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Opportunity Analyzer: Systemic Sclerosis (Scleroderma) - Opportunity Analysis and Forecast to 2024

Summary

Systemic sclerosis (SSc) is a complex autoimmune disease that affects the skin and multiple internal organs. Common manifestations of SSc that are included in this report are skin fibrosis, lung fibrosis, and digital vasculopathy (including Raynaud’s phenomenon [RP], and digital ulcers [DUs]). Although the etiology is not completely understood, it is believed to be caused by environmental triggers within genetically susceptible individuals. The clinical presentation of the disease varies between patients and treatment is mostly directed at managing its complications within each internal organ, as there are no systemic or disease-modifying treatments that significantly alter the course of the disease. Most drugs used to treat SSc are off-label and include immunosuppressive agents for skin and lung fibrosis and vasodilatory agents to treat digital vasculopathy. GlobalData expects the launch of three drugs during the 2014 to 2024 forecast period, including two biologic agents for fibrosis (Genentech/Roche’s Actemra and BMS’ Orencia) and Allergan’s Botox to treat digital vasculopathy.

Highlights

Key Questions Answered

- With three drug launches, two of which are biologics, which products are forecast to generate the highest sales over 2014-2024? How are product launches expected to affect immunosuppressants?
- What do SSc specialists across the 7MM think about the evolving treatment landscape? How will the results from the Scleroderma Lung Study II and update to the 2009 EULAR guidelines affect the management of SSc?
- What corporate strategies have been employed for recent product launches? What opportunities remain for new entrants?
- According to KOLs, what are the most important unmet needs in SSc? Will these needs be addressed by pipeline agents? What needs will remain by the end of the forecast period in 2024?
- How do payers view the unmet needs for SSc and how do reimbursement practices affect drug availability?

Key Findings

- Biologics are expected to account for nearly half of the SSc market in 2024, with Roche/Genentech’s Actemra emerging as a market leader.
- Reimbursement often poses a barrier to patients receiving proper therapy as evidence for use of off-label therapies in SSc is often lacking.
- Unmet needs are expected to remain after the forecast period, as there are no antifibrotic or disease-modifying therapies expected to launch for SSc.
- Several companies have been granted orphan designation and others from the European Medicines Agency (EMA), FDA, and Ministry of Health, Labour and Welfare (MHLW), which all provide incentives for drug development in this area.

Scope

- Overview of SSc, including etiology, pathophysiology, symptoms, and treatment recommendations.
- Annualized SSc market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, and implications for the SSc market.
- Pipeline analysis: comprehensive data split across different phases and emerging trends, specifically Roche/Genentech’s Actemra, Roche/Genentech’s Rituxan, BMS’s Orencia, and Allergan’s Botox.
- Analysis of the current and future market competition in the global SSc market. Insightful review of the key industry and governmental 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 through a review of pipeline products and technologies, and identify companies with the most robust pipeline.
- Develop business strategies by understanding the trends shaping and driving the SSc 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 market from 2014-2024.
- 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

Opportunity Analyzer: Systemic Sclerosis (Scleroderma) - Opportunity Analysis and Forecast to 2024
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 13
1.2 List of Figures 17
2 Introduction 18
2.1 Catalyst 18
2.2 Related Reports 19
2.3 Upcoming Related Reports 19
3 Disease Overview 20
3.1 Etiology and Pathophysiology 23
3.1.1 Etiology 23
3.1.2 Pathophysiology 24
3.2 Symptoms 28
3.3 Disease Management 30
3.3.1 Diagnosis 30
3.3.2 Treatment 32
4 Epidemiology 47
4.1 Disease Background 47
4.2 Risk Factors and Comorbidities 47
4.3 Global Trends 50
4.4 Forecast Methodology 51
4.4.1 Sources Used 52
4.4.2 Sources Not Used 67
4.4.3 Forecast Assumptions and Methods 67
4.5 Epidemiological Forecast for SSc (2014-2024) 80
4.5.1 Diagnosed Prevalent Cases of SSc 80
4.5.2 Age-Specific Diagnosed Prevalent Cases of SSc 81
4.5.3 Sex-Specific Diagnosed Prevalent Cases of SSc 84
4.5.4 Age-Standardized Prevalence of SSc 85
4.5.5 Diagnosed Prevalent Cases of SSc with RP and SSc with DU 86
4.5.6 SSc Segmented into lSSc and dSSc 88
4.5.7 Sex-Specific Diagnosed Prevalent Cases of lSSc 89
4.5.8 Sex-Specific Diagnosed Prevalent Cases of dSSc 90
4.5.9 Diagnosed Prevalent Cases of dSSc with ILD and Cases with Kidney Disease 91
4.6 Discussion 92
4.6.1 Epidemiological Forecast Insight 92
4.6.2 Limitations of the Analysis 93
4.6.3 Strengths of the Analysis 94
5 Current Treatment Options 95
5.1 Overview 95
5.2 Product Profiles - Tissue Fibrosis 97
5.2.1 Mycophenolate Mofetil 98
5.2.2 Methotrexate 103
5.2.3 Cyclophosphamide 106
5.2.4 Glucocorticoids 110
5.2.5 Azathioprine 115
5.3 Product Profiles - Vasculopathy 117
5.3.1 Tracleer (bosentan) 119
5.3.2 Calcium Channel Blockers 124
5.3.3 Phosphodiesterase 5 Inhibitors 127
5.3.4 Prostacyclins 130
5.3.5 Angiotensin Receptor Blockers 135
5.3.6 Selective Serotonin Reuptake Inhibitors 137
5.4 Other Therapies 140
6 Unmet Needs Assessment and Oppportunity Analysis 143
6.1 Overview 143
6.2 Lack of Anti-Fibrotic Drugs 144
6.2.1 Unmet Need 144
6.2.2 Gap Analysis 145
6.2.3 Opportunity 147
6.3 Lack of Disease-Modifying Therapies 148
6.3.1 Unmet Need 148
6.3.2 Gap Analysis 149
6.3.3 Opportunity 150
6.4 Identification of Prognostic Biomarkers 151
6.4.1 Unmet Need 151
6.4.2 Gap Analysis 153
6.4.3 Opportunity 153
6.5 Earlier Referral and Treatment 153
6.5.1 Unmet Need 153
6.5.2 Gap Analysis 155
6.5.3 Opportunity 155
6.6 Lack of Safe and Effective Therapies 156
6.6.1 Unmet Need 156
6.6.2 Gap Analysis 158
6.6.3 Opportunity 158
7 RandD Strategies 159
7.1 Overview 159
7.1.1 Clinical Research Run by Academic Centers 159
7.1.2 Repurposing of Drugs used for Autoimmune and Cardiovascular Diseases 160
7.1.3 Small Biotech Companies Entering the Space 161
7.1.4 Big Pharma Strategies 162
7.1.5 Orphan Drug and Other Special Designations 163
7.2 Clinical Trial Design 164
8 Pipeline Assessment 166
8.1 Overview 166
8.2 Promising Drugs in Clinical Development 166
8.2.1 Rituxan (rituximab) 167
8.2.2 Actemra (tocilizumab) 176
8.2.3 Orencia (abatacept) 184
8.2.4 Botox 190
8.3 Innovative Early-Stage Approaches 197
8.3.1 Adempas (riociguat) 200
8.3.2 Disitertide (P144 cream) 201
8.3.3 Resunab (JBT-101) 202
8.3.4 ARG201 203
8.3.5 Aimspro 203
8.3.6 Benlysta (belimumab) 204
9 Pipeline Valuation Analysis 206
9.1 Clinical Benchmarking of Key Pipeline Drugs 206
9.1.1 Fibrotic Manifestations 206
9.1.2 Digital Vasculopathy 208
9.2 Commercial Benchmark of Key Pipeline Drugs 209
9.2.1 Fibrotic Manifestations 209
9.2.2 Digital Vasculopathy 211
9.3 Competitive Assessment 212
9.4 Top Line Ten Year Forecast 214
9.4.1 US 220
9.4.2 5EU 222
9.4.3 Japan 223
10 Appendix 225
10.1 Abbreviations 225
10.2 Bibliography 233
10.3 Methodology 259
10.4 Forecasting Methodology 259
10.4.1 Diagnosed Patients 259
10.4.2 Percent Drug-Treated Patients 260
10.4.3 Drugs Included in Each Therapeutic Class 260
10.4.4 Launch and Patent Expiry Dates 262
10.4.5 General Pricing Assumptions 262
10.4.6 Individual Drug Assumptions 264
10.4.7 Generic Erosion 271
10.4.8 Pricing of Pipeline Agents 271
10.5 Physicians and Specialists Included in this Study 272
10.6 Primary Research - Prescriber Survey 274
10.7 About the Authors 275
10.7.1 Author 275
10.7.2 Therapy Area Director 275
10.7.3 Epidemiologist 276
10.7.4 Global Head of Healthcare 276
10.8 About GlobalData 277
10.9 Disclaimer 277

1.1 List of Tables
Table 1: Symptoms of Systemic Sclerosis 29
Table 2: 2013 ACR/EULAR Criteria for the Classification of SSc (Scleroderma) 31
Table 3: Treatments for Skin Involvement 38
Table 4: Treatments for Digital Vasculopathy 41
Table 5: Treatments for SSc-ILD 44
Table 6: Treatments for SSc-PAH 46
Table 7: Risk Factors and Comorbidities for SSc 48
Table 8: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc 52
Table 9: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc with RP 53
Table 10: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc with DU 54
Table 11: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of SSc, Segmented by lSSc and dSSc 55
Table 12: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of dSSc with ILD 56
Table 13: 7MM, Sources of Epidemiological Data Used to Forecast the Diagnosed Prevalent Cases of dSSc with Kidney Disease 57
Table 14: 7MM, Diagnosed Prevalent Cases of SSc, Both Sexes, Ages ?18 Years, Select Years, 2014-2024 80
Table 15: 7MM, Age-Specific Diagnosed Prevalent Cases of SSc, Both Sexes, N (Row%), 2014 82
Table 16: 7MM, Sex-Specific Diagnosed Prevalent Cases of SSc, Ages ?18 Years, N (Row %), 2014 84
Table 17: 7MM, Diagnosed Prevalent Cases of SSc with RP, and SSc with DU, Both Sexes, Ages ?18 Years, N (% of Diagnosed Prevalent SSc Cases), 2014 87
Table 18: 7MM, Sex-Specific Diagnosed Prevalent Cases of lSSc, Ages ?18 Years, N (Row %), 2014 90
Table 19: 7MM, Sex-Specific Diagnosed Prevalent Cases of dSSc, Ages ?18 Years, N (Row %), 2014 91
Table 20: 7MM, Diagnosed Prevalent Cases of dSSc with ILD and dSSc with Kidney Disease, Both Sexes, Ages ?15 Years, N (% of Diagnosed Prevalent dSSc Cases), 2014 92
Table 21: Leading Treatments for SSc, 2015 96
Table 22: Product Profile - Mycophenolate mofetil 99
Table 23: Clinical Trials for MMF in SSc 100
Table 24: Product Profile - Methotrexate 104
Table 25: Clinical Trials for MTX in SSc 105
Table 26: Product Profile - Cyclophosphamide 108
Table 27: Clinical Trials for Cyclophosphamide in SSc 109
Table 28: AEs in SSc-ILD Patients Treated with Cyclophosphamide 110
Table 29: Product Profile - Glucocorticoids 112
Table 30: Clinical Trials for Glucocorticoids in SSc 114
Table 31: Product Profile - Azathioprine 116
Table 32: Product Profile - Tracleer 120
Table 33: Clinical Trials for Tracleer in SSc 122
Table 34: AEs Reported in Tracleer Label 123
Table 35: Tracleer SWOT Analysis, 2015 124
Table 36: Product Profile - Calcium Channel Blockers 125
Table 37: AEs Reported in Procardia Label 126
Table 38: Product Profile - Phosphodiesterase Inhibitors 128
Table 39: Clinical Trials for Sildenafil in SSc patients with RP and DUs 129
Table 40: Product Profile - Prostacyclins 132
Table 41: Clinical Trials for IV Prostanoids in SSc 133
Table 42: Adverse Reactions in an RCT of IV Iloprost 134
Table 43: Product Profile - Angiotensin Receptor Blockers 136
Table 44: Product Profile - Selective Serotonin Reuptake Inhibitors 138
Table 45: Frequency of Adverse Effects for Fluoxetine and Nifedipine in Primary and Secondary Raynaud's 139
Table 46: Summary of Minor Therapeutic Drug Classes Used to Treat SSc, 2015 142
Table 47: Unmet Needs and Opportunities in SSc, 2015 144
Table 48: SSc - Late Stage Pipeline, October 2015 167
Table 49: Product Profile - Rituxan 172
Table 50: Clinical Investigations of Rituxan for SSc 174
Table 51: Rituxan SWOT Analysis, 2015 175
Table 52: Product Profile - Actemra 180
Table 53: Results of the FaSScinate Trial in dSSc 181
Table 54: Clinical Investigations of Actemra for SSc 182
Table 55: Actemra SWOT Analysis, 2015 183
Table 56: Product Profile - Orencia 187
Table 57: Orencia SWOT Analysis, 2015 189
Table 58: Product Profile - Botox 194
Table 59: Hand Strength in SSc Patients with Secondary RP Treated with BTX-A 195
Table 60: Clinical Investigations of Botox for SSc, October 2015 196
Table 61: Botox SWOT Analysis, 2015 197
Table 62: Early-Stage Pipeline Products in SSc, October 2015 199
Table 63: Clinical Benchmark of Key Drugs for Fibrosis in SSc 208
Table 64: Clinical Benchmark of Key Digital Vasculopathy Drugs for SSc 209
Table 65: Commercial Benchmark of Key Drugs for Fibrosis in SSc 210
Table 66: Commercial Benchmark of Key Digital Vasculopathy Drugs for SSc 212
Table 67: Top-Line Sales Forecasts ($m) for SSc, 2014-2024 217
Table 68: Key Events Impacting Sales for SSc, 2014-2024 219
Table 69: Global SSc Disease Market - Drivers and Barriers, 2014-2024 220
Table 70: Key Launch Dates 262
Table 71: Key Patent Expiries 262
Table 72: Average Body Weight and Surface Area Across the 7MM 264
Table 73: High-Prescribing Physicians (Non-KOLs) Surveyed, by Country 274

1.2 List of Figures
Figure 1: Scleroderma Classification 21
Figure 2: Pathogenesis of SSc 25
Figure 3: Case Flow Map of the Diagnosed Prevalent Cases of SSc 58
Figure 4: 7MM, Diagnosed Prevalent Cases of SSc, Both Sexes, Ages ?18 Years, Selected Years, 2014-2024 81
Figure 5: 7MM, Age-Specific Diagnosed Prevalent Cases of SSc, Both Sexes, 2014 83
Figure 6: 7MM, Sex-Specific Diagnosed Prevalent Cases of SSc, Ages ?18 Years, 2014 85
Figure 7: 7MM, Age-Standardized Diagnosed Prevalence of SSc, 2014 86
Figure 8: 7MM, Diagnosed Prevalent Cases of SSc with RP and SSc with DU, Both Sexes, Ages ?18 Years, N, 2014 88
Figure 9: 7MM, Diagnosed Prevalent Cases of SSc Classified as lSSc and dSSc, Both Sexes, Ages ?18 Years, N, 2014 89
Figure 10: Mediators of Vascular Tone and MOAs that Promote Vasodilation 118
Figure 11: Competitive Assessment of SSc Pipeline Therapies for Fibrosis, 2014-2024 213
Figure 12: Competitive Assessment of SSc Pipeline Therapies for Digital Vasculopathy, 2014-2024 214
Figure 13: Global Sales for SSc by Region, 2014-2024 218

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