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; 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 and Horizon Therapeutic’s dazodalibep), 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, and Horizon Therapeutics’ dazodalibep 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 2032?
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 2032.
- Emerging therapies: Phase 3/PR: 1 drug; Phase 2: 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.
Solution enhancement
Niche & Rare Disease Landscape & Forecast introduces a 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
- Sjogren's Syndrome - Landscape & Forecast - Disease Landscape & Forecast
- Key Findings
- Sjogren's Syndrome Key Findings 2023
- Commercial Outlook
- Key findings
- Regional sales of key therapies to treat Sju00f6gren's syndrome in 2022 and 2032
- 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
- Alternative market scenario
- Alternative market scenario for Sjogren's syndrome through 2032
- Key findings
- 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
- Disease overview
- Epidemiology
- Key findings
- Epidemiology populations
- Disease definition, methods, and sources used
- Diagnosed prevalent cases of Sju00f6gren's syndrome: 2022-2032
- Diagnosed prevalent cases of primary Sju00f6gren's syndrome: 2022-2032
- Diagnosed prevalent cases of secondary Sju00f6gren's syndrome: 2022-2032
- Drug-treated, diagnosed prevalent cases of Sju00f6gren's syndrome in the United States and Europe: 2022-2032
- Key findings
- 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
- Key findings
- 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
- Launch dates for key emerging therapies
- Key ongoing clinical trials of ianalumab in the treatment of 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
- Analysis of the dazodalibep clinical development program
- Expert insight: dazodalibep
- Expectations for launch and sales opportunity of dazodalibep in Sju00f6grenu2019s syndrome
- Frexalimab (SAR441344) clinical profile
- Key ongoing clinical trials of frexalimab (SAR441344) in the treatment of Sju00f6grenu2019s syndrome
- Analysis of the frexalimab (SAR441344) clinical development program
- Expectations for launch and sales opportunity of frexalimab (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
- Analysis of the remibrutinib clinical development program
- Expectations for launch and sales opportunity of remibrutinib in Sju00f6grenu2019s 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
- Key findings
- 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
- Region-specific reimbursement practices
- Appendix
- Abbreviations
- Bibliography
- Key Findings
Naomi López Caraballo, Ph.D., Healthcare Research & Data Analyst, Infectious, Niche, and Rare Diseases. Dr. López Caraballo is a healthcare research and data analyst for the rare disorders therapy market. She holds a Ph.D. in neuroscience and physiology from the New York University School of Medicine and a B.S. in industrial biotechnology from the University of Puerto Rico in Mayaguez.
Mohani Latwal, B.P.T., M.P.H., Epidemiologist, Epidemiology. Prior to joining Clarivate, she worked as a deputy manager at an NGO. She received her bachelor’s degree in physiotherapy from Delhi University and her master’s degree in public health with a specialization in social epidemiology from the Tata Institute of Social Sciences in Mumbai.