DelveInsight’s report “Sjogren’s Syndrome Market Insights, Epidemiology, and Market Forecast-2034,” 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.

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

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

• In 2023, the total Sjogren’s syndrome market size was approximately USD 1,900 million across the 7MM and is anticipated to grow by 2034 over the study period (2020–2034).

• In 2024, the total number of diagnosed Sjögren’s syndrome cases in the 7MM was approximately 3.3 million, and this figure is projected to rise over the forecast period of 2025–2034.

• Among these, the United States reported the highest prevalence in 2024, with around 1.785 million diagnosed cases, a number expected to grow by 2034. In terms of disease severity in the US, approximately 1.515 million cases were classified as mild, while about 265,000 cases were moderate to severe in 2024. Both categories are anticipated to increase throughout the forecast period.

• In 2024, of the type-specific Sjögren’s syndrome cases in the US, approximately 1,070,000 were classified as Primary Sjögren’s Syndrome, while around 710,000 were identified as Secondary Sjögren’s Syndrome.

• Within the EU4 and the UK, the United Kingdom reported the highest number of diagnosed Sjögren’s syndrome cases, whereas Spain recorded the lowest.

• Several emerging therapies, including ianalumab (VAY736), SOTYKTU (deucravacitinib), and dazodalibep (VIB4920), are currently in late-stage clinical development.

• Novartis and Amgen are key players in the Sjögren’s syndrome market, with their respective therapies, CFZ533 (iscalimab) and VIB4920 (dazodalibep), expected to generate the highest revenue across the 7MM by 2034.

• 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.

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Key Trends in Sjogren’s Syndrome Therapeutics Market:

• Emergence of Targeted Biologics: Growing development of B-cell targeted therapies, JAK inhibitors, and other biologics for better disease management.

• Shift Toward Personalized Medicine: Increasing focus on biomarker-driven treatment strategies tailored to individual patient profiles.

• Expansion of Clinical Trials: Rising number of global trials exploring novel immunomodulatory and anti-inflammatory therapies.

• Development of Combination Therapies: Trend toward combining biologics with standard immunosuppressive treatments to improve patient outcomes.

• Adoption of Advanced Drug Delivery Systems: Innovations like subcutaneous and sustained-release formulations to enhance patient compliance and efficacy.

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 2020 to 2034. 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 2020–2034 in the 7MM segmented into:

• Diagnosed Prevalent Cases of Sjogren’s syndrome in the US

• Gender-specific Cases of Sjogren’s syndrome in the US

• Antigen-Specific cases of Sjogren’s syndrome in the US

• Treated cases of Sjogren’s syndrome in the US

• Severity-Specific Cases of Sjogren’s syndrome in the US

• Type-Specific Cases of Sjogren’s syndrome in the US

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

Recent Developments In The Sjogren’s syndrome Treatment Landscape:

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 November 2024, Johnson & Johnson (J&J) has announced encouraging findings from the Phase II DAHLIAS trial evaluating nipocalimab, a neonatal Fc receptor (FcRn) blocker, for the treatment of moderate-to-severe Sjögren’s disease (SjD). This placebo-controlled, multicenter, double-blind study examined the efficacy of nipocalimab in adults with primary Sjögren’s syndrome.

• In June 2024, Johnson & Johnson reported results from the Phase II DAHLIAS dose-ranging study, where its monoclonal antibody nipocalimab showed significant improvements in Sjögren’s disease (SjD) activity in patients. DAHLIAS is a randomized, multicenter, placebo-controlled, double-blind trial that assessed the effects of nipocalimab in adults with primary SjD, a chronic and debilitating autoimmune disorder.

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

• 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: 2020–2034

• 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 (2020–2034)

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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