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.
Author: Informa Pharma Intelligence
Publisher: Datamonitor Healthcare
Published: 23 September 2021
Number of pages:29
This Market Spotlight report covers the Sjögren’s Syndrome market, comprising key marketed and pipeline drugs, clinical trials, recent events and analyst opinion, licensing and asset acquisition deals, probability of success, and a 10-year disease prevalence forecast.
Datamonitor Healthcare estimates that in 2019, there were approximately 2.26 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 overall likelihood of approval of a Phase I arthritis asset is 8.4%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 9.0 years from Phase I to approval, compared to 9.3 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 78% of trials in Phase I–II, and only 22% 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 Japan 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 nine trials.
Novartis leads the industry sponsors with the highest overall number of clinical trials for Sjögren’s syndrome.
22 LICENSING AND ASSET ACQUISITION DEALS
22 With $3bn Viela Acquisition, Horizon Builds A Pipeline
23 CLINICAL TRIAL LANDSCAPE
24 Sponsors by status
25 Sponsors by phase
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of primary Sjögren’s syndrome, 2019–28
16 Figure 2: Overview of pipeline drugs for Sjögren’s syndrome in the US
16 Figure 3: Pipeline drugs for Sjögren’s syndrome, by company
17 Figure 4: Pipeline drugs for Sjögren’s syndrome, by drug type
17 Figure 5: Pipeline drugs for Sjögren’s syndrome, by classification
21 Figure 6: Probability of success in the arthritis pipeline
23 Figure 7: Clinical trials in Sjögren’s syndrome
23 Figure 8: Top 10 drugs for clinical trials in Sjögren’s syndrome
24 Figure 9: Top 10 companies for clinical trials in Sjögren’s syndrome
24 Figure 10: Trial locations in Sjögren’s syndrome
25 Figure 11: Sjögren’s syndrome trials status
26 Figure 12: Sjögren’s syndrome trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of primary Sjögren’s syndrome, 2019–28
13 Table 2: Prevalent cases of primary Sjögren’s syndrome, by gender, 2019
15 Table 3: Marketed drugs for Sjögren’s syndrome
18 Table 4: Pipeline drugs for Sjögren’s syndrome in the US
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