Rashtriya Newsflash

(Albany, New York) – October 26, 2026: DelveInsight’s report, “Systemic Sclerosis Market Insights, Epidemiology, and Market Forecast-2036,” provides a comprehensive analysis of the Systemic Sclerosis 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.

Additionally, it examines Systemic Sclerosis market dynamics, offering a thorough assessment of current and emerging market trends, treatment patterns, and therapeutic developments. The analysis spans major markets, including the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan, equipping decision-makers with actionable intelligence for strategic planning, investment, and research initiatives.

To Know in detail about the Systemic Sclerosis market outlook, drug uptake, treatment scenario and epidemiology trends, Click here; Systemic Sclerosis Market Forecast

Some of the key facts of the Systemic Sclerosis Market Report:

• The Systemic Sclerosis market size was valued at approximately USD 1.9 billion in 2025 and is projected to grow at a CAGR of around 3% during the forecast period from 2026 to 2036.

• In October 2026, Boehringer Ingelheim updated its Phase III VERANDA-SSc study evaluating oral nerandomilast in adults with systemic sclerosis. The randomized, placebo-controlled trial is recruiting participants with limited or diffuse cutaneous systemic sclerosis to assess disease progression, skin thickening, lung function, and safety. The study is designed to evaluate whether nerandomilast can slow disease progression and improve clinical outcomes.

• In September 2026, Liquidia planned to initiate the Phase IIa RE-WARM study of inhaled treprostinil (YUTREPIA) in October 2026. The study is designed to evaluate safety, pharmacodynamics, and potential effects on the frequency, severity, and impact of Raynaud’s phenomenon attacks in patients with systemic sclerosis. YUTREPIA is investigational for this indication and is not FDA-approved to treat systemic sclerosis-associated Raynaud’s phenomenon

• In September 2026, the FDA granted Fast Track designation to Liquidia’s YUTREPIA (treprostinil) inhalation powder for treating Raynaud’s phenomenon associated with systemic sclerosis. The designation is intended to facilitate development and regulatory review for this complication, for which treatment options remain limited. Liquidia announced plans to evaluate the therapy in the Phase IIa RE-WARM study. Fast Track designation is not an FDA marketing approval.

• In September 2026, the Phase III DAISY study of anifrolumab, developed by AstraZeneca, was updated in the clinical trial registry. The study evaluates subcutaneous anifrolumab versus placebo in adults with limited or diffuse cutaneous systemic sclerosis, with the objective of assessing its efficacy and safety. As of the September update, the trial was listed as active but not recruiting. Anifrolumab is approved for certain patients with systemic lupus erythematosus, but remains investigational for systemic sclerosis.

• In March 2026, Aisa Pharma, Inc., a clinical-stage biopharmaceutical company developing treatments for systemic sclerosis, announced results from its Phase II RECONNOITER trial evaluating AISA-021 (cilnidipine), a novel once-daily calcium channel blocker, for systemic sclerosis–associated Raynaud’s phenomenon (SSc-RP). The findings were presented during an oral session at the 9th World Systemic Sclerosis Congress, held in Athens, Greece, from March 5–7, 2026.

• In June 2025, aTyr Pharma announced interim Phase II EFZOCONNECT trial results for efzofitimod, demonstrating favorable safety and tolerability, along with stable or improved mRSS across all patients, meaningful clinical benefits in diffuse SSc-ILD, and promising biomarker responses.

• In April 2025, Calibr-Skaggs Institute for Innovative Medicines (Scripps Research) received FDA clearance for their IND application to study switchable CAR-T therapy (CLBR001 + SWI019) in autoimmune diseases. The upcoming Phase 1 trial will assess safety and efficacy in patients with myositis, systemic sclerosis, lupus, and rheumatoid arthritis, with plans to potentially expand to other conditions.

• In February 2025, the FDA cleared Allogene Therapeutics’ investigational new drug (IND) application for ALLO-329, an allogenic CAR-T cell therapy. Researchers are set to begin the Phase 1 RESOLUTION trial in mid-2025 for autoimmune diseases, including systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathies, and systemic sclerosis.

• Nintedanib and tocilizumab currently anchor the US disease-specific treatment landscape for systemic sclerosis-associated interstitial lung disease, while rituximab provides an additional approved option in Japan.

• The emerging pipeline is moving beyond organ-specific management, with programs such as zola-cel, nerandomilast, efzofitimod, anifrolumab, and inebilizumab evaluating approaches that could address broader immune, fibrotic, or vascular drivers of systemic sclerosis.

• As per DelveInsight’s analyst, the diagnosed prevalent cases of systemic sclerosis in the 7MM were estimated to be ~ 232,400 cases in 2025.

• Among EU4 and the UK, Italy had the highest number (~8%) of diagnosed prevalent cases of systemic sclerosis, while Spain had the lowest number of diagnosed prevalent cases.

• Among the age-specific cases, 40–69 age group (~60%) had the highest prevalent cases in the US followed by 70 and above in 2025.

• In the US, mild organ damage cases of systemic sclerosis was found to be more as compared to moderate and severe organ damage cases in 2025.

• According to DelveInsight estimates, the majority of systemic sclerosis cases in the US are classified as limited cutaneous systemic sclerosis, accounting for approximately 65% of the total cases in 2025, making it the most prevalent subtype compared to diffuse cutaneous systemic sclerosis and systemic sclerosis sine scleroderma.

• In EU4 and the UK had nearly 81,000 cases of systemic sclerosis in 2025.

• The prevalence of Systemic Sclerosis is estimated at approximately 10–30 cases per 100,000 individuals worldwide, although reported estimates vary substantially across countries because of differences in diagnostic criteria, case ascertainment, and healthcare access.

• Key Systemic Sclerosis Companies: Boehringer Ingelheim, Roche, Zenyaku Kogyo, Chugai Pharmaceutical, Kyowa Kirin, GSK, AstraZeneca, Amgen, Mitsubishi Tanabe Pharma, Roche (Genentech), Kiniksa Pharmaceuticals, Boehringer Ingelheim, Kyverna Therapeutics, Cabaletta Bio, and others

• Key Systemic Sclerosis Therapies: OFEV (nintedanib), ACTEMRA (tocilizumab), RITUXAN (rituximab), LUMICEF (brodalumab/KHK-4827), BENLYSTA (belimumab), SAPHNELO (anifrolumab), UPLIZNA (inebilizumab/MT-0551), Vixarelimab (RG6536), Avenciguat (BI 685509), KYV 101, CABA-201, RO7303509, and others

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

Systemic Sclerosis Overview

Systemic Sclerosis (SSc), also known as scleroderma, is a rare autoimmune disorder that causes the body’s immune system to attack its own tissues, leading to thickening and hardening of the skin and connective tissues. This can affect various organs, including the lungs, heart, kidneys, and digestive system. SSc is characterized by fibrosis (scarring) and can result in restricted blood flow, leading to symptoms like skin tightening, difficulty in movement, organ dysfunction, and severe complications if left untreated. It is classified into two main types: limited and diffuse, based on the extent of skin involvement and organ involvement.

Get a Free sample for the Systemic Sclerosis Market Forecast, Size & Share Analysis Report:

https://www.delveinsight.com/report-store/systemic-sclerosis-market

Systemic Sclerosis Epidemiology

The 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.

Systemic Sclerosis Epidemiology Segmentation:

The Systemic Sclerosis market report proffers epidemiological analysis for the study period 2022–2036 in the 7MM segmented into:

• Systemic Sclerosis Total Diagnosed Prevalent Cases

• Systemic Sclerosis Disease Subset-specific Diagnosed Prevalent Cases

• Systemic Sclerosis Age-specific Diagnosed Prevalent Cases

• Systemic Sclerosis Organ Involvement-specific Diagnosed Prevalent Cases

• Systemic Sclerosis Severity by Organ Damage Diagnosed Prevalent Cases

• Systemic Sclerosis Severity by Skin Thickness Diagnosed Prevalent Cases

• Systemic Sclerosis Treated Cases

Download the report to understand which factors are driving Systemic Sclerosis epidemiology trends @ Systemic Sclerosis Epidemiology Forecast

Systemic Sclerosis Drugs Uptake and Pipeline Development Activities

The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Systemic Sclerosis market or expected to get launched during the study period. The analysis covers Systemic Sclerosis 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 Systemic Sclerosis 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 analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Systemic Sclerosis Therapies and Key Companies

• Rituximab (RITUXAN): Zenyaku Kogyo/Chugai Pharmaceutical

• Nemolizumab : Galderma

• OFEV (nintedanib): Boehringer Ingelheim

• ACTEMRA (tocilizumab): Roche

• RITUXAN (rituximab): Zenyaku Kogyo/Chugai Pharmaceutical

• LUMICEF (brodalumab/KHK-4827): Kyowa Kirin

• BENLYSTA (belimumab): GSK

• SAPHNELO (anifrolumab): AstraZeneca

• UPLIZNA (inebilizumab/MT-0551): Amgen (Horizon Therapeutics)/ Mitsubishi Tanabe Pharma

• Vixarelimab (RG6536): Roche (Genentech)/ Kiniksa Pharmaceuticals

• Avenciguat (BI 685509): Boehringer Ingelheim

• KYV 101: Kyverna Therapeutics

• CABA-201: Cabaletta Bio

• RO7303509: Roche (Genentech)

Discover more about therapies set to grab major Systemic Sclerosis market share @ Systemic Sclerosis Treatment Landscape

Systemic Sclerosis Market Strengths

• Based on the role of B cells and the published clinical datas with CD19-CAR T therapy in systemic sclerosis, it is believed that CABA-201 may transform the treatment for systemic sclerosis.

• Kyowa Kirin submitted an sNDA for brodalumab in treating systemic sclerosis. Launch of this drug will boost the systemic sclerosis market.

Systemic Sclerosis Market Opportunities

• Development of a potential biomarker that allows for tracking and predicting the severity and potential progress of the disease and the effectiveness of any therapeutic intervention

• Since pulmonary involvement is a leading cause of morbidity and mortality in SSc, there is a need for more effective treatments that can stabilize or improve lung function and delay disease progression.

Scope of the Systemic Sclerosis Market Report

• Study Period: 2022–2036

• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]

• Key Systemic Sclerosis Companies: Boehringer Ingelheim, Roche, Zenyaku Kogyo, Chugai Pharmaceutical, Kyowa Kirin, GSK, AstraZeneca, Amgen, Mitsubishi Tanabe Pharma, Roche (Genentech), Kiniksa Pharmaceuticals, Boehringer Ingelheim, Kyverna Therapeutics, Cabaletta Bio, and others

• Key Systemic Sclerosis Therapies: OFEV (nintedanib), ACTEMRA (tocilizumab), RITUXAN (rituximab), LUMICEF (brodalumab/KHK-4827), BENLYSTA (belimumab), SAPHNELO (anifrolumab), UPLIZNA (inebilizumab/MT-0551), Vixarelimab (RG6536), Avenciguat (BI 685509), KYV 101, CABA-201, RO7303509, and others

• Systemic Sclerosis Therapeutic Assessment: Systemic Sclerosis current marketed and Systemic Sclerosis emerging therapies

• Systemic Sclerosis Market Dynamics: Systemic Sclerosis market drivers and Systemic Sclerosis market barriers

• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies

• Systemic Sclerosis Unmet Needs, KOL’s views, Analyst’s views, Systemic Sclerosis Market Access and Reimbursement

To know more about Systemic Sclerosis companies working in the treatment market, visit @ Systemic Sclerosis Clinical Trials and Therapeutic Assessment

Table of Contents

1. Systemic Sclerosis Market Report Introduction

2. Executive Summary for Systemic Sclerosis

3. SWOT analysis of Systemic Sclerosis

4. Systemic Sclerosis Patient Share (%) Overview at a Glance

5. Systemic Sclerosis Market Overview at a Glance

6. Systemic Sclerosis Disease Background and Overview

7. Systemic Sclerosis Epidemiology and Patient Population

8. Country-Specific Patient Population of Systemic Sclerosis

9. Systemic Sclerosis Current Treatment and Medical Practices

10. Systemic Sclerosis Unmet Needs

11. Systemic Sclerosis Emerging Therapies

12. Systemic Sclerosis Market Outlook

13. Country-Wise Systemic Sclerosis Market Analysis (2022–2036)

14. Systemic Sclerosis Market Access and Reimbursement of Therapies

15. Systemic Sclerosis Market Drivers

16. Systemic Sclerosis Market Barriers

17. Systemic Sclerosis Appendix

18. Systemic Sclerosis Report Methodology

19. DelveInsight Capabilities

20. Disclaimer

21. About DelveInsight

About DelveInsight

DelveInsight is a leading Healthcare 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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