Market Share in Infectious Disease Molecular Testing

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    14-Apr-2017

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  • Market Share in

    Infectious Disease

    Molecular Testing Infectious disease is a key area to watch in molecular, though

    it has many applications. This brief White Paper reviews the

    market share picture for molecular testing. It is based on

    Kalorama Informations 7th

    Edition of its World Market for

    Molecular Diagnostics report.

    There is little gray area in terms of undetermined market share

    in molecular infectious disease diagnostics. Eight companies are

    estimated to account for 86% of the global market (Figure

    accompanying). Roche Diagnostics has been an unmovable

    leader with a market share estimated at 21%. The companys

    resources and history in the market have allowed it to adapt and diversify as needed, most

    recently with its Liat system for CLIA-waived molecular infectious disease testing, HPV assay

    FDA-approved for primary screening, and new viral load assays for its cobas 6800/8800 core lab

    virology systems. Hologic claims a large market share through its leadership in the molecular

    CT/NG and HPV testing space. Cepheid and bioMrieux have significantly increased market

    share in molecular infectious disease diagnostics over the past few years through respective

    placements of GeneXpert and FilmArray systems in hospital labs. The success of Cepheid and

    bioMrieux validates the development efforts of competitors in

    the same space of decentralized molecular testing. Remaining market leaders Becton,

    Dickinson & Co. (BD), Abbott Diagnostics, Siemens Healthcare Diagnostics have been

    markedly less dynamic in molecular infectious disease testing, though BD has been active in

    more fully addressing its markets in HAI and womens health/sexual health. Abbott and Siemens

    have stuck more to core molecular infectious disease markets in virology (HIV/hepatitis).

  • Clinical molecular diagnostics refer to in vitro diagnostic (IVD) tests used in patient health care

    that detect, quantify or characterize nucleic acid analytes, whether pathogenic nucleic acid,

    patient DNA or patient RNA. As an IVD market, molecular diagnostics refer to the relevant test

    kits, other reagents and instruments that are used for clinical testing in settings that include

    reference laboratories, independent labs, hospital labs, other centralized clinical labs and near-

    patient testing sites such as clinics and physician offices.

    The primary technologies for clinical molecular diagnostics include nucleic acid amplification

    tests (NAATs) based on real-time PCR (qPCR) and other amplification-detection protocols;

    direct nucleic acid probe tests such as in situ hybridization (ISH) and its fluorescent ISH (FISH);

    next-generation sequencing (NGS); amplification followed by probe-based hybridization on

    arrays (or microarrays); and other related methods.

    The market for infectious disease diagnostics was traditionally dominated by virology or HIV

    and hepatitis testing including infection diagnosis, virus genotyping, and viral load testing.

    Together, HIV and hepatitis still represent roughly 40% of the entire molecular diagnostics

    market in infectious diseases. Hospital-acquired infections and bloodstream infections now

    represent the largest market segment due to the threat of antimicrobial resistance (AMR) in

    hospitals and rising complexity of testing deployed in cases of inpatient infections. Molecular

    assays have been highly successful in hospital markets due to their unique ability to identify the

    infection and characterize resistance within actionable timelines.

  • N O W P U B L I S H E D

    The World Market for Molecular Diagnostics 7th Edition

    http://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/

    Molecular tests have become routine and expanded to all levels of healthcare from the

    pathology lab all the way to the doctors office and clinics of

    the developing world. Molecular diagnostics now represents

    more than one-tenth of the global IVD market with a growth

    trajectory secured through platform innovation in lower-cost

    nucleic acid amplification tests (NAATs) and clinical next-

    generation sequencing (NGS).

    Kalorama Information has now published its 7th

    edition of The

    World Market for Molecular Diagnostics. This

    comprehensive report provides detailed information on

    relevant test kits, other reagents and instruments that are used for clinical testing. Market data is

    provided, products on the market detailed and trends discussed. While not matching its

    explosive market growth in years past, clinical molecular diagnostics has delivered on its

    promise in health care. Kalorama Information analyst Emil Salazar details the status of the

    molecular diagnostics market, as it stands in 2017.

    The major applications of clinical molecular

    diagnostics include the following, and are covered in

    the report:

    Infectious disease diagnostics - molecular

    microbiology and virology, including the detection,

    identification, quantification and nucleic-acid based

    resistance or susceptibility profiling of pathogens.

    Blood transfusion diagnostics - nucleic acid

    screening (NAT) of donated blood, often pooled

    samples, for the detection of active infections

    responsible for transfusion transmitted infections

    Molecular diagnostics is

    demonstrating revenue growth

    at more than twice the rest of

    the IVD market While not

    matching its explosive market

    growth in years past, clinical

    molecular diagnostics has

    delivered on its promise in

    healthcare -Emil Salazar, IVD Analyst and

    Author

    Detailed Market Intelligence in All Segments of Molecular Testing - Based on Real Company Events and Intelligence

    http://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/

  • Histology / cytology diagnostics - largely synonymous with in situ hybridization (ISH)

    methods that use direct hybridization of chromogenic (CISH) or fluorescent (FISH)

    nucleic acid probes within slided tissue or suspended cell samples viewed under

    microscopy.

    Cancer diagnostics - tissue, blood and urine samples can be assayed using nucleic acid

    amplification tests (NAATs) or sequencing to diagnose, prognose and identify key

    mutations for targeted therapies; future additional capabilities are premised on liquid

    biopsy sampling (non-invasive fluid samples such as venous blood or urine) and next-

    generation sequencing (NGS).

    Transplant diagnostics - various PCR-based

    methodologies, Sanger sequencing and NGS used to type

    HLA alleles in low to high resolution in order to match

    donors and recipients.

    Inherited disease diagnostics - diagnosis of rare genetic

    diseases and other inherited traits.

    Once esoteric, molecular tests have become routine and

    expanded to all levels of healthcare from the pathology lab all

    the way to the doctors office and clinics of the developing

    world. Kalorama Information analyst Emil Salazar details the

    status of the molecular diagnostics market, as it stands in 2017.

    Detailed Market Analysis

    As part of its coverage, the following is included::

    Molecular Diagnostics for Infectious Disease Market, 2016-2021

    Molecular Diagnostics for Cancer Market 2016-2021

    Molecular Diagnostics for NAT Blood Screening Market 2016-2012

    Molecular Diagnostics for Hepatitis Market

    HIV Molecular Diagnostics Market, 2016 to 2021

    HAIs/Sepsis Molecular Diagnostics Market, 2016 to 2021

    CT/NG Molecular Diagnostics Market, 2016 to 2021

    HPV Molecular Diagnostics Market, 2016 to 2021

    Respiratory Molecular Diagnostics Market, 2016 to 2021

    Mycobacteria/TB Molecular Diagnostics Market, 2016 to 2021

    Other Infectious Disease Molecular Diagnostics Market, 2016 to 2021

    in situ hybridization (ISH) Market by Application (Genetic Disorders, Cancer,

    Infectious and Other) 2016 to 2021

    Other Histology Molecular Diagnostics Market, 2016 to 2021

    Inherited Diseases Molecular Diagnostics Market, 2016 to 2021

    Transplant Diagnostics Molecular Diagnostics Market, 2016 to 2021

    Kaloramas Report Contains Superior Graphics Designed to Clearly Explain Changes in the Market

  • Market Share and Global Segmentation

    There are a great number of companies participating in these segments of molecular diagnostics,

    from molecular specialists to the top-tier IVD companies. This report offers superior detail,

    identifying market share not only for the overall molecular diagnostics market but for molecular

    test categories, including:

    Molecular Blood Testing Market Share Analysis

    Molecular Cancer Testing Market Share Analysis

    Molecular Transplantation Market Share Analysis

    Molecular Infectious Disease Market Share Analysis

    Inherited Disease Testing Market Share Analysis

    The segmented market share allows competitors and interested market-watchers to see not only

    how a company is performing in the overall molecular diagnostics market, but also in their

    specialty area.

    To assist in global business planning efforts, this report contains market estimates for major

    world regions including the United States, Europe, Japan, China and Latin America. Data in the

    report includes:

    Regional Markets for Molecular Blood Screening Geographic Market Segmentation

    ( United States, Europe, Japan, China, Latin America, Rest of World)

    Regional Markets for Molecular Cancer Testing Market Share ( United States,

    Europe, Japan, China, Latin America, Rest of World)

    Regional Markets for Molecular Transplantation Market Share ( United States,

    Europe, Japan, China, Latin America, Rest of World)

    Regional Markets for Molecular Infectious Disease Market Share ( United States,

    Europe, Japan, China, Latin America, Rest of World)

    Regional Markets for Inherited Disease Testing Market Share ( United States,

    Europe, Japan, China, Latin America, Rest of World)

  • Superior Company Profiling

    This report contains profiles of major companies competing in molecular diagnostics. For each

    company, revenues, market share, products on the market and acquisitions and other deals are

    detailed. The following companies are profiled in the report:

    Abbott Diagnostics

    Advanced Cell Diagnostics

    Affymetrix (Thermo Fisher Scientific)

    Agilent Technologies

    Alere

    Amoy Diagnostics

    Applied Spectral Imaging

    Beckman Coulter (Danaher)

    Becton, Dickinson & Co. (BD)

    Beijing Genomics Institute (BGI)

    Berry Genomics

    Biocartis

    bioMrieux

    Bio-Rad Laboratories

    Cepheid (Danaher)

    Covaris

    Dako (Agilent Technologies)

    Eiken Chemical

    Epigenomics

    Exosome Diagnostics

    Genmark Diagnostics

    Grifols

    Immucor

    Janssen Diagnostics (Johnson & Johnson)

    Leica Biosystems (Danaher)

    Luminex Corporation

    Meridian Bioscience

    Nanosphere (Luminex)

    Nanostring Technologies

    Qiagen

    Quidel

    Roche Diagnostics

    Siemens Healthcare Diagnostics

    Thermo Fisher Scientific

    Others

    FOR MORE INFORMATION, OR TO ORDER:

    http://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/

    http://www.kaloramainformation.com/Molecular-Diagnostics-Edition-10595682/