The Worldwide Market for Point-of-Care (POC) Testing (Infectious Disease Testing, POC Cancer Tests, Rapid Coagulation, Urine Testing, Lipid Tests, Pregnancy Testing, Glucose Testing and Other POC)

An in-depth look at the global POC testing market yielded several interesting facts that are explored in this study. Emerging technological innovations in smartphones, biosensors, lab-on-a-chip and wearable devices are influencing the POC landscape. The driving force behind these innovations in the health arena is to provide expedited diagnosis where the patient is seen or in the patient’s home. The POC diagnostic industry will be part of a paradigm shift from curative medicine to predictive, personalized and preemptive medicine.

Diagnostic tests performed outside the central laboratory or decentralized testing is generally known as point-of-care (POC). Over the years, 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 menu for point-of-care testing continues to expand. The traditional set of POC tests includes: blood glucose testing, blood gas and electrolytes analysis, rapid coagulation testing, rapid cardiac markers diagnostics, drugs of abuse screening, urine strips testing, pregnancy testing, fecal occult blood analysis, hemoglobin diagnostics, infectious disease testing and cholesterol screening.

In the past 5-10 years the following tests were added: HgA1c, B-Type Natriuretic Peptide (BNP), whole-blood lactate, D-Dimer, C-Reactive Protein (CRP).

Moreover, 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.

Where are Point of Care Tests Winning?

Molecular POC tests in physician office are already available for respiratory infections and more. The capacity to provide precise answers for time sensitive tests such as sexually transmissible diseases and other infections will drive the market for POC molecular test devices. Ease of use is a plus for hospital labs. Worldwide, lab budgets are being cut for test send-outs and there are not enough trained technologists to run molecular tests in their present configuration.

A major factor in achieving this goal of more precise and personalized therapeutic options is the use of advanced algorithm driven information technologies that can turn test data into actionable medical decision-making information. This trend is driven by the involvement of major information technology companies and payers that are tired of paying for drugs that often have limited positive patient outcome.

Information about diseases, therapies and tests is readily available via the Internet and a growing number of apps on personal digital assistants (PDAs) including all sorts of smart phones. Wearable devices participate in this area by collecting vital sign data that are then analyzed by IT tools to provide health care improvement instructions.

These are among the companies covered in The Worldwide Market for Point of Care (POC) Testing Technologies

Who's Competing in the Market for Point of Care Diagnostics?

Large and small companies are involved in the development and/or marketing of POC testing. The market is considered evolving with growth opportunity. Developing and developed markets alike have room to grow due to an aging population worldwide. Key companies such as Roche, LifeScan, Abbott /Alere and Siemens Healthineers will likely maintain leading positions in the market through continued product innovation and strategic alliances and mergers.

Among the top and/or innovative competitors discussed within Corporate Profiles are:

• 1 Step Detect Associates
• Abaxis
• Abbott Labs
• Abingdon Health
• Access Bio
• AccuBioTech Co
• Accutech
• Accriva Diagnostics
• ACON Laboratories
• Aerscher Diagnostics
• Akers Biosciences
• Alere
• Alfa Scientific Designs
• American Bio Medica
• AmniSure
• Aquila Diagnostic System
• Arlington Scientific
• Arkray
• Artron Laboratories
• Atlas Genetics
• Atlas Link Biotech
• Ativa Medical Corp
• Audit Diagnostics
• Autobio Diagnostics
• Augurix Diagnostic
• Axxin
• Beckman Coulter
• Becton Dickinson
• Beijing Wantai Biological Pharmaceuticals
• Bhat Bio-Tech India Private Ltd.
• bioLytical Laboratories
• Biomerica
• biOracle Limited
• BioMedomics
• Biomeme
• bioMerieux SA
• Biophor Diagnostics
• Bio-Rad Laboratories
• Bioscan Screening Systems
• Biotron Diagnostics
• Biosensia
• Boditech Med
• Boson Biotech
• BTNX
• Calypte Biomedical Corp
• CARE Products
• Cepheid
• Chembio Diagnostic Systems
• Church & Dwight
• Clarity Diagnostics
• Confirm Biosciences
• CTK Biotech
• Daktari Diagnostics
• Danaher Corporation
• Dexcom
• DIALAB
• DiaSys Diagnostic Systems
• Diaxohit
• Diazyme Laboratories
• DNA Electonics Ltd.
• Dragerwerk AG
• Dr Fooke-Achterrath
• DRG International
• Eiken Chemical
• EKF Diagnostics
• ELITechGroup, Inc
• Enterix
• Entopsis
• Eurolyser Diagnostica
• EY Laboratories
• Exalenz Bioscience
• FABPulous B.V.
• Fio Corp
• First Check Diagnostics
• GenBio
• Genedrive
• GeTein BioMedical
• GlysBy
• Helena Labs
• Hema Diagnostic System
• Hemosure
• HORBIA
• Immunosciences Lab
• InSilixa
• Instrumentation Laboratory
• JAL Innovations
• Jant Pharmacal
• J. Mitra & Co Pvt
• LamdaGen Corp
• LifeScan
• LifeSign
• Macherey-Nagel
• Magnasense Technologies
• Mbio Diagnostics
• Medix Biochemica
• MedMira
• Medtronic
• Menarini Diagnostics
• Meridian BioScience
• Metaara Medical Technologies
• Micronics
• Nano-Ditech Corporation
• Noble Medical
• Nova Biomedical
• Oasis Diagnostics
• Operon
• OPKO Health
• OPTI Medical Systems
• OraSure Technologies
• Ortho Clinical Diagnostics
• Polymed Therapeutics
• Polymedco
• Polymer Technologies
• Preventis
• Princeton Biomeditech
• QuantuMDx Group
• Quidel
• Radiometer Medical
• RENESA UG
• Response Biomedical
• Reszon Diagnostics
• Rheonix
• Roche Diagnostics
• Samsung Healthcare
• Savyon Diagnostics
• Sekisui Diagnostics
• Siemens Healthcare
• Siloam Biosciences
• Spectral Medical
• Sysmex
• TECHLAB
• Teco Diagnostics
• Tosoh
• Trinity Biotech
• Trividia Health
• Tulip Diagnostics
• Veredus Laboratories
• Vircell
• WAMA Diagnostica
• Wave 80 Biosciences
• Werfen
• Xagenic

Conclusion One – Paradigm shift toward prevention and early detection of disease

The development of smaller devices and Bluetooth communication has dramatically changed the patient/physician roles. Patients are more interested in playing a bigger role in their own healthcare. This will lead to more personalized healthcare with interventions tailored to specific patients.

Conclusion Two –POC Molecular Diagnostics continue to make inroads

Molecular POC diagnostics is at the nexus of low-complexity rapid testing performed near the patient and high-technology clinical molecular diagnostics. The emergent molecular POC test space seeks to leverage the key strengths of both segments – rapid results with ease of use operation and high sensitivity and specificity results – to address critical testing areas relating to emergency care, rapid clinical intervention, effective field screening, and the control of high-burden diseases in the developing world.

Conclusion Three- Technological progress is expanding the POC test market

Technological progress is expanding the domain of rapid and point-of-care tests. Led by the U.S. population, the global client base for POC products and tests (including physician offices and other primary care settings such as clinics and mobile labs) is significant – accounting for $19.5 billion in sales in 2017 – and will endure through episodes of healthcare expansion and reform found worldwide. However, the role of POC tests remains contentious due to questions regarding quality control or accuracy and added costs. In the United States, recent results of the GPA Waived Project have vindicated regulatory concerns regarding the quality of CLIA-waived testing that have also stalled the introduction of additional test waivers. Skepticism regarding POC test accuracy is significantly stronger abroad, with much more limited test menus for reimbursement or outright bans on testing at unaudited or uncertified office labs.