The Systemic Lupus Erythematosus (SLE) market is
currently under-served by targeted therapies. Whilst the only Food and Drug
Administration (FDA) approved biologic, Benlysta (belimumab), generated sales
of $111m in 2012, there is little evidence that the drug’s performance is
significantly superior to other B-cell targeted therapies such as Rituxan
(rituximab), where unlicensed use is commonplace for refractory SLE patients.
Therapeutics entering the market do not face the level of
competition from currently marketed programs as in other markets such as the
Rheumatoid Arthritis (RA) market. Emerging market entrants that appear to offer
significant therapeutic benefits are likely to cause dramatic change to the
market landscape.
Highly Diversified Range of Innovative Programs in the
Pipeline: Although the SLE pipeline comprises only 74 active developmental
programs, over 67% of these programs are biologics and around 31% involve
first-in-class molecules. Only a very small number of products are repositioned
from other indications and there is also a high level of diversity in terms of
novel therapeutic targets. Innovative programs also target molecules that have
only recently gained recognition as having therapeutic value in the treatment
of SLE. However, some of these programs have only been validated in animal
models and therefore require further clinical assessment in order to establish
how they compete against established antibody and small molecule
disease-modifying therapies. Other first-in-class programs have advanced to
late-stage clinical trials.
A growing understanding of the signaling pathways
underlying SLE pathophysiology including, but not limited to, B cells, T cells
and intracellular kinases is being translated into a higher number of novel
targeted therapeutics entering the developmental pipeline. However, a high
level of sustained investment in the development of cytokine blocking
strategies is present, as therapies targeting the interferon pathway are relatively
common in the pipeline.
Sparse Licensing Deals and Co-development Deals
Landscape: Sharing financial and developmental risks between pharmaceutical
companies is a highly desirable strategy in SLE drug development, and in many
cases, critical to the success of companies with limited financial resources.
Although the licensing and co-development deals landscape is relatively small
as an indication by industry standards, many high-profile developmental
programs have been involved, particularly where licensee companies have yet to
generate stable net income.
In the licensing agreement landscape, developmental drugs
that inhibit intracellular kinases targeting therapies have fetched the highest
valuations. It is likely that their commercial attractiveness is due to several
reasons, such as their clinical efficacy in the treatment of diseases.
Additionally, this could be due to the fact that kinase inhibitors are
under-served in the current SLE market, which presents minimal barriers to
market entry. This also appears to be the case for B and T cell targeting
therapies. Interestingly, the co-development landscape is saturated with
biologics, all of which target cytokines and lymphocyte antigens and many of
which are first-in-class, thus indicating a high level of commercial appeal in
innovative therapies.
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