DelveInsight’s “Systemic Sclerosis Market Insights, Epidemiology, and Market Forecast-2034″ report offers an in-depth understanding of the Systemic Sclerosis, historical and forecasted epidemiology as well as the Systemic Sclerosis market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.
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 is anticipated to grow with a significant CAGR during the study period (2020-2034)
In March 2025, Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on developing innovative therapies for fibro-inflammatory diseases with significant unmet needs, announced a new scientific presentation that further validates the potential of nebokitug (CM-101) as a promising treatment for systemic sclerosis (SSc).
In December 2024, Zura Bio Limited (Nasdaq: ZURA), a clinical-stage immunology company focused on developing novel dual-pathway antibodies for autoimmune and inflammatory diseases, announced the initiation of TibuSURE, a Phase 2 global study to evaluate tibulizumab for the treatment of systemic sclerosis (SSc) in adults.
In March 2024, CABA-201 was awarded Orphan Drug Designation (ODD) for systemic sclerosis treatment. Additionally, in January 2024, the US FDA granted it Fast Track Designation (FTD) for the same condition.
In March 2024, Kyverna Therapeutics, Inc. (Kyverna), a clinical-stage biopharmaceutical company dedicated to developing cell therapies for autoimmune disease patients, announced today the publication in Med1 of a report detailing the first use of KYV-101, a fully human anti-CD19 chimeric antigen receptor (CAR) T-cell product candidate, in two patients with progressive multiple sclerosis (MS). This treatment was part of a named patient program for critically ill patients who did not respond to conventional therapies.
According to the National Organization for Rare Disorders, systemic scleroderma impacts between 40,000 and 165,000 individuals in the US. While it can manifest at any age, symptoms most commonly start in midlife.
According to Adigun et al. (2022), systemic sclerosis shows a female predominance with a female-to-male ratio of approximately 5:1. Females generally develop SSc at a younger age compared to males. The peak age of onset is between 45 to 54 years for African American females and between 55 to 64 years for European American females.
Key Systemic Sclerosis Companies: Kyowa Hakko Kirin, AstraZeneca, Biocad, Boehringer Ingelheim, Janssen Pharmaceutical K.K., Mitsubishi Tanabe Pharma, Maruho Co., Ltd., Amgen, Cabaletta Bio, Kyverna Therapeutics, Lawson Health Research Institute, GlaxoSmithKline, Kyowa Kirin Co., Ltd., Cumberland Pharmaceuticals, Bangabandhu Sheikh Mujib Medical, Scleroderma Research Foundation, Prometheus Biosciences, Genentech, Inc., Changchun GeneScience Pharmaceutical, aTyr Pharma, Inc., Bristol-Myers Squibb, and others
Key Systemic Sclerosis Therapies: LUMICEF (brodalumab), SAPHNELO (anifrolumab), Divozilimab, Avenciguat (BI 685509), Guselkumab Dose 1, Inebilizumab, nemolizumab, HZN-825 BID, CABA-201, KYV-101, Brentuximab vedotin, Belimumab, KHK4827, Oral Ifetroban, Tofacitinib, Amlitelimab, Tulisokibart, Vixarelimab, GenSci048, efzofitimod 450 mg, BMS-986278., 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.
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Systemic Sclerosis Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2020 to 2034. 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 2020–2034 in the 7MM segmented into:
Total Prevalence of Systemic Sclerosis
Prevalent Cases of Systemic Sclerosis by severity
Gender-specific Prevalence of Systemic Sclerosis
Diagnosed Cases of Episodic and Chronic Systemic Sclerosis
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
LUMICEF (brodalumab): Kyowa Hakko Kirin
SAPHNELO (anifrolumab) : AstraZeneca
Divozilimab: Biocad
Avenciguat (BI 685509): Boehringer Ingelheim
Guselkumab Dose 1: Janssen Pharmaceutical K.K.
Inebilizumab: Mitsubishi Tanabe Pharma
nemolizumab: Maruho Co., Ltd.
HZN-825 BID: Amgen
CABA-201: Cabaletta Bio
KYV-101: Kyverna Therapeutics
Brentuximab vedotin: Lawson Health Research Institute
Belimumab: GlaxoSmithKline
KHK4827: Kyowa Kirin Co., Ltd.
Oral Ifetroban: Cumberland Pharmaceuticals
Tofacitinib: Bangabandhu Sheikh Mujib Medical
Amlitelimab: Scleroderma Research Foundation
Tulisokibart: Prometheus Biosciences
Vixarelimab: Genentech, Inc.
GenSci048: Changchun GeneScience Pharmaceutical
efzofitimod 450 mg: aTyr Pharma, Inc.
BMS-986278: Bristol-Myers Squibb
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: 2020–2034
Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
Key Systemic Sclerosis Therapies: LUMICEF (brodalumab), SAPHNELO (anifrolumab), Divozilimab, Avenciguat (BI 685509), Guselkumab Dose 1, Inebilizumab, nemolizumab, HZN-825 BID, CABA-201, KYV-101, Brentuximab vedotin, Belimumab, KHK4827, Oral Ifetroban, Tofacitinib, Amlitelimab, Tulisokibart, Vixarelimab, GenSci048, efzofitimod 450 mg, BMS-986278, 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 (2020–2034)
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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