Companion Dx Partnerships, M&A Deals Help Spur IVD Market Growth – PWC Report
This article was originally published in The Gray Sheet
A report from PricewaterhouseCoopers suggests the in vitro diagnostics market will see accelerated growth next year due in part to a surge in companion diagnostics partnerships and M&A deals.
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Clinical laboratories in the US and Europe are facing pressure from all sides as budget cuts and staffing shortages compete with a growing demand for ever-more-sophisticated lab tests to serve an aging population. As a result, lab directors are seeking innovative ways to improve efficiency and do more with less, and those goals are driving innovation in technology-based solutions such as laboratory automation and informatics. These solutions are increasingly becoming integrated into the total laboratory process – encompassing not only sample analysis, but also up- and downstream workflows – paving the way for the fully integrated, automated lab of the future.
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Either an IND or an IDE will be sufficient for companion diagnostic studies, a CDRH diagnostics official clarified last week. That is among the issues that will be addressed in an upcoming co-development draft guidance.