This Market Spotlight report covers the Sjogren'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.
The author estimates that in 2017, there were approximately 2.2 million prevalent cases of primary Sjogren's syndrome worldwide, and forecaststhat number to increase to 2.5 million prevalent cases by 2026.
Primary Sjogren's syndrome has a female predominance. Globally, the author estimates that in 2017, 90.4% of cases aged 15 years and over were female.
Evoxac, a muscarinic agonist specific to M1 receptors, is the only FDA-approved drug for Sjogren's syndrome. The majority of industry-sponsored drugs in active clinical development for Sjogren's syndrome are in Phase II, with only one drug in Phase III.
Therapies in mid-to-late-stage development for Sjogren's syndrome focus on a wide variety of targets. The pipeline drugs for Sjogren's syndrome are administered via the oral, intravenous, and subcutaneous routes.
High-impact upcoming events for drugs in the Sjogren's syndrome space comprise topline Phase II trial results for GS-9876, and Phase IIa trial results for prezalumab and UCB5857.
The overall likelihood of approval of a Phase I arthritis asset is 10.8%, and the average probability a drug advances from Phase III is 79.2%. Drugs, on average, take 8.2 years from Phase I to approval, compared to 8.7 years in the overall autoimmune/immunology space.
There have been only four licensing and asset acquisition deals involving Sjogren'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 during the period.
The distribution of clinical trials across Phase I-IV indicates that the majority of trials for Sjogren'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 Sjogren'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 Sjogren's syndrome space is dominated by completed trials. Novartis and Roche have the highest number of completed clinical trials for Sjogren's syndrome, with seven trials each.