Molecular
diagnostics tests are used for detecting disturbance between
specific sequences in DNA or RNA, which may be associated with
disease. The disturbance between a single nucleotide polymorphism
(SNP), deletions, rearrangements, insertions, and others factors lead
to various diseases. Disease that are diagnosed by using molecular
diagnostic test includes infectious diseases, oncology, virology, and
STDs. Molecular diagnostics are capable of detecting specific disease
which helps in providing precision medicine to patients. Government
of various economies are focused on research and development of
precision medicine, which is expected to drive growth of the
molecular diagnostics market over the forecast period. For instance,
in 2015, the U.S. government launched Precision Medicine Initiative
(PMI), to increase awareness regarding advancement in the precision
medicine field.
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High prevalence of infectious disease and increasing incidences of
cancer are expected to be the major factor fueling growth of the
market over forecast period. For instance, according to the Centers
for Disease Control and Prevention (CDC), in 2015, around 5,251
deaths were reported due to influenza infection in the U.S.
Furthermore, according to a National Cancer Institute, 2016, an
estimated 16.8 million new cases of cancer were diagnosed in the U.S.
with an estimated 595,690 deaths from the disease. The number of
people with cancer is expected to rise to 19 million by 2024.
The molecular diagnostics market is estimated to be valued at
US$8,623.2 Mn in 2017 and is expected to witness a robust CAGR of
11.5% during the forecast period (2017-2025).
Market Dynamics
The global molecular diagnostics market is projected to witness
significant growth over the forecast period, owing to rapid
advancements in technology for development of novel biomarkers. For
instance, in June 2017, Qiagen N.V. expanded its biomarker content
portfolio by adding new biomarkers for microsatellite instability
(MSI) and Mismatch repair (MMR) in its NGS panels. This extension in
the product portfolio was done to cater to growing demand for
molecular diagnostics for immuno-oncology therapies. Furthermore,
precision medicine aids in treatment of diseases and prevention based
on individual’s genes, lifestyle, and environment. This helps to
offer proper treatment, which has led to high demand for precision
medicine, in turn, favoring growth of the market. However, stringent
regulation by FDA to regulate molecular diagnostic tests is expected
to be major factor restraining growth of the market. The FDA
regulates molecular diagnostic tests in various ways, including in
some instances, wherein, certain tests require regulatory pathways as
complex as Class III medical devices.
Growth in biomarker identification is expected to foster growth of
the molecular diagnostics market
Application of biomarkers in molecular diagnostic is increasing, due
to advantages of biomarkers such as aiding in early detection of
specific diseases. For instance, biomarkers are used in detection of
ABO haemolytic diseases in new born, Huntington's disease and
hereditary haemochromatosis, and cystic fibrosis. Biomarkers are also
used in detection of disorders related to chromosome structure such
as Turner syndrome, Down syndrome, patau syndrome, and Edwards’s
syndrome. Furthermore, biomarker also have wide application in
therapeutic areas, which includes neurological diseases, metabolic
disorders, immune deregulation, and oncology.
Regional insights
North America accounts for the largest share in the global molecular
diagnostics market and this is attributed to increasing adoption of
precision medicine and growing prevalence of cancer. According to a
National Cancer Institute, 2016, an estimated 16.8 million new cases
of cancer were diagnosed in the U.S., with around 595,690 deaths from
the disease. The number of people with cancer is expected to rise to
19 million by 2024, in turn increasing the demand of the molecular
diagnostics market in the near future.
Top Key Players
Key players in the market are involved in new product launches to
cater to increasing demand for molecular diagnostic. For instance, in
August 2016 Abbott Laboratories introduced Alinity, a next generation
system, used for immunoassay, clinical chemistry, point-of-care,
hematology, blood and plasma screening, and molecular diagnostics.
Some of the other key players in the global molecular diagnostics
market include Hologic,Inc., Grifols, S.A., Abbott Laboratories,
Qiagen N.V., F. Hoffmann-La Roche Ltd., Siemens Healthineers, Becton,
Dickinson and Company, and Beckman Coulter, Inc.
Detailed Segmentation:
• Global Molecular Diagnostics Market, By Product Type:
- Reagents & Kits (Consumables)
- Instruments
• Global Molecular Diagnostics Market, By Application
- Oncology
- Genetic Testing
- Microbiology
- STDs
- Blood Screening
- Virology
- Tissue Typing
- Prenatal Diagnosis
- Others
• Global Molecular Diagnostics Market, By End User:
- Hospitals
- Diagnostic Laboratories
- Academic and Research Labs
- Others
• Global Molecular Diagnostics Market, By Region:
- North America
- Europe
- Asia Pacific
- Latin America
- Middle East
- Africa
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