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.
Markets 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.