Table of Contents
1: EXECUTIVE SUMMARY
INTRODUCTION
SCOPE AND METHODOLOGY
SIZE AND GROWTH OF THE MARKET
Table 1-1: Global POC Test Market, 2014-2021
TRENDS AFFECTING THE MARKET
COMPETITIVE OUTLOOK
2: INTRODUCTION AND OVERVIEW
POINT-OF-CARE DIAGNOSTICS TESTING
INDUSTRY REGULATIONS
POC INDUSTRY DRIVERS
Patient 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
Cardiovascular Disease
Diabetes
Drug Abuse
Central Nervous System Stimulants
Prevalence and Number of Illicit Drug Users
The World Market for Point of Care Diagnostics
February ii 2017 © Kalorama Information
Table 2-1: Estimated Number and Prevalence of Drug Users by Region and Age (15-64) (Africa, North America, South America, Asia,
Europe, Oceania, Global Total)
Infectious Disease
Pregnancy and Fertility
World Demographics
Table 2-2: World Population by Selected Geographical Region, 2010 – 2050 (Africa, Asia, Europe, North America, Oceania, Latin
America, World)
Global Aging Population
3: 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
Table 3-1: Selected Glucose Self-Test Meter Innovations
Table 3-2: Selected Apps and Glucose Management IT
Continuous Self-Testing
Glycated Hemoglobin Tests
Professional
MARKET SIZE AND GROWTH IN GLUCOSE
POC Glucose Self-Testing
POC Glucose Professional Testing
MARKET SHARE ANALYSIS – POC GLUCOSE MARKET
Figure 3-1: Global POC Glucose Test Manufacturers by Percent, 2016
4: POC BLOOD AND ELECTROLYTES TESTING MARKET
TYPES OF BLOOD AND ELECTROLYTES TESTS
Hemoglobin/Hematocrit
WBC
Blood Gases
Electrolytes
PRODUCTS
Table 4-1: Selected POC Hemoglobin and Hematocrit Systems, 2016
Table 4-2: Selected POC Hematology Analyzer Systems, 2016
MARKET SIZE AND GROWTH
Table 4-3: Global POC Blood and Electrolytes Testing Market Analysis, 2014-2021
POC Blood and Electrolyte Self-Testing
POC Blood and Electrolyte Professional Testing
Table 4-4: Global POC Blood and Electrolyte Professional Testing Market Analysis, 2016-2021
MARKET SHARE ANALYSIS IN BLOOD AND ELECTROLYTE TESTING
Table 4-5: Global POC Blood and Electrolyte Testing Market, Revenues and Market Share of Leading Suppliers, 2016
Figure 4-1: Global POC Blood and Electrolyte Testing Market Manufacturers by Percent, 2016
5: POC RAPID COAGULATION
PRODUCTS
Table 5-1: Selected POC Coagulation Innovations
Platelet Testing
Table 5-2: Selected Platelet Activity Test Innovations
MARKET SIZE AND GROWTH
Table 5-3: Global Rapid Coagulation Testing Market Analysis, 2014-2021
POC Rapid Coagulation Self-Testing
Table 5-4: POC Rapid Coagulation Self-Testing Market Analysis, 2016-2021
POC Rapid Coagulation Professional Testing
Table 5-5: POC Rapid Coagulation Professional Testing Market Analysis, 2016-2021
MARKET SHARE ANALYSIS IN COAGULATION TESTING
Table 5-6: Global POC Rapid Coagulation Testing Market, Revenues and Market Share of Leading Suppliers, 2016
Figure 5-1: Global POC Rapid Coagulation Testing Market, Market Share % of Leading Suppliers, 2016
6: POC RAPID CARDIAC MARKERS
PRODUCTS
MARKET SIZE AND GROWTH
Table 6-1: Total Rapid Cardiac Markers Tests Market Analysis, 2016-2021
MARKET SHARE ANALYSIS
Table 6-2: Global POC Cardiac Markers Test Market, Revenues and Market Share of Leading Suppliers, 2016 (in millions $)
Figure 6-1: Global POC Cardiac Test Manufacturers by Percent, 2016
7: POC DRUG TESTING
PRODUCTS
Urine
Oral
Blood
Hair
MARKET SIZE AND GROWTH
POC Drugs of Abuse Self-Testing
POC Drugs of Abuse Professional Testing
The World Market for Point of Care Diagnostics
February iv 2017 © Kalorama Information
MARKET SHARE ANALYSIS IN DRUG ABUSE TESTING
Table 7-1: Global POC Drugs of Abuse Testing Market, Revenues and Market Share of Leading Suppliers, 2016
Figure 7-1: Global POC Drug of Abuse Testing Manufacturers by Percent, 2016
8: POC PREGNANCY AND FERTILITY TESTING
PRODUCTS
Table 8-1: 2016 Pregnancy and Fertility CLIA Waivers (Manufacturer and Instrument / Assay), Manufacturer’s Instrument / Device /
Assay
MARKET SIZE AND GROWTH
Table 8-2: Global POC Pregnancy and Fertility Testing Market Analysis, 2014-2021
POC Pregnancy and Fertility Self-Testing
Table 8-3: POC Pregnancy and Fertility Self-Testing Market Analysis, 2016-2021
POC Pregnancy and Fertility Professional Testing
Table 8-4: POC Pregnancy and Fertility Professional Testing Market Analysis, 2016-2021
MARKET SHARE ANALYSIS IN PREGNANCY TESTING
Table 8-5: Global POC Pregnancy and Fertility Testing Market, Revenues and Market Share of Leading Suppliers, 2016
Figure 8-1: Global POC Pregnancy and Fertility Testing Manufacturers by Percent, 2016
9: POC COLON CANCER SCREENING/FECAL OCCULT BLOOD TESTING
PRODUCTS
Table 9-1: Selected POC Colon Cancer Tests
MARKET SIZE AND GROWTH
Table 9-2: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis: 2014-2021 .. 119
POC Colon Cancer Screening/Fecal Occult Blood Self-Testing
Table 9-3: POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis, 2016-2021
POC Colon Cancer Screening/ Fecal Occult Blood Professional Testing
Table 9-4: POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2014-2019 (in millions of dollars)
MARKET SHARE ANALYSIS IN POC COLON CANCER SCREENING
Table 9-5: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market, Revenues and Market Share of Leading Suppliers,
2016
Figure 9-1: Global POC Colon Cancer Screening/Fecal Occult Blood Testing Manufacturers (%), 2016
10: POC INFECTIOUS DISEASE TESTING
PRODUCTS
MARKET SIZE AND GROWTH
POC Infectious Disease Self-Testing
POC Infectious Disease Professional Testing
COMPETITIVE ANALYSIS
Figure 10-1: Global POC Infectious Disease Test Manufacturers by Percent, 2016
11: POC CHOLESTEROL TESTING
PRODUCTS
MARKET SIZE AND GROWTH
Table 11-1: Global POC Cholesterol Testing Market Analysis, 2014-2021
POC Cholesterol Self-Testing
Table 11-2: POC Cholesterol Self-Testing Market Analysis, 2016-2021
POC Cholesterol Professional Testing
Table 11-3: POC Cholesterol Professional Testing Market Analysis, 2016-2021
MARKET SHARE ANALYSIS IN POC CHOLESTEROL TESTING
Table 11-4: Global POC Cholesterol Testing Market, Revenues and Market Share of Leading Suppliers, 2016 (in millions $)
Figure 11-1: Global POC Cholesterol Testing Manufacturers by Percent, 2016
12: POC CANCER TUMOR MARKER TESTING
PRODUCTS
Table 12-1: Selected Companies Developing and/or Marketing POC Tests for Oncology Indications
MARKET SIZE AND GROWTH
Table 12-2: Global POC Cancer Testing Market Analysis, 2014-2021
MARKET SHARE ANALYSIS IN GLOBAL POC CANCER TUMOR TESTING
Table 12-3: Global POC Cancer Testing Market, Revenues and Market Share of Leading Suppliers, 2016 . 142
Figure 12-1: Global POC Cancer Testing Manufacturers by Percent, 2016
13: POC URINE STRIP TESTING
PRODUCTS
MARKET SIZE AND GROWTH
POC Urine Strip Self-Testing
POC Urine Test Strip Professional Testing
COMPETITIVE ANALYSIS
Figure 13-1: Global POC Urine Strip Testing Manufacturers by Percent, 2016
14: MISCELLANEOUS POC TESTING
MICROBIOLOGY
TSH
ALLERGY
AUTOIMMUNE
OTHERS
MARKET SIZE AND GROWTH
Table 14-1: Global Miscellaneous POC Testing Market Analysis, 2014-2021
15: ISSUES AND TRENDS IN POINT OF CARE
OVERVIEW
The World Market for Point of Care Diagnostics
WEARABLES
Table 15-1: Selected Wearable Devices
BREATH TEST ADVANCES
Table 15-2: Selected Disease Markers in Exhaled Breath
REIMBURSEMENT CHALLENGES
COMPETITION
POC AND MOLECULAR DIAGNOSTICS
Table 15-3: Market Available Molecular POC Diagnostic Platforms
POC AND BIOSENSORS AND MICROFLUIDICS
Table 15-4: Selected Biochip and Biosensor Players, 2016
POC CONNECTIVITY
THE EMERGENCE OF NON-INVASIVE TECHNOLOGIES
Saliva and Swab
Optical Techniques
16: OVERALL GLOBAL POC TESTING MARKET AND MARKET SHARE ANALYSIS
MARKET OVERVIEW
Table 16-1: Global POC Test Market, 2014-2021
MARKET ANALYSIS BY PRODUCT CATEGORIES
Table 16-2: Global POC Testing Market Analysis by Product Category, 2016 (Professional, Self-Testing) .. 176
MARKET ANALYSIS BY SUBCATEGORY
POC Professional Testing
Table 16-3: Global POC Professional Testing Market Analysis by Product Subcategory, 2016 (Drugs of Abuse, Blood & Electrolytes,
Glucose, Infectious Disease, Rapid Coagulation, Cardiac Markers, Fecal Occult Blood, Lipid, Pregnancy & Fertility, Miscellaneous, Urine
Strip, Cancer, Total)
POC Self-Testing
Table 16-4: Global POC Self-Testing Market Analysis by Product Category, 2016 (Glucose, Pregnancy & Fertility, Fecal Occult Blood,
Rapid Coagulation, Drugs of Abuse, Urine Strip, Infectious Disease, Lipid)
MARKET ANALYSIS BY COUNTRY
United States
Europe
Japan
Rest of World
Table 16-5: Global POC Testing Analysis by Region/Country, 2016 (United States, Europe, Japan, ROW, Total)
Figure 16-1: Global POC Testing Market Analysis Percent by Region/Country, 2016 (United States, Europe, Japan, ROW)
Table 16-6: Global POC Testing Market Analysis by European Region, 2016 (W. Europe, E. Europe)
Figure 16-2: Global POC Testing Market Analysis by European Region, 2016 (Germany, France, UK, Italy, Spain, Others)
Table 16-7: Global POC Testing Market Analysis by Rest of World Region/Country, 2016 (China, India, Brazil, Other, Total)
Figure 16-3: Global POC Testing Market Analysis by Rest of World Region/Country, 2016 (China, India, Brazil, Other)
MARKET CONCLUSIONS
Conclusion One
Conclusion Two
Conclusion Three
Conclusion Four
Conclusion Five
Conclusion Six
MARKET SHARE ANALYSIS
Table 16-8: Global POC Testing Market Revenues and Market Share of Leading Suppliers, 2016
Figure 16-4: Global POC Testing Market Share by Leading Suppliers, 2016
17: CORPORATE PROFILES
OVERVIEW
ABAXIS, INC.
Table 17-1: Abaxis Corporate Summary
Company Overview
Products
Performance Review
Table 17-2: Abaxis Revenue (2013-2016)
ABBOTT LABORATORIES
Table 17-3: Abbott Corporate Summary
Company Overview
Product
Performance Review
Table 17-4: Abbott Laboratories Revenue (2013-2016)
ABINGDON HEALTH, LTD.
Table 17-5: Abingdon Health Corporate Summary
Company Overview
Products
ACCUBIOTECH CO, LTD.
Table 17-6: AccuBioTech Summary
Company Overview
Products
ACCRIVA DIAGNOSTICS
Table 17-7: Accriva Diagnostics Summary
Company Overview
Products
ACON LABORATORIES, INC
Table 17-8: ACON Laboratories Corporate Summary
The World Market for Point of Care Diagnostics
February viii 2017 © Kalorama Information
Company Overview
Products
AERSCHER DIAGNOSTICS, LLC
Table 17-9: Aerscher Diagnostics Summary
Company Overview
Products
ALERE INC
Table 17-10: Alere Corporate Summary
Company Overview
Product
Performance Review
Table 17-11: Alere Revenue (2013-2016)
ALFA SCIENTIFIC DESIGNS, INC
Table 17-12: Alfa Scientific Summary
Company Overview
Products
AMERICAN BIO MEDICA CORPORATION
Table 17-13: American Bio Medica Summary
Company Overview
Products
AQUILA DIAGNOSTIC SYSTEMS, INC
Table 17-14: Aquila Diagnostic Systems Summary
Company Overview
ARKRAY
Table 17-15: Arkay Corporate Summary
Company Overview
Products
ARTRON LABORATORIES, INC
Table 17-16: Artron Laboratories Summary
Company Overview
ATLAS GENETICS LTD.
Table 17-17: Atlas Genetics Corporate Summary
Company Overview
Products
ATLAS LINK BIOTECH CO., LTD
Table 17-18: Atlas Link Biotech Summary
Company Overview
ATIVA MEDICAL CORPORATION
Table 17-19: Ativa Medical Summary
Company Overview
AUTOBIO DIAGNOSTICS CO., LTD
Table 17-20: Autobio Summary
Company Overview
AUGURIX DIAGNOSTIC
Table 17-21: Augurix Diagnostic Summary
Company Overview
AXXIN
Table 17-22: Axxin Summary
Company Overview
BECKMAN COULTER, INC
Table 17-23: Beckman Coulter Corporate Summary
Company Overview
Products
Performance Review
Table 17-24: Beckman Coulter (2013-2016)
BIOLYTICAL LABORATORIES
Table 17-25: bioLytical Laboratories Summary
Company Overview
BIOMERICA
Table 17-26: Biomerica Summary
Company Overview
BIOPTIX, INC
Table 17-27: Bioptix Summary
Company Overview
BIORACLE LIMITED
Table 17-28: biOracle Summary
Company Overview
BIOMEDOMICS, INC
Table 17-29: BioMedomics Summary
Company Overview
BIOMEME, INC
Table 17-30: Biomeme Corporate Summary
Company Overview
BIOMERIEUX SA
Table 17-31: bioMerieux SA Corporate Summary
Company Overview
Products
Performance Review
Table 17-32: bioMerieux Revenues (2013-2016)
BIOSENSIA
Table 17-33: Biosensia Summary
Company Overview
The World Market for Point of Care Diagnostics
February x 2017 © Kalorama Information
CALYPTE BIOMEDICAL CORPORATION
Table 17-34: Calypte Biomedical Summary
Company Overview
CEPHID
Table 17-35: Cephid Corporate Summary
Company Overview
Products
Performance Review
Table 17-36: Cephid Revenues (2013-2016)
CHEMBIO DIAGNOSTIC SYSTEMS, INC.
Table 17-37: Chembio Diagnostic Corporate Summary
Company Overview
Products
Performance Review
Table 17-38: Chembio Diagnostics Revenues (2013-2016)
CHURCH & DWIGHT CO. INC
Table 17-39: Church & Dwight Corporate Summary
Company Overview
Products
Performance Review
Table 17-40: Church & Dwight Revenue (2013-2016)
DAKTARI DIAGNOSTICS
Table 17-41: Daktari Diagnostics Summary
Company Overview
DANAHER CORPORATION
Table 17-42: Danaher Corporation Summary
Company Overview
DEXCOM, INC
Table 17-43: DexCom Summary
Company Overview
Products
Performance Review
Table 17-44: DexCom Revenue (2013-2016)
DNA ELECTRONICS LTD. (DNAE)
Table 17-45: DNA Electronics Corporate Summary
Company Overview
DRAGERWERK AG & CO. KGAA
Table 17-46: Dragerwerk Corporate Summary
Company Overview
Products
Company Financials
Table 17-47: Drager Revenue (2013-2016)
EIKEN CHEMICAL CO LTD.
Table 17-48: Eiken Chemical Corporate Summary
Company Overview
Products
Performance Review
Table 17-49: Eiken Chemical Revenue (2013-2016)
EKF DIAGNOSTICS HOLDINGS PLC
Table 17-50: EKF Diagnostics Corporate Summary
Company Overview
Products
Performance Review
Table 17-51: EKF Diagnostics Revenue (2013-2016)
ENIGMA DIAGNOSTICS, LTD.
Table 17-52: Enigma Diagnostics Corporate Summary
Company Overview
Products
ENTERIX, INC
Table 17-53: Enterix Corporate Summary
Company Overview
Products
ENTOPSIS
Table 17-54: Entopsis Corporate Summary
Company Overview
Products
EPISTEM/GENEDRIVE
Table 17-55: Epistem/Genedrive Corporate Summary
Company Overview
Products
EY LABORATORIES
Table 17-56: EY Laboratories Summary
Company Overview
EXALENZ BIOSCIENCE LTD.
Table 17-57: Exalenz Bioscience Summary
Company Overview
FABPULOUS B.V.
Table 17-58: FABPulous Corporate Summary
Company Overview
Products
FIO CORPORATION
Table 17-59: Fio Corporate Summary
The World Market for Point of Care Diagnostics
February xii 2017 © Kalorama Information
Company Overview
Products
HELENA LABORATORIES
Table 17-60: Helena Laboratories Corporate Summary
Company Overview
Products
HEMA DIAGNOSTIC SYSTEMS, LLC
Table 17-61: Hema Diagnostics Systems Corporate Summary
Company Overview
Products
INSILIXA, INC
Table 17-62: InSilixa Corporate Summary
Company Overview
Products
INSTRUMENTATION LABORATORY
Table 17-63: Instrumentation Laboratory Corporate Summary
Company Overview
Products
JANT PHARMACAL CORPORATION
Table 17-64: Jant Pharmacal Summary
Company Overview
Products
LAMDAGEN CORPORATION
Table 17-65: LamdaGen Corporate Summary
Company Overview
LIFESCAN, INC
Table 17-66: LifeScan Corporate Summary
Company Overview
Products
Performance Review
Table 17-67: LifeScan Revenue (2013-2016)
LIFESIGN, LLC
Table 17-68: LifeSign Summary
Company Overview
MACHEREY-NAGEL GMBH & CO. KG
Table 17-69: Macherey-Nagel Corporate Summary
Company Overview
Products
MAGNASENSE TECHNOLOGIES
Table 17-70: Magnasense Technologies Summary
Company Overview
MBIO DIAGNOSTICS, INC
Table 17-71: Mbio Diagnostics Summary
Company Overview
MEDIX BIOCHEMICA
Table 17-72: Medix Biochemica Summary
Company Overview
Products
MEDMIRA, INC
Table 17-73: MedMira Corporate Summary
Company Overview
Products
Performance Review
Table 17-74: MedMira Revenue (2013-2016)
MENARINI DIAGNOSTICS
Table 17-75: Menarini Diagnostics Summary
Company Overview
Products
MERIDIAN BIOSCIENCE, INC
Table 17-76: Meridian BioScience Corporate Summary
Company Overview
Products
Performance Review
Table 17-77: Meridian Bioscience Revenue (2013-2016)
METAARA MEDICAL TECHNOLOGIES, INC
Table 17-78: Metaara Medical Technologies Summary
Company Overview
MICRONICS, INC
Table 17-79: Micronics Summary
Company Overview
NOVA BIOMEDICAL, CORP.
Table 17-80: Nova Biomedical Corporate Summary
Company Overview
Products
OPKO HEALTH, INC
Table 17-81: OPKO Health Corporate Summary
Company Overview
Products
Performance Review
Table 17-82: OPKO Health Revenue (2013-2016)
ORASURE TECHNOLOGIES, INC.
Table 17-83: OraSure Technologies Corporate Summary
The World Market for Point of Care Diagnostics
February xiv 2017 © Kalorama Information
Company Overview
Products
Performance Review
Table 17-84: OraSure Revenue (2013-2016)
ORTHO CLINICAL DIAGNOSTICS
Table 17-85: Ortho Clinical Diagnostics Corporate Summary
Company Overview
Products
Performance Review
Table 17-86: Ortho Clinical Diagnostics Revenue (2013-2016)
POLYMED THERAPEUTICS INC.
Table 17-87: Polymed Therapeutics Corporate Summary
Company Overview
Products
POLYMEDCO, INC
Table 17-88: Polymedco Corporate Summary
Company Overview
Products
POLYMER TECHNOLOGIES, INC (PTS DIAGNOSTICS)
Table 17-89: Polymer Technologies Corporate Summary
Company Overview
Products
QUANTUMDX GROUP LIMITED
Table 17-90: QuantuMDx Group Corporate Summary
Company Overview
Products
QUIDEL CORPORATION
Table 17-91: Quidel Corporate Summary
Company Overview
Products
Performance Review
Table 17-92: Quidel Revenue (2013-2016)
RADIOMETER MEDICAL A/S
Table 17-93: Radiometer Medical Corporate Summary
Company Overview
Products
Performance Review
Table 17-94: Radiometer Revenue (2013-2016)
RESPONSE BIOMEDICAL CORP
Table 17-95: Response Biomedical Corporate Summary
Company Overview
Products
Performance Review
Table 17-96: Response Biomedical Revenue (2013-2016)
RHEONIX, INC
Table 17-97: Rheonix Corporate Summary
Company Overview
Products
ROCHE DIAGNOSTIC CORPORATION
Table 17-98: Roche Corporate Summary
Company Overview
Products
Performance Review
Table 17-99: Roche Revenue (2013-2016)
SAMSUNG HEALTHCARE
Table 17-100: Samsung Healthcare Corporate Summary
Company Overview
Products
SAVYON DIAGNOSTICS
Table 17-101: Savyon Diagnostics Summary
Company Overview
Products
SEKISUI DIAGNOSTICS
Table 17-102: Sekisui Diagnostics Summary
Company Overview
Products
SIEMENS HEALTHINEERS
Table 17-103: Siemens Healthineers Corporate Summary
Company Overview
Products
Performance Review
Table 17-104: Siemens Healthineers Revenue (2013-2016)
SILOAM BIOSCIENCES, INC
Table 17-105: Siloam Biosciences Summary
Company Overview
Products
SPECTRAL MEDICAL, INC
Table 17-106: Spectral Medical Summary
Company Overview
SYSMEX CORPORATION
Table 17-107: Sysmex Corporate Summary
Company Overview
The World Market for Point of Care Diagnostics
February xvi 2017 © Kalorama Information
Products
Performance Review
Table 17-108: Sysmex Revenue (2013-2016)
TRINITY BIOTECH PLC
Table 17-109: Trinity Biotech Corporate Summary
Company Overview
Products
Performance Review
Table 17-110: Trinity Biotech Revenue (2013-2016)
VEREDUS LABORATORIES PTE LTD
Table 17-111: Veredus Labs Corporate Summary
Company Overview
Products
WAVE 80 BIOSCIENCES
Table 17-112: Wave 80 Biosciences Summary
Company Overview
XAGENIC
Table 17-113: Xagenic Corporate Summary
Company Overview
Products
