Biomedical Engineering Reference
In-Depth Information
FIGURE 2.2
FP pipeline, split by therapy area and stage of development.
two, even though we believe FPs represent attractive licens-
ing targets for these multinational companies. In this section,
we look at the split by stage of development, therapeutic
focus, and partnership status and trends in collaboration.
The focus on autoimmune and oncology is typical of
biotech markets [42] (especially those in the earlier stage
of development), with a study in 2008 showing that 78% of
analyzed ongoing biotech trials were in these therapeutic
areas [43]. Autoimmune and oncology are attractive because
R&D investment in these areas yields a high number of
targets. Also important is the high unmet need in many of
these areas (particularly oncology), and the chance for
higher reimbursement. Both are popular with developers
of drugs that focus on modulating specific targets in the body
that are well validated in disease etiology (e.g., Enbrel's
targeting of TNF-
a
) that are not characterized by low
bioavailability (in contrast to many indications in therapy
areas such as CNS, where bioavailability and well-validated
targets are difficult to achieve). This targeted approach is
likely to improve clinical progression success rates, which is
important as drugs progressing through clinical develop-
ment for either oncology or autoimmune diseases have had
below-average probability of entry into Phase III and into
approval, above-average Phase III trial duration and above-
average costs associated with clinical development [1].
More recently, a study in 2011 showed that oncology had
the lowest success rate in Phase III clinical trials in all
therapeutic areas examined, even though it was the most
focused-on therapeutic area
29
[44]. The same study also
showed that biotech drugs targeting different cancers had
different success rates, with those targeting head and neck,
renal cell carcinoma, ovarian, and breast cancer having the
2.4.1 Breakdown by Stage of Development: Half of the
FP Pipeline is in Phase II
Out of the 43 FP programs we have identified, 53% are in
Phase II (including more advanced Phase I/II trials), 28% are
in Phase III (including more advanced Phase II/III trials),
and 19% are on the market or have been submitted to
regulators (Figure 2.2).
2.4.2 Therapeutic Focus of FPs: Oncology and
Autoimmune Dominate
Oncology and autoimmune are the most common focus
therapeutic areas for these 43 FP programs, accounting
for 63% of programs. Although autoimmune disease leads
the FP market in terms of 2016 forecast sales (we estimate it
will account for 78% of total 2016 sales), it is a less focused-
on therapeutic area for earlier-stage FP development,
accounting for only six (14%) of the FP programs identified.
While surprising, this can in part be explained by the success
of TNFis, meaning it can now be difficult to penetrate high-
sales autoimmune disease markets such as RA. Oncology
accounts for 47% of all Phase II and above FP development
programs, followed by autoimmune, and hematology and
cardiovascular; both at 16%. The remaining 21% is made up
from infectious disease, metabolic, musculoskeletal, oph-
thalmology, and urology (in order of weighting).
29
See BIO's presentation “BIO/BioMedTracker Clinical Trial Suc-
cess Rates Study”.
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