The Worldwide Market for Point-of-Care (POC) Diagnostics, 7th Edition

This report represents the 7th edition of a fast-growing and competitive category of the in vitro diagnostic market. Point-of-care (POC) tests are diagnostics performed outside the central laboratory or executed via decentralized testing. POC testing has skyrocketed in the last 20 years as demand for accurate and fast testing has grown both inside and outside the hospital setting. 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.

The 7th edition of Kalorama’s Worldwide Market for Point-of-Care (POC) Diagnostics takes a deep look at the POC diagnostic industry, part of a paradigm shift from curative medicine to predictive, personalized and preemptive medicine.

Global Market Analysis
The global POC testing market is composed of two major categories: professional testing, which includes physician office labs, clinic labs, employer labs and hospital labs, and self-testing, which includes home, drug store testing and continuous glucose testing. The report presents market analysis by product categories, market analysis by subcategory, market analysis by device technology, market analysis by country (including the United States, Europe, Japan, and rest of world), and competitive analysis. The following global market data is provided:
• Global POC Test Market, 2019-2024 (in millions $ at manufacturer level)
• Global POC Testing Market Analysis by Product Category, 2019 (in millions $) (Self-Testing, Professional Testing, Total)
• Global POC Self-Testing Market Analysis by Product Category, 2019 (in millions$) (Glucose [includes CGM], Pregnancy & Fertility, Fecal Occult Blood, Rapid Coagulation, Drugs of Abuse, Urine, Infectious Disease, Lipid, Total)
• Global POC Self-Testing Market Analysis by Product Category, 2019 (by %) (Infectious Disease, Urine, DOA, Coagulation, FOB, Pregnancy, Glucose)
• Global POC Professional Testing Market Analysis by Product Subcategory, 2019 (in millions$) (Drugs of Abuse, Glucose includes HbA1c, Blood & Electrolytes, Infectious Disease, Rapid Coagulation, Fecal Occult Blood, Cardiac Markers, Lipid, Pregnancy & Fertility, Miscellaneous, Urine, Cancer Tumor Markers, Total)
• Global POC Professional Testing Market Analysis by Product Subcategory, 2019 (by %) (Tumor Markers, Urine, Misc, Pregnancy, Lipid, Cardiac Markers, Rapid Coag, FOB, Infectious Disease, Blood/ Electrolytes, Glucose/ HbA1c, DOA)
• POC Testing by End-user, 2019 (%) (Hospitals, Others)
• Global POC Market by Technology by Sales, 2019 (%) (LFA, Biosensors, Analyzers, Strips)

Regional Market Analysis
The POC market is also broken out by geographic region:
• Global POC Testing Analysis by Region/Country, 2019 (in millions $) (United States, Europe, Japan, ROW, Total)
• Global POC Testing Market Analysis by European Region, 2019 (in millions $) (W. Europe, E. Europe, Total)
• Europe POC Testing Percentage Participation, by Country, 2019 (Germany, UK, France, Italy, Switzerland/ Sweden, Spain, Other)
• Global POC Testing Market Analysis by Rest of World Region/Country, 2019 (in millions $) (Latin America and Mexico, China, Australia, South Korea, India, Other, Total)
• POC Blood Glucose Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Blood and Electrolytes Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Rapid Coagulation Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Rapid Cardiac Markers Testing Regional Market Analysis, 2019 (US; Europe; Japan; Latin America, India, Asia Pacific and the Middle East; RoW)
• POC Substance Abuse Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Pregnancy and Fertility Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Colon Cancer Screening/FOB Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Infectious Disease Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Lipid Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Cancer Tumor Marker Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Urine Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)
• POC Miscellaneous Testing Regional Market Analysis, 2019 (US, Europe, Japan, RoW)

Segment Size and Growth
POC test devices have contributed significantly to the growth of the overall diagnostics market over the past 10 years. More diagnostic manufacturers have pursued CLIA waiver status for their POC devices and CE Mark for POC or self-use. At the same time more, decentralized test venues invest in non-waived rapid tests and instruments. POC testing appears to be headed for an even bigger role in diagnosis and monitoring patient care. New technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, a remote caregiver service for consultation or an electronic medical record. As the menu for point-of-care testing continues to expand, the report looks in-depth at the following market segments:
• Global POC Glucose (including CGM and HbA1c) Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Diabetes Sales by Test Category, 2019-2024 (Glucose, Self-test; Glucose, professional; Glucose, continuous; HbA1c, POC; TOTAL; $ millions)
• Global POC Glucose Self-Testing Market (excludes continuous glucose devices) 2019-2024 (in millions $ at manufacturer level)
• Global POC Continuous Glucose Self-Testing Market 2019-2024 (in millions $ at manufacturer level)
• Global POC Glucose Professional Testing Market (excludes HbA1c testing) 2019-2024 (in millions $ at manufacturer level)
• Global POC Glucose HbA1c Professional Testing Market 2019-2024 (in millions $ at manufacturer level)
• Global POC Blood and Electrolytes Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Blood & Electrolytes Revenues by Test Category, 2019-2024 ($ millions) (Blood Gases & Electrolytes [inc critical care], Hematocrit/Hemoglobin, WBC other routine)
• Global POC Blood & Electrolytes Sales by Test Category, 2019-2024 ($ millions) (Blood Gases & Electrolytes [inc critical care], Hematocrit/Hemoglobin, WBC other routine)
• Global Rapid Coagulation Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Total Rapid Cardiac Markers Tests Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Drugs of Abuse Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Drugs of Abuse Self Testing Market, 2019-2024 (includes continuous glucose devices)
• Global POC Drugs of Abuse Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Pregnancy and Fertility Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Pregnancy and Fertility Self-Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Pregnancy and Fertility Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Colon Cancer Screening/Fecal Occult Blood Testing Market Analysis: 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Colon Cancer Screening/Fecal Occult Blood Self-Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Colon Cancer Screening/Fecal Occult Blood Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Testing Market Analysis: 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Revenues and Percent of Infectious Disease Market by Disease Type, 2019 (in millions $) (Influenza, HIV, STD, Hepatitis, Malaria, C. difficile, E. coli, H. pylori, Home Test/OTC, Others, Total)
• POC Infectious Disease Self-Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Infectious Disease Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Infectious Disease Revenues and Percent of Infectious Disease Market by Disease Type, 2018 (in millions $) (Influenza, HIV, STD, Hepatitis, Malaria, C. difficile, E. coli, H. pylori, Home Test/OTC, Others, Total)
• Global POC Lipid Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Lipid Self-Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Lipid Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Cancer Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Urine Testing Market Analysis, 2016-2028 (in millions of dollars at the manufacturer’s level)
• POC Urine Self-Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• POC Urine Professional Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global Miscellaneous POC Testing Market Analysis, 2019-2024 (in millions of dollars at the manufacturer’s level)
• Global POC Miscellaneous Sales by Test Category, 2019-2024 (Microbiology, TSH, Allergy, Autoimmune, Others TOTAL; $ millions) (Microbiology, TSH, Allergy, Autoimmune, Others, Total)

Competitor Analysis
Developing and developed markets alike have room to grow due to an aging population worldwide, drawing companies both large and small into the development and/or marketing of POC tests. Among the innovative competitors discussed within the report’s corporate profiles are:
• 1 Step Detect Associates, LLC
• Abaxis, Inc.
• Abbott Laboratories
• Abingdon Health, Ltd.
• AccessBio, Inc.
• AccuBioTech Co, Ltd.
• ACON Laboratories, Inc
• Aerscher Diagnostics, LLC
• Akers Biosciences, Inc.
• Alfa Scientific Designs, Inc
• American Bio Medica Corporation
• AmniSure International
• Aquila Diagnostic Systems, Inc
• Arkray, Inc.
• Arlington Scientific, Inc.
• Artron Laboratories, Inc
• Ascensia Diabetes Care Holdings AG
• Ativa Medical Corporation
• Atlas Link Biotech Co., Ltd
• Audit Diagnostics
• Augurix Diagnostic
• Autobio Diagnostics Co., Ltd
• Axxin
• Beckman Coulter, Inc
• Becton Dickinson (BD)
• Beijing Wantai Biological Pharmacy Enterprise Co., Ltd.
• Bhat Bio-Tech India Private Ltd. (BBI)
• binx health
• bioLytical Laboratories
• BioMedomics, Inc
• Biomeme, Inc
• Biomerica, Inc.
• bioMérieux SA
• Biophor Diagnostics, Inc
• Bio-Rad Laboratories Inc.
• Bioscan Screening Systems, Inc.
• Biosensia Ltd.
• Biotron Diagnostics, Inc.
• BNTX Inc.
• Boditech Med Inc
• Boson Biotech Co. Ltd
• Calypte Biomedical Corporation
• CARE Products, Inc.
• Cepheid, Inc
• Chembio Diagnostics, Inc.
• Church & Dwight Co. Inc
• Clarity Diagnostics, LLC
• Confirm Biosciences
• CTK Biotech, Inc.
• Daktari Diagnostics
• Danaher Corporation
• Dexcom, Inc
• DIALAB GmbH
• DiaSys Diagnostic Systems GmbH
• Diazyme Laboratories, Inc.
• DNA Electronics Ltd. (DNAe)
• Drägerwerk AG & Co. KGaA
• Dr. Fooke-Achterrath Laboratorien GmbH
• DRG International, Inc.
• DxGen Corp.
• Eiken Chemical Co Ltd.
• EKF Diagnostics Holdings plc
• ELITechGroup, Inc.
• Enterix, Inc. (Clinical Genomics)
• Entopsis
• Eurobio Scientific
• Eurolyser Diagnostica GmbH
• Exact Sciences
• Exalenz Bioscience Ltd.
• EY Laboratories
• Fio Corporation
• First Check Diagnostics LLC
• GenBio
• genedrive plc
• GenePOC
• GeTein BioMedical, Inc.
• GlysBy snc
• Helena Laboratories
• Hemosure, Inc.
• HORIBA, Ltd.
• Immunosciences Lab, Inc.
• Immunostics, Inc
• InSilixa, Inc
• Instrumentation Laboratory
• JAL Innovation PTE LTD
• Jant Pharmacal Corporation
• J. Mitra & Co Pvt. Ltd
• LamdaGen Corporation
• LifeScan, Inc
• LifeSign, LLC
• Loop Medical
• Macherey-Nagel GmbH & Co. KG
• Magnasense Technologies
• MBio Diagnostics, Inc
• Medix Biochemica
• MedMira, Inc
• Medtronic, Inc.
• Menarini Diagnostics srl.
• Meridian Bioscience, Inc
• MiCo BioMed USA
• Nano-Ditech Corporation
• NG Biotech
• Noble Medical, Inc
• Nova Biomedical Corp.
• NuGenerex Diagnostics
• Oasis Diagnostics Corporation
• Operon S.A.
• OPKO Health, Inc
• OPTI Medical Systems, Inc
• OraSure Technologies, Inc.
• Polymedco, Inc
• Polymed Therapeutics Inc.
• Polymer Technologies, Inc (PTS Diagnostics)
• Preventis GmbH
• Princeton Biomeditech Corporation
• QuantuMDx Group Limited
• Quidel Corporation
• Radiometer Medical A/S
• Randox Laboratories Limited
• RENESA UG
• Response Biomedical Corp
• Reszon Diagnostics International Sdn. Bhd.
• Rheonix, Inc
• Roche Diagnostic Corporation
• Samsung Healthcare
• Savyon Diagnostics
• Sekisui Diagnostics LLC
• Siemens Healthineers GmbH
• Spectral Medical, Inc
• Sysmex Corporation
• TECHLAB, Inc.
• Teco Diagnostics
• Trinity Biotech PLC
• Trividia Health
• Tulip Diagnostics Ltd
• VedaLab
• Veredus Laboratories PTE Ltd
• Vircell
• WAMA Diagnostica
• Wave 80 Biosciences
• Werfen

Market Issues and Trends
An in-depth look at the global POC testing market yields several interesting facts that are explored in this report. Emerging technological innovations in smartphones, biosensors, lab-on-a-chip and wearable devices are influencing the POC landscape. Worldwide Market for Point-of-Care (POC) Diagnostics explores the main issues and trends affecting this market, influencing its move into the future. These include wearables, patient-centered healthcare, regulatory hurdles, and reimbursement challenges. Factors driving the development of POC tests are discussed as well, including patient-focused drivers, medical/healthcare-related drivers, technology drivers, and economic drivers.