Sjögren's Syndrome Market to Witness Sustained Growth During the Forecast Period (2026-2036) Due to the Development of Targeted Immunotherapies, FcRn Inhibitors, TYK2 Inhibitors, and Cell Therapies | DelveInsight
The Sjögren's syndrome market is undergoing a notable transformation, moving beyond traditional symptomatic management toward targeted immunomodulatory therapies. Emerging candidates, including Telitacicept (Vor Biopharma), Dazodalibep (Amgen), Nipocalimab (Johnson & Johnson), Deucravacitinib (SOTYKTU; Bristol-Myers Squibb), and others, are drawing considerable attention for their potential to target underlying disease pathways, modulate autoimmune activity, and restore or improve glandular function.
LAS VEGAS, Sept. 16, 2026 /PRNewswire/ -- Recently published Sjogren's Syndrome Market Insights report includes a comprehensive understanding of current treatment practices, Sjogren's syndrome emerging drugs, market share of individual therapies, and current and forecasted market size from 2022 to 2036, segmented into leading markets [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Sjogren's Syndrome Market Summary
Discover Sjogren's syndrome clinical trial 2026 update press release @ https://www.delveinsight.com/report-store/sjogrens-syndrome-market-size
Key Factors Driving the Growth of the Sjogren's Syndrome Market
Aparna Thakur, Project Manager of Forecasting & Analytics at DelveInsight, said that Ianalumab, with its dual mechanism, positive Phase III results, and FDA Breakthrough Therapy designation, has the potential to become the first targeted disease-modifying therapy, driving a paradigm shift in treatment.
Sjogren's Syndrome Market Analysis
Sjogren's Syndrome Competitive Landscape
Some of the Sjogren's syndrome drugs under development include Telitacicept (Vor Biopharma), Dazodalibep (Amgen), Nipocalimab (Johnson & Johnson), Deucravacitinib (SOTYKTU; Bristol-Myers Squibb), Lanalumab (VAY736; Novartis), IMVT-1402 (Immunovant Sciences GmbH), Rapcabtagene autoleucel (YTB323; Novartis), AlloNK (Artiva Biotherapeutics), RSLV-132 (Resolve Therapeutics), and others.
Vor Biopharma's Telitacicept is a recombinant fusion protein under development for Sjögren's disease that simultaneously targets B-lymphocyte stimulator (BLyS/BAFF) and a proliferation-inducing ligand (APRIL), two key cytokines involved in B-cell activation and autoantibody production. In June 2025, Vor Biopharma secured exclusive development and commercialization rights to telitacicept outside Greater China from RemeGen. The therapy has an established clinical and regulatory track record in China, where it is approved for generalized myasthenia gravis (gMG), systemic lupus erythematosus (SLE), rheumatoid arthritis and Sjögren's disease, while regulatory submissions are under review for IgA nephropathy.
Building on its clinical experience across multiple autoimmune indications, telitacicept is advancing through global development programs spanning North America, Europe, Latin America, and Asia. Its broad mechanism and established clinical profile position it as a potential disease-modifying therapy for Sjögren's disease. Topline results from the ongoing global Phase III trial are expected in H1 2027 and could serve as a key catalyst for further regulatory submissions and commercial expansion.
Amgen's Dazodalibep is an investigational biologic targeting the CD40-CD40L pathway, a critical mediator of immune activation and autoimmune inflammation. By inhibiting CD40L-driven signaling, the therapy is designed to modulate disease activity, potentially improve glandular function, and alleviate hallmark symptoms of Sjögren's disease, including dry eyes and dry mouth. Clinical studies have demonstrated encouraging efficacy, supporting its potential as a disease-modifying treatment option in this underserved patient population. Dazodalibep is also backed by composition-of-matter patents covering its polypeptide structure, with intellectual property protection extending through 2034 in the United States and 2032 in Europe. This patent estate could support sustained market exclusivity and provide opportunities for long-term lifecycle management.
Resolve Therapeutics' RSLV-132 is a first-in-class RNase-Fc fusion protein designed to degrade extracellular RNA and thereby reduce activation of Toll-like receptors (TLR7 and TLR8) and downstream type I interferon signaling implicated in Sjögren's syndrome. The therapy is being investigated across autoimmune diseases characterized by dysregulated interferon signaling, including primary Sjögren's syndrome. In December 2024, Resolve Therapeutics initiated a randomized, placebo-controlled Phase II study (NCT06440525) evaluating RSLV-132 in patients with moderate-to-severe Sjögren's syndrome. The ongoing trial is assessing its potential to improve key disease manifestations, including fatigue, dryness, pain, and overall symptom burden, with study completion anticipated in December 2026. Positive findings could further validate extracellular RNA degradation as a therapeutic strategy and support subsequent clinical development in Sjögren's syndrome.
The anticipated launch of these emerging therapies are poised to transform the Sjogren's syndrome market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the Sjogren's syndrome market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth.
Discover more about the latest treatments for Sjogren's syndrome 2026 @ Sjogren's Syndrome Therapeutics Clinical Trials
Recent Developments in the Sjogren's Syndrome Market
Sjogren's Syndrome Epidemiology Segmentation
The Sjogren's syndrome epidemiology section provides insights into the historical and current Sjogren's syndrome patient pool and forecasted trends for the leading markets. In 2025, the diagnosed prevalent cases of Sjögren's disease were approximately ~180,000 in males, while females accounted for ~1.6 million cases, significantly higher than males, in the US.
The Sjogren's syndrome treatment market report proffers epidemiological analysis for the study period 2022–2036 in the leading markets, segmented into:
Sjogren's Syndrome Market Report Metrics
Details
Study Period
2022–2036
Coverage
7MM [The United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan].
Sjogren's Syndrome Epidemiology Segmentation
Diagnosed Prevalent Cases of Sjogren's Disease, Type-specific Diagnosed Prevalent Cases of Sjogren's Disease, Gender-specific Diagnosed Prevalent Cases of Sjogren's Disease, Severity-specific Diagnosed Prevalent Cases of Sjogren's Disease, Antigen-specific Diagnosed Prevalent Cases of Sjogren's Disease, and Total Treated Cases of Sjogren's Disease
Key Sjogren's Syndrome Companies
Vor Biopharma, Amgen, Johnson & Johnson, Bristol-Myers Squibb, Novartis, Immunovant Sciences GmbH, Artiva Biotherapeutics, Resolve Therapeutics, and others
Key Sjogren's Syndrome Therapies
Telitacicept, Dazodalibep, Nipocalimab, Deucravacitinib (SOTYKTU), Lanalumab (VAY736), IMVT-1402, Rapcabtagene autoleucel (YTB323), AlloNK, RSLV-132, and others
Scope of the Sjogren's Syndrome Market Report
Download the report to understand the Sjogren's syndrome treatment market @ Sjogren's Syndrome Drugs
Table of Contents
1
Sjogren's Syndrome Market Key Insights
2
Sjogren's Syndrome Market Report Introduction
3
Executive Summary of Sjogren's Disease
4
Key Events
5
Epidemiology and Market Forecast Methodology
6
Sjogren's Disease Market Overview at a Glance
6.1
Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
6.2
Market Share (%) Distribution of Sjogren's Disease By Therapies in the 7MM, in 2026
6.3
Market Share (%) Distribution of Sjogren's Disease By Therapies in the 7MM, in 2036
7
Disease Background and Overview of Sjogren's Disease
7.1
Introduction
7.2
Classification of Sjogren's syndrome
7.3
Signs and Symptoms
7.4
Etiology
7.5
Pathogenesis
7.6
Clinical Manifestations
7.7
Biomarkers in Sjogren's Syndrome
7.8
Diagnosis of Sjogren's Syndrome
8
Treatment and Management
8.1
Current Treatment Practices
8.2
Treatment Algorithm
8.3
Diagnosis and Treatment Guidelines
8
Epidemiology and Patient Population of Sjogren's Disease
8.1
Key Findings
8.2
Assumptions and Rationale
8.3
Total Diagnosed Prevalent Cases of Sjogren's Disease in the 7MM
8.4
The United States
8.4.1
Diagnosed Prevalent Cases of Sjogren's Disease in United States
8.4.2
Type-specific Diagnosed Prevalent Cases of Sjogren's Disease in United States
8.4.3
Gender-specific Diagnosed Prevalent Cases of Sjogren's Disease in United States
8.4.4
Severity-specific Diagnosed Prevalent Cases of Sjogren's Disease in United States
8.4.5
Antigen-specific Diagnosed Prevalent Cases of Sjogren's Disease in United States
8.4.6
Total Treated Cases of Sjogren's Disease in United States
8.5
EU4 and the UK
8.6
Japan
9
Patient Journey of Sjogren's Disease
10
Emerging Drugs of Sjogren's Disease
10.1
Competitive landscape of Emerging Therapies
10.2
Telitacicept (RC18): Vor Biopharma
10.2.1
Drug Description
10.2.2
Other Developmental Activities
10.2.3
Clinical Development
10.2.3.1
Clinical Trials Information
10.2.4
Safety and Efficacy
10.2.5
Analyst's Views
10.3
Dazodalibep: Amgen
Note: List to be continued in the report
11
Sjogren's Disease Market: 7MM Analysis
11.1
Key Findings
11.2
Sjogren's Syndrome Market Outlook
11.3
Conjoint Analysis
11.4
Key Sjogren's Syndrome Market Forecast Assumptions
11.5
Total Market Size of Sjogren's Disease in the 7MM
11.6
Total Market Size of Sjogren's Disease by Therapies in the 7MM
11.7
The United States Sjogren's Syndrome Market
11.7.1
Total Market Size of Sjogren's Disease in the United States
11.7.2
Total Market Size of Sjogren's Disease by Therapies in the United States
11.8
EU4 and the UK Sjogren's Syndrome Market
11.9
Japan Sjogren's Syndrome Market
12
Unmet Needs of Sjogren's Disease
13
SWOT Analysis of Sjogren's Disease
14
KOL Views of Sjogren's Disease
15
Market Access and Reimbursement of Sjogren's Disease
15.1
The United States
15.2
EU4 and the UK
15.3
Japan
15.4
Summary and comparison of Market Access and Pricing Policy Developments in 2025
15.5
Market Access and Reimbursement of Sjogren's Disease Therapies
16
Bibliography
17
Sjogren's Syndrome Market Report Methodology
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