Sjogrens Syndrome Market: Opportunity Analysis and Forecast to 2024
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About
Sjogrens Syndrome Market
Sjgrens syndrome (SS) is a slow
progressing chronic autoimmune disease, which predominantly affects
middle-aged women, and is characterized by lymphocytic infiltration
of the exocrine glands, mainly the lacrimal and salivary glands,
resulting in reduced secretory functions and ocular and oral dryness.
The syndrome can also cause many systemic manifestations, targeting
various organs of the body. Current treatment of patients with SS is
challenging, with few effective therapeutic agents available. Due to
the multi-factorial nature of SS, agents are required to treat
glandular symptoms of the disease mainly salivary and lachrymal and
also any extraglandular manifestations that may arise. However, many
of the agents that are available either only treat the symptoms of
the disease, are used off-label for the treatment of SS, or are
considered ineffective in many patients.
The SS market is now set to enter
a new phase with the potential approval of the first biologic agent
for SS treatment.
Highlights
Key Questions Answered
The SS market is marked by the
presence of a number of unmet needs. What are the main unmet needs in
this market? Will the drugs under development fulfil the unmet needs
of the SS market?
The late-stage SS pipeline
includes the biologic treatment Orencia (abatacept). Will this
late-stage drug make a significant impact on the SS market? Will this
drug reach peak sales by the end of the forecast period?
The current SS market is dominated
by the use of off-label therapies. How will the approval of the first
biologic agent for the treatment of SS change the drug treatment
landscape? What are the key drivers and barriers to market growth?
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Table of Contents
1 Table of Contents 9
1.1 List of Tables 13
1.2 List of Figures 16
2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 18
3 Disease Overview 19
3.1 Etiology and Pathophysiology
19
3.1.1 Etiology 19
3.1.2 Pathophysiology 20
3.2 Symptoms 21
3.3 Diagnosis 23
3.4 Prognosis 29
4 Epidemiology 31
4.1 Disease Background 31
4.2 Risk Factors and Comorbidities
32
4.3 Global Trends 34
4.3.1 7MM Diagnosed Prevalent
Cases 36
4.3.2 5EU Diagnosed Prevalent
Cases 37
4.3.3 Japan Diagnosed Prevalent
Cases 37
4.4 Forecast Methodology 37
4.4.1 Sources Used 41
4.4.2 Sources Not Used 43
4.4.3 Forecast Assumptions and
Methods 44
4.5 Epidemiological Forecast for
SS (2014-2024) 48
4.5.1 Diagnosed Prevalent Cases of
SS 48
4.5.2 Age-Specific Diagnosed
Prevalent Cases of Primary SS 54
4.5.3 Sex-Specific Diagnosed
Prevalent Cases of Primary SS 56
4.5.4 Age-Standardized Diagnosed
Prevalence of Primary SS 58
4.5.5 Ocular and Oral
Manifestations 60
4.6 Discussion 61
4.6.1 Epidemiological Forecast
Insight 61
4.6.2 Limitations of the Analysis
63
4.6.3 Strengths of the Analysis 63
5 Current Treatment Options 65
5.1 Overview 65
5.1.1 General Preventative
Measures 68
5.2 Product Profiles - Major
Brands, Cholinergic Agonists 69
5.2.1 Salagen (Pilocarpine
Hydrochloride) 69
5.2.2 Evoxac (Cevimeline
Hydrochloride) 77
5.3 Off-Label Treatments and Drug
Classes 83
5.3.1 Tear and Saliva Substitutes
83
5.3.2 Cyclosporine Ophthalmic
Emulsion - Restasis, Ikervis, Papilock Mini 86
5.3.3 Topical Ophthalmic
Corticosteroids - Prednisolone, Fluorometholone, Loteprednol 93
5.3.4 Antimalarial Agents
Hydroxychloroquine 97
5.3.5 Other Systemic
Immunosuppressive Therapies - Methotrexate, Azathioprine,
Cyclophosphamide 102
5.3.6 Systemic Corticosteroids -
Prednisolone, Methylprednisolone 111
5.3.7 Biologic Agents - Rituxan
(Rituximab) 117
6 Unmet Needs Assessment and
Opportunity Analysis 127
6.1 Overview 127
6.2 Sjgrens Syndrome Treatments
with Improved Efficacy 128
6.2.1 Unmet Need 128
6.2.2 Gap Analysis 130
6.2.3 Opportunity 131
6.3 Earlier Sjgrens Syndrome
Diagnosis 133
6.3.1 Unmet Need 133
6.3.2 Gap Analysis 134
6.3.3 Opportunity 136
6.4 Treatment Guidelines to
Improve Patient Access to Therapies 137
6.4.1 Unmet Need 137
6.4.2 Gap Analysis 139
6.4.3 Opportunity 140
6.5 Improved Public and Patient
Awareness of Sjgrens Syndrome 140
6.5.1 Unmet Need 140
6.5.2 Gap Analysis 141
6.5.3 Opportunity 141
7 Research and Development
Strategies 143
7.1 Overview 143
7.1.1 Evaluation of Biologic
Therapies Marketed for Other Autoimmune Diseases 143
7.1.2 Inhibition of Immunological
Mechanisms Involved in Sjgrens Syndrome 146
7.2 Clinical Trial Design 147
7.2.1 Patient Number 147
7.2.2 Inclusion Criteria 148
7.2.3 Efficacy Endpoints 151
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8 Pipeline Assessment 154
8.1 Overview 154
8.2 Promising Drugs in Clinical
Development 154
8.2.1 Orencia (Abatacept) 154
8.3 Innovative Early-Stage
Approaches 164
9 Pipeline Valuation Analysis 166
9.1 Clinical Benchmark of Key
Pipeline Drugs 166
9.2 Commercial Benchmark of Key
Pipeline Drugs 167
9.3 Competitive Assessment 167
9.4 Top-Line Ten-Year Forecast 170
9.4.1 US 173
9.4.2 5EU 174
9.4.3 Japan 175
10 Appendix 177
10.1 Bibliography 177
10.2 Abbreviations 191
10.3 Methodology 195
10.4 Forecast Methodology 195
10.4.1 Percent Diagnosed Patients
195
10.4.2 Percent Drug-Treated
Patients 196
10.4.3 Drugs Included in Each
Therapeutic Class 196
10.4.4 Launch and Patent Expiry
Dates 196
10.4.5 General Pricing Assumptions
197
10.4.6 Individual Drug Assumptions
198
10.5 Physicians and Specialists
Included in This Study 203
10.6 About the Authors 205
10.6.1 Analyst 205
10.6.2 Therapy Area Director 205
10.6.3 Epidemiologist 206
10.6.4 Global Director of Therapy
Analysis and Epidemiology 206
10.6.5 Global Head of Healthcare
207
10.7 About GlobalData 208
10.8 Disclaimer 208
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