Sjögren's syndrome (SS) is a progressive autoimmune disease characterized by chronic inflammation and lymphocytic infiltration of the exocrine glands that may occur alone (primary SS) or with a comorbid autoimmune condition (secondary SS). Symptomatic therapies to treat dry eyes, dry mouth, and/or specific extraglandular manifestations (commonly arthralgia and fatigue) are the cornerstone of disease management. Systemic manifestations are most often treated with hydroxychloroquine or, in severe cases, systemic immunomodulators (e.g., azathioprine, methotrexate). Therapies with disease-modifying potential (e.g., Novartis's iscalimab and ianalumab) are in development for SS, targeting key pathways believed to drive pathological processes in the disease. These putative disease-modifying therapies have the potential to transform the management of SS, although such success has been a challenge to date.

QUESTIONS ANSWERED

  • How large is the SS population, and how will its size change over time?
  • How is SS currently managed? Which drugs are the most important, and what drives their use?
  • Which unfulfilled clinical needs are the most pressing?
  • Which pipeline products are the most promising, and what sales might they garner in the SS market? What therapies of note are progressing in earlier phases?
  • What are the drivers of and constraints in the SS market, and how will the market evolve through 2029?

CONTENT HIGHLIGHTS

  • Geographies: United States and EU5.
  • Primary research: Six country-specific interviews with thought-leading rheumatologists supported by survey data collected for this study.
  • Epidemiology: Diagnosed and drug-treated prevalent cases of SS by country, diagnosed prevalence of primary and secondary SS.
  • Forecast: Drug-level sales and patient share of key SS therapies in 2019 and 2029.
  • Emerging therapies: Phase II: 6 drugs; coverage of select preclinical and Phase I products.

Table of contents

  • Sjogren's Syndrome - Landscape & Forecast - Disease Landscape & Forecast
    • COVID-19
      • Key Findings
        • Sjogren's Syndrome Key Findings 2020
      • Commercial Outlook
        • Key Findings
          • Regional Sales of Key Therapies to Treat Sjögren's Syndrome in 2019 and 2029
          • Sjögren’s Syndrome SWOT Analysis
        • COVID-19: Areas of Potential Forecast Impact
          • Drivers and Constraints
            • What Factors Are Driving Sales in Sjögren’s Syndrome?
            • What Factors Are Constraining Sales in Sjögren’s Syndrome?
          • Drug-Class-Specific Trends
            • Biologics
        • Forecast
          • Sales of Key Therapies in Sjögren’s Syndrome
        • Etiology and Pathophysiology
          • Disease Overview
            • Clinical Presentation
              • Autoimmune Diseases Commonly Associated with Sjögren’s Syndrome
              • Key Extraglandular or Systemic Manifestations of Sjögren’s Syndrome
              • Increased Risk of Lymphoma in Sjögren’s Syndrome Patients
              • Sjögren’s Syndrome Disease Activity Indices
            • Etiology
              • Key Genes Implicated in Sjögren’s Syndrome Etiology and Pathogenesis
              • Sjögren’s Syndrome Pathogenesis
            • Pathophysiology
              • Dysregulation of Immune Function
              • Key Pathophysiologic Features of Sjögren’s Syndrome
              • Key Autoantibodies Commonly Found in Sjögren’s Syndrome Patients
            • Key Pathways and Drug Targets
              • Key Drug Targets in Sjögren’s Syndrome
          • Epidemiology
            • Key Findings
              • Epidemiology Populations
                • Disease Definition
                • Methods
                • Sources Used for the Diagnosed Prevalence of Sjögren's Syndrome
                • Diagnosed Prevalent Cases of Sjögren's Syndrome in the United States and Europe: 2019-2029
                • Diagnosed Prevalent Cases of Primary Sjögren's Syndrome in the United States and Europe: 2019-2029
                • Diagnosed Prevalent Cases of Secondary Sjögren's Syndrome in the United States and Europe: 2019-2029
                • Drug-Treated, Diagnosed Prevalent Cases of Sjögren's Syndrome in the United States and Europe (thousands): 2019-2029
            • Current Treatment
              • Key Findings
                • Diagnosis
                  • Key Diagnostic Tests
                  • Treatment Providers and Referral Patterns
                  • 2016 ACR / EULAR Classification Criteria for Primary Sjögren's Syndrome
                • Treatment Goals
                  • Key Endpoints Used in Clinical Trials for Sjögren’s Syndrome
                • Key Current Therapies
                  • Overview
                  • Mechanism of Action of Key Current Drug Classes Used for Sjögren’s Syndrome
                  • Current Treatments Used for Sjögren’s Syndrome
                  • Market Events Impacting the Use of Key Current Therapies in Sjögren’s Syndrome
                  • Clinical Trial Outcomes for Pilocarpine
                  • Advantages and Disadvantages of Pilocarpine
                  • Key Results from Select Clinical Trials Investigating Pilocarpine for the Treatment of Sjögren’s Syndrome
                  • Expert Insight: Pilocarpine
                  • Clinical Trial Outcomes for Cevimeline
                  • Advantages and Disadvantages of Cevimeline
                  • Key Results from Select Clinical Trials Investigating Cevimeline for the Treatment of Sjögren’s Syndrome
                  • Clinical Trial Outcomes for Ophthalmic Cyclosporine
                  • Advantages and Disadvantages of Ophthalmic Cyclosporine
                  • Key Results from Select Clinical Trials Investigating Ophthalmic Cyclosporine for the Treatment of Sjögren’s Syndrome
                  • Expert Insight: Ophthalmic Cyclosporine
                  • Advantages and Disadvantages of Xiidra
                  • Key Results from Select Clinical Trials Investigating Xiidra
                  • Hydroxychloroquine
                  • Advantages and Disadvantages of Hydroxychloroquine
                  • Key Results from Select Clinical Trials Investigating Hydroxychloroquine for the Treatment of Sjögren’s Syndrome
                  • Expert Insight: Hydroxychloroquine
                  • Methotrexate
                  • Azathioprine
                  • Advantages and Disadvantages of Conventional Systemic Therapies
                  • Expert Insight: Conventional Systemic Therapies
                  • Clinical Trial Outcomes for Rituximab
                  • Advantages and Disadvantages of Rituximab
                  • Expert Insight: Rituximab
                  • Clinical Trial Outcomes for Benlysta
                  • Advantages and Disadvantages of Benlysta
                  • Expert Insight: Benlysta
                  • Key Results from Select Clinical Trials Investigating Orencia for the Treatment of Sjögren’s Syndrome
                  • Advantages and Disadvantages of Orencia
                  • Expert Insight: Orencia
                  • Advantages and Disadvantages of Actemra / RoActemra
                • Medical Practice
                  • Overview
                  • Treatment Guidelines
                  • Regional Sjögren's Syndrome Treatment Guidelines
                  • Factors Influencing Drug Selection in Sjögren’s Syndrome
                  • Generalized Treatment Decision Tree for Sjögren’s Syndrome
              • Unmet Need Overview
                • Current and Future Attainment of Unmet Needs in Sjögren’s Syndrome
                • Top Unmet Needs in Sjögren’s Syndrome: Current and Future Attainment
                • Expert Insight: Unmet Needs in Sjögren’s Syndrome
              • Emerging Therapies
                • Key Findings
                  • Pipeline Trends for Sjögren’s Syndrome
                • Key Emerging Therapies
                  • Notable Developments Among Key Emerging Therapies for Sjögren’s Syndrome
                  • Key Therapies in Development for Sjögren’s Syndrome
                  • Analysis of the Ianalumab Clinical Development Program
                  • Expert Insight: Ianalumab
                  • Expectations for Launch and Sales Opportunity of Ianalumab in Sjögren’s Syndrome
                  • Iscalimab Clinical Profile
                  • Key Ongoing Clinical Trials of Iscalimab in the Treatment of Sjögren’s Syndrome
                  • Analysis of the Iscalimab Clinical Development Program
                  • Expert Insight: Iscalimab
                  • Expectations for Launch and Sales Opportunity of Iscalimab in Sjögren’s Syndrome
                  • Dazodalibep Clinical Profile
                  • Key Ongoing Clinical Trials of Dazodalibep in the Treatment of Sjögren’s Syndrome
                  • Analysis of the Dazodalibep Clinical Development Program
                  • Expert Insight: Dazodalibep
                  • Expectations for Launch and Sales Opportunity of Dazodalibep in Sjögren’s Syndrome
                  • RSLV-132 Clinical Profile
                  • Analysis of the RSLV-132 Clinical Development Program
                  • Expert Insight: RSLV-132
                  • Expectations for Launch and Sales Opportunity of RSLV-132 in Sjögren’s Syndrome
                  • Remibrutinib Clinical Profile
                  • Key Ongoing Clinical Trials of Remibrutinib in the Treatment of Sjögren’s Syndrome
                  • Analysis of the Remibrutinib Clinical Development Program
                  • Expectations for Launch and Sales Opportunity of Remibrutinib in Sjögren’s Syndrome
                  • Branebrutinib
                  • Branebrutinib Clinical Profile
                  • Key Ongoing Clinical Trials of Branebrutinib in the Treatment of Sjögren's Syndrome
                  • Analysis of the Branebrutinib Clinical Development Program
                  • Expectations for Launch and Sales Opportunity of Branebrutinib in Sjögren's Syndrome
                  • Expert Insight: Tyrosine Kinase Inhibitors
                • Early-Phase Pipeline Analysis
                  • Compounds in Early-Phase Development for Sjögren’s Syndrome
                • Key Discontinuations and Failures in Sjögren’s Syndrome
                  • Key Discontinuations and Failures
                • Patient Registries
                  • Patient Registries for Sjögren's Syndrome
                  • Prominent Sjögren’s Syndrome Patient Organizations
              • Access & Reimbursement Overview
                • Region-Specific Reimbursement Practices
                  • Key Market Access Considerations in Sjögren's Syndrome: United States
                  • General Reimbursement Environment: United States
                  • Key Market Access Considerations in Sjögren's Syndrome: EU5
                  • General Reimbursement Environment: EU5
              • Appendix
                • Key Abbreviations Related to Sjögren's Syndrome
                • Brands, Marketers, and Generic Availability of Key Therapies for Sjögren’s Syndrome, by Market
                • Bibliography

            Author(s): Andrew Russell

            John leads DRG’s Infectious, Niche, & Rare Diseases team and manages the market research portfolio across niche and rare diseases, anti-infectives, and vaccines. Prior to his current role, he was a Director on the team overseeing syndicated and custom work on niche and rare disease markets, as well as atopic dermatitis content in DRG’s Dermatology portfolio. He also served as a DRG analyst in the neurology space, focused mainly on the multiple sclerosis market. John holds a Ph.D. from the University of Massachusetts Medical School and a Bachelor’s degree from Worcester Polytechnic Institute.