Introduction:
Last Updated 11 November 2009 Drug development for SLE continues to be a formidable
challenge; drug development and regulatory hurdles, the small and heterogeneous
population, and the multiplicity of manifestations all contribute to this
challenge. During our forecast period, an influx of premium-priced biologics
will drive strong market growth. We forecast that sales of SLE therapies will
more than quadruple over our 2008-2018 forecast period. The SLE market also
reflects an unusual dynamic—the continued off-label use of several therapies
that have failed clinical trials—underscoring the high unmet need and
opportunity in this indication.
Questions Answered in This Report:
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The entry of several premium-priced branded agents during our
forecast period and the continued uptake of the few current branded agents in
the market will transform the predominantly generic SLE market.
Will agents
securing regulatory approval for SLE and lupus nephritis drive market growth?
How will approval for specific manifestations of SLE and for different
subpopulations shape the market?
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Rituximab (Biogen
Idec/Roche/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera) failed clinical
trials for both SLE and lupus nephritis.
How will this setback impact
rituximab’s uptake among patients with SLE manifestations that are refractory
to current treatments?
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Several novel B-cell modulators—belimumab (Human Genome
Sciences/GlaxoSmithKline’s Benlysta), Immunomedics/UCB’s epratuzumab, Biogen
Idec/Roche’s ocrelizumab—will launch during our forecast period.
Which of
these agents will have the greatest uptake and why? Will these agents compete
with currently used cytotoxic agents and immunosuppressants, or will physicians
incorporate new therapies in combination regimens?
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Mycophenolate sodium (Novartis’s Myfortic) will launch for SLE
in 2010 in Europe.
How will this agent’s launch affect the use of current
immunosuppressants for both induction and maintenance regimens?Scope:
Markets covered: United States, France, Germany,
Italy, Spain, United Kingdom, Japan.
Primary research: 26 country-specific interviews with
rheumatologists and nephrologists.
Epidemiology: Diagnosed prevalence of SLE; diagnosed and
drug-treated populations.
Emerging therapies: Phase II: 5 drugs; Phase III: 5
drugs; preregistration: 1 drug. Coverage of 7 select preclinical and Phase I
products.
Market forecast features: Our 2008-2018 forecast is
based on a patient-based model in which we estimate 2008 SLE sales based on
epidemiological data, treated days, compliance, annual pricing, and
country-specific prescribing practices, reconciled with company-reported and
drug-audit SLE sales. We use the opinions of key thought leaders in SLE and of
other physicians with large SLE practices to inform our forecast for drugs in
development.