Introduction:Last Updated 25 November 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 belimumab (GlaxoSmithKline’s Benlysta), the first new agent in 50 years, have lowered some drug development hurdles, and a growing list of emerging agents has ushered in a new era of SLE drug development. We forecast that sales of SLE therapies will increase approximately four-fold during our 2012-2022 forecast period, driven largely by the entry and uptake of premium-priced biologics.
Questions Answered in This Report:
The entry of the premium-priced branded agents belimumab (GlaxoSmithKline’s Benlysta), epratuzumab (UCB/Immunomedics), tabalumab (Eli Lilly), blisibimod (Anthera Pharmaceuticals), and rigerimod (ImmuPharma’s Lupuzor, P140) 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 agents?
Rituximab (Biogen Idec/Roche/Genentech/Chugai/Zenyaku Kogyo’s Rituxan, Roche’s MabThera) failed clinical trials for both SLE and lupus nephritis. Despite this, the agent garners off-label use in treatment-refractory patients and is the 2012 sales leader. Will rituximab continue to play a role in the SLE treatment algorithm? How will the entry of biosimilar rituximab and the approval of abatacept for lupus nephritis 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. In markets where the drug has launched, how are physicians using the drug and what are their perceptions of its efficacy and its current and future role in treating SLE? Will any agents in the SLE pipeline challenge belimumab?
covered: United States, France, Germany, Italy, Spain, United Kingdom, Japan.
Primary research: 35 country-specific interviews with rheumatologists and nephrologists.
Epidemiology: Diagnosed prevalence of SLE; diagnosed prevalence of SLE by flares and persistently active disease; diagnosed prevalent cases of SLE with lupus nephritis; diagnosed and drug-treated populations.
Emerging therapies: Phase II: 11 drugs; Phase III: 5 drugs.
Market forecast features: Our 2012-2022 forecast is based on a patient-based model. We estimate 2012 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 development.