This Market Spotlight report covers the Sjögren’s syndrome market, comprising key pipeline and marketed drugs, clinical trials, upcoming events, patent information, a 10-year disease prevalence forecast, and licensing and acquisition deals.

Key Takeaways

• Datamonitor Healthcare estimates that in 2018, there were approximately 2.3 million prevalent cases of primary Sjögren’s syndrome worldwide, and forecasts that number to increase to 2.5 million prevalent cases by 2027.
• Primary Sjögren’s syndrome has a female predominance. Globally, Datamonitor Healthcare estimates that in 2018, 90.4% 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 Benlysta SC. The overall likelihood of approval of a Phase I arthritis asset is 9.6%, and the average probability a drug advances from Phase III is 78.3%. Drugs, on average, take 8.7 years from Phase I to approval, compared to 9.0 years in the overall autoimmune/immunology space.
• There have been only four licensing and asset acquisition deals involving Sjögren’s syndrome drugs during 2014–19. The exclusive licensing and collaboration agreement between Eli Lilly and Hanmi for $690m, regarding the development and commercialization of Hanmi’s oral BTK inhibitor HM71224 for the treatment of autoimmune and other diseases, was the largest deal.
• 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 72% of trials in Phase I–II, and only 28% in Phase III–IV.
• The US has a substantial lead in the number of Sjögren’s syndrome clinical trials globally. The UK leads the major EU markets, while Japan has the top spot in Asia.
• Clinical trial activity in the Sjögren’s syndrome space is dominated by completed trials. Roche has the highest number of completed clinical trials for Sjögren’s syndrome, with eight trials.
• Novartis leads the industry sponsors with the highest overall number of clinical trials for Sjögren’s syndrome, followed by BristolMyers Squibb.