucose Monitors, 2009

Table 7-4: Selected Continuous BGM Sales by Company, 2008

Table 7-5: Selected Continuous Blood Glucose Systems, 2009

Table 7-6: Glucose Meters that use GDH-PQQ technology

Table 7-7: Selected POC HbA1c Devices, 2009

Table 7-8: Worldwide Sales, POC CVD markers (Cholesterol -Professional, Cholesterol OTC, AMI Enzymes), 2008-2013

Table 7-9: Selected POC Hematology Systems, 2009

Table 7-10: World POC Coagulation Sales(PT-Professional, PT OTC, ACT), 2008 (million)

Table 7-11: Selected CLIA Waived PT Devices

Table 7-12: Selected Rapid HIV Tests on the Market

Table 7-13: Selected Rapid Infectious Disease Test Innovations

Table 7-14: Selected Women’s Health OTC Tests

Table 7-15: Selected POC Platform Innovations, 2008/2009