The systemic lupus erythematosus (SLE) and lupus nephritis (LN) market across the seven major markets (7MM*) is forecast to grow from $2.4 billion in 2024 to $5.9 billion in 2034, at a compound annual growth rate (CAGR) of 9.6%, according to GlobalData, a leading intelligence and productivity platform.

GlobalData’s latest report, “Systemic Lupus Erythematosus and Lupus Nephritis: Seven-Market Drug Forecast and Market Analysis 2024–34“, reveals that the growth will be mainly driven by the new entries of nine pipeline agents targeting disease modification, representing a shift in a market that was predominantly dominated by the off-label use of steroids, wide-spectrum immunosuppressants, and antimalarials. The shift is expected to significantly improve safety, efficacy, and thus treatment outcomes and quality of life of SLE and LN patients.

Zaid Mahmood, Immunology Analyst at GlobalData, comments: “One of the most significant unmet needs highlighted by key opinion leaders (KOLs) was the paucity of treatment options that offer favorable safety and efficacy compared to the wide-spectrum immunosuppressants, as well as the inability to gain a meaningful reduction in corticosteroid doses, which pose a significant risk of infection, the leading cause of death in lupus patients.”

Among the most promising recent and future entrants, GlobalData identifies Gazyva (obinutuzumab), ianalumab, and dapirolizumab pegol, as the drugs that will dominate the market growth, offering more targeted mechanisms such as enhanced B-cell depletion and novel immunomodulation. The broader pipeline is also anticipated to deliver a significant enhancement in efficacy and steroid reductions, as demonstrated in pivotal trial results.

Mahmood concludes: “While the SLE and LN market is poised to grow with the entry of novel pipeline therapies and increased prevalence, this growth is expected to be constrained by several barriers. Most notably, the entry of biosimilars for belimumab and anifrolumab, the current market leading biologics, are expected to offer a cheaper alternative to their branded originators. Additionally, adoption of pipeline therapies may be slow due to limited physician experience with novel mechanisms in treatment of lupus, coupled with anticipated high treatment costs that may lead to access restrictions.”

*7MM: the US, France, Germany, Italy, Spain, the UK, and Japan