World Markets for Point of Care Diagnostics 2009-13

Point of care diagnostics is one of the most dynamic parts of the diagnostics industry and an area where several major competitors are battling for market share. Point-of-care testing (POC) is defined as diagnostic testing at or near the site of patient care. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of med...

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Point of care diagnostics is one of the most dynamic parts of the diagnostics industry and an area where several major competitors are battling for market share. Point-of-care testing (POC) is defined as diagnostic testing at or near the site of patient care. Over the years, the increasing introduction of transportable, portable, and handheld instruments has resulted in the migration of POC testing from the hospital environment to a range of medical environments including the workplace, home, disaster care and most recently, convenience clinics.


Manufacturers are increasingly introducing minimally invasive tests that can be easily performed on a patient’s saliva, urine, breath or other bodily by-products.
This report covers the following POC test segments with current market size and forecasts:

• Glucose


• Pregnancy/Ovulation


• Coagulation/PT


• Fecal Occult Blood


• Drugs of Abuse


• H. pylori


• HIV


• Cholesterol


• Other


• Glucose


• Critical Care


• Pregnancy


• Infectious Diseases


• Cardiac Markers


• Cholesterol/Lipids


• Coagulation/PT, ACT


• bA1c


• Hemoglobin


• Fecal occult blood


• Drugs of Abuse


• Bilirubin

In addition to the total POC diagnostic market, the report also covers the impact on POC markets of the following trends:

• Miniturization


• Digital Technology


• Aging Population


• POC Advantages and Disadvantages


• Emerging World Markets


• Consolidation in IVD


• Physician Office Labs


• Retail Clinics


• Wellness Initiatives

As a worldwide report, this report breaks up revenue for POC diagnostics in the following regions:

• U.S.


• Europe


• Asia


• Rest of World

This report is the result of primary and secondary research - interviews with experts in the POC diagnostics industry, a review of annual reports and news articles in the area of POC diagnostics, and the analysis of Kalorama's diagnostics experts, who have observed the industry for the past decade. The most important part of Kalorama's anlaysis is its superior analysis of company activities and their true significance in the marketplace. The following companies are examined in detail:

• 77 Elektronika Kft


• Abbott Diagnostics


• Acrongenomics Inc.


• AgaMatrix, Inc


• Agilent Technologies Inc


• Alere Medical Inc


• ARKRAY


• Axis-Shield plc


• Bayer Diabetes Care


• Beckman Coulter Inc.


• Bio-Rad Laboratories Inc.


• BIOSAFE Medical Technologies, Inc.


• Biosign Technologies Inc.


• BodyTel Scientific Inc.


• Chembio Diagnostics, Inc.


• Chempaq A/S


• Cholestech Corporation


• Concateno Plc / Cozart Plc


• Crescent Diagnostics Ltd.


• DexCom, Inc.


• Diabetech, LP


• Diazyme Laboratories


• DNA Direct, Inc.


• DNAFORM


• DNAPrint Genomics, Inc.


• EKF-diagnostic GmbH


• Epocal, Inc.


• Gentag Inc.


• Genzyme Corporation


• GlucoLight Corporation


• GlucoStats System


• GlucoTec, Inc.


• HealthPia America


• Heidelberger-Medical-Marketing GmbH (HMM GmbH)


• HemoCue AB


• Integrity Applications Ltd.


• Inverness Medical Innovations


• Lifescan Inc.


• Luminous Medical, Inc.


• Medtronic Inc.


• A. Menarini Diagnostics


• Menssana Research, Inc.


• Micronics Inc.


• Multilyte Limited


• MycroLab Pty Ltd.


• Neuroptix Corporation


• OraSure Technologies, Inc.


• OrSense Ltd.


• OrthoClinical Diagnostics.


• Philips Medical Systems


• PointCare Technologies, Inc.


• Polymedco, Inc.


• Quadraspec


• Qualigen, Inc.


• Quidel Corporation


• Quotient Diagnostics


• RainDance Technologies, Inc. (RDT)


• Roche Diagnostics


• SpheroSense Technologies Inc


• Taidoc Technology Corp.


• Veralight

Healthcare Industry

CHAPTER ONE: EXECUTIVE SUMMARY

• Market Analysis


• Breakdown of POC Testing By Type


• Promising POC Segments


• Location of Testing


• Developments In Point of Care Diagnostics


• Impactful Trends: Retail Clinics, Physician Office Labs and Wellness Testing




• Retail Clinics


• Physician Office Labs (POLs)


• Wellness Testing

CHAPTER TWO: INTRODUCTION

• Overview


• The Commercial Outlook for POC Tests


• Non-Blood Sampling: Saliva, Buccal, Breath


• Miniaturization, Digitization and Informatics


• The Pros and Cons of POC Testing


• Developments in POC Testing




• Expansion of CLIA-Waived Tests


• POC in World Markets


• Telemedicine Goes Wireless

CHAPTER THREE: MARKET ANALYSIS

• Market Overview


• World POC Markets

CHAPTER FOUR: BLOOD GLUCOSE MONITORING

• Background and History


• Urine Testing


• Blood Testing


• Colorimetric Monitors


• Modern Glucose Monitors


• Leading Products


• United States


• Professional POC Glucose Testing


• Glucose Self-Testing

CHAPTER FOUR: PROMISING POC SEGMENTS

• Cardiology/Cardiac Markers


• Coagulation/PT Testing


• Professional Use


• Decentralized Coagulation Testing - OTC


• Infectious Diseases


• POC Hematology Products

CHAPTER FIVE: RETAIL CLINICS, PHYSICIAN OFFICE LABS AND WELLNESS TESTING MARKETS

• Overview


• Retail Clinics


• Retail Clinic POC Diagnostics Sales


• Physician Office Labs (POLs)


• Wellness Testing

CHAPTER SEVEN: COMPANY PROFILES

• 77 Elektronika Kft




• Recent Revenue History


• Key Comment


• Details




• Abbott Diagnostics




• Recent Revenue History


• Key Comment


• Details




• Acrongenomics Inc.




• Recent Revenue History


• Key Comment


• Details




• AgaMatrix, Inc




• Recent Revenue History


• Key Comment


• Details




• Agilent Technologies Inc




• Recent Revenue History


• Key Comment


• Details




• Alere Medical Inc




• Recent Revenue History


• Key Comment


• Details




• ARKRAY




• Recent Revenue History


• Key Comment


• Details




• Axis-Shield plc




• Recent Revenue History


• Key Comment


• Details




• Bayer Diabetes Care




• Recent Revenue History


• Key Comment


• Details




• Beckman Coulter Inc.




• Recent Revenue History


• Key Comment


• Details




• Bio-Rad Laboratories Inc.




• Recent Revenue History


• Key Comment


• Details




• BIOSAFE Medical Technologies, Inc.




• Recent Revenue History


• Key Comment


• Details




• Biosign Technologies Inc.




• Recent Revenue History


• Key Comment


• Details




• BodyTel Scientific Inc.




• Recent Revenue History


• Key Comment


• Details




• Chembio Diagnostics, Inc.




• Recent Revenue History


• Key Comment


• Details




• Chempaq A/S




• Recent Revenue History


• Key Comment


• Details




• Cholestech Corporation




• Recent Revenue History


• Key Comment


• Details




• Concateno Plc / Cozart Plc




• Recent Revenue History


• Key Comment


• Details




• Crescent Diagnostics Ltd.




• Recent Revenue History


• Key Comment


• Details




• DexCom, Inc.




• Recent Revenue History


• Key Comment


• Details




• Diabetech, LP




• Recent Revenue History


• Key Comment


• Details




• Diazyme Laboratories




• Recent Revenue History


• Key Comment


• Details




• DNA Direct, Inc.




• Recent Revenue History


• Key Comment


• Details




• DNAFORM




• Recent Revenue History


• Key Comment


• Details




• DNAPrint Genomics, Inc.




• Recent Revenue History


• Key Comment


• Details




• EKF-diagnostic GmbH




• Recent Revenue History


• Key Comment


• Details




• Epocal, Inc.




• Recent Revenue History


• Key Comment


• Details




• Gentag Inc.




• Recent Revenue History


• Key Comment


• Details




• Genzyme Corporation




• Recent Revenue History


• Key Comment


• Details




• GlucoLight Corporation




• Recent Revenue History


• Key Comment


• Details




• GlucoStats System




• Recent Revenue History


• Key Comment


• Details




• GlucoTec, Inc.




• Recent Revenue History


• Key Comment


• Details




• HealthPia America




• Recent Revenue History


• Key Comment


• Details




• Heidelberger-Medical-Marketing GmbH (HMM GmbH)




• Recent Revenue History


• Key Comment


• Details




• HemoCue AB




• Recent Revenue History


• Key Comment


• Details




• Integrity Applications Ltd.




• Recent Revenue History


• Key Comment


• Details




• Inverness Medical Innovations




• Recent Revenue History


• Key Comment


• Details




• Lifescan Inc.




• Recent Revenue History


• Key Comment


• Details




• Luminous Medical, Inc.




• Recent Revenue History


• Key Comment


• Details




• Medtronic Inc.




• Recent Revenue History


• Key Comment


• Details




• A. Menarini Diagnostics




• Recent Revenue History


• Key Comment


• Details




• Menssana Research, Inc.




• Recent Revenue History


• Key Comment


• Details




• Micronics Inc.




• Recent Revenue History


• Key Comment


• Details




• Multilyte Limited




• Recent Revenue History


• Key Comment


• Details




• MycroLab Pty Ltd.




• Recent Revenue History


• Key Comment


• Details




• Neuroptix Corporation




• Recent Revenue History


• Key Comment


• Details




• OraSure Technologies, Inc.




• Recent Revenue History


• Key Comment


• Details




• OrSense Ltd.




• Recent Revenue History


• Key Comment


• Details




• OrthoClinical Diagnostics.




• Recent Revenue History


• Key Comment


• Details




• Philips Medical Systems




• Recent Revenue History


• Key Comment


• Details




• PointCare Technologies, Inc.




• Recent Revenue History


• Key Comment


• Details




• Polymedco, Inc.




• Recent Revenue History


• Key Comment


• Details




• Quadraspec




• Recent Revenue History


• Key Comment


• Details




• Qualigen, Inc.




• Recent Revenue History


• Key Comment


• Details




• Quidel Corporation




• Recent Revenue History


• Key Comment


• Details




• Quotient Diagnostics




• Recent Revenue History


• Key Comment


• Details




• RainDance Technologies, Inc. (RDT)




• Recent Revenue History


• Key Comment


• Details




• Roche Diagnostics




• Recent Revenue History


• Key Comment


• Details




• SpheroSense Technologies Inc




• Recent Revenue History


• Key Comment


• Details




• Taidoc Technology Corp.




• Recent Revenue History


• Key Comment


• Details




• Veralight




• Recent Revenue History


• Key Comment


• Details

TABLE OF EXHIBITS



CHAPTER ONE: EXECUTIVE SUMMARY

• Figure 1-1: POC Diagnostics Market vs. IVD Market, 2008




• Table 1-1: POC Diagnostics Market 2008 and 2013




• Figure 1-2: Breakdown of POC Test by Type




• Figure 1-3: POC Test Use by Location (Home, Physician Office, Disaster Care, Retail Clinic, Hospital, Workplace-Related)




• Table 1-2: Number of Retail Clinics by Type of Retail Outlet, 2001-2011




• Table 1-3: Physician Office Laboratories in the United States 2002 to 2006

CHAPTER THREE: MARKET ANALYSIS

• Figure 3-1: Geographic Breakdown of POC Test Sales by Region, 2008 (U.S., Europe, Japan/Asia, ROW)




• Table 3-1: POC Diagnostic Sales by Region (US, Europe, Japan, ROW)




• Table 3-2: World POC OTC Sales by Test Category (Glucose, Pregnancy/Ovulation, Coagulation/PT, Fecal Occult Blood, Drugs of Abuse, H. Pylori, HIV, Cholesterol, Other) 2008-2013




• Figure 3-2: World Market for POC OTC Sales Excluding Glucose 2008-2013




• Table 3-3: World Professional POC Sales by Test Category (Glucose, Critical Care, Pregnancy, Infectious Diseases, Cardiac Markers, Cholesterol/Lipids, Coagulation/PT/ACT, HbA1c, Hemoglobin, Fecal Occult Blood, Drugs of Abuse, Bilirubin, Other) 2007-2012




• Figure 3-3: World Market for Professional POC Sales Excluding Glucose 2008-2013

CHAPTER FOUR: BLOOD GLUCOSE MONITORING

• Figure 4-1: The Prevalence of Diabetes in the United States: Type I and Type II, 2007 - 2013




• Table 4-1: Glucose Monitoring Self-Testing Sales by Region (US, Europe, Japan, ROW), 2008 and 2013




• Figure 4-2: Glucose Testing Market Share

PROMISING POC SEGMENTS

• Table 5-1: Worldwide Sales of OTC POC Cardiac IVDs (Cholesterol/Lipid) 2008-2013




• Table 5-2: Worldwide Sales of Selected POC Professional Cardiac IVDs (AMI, Cholesterol/Lipids) 2008-2013




• Figure 5-1 Decentralized (POC) Coagulation Testing, Professional: 2008 and 2013 ($millions)




• Figure 5-2: Coagulation POC Testing by Region (US, Europe, ROW)




• Table 5-3: CLIA Waived PT Devices




• Figure 5-3: Decentralized (POC) Coagulation Testing, Over the Counter: 2008 and 2013 ($millions)




• Table 5-4: Selected POC Tests for Infectious Diseases, 2006-2007 (Company, Country, Infectious Disease Tested, Test, Status)




• Table 5-5: Selected POC Hematology Systems




• Table 5-6: Hematology POC Sales, 2008 by Region (US, Europe, ROW)

CHAPTER FIVE: RETAIL CLINICS, PHYSICIAN OFFICE LABS AND WELLNESS TESTING MARKETS

• Table 6-1: Number of Retail Clinics by Type of Retail Outlet, 2001-2011




• Table 6-2: U.S. Professional POC Test Sales to Retail Clinics, 2008-2013




• Table 6-3: Physician Office Laboratories in the United States (Number of Labs, waived POLs, non-waived POLs) 1995 to 2007




• Table 6-4: Worldwide Rapid Physician Office Lab Diagnostic Test Reagent Sales by Segment (Coagulation/PT, Cholesterol Panel, TSH, HbA1c, Urines, PSA, Pregnancy/LH, Flu, Glucose, Cardiac/Troponin, BNP, FOB, Hepatitis, Strep A, Hgb/Hct, Respiratory Viruses, HIV, Infectious Diseases, DAU, Bili, Other) 2008-2013




• Figure 6-1: Breakdown of Physician Office Lab Tests by Revenue (Coag, Cholesterol Panel, TSH, HbA1c, Urines, PSA, Pregnancy, Flu, Glucose, |Cardiac, FOB, Hepatitis, Strep A, HIV, Other)




• Table 6-5: Worldwide Rapid POL Diagnostic Test Reagent Sales by Lab Type (CLIA-Waived, Moderately Complex)




• Figure 6-2 Projected Increase in Cholesterol/Lipid Testing