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Market Spotlight: Sjögren's Syndrome

  • ID: 4775346
  • Report
  • November 2019
  • Region: Global
  • 35 pages
  • Datamonitor Healthcare

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FEATURED COMPANIES

  • Bristol-Myers Squibb
  • Eli Lilly
  • Hanmi
  • Novartis
  • Roche
  • MORE
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
  • The author 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, the author 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 9.6%, and the average probability a drug advances from Phase III is 78.3%. Drugs, on average, take 8.7 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 2014–19. 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 72% of trials in Phase I–II, and only 28% 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. Roche 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.
Note: Product cover images may vary from those shown

FEATURED COMPANIES

  • Bristol-Myers Squibb
  • Eli Lilly
  • Hanmi
  • Novartis
  • Roche
  • MORE
Contents

Overview

Key Takeaways

Disease Background

Treatment
  • Dry eyes
  • Dry mouth
  • Other glandular manifestations
  • Extraglandular manifestations
Epidemiology

Marketed Drugs

Pipeline Drugs

Recent Events and Analyst Opinion
  • Mutliple Drugs for Sjogren's Syndrome (October 24, 2019)
  • RSLV-132 for Sjögren's Syndrome (June 13, 2019)
Key Upcoming Events

Probability of Success

Licensing and Asset Acquisition Deals
  • Advanz Obtains Two Commercial Products From Eisai
Parent Patents

Clinical Trial Landscape
  • Sponsors by status
  • Sponsors by phase
Bibliograpy
  • Prescription information
Appendix

List of Figures
Figure 1: Trends in prevalent cases of primary Sjögren’s syndrome, 2018-27
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 classification
Figure 6: RSLV-132 for Sjögren's Syndrome (June 13, 2019): Phase II - Study 132-04
Figure 7: Key upcoming events in Sjögren’s syndrome
Figure 8: Probability of success in the Sjögren’s syndrome pipeline
Figure 9: Licensing and asset acquisition deals in Sjögren’s syndrome, 2014-19
Figure 10: Parent patents in Sjögren’s syndrome
Figure 11: Clinical trials in Sjögren’s syndrome
Figure 12: Top 10 drugs for clinical trials in Sjögren’s syndrome
Figure 13: Top 10 companies for clinical trials in Sjögren’s syndrome
Figure 14: Trial locations in Sjögren’s syndrome
Figure 15: Sjögren’s syndrome trials status
Figure 16: Sjögren’s syndrome trials sponsors, by phase

List of Tables
Table 1: Prevalent cases of primary Sjögren’s syndrome, 2018-27
Table 2: Prevalent cases of primary Sjögren’s syndrome, by gender, 2018
Table 3: Prevalence of primary Sjögren’s syndrome, by gender, 2018
Table 4: Marketed drugs for Sjögren’s syndrome
Table 5: Pipeline drugs for Sjögren’s syndrome in the US
Table 6: Mutliple Drugs for Sjogren's Syndrome (October 24, 2019)
Table 7: RSLV-132 for Sjögren's Syndrome (June 13, 2019)
Note: Product cover images may vary from those shown
  • Bristol-Myers Squibb
  • Eli Lilly
  • Hanmi
  • Novartis
  • Roche
Note: Product cover images may vary from those shown
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