Market Spotlight: Sjogren's Syndrome
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当レポートでは、シェーグレン症候群 (乾燥症候群) の治療薬市場について分析し、疾患の概要や患者数の推移・見通し、現段階での主な治療法および治験・認可状況、シェーグレン症候群治療薬市場の動向見通し (今後10年間分)、資本取引の動き、現在開発中の治験の進行状況などを調査しております。
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.
Datamonitor Healthcare estimates that in 2018, there were approximately 2.3 million prevalent cases of primary Sjogren's syndrome worldwide, and forecasts that number to increase to 2.5 million prevalent cases by
2027. Primary Sjogren'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 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, filgotinib, and Benlysta SC.
The overall likelihood of approval of a Phase I arthritis asset is 10.5%, and the average probability a drug advances from Phase III is 79.7%. Drugs, on average, take 8.5 years from Phase I to approval, compared to 8.8 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.
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 71% of trials in Phase I-II, and only 29% 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. Roche has the highest number of completed clinical trials for Sjogren's syndrome, with eight trials.
Novartis leads the industry sponsors with the highest overall number of clinical trials for Sjogren's syndrome, followed by BristolMyers Squibb.