The global multiplex
biomarker imaging market is estimated to be valued at US$ 270 Mn in
the year 2017 and is estimated to touch a value of US$ 843 Mn in the
year 2027, exhibiting a CAGR of 12% during the period of assessment
(2017-2027).
Increased
spending on cancer diagnostic and monitoring
Growing incidence of
cancer is resulting in increased spending by governments in various
countries globally. Complications arising due to late diagnosis of
cancer, especially with regard to blood and lung cancer, are
resulting in need for more expensive treatments and medical
procedures. The commercial success of multiplex biomarker imaging in
research activities is driving demand for these systems in cancer
research sector and is also expected to attract investment
opportunities on clinical diagnostics applications in the near
future. In order to curb the cancer wave, government in some
countries are spending substantially on cancer diagnostic services
and campaigns. According to National Health Society (NHS), U.K.,
cancer services incur a cost of around US$ 8.3 Bn to NHS, of which,
majority of this amount is spent on diagnosis and monitoring. This
shows the potential for multiplex biomarker imaging industry in
cancer diagnostic and monitoring in future.
Increase in
demand for multiplexing in multispectral imaging
Demand for
multispectral imaging is increasing within multiplex biomarker
imaging as it optimizes the opportunities for multiplexing while at
the same time overcoming the effects of auto-fluorescence. These
could serve multiple purposes such as detection of exact tumour
location, expression of appropriate targetable surface markers,
oxy-deoxy haemoglobin status, presence of necrosis or apoptosis and
documentation of drug delivery. An increase in production base of
multispectral imaging devices that could provide multiplexing is
expected to fuel the revenue growth of device manufacturers.
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Unclear
regulatory guidance on the commercial sale of digital pathology
imaging products
There is no clear
regulatory guidance on commercial diagnostic use of whole slide
imaging (WSI) products including multiplex biomarker imaging systems.
As such regulatory bodies have indicated that there is no definitive
period within which such guidelines could be formulated. In the U.S.,
multiplex biomarker imaging devices have found main usage in cancer
research in translation laboratories and academic institutes. This
hampers profit generation of the multiplex biomarker imaging system
manufacturers as they are not able to target commercial clinical
diagnostic laboratories.
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Instruments
largely used for research purpose only
Currently, multiplex
biomarker imaging products are approved for research use only. Both
across Europe and North America, multiplex biomarker imaging products
are directly sold by companies; along with software and multiple year
service agreements to laboratories, biopharmaceutical companies and
academic institutes. This makes pricing restrictive as reimbursement
rates in these regions have gone down largely. In absence of
documented benefits, these systems are yet to be utilized fully.
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