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

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