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(Albany, New York) – September 29, 2026: DelveInsight’s report “Sjogren’s Syndrome Market Insights, Epidemiology, and Market Forecast-2036,” provides a comprehensive analysis of the Sjogren’s Syndrome landscape. The report delivers detailed insights into the disease, including historical and projected epidemiology, helping stakeholders understand the prevalence, incidence, and patient demographics across key regions.

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Some of the key facts of the Sjogren’s syndrome Market Report:

• The Sjögren’s disease market size across the 7MM was valued at approximately USD 1 billion in 2025 and is projected to reach nearly USD 10 billion by 2036, expanding at a CAGR of 26.2% during the forecast period from 2026 to 2036.

• In September 2026, DDY391/MRT-6160: Phase II Initiation: Novartis initiated the Phase II study of DDY391 in Sjögren’s disease, triggering a $50 million milestone payment to Monte Rosa Therapeutics.

• In August 2026, Novartis’ Phase III THALASSA study evaluating ianalumab in patients with high-symptom-burden Sjögren’s disease was listed as recruiting, with the study initiated in July 2026.

• In July 2026, The Sjögren’s disease Phase IIa/b study of DDY391 was registered, evaluating the VAV1-directed molecular glue degrader for up to 52 weeks. The study is designed to assess efficacy, safety, tolerability, and dose response to support potential Phase III development.

• In June 2026, Johnson & Johnson reported new biomarker exploratory analyses from the Phase II DAHLIAS study evaluating nipocalimab in adults with moderate-to-severe Sjögren’s disease, a showing that participants with elevated autoantibody and immunoglobulin G (IgG) levels, who are often those who experience more substantial disease burden, showed greater clinical response rates.

• In May 2026, Researchers and sponsors continued to evaluate data from pivotal clinical studies of ianalumab and dazodalibep, while ongoing research efforts investigated novel therapeutic approaches targeting B-cell signaling, CD40-CD40L pathway interactions, and FcRn-mediated autoantibody mechanisms to address underlying disease processes.

• In April 2026, Novartis reported that ianalumab had received FDA Priority Review, while regulatory submissions had been completed in the US, Europe, and Japan, marking the transition of the program into global regulatory review.

• In April 2026, Enrollment and patient follow-up activities remained ongoing across multiple global Phase III clinical trials evaluating innovative immunomodulatory therapies for Sjögren’s syndrome, with efforts focused on lowering systemic disease burden and enhancing salivary and lacrimal gland function.

• In February 2026, Amgen continued to advance dazodalibep through its Phase III clinical program, including the HZNP-DAZ-301 and HZNP-DAZ-303 trials, which are evaluating the therapy in patients with moderate-to-severe Sjögren’s syndrome. These studies are designed to assess the treatment’s impact on systemic disease activity, symptom severity, and patient-reported clinical outcomes.

• In January 2026, Novartis announced that the U.S. Food and Drug Administration has granted Breakthrough Therapy designation to ianalumab for the treatment of Sjögren’s disease, the second most common rheumatic autoimmune disorder. Ianalumab is a fully human monoclonal antibody with a dual mechanism of action, targeting B-cells by both depleting them and inhibiting their activation and survival through BAFF-R blockade. Novartis intends to begin global regulatory submissions for ianalumab in early 2026. If approved, it would become the first targeted therapy for patients with Sjögren’s disease.

• In December 2025, Amgen carried out a Phase 3 randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of dazodalibep in participants with Sjögren’s syndrome exhibiting moderate-to-severe systemic disease activity.

• In December 2025, Novartis Pharmaceuticals announced a clinical study to evaluate the efficacy, safety, and tolerability of ianalumab (VAY736) in patients with active Sjögren’s syndrome. The study aims to assess the effects of monthly subcutaneous (s.c.) administration of ianalumab (VAY736) versus placebo in this patient population.

• In December 2025, Bristol Myers Squibb has initiated a Phase 3 clinical trial to evaluate the safety and efficacy of two dosing regimens of deucravacitinib in adult patients with active Sjögren’s syndrome.

• In August 2025, Novartis was seeking approval for its Sjögren’s disease therapy after positive results from two Phase III trials. The NEPTUNUS-1 (NCT05350072) and NEPTUNUS-2 (NCT05349214) studies evaluating ianalumab achieved their primary goal of reducing disease activity, as measured by the EULAR Sjögren’s Syndrome Disease Activity Index (ESSDAI) compared to placebo. The trials included 749 patients, with NEPTUNUS-1 assessing monthly intravenous ianalumab and NEPTUNUS-2 evaluating the safety and efficacy of subcutaneous ianalumab administered either monthly or every three months.

• In March 2025, Johnson & Johnson announced that the US FDA has granted investigational nipocalimab Fast Track designation (FTD) for the treatment of adult patients with moderate-to-severe Sjogren’s disease, having previously been granted Breakthrough Therapy designation (BTD) for the investigational therapy late last year.

• In March 2025, Drawing on results from the Phase II DAHLIAS (NCT04968912) trial, the FDA has awarded Fast Track designation (FTD) to nipocalimab for the treatment of moderate-to-severe Sjögren’s disease. This marks the first Fast Track granted to an FcRn blocker for this condition and is expected to accelerate the development of the investigational therapy, which, if approved, would become the first FcRn blocker indicated for this autoantibody-driven disease.

• In March 2025, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation (FTD) to its investigational therapy, nipocalimab, for treating adults with moderate-to-severe Sjögren’s disease (SjD). This follows the Breakthrough Therapy designation (BTD) received for the same therapy late last year. Presently, there are no advanced treatments approved specifically for this condition.

• In 2025, the Sjögren’s disease market size in the US was nearly USD 700 million. This figure is expected to grow significantly with the introduction of emerging therapies.

• The total market size of EU4 and the UK was estimated to approximately USD 300 million in 2025.

• Among EU4 and the UK, Germany accounted for the highest market share with approximately USD 150 million in 2025, followed by the UK with approximately USD 60 million in the respective year, and France capturing the least market with nearly USD 10 million in 2025.

• In 2025, the total market size of Sjögren’s disease was more than USD 30 million in Japan, which is anticipated to increase during the forecast period (2026–2036).

• In the US, total diagnosed prevalent cases of Sjögren’s disease were approximately 730,000 in 2025, supported by improved recognition of patients presenting with persistent sicca symptoms and the increasing adoption of serological testing, which facilitates disease identification and diagnosis.

• According to DelveInsight analysis, gender-specific diagnosed prevalent cases of Sjögren’s disease in the US in 2025 were predominantly female, accounting for more than 650,000 cases, compared with around 75,000 male cases, reflecting the disease’s established female predominance.

• In 2025, Anti-Ro/SSA-positive cases represented the largest antibody-specific segment of diagnosed prevalent Sjögren’s disease cases across EU4 and the UK, totaling to approximately 410,000 cases, followed by Anti-La/SSB-positive cases at around 290,000.

• According to DelveInsight analysis, Japan recorded approximately 120,000 diagnosed prevalent cases of Sjögren’s disease in 2025, of which nearly 82,000 were mild cases, while around 35,000 were moderate-to-severe cases, indicating a substantial diagnosed patient pool with varying disease severity.

• Key Sjogren’s syndrome Companies: Astellas Pharma, Immunovant Sciences, NK Cells Artiva Biotherapeutics, Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others

• Key Sjogren’s syndrome Therapies: ASP5502, IMVT-1402, Allogeneic, R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others

Sjogren’s syndrome Overview

Sjogren’s Syndrome is a chronic autoimmune disorder in which the body’s immune system attacks its own moisture-producing glands, primarily affecting the salivary and tear glands. This leads to persistent dry mouth and dry eyes, and it can also cause fatigue, joint pain, and involvement of other organs such as the kidneys, lungs, or nervous system. Sjogren’s syndrome can occur alone (primary) or alongside other autoimmune diseases like rheumatoid arthritis or lupus (secondary). While there is no cure, treatment focuses on relieving symptoms, preventing complications, and managing systemic manifestations.

To Know in detail about the Sjogren’s syndrome market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Sjogren’s syndrome Market Insights

Sjogren’s Syndrome Epidemiology

The Sjogren’s Syndrome epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Sjogren’s syndrome Epidemiology Segmentation:

The Sjogren’s syndrome market report proffers epidemiological analysis for the study period 2022–2036 in the 7MM segmented into:

• Total Diagnosed Prevalent Cases of Sjögren’s Disease

• Type-specific Diagnosed Prevalent Cases of Sjögren’s Disease

• Gender-specific Cases of Sjögren’s Disease

• Antibody-specific Cases of Sjögren’s Disease

• Severity Specific Distribution (ESSDAI Score)

• Treated Cases of Sjögren’s Disease

Download the report to understand which factors are driving Sjogren’s syndrome epidemiology trends @ Sjogren’s syndrome Epidemiological Insights

Sjogren’s syndrome Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Sjogren’s syndrome market or expected to get launched during the study period. The analysis covers Sjogren’s syndrome market uptake by drugs, patient uptake by therapies, and sales of each drug.

Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.

The report also covers the Sjogren’s syndrome Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyses recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Sjogren’s syndrome Therapies and Key Companies

• Ianalumab (VAY736): Novartis

• Nipocalimab (IMAAVY): Johnson & Johnson

• ASP5502: Astellas Pharma Inc

• IMVT-1402: Immunovant Sciences

• Allogeneic: NK Cells Artiva Biotherapeutics

• R-2487: Rise Therapeutics

• BMS-986325: Bristol-Myers Squibb

• RSLV-132: Resolve Therapeutics

• CFZ533: Novartis

• VIB4920: Horizon Therapeutics

• VAY736: Novartis

• Dazodalibep (VIB4920): Horizon Therapeutics (Amgen)

• OXERVATE (cenegermin): Dompe Farmaceutici

• Tivanisiran (SYL1001): Sylentis

• Lusvertikimab (formerly OSE-127): OSE Immunotherapeutics/Servier

• Nipocalimab: Johnson & Johnson

To know more about Sjogren’s syndrome treatment, visit @ Sjogren’s syndrome Medications

Sjogren’s syndrome Market Drivers

• Rising Prevalence of Autoimmune Disorders: Increasing cases of Sjögren’s syndrome globally, particularly among women, drive demand for therapies.

• Advancements in Targeted Biologics: Development of B-cell targeted therapies, JAK inhibitors, and other immunomodulatory drugs improves treatment outcomes.

• Growing Awareness and Early Diagnosis: Enhanced awareness among physicians and patients facilitates timely treatment initiation.

• Expansion of Clinical Trials: Rising global R&D activity accelerates the development of novel therapies.

• Shift Toward Personalized Medicine: Biomarker-driven and patient-specific treatment approaches enhance therapeutic effectiveness.

Sjogren’s syndrome Market Barriers

• Limited Approved Therapies: Few disease-modifying treatments are currently approved, restricting treatment options.

• High Treatment Costs: Biologics and advanced therapies are expensive, limiting patient access.

• Diagnostic Challenges: Non-specific symptoms and slow disease progression can delay diagnosis.

• Variability in Patient Response: Heterogeneous disease manifestations make treatment standardization difficult.

• Regulatory and Reimbursement Hurdles: Complex approval processes and limited insurance coverage may hinder market expansion.

Scope of the Sjogren’s syndrome Market Report

• Study Period: 2022–2036

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Sjogren’s syndrome Companies: Astellas Pharma, Immunovant Sciences, NK Cells Artiva Biotherapeutics, Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others

• Key Sjogren’s syndrome Therapies: ASP5502, IMVT-1402, Allogeneic, R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others

• Sjogren’s syndrome Therapeutic Assessment: Sjogren’s syndrome current marketed and Sjogren’s syndrome emerging therapies

• Sjogren’s syndrome Market Dynamics: Sjogren’s syndrome market drivers and Sjogren’s syndrome market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Sjogren’s syndrome Unmet Needs, KOL’s views, Analyst’s views, Sjogren’s syndrome Market Access and Reimbursement

Discover more about therapies set to grab major Sjogren’s syndrome market share @ Sjogren’s syndrome Treatment Landscape

Table of Contents

1. Sjogren’s syndrome Market Report Introduction

2. Executive Summary for Sjogren’s syndrome

3. SWOT analysis of Sjogren’s syndrome

4. Sjogren’s syndrome Patient Share (%) Overview at a Glance

5. Sjogren’s syndrome Market Overview at a Glance

6. Sjogren’s syndrome Disease Background and Overview

7. Sjogren’s syndrome Epidemiology and Patient Population

8. Country-Specific Patient Population of Sjogren’s syndrome

9. Sjogren’s syndrome Current Treatment and Medical Practices

10. Sjogren’s syndrome Unmet Needs

11. Sjogren’s syndrome Emerging Therapies

12. Sjogren’s syndrome Market Outlook

13. Country-Wise Sjogren’s syndrome Market Analysis (2022–2036)

14. Sjogren’s syndrome Market Access and Reimbursement of Therapies

15. Sjogren’s syndrome Market drivers

16. Sjogren’s syndrome Market barriers

17. Sjogren’s syndrome Appendix

18. Sjogren’s syndrome Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. It supports Pharma companies by providing comprehensive end-to-end solutions to improve their performance.

It also offers Healthcare Consulting Services, which benefits in market analysis to accelerate the business growth and overcome challenges with a practical approach.

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