World Point of Care Diagnostics Market Size and Market Share Analysis

 
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Published Feb 3, 2017 | 401 Pages | Pub ID: KLI15242496

World Point of Care Diagnostics Market Size and Market Share Analysis

Visit our 'Point of Care Testing' curated page for complete industry coverage.

Kalorama Information estimates the point of care diagnostics testing market at $18.4 billion, according to our latest market research study conducted this year. Emerging technological innovations in smartphones, biosensors, lab-on-a-chip and wearable devices are transforming the point of care diagnostic market. The driving force behind these innovations in healthcare is to provide expedited diagnosis where the patient is seen or in the patient’s home. The POC diagnostics industry will be part of a paradigm shift from curative medicine to predictive, personalized and preemptive medicine. Globally, millions of dollars are spent annually on point of care diagnostic testing, both professional testing and self-testing. 

What's the size of the market opportunity in each rapid and near-patient diagnostic testing segment?  Who's winning in point of care diagnostics market share?  Kalorama Information's updated superior resource, World Point of Care Diagnostics Market Size and Market Share Analysisfocuses on the global market for point of care diagnostics. 

In-Depth Point of Care Diagnostics Market Information, including:

  • Market Sizes and Market Share by Test Segment
  • Global Market Data
  • Over 80 Detailed Profiles of POC Testing Companies
  • Global POC Testing Market Revenues and Market Share of Leading Suppliers, 2016
  • Global POC Testing Market Analysis by Product Category, 2016 (Professional, Self-Testing)
  • 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)
  • 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)
  • POC Testing Analysis by Region/Country, 2016 (United States, Europe, Japan, ROW, Total)
  • POC Testing Market Analysis by European Region, 2016 (Germany, France, UK, Italy, Spain, Others)
  • POC Testing Market Analysis by Rest of World Region/Country, 2016 (China, India, Brazil, Other, Total)
Kalorama's Information's report, World Point of Care Diagnostics Market Size and Market Share Analysis, features in-depth analysis of the market for the traditional set of point of care diagnostics tests: 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). 

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. 

Who is Leading Point of Care Testing?

Roche, Alere, Abbott, and Siemens are among the largest companies in point of care (POC) diagnostics in terms of revenues, according to Kalorama Information. Together these companies make up three-fourths of the entire point of care diagnostics market. Point of care systems are designed to deliver test results in a location and timing to be useful during a patient visit. They consist of devices such as glucose meters operated by a patient or small analyzers operated in a physician office lab.

Roche dominated the point of care diagnostics market as it does in several other in IVD (in vitro diagnostics) categories.  Coagulation and glucose testing are key areas. In June 2015, Roche introduced the cobas c 513 blood glucose analyzer. It is a dedicated, high-throughput HbA1c analyzer suitable for diagnosis, monitoring and risk identification of diabetes patients.

Waltham, MA-based Alere secured the second market position Alere participates in nearly all POC test segments but has a dominating position in rapid cardiac markers.

World Point of Care Diagnostics Market Size and Market Share Analysis' geographic scope is worldwide with information for specific geographical regions; world demographics, and other general issues affecting the point of care testing market. The market summary includes market analysis by product and region and a competitive analysis of leading POC providers. 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. 

Top and/or Innovative Point of Care Diagnostics Companies discussed include:

  • Abaxis
  • Abbott Labs
  • Abingdon Health
  • AccuBioTech Co
  • Accriva
  • ACON
  • Aerscher Diagnostics
  • Alere
  • Alfa Scientific Designs
  • American Bio Medica
  • Aquila Diagnostic System
  • Arkray
  • Artron Laboratories
  • Atlas Genetics
  • Atlas Link Biotech
  • Ativa Medical Corp
  • Autobio Diagnostics
  • Augurix Diagnostic
  • Axxin
  • Beckman Coulter
  • bioLytical Laboratories
  • Biomerica
  • Bioptix
  • biOracle Limited
  • BioMedomics
  • Biomeme
  • bioMerieux SA
  • Biosensia
  • Calypte Biomedical Corp
  • Cephid
  • Chembio Diagnostic Systems
  • Church & Dwight
  • Dakaria Diagnostics
  • Danaher Corporation
  • DexCom
  • DNA Electronics
  • Dragerwerks
  • Eiken Chemical
  • EKF Diagnostics
  • Enigma Diagnostics
  • Enterix
  • Entopsis
  • Epistem/Genedrive
  • EY Laboratories
  • Exalenz Bioscience
  • FABPulous B.V.
  • Fio Corp
  • Helena Labs
  • Hema Diagnostic System
  • InSilixa
  • Instrumentation Laboratories
  • Jant Pharmacal
  • LamdaGen Corp
  • LifeScan
  • LifeSign
  • Macherey-Nagel
  • Magnasense Technologies
  • Mbio Diagnostics
  • Medix Biochemical
  • MedMira
  • Menarini Diagnostics
  • Meridian BioScience
  • Metaara Medical Technologies
  • Nova Biomedical
  • OPKO Health
  • OraSure
  • Ortho Clinical Diagnostics
  • Polymed Therapeutics
  • Polymedco
  • Polymer Technologies
  • QuantuMDx Group
  • Quidel
  • Radiometer Medical
  • Response Biomedical
  • Roche Diagnostics
  • Samsung Healthcare
  • Savyon Diagnostics
  • Sekisui Diagnostics
  • Siemens Healthcare
  • Siloam Biosciences
  • Spectral Medical
  • Sysmex
  • Trinity Biotech
  • Veredus Laboratories
  • Wave 80 Biosciences
  • Xagenic
The information for World Point of Care Diagnostics Market Size and Market Share Analysis was gathered using both primary and secondary research including comprehensive research of secondary sources such as company literature, databases, investment reports, and medical and business journals. Telephone interviews and email correspondence were the primary method of gathering information. For the purpose of this study, Kalorama Information conducted interviews with more than 30 key industry officials, consultants, health care providers, and government personnel. These sources were the primary basis in gathering information specifically relating to revenue and market share data presented in this report. Additional interviews were completed with relevant company representatives including marketing directors, division managers, and product representatives.

Issues & Trends Affecting the Point of Care Diagnostics Testing Market include:

  • Wearables
  • Breath Test Advances
  • Reimbursement Challenges
  • Competition
  • POC and Molecular Diagnostics
  • POC and Biosensors and Microfluidics
  • POC Connectivity
  • The Emergence of Non-invasive Technologies

POC Market Trend: Molecular Diagnostics

The year 2015 was a game changer for point of care and molecular diagnostics. Prior to this time, molecular diagnostics were conducted in core labs. In January 2015, FDA granted Alere  its first CLIA waiver for a nucleic acid-based test, i Influenza A&B. This was followed by Roche’s CLIA waiver for the cobas Liat System and Strep A. By the beginning of 2016, many more systems also received CLIA waivers including Cepheid’s Xpert Flu+RSV Xpress.  

It is anticipated that many more companies will rush to develop new products for POC molecular diagnostic testing. Advances and innovations in microfluidics; isothermal and other alternative amplification chemistries; test automation; primers and probes; and nextgeneration sequencing (NGS) methods have been the most significant to the development of decentralized molecular diagnostics. In many cases, these technologies work together to facilitate clinical molecular testing in an automated manner within a smaller device.

POC Market Trend: Connectivity

Connectivity is an important aspect of the POC market.  The healthcare team needs to have  access to results to make timely care decisions. The EHR allows for quicker diagnosis and treatment.  Connectivity in POC testing has transcended the interface between device and user or computer to now support the integration of POC and POL testing results in greater laboratory information and health information systems (LIS/HIS). Healthcare consolidation has intensified demand for data and results availability from POC testing on organization systems that can be shared among clinics, hospitals, and affiliated laboratories. Suppliers of POC testing products and third-party vendors have appropriately standardized POC instrument-desktop/laptop computer connectivity, complete with data management software or features, and have developed solutions for data conversion and availability on same-party and third-party information systems. Continued consolidation in healthcare systems and mounting pressure to coordinate care and eliminate unnecessary repeat.
 

POC Market Trend: Saliva Testing

Numerous researchers have explored saliva testing as a means of detecting oral cancer. The principal market for oral cancer testing is in dentistry, where biopsies are drawn from mouth tissue for analysis by a pathologist. In San Antonio, a team of researchers from Rice University have developed a prototype lab-on-a-chip or biochip test for oral cancer using a swabbed oral saliva sample. An associated study found that the developed rapid test showed comparable rates of accuracy in detecting cancer and determining malignant and premalignant lesions as biopsied pathology tests. Another professor at Michigan State University is cooperating with PeriRx to perform FDA trials for a similar saliva test using oral cancer biomarkers. 

Salivary hormone testing has also been used to assess insulin resistance, breast cancer, thyroid dysfunction, polycystic ovary disease, adrenal dysfunction, estrogen dominance and androgen deficiency. Most of these tests are promoted directly to consumers. Such tests are not covered under government health insurance plans or private insurers. There are hundreds of labs worldwide that offer saliva and buccal swab assays for hormones and molecular analysis. However, such tests are generally absent from POC portfolios and like most home testing services have come under scrutiny from the FDA, dissuading many physicians from implementing the tests. 

The U.S. National Center for Dental and Craniofacial Research, part of the National Institutes of Health (NIH), is funding a project to create a catalog of all the proteins in saliva, called the Salivary Proteome Program, which should encourage the future development of salivary diagnostic tests.  By determining the normal ranges of proteins in saliva, researchers can develop tests to detect abnormal protein levels. 
Researchers in the UCLA Human Salivary Proteome Project have made progress in proteomic cataloging, although significant work remains before a comprehensive catalogue of salivary secretory proteins – achieved using all available analytical methods – is compiled. The delay in diagnostic product development is rooted in the technical difficulty in developing adequately sensitive and specific tests for salivary analytes, which could compete with established blood-based cancer and other disease tests (excluding inherent salivary market test applications, such as for oral cancer).

Point of Care Market Trend: Optical Techniques

Many advances in optical testing of diagnostic samples have come in the fields of flow cytometry, hematology, and histology or anatomic pathology including digital pathology
technologies.. However, widely diverse diagnostic markers remain that do not require high complexity fluorescence staining such as molecular in-situ hybridization (ISH) or advanced immunodiagnostics. Visual or optical confirmation of results via fluorescence in other simpler immunodiagnostic formats is available to POC testing. Optical techniques for the characterization and detection of pre-cancerous lesions in the cervix and gastrointestinal or colorectal tract are of greatest relevance to POC markets. Such applications are aimed at mitigating or minimizing biopsy procedures and the general displacement of invasive procedures that are not necessarily any more successful in cancer screening and carry many added costs for health care. 

Point-of-Care Market Trend: Connectivity

Connectivity is an important aspect of the POC market.  The healthcare team needs to have  access to results to make timely care decisions. The EHR allows for quicker diagnosis and treatment.  Connectivity in POC testing has transcended the interface between device and user or computer to now support the integration of POC and POL testing results in greater laboratory information and health information systems (LIS/HIS). Healthcare consolidation has intensified demand for data and results availability from POC testing on organization systems that can be shared among clinics, hospitals, and affiliated laboratories. Suppliers of POC testing products and third-party vendors have appropriately standardized POC instrument-desktop/laptop computer connectivity, complete with data management software or features, and have developed solutions for data conversion and availability on same-party and third-party information systems. Continued consolidation in healthcare systems and mounting pressure to coordinate care and eliminate unnecessary repeat. 

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        $93.00 Included
      •  
        $171.00 Included

      • $93.00 Included
        •   Chembio Diagnostics Revenues (2013-2016) ($ millions)

    • $93.00 Included
      •   Church & Dwight Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   Church & Dwight Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Daktari Diagnostics Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Danaher Corporation Summary
      •  
        $93.00 Included

    • $94.00 Included
      •   DexCom Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   DexCom Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   DNA Electronics Corporate Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Dragerwerk Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   Drager Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Eiken Chemical Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   Eiken Chemical Revenue (2013-2016) ($ millions)

    • $113.00 Included
      •   EKF Diagnostics Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   EKF Diagnostics Revenue (2013-2016) ($ millions)

    • $168.00 Included
      •   Enigma Diagnostics Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Enterix Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Entopsis Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $135.00 Included
      •   Epistem/Genedrive Corporate Summary
      •  
        $93.00 Included
      •  
        $110.00 Included

    • $93.00 Included
      •   EY Laboratories Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Exalenz Bioscience Summary
      •  
        $93.00 Included

    • $99.00 Included
      •   FABPulous Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $121.00 Included
      •   Fio Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Helena Laboratories Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $143.00 Included
      •   Hema Diagnostics Systems Corporate Summary
      •  
        $93.00 Included
      •  
        $102.00 Included

    • $110.00 Included
      •   InSilixa Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Instrumentation Laboratory Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Jant Pharmacal Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   LamdaGen Corporate Summary
      •  
        $93.00 Included

    • $177.00 Included
      •   LifeScan Corporate Summary
      •  
        $112.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   LifeScan Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   LifeSign Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Macherey-Nagel Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Magnasense Technologies Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Mbio Diagnostics Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Medix Biochemica Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $102.00 Included
      •   MedMira Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   MedMira Revenue (2013-2016) ($ millions)

    • $134.00 Included
      •   Menarini Diagnostics Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $204.00 Included
      •   Meridian BioScience Corporate Summary
      •  
        $93.00 Included
      •  
        $167.00 Included

      • $93.00 Included
        •   Meridian Bioscience Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Metaara Medical Technologies Summary
      •  
        $93.00 Included

    • $93.00 Included
      •   Micronics Summary
      •  
        $93.00 Included

    • $147.00 Included
      •   Nova Biomedical Corporate Summary
      •  
        $93.00 Included
      •  
        $119.00 Included

    • $183.00 Included
      •   OPKO Health Corporate Summary
      •  
        $93.00 Included
      •  
        $107.00 Included

      • $93.00 Included
        •   OPKO Health Revenue (2013-2016) ($ millions)

    • $172.00 Included
      •   OraSure Technologies Corporate Summary
      •  
        $93.00 Included
      •  
        $106.00 Included

      • $93.00 Included
        •   OraSure Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Ortho Clinical Diagnostics Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   Ortho Clinical Diagnostics Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Polymed Therapeutics Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Polymedco Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $120.00 Included
      •   Polymer Technologies Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $268.00 Included
      •   QuantuMDx Group Corporate Summary
      •  
        $142.00 Included
      •  
        $118.00 Included

    • $202.00 Included
      •   Quidel Corporate Summary
      •  
        $93.00 Included
      •  
        $163.00 Included

      • $93.00 Included
        •   Quidel Revenue (2013-2016) ($ millions)

    • $168.00 Included
      •   Radiometer Medical Corporate Summary
      •  
        $93.00 Included
      •  
        $120.00 Included

      • $93.00 Included
        •   Radiometer Revenue (2013-2016) ($ millions)

    • $182.00 Included
      •   Response Biomedical Corporate Summary
      •  
        $93.00 Included
      •  
        $144.00 Included

      • $93.00 Included
        •   Response Biomedical Revenue (2013-2016) ($ millions)

    • $139.00 Included
      •   Rheonix Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $224.00 Included
      •   Roche Corporate Summary
      •  
        $93.00 Included
      •  
        $170.00 Included

      • $93.00 Included
        •   Roche Revenue (2013-2016) ($ millions)

    • $95.00 Included
      •   Samsung Healthcare Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Savyon Diagnostics Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Sekisui Diagnostics Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $338.00 Included
      •   Siemens Healthineers Corporate Summary
      •  
        $93.00 Included
      •  
        $232.00 Included

      • $93.00 Included
        •   Siemens Healthineers Revenue (2013-2016) ($ millions)

    • $93.00 Included
      •   Siloam Biosciences Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

    • $93.00 Included
      •   Spectral Medical Summary
      •  
        $93.00 Included

    • $95.00 Included
      •   Sysmex Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

      • $93.00 Included
        •   Sysmex Revenue (2013-2016) ($ millions)

    • $236.00 Included
      •   Trinity Biotech Corporate Summary
      •  
        $93.00 Included
      •  
        $203.00 Included

      • $93.00 Included
        •   Trinity Biotech Revenue (2013-2016) ($ millions)

    • $171.00 Included
      •   Veredus Labs Corporate Summary
      •  
        $93.00 Included
      •  
        $118.00 Included

    • $93.00 Included
      •   Wave 80 Biosciences Summary
      •  
        $93.00 Included

    • $117.00 Included
      •   Xagenic Corporate Summary
      •  
        $93.00 Included
      •  
        $93.00 Included

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