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Opportunity Analyzer: Sjögren’s Syndrome - Opportunity Analysis and Forecast to 2024

Summary

Sjögren’s 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?

Key Findings

- The main driver of the expansion of the SS market will be the anticipated approval of the first biologic agent for the treatment of SS, Bristol-Myers Squibb’s Orencia (abatacept).
- Growth will also be driven by an increase in the prescribing of off-label biologic therapies for the treatment of SS, such as Genentech/Biogen’s Rituxan (rituximab). However, this growth will be dampened by the anticipated entry of cheaper rituximab biosimilars.
- Until the first biologic agent is approved for the treatment of SS, physicians will continue to have difficulty in gaining reimbursement for the use of off-label biologics in their patients, due to their expense and the lack of treatment guidelines to help payers in making reimbursement decisions.
- A number of randomized controlled trials evaluating biologics in SS have failed, bringing into question the design of the clinical trials. It is believed that as more robust scoring systems and an accurate disease activity index are used in SS clinical trials, studies will be more capable of providing clinically relevant information, with an increased likelihood of detecting efficacy.

Scope

- Overview of SS, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized SS therapeutics market revenue, annual cost of therapy, and treatment usage pattern data from 2014 and forecast for 10 years to 2024.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications for the SS therapeutics market.
- 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 SS 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 through a review of pipeline products and technologies, and by identifying the companies with the most robust pipeline. Additionally a list of acquisition targets included in the pipeline product company list.
- Develop business strategies by understanding the trends shaping and driving the global SS therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global SS therapeutics market in future.
- Formulate effective sales and marketing strategies by understanding the competitive landscape and by analysing 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 SS therapeutics 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: Sjögren’s Syndrome - Opportunity Analysis and Forecast to 2024
1 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 Sjögren's 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 Sjögren's 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 Sjögren's 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 Sjögren's 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
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

1.1 List of Tables
Table 1: Prevalence of Systemic Symptoms in Patients Diagnosed with Primary Sjögren's Syndrome 22
Table 2: Clinical Features of Sjögren's Syndrome 23
Table 3: Classification Criteria for Sjögren's Syndrome 24
Table 4: AECG Classification Criteria for Sjögren's Syndrome (2002) 27
Table 5: AECG Rules for Sjögren's Syndrome Classification (2002) 28
Table 6: ACR Criteria for Sjögren's Syndrome (2012) 28
Table 7: Japanese MHLW Criteria for the Diagnosis of Sjögren's Syndrome (1999) 29
Table 8: Risk Factors and Comorbidities for SS 33
Table 9: 7MM, Sources Used to Forecast the Diagnosed Prevalent Cases of Primary SS 38
Table 10: 7MM, Sources Used to Forecast the Oral and Ocular Manifestations of SS 39
Table 11: 7MM, Sources Not Used in the Epidemiological Analysis of SS 44
Table 12: Diagnosed Prevalent Cases of SS, Age ?18 Years, Both Sexes, N, 2014-2024 53
Table 13: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary SS, Age ?18 Years, Both Sexes, N, 2014 55
Table 14: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary SS, Age ?18 Years, N, 2014 57
Table 15: Key Marketed Products for Sjögren's Syndrome, 7MM 67
Table 16: Product Profile ? Salagen 72
Table 17: Incidence of Adverse Events ?10% in Any Treatment Group 74
Table 18: Summary of the Frequency of Adverse Reactions Related to Salagen Treatment 75
Table 19: Salagen SWOT Analysis, 2015 76
Table 20: Product Profile ? Evoxac 78
Table 21: Change in Patients' Assessment of Dry Mouth Between Baseline and Final Value* 79
Table 22: Effect of Evoxac on Salivary Flow at Clinical Trial End Point 80
Table 23: Incidence of Adverse Events Reported by ?10% of Patients in Any Treatment Group (15mg and 30mg Evoxac Study), N (%) 80
Table 24: Incidence of Adverse Effects with Evoxac Treatment, N (%) 81
Table 25: Incidence of Adverse Events Reported by ?10% of Patients in Any Treatment Group (30 and 60mg Evoxac Study), N (%) 82
Table 26: Evoxac SWOT Analysis, 2015 83
Table 27: Product Profile - Cyclosporine Ophthalmic Emulsion 89
Table 28: Cyclosporine Ophthalmic Emulsion SWOT Analysis, 2012 92
Table 29: Product Profile - Topical Ophthalmic Corticosteroids 94
Table 30: Efficacy of Systemic Immunosuppressive Therapy in Sjögren's Syndrome Clinical Trials 95
Table 31: Topical Corticosteroids SWOT Analysis, 2015 96
Table 32: Product Profile - Hydroxychloroquine 99
Table 33: Antimalarial Therapy SWOT Analysis, 2015 102
Table 34: Major Systemic Immunosuppressive Therapies Used to Treat Patients with SS 104
Table 35: Product Profile - Systemic Immunosuppressive Therapies 106
Table 36: Efficacy of Systemic Immunosuppressant Drugs in Sjögren's Syndrome Clinical Trials 108
Table 37: Systemic Immunosuppressive Therapy SWOT Analysis, 2015 111
Table 38: Product Profile - Systemic Corticosteroids 115
Table 39: Systemic Corticosteroids SWOT Analysis, 2015 117
Table 40: Product Profile - Rituxan 122
Table 41: Efficacy of Rituxan in Sjögren's Syndrome Clinical Trials 124
Table 42: Rituxan SWOT Analysis, 2015 126
Table 43: Unmet Need in Sjögren's Syndrome 127
Table 44: Mechanism of Action of Pipeline Products for Sjögren's Syndrome, 7MM 146
Table 45: Late-Stage Pipeline Products for Sjögren's Syndrome, 7MM 154
Table 46: Product Profile - Orencia 158
Table 47: Summary of Orencia Efficacy in Primary SS Patients (Open-Label Pilot Study) 160
Table 48: Orencia SWOT Analysis, 2014 163
Table 49: Early-Stage Pipeline Products for Sjögren's Syndrome, 7MM 164
Table 50: Clinical Benchmark of Key Pipeline Drug - Sjögren's Syndrome Treatments 166
Table 51: Commercial Benchmark of Key Pipeline Drug - Sjögren's Syndrome Treatments 167
Table 52: Top-Line Sales Forecasts ($m) for the Sjögren's Syndrome Market in the 7MM, 2014-2024 171
Table 53: Key Events Impacting Sales for the Sjögren's Syndrome Market, 2014?2024 172
Table 54: Sjögren's Syndrome Market - Drivers and Barriers, 2014-2024 173
Table 55: Launch Dates in the Sjögren's Syndrome Market, 2014-2024 196
Table 56: Patent Expiry Dates in the Sjögren's Syndrome Market, 2014-2024 197
Table 57: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 204

1.2 List of Figures
Figure 1: Diagnosed Prevalence Rate of SS in the 7MM, 2014 36
Figure 2: Case Flow Map for Primary SS: US, Germany, Italy, UK, and Japan 40
Figure 3: Case Flow Map for Primary SS: France and Spain 41
Figure 4: 7MM, Diagnosed Prevalent Cases of Primary SS, Age ?18 Years, Both Sexes, N, Selected Years, 2014-2024 49
Figure 5: 7MM, Diagnosed Prevalent Cases of Secondary SS, Age ?18 Years, Both Sexes, N, Selected Years, 2014-2024 51
Figure 6: 7MM Diagnosed Prevalent Cases of SS, Age ?18 Years, Both Sexes, N, Selected Years, 2014-2024 54
Figure 7: 7MM, Age-Specific Diagnosed Prevalent Cases of Primary SS, Age ?18 Years, Both Sexes, N, 2014 56
Figure 8: 7MM, Sex-Specific Diagnosed Prevalent Cases of Primary SS, Age ?18 Years, N, 2014 58
Figure 9: 7MM, Age-Standardized Diagnosed Prevalence of Primary SS, Age ?18 Years , 2014 59
Figure 10: 7MM, Ocular and Oral Manifestations of SS in the Diagnosed Prevalent Cases of SS, Age ?18 Years , 2014 61
Figure 11: Competitive Assessment of the Late-Stage Pipeline Agent Orencia for Sjögren's Syndrome 168
Figure 12: Sales for the Sjögren's Syndrome Market in the 7MM, 2014?2024 172

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