Market Spotlight: Sjögren’s Syndrome
Market Spotlight: Sjögren’s Syndrome
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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
- Description
- Contents
This Market Spotlight report covers the Sjögren’s Syndrome market, comprising key marketed and pipeline drugs, clinical trials, upcoming events, recent events and analyst opinion, probability of success, 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 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 9.9%, and the average probability a drug advances from Phase III is 80%. Drugs, on average, take 8.8 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 2015–20. 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 74% of trials in Phase I–II, and only 26% 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 eight trials.
- Novartis leads the industry sponsors with the highest overall number of clinical trials for Sjögren’s syndrome, followed by BristolMyers Squibb.
CONTENTS
5 OVERVIEW
6 KEY TAKEAWAYS
7 DISEASE BACKGROUND
8 TREATMENT
8 Dry eyes
8 Dry mouth
8 Other glandular manifestations
9 Extraglandular manifestations
10 EPIDEMIOLOGY
15 MARKETED DRUGS
17 PIPELINE DRUGS
22 RECENT EVENTS AND ANALYST OPINION
22 Iscalimab for Sjögren’s Syndrome (January 23, 2020)
23 Mutliple Drugs for Sjogren’s Syndrome (October 24, 2019)
24 RSLV-132 for Sjögren’s Syndrome (June 13, 2019)
26 KEY UPCOMING EVENTS
27 PROBABILITY OF SUCCESS
28 LICENSING AND ASSET ACQUISITION DEALS
28 Advanz Obtains Two Commercial Products From Eisai
29 PARENT PATENTS
30 CLINICAL TRIAL LANDSCAPE
31 Sponsors by status
32 Sponsors by phase
34 BIBLIOGRAPHY
34 Prescription information
35 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of primary Sjögren’s syndrome, 2018–27
17 Figure 2: Overview of pipeline drugs for Sjögren’s syndrome in the US
17 Figure 3: Pipeline drugs for Sjögren’s syndrome, by company
18 Figure 4: Pipeline drugs for Sjögren’s syndrome, by drug type
18 Figure 5: Pipeline drugs for Sjögren’s syndrome, by classification
23 Figure 6: Iscalimab for Sjögren’s Syndrome (January 23, 2020): Phase II – Primary Sjögren
25 Figure 7: RSLV-132 for Sjögren’s Syndrome (June 13, 2019): Phase II – Study 132-04
26 Figure 8: Key upcoming events in Sjögren’s syndrome
27 Figure 9: Probability of success in the Sjögren’s syndrome pipeline
28 Figure 10: Licensing and asset acquisition deals in Sjögren’s syndrome, 2015–20
29 Figure 11: Parent patents in Sjögren’s syndrome
30 Figure 12: Clinical trials in Sjögren’s syndrome
30 Figure 13: Top 10 drugs for clinical trials in Sjögren’s syndrome
31 Figure 14: Top 10 companies for clinical trials in Sjögren’s syndrome
31 Figure 15: Trial locations in Sjögren’s syndrome
32 Figure 16: Sjögren’s syndrome trials status
33 Figure 17: Sjögren’s syndrome trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of primary Sjögren’s syndrome, 2018–27
13 Table 2: Prevalent cases of primary Sjögren’s syndrome, by gender, 2018
14 Table 3: Prevalence of primary Sjögren’s syndrome, by gender, 2018
16 Table 4: Marketed drugs for Sjögren’s syndrome
19 Table 5: Pipeline drugs for Sjögren’s syndrome in the US
22 Table 6: Iscalimab for Sjögren’s Syndrome (January 23, 2020)
23 Table 7: Mutliple Drugs for Sjogren’s Syndrome (October 24, 2019)
24 Table 8: RSLV-132 for Sjögren’s Syndrome (June 13, 2019)
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