DelveInsight's “Sjogren’s Syndrome Market Insight, Epidemiology and Market Forecast – 2034” report delivers an in-depth understanding of Sjogren’s Syndrome, historical and forecasted epidemiology as well as the Sjogren’s Syndrome market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
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Key Takeaways from the Sjogren’s Syndrome Market Report
- In December 2025, Amgen conducted a phase 3 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Dazodalibep in Participants With Sjögren's Syndrome With Moderate-to-severe Systemic Disease Activity.
- In December 2025, Novartis Pharmaceuticals announced a study of the clinical efficacy, safety and tolerability of ianalumab (VAY736) in patients with active Sjogren's syndrome. The purpose of the study is to demonstrate the clinical efficacy, safety and tolerability of ianalumab (VAY736) administered subcutaneously (s.c.) monthly compared to placebo in patients with active Sjogren's syndrome.
- In December 2025, Bristol-Myers Squibb initiated a phase 3 study is to assess the safety and efficacy of two doses of Deucravacitinib in adult participants with Active Sjögren's Syndrome.
- In the US, nearly 1,500,000 diagnosed prevalent cases of Sjogren’s syndrome were observed in the year 2023, which is expected to increase during the forecast period (2024–2034).
- In the US, the highest number of antigen-specific cases accounted for auto-antibodies (+ve), followed by anti-Ro/SSA (+ve) and anti-La/SSB (+ve) in 2023.
- As per DelveInsight’s analysis, a higher number of cases were observed for mild than moderate to severe, based on severity-specific cases of Sjogren’s syndrome, throughout the 7MM.
- Among EU4 and the UK, the majority of Sjogren’s syndrome cases were reported in females. The highest number of gender-specific cases was observed in the United Kingdom in 2023.
- In 2023, the US accounted for the highest number of treated cases, whereas Japan had the lowest number of treated cases. In Japan, there were around 54,000 treated cases of Sjogren’s syndrome in 2023. These cases are likely to rise by 2034.
- The leading Sjogren's Syndrome Companies such as ADVANZ Pharma, Daiichi Sankyo, Resolve Therapeutics, GlaxoSmithKline, VIELABIO, RemeGen, Bristol Myers Squibb, TearSolutions, Pfizer Inc., AstraZeneca plc, Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, AbbVie Inc., Eli Lilly and Company, Biogen Inc., Amgen Inc., Celgene Corporation, Genentech, Inc, Boehringer Ingelheim International GmbH, Takeda Pharmaceutical Company Limited, Gilead Sciences, Inc., Merck & Co., Inc., Vertex Pharmaceuticals Incorporated, Bayer AG, and others.
- Promising Sjogren’s Syndrome Pipeline Therapies such as Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib and others.
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Sjogren’s Syndrome Epidemiology Segmentation in the 7MM
- Sjogren’s Syndrome Diagnosed Prevalence Cases
- Sjogren’s Syndrome Gender-specific Cases
- Sjogren’s Syndrome Type-Specific Cases
- Sjogren’s Syndrome Severity-Specific Cases
- Sjogren’s Syndrome Antibody-Specific cases
- Sjogren’s Syndrome Treated cases
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Marketed Sjogren’s syndrome Therapies
- SALAGEN (pilocarpine): ADVANZ Pharma
SALAGEN (pilocarpine) tablets are made from the naturally occurring alkaloid pilocarpine obtained from the leaflets of the South American shrub Pilocarpus jaborandi. Pilocarpine HCl is a cholinomimetic (cholinergic parasympathomimetic) agent capable of exerting a broad spectrum of pharmacologic effects with predominant muscarinic action. SALAGEN indications include the treatment of symptoms of dry mouth from salivary gland hypofunction caused by radiotherapy for cancer of the head and neck and the treatment of symptoms of dry mouth in patients with Sjogren’s syndrome.
- EVOXAC (cevimeline): Daiichi Sankyo
EVOXAC (cevimeline) is a cholinergic agonist which binds to muscarinic receptors. Muscarinic agonists in enough dosage can increase the secretion of exocrine glands, such as salivary and sweat glands, and increase the tone of the smooth muscle in the gastrointestinal and urinary tracts. EVOXAC was developed by Daiichi Sankyo and is approved in the US, Europe, and Japan to treat patients with symptoms of dry mouth in patients with Sjogren’s syndrome. In January 2022, Daiichi Sankyo entered into an agreement with Cosette Pharmaceuticals; Daiichi Sankyo divested, and Cosette acquired rights for manufacturing, commercialization, and certain other rights for EVOXAC (cevimeline HCL) in the US.
Emerging Sjogren’s Syndrome Drugs
- CFZ 533 (iscalimab): Novartis
CFZ 533 (iscalimab) is a novel, fully human IGg1 anti-CD40 monoclonal antibody, preventing cluster of differentiation (CD40) pathway signaling and activation of CD40+ cell types. Currently, it is being evaluated in a Phase II clinical trial to treat patients with Sjogren’s syndrome. Apart from this indication, the company is also developing this molecule to treat patients with generalized myasthenia gravis, grave disease, rheumatoid arthritis, lupus nephritis, and renal transplant rejection.
- VIB4920 (dazodalibep): Amgen
Dazodalibep is a CD40 ligand antagonist that blocks T-cell interaction with CD40-expressing B cells, disrupting the overactivation of the CD40 ligand co-stimulatory pathway. Currently, Amgen is in the recruiting phase for its Phase III clinical development of dazodalibep, an investigational medicine for the treatment of Sjogren’s syndrome. In November 2023, Amgen announced promising results from its Phase II study of dazodalibep for treating Sjogren’s syndrome.
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Sjogren’s Syndrome Companies
ADVANZ Pharma, Daiichi Sankyo, Resolve Therapeutics, GlaxoSmithKline, VIELABIO, RemeGen, Bristol Myers Squibb, TearSolutions, Pfizer Inc., AstraZeneca plc, Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, AbbVie Inc., Eli Lilly and Company, Biogen Inc., Amgen Inc., Celgene Corporation, Genentech, Inc, Boehringer Ingelheim International GmbH, Takeda Pharmaceutical Company Limited, Gilead Sciences, Inc., Merck & Co., Inc., Vertex Pharmaceuticals Incorporated, Bayer AG, and others.
Sjogren’s Syndrome Market Outlook
At present, the therapeutic Sjogren’s syndrome market size in the US is mainly accounted for by local therapies, systemic therapy, and biological therapies. The local therapies mainly include pilocarpine, cevimeline, topical fluoride, topical cyclosporine, autologous serum eye drops, and others. Systemic therapy mainly uses corticosteroids, hydroxychloroquine, and immunosuppressants. Methotrexate (MTX), Cyclosporine A, Azathioprine, Leflunomide, and Mycophenolic acid are also commonly used DMARDs. Biological therapy with rituximab is in extensive use in the US market. Along with this, TNF-alpha inhibitors, BAFF, and others are in development.
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Scope of the Sjogren’s Syndrome Market Report
- Coverage- 7MM
- Study Period- 2020-2034
- Sjogren’s Syndrome Companies- ADVANZ Pharma, Daiichi Sankyo, Resolve Therapeutics, GlaxoSmithKline, VIELABIO, RemeGen, Bristol Myers Squibb, TearSolutions, Pfizer Inc., AstraZeneca plc, Novartis AG, Sanofi S.A., Roche Holding AG, Johnson & Johnson, AbbVie Inc., Eli Lilly and Company, Biogen Inc., Amgen Inc., Celgene Corporation, Genentech, Inc, Boehringer Ingelheim International GmbH, Takeda Pharmaceutical Company Limited, Gilead Sciences, Inc., Merck & Co., Inc., Vertex Pharmaceuticals Incorporated, Bayer AG, and others.
- Sjogren’s Syndrome Pipeline Therapies- Baricitinib, Hydroxychloroquine, HZN-1116, Nipocalimab, RSLV-132, Lanraplenib, Filgotinib and others.
- Sjogren’s Syndrome Competitive Intelligence Analysis: SWOT analysis and Market entry strategies
- Sjogren’s Syndrome Unmet Needs, KOL's views, Analyst's views, Sjogren’s Syndrome Market Access and Reimbursement
Table of Contents
1. Key Insights
2. Sjogren’s Syndrome Market Report Introduction
3. Country-wise Sjogren’s Syndrome Market Overview at a Glance
4. Sjogren’s Syndrome Market Overview by Therapeutic Class
5. Methodology of Sjogren’s Syndrome Epidemiology and Market
6. Sjogren’s Syndrome Executive Summary
7. Key Events
8. Sjogren’s Syndrome Disease Background and Overview
9. Sjogren’s Syndrome Epidemiology and Patient Population
10. Sjogren’s Syndrome Patient Journey
11. Sjogren’s Syndrome Marketed Drugs
12. Sjogren’s Syndrome Emerging Drugs
13. Sjogren’s Syndrome: Market Analysis
14. Key Opinion Leaders' Views
15. Sjogren’s Syndrome SWOT Analysis
16. Sjogren’s Syndrome Unmet needs
17. Sjogren’s Syndrome Market Access and Reimbursement
18. Appendix
19. Sjogren’s Syndrome Report Methodology
20. DelveInsight Capabilities
21. Disclaimer
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