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M&A Surges, Companion Diagnostics Accelerate, and Early Detection Offers New Prospects, Finds PwC's Biennial Review of the In Vitro Diagnostics Industry
Date:12/6/2011

rma Weighing Options for Accessing Diagnostics Innovation

As pharmaceutical companies pursue external partnerships to access diagnostic innovation, four business models have emerged as regards to their in-house diagnostics capability, according to PwC:  (1) Development of a standalone diagnostics division may provide technology that is relevant for in-house drug-diagnostic cooperation; (2) creation of a diagnostics business unit within the pharma division may help develop diagnostics primarily to support in-house drug development programs; (3) establishment of a diagnostics business development group may help guide a company's diagnostics licensing activities; and (4) creation of a standalone life sciences research products division may help provide technology that could be adapted for an in-house clinical companion diagnostic use.

"The IVD sector has attracted exceptional levels of interest, especially reflected in the acceleration of companion diagnostics partnerships with pharmaceutical companies. This momentum will continue as long as innovation and growth prospects in key market segments, such as molecular and tissue diagnostics, remain strong, and rapid action is taken by stakeholders to create a favourable environment for sustaining such innovation, including pricing, regulatory pathways, clinical trial design, reimbursement and drug-diagnostic value-sharing," said Loic Kubitza, director, pharmaceutical & life sciences advisory services, PwC Luxembourg, and author of the report.

In July, The Food and Drug Administration released draft guidance on companion diagnostics that could clarify its future direction. In addition, the U.S. government announced plans to develop a genetic testing registry to support wider adoption of personalized medicine in practice.  Also, the FDA's issuance of a black-box warning for a blockbuster d
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