Systemic lupus erythematosus (SLE) is a systemic inflammatory autoimmune disease that can affect any organ or tissue and is the prototypic autoimmune disease. As a multisystem disorder, SLE is heterogeneous in nature-no two cases of lupus are alike-and can affect multiple major organ systems in the body, one of its most severe manifestations includes renal (kidney) involvement, known as lupus nephritis (LN). The etiology of SLE and LN remains incompletely understood, but genetic and environmental factors have been shown to play pivotal roles in the development of the disease.
To date, the cornerstone of lupus therapy still relies on generic steroids and unspecific immunosuppressive agents; both of which are associated with severe adverse events (SAEs) and contribute significantly to the morbidity and mortality in lupus. The much anticipated approval of Benlysta (belimumab) in 2011 had only a small impact on the treatment paradigm, and off-label Rituxan/MabThera (rituximab) remains the market leader in terms of sales. R&D efforts in lupus are high, however late-stage clinical failure remains a major barrier to market entry. The anticipated release of six new pipeline agents for SLE and LN will have the potential to revolutionize the lupus treatment. GlobalData expects the global SLE and LN market-which, for the purposes of this report, comprises the seven major pharmaceutical markets (7MM; US, France, Germany, Italy, Spain, UK, Japan)-to expand during the next decade at an astonishing CAGR of 10.6%, reaching total sales of $3.2 billion by 2025.