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.
- Description
- Contents
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.
Key Takeaways
- 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% of cases were in females.
- Evoxac, a muscarinic agonist specific to M1 receptors, is the only FDA approved drug 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 wide variety of targets. The majority of pipeline drugs in mid-to-late-stage development are administered via the oral, intravenous, and subcutaneous routes.
- High impact upcoming events for drugs in the Sjögren’s syndrome space comprise topline Phase II trial results for GS-9876, and Phase IIa trial results for UCB5857 and MEDI5872.
- There have been only two licensing and asset acquisition deals involving Sjogren’s syndrome drugs during 2013–18. 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 68.9% of trials in Phase I–II, and only 31.1% 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 has the highest number of completed clinical trials for this condition, with seven trials.
- Bristol-Myers Squibb and Novartis lead industry sponsors with the highest number of clinical trials for Sjögren’s syndrome
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 Approvals by country
19 PIPELINE DRUGS
25 KEY UPCOMING EVENTS
26 LICENSING AND ASSET ACQUISITION DEALS
26 OSE Immunotherapeutics Licenses IL-7 Antagonist To Servier
27 PARENT PATENTS
28 CLINICAL TRIAL LANDSCAPE
29 Sponsors by status
30 Sponsors by phase
32 BIBLIOGRAPHY
32 Prescription information
33 APPENDIX
LIST OF FIGURES
12 Figure 1: Trends in prevalent cases of primary Sjögren’s syndrome, 2016–25
19 Figure 2: Overview of pipeline drugs for Sjögren’s syndrome in the US
20 Figure 3: Pipeline drugs for Sjögren’s syndrome, by company
20 Figure 4: Pipeline drugs for Sjögren’s syndrome, by drug type
20 Figure 5: Pipeline drugs for Sjögren’s syndrome, by classifications
25 Figure 6: Key upcoming events in Sjögren’s syndrome
26 Figure 7: Licensing and asset acquisition deals in Sjögren’s syndrome, 2013–18
27 Figure 8: Parent patents in Sjögren’s syndrome
28 Figure 9: Clinical trials in Sjögren’s syndrome
28 Figure 10: Top 10 drugs for clinical trials in Sjögren’s syndrome
29 Figure 11: Top 10 companies for clinical trials in Sjögren’s syndrome
29 Figure 12: Trial locations in Sjögren’s syndrome
30 Figure 13: Sjögren’s syndrome trials status
31 Figure 14: Sjögren’s syndrome trials sponsors, by phase
LIST OF TABLES
11 Table 1: Prevalent cases of primary Sjögren’s syndrome, 2016–25
13 Table 2: Prevalent cases of primary Sjögren’s syndrome, by gender, 2016
14 Table 3: Prevalence of primary Sjögren’s syndrome, by gender, 2016
16 Table 4: Marketed drugs for Sjögren’s syndrome
18 Table 5: Approvals by country for Sjögren’s syndrome
22 Table 6: Pipeline drugs for Sjögren’s syndrome in the US
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