Systemic Sclerosis-Associated Interstitial Lung Disease Market is Expected to Witness a Substantial Positive Shift During the Forecast Period of 2024-2034 | DelveInsight

DelveInsight's "Systemic Sclerosis-associated Interstitial Lung Disease Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of Systemic Sclerosis-associated Interstitial Lung Disease, historical and forecasted epidemiology, and the Systemic Sclerosis-associated Interstitial Lung Disease Market trends in the United States, EU4 (Germany, Spain, Italy, and France), the United Kingdom, and Japan.

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Key Takeaways from Systemic Sclerosis-Associated Interstitial Lung Disease Market Report
• The Systemic Sclerosis-associated Interstitial Lung Disease Market is anticipated to witness a substantial positive shift owing to better uptake of existing drugs, the expected market launch of one-time gene therapies, and raised awareness.
• The United States accounts for the largest Systemic Sclerosis-Associated Interstitial Lung Disease Market Size, in comparison to EU4 (Germany, Spain, Italy, France), the United Kingdom, and Japan.
• The predominance of SSc-ILD cases in females in the US is due to the higher prevalence of systemic sclerosis in women, which is likely driven by complex genetic and hormonal factors.
• Severity-specific prevalence data suggests that the cases of the moderate type are much higher than the severe type of SSc-ILD.
• Among EU4 and the UK, the United Kingdom had the highest diagnosed prevalent cases of SSc-ILD in 2023, followed by Italy and France, while Germany had the lowest.
• In 2023, the highest number of patients diagnosed with SSc-ILD belonged to the age group 65 and above, and the lowest to the 0-18 age group.
• In 2023, the maximum number of diagnosed prevalent SSc-ILD cases in the US were found with moderate severity stage.
• Among EU4 and the UK, the UK constituted the highest Systemic Sclerosis-Associated Interstitial Lung Disease Market Size in 2023.
• The Systemic Sclerosis-Associated Interstitial Lung Disease Companies include Roche, Boehringer Ingelheim, Prometheus Biosciences, Genentech, GlaxoSmithKline, Merck & Co, and others.
• Promising Systemic Sclerosis-Associated Interstitial Lung Disease Therapies include GSK1550188/Belimumab (BENLYSTA), PRA023, vixarelimab (KPL-716), and others.

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Recent Developments in the Systemic Sclerosis-Associated Interstitial Lung Disease Market
• In January 2026, GlaxoSmithKline announced result of A Phase 2/3, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Evaluate The Efficacy And Safety of Belimumab Administered Subcutaneously in Adults With Systemic Sclerosis Associated Interstitial Lung Disease (SSC-ILD).

What is Systemic Sclerosis-Associated Interstitial Lung Disease?
Systemic Sclerosis (SSc) is characterized by fibrosis, vasculopathy, and inflammation, affecting multiple organs. Pulmonary involvement can lead to interstitial lung disease (ILD) and/or pulmonary arterial hypertension (PAH). While the exact cause of SSc-ILD is unclear, environmental, immune, and genetic factors are implicated. SSc patients are at high risk of developing ILD, which can result in lung inflammation and scarring, leading to respiratory failure.
The diagnosis of SSc-ILD relies primarily on detecting interstitial lung disease on high-resolution computed tomography (HRCT) of the chest in patients with known SSc, while ruling out other causes of pulmonary parenchymal disease. A comprehensive clinical evaluation, including respiratory symptom assessment, is vital for all newly diagnosed SSc patients to identify potential lung involvement early. Early recognition is crucial as ILD significantly impacts morbidity and mortality in this population.

Systemic Sclerosis-Associated Interstitial Lung Disease Epidemiology Segmentation in the 7MM
• Total Diagnosed Prevalent Cases
• Age-specific Diagnosed Prevalent Cases
• Gender-specific Diagnosed Prevalent Cases
• Severity-specific Diagnosed Prevalent Cases

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Systemic Sclerosis-Associated Interstitial Lung Disease Approved Therapies
• ACTEMRA/ROACTEMRA (tocilizumab): Roche
In March 2021, the FDA approved ACTEMRA (tocilizumab) subcutaneous injection for slowing the rate of decline in pulmonary function in adult patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Tocilizumab is a monoclonal antibody that selectively binds to the interleukin-6 receptor and prevents IL-6 from binding to its receptor (IL-6R) on the liver, lung, and synovial fibroblasts. In the liver, IL-6 can increase the production of C-reactive protein, serum amyloid A, fibrinogen, and hepcidin, and decrease albumin synthesis; these liver mediator effects can cause amyloidosis, cardiovascular events, edema, and anemia.

• OFEV (nintedanib): Boehringer Ingelheim
In 2019, the FDA approved OFEV (nintedanib) as the first and only medicine to slow the rate of decline in pulmonary function in patients with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Ofev is already approved in the US for the treatment of patients living with idiopathic pulmonary fibrosis (IPF), and has been shown to slow IPF progression by reducing the annual rate of decline in lung function, as measured by forced vital capacity (FVC). Ofev's active ingredient, nintedanib, is a tyrosine kinase inhibitor (TKI) that inhibits the growth factor receptors involved in the progression of pulmonary fibrosis, including platelet-derived growth factor receptor (PDGFR), fibroblast growth factor receptor (FGFR), and vascular endothelial growth factor receptor (VEGFR).
Systemic Sclerosis-Associated Interstitial Lung Disease Pipeline Analysis

• GSK1550188/Belimumab (BENLYSTA): GlaxoSmithKline
Belimumab (BENLYSTA), being developed by GSK, is a fully human monoclonal antibody that prevents B cells from differentiating. The company initiated a Phase III trial of belimumab for SSc-ILD in September 2023. In February 2023, the US FDA granted Orphan Drug Designation (ODD) to BENLYSTA to treat SSc.

• PRA023: Merck
PRA023 is a humanized IgG1 monoclonal antibody (mAb) with a dual mechanism of action, targeting both inflammation and fibrosis, which provides a strong rationale for advancing PRA023 into clinical trials. It is currently in development for treating ulcerative colitis (UC), Crohn's Disease (CD), and SSc-ILD. In January 2022, the FDA granted Fast Track Designation (FTD) for PRA023 to treat SSc-ILD, and the drug is currently recruiting participants in Phase II. In June 2023, Prometheus Biosciences became a subsidiary of Merck & Co., Inc.

Systemic Sclerosis-Associated Interstitial Lung Disease Companies
Roche, Boehringer Ingelheim, Prometheus Biosciences, Genentech, GlaxoSmithKline, Merck & Co, and others

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Systemic Sclerosis-Associated Interstitial Lung Disease Market Outlook
Key Systemic Sclerosis-Associated Interstitial Lung Disease Companies, such as Prometheus Biosciences, Genentech, GlaxoSmithKline, Merck & Co, and others, are evaluating their lead candidates in different stages of clinical development, aiming to investigate their products for the treatment of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD). The current Systemic Sclerosis-Associated Interstitial Lung Disease pipeline consists of potential drugs including, but not limited to, PRA023, belimumab (GSK1550188), and vixarelimab (KPL-716). Among EU4 and the UK, the UK constituted the highest Systemic Sclerosis-Associated Interstitial Lung Disease Market Size in 2023.

The uptake rate of potential Systemic Sclerosis-Associated Interstitial Lung Disease drugs expected to launch during 2024-2034 depends on the competitive landscape, safety and efficacy data, along with order of market entry. It is important that key Systemic Sclerosis-Associated Interstitial Lung Disease Companies evaluating their novel therapies in pivotal and confirmatory trials remain vigilant when selecting appropriate comparators, to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Scope of the Systemic Sclerosis-Associated Interstitial Lung Disease Market Report
• Study Period: 2020-2034
• Forecast Period: 2024-2034
• Coverage: 7MM
• Systemic Sclerosis-Associated Interstitial Lung Disease Companies: Roche, Boehringer Ingelheim, Prometheus Biosciences, Genentech, GlaxoSmithKline, Merck & Co, and others
• Systemic Sclerosis-Associated Interstitial Lung Disease Drugs: ACTEMRA/ROACTEMRA (tocilizumab), OFEV (nintedanib), GSK1550188/Belimumab (BENLYSTA), PRA023, and others
• Systemic Sclerosis-Associated Interstitial Lung Disease Therapeutic Assessment: Systemic Sclerosis-associated Interstitial Lung Disease current marketed and emerging therapies
• Systemic Sclerosis-Associated Interstitial Lung Disease Market Dynamics: Systemic Sclerosis-associated Interstitial Lung Disease market drivers and market barriers
• Competitive Intelligence Analysis: SWOT analysis, Conjoint Analysis, Market entry strategies
• Systemic Sclerosis-Associated Interstitial Lung Disease Unmet Needs, KOL's views, Analyst's views, Systemic Sclerosis-Associated Interstitial Lung Disease Market Access and Reimbursement

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Table of Contents
1. Key Insights
2. Systemic Sclerosis-associated Interstitial Lung Disease Executive Summary
3. Competitive Intelligence Analysis for Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD)
4. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD): Market Overview at a Glance
5. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD): Disease Background and Overview
6. Patient Journey
7. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) Epidemiology and Patient Population
8. Treatment Algorithm, Current Treatment, and Medical Practices
9. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) Unmet Needs
10. Key Endpoints of Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) Treatment
11. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) Marketed Products
12. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD) Emerging Therapies
13. Systemic Sclerosis-associated Interstitial Lung Disease (SSc-ILD): Seven Major Market Analysis
14. Attribute Analysis
15. 7MM: Systemic Sclerosis-associated Interstitial Lung Disease Market Outlook
16. Systemic Sclerosis-associated Interstitial Lung Disease Market Access and Reimbursement Overview
17. Systemic Sclerosis-associated Interstitial Lung Disease KOL Views
18. Systemic Sclerosis-associated Interstitial Lung Disease Market Drivers
19. Systemic Sclerosis-associated Interstitial Lung Disease Market Barriers
20. Appendix
21. DelveInsight Capabilities
22. Disclaimer
23. About DelveInsight

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