Global Digital Pathology Systems Market: Technological Advancements and Approval from FDA will Define Future Outlook of Market

Digital pathology is an emerging technology and has the potential to improve the results across various applications such as diagnostic tests, drug discovery and development, and academic and research purposes. Advancements in information technology and favourable healthcare reforms have augmented the growth of the global digital pathology systems market. The global digital pathology systems market is estimated to expand at a CAGR of 11.9% during the period between 2014 and 2020. The overall market is expected to be worth US$492.8 mn by 2020. The rising healthcare spending and increasing workload of pathologists have fuelled the demand for digital pathology systems. However, sampling error, high initial setup cost, and stringent regulatory compliance might prolong the approval process of these systems, thereby significantly reducing the adoption of digital pathology systems.

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New Technique to Provide High-Resolution Digital Microscopy Images
On the basis of technology, the global digital pathology systems market has been broadly categorized into telepathology and virtual microscopy. The demand for virtual microscopy has been the highest in 2013 and is expected to grow further in the coming years. Digitization of microscopic slides in virtual microscopy ensures accurate disease diagnosis and drug discovery. Some of the recent developments in the field of virtual microscopy will further fuel the demand for the technology.

Researchers at the California NanoSystems Institute have developed a new technique to enhance the quality of digital microscopy images, thereby improving the resulting disease diagnoses. The new development might prove to be a significant step for the production of digital imagery in microscopy. So far, digital imagery in microscopy has often led to blurry and pixilated images.
Wavelength scanning pixel super-resolution method captures a number of digital images of the same sample at different wavelengths of light. The pixels in each of the captured images are further divided into smaller pixels, thereby producing a much higher-resolution digital image of the examined specimen.

First FDA-Approved Digital Pathology System Might Develop Soon
Some of the key manufacturers in the global digital pathology systems market are Olympus Corporation, Leica Biosystems, Philips Healthcare, Mikroscan Technologies Inc., Ventana Medical Systems Inc., and GE Healthcare. The manufacturers are shifting their focus from the saturated market in North America to the emerging market across Asia Pacific. So far, manufacturers have not been able to comply with the stringent regulatory requirements set by the U.S. Food and Drug Administration (FDA) regarding the approval of digital pathology systems. Hence, there has been no FDA-approved digital pathology system in the market yet. However, the future looks positive with a recent development.

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GE Healthcare, in partnership with the University of Pittsburgh Medical Center (UPMC), had founded a company named Omnyx in 2008. The company seems to be on its way to develop the first FDA-approved digital pathology system for clinical use. Omnyx had filed for FDA-approval in 2014, however the system manufactured by the company was classified as a Class III device, with the highest risk classification. The FDA has recently changed its status to a Class II device with fewer regulatory requirements. This is expected to boost the global digital pathology systems market.

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