how much does it cost to launch and commercialize a companion diagnostic test?
TRANSCRIPT
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 TOLAUNCH AND COMMERCIALIZE
A COMPANION DIAGNOSTIC TEST?
LOWEND
Development andManufacturing Costs(US $million)
Technology acquisitionand protection
QSR and FDA compliance
GMP manufacturing
Platform development( buy in or make)
R&D ( based on 1-3 yearsof FTEs at 200k/yrloaded spend)
Clinical Utility trialsretrospective versus prospective
Admin and financing
0.6
1 3
0.5
3
3 8
1
3 5
10
20
5
4
20.1Total costs to commercialize
3
1 4
2
2 10
25
12
12.1 55Subtotal coststo launch
8 51Subtotal costs todrive adoption
Sales and Marketing Costs ( US market only)
Direct sales team ( assumingrequired for 3 years)
Health technologyassessment and payernegotiations
Clinical education( guidelines - KOL endorsementmulti stakeholder education)
Marketing ( launch meetings,representative detail aids,online marketing)
DefinitionsLow end - a follow on diagnostic product where a similar test exists in the market aHigh 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
LOWEND
HIGHEND
HIGHEND
106