Press release
Systemic Sclerosis Market Research (2025-2033): Emerging Drugs, Biotech Startups, and Growth Areas
Systemic Sclerosis Market Size
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Latest Mergers and Acquisitions
• Zura Bio's Phase 2 study for tibulizumab in systemic sclerosis continues to advance with topline results expected in 2H 2026.
• Galderma initiated Phase II clinical trials of nemolizumab targeting SSc (including chronic itch component), expanding the pipeline of novel monoclonal approaches.
• Ongoing research highlights CAR‐T and immune reset strategies (e.g., CD19 CAR‐T in autoimmune disease baskets) that could influence future SSc therapy design.
• Early Phase 2 data on efzofitimod show promise for SSc‐related ILD with skin score improvement, supporting further development.
Leading Key Players:
Novartis AG, Pfizer Inc., Teva Pharmaceuticals USA, Inc., Eli Lilly and Company, AUROBINDO PHARMA LIMITED, GSK plc, Certa Therapeutics, F. Hoffmann-La Roche Ltd, Boehringer Ingelheim International GmbH, and Sun Pharmaceutical Industries Ltd,
Key Developments:
January 2026
USA
• Boehringer Ingelheim kicked off a new clinical study in adults with systemic sclerosis (SSc), covering both diffuse and select limited cutaneous forms.
• The SSc clinical trial landscape continues to grow, with over 40 companies advancing 50+ therapies, reflecting a surge in R&D activity.
Japan
• Japan reinforced its support for orphan drug development, creating incentives that boost research and innovation in rare disease treatments, including SSc.
Europe
• Europe saw steady progress in SSc research, with clinical trials and collaborative projects expanding market development and patient recruitment.
December 2025
USA
• Rheumatologists expressed growing confidence in the SSc treatment pipeline, particularly with emerging therapies like AstraZeneca's anifrolumab (Saphnelo).
Japan
• Japan's healthcare sector continued driving innovation for rare autoimmune disorders, supporting SSc market growth through strategic biotech partnerships.
Europe
• European trends highlighted increased use of antifibrotic and immunomodulatory therapies, helping manage systemic sclerosis and associated complications.
November 2025
USA
• Insights from the US market revealed a strong unmet need for SSc treatments, alongside optimism about pipeline developments among rheumatology specialists.
Japan
• Key collaborations and regional R&D efforts focused on localized biologics and targeted therapies, strengthening Japan's SSc ecosystem.
Europe
• European initiatives advanced diagnostic capabilities and expanded treatment access for SSc through collaborative programs and targeted funding.
Growth Forecast Projected:
The Global Systemic Sclerosis Market is anticipated to rise at a considerable rate during the forecast period, between 2025 and 2032. In 2024, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.
Research Process:
Both primary and secondary data sources have been used in the global Systemic Sclerosis Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.
Latest Developments (2025-2026)
United States: Recent Industry Developments
✅ Jan 2026: Horizon Therapeutics launched an advanced treatment targeting fibrosis in systemic sclerosis patients.
✅ Dec 2025: Clinical trials for novel anti-fibrotic biologics showed promising efficacy in slowing disease progression.
✅ Nov 2025: FDA approved an updated patient monitoring protocol integrating digital health tools for systemic sclerosis management.
Japan: Recent Industry Developments
✅ Jan 2026: Eisai Co. initiated combination therapy trials focusing on autoimmune modulation in systemic sclerosis.
✅ Dec 2025: Japanese hospitals expanded access to biologic therapies for severe cases of systemic sclerosis.
✅ Nov 2025: Research collaborations advanced early diagnostic biomarkers for improved patient outcomes.
Middle East: Recent Industry Developments
✅ Jan 2026: Gulf-based clinics adopted global best practices for systemic sclerosis management, emphasizing early intervention.
✅ Dec 2025: Pharmaceutical partnerships expanded the availability of antifibrotic and immunomodulatory therapies.
✅ Nov 2025: Awareness campaigns improved early diagnosis rates in high-risk patient populations.
Europe: Recent Industry Developments
✅ Jan 2026: European Medicines Agency fast-tracked approval of new systemic sclerosis treatment for rare autoimmune cases.
✅ Dec 2025: Multi-country trials tested efficacy of combination biologics targeting skin and organ fibrosis.
✅ Nov 2025: Advanced patient registries launched to monitor long-term outcomes and optimize therapeutic strategies.
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Key Segmentations:
By Disease Type: Limited Cutaneous Systemic Sclerosis (IcSSc), Diffuse Cutaneous Systemic Sclerosis (dcSSc)
By Drug Type: Immunosuppressants, Phosphodiesterase 5 (PDE-5) Inhibitors, Endothelin Receptor Antagonists (ERAs), Prostacyclin Analogues, Calcium Channel Blockers, Others
By Distribution Channels: Hospital Pharmacies, Retail Pharmacies, Online Pharmacies
Regional Analysis for Market:
⇥ North America (U.S., Canada, Mexico)
⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)
⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)
⇥ South America (Colombia, Brazil, Argentina, Rest of South America)
⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)
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FAQ
Q1: What is the current size of the Systemic Sclerosis Market?
A: The Systemic Sclerosis Market was valued at US$ 2,259.64 Million in 2023 and is forecasted to reach US$ 4,132.66 Million by 2033
Q2: What is the growth rate of the Systemic Sclerosis Market?
A: The Systemic Sclerosis market is projected to grow at a (CAGR of 6.4%) between 2025 and 2033.
Latest Landscape in Systemic Sclerosis
✅ New clinical trials of nemolizumab (anti-IL-31) for SSc symptom and fibrosis targeting are starting Phase II in H2 2025.
✅ Approved antifibrotic nintedanib and IL-6 inhibitor tocilizumab now reduce lung function decline in SSc-ILD patients globally.
✅ Rituximab received approval in Japan for systemic sclerosis, showing improvement in skin sclerosis and lung outcomes.
✅ Research into personalized, biomarker-driven therapies including CAR-T and bispecific agents is expanding the SSc therapeutic pipeline.
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