Point of Care Diagnostics

Point of Care Diagnostics

Use this report to:

• Receive a complete review and analysis of the current POC markets as well as forecasts the market through 2014 in constant dollars.
• Understand federal regulations of POC testing, international developments and patents for POC testing technologies.
• Determine the POC Diagnostics market at the global level focusing on the accelerating growth in this important diagnostic market segment and the key industry players.
• See forecasts from 2009-2014 with breakdowns of the US and worldwide markets to help analyze trends in the market that will shape the future POC market

Introduction

POC testing includes those tests that are used outside the traditional laboratory. This can be a range of users, including patients, physicians, outpatient clinics, community health centers, and pharmacies.

Tests included in this report are those that do not require any specialized training to perform and are performed easily and results produced in a minimal time frame.

POC testing describes the emergence of disease state management and testing facilities in doctor's offices, clinics, bedside, and pharmacies. POC diagnostic testing, or testing performed at the patient bedside, allows physicians to diagnose patients more rapidly than traditional laboratory-based testing. Rapid results can enable better patient management decisions, improved patient outcomes, and a reduction in the overall cost of care.

The armamentarium of POC products includes handheld instruments, small analytical instruments, instruments with multi-test capabilities, diagnostic kits (such as dipsticks and cassette devices), and portable data systems to collect, manage, and process test data.

This study will describe the market for POC Diagnostics at the global level. Specifically, the report: describes the POC industry, estimates the current and future market size, provides breakdowns for U.S. markets, describes product segments and the continuous updating of POC products, analyzes market influences in the industry and predicts the changes that will shape the future POC market, discusses trends within the market and provides a future outlook, reviews business activities of market leaders and lists patents for POC technologies.

It provides a complete review and analysis of the current POC markets as well as forecasts the market through 2014 in constant dollars. In addition, it provides an examination and description of products, current and emerging technologies, and company profiles. The study also covers federal regulation of POC testing, international developments, and patents for POC testing technologies.

The major product segments of the POC market, as defined by BCC, are: blood chemistry and electrolyte testing, cardiac marker testing, cholesterol testing/monitoring, drug and alcohol screening, glucose monitors and supplies, infectious disease detection and testing, pregnancy and fertility tests, hemoglobin/hemostasis testing/monitoring, tumor marker detection, urine chemistry analyses.

Scope of Study The scope of this report is broad and includes:

• Analysis of the market's trends, with data for 2008, estimates for 2009, and projections, including 5-year compound annual growth rates (CAGRs), through 2014
• Description of the POC industry, estimates the current and future market size, providing breakdowns for U.S. markets and also description of product segments and the continuous updating of POC products
• Discussion of federal regulation of POC testing, international developments, and patents for POC testing technologies.
• Focus on influential factors, such as patents and company profiles.

Contents

• Chapter One: Introduction
  • Study Goals and Objectives
  • Reasons for Doing The Study
  • Scope of Report
  • Defining POC
  • Methodology
  • Analyst Credentials
  • Related Reports
  • BCC Online Services
  • Disclaimer
• Chapter Two: Summary
  • Overview
  • Major Findings
  • Summary Table Forecast of The Global POC Market by
  • Test Type, Through 2014 ($ Millions)
  • Summary Figure Forecast of The Global POC Market
  • by Test Type, 2009 and 2014 ($ Millions)
• Chapter Three: Industry Overview
  • What Is POC Testing?
  • Overview of POC Market
  • POC As Part of Clinical Diagnostics Industry
  • Structure
  • Medical Benefits Derived From Immediate
  • Diagnostic Testing
  • POC Testing Sites
  • Table 1 Selected Key Statistics For POC Testing Sites
  • Home Use/Self-Care
  • Emergency Rooms (ER)
  • Critical-Care Units (CCU)
  • Bedside Testing
  • Table 2 Number of Hospitals For Selected
  • Countries, 2009
  • Operating Rooms (OR)/procedure Rooms (PR)
  • Physicians Offices/ Clinics/ Treatment Centers/
  • Other Noncritical=Care Sites
  • Table 3 Number of U.s. Healthcare Facilities by
  • Type, 2006*
  • POC Product Segments
  • POC Clinical Assay Categories
  • Blood Chemistry and Electrolytes
  • Cardiac Marker
  • Cholesterol Testing/monitoring
  • Drug and Alcohol Screening
  • Glucose Testing and Monitoring
  • Infectious Disease Testing
  • Pregnancy and Fertility Testing
  • Hemoglobin and Hemostasis
  • Tumor Marker
  • Urinalysis/urine Chemistry
  • Commonly Performed POC Tests
  • Table 4 Selected POC Tests - Clia Waived
  • Significance of Clia In The United States
  • Other Regulatory Agencies
  • FDA
  • Good Manufacturing Practice (GMP)
  • Table 5 Pertinent Parameters of Gmp Regulations
  • Affecting In Vitro Diagnostics
  • Driving Forces of The POC Market
  • Cost Containment
  • Rising Healthcare Costs
  • Table 6 Health Expenditures As Percent of Gdp by
  • Country, 1980-2006 (%)
  • Figure 1 Health Expenditures As Percent of Gdp by
  • Country, 1980-2006 (%)
  • Average Length of Stay
  • Table 7 Hospital Usage Statistics, by Country (Days)
  • Figure 2 Hospital Usage Statistics, by Country (Days)
  • Global Shortage of Healthcare Workers
  • Technological Advancement
  • Availability - Ease of Use Devices
  • New Technologies
  • Biosensors
  • Changes In Incidence of Disease
  • Table 8 Prevalence of Selected Diseases In The Global
  • Population, 2008-2009 (Million Cases)
  • Asthma
  • Cardiovascular Disease
  • Cancer
  • Diabetes
  • Diarrheal Disease
  • HIV
  • Infertility
  • Influenza
  • Malaria
  • Pregnancy
  • Pulmonary Disease
  • Tuberculosis
  • Aging Population
  • Table 9 Estimated World Population and Annual
  • Growth by Selected Age Group and Selected Years,
  • Through 2030 (Millions)
  • Figure 3 Estimated World Population by Selected Age
  • Group and Selected Years, 2000-2030 (Millions)
  • Table 10 World Population by Selected Country,
  • Through 2014 (Millions)
  • Figure 4 World Population by Selected Country,
  • 2007-2014 (Millions)
• Chapter Four: The POC Market
  • Market Overview
  • Table 11 Global Forecast For The POC Market by
  • Segment, Through 2014 ($ Millions)
  • Figure 5 Global Forecast For The POC Market by
  • Segment, 2007-2014 ($ Millions)
  • Competitor Market Share
  • Table 12 Market Share of POC Market Participants,
  • 2009 (Percent/$ Millions)
  • Market Share of POC Market Participants, 2009 (%)
  • Market Structure
  • Distribution
  • Figure 7 Distribution Channels: POC Diagnostic
  • Devices
  • Promotion
  • Strategic Alliances and Mergers
  • Market Components
  • Blood Chemistry and Electrolyte Testing
  • Blood Chemistry Parameters
  • Electrolytes
  • Clia Quality Control (Qc) Requirements For
  • Blood Gas Analysis
  • Market Size
  • Table 13 Forecast of The Global POC Blood Gas/
  • electrolyte Testing Market by Region, Through
  • 2014 ($ Millions)
  • Figure 8 Forecast of The Global POC Blood Gas/
  • electrolyte Testing Market by Region, 2007-2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 14 Relative Market Share of POC Blood
  • Chemistry Analyzer Manufacturers by Company, 2009
  • (Percent/$ Millions)
  • Figure 9 Relative Market Share Blood Gas Analyzer
  • Manufacturers by Company, 2009 (%)
  • Table 15 Recently (2008-2009) Clia-approved Blood
  • Chemistry Analyzers
  • Radiometer America, Inc.
  • ABL80 FLEX
  • NPT7
  • Radiance Stat Analyzer and Data Management
  • Software
  • Nova Biomedical
  • Stat Profile Phox Product Line
  • Table 16 Nova Biochemical POC Stat Profile Phox
  • Series by Available Tests
  • Stat Profile CCX Product Line
  • Table 17 Nova Biochemical POC Stat Profile CCX Series
  • by Available Tests
  • Point-of-care Manager (PDM)
  • Cumulative Patient Reports
  • Siemens Healthcare
  • Rapidpoint 400/405
  • Rapidcomm Data Management System
  • Roche Diagnostics
  • Cobas B 121 System
  • Cobas B 221 Blood Gas System
  • Abbott Diagnostics
  • i-STAT
  • International Technidyne Corp. (ITC)
  • Irma Trupoint Blood Analysis System
  • Avoximeter Whole Blood Co-oximeter/oximeter
  • System
  • Cardiac Marker Testing
  • Market Size
  • Table 18 Forecast of The Global POC Cardiac Marker
  • Testing Market by Region, Through 2014 ($ Millions)
  • Figure 10 Forecast of The Global POC Cardiac Marker
  • Testing Market by Region, 2007-2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 19 Relative Market Share of POC Cardiac Marker
  • Manufacturers by Company, 2009 (Percent/$ Millions)
  • Figure 11 Relative Market Share of POC Cardiac
  • Marker Manufacturers by Company, 2009 (%)
  • Inverness Medical Innovations
  • Triage System
  • Roche
  • Cardiac Reader System
  • Abbott
  • iSTAT 1
  • Response Biomedical
  • Ramp System
  • Cholesterol Testing
  • Market Size
  • Table 20 Forecast of The Global Cholesterol
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Figure 12 Forecast of The Global Cholesterol POC
  • Rapid Test Market, 2007-2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 21 Relative Market Share of Cholesterol
  • POC Rapid Test Manufacturers by Company, 2009 ($ Millions)
  • Figure 13 Relative Market Share of Cholesterol POC
  • Rapid Test Manufacturers by Company, 2009 (%)
  • Table 22 Recently (2008-2009) Clia-approved
  • Cholesterol Tests
  • Inverness Medical Innovations
  • Roche Diagnostics
  • Abaxis
  • Drug and Alcohol Abuse Testing
  • Market Size
  • Table 23 Forecast of The Global Drug and Alcohol
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Figure 14 Forecast of The Global Drug and Alcohol POC
  • Rapid Test Market by Region, 2007-2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 24 Relative Market Share of Drug and Alcohol
  • POC Rapid Test Manufacturers by Company, 2009
  • (Percent/$ Millions)
  • Figure 15 Relative Market Share of Drug and Alcohol
  • POC Rapid Test Manufacturers by Company, 2009 (%)
  • Table 25 Recently (2008-2009) Clia-approved POC
  • Drug and Alcohol Screening Tests by Manufacturer
  • Inverness Medical Innovations
  • Phamatech
  • Psychemedics
  • Orasure Technologies
  • Glucose Testing
  • Market Size
  • Table 26 Forecast of The Global POC Glucose Meter
  • Market by Region, Through 2014 ($ Millions)
  • Figure 16 Forecast of The Global POC Glucose Meter
  • Market by Region, 2007-2014 ($ Millions)
  • Table 27 Market Share For The Global POC Glucose
  • Meter Market by Component, 2009 ($ Millions)
  • Figure 17 Market Share For The Global POC Glucose
  • Meter Market by Component, 2009 (%)
  • Market Participants and Market Shares
  • Table 28 Relative Market Share For Glucose Meters
  • and Supplies Manufacturers by Company, 2009
  • (Percent/$ Millions)
  • Figure 18 Relative Market Share For Glucose Meters
  • and Supplies Manufacturers by Company, 2009 (%)
  • Table 29 Recently (2008-2009) Approved Clia-waived
  • Blood Glucose Meters by Manufacturer
  • Roche Diagnostics
  • Accu-chek Active System
  • Accu-chek Inform System
  • Accu-chek Inform Ii
  • Accu-chek Voicemate System
  • Johnson and Johnson
  • Lifescan - Onetouch Ultra Meter
  • Table of Contents, continued
  • Glucose monitoring test
  • market reached approximately
  • $7.7 million
  • in 2009 and is projected
  • to reach $9.9 billion in
  • 2014, at a CAGR of 5.1%.
  • To place an order for
  • Point of Care
  • Diagnostics
  • call 866-285-7215
  • November 2009
  • Report ID: HLC043B
  • Price: $4850 (PDF)
  • Lifescan - Onetouch Ultra 2 Meter
  • Lifescan Onetouch Ultrasmart Meter
  • Lifescan Onetouch Induo System
  • Lifescan Onetouch Basic Meter
  • Lifescan Onetouch Surestep Meter
  • Lifescan Onetouch Ultralink Meter
  • Lifescan Onetouch Diabetes Management
  • Software
  • Abbott Diabetes Care
  • Freestyle Blood Glucose Monitoring System
  • Precision Xtra Blood Glucose and Ketone
  • Monitoring System
  • i-STAT 1
  • Home Diagnostics, Inc.
  • Sidekick Testing System
  • Truetrack Smart System
  • Prestige IQ Blood Glucose Monitor
  • Table 30 Selected Listing of Retailers Selling Home
  • Diagnostic's Meters
  • Data Management Systems
  • Table 31 Selected Listing of Blood Glucose Monitors
  • Capable of Interacting With Computer Software by
  • Company
  • Infectious Disease Testing
  • Strep A
  • Table 32 Recently (2008-2009) Clia-approved Strep A
  • Tests by Manufacturer
  • Influenza
  • Table 33 Recently (2008-2009) Clia-approved
  • Influenza Tests by Manufacturer
  • Chlamydia/trichomonas
  • RSV
  • Table 34 Recently (2008-2009) Clia-approved Rsv
  • Tests by Manufacturer
  • HIV Testing
  • Inverness Medical
  • Orasure
  • Trinity Biotech, Plc
  • Infectious Mononucleosis
  • Table 35 Recently (2008-2009) Clia-approved
  • Infectious Mononucleosis Tests
  • H. Pylori
  • Table 36 Recently (2008-2009) Clia-approved H. Pylori
  • Tests by Manufacturer
  • Market Size
  • Table 37 Forecast of The Global Infectious Disease
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Figure 19 Forecast of The Global Infectious Disease
  • POC Rapid Test Market by Region, 2007-2014 ($ Millions)
  • Table 38 Market Share For The Global POC Infectious
  • Disease Market by Test Type, 2009 ($ Millions)
  • Figure 20 Market Share For The Global POC Infectious
  • Disease Market by Test Type, 2009 (%)
  • Market Participants and Market Shares
  • Table 39 Relative Market Share of Infectous Disease
  • POC Rapid Test Manufacturers by Company, 2009 ($ Millions)
  • Figure 21 Relative Market Share of Infectious Disease
  • POC Rapid Test Manufacturers by Company, 2009 (%)
  • Strep A
  • Influenza
  • Chlamydia
  • Pregnancy and Fertility Testing
  • Market Size
  • Table 40 Forecast of The Global Pregnancy/fertility
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Figure 22 Forecast of The Global Infectious Disease
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Table 41 Market Share For The Global POC Pregnancy/
  • fertility Market by Test Type, 2009 (Percent/$ Millions)
  • Figure 23 Market Share For The Global POC
  • Pregnancy/fertility Market by Test Type, 2009 (%)
  • Market Participants and Market Shares
  • Table 42 Relative Market Share of Pregnancy/fertility
  • POC Rapid Test Manufacturers by Company, 2009 ($ Millions)
  • Figure 24 Relative Market Share of Pregnancy/fertility
  • POC Rapid Test Manufacturers by Company, 2009 (%)
  • Table 43 Recent (2008-2009) Clia Approved
  • Pregnancy Tests by Manufacturer
  • Hemoglobin/hemostasis
  • Hematology and Hemostasis
  • Hemostasis (Coagulation)
  • Market Size
  • Table 44 Forecast of The Global Hemoglobin/
  • hemostasis POC Rapid Test Market by Region,
  • Through 2014 ($ Millions)
  • Figure 25 Forecast of The Global Hemoglobin/
  • hemostasis POC Rapid Test Market by Region, 2007-
  • 2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 45 Relative Market Share of Hemoglobin/
  • hemostasis POC Rapid Test Manufacturers by
  • Company, 2009 ($ Millions)
  • Figure 26 Relative Market Share of Hemoglobin/
  • hemostasis POC Rapid Test Manufacturers by
  • Company, 2009 (%)
  • Table 46 Recently (2008-2009) Clia Approved
  • Hematology Tests
  • Tumor Marker Testing
  • Fecal and Gastric Occult Blood
  • Bladder Tumor Antigen Test
  • Market Size
  • Table 47 Forecast of The Global Tumor Marker
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Figure 27 Forecast of The Global Tumor Marker
  • POC Rapid Test Market by Region, Through 2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 48 Relative Market Share of Tumor Marker
  • POC Rapid Test Manufacturers by Company, 2009 ($ Millions)
  • Figure 28 Relative Market Share of Tumor Marker POC
  • Rapid Test Manufacturers by Company, 2009 (%)
  • Table 49 Recently (2008-2009) Clia Approved Fecal
  • Occult Blood Tests by Manufacturer
  • Urine Chemistry Testing
  • Market Size
  • Table 50 Forecast of The Global POC Urine Chemistry
  • Analyzer Market by Region, Through 2014 ($ Millions)
  • Figure 29 Forecast of The Global POC Urine Chemistry
  • Analyzer Market, 2007-2014 ($ Millions)
  • Market Participants and Market Shares
  • Table 51 Relative Market Share of POC Urine
  • Chemistry Analyzer Manufacturers by Company, 2009 ($ Millions)
  • Figure 30 Relative Market Share of POC Urine
  • Chemistry Analyzer Manufacturers by Company,
  • 2009 (%)
  • Table 52 Recently (2008-2009) Clia-approved Urine
  • Chemistry Analyzers by Manufacturer
  • Misc Testing
  • Vaginal pH Tests
  • Table 53 Recently (2008-2009) Clia-approved Vaginal
  • Ph Tests by Manufacturer
  • Thyroid Stimulating Hormone (TSH) Tests
  • Table 54 Recently (2008-2009) Clia-approved TSH
  • Tests by Manufacturer
  • Table of Contents, continued
  • To place an order for
  • Point of Care
  • Diagnostics
  • call 866-285-7215
  • November 2009
  • Report ID: HLC043B
  • Price: $4850 (PDF)
  • Male Reproductive Tests
  • Table 55 Recently (2008-2009) Clia-approved Male
  • Reproductive Test by Manufacturer
• Chapter Five: Technology Applications
  • Biosensors
  • What Are Biosensors?
  • Catalytic Sensors
  • Affinity Sensors
  • Electrodes
  • What Are Electrodes?
• Chapter Six: Patent Analysis
  • Number of Recently Issued Patents
  • Table 56 Results of U.s. Patent Search For POC
  • Categories, September 2008-september 2009(Number)
  • Figure 31 U.S. Patents by POC Categories, September
  • 2008-september 2009 (Number)
  • Analysis of Patent by Subject
  • Table 57 U.S. Patents by Subject Area, September
  • 2008 To September 2009 (Number)
  • Patent Assignees
  • Table 58 U.S. Patent Assignees, September 2008 to
  • September 2009 (Number)
  • Figure 32 U.S. Patents by Country, September 2008-
  • september 2009 (Number)
  • Recently Issued Patents
  • Glucose Meters
  • Hematology
  • Coagulation Assay
  • Immunoassay
  • Hematology
• Chapter Seven: Worldwide POC Market
  • Market Size
  • Table 59 Global Forecast (U.S. and Worldwide) For The
  • POC Market, Through 2014
  • Figure 33 Global (U.S. and Worldwide) Forecast For
  • The POC Market 2009 and 2014 ($ Millions)
  • Global Market Shares
  • Table 60 POC Global Market Share by Country, 2009(Percent/$ Millions)
  • Figure 34 POC Global Market Share by Country,2009 (%)
  • Presence of Manufacturers In The Worldwide Market
  • Table 61 Market Share of Top 10 POC Market
  • Participants, 2009 ($ Millions)
  • Figure 35 Market Share of Top 10 POC Market
  • Participants, 2009 (%)
• Chapter Eight: Profiles of Major Market Participants
  • Overview of Market Participants
  • Company Profiles
  • Abaxis
  • Table 62 Abaxis' Company Revenues, 2007-2010* ($ Millions)
  • Abbott Laboratories
  • Table 63 Abbott's Company Revenues, 2006-2009 ($ Millions)
  • Becton, Dickinson, & Co.
  • Table 64 Bd's Company Revenues, 2006-2009 ($ Millions)
  • Danaher Corp./radiometer
  • Table 65 Danaher's Company Revenues, 2006-2009 ($ Millions)
  • International Technidyne Corp.
  • Table 66 Thoratec's Company Revenues, 2006-2009 ($ Millions)
  • Inverness Medical Innovations
  • Table 67 Inverness Medical's Company Revenues, 2006-2009 ($ Millions)
  • Johnson & Johnson
  • Table 68 Johnson & Johnson's Company Revenues, 2006-2009 ($ Millions)
  • Nova Biomedical
  • Orasure Technologies
  • Table 69 Orasure's Company Revenues, 2006-2009 ($ Millions)
  • Quidel Corp.
  • Table 70 Quidel's Company Revenues, 2006-2009 ($ Millions)
  • Roche
  • Table 71 Roche Group's Revenues, 2006-2009 ($ Millions)
  • Siemens Medical Solutions
  • Table 72 Siemens' Company Revenues, 2006-2009 ($ Millions)
• Appendix
  • Key Sources of Information
  • Abaxis
  • Abbott Laboratories
  • Beckman Coulter, Inc.
  • Church & Dwight Co., Inc.
  • Clinical Diagnostics Division
  • Becton Dickinson & Co.
  • Hemocue Ab
  • Henry Schein, Inc.
  • Home Diagnostics, Inc.
  • International Technidyne Corp.
  • Inverness Medical Innovations
  • Johnson & Johnson
  • Nova Biomedical
  • Orasure Technologies
  • Phamatech, Inc.
  • Pss World Medical, Inc.
  • Psychemedics Corp.
  • Quest Diagnostics
  • Quidel Corp.
  • Radiometer America, Inc.
  • Response Biomedical Corp.
  • Roche
  • Siemens Medical Solutions
  • Trinity Biotech, Plc

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