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

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Major TOC Market:

1 KEY TAKEAWAYS

2 DISEASE BACKGROUND

3 TREATMENT
4 Dry eyes
5 Dry mouth
6 Other glandular manifestations
7 Extraglandular manifestations

8 EPIDEMIOLOGY

9 MARKETED DRUGS
10 Approvals by country

11 PIPELINE DRUGS

12 KEY UPCOMING EVENTS

13 LICENSING AND ASSET ACQUISITION DEALS
14 OSE Immunotherapeutics Licenses IL-7 Antagonist To Servier

15 PARENT PATENTS

16 CLINICAL TRIAL LANDSCAPE
17 Sponsors by status
18 Sponsors by phase

19 BIBLIOGRAPHY
20 Prescription information

21 APPENDIX

LIST OF FIGURES
Figure 1: Trends in prevalent cases of primary Sjögren’s syndrome, 2016–25
Figure 2: Overview of pipeline drugs for Sjögren’s syndrome in the US
Figure 3: Pipeline drugs for Sjögren’s syndrome, by company
Figure 4: Pipeline drugs for Sjögren’s syndrome, by drug type
Figure 5: Pipeline drugs for Sjögren’s syndrome, by classifications
Figure 6: Key upcoming events in Sjögren’s syndrome
Figure 7: Licensing and asset acquisition deals in Sjögren’s syndrome, 2012–17
Figure 8: Parent patents in Sjögren’s syndrome
Figure 9: Clinical trials in Sjögren’s syndrome
Figure 10: Top 10 drugs for clinical trials in Sjögren’s syndrome
Figure 11: Top 10 companies for clinical trials in Sjögren’s syndrome
Figure 12: Trial locations in Sjögren’s syndrome
Figure 13: Sjögren’s syndrome trials status
Figure 14: Sjögren’s syndrome trials sponsors, by phase

LIST OF TABLES
  Table 1: Prevalent cases of primary Sjögren’s syndrome, 2016–25
  Table 2: Prevalent cases of primary Sjögren’s syndrome, by gender, 2016
  Table 3: Prevalence of primary Sjögren’s syndrome, by gender, 2016
  Table 4: Marketed drugs for Sjögren’s syndrome
  Table 5: Approvals by country for Sjögren's syndrome
  Table 6: Pipeline drugs for Sjögren’s syndrome in the US

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