Sjogren's Syndrome Market Growth Outlook 2036 Epidemiology, Pipeline Therapies, and Revenue Forecast - DelveInsight

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
• In 2023, the total Sjogren's syndrome market size was approximately USD 1,900 million across the 7MM and is anticipated to grow by 2036 over the study period (2022-2036).
• 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, 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 diagnosed prevalent population of Sjögren's syndrome across the seven major markets (7MM) was estimated at approximately 3.35 million cases, with projections indicating continued growth through 2036. The United States represented the largest share of the patient population, accounting for nearly 1.8 million diagnosed cases in 2025.
• Market growth is expected to be driven by emerging therapies with the potential to reshape the treatment landscape, including ianalumab (VAY736), iscalimab (CFZ533), RSLV-132, dazodalibep (VIB4920), OXERVATE (cenegermin), SOTYKTU (deucravacitinib), and other innovative pipeline candidates.
• In 2025, the diagnosed prevalent cases of Sjogren's Syndrome were the highest in the US accounting for ~1,800,000 cases which are estimated to increase by 2036.
• In the US, among the severity-specific cases, ~1,530,000 accounted for mild and ~271,000 accounted for moderate to severe cases in 2025. These cases are expected to increase during the forecast period.
• In the year 2025, among the type-specific cases of Sjogren's Syndrome ~1,080,000 cases accounted for Primary Sjogren's Syndrome and ~720,000 cases accounted for Secondary Sjogren's Syndrome respectively, in the US.
• Among EU4 and the UK, the United Kingdom accounted for the highest diagnosed prevalent cases of Sjogren's Syndrome, whereas Spain accounted for the least number of cases.
• 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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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
• 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

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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 ImmunotherapeuticsServier
• Nipocalimab Johnson & Johnson

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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

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Company Name DelveInsight Business Research LLP
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Country United States
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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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