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, 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). Dry eye in SS is treated with eye drops (e.g., Novartis’s Xiidra); dry mouth is treated with artificial saliva or muscarinic receptor agonists. Therapies with disease-modifying potential 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 SS is an indication in which success has historically proven to be a challenge.


  • 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 (e.g., Novartis’s iscalimab), and what sales might they garner in the SS market? What therapies of note are progressing in earlier phases?
  • What are the drivers and constraints in the SS market, and how will the market evolve through 2028?


  • 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, prevalence of primary SS
  • Forecast: Drug-level sales and patient share of key SS therapies in 2018 and 2028
  • Emerging Therapies: Phase II: 9 drugs; coverage of select preclinical and Phase I products

Table of contents

  • Disease Landscape & Forecast
    • COVID-19
    • Commercial Outlook
      • Key Findings
      • 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
      • Alternative Market Scenarios
    • Forecast
    • Etiology and Pathophysiology
      • Disease Overview
      • Clinical Presentation
        • Autoimmune Diseases Commonly Associated with Sjögren's Syndrome
        • Increased Risk of Lymphoma in Sjögren's Syndrome Patients
        • Sjögren's Syndrome Disease Activity Indices
      • Etiology
      • Pathophysiology
        • Dysregulation of Immune Function
      • Key Pathways and Drug Targets
    • Epidemiology
      • Key Findings
      • Epidemiology Populations
        • Diagnosed Prevalent Cases
        • Drug-Treated Cases of Sjögren's Syndrome
    • Current Treatment
      • Key Findings
      • Diagnosis
        • Treatment Providers and Referral Patterns
      • Treatment Goals
      • Key Current Therapies
        • Overview
        • Muscarinic Receptor Agonists
        • Anti-Inflammatory Ophthalmic Drugs
        • Antimalarials
        • Conventional Systemic Therapies
        • Biologics
      • Medical Practice
        • Overview
        • Treatment Guidelines
        • Region-Specific Treatment Practices
    • Unmet Need Overview
      • Current and Future Attainment of Unmet Needs in Sjögren's Syndrome
    • Emerging Therapies
      • Key Findings
      • Key Emerging Therapies
        • Notable Developments Among Key Emerging Therapies for Sjögren's Syndrome
        • B-cell Activation Factor Inhibitors
        • CD40 Inhibitors
        • PI3K Inhibitors
        • Ribonuclease Fc Fusion Proteins
        • Tyrosine Kinase Inhibitors
      • Early-Phase Pipeline Analysis
      • Patient Registries
        • Patient Organizations
    • Access & Reimbursement Overview
      • Region-Specific Reimbursement Practices
        • United States
        • EU5
      • Looking for More?
    • Methodology
      • Bottom-Up Forecasting Overview
        • Patient Populations
        • Drug-Specific Assumptions
      • Bottom-Up Forecast Assumptions
        • General Sources of Data
        • General Statements About Pricing
        • Dosing, Days of Therapy, and Compliance
        • Biosimilar Erosion
        • Out-Year Forecasting
      • Primary Market Research
        • Experts Interviewed
    • Appendix
      • Bibliography

Author(s): John Crowley; Sunali D. Goonesekera, SM

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 from the University of Massachusetts Medical School and a Bachelor’s degree from Worcester Polytechnic Institute.

Sunali Goonesekera is an Associate Epidemiologist at Decision Resources Group. Sunali holds a Master’s degree in Epidemiology from the Harvard School of Public Health and a in Biology (Honors) from Dartmouth College. Prior to joining Decision Resources Group, Sunali conducted epidemiological research and lead authored two manuscripts on racial/ethnic disparities in metabolic diseases at the New England Research Institutes. She has contributed to multiple publications in peer-reviewed journals in epidemiology and in the biological sciences.

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