ever, two-thirds of those products
were launched between 2011
and 2015. It also appears that the
potential of first-time launches to
generate high revenue is improving; between 2011 and 2015, seven
products (Imbruvica®, Incivek®,
Kerydin®, Kyprolis®, Linzess®,
Lonsurf®, and Tivicay®) achieved
over $100 million in first year
sales, whereas only one product
(Ampyra®) had done so between
2006 and 2010.2 (See Figure 1)
THE LAUNCH CHALLENGE
Whether for a small or large
company, launching a drug successfully is a colossal undertaking.
According to PhRMA, on average
it takes about 10 years and up to
$2.6 billion to bring a product to
market. And the risk of failure is
infamously high; the probability
that a drug entering clinical stud-
ies will actually make it to market
is less than 12 percent.
3 The costs
and risks of late-phase develop-
ment and commercialization are
tied to several industry trends:
• The legal and regulatory hur-
dles to approval are constantly
changing—in particular, regula-
tors tend to be requiring more
extensive clinical trials, often
with commitments for post-mar-
keting surveillance.
• The marketplace is ever more
competitive and the expectations
of stakeholders such as regula-
tors, payers, providers, patients
and patient advocacy groups are
ever higher. There is an increas-
ing trend towards patient-fo-
cused drug development which
requires a better understanding
of how a disease impacts the
quality of life (QOL) and sur-
vival of a patient. Stakeholders
are requiring more real-world
evidence on how new drugs and
technologies impact patients’
QOL and survival rates in the
real world settings and not only
data from clinical trials.
• Regulators need this data
to understand safety of a new
product when it becomes
widely available, typically
through post marketing surveillance.
• Payers need this data to determine the clinical value of a
new product, its cost effectiveness and ultimately its optimal
formulary placement.
Incivek generated 1.4B in first year sales. Not shown on the chart because of scale
