Develop Business Strategies Of Systemic Sclerosis (Scleroderma) Market 2024
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About
Systemic Sclerosis (Scleroderma) Market
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 Raynauds 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/Roches Actemra
and BMS Orencia) and Allergans 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?
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Key Findings
- Biologics are expected to
account for nearly half of the SSc market in 2024, with
Roche/Genentechs 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/Genentechs Actemra, Roche/Genentechs Rituxan, BMSs Orencia, and
Allergans 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.
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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
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