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
- The total Sjogren's syndrome treatment market size is expected to grow positively by 2036 in the leading markets.
- The United States accounted for the largest Sjogren's syndrome treatment market size in the 7MM in 2025, compared to other major markets, including the EU4 countries (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
- In 2025, the total diagnosed prevalent cases of Sjogren's disease were ~3.3 million in the 7MM, which are expected to increase during the forecast period, i.e., 2026-2036.
- Leading Sjogren's syndrome companies, such as Vor Biopharma, Amgen, Johnson & Johnson, Bristol-Myers Squibb, Novartis, Immunovant Sciences GmbH, Artiva Biotherapeutics, Resolve Therapeutics, and others, are developing new Sjogren's syndrome treatment drugs that can be available in the Sjogren's syndrome market in the coming years.
- The promising Sjogren's syndrome therapies in clinical trials include Telitacicept, Dazodalibep, Nipocalimab, Deucravacitinib (SOTYKTU), Lanalumab (VAY736), IMVT-1402, Rapcabtagene autoleucel (YTB323), AlloNK, RSLV-132, and others.
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
- Increasing Prevalence of Autoimmune Disorders: The growing burden of autoimmune diseases is contributing to greater clinical attention toward Sjögren's syndrome. Improved understanding of its systemic manifestations is also expanding the diagnosed patient population.
- Growing Demand for Targeted Therapies: Limitations of symptomatic treatments have created a significant need for therapies that address the underlying autoimmune mechanisms. This unmet need is encouraging pharmaceutical companies to develop targeted and disease-modifying treatments.
- Expansion of Biologic and Immunomodulatory Therapies: Advances in understanding B-cell activity, T-cell pathways, cytokine signaling, and other immune mechanisms are driving interest in biologic and immunomodulatory treatments. These approaches could potentially improve outcomes for patients with moderate-to-severe disease.
- Advancements in Clinical Research and Drug Development: Key emerging therapies, including 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, aim to modulate B-cell activity, reduce pathogenic autoantibodies and inflammation, improve glandular function, and provide disease-modifying alternatives to current symptomatic treatments.
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
- The Sjögren's syndrome treatment landscape is poised for a significant transformation, evolving beyond the long-standing dependence on symptomatic and off-label therapies toward a new generation of targeted, disease-modifying treatments.
- These emerging therapies have the potential to address underlying disease mechanisms, improve control of systemic manifestations, and enhance long-term patient outcomes.
- A key factor shaping the Sjögren's syndrome market is the lack of FDA-approved disease-modifying therapies.
- Current management is largely centered on symptomatic treatment and off-label immunosuppressive agents, which may offer limited control of systemic disease manifestations and do not directly modify the underlying disease process.
- Currently, SALAGEN (pilocarpine) and EVOXAC (cevimeline) are approved for the management of dry mouth symptoms associated with Sjögren's syndrome.
- However, these therapies primarily address symptomatic burden rather than the broader systemic pathology of the disease.
- The emerging pipeline is increasingly focused on targeted approaches, with several promising candidates advancing through mid- to late-stage clinical development.
- Notable therapies include ianalumab (VAY736), telitacicept, dazodalibep (VIB4920), and RSLV-132, among others, reflecting growing efforts to develop more effective disease-modifying treatment options.
- Overall, the anticipated introduction of these emerging therapies between 2026 and 2036 is expected to reshape the 7MM Sjögren's syndrome market, potentially expanding treatment options, addressing significant unmet needs, and driving a shift toward more targeted disease management.
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
- In June 2026, Vor Bio announced that China's National Medical Products Administration (NMPA) has granted approval for telitacicept to treat adults with Sjögren's disease (SjD).
- In June 2026, Novartis announced the presentation of new Phase III and extension study data for ianalumab in Sjögren's disease at the EULAR 2026 Congress, highlighting its efficacy and safety in patients with the disease.
- In June 2026, Johnson & Johnson reported biomarker exploratory results from the Phase II DAHLIAS study of nipocalimab in moderate-to-severe Sjögren's Disease. The analysis showed that patients with elevated autoantibodies and IgG levels experienced higher clinical response rates, and the findings were presented at the 2026 EULAR Congress.
- In May 2026, Vor Bio reported its Q1 2026 financial results and corporate updates, highlighting that enrollment is ongoing in the UPSTREAM Sjogren's Disease Phase III registrational trial evaluating the efficacy and safety of telitacicept in Sjögren's Disease.
- In April 2026, Amgen reported its Q1 2026 financial results and updated progress on dazodalibep, a CD40L-inhibiting fusion protein. Two Phase III trials in Sjögren's Disease are ongoing, targeting patients with systemic disease activity and those with high symptom burden, with completion expected in H2 2026.
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:
- 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
- Total Treated Cases of Sjogren's Disease
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
- Sjogren's Syndrome Patient Population Forecast
- Sjogren's Syndrome Therapeutics Market Size
- Sjogren's Syndrome Pipeline Analysis
- Sjogren's Syndrome Market Size and Trends
- Sjogren's Syndrome Market Opportunity
- Sjogren's Syndrome Market Unmet Needs
- KOL's Views on Sjogren's Syndrome
- Sjogren's Syndrome Market Access and Reimbursement
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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