Sjogren's Syndrome Market Outlook 2034: Clinical Trials, Market Size, Medication, Prevalence, Companies by DelveInsight

Sjogren's syndrome companies are Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others.
Sjogren's Syndrome Market Summary

In 2023, the Sjogren's syndrome market size was approximately USD 1.9 billion across the seven major markets (7MM) and is projected to grow through 2034. Sjogren's syndrome is an autoimmune disorder primarily causing dysfunction of the salivary and lacrimal glands, leading to symptoms like dry eyes and dry mouth. It is classified into primary Sjogren's syndrome (occurring alone) and secondary Sjogren's syndrome (associated with other autoimmune diseases such as rheumatoid arthritis and lupus). Besides glandular symptoms, the disease can affect multiple organs, causing joint pain, skin rashes, and other systemic issues.

Sjogren's syndrome Diagnosis involves clinical evaluation, ocular and oral assessments, blood tests, and salivary gland biopsies or ultrasounds. In 2023, about 3 million cases were diagnosed in the 7MM, with numbers expected to rise. Currently, no cure exists; treatment is symptomatic, focusing on relieving dryness and systemic symptoms using artificial tears, saliva substitutes, secretagogues, and immunosuppressants for severe cases.

Emerging Sjogren's syndrome therapies like lanalumab, CFZ533 (iscalimab), and VIB4920 (dazodalibep) show promise for changing the treatment landscape. The U.S. dominates the Sjogren's syndrome market, representing about 62% in 2023. Despite progress, unmet needs remain for better therapies and biomarkers. Notably, in November 2024, the FDA granted Breakthrough Therapy designation to nipocalimab for moderate-to-severe Sjogren's disease, signaling advancement in treatment options.

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DelveInsight's report titled "Sjogren's Syndrome Market Insights, Epidemiology, and Market Forecast-2034" delivers a comprehensive analysis of Sjogren's syndrome, including its historical and projected epidemiology as well as market trends across the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan.

The Sjogren's syndrome market is anticipated to experience significant growth during the forecast period, driven by rising disease prevalence and increasing awareness. Additionally, the introduction of multiple pipeline therapies at various development stages is expected to markedly transform the market landscape. This report details current treatment protocols, emerging therapies, and the market share of individual treatments while providing market size estimates and forecasts from 2020 to 2034 across the seven major markets. It also examines existing treatment algorithms, key market drivers and barriers, and unmet medical needs, offering insights to identify optimal opportunities and evaluate the full potential of the Sjogren's syndrome market.

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

* In 2023, the overall market size for Sjogren's syndrome was approximately USD 1,900 million, with projections indicating growth throughout the study period (2020-2034) across the 7 major markets (7MM) by 2034.
* Novartis and Amgen are prominent players in the Sjogren's syndrome market, with their respective drugs CFZ533 (iscalimab) and VIB4920 (dazodalibep) expected to generate the highest revenues across the seven major markets (7MM) by 2034.
* In 2023, around 1.5 million diagnosed cases of Sjogren's syndrome were reported across the 7MM, with this number predicted to rise throughout the forecast period from 2024 to 2034.
* In the United States in 2023, antigen-specific Sjogren's syndrome cases were mostly linked to auto-antibody positivity, particularly anti-Ro/SSA and anti-La/SSB antibodies.
* The U.S. recorded the greatest number of treated Sjogren's syndrome cases in 2023, while Japan reported the fewest, with about 54,000 treated patients. Both countries are expected to see increases in treated cases by 2034.
* Within the EU4 countries and the UK, Sjogren's syndrome predominantly affects females, with the UK showing the highest number of gender-specific cases in 2023.
* Companies involved in developing treatments for Sjogren's syndrome include Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Amgen (partnering with Horizon), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, among others.
* Several emerging therapies for Sjogren's syndrome are in various clinical trial phases, including R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others, all anticipated to significantly impact the market in coming years.
* In March 2025, Johnson & Johnson announced that the FDA granted Fast Track designation to its investigational drug nipocalimab for treating adults with moderate-to-severe Sjogren's disease, following its Breakthrough Therapy designation granted late the previous year. Currently, no advanced treatments are approved specifically for this condition.
* In November 2024, Johnson & Johnson revealed that the FDA awarded Breakthrough Therapy Designation to nipocalimab for moderate-to-severe Sjogren's disease, a chronic autoimmune disorder with no approved advanced therapies. Nipocalimab is the first therapy to receive this designation for Sjogren's disease, marking its second Breakthrough Therapy Designation after one for treating alloimmunized pregnant individuals at risk of severe hemolytic disease of the fetus and newborn.
* In June 2024, Johnson & Johnson reported positive results from the Phase II DAHLIAS study, where nipocalimab demonstrated significant improvement in Sjogren's disease activity. This randomized, multicenter, placebo-controlled, double-blind trial evaluated nipocalimab's effects in adults with primary Sjogren's syndrome, a chronic autoimmune condition.

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Sjogren's syndrome Overview

Sjogren's syndrome (SS) is a chronic autoimmune disorder characterized by lymphocytic infiltration and subsequent dysfunction of exocrine glands, predominantly affecting the salivary and lacrimal glands. This results in hallmark clinical manifestations such as keratoconjunctivitis sicca (dry eyes) and xerostomia (dry mouth), collectively termed sicca syndrome. Sjogren's syndrome is classified into two forms: primary Sjogren's syndrome (pSS), occurring independently, and secondary Sjogren's syndrome (sSS), which coexists with other autoimmune diseases such as rheumatoid arthritis or systemic lupus erythematosus.

Beyond glandular involvement, Sjogren's syndrome can present with systemic extraglandular manifestations affecting multiple organ systems, including musculoskeletal, renal, pulmonary, neurological, and dermatological domains. The pathophysiology involves aberrant activation of the immune system, autoantibody production (notably anti-Ro/SSA and anti-La/SSB), and chronic inflammation leading to tissue damage.

Sjogren's syndrome Diagnosis is based on clinical evaluation, serological testing for specific autoantibodies, ocular and oral assessments, and histopathological analysis of minor salivary gland biopsies. Despite advances in understanding, there is currently no curative therapy for Sjogren's syndrome; management focuses on symptomatic relief using artificial tears and saliva substitutes, secretagogues, and immunomodulatory agents for systemic involvement.

Emerging Sjogren's syndrome therapeutic research targets underlying immunopathogenic mechanisms with novel biologics and small molecules aimed at modifying disease progression. The prevalence of Sjogren's syndrome is increasing globally, driving a growing demand for effective diagnostics and advanced therapeutic interventions.

Sjogren's syndrome Epidemiology

In 2023, the United States reported approximately 1.5 million diagnosed prevalent cases of Sjogren's syndrome, with this figure projected to rise throughout the forecast period from 2024 to 2034.

Among Sjogren's syndrome cases in the US in 2023, the majority were antigen-specific with positive auto-antibodies, followed by cases positive for anti-Ro/SSA and anti-La/SSB antibodies, respectively.

Segmented by:

The Sjogren's syndrome market report proffers epidemiological analysis for the study period 2020-2034 in the 7MM segmented into:

* Total Prevalence of Sjogren's syndrome
* Prevalent Cases of Sjogren's syndrome by severity
* Gender-specific Prevalence of Sjogren's syndrome
* Diagnosed Cases of Episodic and Chronic Sjogren's syndrome

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Sjogren's Syndrome Market Outlook

The current Sjogren's syndrome therapeutic market in the US is primarily composed of local therapies, systemic treatments, and biologics. Local therapies include pilocarpine, cevimeline, topical fluoride, topical cyclosporine, and autologous serum eye drops. Systemic treatment involves corticosteroids, hydroxychloroquine, immunosuppressants, and disease-modifying antirheumatic drugs (DMARDs) like methotrexate, cyclosporine A, azathioprine, leflunomide, and mycophenolic acid. Rituximab is widely used as a biological therapy, while TNF-alpha inhibitors and BAFF-targeting agents remain in development.

Pilocarpine and cevimeline, FDA-approved secretagogues, stimulate salivary and lacrimal gland secretion but are limited by side effects such as sweating and gastrointestinal discomfort. Despite available treatments, SS remains challenging to manage due to symptom complexity and frequent comorbidities, underscoring the need for SS-specific outcome measures and better diagnostic biomarkers for patient stratification.

In response, drug developers are increasingly focusing on SS-specific targeted therapies. Several promising candidates, including RSLV-132, VAY736, CFZ533, OXERVATE, VIB4920, and SOTYKTU, are progressing through mid-stage clinical trials. These emerging therapies, backed by major pharmaceutical companies, are expected to transform the SS treatment landscape by 2030, addressing the significant unmet needs in this market.

The Sjogren's syndrome market is driven by several factors, including the rising prevalence of autoimmune disorders, increased awareness and early diagnosis, and advancements in immunology and biologic therapies. As more patients and healthcare professionals recognize the chronic nature and systemic impact of Sjogren's syndrome, the demand for effective treatment options continues to grow. Ongoing research into disease mechanisms has led to the development of targeted therapies, such as immunomodulators and biologics, which offer hope for improved symptom control and disease management. Additionally, government initiatives and healthcare investments in autoimmune disease research further support market expansion.

However, the Sjogren's syndrome market also faces significant barriers. One of the primary challenges is the lack of a definitive cure and the limited availability of disease-specific therapies, with most treatments focusing only on symptom relief. Delayed diagnosis due to the overlapping symptoms with other conditions also hinders timely intervention. Furthermore, high costs of biologics, limited reimbursement policies in certain regions, and inadequate clinical trial data for emerging therapies restrict widespread adoption. Despite these obstacles, continued advancements in biotechnology and increased collaborations between pharmaceutical companies and research institutions are expected to address current limitations and drive future growth in the Sjogren's syndrome market.

According to DelveInsight, the Sjogren's syndrome market in 7MM is expected to witness a major change in the study period 2020-2034.

Sjogren's syndrome Drugs Uptake and Pipeline Development Activities

SALAGEN (pilocarpine): ADVANZ Pharma

SALAGEN tablets contain pilocarpine, a natural alkaloid extracted from the leaves of the South American shrub Pilocarpus jaborandi. Pilocarpine hydrochloride acts as a cholinomimetic agent, specifically targeting muscarinic receptors to produce a range of pharmacological effects. SALAGEN is indicated for managing dry mouth symptoms caused by salivary gland hypofunction due to radiotherapy in head and neck cancer patients, as well as for relieving dry mouth in individuals with Sjogren's syndrome.

EVOXAC (cevimeline): Daiichi Sankyo

EVOXAC, developed by Daiichi Sankyo, is a muscarinic receptor agonist that stimulates secretion from exocrine glands such as salivary and sweat glands and enhances smooth muscle tone in the gastrointestinal and urinary systems. It is approved for treating dry mouth symptoms in Sjogren's syndrome patients across the US, Europe, and Japan. In January 2022, Daiichi Sankyo transferred US manufacturing and commercialization rights of EVOXAC (cevimeline HCl) to Cosette Pharmaceuticals.

CFZ 533 (iscalimab): Novartis

CFZ 533 is a fully human IgG1 anti-CD40 monoclonal antibody designed to inhibit CD40 signaling and activation of CD40-positive cells. It is currently undergoing Phase II trials for Sjogren's syndrome and is also being investigated for generalized myasthenia gravis, Graves' disease, rheumatoid arthritis, lupus nephritis, and kidney transplant rejection.

VIB4920 (dazodalibep): Amgen

Dazodalibep, a CD40 ligand antagonist, blocks the interaction between T cells and CD40-expressing B cells, thereby interrupting the overactivation of the CD40 co-stimulatory pathway. Amgen is recruiting patients for a Phase III trial of dazodalibep in Sjogren's syndrome treatment. In November 2023, Amgen reported encouraging results from its Phase II study of this drug for Sjogren's syndrome.

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Sjogren's syndrome Therapies and Key Companies

* SALAGEN (pilocarpine): ADVANZ Pharma
* EVOXAC (cevimeline): Daiichi Sankyo
* CFZ 533 (iscalimab): Novartis
* VIB4920 (dazodalibep): Amgen
* SOTYKTU (deucravacitinib): Bristol Myers Squibb
* VAY736 (ianalumab): Novartis
* OXERVATE (cenegermin): Dompe Farmaceutici

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: Rise Therapeutics, Bristol-Myers Squibb (NYSE: BMY), Resolve Therapeutics, Novartis (SWX: NOVN), Horizon Therapeutics (acquired by Amgen (NASDAQ: AMGN)), Dompe Farmaceutici, Sylentis, OSE Immunotherapeutics (EPA: OSE), Servier, and Johnson & Johnson (NYSE: JNJ), among others.
* Key Sjogren's syndrome Therapies: SALAGEN (pilocarpine), EVOXAC (cevimeline), CFZ 533 (iscalimab), VIB4920 (dazodalibep), SOTYKTU (deucravacitinib), VAY736 (ianalumab), OXERVATE (cenegermin), 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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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.

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