Since the FDA approval and commercial successes of Roche’s Herceptin (trastuzumab) and Novartis’ Gleevec (imatinib), the companion diagnostic industry has moved from being viewed skeptically — to essential. What started out as a handful of oncology drugs and corresponding diagnostics has expanded to include additional therapeutic areas. The growth in companion-diagnostic utilization is a trend likely to continue as we close in on realizing the full potential proffered by precision medicine. According to Research and Markets, the global companion diagnostics market is poised to grow at a CAGR of around 18.5 percent over the next decade, potentially reaching $16.24 billion by 2025. “When presenting a companion diagnostic offering to biopharmaceutical executives after a drug has been launched, I have watched their eyes grow bigger and bigger as they realize they have hitched their per-share earnings to a business that doesn’t respond to traditional marketing activity,” says Alan Wright, M.D., chief medical officer for Roche Diagnostics Corporation in Indianapolis. “Essentially, we have to do Diagnostics 101 with these executives and explain how different the market is from that of biopharma.” He should know. After all, Dr. Wright (no relation) not only works for the largest in-vitro diagnostic development company in the world, but in his career prior, he spent more than a decade on the PBM (pharmacy benefit manager) side of the business with CVS Caremark and Advance PCS. Dr. Wright sat down with Life Science Leader to share his experienced perspective regarding some of the nuances of launching a drug that requires a companion diagnostic.