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 - follow on product, existing owned platform, infectious diseaseHigh end - new assay, new platform, new technology, oncology or chronic disease

Source - http://www.diaceutics.com/mystery-solved-what-cost-develop-and-launch-diagnostic#sthash.lqtwab8H.dpuf

LOWEND

HIGHEND

HIGHEND

106