Innovation
in the Biopharmaceutical Pipeline: A Multidimensional View. (.pdf is here).
Very interesting reading! The numbers and the scale are amazing!
As illustrated in Figure 2 below, as of
December 2011, there were more than 17,000 projects (i.e., unique molecule-indication
combinations) in clinical development and a total of about 12,000 products (or
new medicines that would be submitted for FDA review as NMEs) in development.
§ Preclinical research accounted for the
highest number of projects (over 9,000) and potential new medicines (over
6,500). These figures are likely an underestimate, as many preclinical research
activities may not yet have been the subject of news or analyst coverage or may
only be known to the researchers and manufacturers involved, and therefore
would not yet be reflected in the dataset.
§ Over 5,400 new products were in clinical
development (defined in this report as products in Phase I, II, III, or having
been filed with the FDA, or approved by the FDA, but not yet on the market in
the U.S.). Since a single product may be investigated for multiple indications,
and because the data include additional indications for products already
approved and on-market, the number of pipeline projects in clinical development
is larger, or about 8,000.
Consistent with previous studies showing
high attrition rates between Phase II and the much more expensive and lengthy
Phase III clinical trial stage, there were many fewer compounds at each progressive
phase of development. Whereas there were 2,329 molecules recorded in Phase II
clinical trials, there were only 833 products in Phase III trials. A total of
82 products in the dataset had completed Phase III clinical trials and had
either been filed with the FDA or were approved by the FDA, but had not yet
been launched in the U.S.
And the numbers is not the only
thing! There are a lot of innovative products! For sure!
A range of novel scientific
approaches to address various diseases and conditions were being
pursued. Broad classes of
scientific “platforms” readily identifiable in the dataset revealed:
- 245 projects using cell
therapy;
- 127 projects using antisense
RNA interference therapy (an approach that targets RNA, which
carries genetic information that
creates proteins, rather than proteins themselves);
- 102 projects using monoclonal
antibodies joined to cytotoxic agents to target tumor cells
while sparing nearby healthy
cells; and
-
99 projects using gene therapy.
Well, I guess in about 10 years we
will get cured all diseases and people will die absolutely healthy!
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