Systemic Lupus Erythemato?sus: High Level of Pipeline Innovation Provides Positive Market Outlook

While the Systemic Lupus Erythematosus (SLE) treatment market is predominantly limited to Benlysta and off-label Rituxan, new emerging entrants, which appear to offer significant therapeutic benefits, will cause dramatic changes to the future SLE biological treatment market landscape, says a new report from business intelligence provider GBI Research.

The company’s latest report* states that there are extensive research efforts into innovative biologic programmes in the SLE pipeline, which target a wide range of cytokines modulators, as well as including cellular targets of the immune system. In fact, cytokine modulators now constitute the largest proportion (33%) of all active pipeline programmes for SLE.

In addition, several experimental programmes exhibit novel properties and mechanisms of action, which are different from those currently available, and are expected to gain marketing approval within the next decade. These include the first-in-class LymphoCide (epratuzumab) and Lupuzor (forigerimod), which have shown positive clinical efficacy and safety profiles on small-scale studies.

Ling Zhuang, PhD, Analyst for GBI Research, says: “These first-in-class programmes are likely to expand the range of treatments available for SLE patients and establish new niches in the market.”

However, there is a large unmet need both in the diagnosis and treatment of SLE.

Zhuang says: “Due to heterogeneous manifestations, there is no single parameter that is sensitive or specific enough to correctly identify overall or organ-specific disease progression in all SLE patients, thereby hampering disease management and clinical research.

“The main unmet need in the current market is a range of efficient drugs with lower risks of infection, toxicity and minimal impact on fertility, because the overall majority of SLE patients are women of child-bearing age,” Zhuang concludes.

*Frontier Pharma: Systemic Lupus Erythematosus — Identifying and Commercializing First-in-Class Innovation