Sjogrens 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; the disease 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 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 are in development for SS (e.g., Novartis’s iscalimab and ianalumab), 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 SS is an indication in which such success has historically been a challenge.

Questions answered

  • How large is the SS population and how will its size change over time?
  • How is SS currently managed? What are the current 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 clinical roles will Novartis’s iscalimab and ianalumab play in the evolving SS treatment landscape?
  • What are the drivers of and constraints in the SS market, and how will the market evolve through 2031?

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 by subtype.
  • Forecast: Drug-level sales and patient share of key SS therapies through 2031.
  • Emerging therapies: Phase III/PR: 1 drug; Phase II: 7+ drugs; coverage of select early-phase products.

Product description

Niche & Rare Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

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Solution enhancement

Niche & Rare Disease Landscape & Forecast introduces a new Drug Pipeline chapter with real-time, global pipeline intelligence content directly from Cortellis. This chapter is updated daily and features interactive figures that can be easily downloaded for detailed analysis or presentations.

Table of contents

  • Sjogrens Syndrome - Landscape & Forecast - Disease Landscape & Forecast
    • Key findings
      • Sjogren's syndrome key findings 2022
        • Title
        • Key takeaways
        • The SS therapy market will add more than $1.9 billion in annual sales of brand-name drugs by 2031 due to the launch of the first approved DMTs for this disease
        • Novartisu2019s ianalumab and iscalimab will be the first DMTs to enter the SS market by 2027 and 2028, respectively
        • The drug-treated SS patient population will grow slightly owing to an increase in prevalent cases and general population growth
        • Current treatment strategies for SS target symptoms using predominantly generic drugs or off-label prescriptions of biologics
        • The approval of safe and effective DMTs for SS remains a major unmet need
        • About the analysts
    • Commercial outlook
      • Key findings
        • Regional sales of key therapies to treat Sju00f6gren's syndrome in 2021 and 2031
        • 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): 2021-2031
        • 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
              • Expert insight: treatment goals
            • 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
              • Expert insight: 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
                • 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
                • Expert insight: tyrosine kinase inhibitors
                • 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 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
              • Early-phase pipeline analysis
                • Compounds in early-phase development for Sju00f6grenu2019s syndrome
              • Symptomatic therapy in development for Sju00f6grenu2019s syndrome
                • Symptomatic therapy in late-phase 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
              • Orphan drug designation
              • 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
                • Abbreviations
                • Bibliography

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