Market Spotlight: Sjögren’s Syndrome
Disease Overview
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.
Market Snapshot
Datamonitor Healthcare estimates that in 2016, there were approximately 2.2 million
prevalent cases of primary Sjögren’s syndrome worldwide, and forecasts that number to
increase to 2.5 million prevalent cases by 2025.
Primary Sjögren’s syndrome has a female predominance. Globally, Datamonitor Healthcare
estimates that in 2016, 90.43% of cases aged 15 years and over were in females.
Evoxac, a muscarinic agonist specific to M1 receptors, is the only drug approved by the US
Food and Drug Administration 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 mid-to-late-stage development for Sjögren’s syndrome focus on a variety of
targets. The majority of pipeline drugs in mid-to-late-stage development are administered
orally, with the remainder including intravenous and subcutaneous formulations.
High-impact upcoming events for drugs in the Sjögren’s syndrome space include topline
Phase II trial results. There was only one licensing agreement during 2012–17. The deal
was an exclusive licensing and collaboration agreement between Eli Lilly and Hanmi for
$690.0m, regarding the development and commercialization of Hanmi's oral BTK inhibitor,
HM71224, for the treatment of autoimmune and other diseases.
The clinical trials distribution across Phase I–IV indicates that the majority of trials for
Sjögren's syndrome have been in early and mid-phases of development, with 69% of trials
in Phase I–II, and only 31% 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.
Novartis and Roche have the highest number of completed clinical trials for this condition,
with six and five, respectively. Novartis leads industry sponsors with the highest number of
clinical trials for Sjögren’s syndrome
Exclusive Sample Report @
Major TOC Market:
1 KEY TAKEAWAYS
2 DISEASE BACKGROUND
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