Biomedical Engineering Reference
In-Depth Information
Table 3.1
Number of compounds in therapeutic areas
a
as of Dec 31, 2010 (PharmaProjects
2010
)
Number of
compounds
Therapeutic areas
A
1,442
Alimentary/metabolic products (including gastrointestinal group)
B
447
Blood and clotting products
C
800
Cardiovascular products
D
508
Dermatological products
F
1,548
Formulations
G
480
Genitourinary (including sex hormones)
H
166
Hormonal products (excluding sex hormones)
I
543
Immunological products
J
1,710
Anti-infective products
K
2,608
Anticancer products
M
1,093
Musculoskeletal products
N
1,936
Neurological products
P
94
Antiparasitic products
R
601
Respiratory products
S
410
Sensory products
T
2,330
Biotechnology products
Total
16,716
a
PharmaProjects (
2010
) reports a compound which targets multiple therapeutic areas in both areas,
hence it should be noted that there are 9,717 total compounds under development, and 16,716
projects which may target the same compound for different diseases
investment close to $500 million may be required just for the opportunity to launch
a drug (Blau et al.
2004
) provided it successfully passes Phase III trials. Other fac-
tors contributing to cost increases include the advent of biotechnology and the shift
towards treatments for chronic and degenerative diseases (Yeoh
1994
). The invest-
ment figure can vastly vary depending on the level of data required by the FDA,
which in turn depends on the nature of the innovation. For instance, the costs are
dramatically higher for new chemical entities (NCEs) or NMEs which represent
more “radical” innovation involving new active pharmaceutical ingredients (APIs)
as compared to utilizing existing entities to formulate a new drug.
It is well known that only one in every 5,000-10,000 potential compounds inves-
tigated by pharmaceutical companies is granted FDA approval (which is a critical
benchmark since the USA forms the single largest market for ethical drugs sales).
Thus, portfolios of pharmaceutical firms usually include compounds in diversified
therapeutic categories to spread the risk of failure of any given research program or
project. The top 25 firms have between 43 and 304 compounds in their portfolio
(PharmaProjects
2010
), with the largest portfolios coming from Pfizer (304 com-
pounds), GSK (289 compounds), and Merck (249 compounds). It is typical for the
top ten firms to source 30-40 % of the compounds in their portfolio from external
parties (PharmaProjects
2010
).
As of December 2010, there are 9,717 drug compounds corresponding to 16,716
projects under active development or launch (the same compound targeted at differ-
ent diseases counts as multiple projects). These projects can be grouped into roughly
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