Product Code: GDHC221PIDR
Systemic sclerosis (SSc) is a rare, multisystem autoimmune disease that causes progressive fibrosis of the skin and internal organs, as well as vascular dysfunction. The presentation of the disease is heterogeneous, both in the organ systems affected and the overall severity of symptoms. The most common complications of SSc include digital vasculopathy (Raynaud's phenomenon and digital ulcers), skin fibrosis, lung fibrosis or interstitial lung disease (ILD), pulmonary arterial hypertension, gastrointestinal issues, arthritis, myopathy, and scleroderma renal crisis. As there are no systemic disease-modifying therapies currently available that significantly alter the course of the disease, the SSc treatment paradigm is to manage complications within individual organ systems as they occur.
GlobalData's report and forecast model focus specifically on the treatment of SSC-associated digital vasculopathy, skin fibrosis, and ILD. Most of the drugs used to treat these disease manifestations are decades-old generic agents that have been repurposed from other indications, including immunosuppressive agents (such as methotrexate, mycophenolate mofetil, and cyclophosphamide) and vasodilative cardiovascular drugs (such as calcium channel blockers, PDE5 inhibitors, and prostacyclin analogs). The vast majority of SSc therapies are used off-label. However, there has recently been a major shift in the SSc market landscape, and new players are beginning to enter the space.
GlobalData projects that the global SSc market, which comprises the seven major pharmaceutical markets (7MM) (US, France, Germany, Italy, Spain, UK, and Japan), will experience strong growth during the forecast period, at a Compound Annual Growth Rate (CAGR) of 14.0%, with sales growing from $498.0M in 2020 to $1.8B in 2030. Global growth in the SSc market will be driven by uptake of Boehringer Ingelheim's (BI) recently launched Ofev (nintedanib) and Roche/Genentech's Actemra/RoActemra (tocilizumab) for the treatment of SSc-associated ILD, along with the anticipated approval and launch of six pipeline therapies. This growth will be limited by sales erosion from generic nintedanib and biosimilars.
In this report, GlobalData focuses its market forecast analysis on six Phase III and late Phase II products expected to be licensed for SSc between 2020 and 2030. These include four small molecule drugs-Civi BioPharma/Eicos Sciences' IV Civi-030 (iloprost), Horizon Therapeutics' HZN-825, Kadmon Corporation's belumosudil mesylate, and Mitsubishi Tanabe Pharma's dersimelagon-and two monoclonal antibodies currently marketed for the treatment of PSO and PsA-Kyowa Kirin's Lumicef (brodalumab) and J&J's Tremfya (guselkumab).
Although key opinion leaders (KOLs) interviewed by GlobalData were pleased to see such an innovative late-stage pipeline for SSc, they did highlight major, lingering unmet needs in the field. These include needs for the development of disease-modifying and anti-fibrotic therapies, earlier diagnosis and treatment, and improved prognostic biomarkers. KOLs were optimistic about the future of SSc but believed there was significant work left to be done in this space.
- The greatest drivers of growth in the global SSc market will be the recent launches of Ofev and Actemra/RoActemra for the treatment of ILD associated with SSc, the anticipated approval and launch of six pipeline therapies, a steadily climbing diagnosed prevalence rate, and a growing overall treatment rate due to growing access to new therapies.
- The main barriers to growth in the SSc market will be significant market share erosion from biosimilars and nintedanib generics as well as a historical treatment paradigm that focuses on the off-label use of inexpensive generic products.
- KOLs expressed enthusiasm for the six pipeline agents in development. Of these agents, KOLs were most interested in Civi Biopharma/Eicos Sciences' Civi-030, Horizon Therapeutics' HZN-825, and Kadmon Corporation's belumosudil mesylate.
- The most important unmet needs in SSc are those for the development of disease-modifying and anti-fibrotic therapies, earlier diagnosis and treatment, and improved prognostic biomarkers.
KEY QUESTIONS ANSWERED
For the first time ever, treatment options for patients with SSc are beginning to expand.
- What impact will the recently launched drugs, Ofev and Actemra/RoActemra, have on the treatment of SSc throughout the 7MM?
- What pipeline agents are currently in late-stage clinical development, and which are the most promising?
Growing interest in SSc by the pharmaceutical industry is transforming research and development practices in the field.
- What are the main R&D trends in the SSc market and which companies are leading the way?
- How is clinical trial design for SSc changing and in what ways does it differ depending on disease manifestation?
KOLs interviewed by GlobalData have indicated that there are still many remaining unmet needs within the SSc indication.
- What are the main unmet needs in the SSc market?
- How can the pharmaceutical industry address these needs?
- To what degree will the therapies under development fulfill these unmet needs?
- Overview of SSc including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Topline SSc therapeutics market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
- Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting SSc therapeutics sales in the 8MM.
- Pipeline analysis: Comprehensive data split across different phases, 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, restraints and challenges. Each trend is independently researched to provide qualitative analysis of its implications.
Reasons to Buy
The report will enable you to -
- Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
- Develop business strategies by understanding the trends shaping and driving the global SSc therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global 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 global SSc therapeutics market from 2020-2030.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.
Table of Contents
Table of Contents
1 Systemic Sclerosis: Executive Summary
- 1.1 New Drug Approvals Expected to Drive Strong Growth in SSc
- 1.2 Current SSc Market Dynamics Reflect a Blend of New and Old R&D Strategies
- 1.3 While Outlook in SSc Improves, Opportunities Remains to Improve Patient Outcomes
- 1.4 SSc Pipeline Targets the Skin, Lungs, and Vasculature with New MOAs
- 1.5 What Do Physicians Think?
- 2.1 Catalyst
- 2.2 Related Reports
- 2.3 Upcoming Related Reports
3 Disease Overview
- 3.1 Etiology and Pathophysiology
- 3.1.1 Etiology
- 3.1.2 Pathophysiology
- 3.2 Disease Classification
- 4.1 Disease Background
- 4.2 Risk Factors and Comorbidities
- 4.3 Global and Historical Trends
- 4.4 7MM Forecast Methodology
- 4.4.1 Sources
- 4.4.2 Forecast Assumptions and Methods
- 4.4.3 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SSc - 7MM
- 4.4.4 Forecast Assumptions and Methods: Diagnosed Prevalent Cases of SSc by Subtype
- 4.4.5 Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
- 4.4.6 Diagnosed Prevalent Cases of by other Internal Organ Involvement and Comorbidities
- 4.5 Epidemiological Forecast for Systemic Sclerosis (2020-2030)
- 4.5.1 Diagnosed Prevalent Cases of SSc
- 4.5.2 Age-Specific Diagnosed Prevalent Cases of SSc
- 4.5.3 Sex-Specific Diagnosed Prevalent Cases of SSc
- 4.5.4 Diagnosed Prevalent Cases of SSc by Subtype
- 4.5.5 Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
- 4.5.6 Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement
- 4.5.7 Diagnosed Prevalent Cases of SSc with Comorbid Malignancy
- 4.6 Discussion
- 4.6.1 Epidemiological Forecast Insight
- 4.6.2 COVID-19 Impact
- 4.6.3 Limitations of the Analysis
- 4.6.4 Strengths of the Analysis
5 Disease Management
- 5.1 Diagnosis
- 5.2 Treatment
- 5.2.1 Digital Vasculopathy
- 5.2.2 Skin and Lung Fibrosis
- 5.2.3 Other Organ Involvement
6 Competitive Assessment
7 Unmet Needs and Opportunity Assessment
- 7.1 Overview
- 7.2 Lack of Disease-Modifying Therapies
- 7.3 Lack of Anti-Fibrotic Drugs
- 7.4 Earlier Referral and Treatment
- 7.5 Improved Prognostic Biomarkers
8 R&D Strategies
- 8.1 Overview
- 8.1.1 Repurposing of Drugs Used for Autoimmune and Cardiovascular Diseases
- 8.1.2 Big Pharma Forges Ahead in SSc-ILD Approvals
- 8.1.3 New Mechanisms of Action for Early Dc-SSc
- 8.2 Clinical Trial Design
- 8.2.1 Early Dc-SSc
- 8.2.2 SSc-ILD
- 8.2.3 Digital Vasculopathy
9 Pipeline Assessment
- 9.1 Overview
- 9.2 Promising Drugs in Clinical Development
- 9.2.1 Civi-030
- 9.2.2 HZN-825
- 9.2.3 Belumosudil Mesylate
- 9.2.4 Dersimelagon
- 9.2.5 Lumicef and Tremfya
- 9.3 Other Drugs of Note
10 Pipeline Valuation Analysis
- 10.1 Overview
- 10.2 Competitive Assessment
- 10.2.1 Skin Fibrosis
- 10.2.2 Lung Fibrosis
- 10.2.3 Digital Vasculopathy
11 Current and Future Players
- 11.1 Overview
- 11.2 Deal-Making Trends
12 Market Outlook
- 12.1 Global Markets
- 12.1.1 Forecast
- 12.1.2 Drivers and Barriers - Global Issues
- 12.2 US
- 12.2.1 Forecast
- 12.2.2 Key Events
- 12.2.3 Drivers and Barriers
- 12.3 5EU
- 12.3.1 Forecast
- 12.3.2 Key Events
- 12.3.3 Drivers and Barriers
- 12.4 Japan
- 12.4.1 Forecast
- 12.4.2 Key Events
- 12.4.3 Drivers and Barriers
List of Tables
List of Tables
- Table 1: SSc Key Metrics in the 7MM
- Table 2: Classification Groups for SSc
- Table 3: Risk Factors and Comorbidities for SSc
- Table 4: Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement
- Table 5: 2013 ACR/EULAR Criteria for the Classification of SSc
- Table 6: Frequency and Clinical Correlation of Select SSc-associated Nuclear Autoantibodies
- Table 7: Treatment Guidelines for SSc
- Table 8: Comparison of Provisional ACR-CRISS and Revised ACR-CRISS
- Table 9: Key Deals in SSc Market, 2016-2021
- Table 10: SSc Market - Global Drivers and Barriers, 2020-2030
- Table 11: Key Events Impacting Sales for SSc in the US, 2020-2030
- Table 12: SSc Market - Drivers and Barriers in the US, 2020-2030
- Table 13: Key Events Impacting Sales for SSc in the 5EU, 2020-2030
- Table 14: SSc Market - Drivers and Barriers in the 5EU, 2020-2030
- Table 15: Key Events Impacting Sales for SSc in Japan, 2020-2030
- Table 16: SSc Market - Drivers and Barriers in Japan, 2020-2030
- Table 17: High-Prescribing Physicians (non-KOLs) Surveyed, By Country
List of Figures
List of Figures
- Figure 1: Global (7MM) Sales Forecast by Country for SSc in 2020 and 2030
- Figure 2: Analysis of the Company Portfolio Gap in SSc During the Forecast Period
- Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Skin Fibrosis, MMF and MTX
- Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Lung Fibrosis, MMF and Ofev
- Figure 5: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for SSc-Associated Digital Vasculopathy, Generic Epoprostenol
- Figure 6: SSc Pathophysiology and Associated Therapeutic Mechanisms
- Figure 7: 7MM, Diagnosed Prevalence of SSc, Men and Women, %, Ages ≥18 Years, 2020
- Figure 8: 7MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of SSc
- Figure 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Subtype
- Figure 10: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Digital Vasculopathy
- Figure 11: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement - ILD, PAH, and Kidney Disease
- Figure 12: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of SSc by Other Internal Organ Involvement - Cardiac Involvement, Gastrointestinal Involvement, Musculoskeletal Involvement, and Neuromuscular Involvement; and Comorbidity - Malignancy
- Figure 13: 7MM, Diagnosed Prevalent Cases of SSc, N, Both Sexes, Ages ≥18 Years, 2020
- Figure 14: 7MM, Diagnosed Prevalent Cases of SSc by Age, N, Both Sexes, 2020
- Figure 15: 7MM, Diagnosed Prevalent Cases of SSc by Sex, N, Ages ≥18 Years, 2020
- Figure 16: 7MM, Diagnosed Prevalent Cases of SSc by Subtype, N, Both Sexes, Ages ≥18 Years, 2020
- Figure 17: 7MM, Diagnosed Prevalent Cases of SSc by Digital Vasculopathy, N, Both Sexes, Ages ≥18 Years, 2020
- Figure 18: 7MM, Diagnosed Prevalent Cases of SSc with Comorbid Malignancy, N, Both Sexes, Ages ≥18 Years, 2020
- Figure 19: General Treatment Algorithm for SSc-Associated Digital Vasculopathy, 2021
- Figure 20: General Treatment Algorithm for SSc-Associated Skin and Lung Fibrosis, 2021
- Figure 21: Unmet Needs and Opportunities in SSc
- Figure 22: Overview of the Development Pipeline in SSc
- Figure 23: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects Be Licensed for SSc in the 7MM During the Forecast Period
- Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Skin Fibrosis, MMF and MTX
- Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOCs for SSc-Associated Lung Fibrosis, MMF and Ofev
- Figure 26: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC for SSc-Associated Digital Vasculopathy, Generic Epoprostenol
- Figure 27: Analysis of the Company Portfolio Gap in SSc During the Forecast Period
- Figure 28: Global (7MM) Sales Forecast by Country for SSc in 2020 and 2030
- Figure 29: Global (7MM) Sales Forecast by Drug Class for SSc in 2020 and 2030
- Figure 30: Sales Forecast by Drug Class for SSc in the US in 2020 and 2030
- Figure 31: Sales Forecast by Drug Class for SSc in the 5EU in 2020 and 2030
- Figure 32: Sales Forecast by Drug Class for SSc in Japan in 2020 and 2030