Systemic Sclerosis in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2035

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This report covers the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan). The report provides an overview of the current treatment options, pipeline products in development, as well as current and future R&D trends. Key topics covered include a strategic competitive assessment of current and future drugs, unmet needs, KOL insights, and implications for the Systemic Sclerosis market. The base year of the sales forecast model is 2025, and the forecast period is 2025-2035.

The diagnosed prevalent cases of systemic sclerosis (SSc) across the 7MM will increase from 240,486 to 253,997 across the seven major markets (7MM: the US, France, Germany, Italy, Spain, the UK, and Japan).
The SSc therapeutics market was valued at $2.9 billion in 2025 across the 7MM and is projected to grow at a 6.4% compound annual growth rate (CAGR) to $5.4 billion by 2035, driven mainly by the uptake of Jascayd (nerandomilast) and Winrevair (sotatercept), in addition to the launches of three late-stage pipeline agents. Generic erosion of Ofev (nintedanib) from 2026 in the 5EU (five major European markets: France, Germany, Italy, Spain, and the UK) and Japan and from 2029 in the US will partly offset this growth.
The US represents the largest SSc market, accounting for 81% of 7MM sales in 2025 and 74% in 2035, due to a larger patient population, wider availability of higher priced drugs, and later entry of nintedanib generics.

Scope

Overview of SSc – including epidemiology, disease etiology and management.​

Topline SSc drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.​

Key topics covered include assessment of marketed and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU, and Japan over the 10-year forecast period.​

Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.​

Analysis of the current and future market competition in the global SSc therapeutics market. Insightful review of the key industry drivers and barriers.

Reasons to Buy

Develop and design your in-licensing and out-licensing strategies through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline.

Develop business strategies by understanding the trends shaping and driving the seven-market systemic sclerosis (SSc) therapeutics market.​.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact seven-market SSc market in the future.

Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.​

Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.​

Track drug sales in the seven-market SSc therapeutics market from 2025-2035.​

Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments, and strategic partnerships.

Roche
Pfizer
Baxter
Shionogi & Co
Bristol-Myers Squibb
Fuji Pharma
Boehringer Ingelheim
Chugai Pharmaceutical
Biogen
Bayer
Nippon Shinyaku
Acceleron Pharma (now a subsidiary of Merck)
Schering AG
Tanabe Pharma
DuPont Pharma
Eli Lilly
Johnson & Johnson
Allergan (acquired by AbbVie)

Table of Contents

Table of Contents (PowerPoint Deck)

1. Preface

1.1. Contents

1.2. Abbreviations

1.3. Related Reports

2. Executive Summary

3. Disease Overview

3.1. Overview of SSc

3.2. Pathophysiology of SSc

3.3. Phenotypic Subtyping of SSc

3.4. SSc Market SWOT Analysis

4. Epidemiology

4.1. Diagnosed Prevalent Cases of SSc, N, Ages ≥18 Years, Men and Women, 2025─35

4.2. Age-Specific Trends in Diagnosed Prevalent Cases of SSc, N, Men and Women, 2025

4.3. Sex-Specific Diagnosed Prevalent Cases of SSc, N, Ages ≥18 Years, 2025

4.4. Diagnosed Prevalent Cases of SSc by Subtypes, N, Ages ≥18 Years, Men and Women, 2025

4.5. Diagnosed Prevalent Cases of SSc Subtypes by Digital Vasculopathy, N, Ages ≥18 Years, Men and Women, 2025

4.6. Diagnosed Prevalent Cases of SSc Subtypes by Tissue Fibrosis, N, Ages ≥18 Years, Men and Women, 2025

4.7. Diagnosed Prevalent Cases of SSc Subtypes by Systemic Involvement, N, Ages ≥18 Years, Men and Women, 20255.

5. Current Treatment Options

5.1. Treatment Paradigm

5.2. Current Treatment Options: Tissue Fibrosis

5.3. Product Profile: mycophenolate mofetil

5.4. Product Profile: methotrexate

5.5. Product Profile: cyclophosphamide

5.6. Product Profile: Ofev (nintedanib)

5.7. Product Profile: Jascayd (nerandomilast)

5.8. Product Profile: Actemra (tocilizumab)

5.9. Product Profile: Rituxan (rituximab)

5.10. Current Treatment Options: Vasculopathy

5.11. Product Profile: Adempas (riociguat)

5.12. Product Profile: Uptravi (selexipag)

5.13. Product Profile: Winrevair (sotatercept)

5.14. Product Profile: iloprost

5.15. Product Profile: Tracleer (bosentan)

5.16. Product Profile: Botox (onabotulinumtoxin A)

5.17. Patient Flow

6. Unmet Needs and Opportunities

6.1. Unmet Needs in SSc

6.2. Lack of DMTs targeting GI involvement

6.3. Lack of therapies that reverse disease progression

6.4. Delays in referral and treatment initation

6.5. Need for predictive biomarkers to identify patients at risk of progression

7. R&D Strategies

7.1. Trends in Clinical Trial Design in SSc

7.2. Trends in Deal-Making in SSc

8. Pipeline Assessment

8.1. Pipeline Overview

8.2. Late-Stage Pipeline Agents for SSc

8.3. Product Profile: Benlysta (belimumab)

8.4. Product Profile: Saphnelo (anifrolumab)

8.5. Product Profile: Uplizna (inebilizumab)

8.6. Product Profile: zolacabtagene autoleucel

8.7. SSc: Clinical Trials (Phase I/II/III) Overview

9. Market Outlook

9.1. SSc Market Forecast by Country, 2025-35

9.2. SSc Market Forecast by Drug Class, 2025–35

9.3. SSc Market Drivers and Barriers

10. Appendix

10.1. Primary Research: KOL information

10.2. Bibliography

10.3. About the Authors

11. Contact Us

Systemic Sclerosis in Major Markets, Disease Management, Epidemiology, Pipeline Assessment, Unmet Needs and Drug Forecast to 2035 standard reports
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