Introduction:Last Updated 5 February 2013
In the past, systemic
lupus erythematosus (SLE) drug developers faced formidable challenges: drug
development and regulatory hurdles, a small and heterogeneous population, and a
multiplicity of manifestations. Recent positive clinical trial results and regulatory
approval of the first new agent in 50 years will lower some drug development
hurdles and usher in a new era of SLE drug development. We forecast that sales
of SLE therapies will increase almost sixfold during our 2011-2021 forecast
period, driven largely by the entry and uptake of premium-priced biologics. The
SLE market is also driven by an unusual dynamic—the continued off-label use of
several therapies that have failed clinical trials—that further underscores the
high unmet need and opportunity in this indication.
Questions Answered in This Report:
The entry of the premium-priced branded agents belimumab (Human
Genome Sciences/GlaxoSmithKline’s Benlysta), epratuzumab (UCB/Immunomedics),
tabalumab (Eli Lilly), blisibimod (Anthera Pharmaceuticals), and forigerimod
(ImmuPharma/SymBio Pharmaceuticals) during our forecast period will transform
the predominantly generic SLE market. How much market growth will be driven
by agents that secure regulatory approval for SLE and lupus nephritis? How do
interviewed thought leaders perceive the safety and efficacy of these emerging
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? How will the
entry of a biosimilar rituximab affect sales and use of this agent?
The regulatory approval and launch of the novel B-cell
modulator belimumab 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?
What reimbursement challenges do belimumab and other premium-priced branded
agents face in this largely generic market?
covered: United States, France, Germany, Italy, Spain, United
Primary research: 29 country-specific interviews with
rheumatologists and nephrologists.
Epidemiology: Diagnosed prevalence of SLE; diagnosed
prevalence of SLE by flares and persistently active disease; diagnosed and
Emerging therapies: Phase II: 9 drugs; Phase III: 6
drugs. Coverage of 9 select preclinical and Phase I products.
Market forecast features: Our 2011-2021 forecast is
based on a patient-based model. We estimate 2011 SLE sales by using
epidemiological data, treated days, compliance, annual pricing, and
country-specific prescribing practices reconciled with company-reported and
drug-audit SLE sales. We consult key thought leaders in SLE and other
physicians with large SLE practices to inform our forecast for drugs in