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Cranfield, UK, 24th July 2024 – We’re now more than halfway through 2024, and there’s been a lot happening in digital pathology, so I thought I’d take a moment to review my predictions made earlier this year and offer some insight into where we’re at and how recent developments might impact the future.
My first prediction was that we would see an increasing number of FDA approvals as vendors seek to enter the US clinical market. So far this year, there have been 7 FDA approvals for end-to-end solutions, scanners and software IMS vendors, with more expected to come soon.
FDA approvals for digital pathology are still predicated upon a ‘pixel pathway’, which means that vendors gain approval for specific scanners with specific software. Indica Labs for example, is only approved for use with Hamamatsu’s NanoZoomer® S360MD Slide Scanner, meaning it can’t be used with any other scanner for primary diagnosis of surgical pathology slides.
Considering the nascent state of the market, this significantly limits the total addressable market for clinical pathology for each IMS vendor, which is why we expect further approvals with different types of scanners to follow. Vendors should be careful which scanners they prioritise for FDA approval, as our installed base analysis, published earlier this year, revealed significant differences in vendor footprints across geographies.
Growth so far has been strong in the US and is likely to continue with the news of all these approvals. However, I would caution that the market is still very nascent. Huge surges in adoption that increased scanning volumes significantly are unlikely to occur without reimbursement. And whilst CPT codes are available, there isn’t yet a financial component to help drive up scanning volumes.
If you’re interested in learning more about what this news means for your business, reach out to me. Or stay informed and engaged with the latest monthly announcements and developments in the digital pathology market by subscribing to my Digital Pathology News Round-up.
About Imogen Fitt
Imogen joined Signify in 2018 as part of the Healthcare IT team. She holds a 1st class Biomedical Sciences degree from the University of Warwick, where her studies included molecular biology and pharmacology. Since joining the team, Imogen has studied the medical imaging software and hardware markets and is now expanding Signify Research’s Diagnostics and Lifesciences coverage.
About the Diagnostics and Lifesciences Team
The Diagnostics and Lifesciences team provides market intelligence and detailed insights on the multiple healthcare technology markets where the clinical world intersects with the preclinical. Our areas of coverage include digital pathology, laboratory information systems, clinical Real-World Data (cRWD) platforms, oncology information systems, tumour board software, oncology decision support software and radiotherapy IT. Each report provides a data-centric and global outlook of its markets with granular country-level insights. Our research process blends primary data collected from in-depth interviews with healthcare professionals and technology vendors, to provide a balanced and objective view of the market.
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