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), 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.
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
- Sjogren's 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
- Sjogren's syndrome key findings 2022
- 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
- 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
- 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
- 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
- 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
- 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
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, 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.