Overview

This Market Spotlight report covers the Sjögren’s Syndrome market, comprising key marketed and pipeline drugs, key upcoming events, clinical trials, probability of success, and a 10-year disease prevalence forecast.

• Datamonitor Healthcare estimates that in 2021, there were approximately 2.32 million prevalent cases of primary Sjögren’s syndrome worldwide, and forecasts that number to increase to 2.52 million prevalent cases by 2028.
• Primary Sjögren’s syndrome has a female predominance. Globally, Datamonitor Healthcare estimates that in 2019, 90.41% of cases aged 15 years and over were female.
• Evoxac, a muscarinic agonist specific to M1 receptors, and LO2A, which contains isotonic glycerol and 0.015% sodium hyaluronate, are the only approved drugs for Sjögren’s syndrome.
• The majority of industry-sponsored drugs in active clinical development for Sjögren’s syndrome are in Phase II, with only one drug in Phase III.
• Therapies in development for Sjögren’s syndrome focus on a wide variety of targets. The pipeline drugs for Sjögren’s syndrome are administered via the oral, intravenous, and subcutaneous routes.
• The only high-impact upcoming event in the Sjögren’s syndrome space is topline Phase II trial results for HZN-4920. The overall likelihood of approval of a Phase I arthritis asset is 8.5%, and the average probability a drug advances from Phase III is 79.5%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.5 years in the overall autoimmune/immunology space.
• The distribution of clinical trials across Phase I–IV indicates that the majority of trials for Sjögren’s syndrome have been in the early and mid-phases of development, with 79% of trials in Phase I–II, and only 21% in Phase III–IV.
• The US has the highest number of Sjögren’s syndrome clinical trials globally. The UK leads the major European markets, while China has the top spot in Asia.
• Clinical trial activity in the Sjögren’s syndrome space is dominated by completed trials. Novartis has the highest number of completed clinical trials for Sjögren’s syndrome, with eight trials.
• Bristol Myers Squibb leads the industry sponsors with the highest overall number of clinical trials for Sjögren’s syndrome, closely followed by Novartis.