Systemic lupus erythematosus (SLE) is a complex disease characterized by distinct manifestations. Currently, most treatments available to treat SLE are used off-label. The approval of Benlysta in 2011 marked the first new drug to be launched for SLE in more than 50 years. However, SLE remains an area of high unmet need, and significant opportunities exist for pharmaceutical companies that can successfully launch optimal treatment for the indication. Although the heterogeneous nature of the disease impedes drug development and drug companies face formidable challenges ranging from trial design during development to getting reimbursement postapproval, multiple therapies are currently in early- and late-phase development for SLE, and the list is only growing. In this complex environment, we expect the SLE market to increase by more than 200% during the 2016-2026 forecast period, largely driven by the entry and uptake of premium-priced biologics.
Markets covered: United States, France, Germany, Italy, Spain, United Kingdom, and Japan.
Primary research: 18 country-specific interviews with rheumatologists and nephrologists.
Epidemiology: Total diagnosed prevalence of SLE, diagnosed prevalence of nonrenal SLE, diagnosed prevalence of renal SLE (LN), total drug-treated SLE population, drug-treated nonrenal SLE population, drug-treated renal SLE (LN) population.
Population segments in market forecast: Total population, nonrenal SLE population, renal SLE (LN) population.
Emerging therapies: Phase II: 20 drugs; Phase III: 6 drugs; preregistration: 1 drug; registered: 1 drug. Coverage of 8 select preclinical and Phase I products.