Table of Contents
EXECUTIVE SUMMARY
SCOPE AND METHODOLOGY
Size and Growth of the Market
Key Issues and Trends Affecting Market
Leading Competitors
INTRODUCTION
Point of Care Diagnostics Testing
Industry Regulations
POC Industry Drivers
Patent-Focused Drivers
Medical/Healthcare-Related Drivers
Technology Drivers
Economic Drivers
Other Drivers
POC Test Types
Blood
Urine
Saliva
Hair
Optical Technologies
Breath
CONDITIONS EVALUATED BY POC DIAGNOSTIC TESTING
Cancer
Colorectal Cancer
Prostate Cancer
Cardiovascular Disease
Diabetes
Drug Abuse
Club Drugs
GHB
Rohypnol
Ketamine
Narcotic Abuse
Heroin
Narcotic Analgesics
Opium
Central Nervous System Depressant Abuse
Sedative-Hypnotic/Antianxiety Abuse
Alcohol Abuse
Central Nervous System Stimulants
Amphetamine and Amphetamine-Like Agents
Ecstasy
Cocaine Abuse
Marijuana Abuse
Psychedelic Agents
Tobacco
Inhalant Abuse
Steroid Abuse
Miscellaneous Drugs of Abuse
Salvia
Bath Salts
Khat
DXM
Prevalence and Number of Illicit Drug Users
Infectious Disease
Herpes
HTLV
Respiratory Syncytial Virus
Hepatitis
Lyme Disease
Babesiosis
Gonorrhea, Syphilis and Chlamydia
Trichomonas Vaginalis
HIV/AIDS
Helicobacter Pylori
Influenza
Mononucleosis
Streptococcus
Osteoporosis
Pregnancy and Fertility
World Demographics
Global Aging Population
POC BLOOD GLUCOSE TESTS
Types of Blood Glucose Testing
Fasting Blood Sugar (FBS)
2-Hour Postprandial Blood Sugar (PPBS)
Random Blood Sugar
Glucose Tolerance Test
Glucose Urine Test
Glycated Hemoglobin (HbA1c)
Products
Blood Glucose Self-Testing
Continuous Self-Testing
Glycated Hemoglobin Tests
Professional
Market Size and Growth
POC Glucose Self-Testing
POC Glucose Professional Testing
Competitive Analysis
POC BLOOD AND ELECTROLYTES TESTING MARKET
Types of Blood and Electrolytes Tests
Hemoglobin/Hematocrit
WBC
Blood Gases
Electrolytes
Products
Market Size and Growth
POC Blood and Electrolyte Self-Testing
POC Blood and Electrolyte Professional Testing
Competitive Analysis
RAPID COAGULATION
Products
Platelet Testing
Market Size and Growth
POC Rapid Coagulation Self-Testing
POC Rapid Coagulation Professional Testing
Competitive Analysis
POC RAPID CARDIAC MARKERS
Products
Market Size and Growth
Competitive Analysis
POC SUBSTANCE ABUSE TESTING
Products
Urine
Oral
Blood
Hair
Market Size and Growth
POC Drugs of Abuse Self-Testing
POC Drugs of Abuse Professional Testing
Competitive Analysis
POC PREGNANCY AND FERTILITY TESTING
PRODUCTS
MARKET SIZE AND GROWTH
POC Pregnancy and Fertility Self-Testing
POC Pregnancy and Fertility Professional Testing
Competitive Analysis
POC COLON CANCER SCREENING/FECAL OCCULT BLOOD TESTING141
PRODUCTS
Market Size and Growth
POC Colon Cancer Screening/Fecal Occult Blood Self-Testing
POC Colon Cancer Screening/ Fecal Occult Blood Professional Testing
Competitive Analysis
POC INFECTIOUS DISEASE TESTING
PRODUCTS
MARKET SIZE AND GROWTH
POC Infectious Disease Self-Testing
POC Infectious Disease Professional Testing
Competitive Analysis
POC CHOLESTEROL TESTING
PRODUCTS
POC Cholesterol Self-Testing
POC Cholesterol Professional Testing
Competitive Analysis
POC CANCER TESTING
PRODUCTS
MARKET SIZE AND GROWTH
COMPETITIVE ANALYSIS
POC URINE STRIP TESTING
PRODUCTS
MARKET SIZE AND GROWTH
POC Urine Strip Self-Testing
POC Urine Test Strip Professional Testing
Competitive Analysis
MISCELLANEOUS POC TESTING
Microbiology
TSH
Allergy
Autoimmune
MARKET SIZE AND GROWTH
ISSUES AND TRENDS
Overview
Reimbursement Challenges
Competition
POC and Biosensors and Microfluidics
POC Connectivity
The Emergence of Non-Invasive Technologies
Saliva and Swab
Breath
Optical Techniques
TOTAL GLOBAL POC TESTING MARKET AND COMPETITOR ANALYSIS
Market Overview
Market Analysis by Product Categories
Market Analysis by Subcategory
POC Professional Testing
POC Self-Testing
Market Analysis by Country
United States
Europe
Germany
France
UK
Switzerland
Japan
Rest of World
China
India
Market Conclusions
Conclusion One
Conclusion Two
Conclusion Three
Conclusion Four
Competitive Analysis
SEVENTEEN: CORPORATE PROFILES
Overview
Abaxis, Inc
Company Overview
Product
Performance Review
Abbott Laboratories
Company Overview
Product
Performance Review
Accriva Diagnostics
Company Overview
Products
ACON Laboratories, Inc
Company Overview
Products
Alere Inc
Company Overview
Product
Performance Review
Arkray
Company Overview
Products
Beckman-Coulter, Inc.
Company Overview
Products
Performance Review
bioMerieux SA
Company Overview
Products
Performance Review
Church & Dwight Co., Inc
Company Overview
Products
Eiken Chemical Co Ltd.
Company Overview
Products
EKF Diagnostics GmbH
Company Overview
Products
Performance Review
Enterix, Inc
Company Overview
Products
Helena Laboratories
Company Overview
Products
Insight Pharmaceuticals LLC
Company Overview
Products
Instrumentation Laboratory
Company Overview
Products
LifeScan, Inc
Company Overview
Products
Performance Review
Macherey-Nagel GmbH & Co. KG
Company Overview
Products
Meridian BioScience, Inc
Company Overview
Products
Performance Review
Nova Biomedical, Corp.
Company Overview
Products
Opko Health, Inc
Company Overview
Products
Performance Review
OraSure Technologies, Inc
Company Overview
Products
Performance Review
ORTHO CLINICAL DIAGNOSTICS
Company Overview
Products
POLYMED THERAPEUTICS INC.
Polymedco, Inc
Company Overview
Products
POLYMER TECHNOLOGIES, INC (PTS DIAGNOSTICS)
Company Overview
Products
QUIDEL CORPORATION
Company Overview
Products
Performance Review
RADIOMETER MEDICAL APS
Company Overview
Products
RESPONSE BIOMEDICAL CORP
Company Overview
Products
Performance Review
ROCHE DIAGNOSTICS CORPORATION
Company Overview
Products
Performance Review
SIEMENS HEALTHCARE
Company Overview
Products
Performance Review
SYSMEX CORPORATION
Company Overview
Products
Performance Review
TRINITY BIOTECH PLC
Company Overview
Products
Performance Review
LIST OF COMPANIES
LIST OF TABLES AND FIGURES
ONE: EXECUTIVE SUMMARY
Table 1-1
Global POC Diagnostic Testing Market Analysis: 2012-2019
TWO: INTRODUCTION
Table 2-1
Traditional CLIA-Waived Tests
Table 2-2
Annual CLIA Test Waivers by Selected Analyte(s) (Drugs of Abuse and Therapeutic
Drugs, Urinalysis, Glucose Monitoring, General Chemistry, Infectious Diseases,
Other) (2010-2014)
Table 2-3
CLIA-Waived Tests and Analytes
Table 2-4
2014 CLIA Waivers (Manufacturer and Instrument / Assay)
Table 2-5
POC Tests – Ranked by Estimated Volume (2014)
Table 2-6
Types of Inhalants
Table 2-7
Annual Prevalence and Number of Illicit Drug Users Globally by Drug Type 2012
Table 2-8
Estimated Number and Prevalence of Drug Users by Region
Table 2-9
World Population by Selected Geographical Region, 2010 – 2050 (Africa, Asia,
Europe, Northern America, Oceania, Latin America and the Caribbean, World)
Figure 2-1
World Population by Selected Geographical Region, 2010–2050 (Africa, Asia, Europe,
Northern America, Oceania, Latin America and Caribbean)
Table 2-10
Estimated World Population by Age (0-14, 15-64, 65+, Men, Women, Total) and
Geographical Region (Africa, Asia, Europe, Northern America, Oceania, Latin
America and Caribbean, World), 2012
Figure 2-2
Estimated World Population by Age (0-14, 15-64, 65+) and Geographical Region(Africa, Asia, Europe, Northern America, Oceania, Latin America), 2012
Table 2-11
Percent Population Over 65 by Year and Region, 2010-2050 (Africa, Asia, Europe,
Northern America, Oceania, Latin America and the Caribbean, World)
Figure 2-3
Estimated World Population by Age, 2010 and 2050 (0-14, 15-64, 65+)
THREE: POC BLOOD GLUCOSE TESTS
Table 3-1
Selected Glucose Self-Test Meter Innovations
Table 3-2
Selected Apps and Glucose Management IT
Table 3-3
Selected Noninvasive Glucose Monitoring Devices
Table 3-4
Selected Continuous BGM Sales, 2014
Table 3-5
Selected Continuous Blood Glucose System Developments, 2014
Table 3-6
Selected POC HbA1c Devices
Table 3-7
Selected Innovations in POC Hospital-based Glucose Monitoring
Table 3-8
Global POC Glucose Testing Market Analysis: 2012-2019
Figure 3-1
Global POC Glucose Testing Market Analysis: 2012-2019
Table 3-9
Global POC Glucose Self-Testing Market Analysis, 2014 and 2019
Table 3-10
Global POC Glucose Professional Testing Market Analysis, 2014 and 2019
Table 3-11
Global POC Blood Glucose Testing Market Revenues and Market Share of Leading
Suppliers, 2014
Figure 3-2
Global POC Glucose Test Manufacturers by Percent, 2014
FOUR: POC BLOOD AND ELECTROLYTES TESTING MARKET
Table 4-1
Selected POC Hemoglobin and Hematocrit Systems, 2014
Table 4-2
Selected POC Hematology Analyzer Systems, 2014
Table 4-3
Global POC Blood and Electrolytes Testing Market Analysis: 2012-2019
Figure 4-1
Global POC Blood and Electrolytes Testing Market Analysis: 2012-2019
Table 4-4
Global POC Blood and Electrolyte Professional Testing Market Analysis, 2014 andm2019
Table 4-5
Global POC Blood and Electrolyte Testing Market Revenues and Market Share of Leading Suppliers, 2014
Figure 4-2
Global POC Blood and Electrolyte Testing Market Manufacturers by Percent, 2014
FIVE: RAPID COAGULATION
Table 5-1
Selected POC Coagulation Innovations
Table 5-2
Selected Platelet Activity Test Innovations
Table 5-3
Global Rapid Coagulation Testing Market Analysis: 2012-2019
Figure 5-1
Global Rapid Coagulation Testing Market Analysis: 2012-2019
Table 5-4
POC Rapid Coagulation Self-Testing Market Analysis, 2014 and 2019
Table 5-5
POC Rapid Coagulation Professional Testing Market Analysis, 2014 and 2019
Table 5-6
Global POC Rapid Coagulation Testing Market Revenues and Market Share of
Leading Suppliers, 2014
Figure 5-2
Global POC Rapid Coagulation Testing Manufacturers by Percent, 2014
SIX: POC RAPID CARDIAC MARKERS
Table 6-1
Total Rapid Cardiac Markers Tests Market Analysis, 2012-2019
Figure 6-1
Global POC Rapid Cardiac Markers Test Market Analysis, 2012-2019
Table 6-2
Global POC Cardiac Markers Test Market Revenues and Market Share of Leading Suppliers, 2014
Figure 6-2
Global POC Cardiac Test Manufacturers by Percent, 2014
SEVEN: POC SUBSTANCE ABUSE TESTING
Table 7-1
Global POC Drugs of Abuse Testing Market Analysis: 2012-2019
Figure 7-1
Global POC Drugs of Abuse Testing Market Analysis: 2012-2019
Table 7-2
Global POC Drugs of Abuse Self-Testing Market Analysis, 2014 and 2019
Table 7-3
Global POC Drugs of Abuse Professional Testing Market Analysis, 2014
and 2019
Table 7-4
Global POC Drugs of Abuse Testing Market Revenues and Market Share of Leading
Suppliers, 2014
Figure 7-2
Global POC Drug of Abuse Testing Manufacturers by Percent, 2014
EIGHT: POC PREGNANCY AND FERTILITY TESTING
Table 8-1
2014 Pregnancy and Fertility CLIA Waivers (Manufacturer and Instrument / Assay)
Table 8-2
Global POC Pregnancy and Fertility Testing Market Analysis: 2012-2019
Figure 8-1
Global POC Pregnancy and Fertility Testing Market Analysis: 2012-2019
Table 8-3
POC Pregnancy and Fertility Self-Testing Market Analysis, 2014 and 2019
Table 8-4
POC Pregnancy and Fertility Professional Testing Market Analysis, 2014 and 2019
Table 8-5
Global POC Pregnancy and Fertility Testing Market Revenues and Market Share of Leading Suppliers, 2014
Figure 8-2
Global POC Pregnancy and Fertility Testing Manufacturers by Percent, 2014
NINE: POC COLON CANCER SCREENING/FECAL OCCULT BLOOD TESTING
Table 9-1
Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis:
2012-2019
Figure 9-1
Global POC Colon Cancer Screening/ Fecal Occult Blood Testing Market Analysis:
2012-2019
Table 9-2
POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis,2014 and 2019
Table 9-3
POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2014 and 2019
Table 9-4
Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Revenues and Market Share of Leading Suppliers, 2014
Figure 9-2
Global POC Colon Cancer Screening/Fecal Occult Blood Testing Manufacturers by Percent, 2014
TEN: POC INFECTIOUS DISEASE TESTING
Table 10-1
Selected Professional-Use POC Tests for Infectious Diseases
Table 10-2
Global POC Infectious Disease Testing Market Analysis: 2012-2019
Table 10-3
POC Infectious Disease Self-Testing Market Analysis, 2014 and 2019
Table 10-4
POC Infectious Disease Professional Testing Market Analysis, 2014 and 2019
Table 10-5
Global POC Infectious Disease Testing Market Revenues and Market Share of
Leading Suppliers, 2014
Figure 10-2
Global POC Infectious Disease Test Manufacturers by Percent 2014
ELEVEN: POC CHOLESTEROL TESTING
Table 11-1
Global POC Cholesterol Testing Market Analysis: 2012-2019
Figure 11-1
Global POC Cholesterol Testing Market Analysis: 2012-2019
Table 11-2
POC Cholesterol Self-Testing Market Analysis, 2014 and 2019
Table 11-3
POC Cholesterol Professional Testing Market Analysis, 2014 and 2019
Table 11-4
Global POC Cholesterol Testing Market Revenues and Market Share of Leading
Suppliers, 2014
Figure 11-2
Global POC Cholesterol Testing Manufacturers by Percent, 2014
TWELVE: POC CANCER TESTING
Table 12-1
Selected Companies Developing and/or Marketing POC Tests for Hematology/Oncology Indications
Table 12-2
Global POC Cancer Testing Market Analysis: 2012-2019
Figure 12-1
Global POC Cancer Testing Market Analysis: 2012-2019
Table 12-3
Global POC Cancer Testing Market Revenues and Market Share of Leading
Suppliers, 2014
Figure 12-2
Global POC Cancer Testing Manufacturers by Percent, 2014
THIRTEEN: POC URINE STRIP TESTING
Table 13-1
Selected Dipstick Urinalysis Systems, 2014
Table 13-2
Global POC Urine Strip Testing Market Analysis: 2012-2019
Figure 13-1
Global POC Urine Strip Testing Market Analysis: 2012-2019
Table 13-3
POC Urine Strip Self-Testing Market Analysis, 2014 and 2019
Table 13-4
POC Urine Test Strip Professional Testing Market Analysis, 2014 and 2019
Table 13-5
Global POC Urine Strip Testing Market Revenues and Market Share of Leading
Suppliers, 2014
Figure 13-2
Global POC Urine Strip Testing Manufacturers by Percent, 2014
FOURTEEN: MISCELLANEOUS POC TESTING
Table 14-1
Global Miscellaneous POC Testing Market Analysis: 2012-2019
Figure 14-1
Global Miscellaneous POC Testing Market Analysis: 2012-2019
FIFTEEN: ISSUES AND TRENDS
Table 15-1
Selected Biochip and Biosensor Players, 2014
Table 15-2
Selected Disease Markers in Exhaled Breath (Asthma, Breast cancer, Diabetes, Liver function, Lung cancer, Organ rejection, Renal function, Schizophrenia, Gastrointestinal malabsorption / Irritable Bowel Syndrome (IBS) / Celiac disease and food
intolerances / Bacterial overgrowth, Bacterial infection)
SIXTEEN: TOTAL GLOBAL POC TESTING MARKET AND
COMPETITOR ANALYSIS
Table 16-1
Global POC Testing Market Analysis: 2012-2019
Figure 16-1
Global POC Testing Market Analysis: 2012-2019
Table 16-2
Global POC Testing Market Analysis by Product Category, 2014 (Professional,
Self-Testing, Total)
Figure 16-2
Global POC Testing Market Analysis by Product Category, 2014 (Self-Test,
Professional)
Table 16-3
Global POC Professional Testing Market Analysis by Product Subcategory, 2014(Drugs of Abuse, Blood & Electrolytes, Glucose, Infectious Disease, Rapid Coagulation, Cardiac Markers, Fecal Occult Blood, Cholesterol, Pregnancy & Fertility, Miscellaneous, Urine Strip, Cancer, Total)
Figure 16-3
Global POC Professional Market Analysis by Product Subcategory, 2014 (Blood, DOA)
Table 16-4
Global POC Self-Testing Market Analysis by Product Category, 2014 (Glucose,
Pregnancy & Fertility, Fecal Occult Blood, Raid Coagulation, Drugs of Abuse, Urine Strip, Infectious Disease, Cholesterol, Total)
Figure 16-4
Global POC Self-Testing Market Analysis by Product Category, 2014 (PG, Glucose)
Table 16-5
Number of POCs in the United States (Compliance [Moderate and High Complexity], Waiver, Provider-Perfomed Microscopy [PPM], Accreditation [Moderate and High Complexity]) (2005-2013)
Table 16-6
Global POC Testing Market Analysis by Region/Country, 2014 (United States, Europe, Japan, ROW, Total)
Figure 16-5
Global POC Testing Market Analysis by Region/Country, 2014 (US, Europe, Japan, ROW)
Figure 16-6
Global POC Testing Market Analysis by Region/Country, 2019 (US, Europe, Japan, ROW)
Table 16-7
Global EU POC Testing Market Analysis by European Region, 2014(EU W. Europe, EU E. Europe)
Figure 16-7
Global EU POC Testing Market Analysis by European Region, 2014(W. Europe, E. Europe)
Table 16-8
Global POC Testing Market Analysis by Rest of World Region/Country, 2014(China, India, Brazil, Others, Total)
Figure 16-8
Global POC Testing Market Analysis by Rest of World Region/Country, 2014(China, India, Brazil, Others)
Table 16-9
Global POC Testing Market Revenues and Market Share of Leading Suppliers, 2014
Figure 16-9
Global POC Testing Market Share by Leading Suppliers, 2014
SEVENTEEN: CORPORATE PROFILES
Figure 17-1
Abaxis Medical Revenues 2012-2014
Figure 17-2
Abbott Laboratories Revenues 2012-2014
Figure 17-3
Alere Laboratories Revenues 2012-2014
Figure 17-4
Danaher Life Sciences and Diagnostic Businesses Revenues 2012-2014
Figure 17-5
bioMerieux Revenues 2012-2014
Figure 17-6
Church & Dwight Revenues 2012-2014
Figure 17-7
Eiken Chemical Revenues 2012-2014
Figure 17-8
EKF Diagnostics Revenues 2012-2014
Figure 17-9
LifeScan Revenues 2012-2014
Figure 17-10
Meridian BioScience Revenues 2012-2014
Figure 17-11
OPKO Health Revenues 2012-2014
Figure 17-12
OraSure Revenues 2012-2014
Figure 17-13
Quidel Revenues 2012-2014
Figure 17-14
Response Biomedical Revenues 2012-2014
Figure 17-15
Roche Diagnostics Revenues 2012-2014
Figure 17-16
Siemens Revenues 2012-2014
Figure 17-17
Sysmex Revenues 2012-2014
Figure 17-18
Trinity Biotech Revenues 2012-2014
