Scleroderma (Systemic Sclerosis) – Landscape & Forecast – Disease Landscape & Forecast

Systemic sclerosis (SSc) is a rare, progressive, debilitating autoimmune disorder characterized by skin fibrosis, systemic inflammation, and vasculopathy that manifests as Raynaud’s disease, skin thickening, and, often, painful digital ulcers. Mortality risks of pulmonary arterial hypertension (PAH), interstitial lung disease (ILD), and renal crisis are high in SSc patients. The only disease-modifying therapies (DMTs) approved for SSc are Boehringer Ingelheim’s Ofev (nintedanib) and Roche / Genentech’s Actemra / RoActemra (tocilizumab), both of which target the SScILD subpopulation and have demonstrated the ability to slow the progressive loss of lung function. The mid-phase SSc pipeline is large and diverse. Although there is tremendous need for additional effective DMTs, drug development in SSc has been historically challenging due to the heterogeneity of SSc patients and the commensurate challenges with trial design.

QUESTIONS ANSWERED

· How large is the diagnosed SSc population in the United States and EU5, and how will it change over time?

· What is the current treatment landscape in SSc, and how will it change in the next 10 years?

· What do key opinion leaders view as the greatest unmet medical needs in the management of SSc?

· What is the commercial potential of key emerging therapies? How will they fit into the SSc treatment landscape?

PRODUCT DESCRIPTION

Niche & Rare Disease Landscape & Forecast provides comprehensive market intelligence with world-class epidemiology, keen insight into current treatment paradigms, in-depth pipeline assessments, and drug forecasts supported by detailed primary and secondary research.

Table of contents

  • Scleroderma (Systemic Sclerosis) - Landscape & Forecast - Disease Landscape & Forecast
    • Key Findings
      • Scleroderma (Systemic Sclerosis) Key Findings - December 2020
    • Commercial Outlook
      • Key Findings
        • Regional Sales of Key Therapies to Treat Scleroderma (Systemic Sclerosis): 2030
        • Scleroderma (Systemic Sclerosis) SWOT Analysis
      • COVID-19: Areas of Potential Forecast Impact
        • COVID-19: Market Forecast Impact
      • Drivers and Constraints
        • What Factors Are Driving Sales in Scleroderma (Systemic Sclerosis)?
        • What Factors Are Constraining Sales in Scleroderma (Systemic Sclerosis)?
      • Drug-Class-Specific Trends
        • Tyrosine Kinase Inhibitors
        • Interleukin-6 Inhibitors
      • Alternative Market Scenarios
        • Alternative Scenarios for the Scleroderma Market Through 2030
    • Forecast
      • Sales of Key Therapies in Scleroderma (Systemic Sclerosis)
    • Etiology and Pathophysiology
      • Disease Overview
        • Etiology
          • Key Risk Factors for the Development of Scleroderma (Systemic Sclerosis)
        • Pathophysiology
          • Clinical Presentation
            • Key Pathways and Drug Targets
            • Epidemiology
              • Key Findings
                • Epidemiology Populations
                  • Disease Definition
                  • Methods
                  • Sources for Diagnosed Prevalent Cases of Scleroderma (Systemic Sclerosis)
                  • Number of Diagnosed Prevalent Cases of Scleroderma (Systemic Sclerosis) in the Major Pharmaceutical Markets: 2020-2030
                  • Number of Diagnosed Drug-Treated Prevalent Cases of Scleroderma (Systemic Sclerosis) in the Major Markets: 2020-2030
                  • Disease Definition
                  • Methods
                  • Sources Used for Subtypes by Severity
                  • Number of Diagnosed Prevalent Cases of Scleroderma (Systemic Sclerosis) in the Major Pharmaceutical Markets by Severity: 2020-2030
              • Current Treatment
                • Key Findings
                  • Diagnosis
                    • ACR and EULAR Criteria for the Classification of Systemic Sclerosis
                    • Treatment Providers and Referral Patterns
                  • Treatment Goals
                    • Key Endpoints Used in Clinical Trials for Scleroderma (Systemic Sclerosis)
                  • Key Current Therapies
                    • Overview
                    • Mechanism of Action of Key Current Drug Classes Used for Scleroderma (Systemic Sclerosis)
                    • Current Treatments Used for Scleroderma (Systemic Sclerosis)
                    • Use of Key Drug Classes for the Manifestations of Systemic Sclerosis
                    • Clinical Trial Outcomes for ACE Inhibitors
                    • Key Results of Select Clinical Trials Investigating ACE Inhibitors for the Treatment of Systemic Sclerosis
                    • Advantages and Disadvantages of ACE Inhibitors
                    • Expert Insight: ACE Inhibitors
                    • Clinical Trial Outcomes for Autologous Hematopoietic Stem Cell Transplantation
                    • Key Results of Select Clinical Trials Investigating Autologous Stem Cell Transplantation for the Treatment of Systemic Sclerosis
                    • Ongoing Clinical Development of Autologous Hematopoietic Stem Cell Transplant for Scleroderma (Systemic Sclerosis)
                    • Key Ongoing Trials of Autologous Hematopoietic Stem Cell Transplants for Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of Autologous Stem Cell Transplantation
                    • Expert Insight: Autologous Hematopoietic Stem Cell Transplant
                    • Clinical Trial Outcomes for Rituximab
                    • Key Results of Select Clinical Trials Investigating Rituximab for the Treatment of Systemic Sclerosis
                    • Advantages and Disadvantages of Rituximab
                    • Ongoing Clinical Development of Rituximab
                    • Key Ongoing Trials of Rituximab in Scleroderma (Systemic Sclerosis)
                    • Expert Insight: Rituximab
                    • Clinical Trial Outcomes for Calcium-Channel Blockers
                    • Key Results of Select Clinical Trials Investigating Calcium-Channel Blockers for the Treatment of Systemic Sclerosis
                    • Advantages and Disadvantages of Calcium-Channel Blockers
                    • Expert Insight: Calcium-Channel Blockers
                    • Clinical Trial Outcomes for Endothelin Receptor Antagonists
                    • Key Results of Select Clinical Trials Investigating Endothelin Receptor Antagonists for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of Endothelin Receptor Antagonists
                    • Expert Insight: Endothelin Receptor Antagonists
                    • Key Results of Select Clinical Trials Investigating Adempas for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of Adempas
                    • Ongoing Clinical Development of Adempas
                    • Key Ongoing Trials of Adempas in the Treatment of Scleroderma (Systemic Sclerosis)
                    • Expert Insight: Adempas
                    • Clinical Trial Outcomes for Immunosuppressants
                    • Key Results of Select Clinical Trials Investigating Immunosuppressants for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of Immunosuppressants
                    • Ongoing Clinical Development of Immunosuppressants
                    • Key Ongoing Trials of Immunosuppressants in the Treatment of Scleroderma (Systemic Sclerosis)
                    • Expert Insight: Immunosuppressants
                    • Interleukin-6 Inhibitors
                    • Actemra / RoActemra
                    • Clinical Trial Outcomes for Actemra / RoActemra
                    • Advantages and Disadvantages of Actemra / RoActemra
                    • Key Results from Select Clinical Trials Investigating Actemra / RoActemra for the Treatment of Scleroderma
                    • Expert Insight: Actemra / RoActemra
                    • Clinical Trial Outcomes for PDE-5 Inhibitors
                    • Key Results of Select Clinical Trials Investigating PDE-5 Inhibitors for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of PDE-5 Inhibitors
                    • Expert Insight: PDE-5 Inhibitors
                    • Clinical Trial Outcomes for Prostacyclin Analogues
                    • Key Results of Select Clinical Trials Investigating Prostacyclin Analogues for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Advantages and Disadvantages of Prostacyclin Analogues
                    • Ongoing Clinical Development of Prostacyclin Analogues for the Treatment of Scleroderma (Systemic Sclerosis)
                    • Key Ongoing Trials of Prostacyclin Analogues in the Treatment of Scleroderma (Systemic Sclerosis)
                    • Expert Insight: Prostacyclin Analogues
                    • Clinical Trial Outcomes for Ofev
                    • Key Results of Select Clinical Trials Investigating Ofev for the Treatment of Systemic Sclerosis
                    • Advantages and Disadvantages of Ofev
                    • Ongoing Clinical Development of Ofev
                    • Key Ongoing Clinical Trials of Ofev in the Treatment of Scleroderma (Systemic Sclerosis)
                    • Expert Insight: Ofev
                  • Medical Practice
                    • Overview
                    • Treatment Guidelines
                    • Regional Scleroderma (Systemic Sclerosis) Treatment Guidelines
                    • Factors Influencing Drug Selection in Scleroderma (Systemic Sclerosis)
                    • Generalized Treatment Decision Tree for Scleroderma (Systemic Sclerosis)
                • Unmet Need Overview
                  • Current and Future Attainment of Unmet Needs in Scleroderma (Systemic Sclerosis)
                  • Top Unmet Needs in Scleroderma (Systemic Sclerosis): Current and Future Attainment
                  • Expert Insight: Unmet Need in Scleroderma (Systemic Sclerosis)
                • Emerging Therapies
                  • Key Findings
                    • Key Emerging Therapies
                      • Key Therapies in Development for Scleroderma (Systemic Sclerosis)
                      • Lenabasum Profile
                      • Analysis of the Clinical Development Program for Lenabasum
                      • Expert Insight: Lenabasum
                      • Expectations for Market Authorization and Sales Opportunity for Lenabasum in Scleroderma (Systemic Sclerosis)
                      • Esbriet Profile
                      • Key Ongoing Clinical Trials of Esbriet in the Treatment of Scleroderma (Systemic Sclerosis)
                      • Analysis of the Clinical Development Program for Esbriet
                      • Expectations for Market Authorization and Sales Opportunity for Esbriet in Scleroderma (Systemic Sclerosis)
                      • Orencia Profile
                      • Orencia Clinical Development
                      • Expert Insight: Orencia
                      • Expectations for Launch and Sales Opportunity for Orencia in Scleroderma (Systemic Sclerosis)
                    • Early-Phase Pipeline Analysis
                      • Select Compounds in Early-Phase Development for Scleroderma (Systemic Sclerosis)
                    • Key Discontinuations and Failures in Scleroderma
                      • Patient Registries
                        • Patient Registries for Scleroderma (Systemic Sclerosis)
                        • Prominent Scleroderma (Systemic Sclerosis) Patient Organizations
                      • Orphan Drug Designation
                      • Access & Reimbursement Overview
                        • Region-Specific Reimbursement Practices
                          • Key Market Access Considerations in Scleroderma (Systemic Sclerosis): United States
                          • General Reimbursement Environment: United States
                          • Key Market Access Considerations in Scleroderma (Systemic Sclerosis): EU5
                          • General Reimbursement Environment: EU5
                      • Appendix
                        • Scleroderma (Systemic Sclerosis) Bibliography

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