GlobalData, a data and analytics company, on Thursday said that a new first-in-class biological therapies are expected to increase therapy options for patients and drive growth in the coming years.
The systemic lupus erythematosus (SLE) and lupus nephritis (LN) market comprise a wide range of medications, from antimalarials to immunosuppressive agents, which are largely genericised 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, GlobalData stated on Thursday.
“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,” Thomas Keller, Healthcare Analyst at GlobalData, said in a statement.
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 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.
“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,” Keller added.
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.
“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 efficacy and safety profiles to currently available Benlysta, Rituxan, Lupkynis, and Saphnelo,” Keller added.
Currently, GSK, AstraZeneca, Roche, and Aurinia Pharmaceuticals are the key players in the lupus marketplace, and GlobalData anticipates all four companies to have a strong position in this space due to their current product offerings.
“Due to the nature of lupus, there will always be room in the market for novel products, as patients become unresponsive to a specific biologic after chronic use or develop allergic reactions. As such, the overall use of biological therapies will increase in patients with lupus, and the introduction of new biologic drugs will further drive growth in the SLE and LN market,” Keller added.
