We asked four senior executives in the pharma and diagnostic industry to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. Here’s what they came up with. HOW MUCH DOES IT COST TO LAUNCH AND COMMERCIALIZE A COMPANION DIAGNOSTIC TEST? LOW END Development and Manufacturing Costs (US $million) Technology acquisition and protection QSR and FDA compliance GMP manufacturing Platform development ( buy in or make) R&D ( based on 1-3 years of FTEs at 200k/yr loaded spend) Clinical Utility trials retrospective versus prospective Admin and financing 0.6 1 3 0.5 3 3 8 1 3 5 10 20 5 4 20.1 Total costs to commercialize 3 1 4 2 2 10 25 12 12.1 55 Subtotal costs to launch 8 51 Subtotal costs to drive adoption Sales and Marketing Costs ( US market only) Direct sales team ( assuming required for 3 years) Health technology assessment and payer negotiations Clinical education ( guidelines - KOL endorsement multi stakeholder education) Marketing ( launch meetings, representative detail aids, online marketing) Definitions Low end - a follow on diagnostic product where a similar test exists in the market a High end - a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like RA or a range of infectious markers requiring panel performance. Source - http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.lqtwab8H.dpuf LOW END HIGH END HIGH END 106