Sjogren’s Syndrome – Landscape & Forecast – Disease Landscape & Forecast

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? What are the usual treatments, 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 2030?

CONTENT HIGHLIGHTS

  • Geographies: United States and EU5.
  • Primary research: Six country-specific interviews with thought-leading SS specialists 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 2020 and 2030.
  • Emerging therapies: Phase II: 7 key drugs; coverage of select early development products.

Table of contents

  • Sjogren's Syndrome - Landscape & Forecast - Disease Landscape & Forecast
    • Key Findings
      • Sjogren's Syndrome Key Findings 2021
    • Commercial Outlook
      • Key Findings
        • Regional Sales of Key Therapies to Treat Sju00f6gren's Syndrome in 2020 and 2030
        • Sju00f6grenu2019s Syndrome SWOT Analysis
      • Drivers and Constraints
        • What Factors Are Driving Sales in Sju00f6grenu2019s Syndrome?
        • What Factors Are Constraining Sales in Sju00f6grenu2019s Syndrome?
      • Drug-Class-Specific Trends
        • Biologics
    • Forecast
      • Sales of Key Therapies in Sju00f6grenu2019s Syndrome
    • Etiology and Pathophysiology
      • Disease Overview
        • Clinical Presentation
          • Autoimmune Diseases Commonly Associated with Sju00f6grenu2019s Syndrome
          • Key Extraglandular or Systemic Manifestations of Sju00f6grenu2019s Syndrome
          • Increased Risk of Lymphoma in Sju00f6grenu2019s Syndrome Patients
          • Sju00f6grenu2019s Syndrome Disease Activity Indices
        • Etiology
          • Key Genes Implicated in Sju00f6grenu2019s Syndrome Etiology and Pathogenesis
          • Sju00f6grenu2019s Syndrome Pathogenesis
        • Pathophysiology
          • Dysregulation of Immune Function
          • Key Pathophysiologic Features of Sju00f6grenu2019s Syndrome
          • Key Autoantibodies Commonly Found in Sju00f6grenu2019s Syndrome Patients
        • Key Pathways and Drug Targets
          • Key Drug Targets in Sju00f6grenu2019s Syndrome
      • Epidemiology
        • Key Findings
          • Epidemiology Populations
            • Disease Definition
            • Methods
            • Sources Used for the Diagnosed Prevalence of Primary Sju00f6grenu2019s Syndrome, Secondary Sju00f6grenu2019s Syndrome, and Sju00f6grenu2019s Syndrome
            • Diagnosed Prevalent Cases of Sju00f6gren's Syndrome in the United States and Europe: 2021-2031
            • Diagnosed Prevalent Cases of Primary Sju00f6gren's Syndrome in the United States and Europe: 2021-2031
            • Diagnosed Prevalent Cases of Secondary Sju00f6gren's Syndrome in the United States and Europe: 2021-2031
            • Drug-Treated, Diagnosed Prevalent Cases of Sju00f6gren's Syndrome in the United States and Europe (Thousands): 2020-2030
        • Current Treatment
          • Key Findings
            • Diagnosis
              • Key Diagnostic Tests
              • Treatment Providers and Referral Patterns
              • 2016 ACR / EULAR Classification Criteria for Primary Sju00f6gren's Syndrome
            • Treatment Goals
              • Key Endpoints Used in Clinical Trials for Sju00f6grenu2019s Syndrome
            • Key Current Therapies
              • Overview
              • Mechanism of Action of Key Current Drug Classes Used for Sju00f6grenu2019s Syndrome
              • Current Treatments Used for Sju00f6grenu2019s Syndrome
              • Market Events Impacting the Use of Key Current Therapies in Sju00f6grenu2019s Syndrome
              • Clinical Trial Outcomes for Pilocarpine
              • Advantages and Disadvantages of Pilocarpine
              • Key Results From Select Clinical Trials Investigating Pilocarpine for the Treatment of Sju00f6grenu2019s 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 Sju00f6grenu2019s Syndrome
              • Expert Insight: Cevimeline
              • 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 Sju00f6grenu2019s 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 Sju00f6grenu2019s 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 Sju00f6grenu2019s Syndrome
              • Advantages and Disadvantages of Orencia
              • Expert Insight: Orencia
              • Advantages and Disadvantages of Actemra / RoActemra
            • Medical Practice
              • Overview
              • Treatment Guidelines
              • Regional Sju00f6gren's Syndrome Treatment Guidelines
              • Factors Influencing Drug Selection in Sju00f6grenu2019s Syndrome
              • Generalized Treatment Decision Tree for Sju00f6grenu2019s Syndrome
          • Unmet Need Overview
            • Current and Future Attainment of Unmet Needs in Sju00f6grenu2019s Syndrome
            • Top Unmet Needs in Sju00f6grenu2019s Syndrome: Current and Future Attainment
            • Expert Insight: Unmet Needs in Sju00f6grenu2019s Syndrome
          • Drug Pipeline
            • Pipeline
            • Regulatory Milestones
            • Indication Comparison
          • Emerging Therapies
            • Key Findings
              • Key Emerging Therapies
                • Notable Developments Among Key Emerging Therapies for Sju00f6grenu2019s Syndrome
                • Key Therapies in Development for Sju00f6grenu2019s Syndrome
                • Ianalumab
                • Analysis of the Ianalumab Clinical Development Program
                • Expert Insight: Ianalumab
                • Expectations for Launch and Sales Opportunity of Ianalumab in Sju00f6grenu2019s Syndrome
                • Iscalimab Clinical Profile
                • Key Ongoing Clinical Trials of Iscalimab in the Treatment of Sju00f6grenu2019s Syndrome
                • Analysis of the Iscalimab Clinical Development Program
                • Expert Insight: Iscalimab
                • Expectations for Launch and Sales Opportunity of Iscalimab in Sju00f6grenu2019s Syndrome
                • Dazodalibep Clinical Profile
                • Key Ongoing Clinical Trials of Dazodalibep in the Treatment of Sju00f6grenu2019s Syndrome
                • Analysis of the Dazodalibep Clinical Development Program
                • Expert Insight: Dazodalibep
                • Expectations for Launch and Sales Opportunity of Dazodalibep in Sju00f6grenu2019s Syndrome
                • SAR441344 Clinical Profile
                • Key Ongoing Clinical Trials of SAR441344 in the Treatment of Sju00f6grenu2019s Syndrome
                • Analysis of the SAR441344 Clinical Development Program
                • Expectations for Launch and Sales Opportunity of SAR441344 in Sju00f6grenu2019s 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 Sju00f6grenu2019s Syndrome
                • Remibrutinib Clinical Profile
                • Key Ongoing Clinical Trials of Remibrutinib in the Treatment of Sju00f6grenu2019s Syndrome
                • Analysis of the Remibrutinib Clinical Development Program
                • Expectations for Launch and Sales Opportunity of Remibrutinib in Sju00f6grenu2019s Syndrome
                • Branebrutinib
                • Branebrutinib Clinical Profile
                • Key Ongoing Clinical Trials of Branebrutinib in the Treatment of Sju00f6gren's Syndrome
                • Analysis of the Branebrutinib Clinical Development Program
                • Expectations for Launch and Sales Opportunity of Branebrutinib in Sju00f6gren's Syndrome
                • Expert Insight: Tyrosine Kinase Inhibitors
              • Early-Phase Pipeline Analysis
                • Overview
                • Compounds in Early-Phase Development for Sju00f6grenu2019s Syndrome
              • Symptomatic Therapy in Development for Sju00f6grenu2019s Syndrome
                • Symptomatic Therapy in Late-Stage Development for Sju00f6grenu2019s Syndrome
              • Key Discontinuations and Failures in Sju00f6grenu2019s Syndrome
                • Key Discontinuations and Failures
              • Patient Registries
                • Patient Registries for Sju00f6gren's Syndrome
                • Prominent Sju00f6grenu2019s Syndrome Patient Organizations
            • Access & Reimbursement Overview
              • Region-Specific Reimbursement Practices
                • Key Market Access Considerations in Sju00f6gren's Syndrome: United States
                • General Reimbursement Environment: United States
                • Key Market Access Considerations in Sju00f6gren's Syndrome: EU5
                • General Reimbursement Environment: EU5
            • Appendix
              • Bibliography

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