We ask four senior executives to come up with a value on how much it would cost to launch and commercialize a novel diagnostic test. View the infographic to see what they came up with. We defined low end as a follow on diagnostic product where a similar test exists in the market and a high end test which is a new biomarker (needing to establish novel clinical utility), or a new platform likely to be in oncology, a chronic disease like rheumatoid arthritis or a range of infectious markers requiring panel performance. Source http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.ryk5zoEa.dpuf

1. 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
20.1Total costs to commercialize
3
1 4
2
2 10
25
12
12.1 55Subtotal costs
to launch
8 51Subtotal 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
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