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The Market and Potential for Molecular Point of Care Diagnostics: Forecasts to 2018


Attention: There is an updated edition available for this report.

The Market and Potential for Molecular Point of Care Diagnostics

Molecular Point of Care is a budding field in medical diagnostics. Kalorama's report, The Market and Potential for Molecular Point of Care Diagnostics, provides the most current look at this field.  

To assess the opportunity, Kalorama's report examines the molecular diagnostics business and also the point-of-care (POC) diagnostics business as they are now, and then examines at the new combination products.   A good number of companies are producing or considering molecular diagnostic platforms and assays that are made for near-patient or POC testing, and the earliest of these systems are starting to reach the market. The business focus for most of these companies is initially on infectious disease testing, in which rapid test results generate important data that physicians can utilize in making treatment decisions.  

Included in the report is the following:

  • Company portraits for IVD Companies with POC MDX products.
  • Industry Estimates for Market Opportunity Based on Existing Markets, 2013-2018 
  • Expenditure in Molecular POC
  • Microbiology Diagnostics Opportunities 
  • Relevant Accords in Molecular
  • Purchases of Competitors with Near-Patient Solutions
  • Relevant Accords in POC 
  • Analyst Conclusions on Future Trends
POC and Moleuclar are two of the strongest growth segments of the overall IVD industry.  These once were different industry segments, but this is no longer true.  Interest has grown in developing molecular diagnostic platforms that can be used in POC settings.   Indeed, as this new industry research report from Kalorama outlines, the emerging niche of rapid molecular POC testing has attracted almost $700 million in financing in just five years.  

This report presents information derived from publicly available sources such as company reports and announcements, government reports and databases, medical organization reports, medical association announcements, and other publications. The assessment is based on the analyst’s industry knowledge combined with literature searches and discussions with industry pros and experts in the areas of POC testing, decentralized healthcare, and healthcare economics.

Almost 100 competitors involved in this industry are profiled in this report, including the following:
  • Abacus Diagnostica Oy 
  • Access Bio, Inc. 
  • Biocartis SA 
  • BioFire Diagnostics, Inc. 
  • bioMérieux sa 
  • Cepheid 
  • MBio Diagnostics, Inc. 
  • Meridian Bioscience, Inc. 
  • Micronics Inc. (A Sony Group Company) 
  • Molbio Diagnostics Pvt. Ltd. 
  • Nanosphere, Inc. 
  • NetBio, Inc. 
  • NorChip 
  • OptiGene Ltd. 
  • PositiveID Corporation 
  • QIAGEN N.V 
  • Wave 80 Biosciences 
  • Xagenic Inc.
  • and many others 


  • Executive Summary
    • OVERVIEW
    • SCOPE AND METHODOLOGY
    • MARKET OVERVIEWS –MOLECULAR DIAGNOSTIC AND POINT-OF-CARE MARKETS
      • Table Worldwide Molecular Diagnostic Market and Point-of-Care Testing Market
    • FUTURE PROSPECTS –MOLECULAR DIAGNOSTIC NEAR PATIENT/POINT-OF-CARE TESTING
  • Introduction
    • EVOLUTION TOWARDS POINT-OF-CARE IN MOLECULAR DIAGNOSTICS – MARKET DRIVERS
      • Patent focused drivers
      • Medical/Healthcare related drivers
      • Technology drivers
      • Economic drivers
      • Other drivers
    • OVERVIEW OF COMPANIES DEVELOPING
      • RAPID POINT-OF-CARE/NEAR-PATIENT MOLECULAR DIAGNOSTICS PLATFORMS
    • POINT OF VIEW
  • Advances in Molecular Diagnostic Technology
    • MOLECULAR DIAGNOSTIC TECHNOLOGY TODAY
    • ADVANCES AND EMERGING NEW TECHNOLOGIES TO MAKE
      • POC TESTING POSSIBLE
        • Table Selected Companies Developing Rapid and/or Near-Patient/Point-of-Care Molecular Platforms Based on PCR or other Thermal Amplification Technology
        • Table Selected Companies Developing Rapid and/or Near-Patient/Point-of-Care Molecular Platforms Based on LAMP or Other Isothermal Amplification Technology
        • Table Selected Companies with Innovative Technologies and Platforms that Make Molecular Diagnostic POC Testing Possible
    • ADVANCING MOLECULAR DIAGNOSTIC TECHNOLOGY FOR LIMITED RESOURCE SETTINGS – NON-PROFIT ORGANIZATIONS
      • Bill & Melinda Gates Foundation (BMGF)
      • Foundation for Innovative New Diagnostics (FIND)
      • Program for Appropriate Technology in Health (PATH)
      • UNITAID
  • Deals – Companies Targeting Molecular Point-of Need/Point-of-Care
    • INVESTMENTS AND FINANCING AGREEMENTS FOR MOLECULAR DIAGNOSTIC NEAR-PATIENT/POINT-OF-CARE COMPANIES
      • Table Selected Investment Agreements and Other Financing
      • Table Rapid, Near-Patient, or POC Molecular Diagnostic Companies That Received Major Investments during 2009-2013
    • AGREEMENTS BETWEEN WITH OTHER DIAGNOSTIC COMPANIES
      • Table Selected Agreements Between Molecular Diagnostic Companies for Rapid, Point-of-Care, or Near-Patient Molecular Diagnostic Testing
    • ACQUISITIONS OF MOLECULAR DIAGNOSTIC NEAR-PATIENT/POINT-OF-CARE COMPANIES
      • Table Selected Acquisitions of Companies with Technology for Molecular Diagnostic Point-of-Care or Near-Patient Testing
      • Table Selected Molecular Diagnostic Companies Collaborating with Pharmaceutical/Biopharmaceutical Companies for Rapid and/or Near-Patient/Point-of-Care Testing
      • Table Selected Molecular Diagnostic Company Agreements with Suppliers, Manufacturers or OEM Developers for Rapid and/or Near-Patient/Point-of-Care Testing
  • Current Markets
    • MOLECULAR DIAGNOSTICS MARKET OVERVIEW
      • Table Worldwide Molecular Diagnostics Market North America, Europe, Japan, China, ROW), 2013 to 2018 ($ millions)
      • Table Worldwide Molecular Diagnostics Infectious Disease Test Market, 2013 to 2018 ($ millions)
    • POINT-OF CARE-MARKET OVERVIEW
      • Table Worldwide Point-of-Care Testing Market (U.S., Europe, Japan, ROW), 2013 to 2018
    • EMERGING MOLECULAR DIAGNOSTICS POINT-OF-CARE MARKET
      • Table Selected Molecular Diagnostic Tests and Systems Classified as Moderate Complexity in the United States
      • Table Selected Examples of Additional Companies with Rapid IVD Molecular Diagnostic Tests Approved and/or on the Market Outside US, with Potential for Near-Patient or POC Settings
  • Market Opportunities for Molecular Diagnostic Point-of-Care Testing
    • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Infectious Diseases
    • HEALTHCARE ASSOCIATED INFECTIONS
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Healthcare Associated Infections
    • INFLUENZA AND OTHER RESPIRATORY TRACT INFECTIONS
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Influenza
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Other (Non-Influenza) Respiratory Infections
    • SEXUALLY TRANSMITTED DISEASES
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Sexually Transmitted Diseases
    • SEPSIS
      • Table Selected Companies Developing and/or Marketing MDx Rapid Tests for Sepsis
    • SELECTED INFECTIOUS DISEASES IN DEVELOPING COUNTRIES
      • HIV/AIDS
      • Tuberculosis
      • Malaria
        • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for HIV, Tuberculosis, Malaria, or Other Diseases Common in Developing Countries
    • OTHER INFECTIOUS DISEASES
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Other Infectious Diseases
    • HEMATOLOGY/ONCOLOGY
      • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Tests for Hematology/Oncology Indications
    • PHARMACOGENOMIC TESTS
      • Risk of Thrombosis
        • Table Selected Companies Developing and/or Marketing MDx Near-Patient/POC Pharmacogenomic Tests
  • Progress to Date and Ongoing Evolution Towards Molecular Point-of-Care Testing
    • PROGRESS TO DATE AND CURRENT TRENDS
    • ISSUES AND HURDLES FACED BY COMPANIES DEVELOPING MOLECULAR DIAGNOSTIC POC TESTS AND PLATFORMS
    • FUTURE PROSPECTS
  • Company Profiles
    • ABACUS DIAGNOSTICA OY
    • ACCESS BIO, INC.
    • AHRAM BIOSYSTEMS, INC.
    • AKERS BIOSCIENCES, INC.
    • AKONNI BIOSYSTEMS, INC.
    • ALERE INC.
    • AMPLINO
    • ANALYTIK JENA AG
    • AQUILA DIAGNOSTIC SYSTEMS INC.
    • ATLAS GENETICS LTD
    • ATONOMICS A/S
    • AXXIN
    • BD DIAGNOSTICS
    • BIOCARTIS SA
    • BIOFIRE DIAGNOSTICS, INC. (ACQUIRED BY BIOMÉRIEUX)
    • BIOMÉRIEUX SA
    • CANON U.S. LIFE SCIENCES (CLS)
    • CEPHEID
    • CORIS BIOCONCEPT
    • CURETIS AG
    • DESTINA GENOMICS LTD.
    • DIAGNOSTICS FOR ALL (DFA)
    • DIAGNOSTICS FOR THE REAL WORLD, LTD.
    • DIASORIN S.P.A.
    • DIASSESS INC.
    • DNA ELECTRONICS LTD.
    • DXNA, LLC
    • EIKEN CHEMICAL CO., LTD.
    • ENIGMA DIAGNOSTICS LIMITED
    • EPISTEM
    • ESPIRA, INC.
    • FOCUS DIAGNOSTICS, INC. (SUBSIDIARY OF QUEST DIAGNOSTICS INC.)
    • GENEFLUIDICS, INC.
    • GENEPOC INC.
    • GREAT BASIN CORPORATION
    • HAI KANG LIFE CORPORATION LIMITED
    • HAIN LIFESCIENCE GMBH
    • HIBERGENE DIAGNOSTICS LTD
    • ICUBATE, INC.
    • IMMUNEXPRESS GROUP
    • INSTANTLABS
    • INSTRUMENTATION LABORATORY
    • IQUUM, INC.
    • LIFE TECHNOLOGIES CORPORATION
    • LIQUILUME DIAGNOSTICS, INC.
    • LUMORA LTD
    • MAST GROUP LTD.
    • MBIO DIAGNOSTICS, INC.
    • MERIDIAN BIOSCIENCE, INC.
    • MESA TECH INTERNATIONAL, INC.
    • METAARA MEDICAL TECHNOLOGIES INC.
    • MICRONICS INC. (A SONY GROUP COMPANY)
    • MOLBIO DIAGNOSTICS PVT. LTD.
    • MP BIOMEDICALS, LLC
    • MYCROLAB DIAGNOSTICS PTY LTD.
    • NANOBIOSYM (NBS)
      • NANOBIOSYM DIAGNOSTICS (NBSDX)
    • NANOBIOSYS INC.
    • NANODETECTION TECHNOLOGY, INC. (NDT)
    • NANOIVD, INC.
    • NANOMIX, INC.
    • NANOSPHERE, INC.
    • NETBIO, INC.
    • NORCHIP
    • OPTIGENE LTD.
    • POSITIVEID CORPORATION
    • QIAGEN N.V
    • QUANTUMDX GROUP
    • QUIDEL CORPORATION
    • RHEONIX INC.
    • SA SCIENTIFIC
    • SEEGENE, INC.
    • SPARTAN BIOSCIENCE INC.
    • STAT-DIAGNOSTICA
    • T2 BIOSYSTEMS, INC.
    • THERMAL GRADIENT, INC.
    • TWISTDX, LTD. (ACQUIRED BY ALERE)
    • USTAR BIOTECHNOLOGIES (HANGZHOU) LTD.
    • VEREDUS LABORATORIES PTE LTD
    • WAVE 80 BIOSCIENCES
    • XAGENIC INC.

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