The systemic lupus erythematosus (SLE) and lupus nephritis (LN) market comprises a wide range of medications, from anti-malarials to immunosuppressive agents, which are largely genericized to biologics used both off- and on-label. As such, the SLE and LN marketplace is dominated by generics and a few key biologics such as GSK’s Benlysta and Roche’s Rituxan. Notably, Benlysta and AstraZeneca’s Saphnelo are the only drugs that have gained marketing approval specifically for SLE in more than 50 years. However, new first-in-class biological therapies are expected to increase therapy options for patients and drive growth in the coming years, observes GlobalData, a leading data and analytics company.

Thomas Keller, Healthcare Analyst at GlobalData, comments: “The 2021 approval of AstraZeneca’s Saphnelo in the US will mean increasing competition for Benlysta in the coming years. Furthermore, similar to GSK’s strategy with Benlysta, AstraZeneca has initiated the Phase III TULIP subcutaneous (SC) trial in SLE using subcutaneous delivery of Saphnelo, in June 2021. The results of this trial, if positive, are expected to be sufficient to grant approval in the US and EU through a supplemental new drug application/label expansion, respectively.”

Benlysta has managed to grow the lupus market in terms of value, having generated approximately $492.9 million in revenue across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan) in 2018, and also was the first approved biologic therapy for LN in the US, having gained approval in 2020.

The second highest-grossing drug in the SLE and LN market in terms of value is Roche/Biogen Idec’s Rituxan, which GlobalData estimates generated approximately $228.6 million in 2018 across the 7MM despite being an off-label therapy for lupus.

Keller continues: “Roche’s Gazyvaro, currently in Phase III trials, is expected to take the LN market by storm, once approved, as it is a fully humanized version of Rituxan. Additionally, Roche also markets MMF (under the brand name CellCept), an off-label immunosuppressive agent that is commonly prescribed to SLE and LN patients, although generic versions of MMF are also available throughout the 7MM.”

A major trend in the lupus treatment landscape is that many companies with approved therapies in other autoimmune diseases are testing them for efficacy in SLE and LN, as some of the symptoms are similar. Novartis’s Cosentyx for example, with primary indications in psoriasis and axial spondyloarthritis, is now being tested in LN. There is also high R&D activity for the development of new therapies for lupus, with more than three monoclonal antibody (mAB)-based therapies that could potentially enter the SLE and LN market in the coming years.

In particular, Vera Therapeutics’s fusion protein atacicept is among the most promising pipeline drug for SLE and LN, according to GlobalData’s primary and secondary research.

Keller adds: “The introduction of new first-in-class biological therapies will further increase therapy options for SLE and LN patients, and it remains to be seen if any of these products will have superior