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.
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.
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.
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
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
Sukhvinder Singh
Sukhvinder Singh, M.Tech., is a senior analyst on the Infectious, Niche, and Rare Diseases team at Clarivate. He has several years of experience providing research and analytics support in the pharmaceutical domain. He has worked in numerous therapy areas, including ophthalmology, dermatology, neurology, and rare diseases. Prior to joining Clarivate, Mr. Singh was an assistant project manager on the forecasting and analytics team at DelveInsight Business Research. He was responsible for preparing epidemiology and market research reports, which included pipeline assessments, sales forecasting, and commercial opportunity assessments. He earned his master’s degree in technology and biotechnology at Amity University in Noida, India.
Rafael Widjajahakim
Rafael Widjajahakim, M.S., is an analyst on the Infectious, Niche, and Rare Diseases team at Clarivate. Prior to joining the company, he was a clinical research coordinator at University of Massachusetts Medical School. He received his master of science degree in clinical investigation from Boston University and his bachelor of science degree in biology from Suffolk University.