OpportunityAnalyzer:Uveitis - Opportunity Analysis and Forecasts to 2026

OpportunityAnalyzer:Uveitis - Opportunity Analysis and Forecasts to 2026

Summary

Uveitis is an inflammatory condition of the eye affecting mainly the uvea. It encompasses a heterogeneous collection of disorders characterized by ocular inflammation. Currently, there is only a limited number of approved drugs for the treatment of uveitis. Based on the diverse nature of uveitis , there is a high unmet need for varied therapy approaches. Significant efforts are being made to develop new treatments for uveitis, as current pharmacologic management, which is dominated by competitively priced corticosteroids and also immunosuppressive drugs, is notorious for the development of adverse side effects.
 
GlobalData estimates the drug sales for uveitis in 2016 were approximately $416.5M across the 7MM covered in this report. Over the 10-year forecast period, the market is expected to grow to $897.1M at a CAGR of 8.0%.

The anticipated introduction of five new drugs will further drive the market by offering novel treatment mechanisms, including new drug delivery routes and novel, non-corticosteroid drug molecules. These new drugs will expand the options available to treat uveitis patients and contribute to overall market growth.

Scope

- Overview of uveitis: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized uveitis market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including non-infectious mild and moderate anterior uveitis, non-infectious severe anterior uveitis, non-infectious intermediate, posterior and panuveitis), forecast from 2016 to 2026.
- Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the uveitis therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for uveitis therapy. The most promising candidate in Phase III (and Phase II/III) development is profiled.
- Analysis of the current and future market competition in the global uveitis 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.
- Develop business strategies by understanding the trends shaping and driving the global uveitis therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global uveitis therapeutics market in the 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

2
1.1 List of Tables 7
1.2 List of Figures 8
2 Executive Summary 9
2.1 Significant Growth Is Expected in the Uveitis Market from 2016 to 2026 9
2.2 R&D and Corporate Strategies Within the Uveitis Market 11
2.3 A Long-Acting Treatment That Permanently Controls Inflammation, With a Good Short- and Long-Term Safety Profile, Remains Elusive 12
2.4 Market Opportunities for New Entrants 13
2.5 Late-Stage Pipeline Drugs Entering the Uveitis Market Will Be a Key Driver of Growth 14
2.6 What Do Physicians Think? 16
3 Introduction 19
3.1 Catalyst 19
3.2 Related Reports 19
4 Disease Overview 20
4.1 Etiology and Pathophysiology 20
4.1.1 Etiology 21
4.1.2 Pathophysiology 24
4.2 Classification or Staging Systems 26
4.2.1 Uveitis and Systemic Diseases 27
4.3 Symptoms 29
4.4 Prognosis 30
4.5 Quality of Life 31
5 Epidemiology 32
5.1 Disease Background 32
5.2 Risk Factors and Comorbidities 33
5.3 Global and Historical Trends 34
5.3.1 US 36
5.3.2 5EU 37
5.3.3 Japan 38
5.4 Forecast Methodology 39
5.4.1 Sources 40
5.4.2 Forecast Assumptions and Methods 44
5.5 Epidemiological Forecast for Uveitis (2016-2026) 54
5.5.1 Diagnosed Incident Cases of Uveitis 54
5.5.2 Diagnosed Prevalent Cases of Uveitis 55
5.5.3 Age-Specific Diagnosed Prevalent Cases of Uveitis 56
5.5.4 Sex-Specific Diagnosed Prevalent Cases of Uveitis 57
5.5.5 Diagnosed Prevalent Cases by Anatomical Site of Inflammation 58
5.5.6 Diagnosed Prevalent Cases by Etiology 59
5.6 Discussion 60
5.6.1 Epidemiological Forecast Insight 60
5.6.2 Limitations of the Analysis 60
5.6.3 Strengths of the Analysis 61
6 Current Treatment Options 63
6.1 Overview 63
6.2 Diagnosis and Treatment 63
6.2.1 Diagnosis 63
6.2.2 Treatment Guidelines and Leading Prescribed Drugs 64
6.3 Clinical Practice 66
6.4 Humira (Adalimumab) 73
6.4.1 Overview 73
6.4.2 Efficacy 78
6.4.3 Safety 79
6.4.4 SWOT Analysis 81
6.5 Retisert (Flucinolone Acetonide) 81
6.5.1 Overview 81
6.5.2 Efficacy 83
6.5.3 Safety 84
6.5.4 SWOT Analysis 86
6.6 Ozurdex (Dexamethasone Acetate) 86
6.6.1 Overview 86
6.6.2 Efficacy 89
6.6.3 Safety 90
6.6.4 SWOT Analysis 92
7 Unmet Needs and Opportunity Assessment 93
7.1 Overview 93
7.2 Therapies That Maintain Vision and Control Inflammation 94
7.2.1 Unmet Need 94
7.2.2 Gap Analysis 95
7.2.3 Opportunity 97
7.3 Therapies With Improved Safety Profiles 98
7.3.1 Unmet Need 98
7.3.2 Gap Analysis 99
7.3.3 Opportunity 103
7.4 Long-Acting and More Efficient Treatment 104
7.4.1 Unmet Need 104
7.4.2 Gap Analysis 106
7.4.3 Opportunity 109
7.5 Increased Physician Education and Improved Treatment Guidelines 110
7.5.1 Unmet Need 110
7.5.2 Gap Analysis 111
7.5.3 Opportunity 114
7.6 Development of Biomarkers and Different Diagnostic Tests for Various Uveitic Types 115
7.6.1 Unmet Need 115
7.6.2 Gap Analysis 117
7.6.3 Opportunity 117
8 R&D Strategies 118
8.1 Overview 118
8.1.1 Uveitis as an Add-On Indication 118
8.1.2 Uveitis as a First Indication for a New Drug 119
8.1.3 Development of Ophthalmic Routes of Administration 120
8.1.4 Development of Novel Non-steroid Therapies 120
8.2 Clinical Trials Design 121
8.2.1 Lack of High-Quality Outcome Measures 121
8.2.2 Lack of Consensus on Outcome Measures 123
8.2.3 Corticosteroid-Sparing Therapy 123
9 Pipeline Assessment 125
9.1 Overview 125
9.2 Opsiria/DE-109 (Sirolimus) 127
9.2.1 Overview 127
9.2.2 Efficacy 131
9.2.3 Safety 133
9.2.4 SWOT Analysis 134
9.3 Durasert (Fluocinolone Acetonide) 134
9.3.1 Overview 134
9.3.2 Efficacy 140
9.3.3 Safety 141
9.3.4 SWOT Analysis 143
9.4 EGP-437 (Iontophoretic Dexamethasone Phospaste) 144
9.4.1 Overview 144
9.4.2 Efficacy 148
9.4.3 Safety 149
9.4.4 SWOT Analysis 150
9.5 CLS-TA (Triamcinolone Acetonide) 150
9.5.1 Overview 150
9.5.2 Efficacy 156
9.5.3 Safety 157
9.5.4 SWOT Analysis 158
9.6 ADX-102 159
9.6.1 Overview 159
9.6.2 Efficacy 162
9.6.3 Safety 163
9.6.4 SWOT Analysis 164
9.7 Biosimilars Assessment 164
9.8 Amjevita (Adalimumab Biosimilar) 168
9.8.1 Overview 168
9.8.2 SWOT Analysis 170
9.9 Imraldi (Adalimumab Biosimilar) 170
9.9.1 Overview 170
9.9.2 SWOT Analysis 172
9.10 Innovative Early Stage Approaches 173
9.10.1 Tesidolumab (LFG-316) 173
9.10.2 Orencia (Abatacept) 174
9.10.3 Dexamethasone Acetate (DexNP) 177
9.10.4 LME-636 180
9.10.5 Optiquel (B27-PD) 181
9.10.6 Filgotinib 182
9.11 Other Drugs in Development 184
10 Pipeline Valuation Analysis 185
10.1 Clinical Benchmark of Key Pipeline Drugs 185
10.2 Commercial Benchmark of Key Pipeline Drugs 187
10.3 Competitive Assessment 189
10.4 Top-Line 10-Year Forecast 192
10.4.1 US 196
10.4.2 5EU 199
10.4.3 Japan 203
11 Appendix 206
11.1 Bibliography 206
11.2 Abbreviations 220
11.3 Methodology 224
11.3.1 Forecasting Methodology 224
11.3.2 Diagnosed Prevalent Cases 226
11.3.3 Diagnosed Prevalent Cases by Anatomical Site of Inflammation 226
11.3.4 Diagnosed Cases and Drug-Treated Prevalence 226
11.3.5 Disease Severity 227
11.3.6 Drugs Included in Each Therapeutic Class 227
11.3.7 Launch and Patent Expiry Dates 228
11.3.8 General Pricing Assumptions 229
11.3.9 Individual Drug Assumptions 230
11.3.10 Generic Erosion 234
11.3.11 Pricing of Pipeline Agents 235
11.4 Primary Research - KOLs Interviewed for This Report 237
11.5 Primary Research - Prescriber Survey 239
11.6 About the Authors 240
11.6.1 Analyst 240
11.6.2 Therapy Area Director 240
11.6.3 Epidemiologist 240
11.6.4 Managing Epidemiologist 241
11.6.5 Global Director of Therapy Analysis and Epidemiology 241
11.6.6 Global Head and EVP of Healthcare Operations and Strategy 242
11.7 About GlobalData 243
11.8 Contact Us 243
11.9 Disclaimer 244

List Of Tables

1.1 List of Tables
Table 1: Uveitis: Key Metrics in the 7MM 9
Table 2: SUN Working Group Anatomic Classification of Uveitis 26
Table 3: SUN Working Group Descriptors in Uveitis 27
Table 4: SUN Working Group Descriptors in Uveitis 27
Table 5: Systemic Diseases Associated with Uveitis 28
Table 6: Symptoms and Ocular Comorbidities of Uveitis 29
Table 7: Prognosis for Uveitis Patients 30
Table 8: Risk Factors, Comorbidities, and Associated Diseases for Uveitis 33
Table 9: 7MM, Diagnosed Incident Cases of Uveitis, Both Sexes, All Ages, N, Select Years, 2016-2026 54
Table 10: 7MM, Diagnosed Prevalent Cases of Uveitis, Both Sexes, All Ages, N, Select Years, 2016-2026 55
Table 11: Treatment Guidelines for Uveitis 65
Table 12: Most Prescribed Drugs for Uveitis by Class in the Global Markets, 2016 66
Table 13: Summary of Minor Therapeutic Classes, 2016 72
Table 14: Product Profile - Humira 77
Table 15: Humira SWOT Analysis, 2017 81
Table 16: Product Profile - Retisert 83
Table 17: Retisert SWOT Analysis, 2017 86
Table 18: Product Profile - Ozurdex 89
Table 19: Ozudex SWOT Analysis, 2017 92
Table 20: Comparison of Therapeutic Classes in Development for Non-infectious Uveitis, 2016-2026 126
Table 21: Product Profile - Opsiria 131
Table 22: Opsiria SWOT Analysis, 2017 134
Table 23: Product Profile - Durasert 140
Table 24: Durasert SWOT Analysis, 2017 143
Table 25: Product Profile - EGP-437 148
Table 26: EGP-437 SWOT Analysis, 2017 150
Table 27: Product Profile - CLS-TA 156
Table 28: CLS-TA SWOT Analysis, 2017 158
Table 29: Product Profile - ADX-102 162
Table 30: ADX-102 SWOT Analysis, 2017 164
Table 31: Adalimumab Biosimilars Being Developed in the 7MM/Globally 165
Table 32: Product Profile - Amjevita 169
Table 33: Amjevita SWOT Analysis, 2017 170
Table 34: Product Profile - Imraldi 172
Table 35: IMRALDI SWOT Analysis, 2017 172
Table 36: Innovative Early Stage Approaches for Non-infectious Uveitis, 2017 173
Table 37: Drugs in Development for Uveitis, 2017 184
Table 38: Clinical Benchmark of Key Pipeline Drugs - Anterior Uveitis 186
Table 39: Clinical Benchmark of Key Pipeline Drugs - Posterior Segment Uveitis 187
Table 40: Commercial Benchmark of Key Pipeline Drugs - Anterior Uveitis 188
Table 41: Commercial Benchmark of Key Pipeline Drugs - Posterior Segment Uveitis 189
Table 42: Key Events Impacting Sales for Uveitis, 2016-2026 195
Table 43: Uveitis Market - Global Drivers and Barriers, 2016-2026 196
Table 44: Key Historical and Projected Launch Dates for Uveitis 228
Table 45: Key Historical and Projected Patent Expiry Dates for Uveitis 229
Table 46: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 239

List Of Figures

1.2 List of Figures
Figure 1: Global Sales Forecast by Country for Uveitis in 2016 and 2026 11
Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, Pred Forte 15
Figure 3: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against Local Therapy, Triesence 16
Figure 4: Anatomy of the Eye 21
Figure 5: Hypothetical Pathogenetic Model of Autoimmune Uveitis 23
Figure 6: Schematic Representation of T-helper Activation In Immune-Mediated Uveitis 25
Figure 7: Age-Standardized Diagnosed Prevalence of Uveitis, Men, All Ages, 2006-2026 35
Figure 8: Age-Standardized Diagnosed Prevalence of Uveitis, Women, All Ages, 2006-2026 36
Figure 9: Case Flow Map for Diagnosed Incident and Prevalent Cases of Uveitis 39
Figure 10: Sources Used for Diagnosed Incidence 40
Figure 11: Sources Used for Diagnosed Incident Cases by Anatomical Location of Inflammation 41
Figure 12: Sources Used for Diagnosed Incident Cases by Course of Disease 42
Figure 13: Sources Used for Diagnosed Incident Cases by Severity 42
Figure 14: Sources Used and Not Used for Diagnosed Prevalence 43
Figure 15: Sources Used for Diagnosed Prevalent Cases by Anatomical Location of Inflammation 44
Figure 16: 7MM, Age-Specific Diagnosed Prevalent Cases of Uveitis, Both Sexes, N, 2016 56
Figure 17: 7MM, Sex-Specific Diagnosed Prevalent Cases of Uveitis, All Ages, N, 2016 57
Figure 18: 7MM, Diagnosed Prevalent Cases of Uveitis by Anatomical Site of Inflammation, Both Sexes, All Ages, N, 2016 58
Figure 19: 7MM, Diagnosed Prevalent Cases of Uveitis by Etiology, Both Sexes, All Ages, N, 2016 59
Figure 20: Current Treatment of Uveitis 68
Figure 21: Unmet Need and Opportunity in Non-infectious Uveitis, 2017 94
Figure 22: Overview of the Development Pipeline in Non-infectious Uveitis 125
Figure 23: Key Phase II/III Trials for the Promising Pipeline Agents that GlobalData Expects Will Be Licensed for Non-infectious Uveitis in the 7MM During the Forecast Period 126
Figure 24: Competitive Assessment of the Late-Stage Pipeline Drugs for Anterior Segment Uveitis Benchmarked Against the SOC, Pred Forte 191
Figure 25: Competitive Assessment of the Late-Stage Pipeline Drugs for Posterior Segment Uveitis Benchmarked Against the local therapy, Triesence 192
Figure 26: Global (7MM) Sales Forecast by Country for Uveitis in 2016 and 2026 193
Figure 27: Global Sales Forecast by Class for Uveitis in 2016 and 2026 194
Figure 28: Sales Forecast by Class for Uveitis in the US in 2016 and 2026 199
Figure 29: Sales Forecast by Class for Uveitis in the 5EU in 2016 and 2026 202
Figure 30: Sales Forecast by Class for Uveitis in Japan in 2016 and 2026 205

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