Sjogren's Syndrome Market Forecast 2034: Clinical Trials, EMA, PDMA, FDA Approval, Treatment Market, Epidemiology, Revenue, Statistics, Therapies, and Companies by DelveInsight

Sjogren's Syndrome companies include Horizon Therapeutics (Amgen), Dompe Farmaceutici, Johnson & Johnson, Resolve Therapeutics, Sylentis, Horizon Therapeutics, OSE Immunotherapeutics, Rise Therapeutics, Novartis, Servier, Bristol-Myers Squibb, and others.
(Albany, USA) DelveInsight's "Sjogren's syndrome Market Insights, Epidemiology, and Market Forecast-2034 report offers an in-depth understanding of the Sjogren's syndrome, historical and forecasted epidemiology as well as the Sjogren's syndrome market trends in the United States, EU5 (Germany, Spain, Italy, France, and United Kingdom) and Japan.

The Sjogren's syndrome market report provides current treatment practices, emerging drugs, the market share of the individual therapies, and the current and forecasted Sjogren's syndrome market size from 2020 to 2034, segmented by seven major markets. The Report also covers current Sjogren's syndrome treatment practice/algorithm, market drivers, market barriers, and unmet medical needs to curate the best opportunities and assesses the underlying potential of the Sjogren's syndrome market.

The Sjogren's syndrome market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage pipeline products will significantly revolutionize the Sjogren's syndrome market dynamics.

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

* The Sjogren's syndrome market size was valued ~USD 1,900 million in 2023 and is anticipated to grow with a significant CAGR during the study period (2020-2034)
* Novartis and Amgen are leading companies in the Sjogren's syndrome market, with their drugs CFZ533 (iscalimab) and VIB4920 (dazodalibep) projected to achieve the highest revenue across the 7MM by 2034.
* Across the 7MM, approximately 1.5 million diagnosed prevalent cases of Sjogren's syndrome were recorded in 2023, with this number anticipated to grow over the forecast period (2024-2034).
* In the US, antigen-specific cases were most commonly associated with auto-antibodies positivity, followed by anti-Ro/SSA positivity and anti-La/SSB positivity in 2023.
* In 2023, the United States recorded the highest number of treated cases of Sjogren's syndrome, while Japan reported the lowest, with approximately 54,000 treated cases. These figures are projected to increase by 2034.
* Within the EU4 and the UK, Sjogren's syndrome predominantly affected females, with the United Kingdom reporting the highest number of gender-specific cases in 2023.
* Sjogren's Syndrome companies working in the treatment market are Rise Therapeutics, Bristol-Myers Squibb, Resolve Therapeutics, Novartis, Horizon Therapeutics, Dompe Farmaceutici, Horizon Therapeutics (Amgen), Sylentis, OSE Immunotherapeutics, Servier, Johnson & Johnson, and others, are developing therapies for the Sjogren's Syndrome treatment
* Emerging Sjogren's Syndrome therapies in the different phases of clinical trials are- R-2487, BMS-986325, RSLV-132, CFZ533, VIB4920, VAY736, Dazodalibep (VIB4920), OXERVATE (cenegermin), Tivanisiran (SYL1001), Lusvertikimab (formerly OSE-127), Nipocalimab, and others are expected to have a significant impact on the Sjogren's Syndrome market in the coming years.
* 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 Sjogren'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 November 2024, Johnson & Johnson (NYSE: JNJ) announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) to nipocalimab for treating adults with moderate-to-severe Sjogren's disease (SjD), a chronic autoantibody condition with significant prevalence and no approved advanced treatments available. Nipocalimab is the first investigational therapy to receive this designation for SjD. This marks the second BTD granted for nipocalimab, following the February designation for treating alloimmunized pregnant individuals at high risk of severe hemolytic disease of the fetus and newborn (HDFN).
* In June 2024, Johnson & Johnson reported results from the Phase II DAHLIAS dose-ranging study, where its monoclonal antibody nipocalimab showed significant improvements in Sjogren's disease (SjD) activity in patients. DAHLIAS is a randomized, multicenter, placebo-controlled, double-blind trial that assessed the effects of nipocalimab in adults with primary SjD, a chronic and debilitating autoimmune disorder.

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Sjogren's syndrome Overview

Sjogren's syndrome is a chronic autoimmune disorder that primarily targets the body's moisture-producing glands, leading to symptoms such as dry eyes and dry mouth. Sjogren's syndrome affects millions of individuals worldwide, with a higher prevalence in middle-aged women. This condition can occur as a primary disease or secondary to other autoimmune disorders like rheumatoid arthritis or lupus. Sjogren's syndrome is caused by the immune system mistakenly attacking healthy tissues, particularly the salivary and lacrimal glands.

Sjogren's syndrome symptoms include fatigue, joint pain, and swelling, dry skin, persistent cough, and swollen salivary glands. In severe cases, Sjogren's syndrome can affect internal organs such as the kidneys, lungs, liver, and nervous system. Diagnosis of Sjogren's syndrome involves blood tests for autoantibodies like anti-SSA/Ro and anti-SSB/La, as well as eye and salivary gland evaluations.

Sjogren's syndrome treatment focuses on symptom management, using artificial tears, saliva substitutes, immunosuppressants, and anti-inflammatory medications. Early detection and personalized therapy can improve the quality of life for patients with Sjogren's syndrome. Ongoing research into Sjogren's syndrome pathogenesis and innovative therapies offers hope for more effective treatment options in the future. Sjogren's syndrome requires a multidisciplinary care approach for optimal disease management.

Sjogren's syndrome Epidemiology Segmentation:

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 Sjogren's Syndrome market outlook of the report helps to build a detailed comprehension of the historical, current, and forecasted Sjogren's Syndrome market trends by analyzing the impact of current Sjogren's Syndrome therapies on the market and unmet needs, and drivers, barriers, and demand for better technology

This segment gives a thorough detail of the Sjogren's Syndrome market trend of each marketed drug and late-stage pipeline therapy by evaluating their impact based on the annual cost of therapy, inclusion and exclusion criteria, mechanism of action, compliance rate, growing need of the market, increasing patient pool, covered patient segment, expected launch year, competition with other therapies, brand value, their impact on the market and view of the key opinion leaders. The calculated Sjogren's Syndrome market data are presented with relevant tables and graphs to give a clear view of the market at first sight.

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

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

* 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

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Sjogren's syndrome Market Drivers

* Increasing Prevalence
* Advancements in Diagnostics
* Sjogren's syndrome Pipeline Therapies
* Supportive Regulatory Environment
* Growing Awareness

Sjogren's syndrome Market Barriers

* Limited Treatment Options
* High Treatment Costs
* Side Effects of Therapies
* Delayed Diagnosis
* Lack of Awareness

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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