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).

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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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