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The World Market for Point of Care (POC) Diagnostics and The Market for Molecular POC Diagnostics

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SKU: KLI15068620 Categories: Diagnostics Market Research, Point-of-Care Diagnostics Pages: 450
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Description

This combined report offering allows customers of Kalorama research to have two titles, combining Kalorama’s authoritative volume covering the entire world POC market with its more focused report on molecular POC systems.

The World Market for Point of Care (POC) Diagnostics presents current analysis of the POC diagnostics industry and the role it plays in medical practice. This report takes an in-depth look at the POC diagnostic testing market, both professional and self-testing.
The report provides data on the size and growth of the following POC market segments:
• Blood Glucose Tests
• Blood and Electrolytes Testing Market
• Rapid Coagulation
• Rapid Cardiac Markers
• Substance Abuse Testing
• Pregnancy and Fertility Testing
• Colon Cancer Screening/Fecal Occult Blood Testing
• Infectious Disease Testing
• Cholesterol Testing
• Cancer Testing
• Urine Strip Testing
• Miscellaneous POC Testing
The World Market for Point of Care (POC) Diagnostics presents the main issues and trends affecting this market, influencing its move into the future. These include:
• Reimbursement Challenges
• Competition
• POC and Biosensors
• POC Connectivity
• The Emergence of Non-invasive Technologies
Point-of care diagnostics using molecular technology were once discussed as a possibility in the future. That is no longer the case as many systems enter the market. Molecular point-of-care (POC) diagnostics are able to improve the sensitivity and specificity of existing near-patient and rapid tests and also expand the diagnostic capabilities at points of care such as hospital critical care units, physician offices, outpatient clinics, and community health posts in the developing world.
 
The Market and Potential for Molecular Point of Care Diagnostics examines the major segments of molecular POC diagnostics, exploring in-depth both current sales and market opportunity.
Kalorama’s report details the companies in the market and products offered. It provides specific market size estimates for a number of segments in testing, including: respiratory tract infections, STDs, women’s health, High Burden Diseases, HAI, Cancer and Other Testing.
To learn more about this industry, purchase The Market and Potential for Molecular Point of Care Diagnostics.
PDFs of both of these reports are provided as part of this offering.

Table of Contents

THE MARKET AND POTENTIAL FOR MOLECULAR POC

ONE: EXECUTIVE SUMMARY

Introduction

Molecular Point-of-Care Diagnostics Defined

Strengths and Weakness of Molecular POC Testing

Component Technologies of Molecular POC Diagnostics

Microfluidics

qPCR

Microarrays

Isothermal Amplification

Test Automation

Primers and Probes

Detection

Next-Generation Sequencing

Leading Platforms in Molecular POC Diagnostics

Investment in Decentralized Molecular Diagnostics – Venture Financing and Public

Offerings (2009-2015)

Global Molecular POC Diagnostics Market (2015-2020)

Major Conclusions

TWO: INTRODUCTION TO MOLECULAR POINT OF CARE DIAGNOSTICS

Introduction

Point-of-Care Diagnostics in Brief

Common Tests and Analytes in POC Diagnostics

Market Drivers for POC Diagnostics

Market Barriers for POC Diagnostics

Molecular Diagnostics

Real-Time PCR (qPCR)

Isothermal Amplification Methods

Microarrays

Sequencing

Common Tests and Analytes in Molecular Diagnostics

Advantages and Disadvantages of Molecular Diagnostics at the Point of Care

Summary

THREE: MOLECULAR POINT OF CARE DIAGNOSTICS DEVELOPMENT AND APPLICATIONS

Introduction

Advances in Molecular Diagnostics

Microfluidics

Isothermal Amplification

Test Automation

Primers and Probes

Detection

Next-Generation Sequencing

Molecular Platforms and Products for Decentralized Testing

Major Testing Applications for Molecular POC Diagnostics

Influenza

Strep A

Respiratory Syncytial Virus (RSV)

Other Respiratory Infections

Chlamydia and Gonorrhea

Group B Streptococcus

Human Papillomavirus

Herpes Simplex Virus

Vaginitis

Human Immunodeficiency Virus (HIV)

Tuberculosis

Hepatitis

Malaria

Other Tropical and Neglected Diseases

Gastrointestinal Infections

Hospital-Acquired Infections (HAIs)

Bloodstream Infections (BSIs)

Pharmacogenetics

Hereditary Disease

Cancer

Conclusions

FOUR: MARKETS FOR MOLECULAR POINT-OF-CARE DIAGNOSTICS

Introduction

Investment in Decentralized Molecular Diagnostics – Venture Financing and Public

Offerings (2009-2015)

Respiratory Tract Infections

Women’s Health and Sexual Health

High-Burden Diseases

Gastrointestinal, Hospital-Acquired and Bloodstream Infections

Non-Infectious Disease Tests – Pharmacogenetics, Hereditary Traits and Cancer

Conclusions

FIVE: COMPANY PROFILES

Abacus Diagnostica

Advanced Liquid Logic (Illumina)

Ahram Biosystems

Akonni Biosystems

Alere (Abbott)

Amplino

Analytik Jena

Aquila Diagnostic Systems

Atlas Genetics

Axxin

Becton, Dickinson & Co. (BD)

Biocartis

Biomeme

bioMérieux

Canon BioMedical

Cepheid

Molecular Healthcare-Acquired Infection (HAI) Testing

Molecular Sexual Health and Women’s Health Testing

Molecular Critical Infectious Disease Testing

Molecular Oncology Testing

Coris BioConcept

Coyote Bioscience

Curetis

DestiNA Genomics

Diagnostics For All

Diagnostics for the Real World

DiaSorin

DiAssess

DNA Electronics

DxNA

Eiken Chemical

Enigma Diagnostics

Entopsis

Epistem

ERBA Molecular (Lumora)

Espira

GenapSys

GeneFluidics

GenePOC

GeneReach Biotechnology

GnuBIO (Bio-Rad)

Great Basin Scientific

Greiner Bio-One

Hai Kang Life

Hain Lifescience

HiberGene Diagnsotics

iCubate

Immunexpress

InSilixa

Lucigen

Mast Group

MBio Diagnostics

Meridian Bioscience

Mesa Biotech

Metaara Medical Technologies

Micronics (Sony)

Molbio Diagnostics

MP Biomedicals

MycroLab Diagnostics

Nanobiosym

NanoBioSys

NanoDetection Technology

NanoIVD

Nanomix

Nanosphere

OptiGene

Orion Diagnostica

Oxford Nanopore Technologies

PositiveID

PreTect

QIAGEN

HPV

Other Activities (Development, Licensing, Investment)

QuantuMDX

Quidel

Rheonix

Roche Diagnostics

Scanogen

Seegene

Spartan Bioscience

STAT-Diagnostica

T2 Biosystems

Thermal Gradient

Ubiquitome

Ustar Biotechnologies

Veredus Laboratories

Wave 80 Biosciences

Xagenic

LIST OF EXHIBITS

ONE: EXECUTIVE SUMMARY

Table 1-1: Advantages of Point-of-Care Diagnostics by Setting – Hospital POC,

POL/Outpatient, Low-Resource and Developing Areas

Table 1-2: Disadvantages of Point-of-Care Diagnostics by Setting – Hospital POC,

POL/Outpatient, Low-Resource and Developing Areas

Table 1-3: Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay

Menu, Planned Assays, Regulatory Status, Procedure Integration, Test

Principles)

Figure 1-1: Investments in Decentralized Molecular Diagnostics Companies

(2014-2015)

Figure 1-2: Molecular POC Diagnostics Market (2015-2020) ($ millions)

TWO: INTRODUCTION TO MOLECULAR POINT OF CARE DIAGNOSTICS

Table 2-1: Advantages of Point-of-Care Diagnostics by Setting – Hospital POC,

POL/Outpatient, Low-Resource and Developing Areas

Table 2-2: Disadvantages of Point-of-Care Diagnostics by Setting – Hospital POC,

POL/Outpatient, Low-Resource and Developing Areas

Table 2-3: Selected Isothermal Amplification Methods and Platform Examples

THREE: MOLECULAR POINT OF CARE DIAGNOSTICS DEVELOPMENT AND APPLICATIONS

Table 3-1: Selected Isothermal Amplification Methods and Platform Examples

Table 3-2: Selected Analyzer Platforms for Decentralized and POC Molecular Testing

with Image Sensor Detectors (CCD, CMOS)

Table 3-3: Selected Analyzer Platforms for Decentralized and POC Molecular Testing

with Photodiode Detectors

Table 3-4: Selected Analyzer Platforms for Decentralized and POC Molecular Testing

with Electrochemical Detectors

Table 3-5: Selected Analyzer Platforms for Decentralized and POC Molecular Testing

with Immunochromatographic Detection

Table 3-6: Selected NGS Platforms for Decentralized and POC Sequencing

Table 3-7: Market-Available Molecular POC Diagnostic Platforms (Vendor, Assay

Menu, Planned Assays, Regulatory Status, Procedure Integration, Test

Principles)

Table 3-8: Market-Available Hospital Molecular Diagnostic Platforms (Vendor, Assay

Menu, Planned Assays, Regulatory Status, Procedure Integration, Test Principles) … 83

Table 3-9: Hospital and POC Molecular Diagnostic Platforms in Development (Vendor,

Assay Menu, Procedure Integration, Test Principles)

Table 3-10: Market-Available Molecular Diagnostic Platforms for Emerging Markets

and the Developing World (Vendor, Assay Menu, Planned Assays, Regulatory Status,

Procedure Integration, Test Principles)

Table 3-11: Molecular Diagnostic Platforms in Development for Emerging Markets

and the Developing World (Vendor, Assay Menu, Procedure Integration, Test

Principles)

Table 3-12: Line Probe Assays and Other Molecular Lateral Flow Test Strips (Vendor,

Assay Menu, Planned Assays, Regulatory Status)

Table 3-13: Potential Entrants into Molecular POC Diagnostics (Vendor, Current

Platform[s], Primary Market for Platform, Assay Menu, Applicable Tech)

Table 3-14: Selected Developmental Molecular POC-Enabling Technologies and

Platforms by Vendor

FOUR: MARKETS FOR MOLECULAR POINT-OF-CARE DIAGNOSTICS

Figure 4-1: Investments in Decentralized Molecular Diagnostics Companies

(2014-2015)

Table 4-1: Investments in Decentralized Molecular Diagnostics Companies

(2014-2015)

Figure 4-2: Molecular Influenza Test POC Market (2015-2020) ($ millions) – Sales /

Market Opportunity

Figure 4-3: Molecular Strep A Test POC Market (2015-2020) ($ millions) – Sales /

Market Opportunity

Figure 4-4: Molecular RSV POC Market (2015-2020) – Sales / Market Opportunity … 135

Figure 4-5: Molecular POC Market for Other Respiratory Infections (2015-2020) –

Sales / Market Opportunity

Table 4-2: Molecular POC Market for Respiratory Tract Infections – Influenza, Strep

A, RSV, Others (2015-2020) – Sales / Market Opportunity

Figure 4-6: Molecular CT/NG POC Market (2015-2020) – Sales / Market

Opportunity

Figure 4-7: Molecular GBS POC Market (2015-2020) – Sales / Market Opportunity … 142

Figure 4-8: Molecular HPV POC Market (2015-2020) – Sales / Market Opportunity .. 144

Figure 4-9: Molecular HSV POC Market (2015-2020) – Sales / Market Opportunity … 146

Figure 4-10: Molecular Vaginitis POC Market (2015-2020) – Sales / Market

Opportunity

Table 4-3: Molecular POC Market for Women’s Health and Sexual Health – CT/NG,

GBS, HPV, HSV, Vaginitis (including TV) (2015-2020) – Sales / Market

Opportunity

Figure 4-11: Molecular HIV POC Market (2015-2020) – Sales / Market Opportunity . 152

Figure 4-12: Molecular TB POC Market (2015-2020) – Sales / Market Opportunity

Figure 4-13: Molecular Hepatitis POC Market (2015-2020) – Sales / Market

Opportunity

Figure 4-14: Molecular Malaria POC Market (2015-2020) – Sales / Market

Opportunity

Figure 4-15: Molecular POC Market for Other Tropical and Neglected Diseases (2015-

2020) – Sales / Market Opportunity

Table 4-4: Molecular POC Market for High-Burden Diseases – HIV, TB, Hepatitis,

Malaria, Other Tropical and Neglected Diseases (2015-2020) – Sales / Market

Opportunity

Figure 4-16: Molecular POC Market for GI Pathogens (2015-2020) – Sales / Market

Opportunity

Figure 4-17: Molecular POC Market for HAIs (2015-2020) – Sales / Market

Opportunity

Figure 4-18: Molecular POC Market for Bloodstream Infections (2015-2020) – Sales /

Market Opportunity

Table 4-5: Molecular POC Market for GI Pathogens, HAIs and Bloodstream Infections

(2015-2020) – Sales / Market Opportunity

Figure 4-19: Molecular POC Market for PGx and Other Genetics Testing (2015-2020) –

Sales / Market Opportunity

Figure 4-20: Molecular POC Market for Cancer Testing (2015-2020) – Sales / Market

Opportunity

Table 4-6: Molecular POC Market for Non-Infectious Diseases – Pharmacogenetics /

Hereditary Traits and Cancer (2015-2020) – Sales / Market Opportunity

Table 4-7: Molecular POC Test Markets for Respiratory Tract Infections, Women’s

Health and Sexual Health, High-Burden Diseases, GI Pathogens, HAIs, Bloodstream

Infections, Pharmacogenetics, Other Genetics, and Cancer Testing (2015-2020) –

Sales / Market Opportunity

FIVE: COMPANY PROFILES

Table 5-1: Alere Revenue (2012-2015)

Table 5-2: Analytik Jena Revenue (FY 2011-2014)

Table 5-3: Becton, Dickinson & Co. (BD) Revenue (FY 2012-2015)

Table 5-4: Biocartis NV Revenue (2012-2015)

Table 5-5: bioMérieux Revenue (2012-2015)

Table 5-6: Cepheid Revenue (2012-2015)

Table 5-7: DiaSorin Revenue (2012-2015)

Table 5-8: Eiken Chemical Revenue (FY 2012-2015)

Table 5-9: Epistem Revenue (FY 2012-2015)

Table 5-10: Great Basin Corporation Revenue (2012-2015)

Table 5-11: Meridian Bioscience Revenue (FY 2012-2015)

Table 5-12: Nanosphere Revenue (2012-2015)

Table 5-13: Orion Diagnostica Revenue (2012-2015)

Table 5-14: PositiveID Revenue (2012-2015)

Table 5-15: QIAGEN Revenue (2012-2015)

Table 5-16: Quidel Corporation Revenue (2012-2015)

Table 5-17: Roche Diagnostics Revenue (2012-2015)

Table 5-18: Seegene Revenue (2012-2015)

Table 5-19: T2 Biosystems Revenue (FY 2012-FY 2015)

THE WORLD MARKET FOR POINT OF CARE TESTS

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

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