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 Information’s 7 th 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 company’s 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 bioMérieux 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 bioMérieux 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 women’s health/sexual health. Abbott and Siemens have stuck more to core molecular infectious disease markets in virology (HIV/hepatitis).
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Market Share in Infectious Disease Molecular Testing
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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 Information’s 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 company’s
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 bioMérieux 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
bioMérieux 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 women’s 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