A notable growth in the systemic lupus erythematosus (SLE) and lupus nephritis (LN) market across the seven major markets (7MM; the US, France, Germany, Italy, Spain, the UK, and Japan) is anticipated by GlobalData according to its latest report, ‘Systemic Lupus Erythematosus and Lupus Nephritis: Seven-Market Drug Forecast and Market Analysis 2024–34‘ (GDHC337PIDR-7M). GlobalData expects a market growth from $2.4bn in 2024 to $5.9bn in 2034 at a compound annual growth rate (CAGR) of 9.6%.
The anticipated growth is mainly driven by ten new pipeline drugs expected to be introduced to the market by 2034, offering safer and more targeted treatment approaches, reducing the reliance on broad-range immunosuppression and steroids, thus reducing risks of secondary infections and poor patient quality of life. Furthermore, a significant enhancement of efficacy is anticipated with the pipeline due to the targeted approach of these treatments, as demonstrated by higher proportions of patients achieving complete renal response or meaningful reductions in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores in pivotal trials.
In 2024, the SLE and LN market was largely dominated by three drugs, including two biologics considered the gold-standard disease-modifying options, GSK’s Benlysta (belimumab) and AstraZeneca’s Saphnelo (anifrolumab), and a small molecule, Aurinia Pharmaceuticals’ Lupkynis (voclosporin). Roche’s Gazyva (obinutuzumab) entered the market for treatment of LN in the US and EU in Q4 2025 and Q1 2026, respectively, offering the first novel entrant into a relatively stagnant market, with further approval in SLE expected in 2026. While biologics are the current gold standard, with Benlysta being the market leader, they do not eliminate the continued reliance on steroids, highlighting a need for newer drugs with lower use of, or even complete elimination of, concomitant steroid use.
The most significant unmet need identified by the key opinion leaders (KOLs) interviewed by GlobalData, as well as high-prescribing clinicians, was the paucity of treatment options that offer favorable safety and efficacy compared to the wide-spectrum immunosuppressants, and the inability to gain a meaningful reduction in corticosteroid doses, since both wide-spectrum immunosuppressants and corticosteroids significantly increase risk of infections, which is found to be the leading cause of death for lupus patients.
The most recent reported data from clinical trials for the late-stage pipeline is highly encouraging and likely to challenge the dominant position of the current market leaders. Some of the most promising drugs anticipated to be launched during the forecast period are ianalumab, Gazyva, and dapirolizumab pegol, as they offer more targeted approaches such as enhanced B-cell depletion and novel immunomodulation. With the disease area actively gaining significant attention in R&D, and the American College of Rheumatology (ACR) and European Alliance of Associations for Rheumatology (EULAR) treatment guidelines incorporating earlier uses of novel, safer, and more effective biologics, the lupus treatment landscape is poised to have a major shift during the forecast period.
The SLE and LN market, while expected to grow, will still be constrained by several barriers, most notably the entry of biosimilars for belimumab and anifrolumab, offering a cheaper alternative to their branded originators, as well as pipeline drugs. Additionally, the adoption of pipeline drugs by clinicians is likely to be slow, due to limited clinical experience coupled with anticipated high treatment costs leading to access restrictions.
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By GlobalData