Introduction:
Last Updated 4 August 2010 In the past, systemic lupus
erythematosus (SLE) drug developers faced formidable challenges: drug
development and regulatory hurdles, the small and heterogeneous population, and
the multiplicity of manifestations all contribute to this challenge. Recent
positive clinical trial results and likely regulatory approval of the first
agent in 50 years will ease some of the drug development hurdles and usher in a
new era of SLE drug development. We forecast that sales of SLE therapies will
quadruple over our 2009-2019 forecast period, driven largely by the entry and
uptake of premium-priced biologics. The SLE market also reflects an unusual
dynamic—the continued off-label use of several therapies that have failed
clinical trials—further underscoring the high unmet need and opportunity in
this indication.
Questions Answered in This Report:
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The entry of the
premium-priced branded agent belimumab (Human Genome Sciences/GlaxoSmithKline’s
Benlysta) during our forecast period and the continued uptake of the few
current branded agents in the market will transform the predominantly generic
SLE market.
How much market growth will be driven by agents securing
regulatory approval for SLE and lupus nephritis? 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.
Will
rituximab continue to play a role in the SLE treatment algorithm? Will
rituximab compete with belimumab?
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The likely regulatory approval and the launch of the novel B-cell
modulator belimumab will make this agent the first in 50 years to secure
regulatory approval for SLE.
Will belimumab compete with currently used
cytotoxic agents and immunosuppressants, or will physicians incorporate
belimumab in combination regimens? Will any agents in the SLE pipeline
challenge belimumab?
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Mycophenolate sodium (Novartis’s Myfortic) will gain formal
approval for SLE in 2012 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: 20 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: 3
drugs; preregistration: 2 drugs. Coverage of 6 select preclinical and Phase I
products.
Market forecast features: Our 2009-2019 forecast is
based on a patient-based model. We estimate 2009 SLE sales using
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.