Sjogren’s Syndrome Market Outlook 2025-2035:
The 7 major Sjogren’s syndrome market reached a value of USD 173.3 Million in 2024. Looking forward, IMARC Group expects the 7MM to reach USD 235.1 Million by 2035, exhibiting a growth rate (CAGR) of 2.82% during 2025-2035. The Sjogren’s Syndrome market is influenced by increasing utilization of targeted and minimally invasive (MI) treatment modalities, such as biologic therapies, regenerative medicine treatments, and novel immunomodulatory therapies, that effectively control symptoms without generating significant systemic side effects. The novel therapies reduce inflammation, alleviate dryness, and enhance immune regulation overall, resulting in improved patient outcomes and quality of life. With the progression of precision medicine, treatment is more and more individualized to the patient, avoiding the need for long-term immunosuppression therapy and reducing side effects. Additionally, wider use of telemedicine and artificial intelligence diagnostics raises early diagnosis and personalized treatment approaches, making care more accessible and effective for patients.
Advances in Early Detection and Diagnostic Technologies: Driving the Sjogren’s Syndrome Market
The most recent diagnostic and treatment technologies are highly transforming the Sjogren’s Syndrome market, increasing disease control and patient outcomes. Advanced imaging technologies, such as salivary gland ultrasonography and optical coherence tomography, enable early and precise diagnosis by assessing glandular inflammation and tear film disruptions. Molecular diagnostics, including PCR and next-generation sequencing (NGS), are increasingly becoming pivotal in the identification of Sjogren’s Syndrome biomarkers, enabling targeted treatment strategies. AI-based diagnostic tools enhance accuracy in disease classification, measurement of severity, and tracking of treatment response, reducing reliance on subjective evaluation. Non-surgical treatments, including regenerative medicine strategies, biologic therapies, and newer tear substitutes, are proving to be effective with few side effects. Also, wearable health technology, such as biosensor patches and smart contact lenses, enables real-time monitoring of salivary function and tear composition, with enhanced outpatient care through the early intervention of conditions. Telemedicine platforms augment the access to rheumatologic and ophthalmologic consultation, allowing for timely diagnosis and treatment advice to be made for patients from remote and underserved locations. All these advancements together spur innovation in the management of Sjogren’s Syndrome, with improved patient quality of life and enhanced long-term outcomes.
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Development of Novel Therapies and Pharmacological Treatments: Contributing to Market Expansion
The Sjogren’s Syndrome market is growing due to the emergence of innovative therapies and progress in pharmacological treatments. Recent developments in biologic agents and small molecules are being explored to specifically address key inflammatory pathways linked to the disease, especially B-cell hyperactivity and pro-inflammatory cytokines like interleukin-17 and BAFF (B-cell activating factor). These innovative therapies offer not only improved effectiveness but also a decrease in side effects and betterment in patient results. The increasing focus on precision medicine has sparked the development of targeted treatments, including monoclonal antibodies and Janus kinase (JAK) inhibitors, aimed at enhancing the modulation of immune responses more effectively. Moreover, groundbreaking drug delivery methods, including liposomal formulations, hydrogels, and nanotechnology-based carriers, are enhancing localized drug application, thus lowering systemic exposure and decreasing side effects. Additionally, continuous studies in regenerative therapies, such as mesenchymal stem cell treatments and gene-focused strategies, seek to restore gland function and mitigate disease advancement. Complementary treatments such as immunomodulators, salivary stimulants, and tear substitutes are being improved to better manage symptoms and improve the quality of life for patients. Combination therapies that merge biologics with anti-inflammatory medications have surfaced as promising approaches for tackling the intricate pathophysiology of Sjögren’s syndrome. Additionally, non-invasive treatment options like peptide-based therapies and bioengineered tear film stabilizers are becoming more popular because of their ease of use and patient-centered focus.
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Marketed Therapies in Sjogren’s Syndrome Market
Evoxac (Cevimeline): Daiichi Sankyo
Evoxac (Cevimeline) is a muscarinic receptor agonist that has been approved for treating dry mouth (xerostomia) in individuals with Sjogren’s Syndrome. It triggers the secretion of saliva by stimulating M3 receptors, enhancing oral hydration and alleviating discomfort linked to dry mouth. Evoxac is a highly tolerated alternative that improves the quality of life for individuals experiencing dryness associated with Sjogren’s Syndrome.
Salagen (Pilocarpine): Advanz Pharma
Salagen (pilocarpine) is a muscarinic agonist employed to alleviate dry mouth (xerostomia) in individuals with Sjogren’s Syndrome by promoting the secretion of saliva from salivary glands. It aids in reducing signs of dry mouth and discomfort, enhancing overall life quality. Nonetheless, possible side effects may involve sweating, nausea, and heightened urination.
Emerging Therapies in Sjogren’s Syndrome Market
VAY736: MorphoSys/Novartis
VAY736 (isatuximab) is a monoclonal antibody aimed at BAFF-R (B-cell activating factor receptor), created by Novartis for treating Sjogren’s Syndrome. Its goal is to manage B-cell survival and differentiation, diminishing inflammation caused by autoimmunity and minimizing damage to glands. Initial clinical trials have demonstrated potential in alleviating symptoms and delaying disease advancement in individuals with Sjogren’s Syndrome.
Dazodalibep: Horizon Therapeutics
Dazodalibep is a new immunomodulatory medication currently being studied for the management of Sjogren’s Syndrome. It is an antagonist of the CD40 ligand (CD40L) that inhibits the CD40/CD40L co-stimulatory pathway, crucial in immune activation and excessive B-cell activity. By blocking this pathway, dazodalibep seeks to lessen systemic inflammation, relieve symptoms, and enhance glandular function in patients with Sjogren’s Syndrome.
Nipocalimab: Janssen Research & Development
Nipocalimab, a monoclonal antibody directed against the neonatal Fc receptor (FcRn), is being investigated as a possible therapy for Sjogren’s Syndrome. The goal is to minimize circulating autoantibodies to lessen the immune-related harm to salivary and lacrimal glands, tackling both systemic and glandular effects of the illness. Its immunomodulatory strategy shows potential for enhancing symptoms and disease advancement in individuals with Sjogren’s Syndrome.
Drug Name | Company Name | MOA | ROA |
VAY736 | MorphoSys/Novartis | Antibody-dependent cell cytotoxicity; B-cell activation factor receptor antagonists | Subcutaneous |
Dazodalibep | Horizon Therapeutics | CD40 ligand inhibitors | Intravenous |
Nipocalimab | Janssen Research & Development | Neonatal Fc receptor antagonists | Subcutaneous |
Detailed list of emerging therapies in Sjogren’s Syndrome is provided in the final report…
Leading Companies in the Sjogren’s Syndrome Market:
An extensive analysis of the competitive landscape in the market is incorporated in the IMARC market research report. Numerous industry leaders are pioneering the development of comprehensive platforms to enhance Sjogren’s Syndrome management worldwide. Prominent participants include MorphoSys/Novartis, Horizon Therapeutics, Janssen Research & Development, Advanz Pharma, Daiichi Sankyo, Resolve Therapeutics, among others. By means of continuous research, the creation of diagnostic instruments, and the broadening of their product ranges to meet the growing need for Sjogren’s syndrome, these companies are driving advancements in the market.
In June 2024, Johnson & Johnson revealed that patients given nipocalimab demonstrated statistically significant (P=0.002) and clinically relevant enhancement in the ClinESSDAIa score at 24 weeks from baseline, according to the Phase 2 DAHLIAS dose-ranging study involving adult patients with Sjögren’s disease (SjD). The reaction was noticeable by Week 4 and kept getting better during the 24-week treatment phase, surpassing the placebo group. These outcomes represent the initial favorable results for nipocalimab in SjD.
Key Players in Sjogren’s Syndrome Market:
The key players in the Sjogren’s Syndrome market who are in different phases of developing different therapies are MorphoSys, Novartis, Horizon Therapeutics, Janssen Research & Development, Advanz Pharma, Daiichi Sankyo, Resolve Therapeutics, and Others.
Regional Analysis:
The major markets for Sjogren’s Syndrome include the United States, Germany, France, the United Kingdom, Italy, Spain, and Japan. According to projections by IMARC, the United States has the largest patient pool for Sjogren’s Syndrome while also representing the biggest market for its treatment. Novel treatments have recently emerged in the Sjogren’s Syndrome market, including advanced biologics, targeted immunotherapies, and FcRn inhibitors aimed at modulating the immune response. New therapeutic strategies focus on reducing systemic inflammation, alleviating glandular dysfunction, and preserving tissue integrity, thereby improving patient outcomes and quality of life.
Innovations in diagnostic tools, including new biomarkers, salivary gland ultrasound, and high-throughput molecular profiling, represent advancements that allow for a quicker and more precise diagnosis of Sjogren’s syndrome. The advancements lessen side effects while enabling tailored treatment approaches. The Sjogren’s syndrome market is significantly shaped by fresh treatment approvals from regulators, heightened R&D spending, and broader partnerships among pharmaceutical firms, diagnostic technology providers, and academic entities. Access to specialist treatment is improving through AI-based diagnostic tools and telemedicine services, especially in remote and underserved areas.
Recent Developments in Sjogren’s Syndrome Market:
- In November 2024, Johnson & Johnson unveiled that nipocalimab had been awarded Breakthrough Therapy designation (BTD) by the US Food and Drug Administration (FDA) for the treatment of adults with moderate-to-severe Sjögren’s disease (SjD). It is a chronic and incapacitating autoantibody condition that is highly prevalent and for which there are currently no approved advanced treatments. For SjD, nipocalimab is the only experimental treatment to be designated as such.
Key information covered in the report.
Base Year: 2024
Historical Period: 2019-2024
Market Forecast: 2025-2035
Countries Covered
- United States
- Germany
- France
- United Kingdom
- Italy
- Spain
- Japan
Analysis Covered Across Each Country
- Historical, current, and future epidemiology scenario
- Historical, current, and future performance of the Sjogren’s Syndrome market
- Historical, current, and future performance of various therapeutic categories in the market
- Sales of various drugs across the Sjogren’s Syndrome market
- Reimbursement scenario in the market
- In-market and pipeline drugs
Competitive Landscape:
This report offers a comprehensive analysis of current Sjogren’s Syndrome marketed drugs and late-stage pipeline drugs.
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In-Market Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
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