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OpportunityAnalyzer: Allergic Conjunctivitis - Opportunity Analysis and Forecasts to 2018

Summary

The allergic conjunctivitis market has remained relatively static over the last few years, due to a limited number of new products. It is currently dominated by dual-acting products and corticosteroid therapies, which form the core treatment options for both acute and chronic allergic conjunctivitis sufferers. Although these therapies provide effective treatment regimens, there are opportunities for the development of alternative treatment choices, improvements in efficacy, safety and compliance. By 2018, there will be three new entrants to the allergic conjunctivitis market. These new products will help drive market growth and offset the impending patent expiries of the majority of the remaining brands (Lotemax, Patanol and Lastacaft) during the forecast period, which will permit the entry of inexpensive generics. Despite these advancements in the treatment landscape, the allergic conjunctivitis market is not expected to experience a noticeable change in terms of growth.

Key Questions Answered

- The allergic conjunctivitis market is marked by the presence of a number of unmet needs in current treatments. What are the main unmet needs in this market? Will the drugs under development fulfil the unmet needs of the allergic conjunctivitis market?
- The late-stage allergic conjunctivitis pipeline consists of a new class of therapy, reformulation of existing, non-approved therapies and a therapy with a novel route of administration. Which drug will have a significant impact on the allergic conjunctivitis market? Which of these drugs will have the highest CAGR, and why?
- The allergic conjunctivitis market is currently dominated by generic drugs. How will the introduction of new therapies change the treatment landscape? How will the drug treatment rates change over the next five years? What are the key drivers and barriers to this change?

Key Findings

- The main driver of the expansion of the allergic conjunctivitis market will be the introduction of three new therapies across the 6 major markets.
- The biggest barrier for the introduction of new therapies will be patent expirations of the majority of the drugs marketed for allergic conjunctivitis, which will result in an increase of generics, and which may negatively impact revenue from branded drugs that are expected to launch in the forecast period.
- The concerns of reducing healthcare costs as part of government austerity measures, particularly in Europe, which will impede market growth. To ensure reimbursement companies will have to work closely together with payers and price their drugs competitively.

Scope

- Overview of allergic conjunctivitis, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized allergic conjunctivitis therapeutics market revenue, annual cost of therapy and treatment usage pattern data from 2013 and forecast for five years to 2018.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the allergic conjunctivitis therapeutics market.
- Pipeline analysis: focus on the five late-stage pipeline drugs discussing emerging trends as well as overview of earlier phase drugs.
- Analysis of the current and future market competition in the global allergic conjunctivitis 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

- 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 allergic conjunctivitis therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global allergic conjunctivitis 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 allergic conjunctivitis therapeutics market from 2013-2018.
- 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

OpportunityAnalyzer: Allergic Conjunctivitis - Opportunity Analysis and Forecasts to 2018
1 Table of Contents

2 Introduction 17
2.1 Catalyst 17
2.2 Related Reports 17
2.3 Upcoming Related Reports 17
3 Disease Overview 18
3.1 Etiology and Pathophysiology 18
3.1.1 Etiology 19
3.1.2 Pathophysiology 21
3.1.3 Prognosis 24
3.1.4 Quality of Life 24
3.1.5 Symptoms 24
4 Epidemiology 26
4.1 Disease Background 26
4.2 Risk Factors and Comorbidities 27
4.3 Global Trends 29
4.4 Forecast Methodology 29
4.4.1 Sources Used 30
4.4.2 Forecast Assumptions and Methods 32
4.5 Epidemiological Forecast for Allergic Conjunctivitis (2013-2023) 33
4.5.1 Total Prevalent Cases of Allergic Conjunctivitis 33
4.5.2 Age-Specific Total Prevalent Cases of Allergic Conjunctivitis 35
4.5.3 Sex-Specific Total Prevalent Cases of Allergic Conjunctivitis 36
4.6 Discussion 38
4.6.1 Epidemiological Forecast Insight 38
4.6.2 Limitations of the Analysis 39
4.6.3 Strengths of the Analysis 40
5 Current Treatment Options Overview 41
5.1 Product Profiles - Major Brands 42
5.1.1 Antihistamines 42
5.1.2 Mast Cell Stabilizers 45
5.1.3 Dual-Acting Products 47
5.1.4 Pataday (olopatadine) 50
5.1.5 Elestat (epinastine) 52
5.1.6 Bepreve (bepotastine) 54
5.1.7 Lastacaft (alcaftadine) 56
5.1.8 Nonsteroidal Anti-Inflammatory Drugs 58
5.1.9 Corticosteroids 61
5.1.10 Lotemax (loteprednol etabonate) 64
5.1.11 Durezol (difluprednate) 67
5.1.12 Immunosuppressants 69
6 Unmet Needs Assessment and Opportunity Analysis 73
6.1 Overview 73
6.2 Unmet Needs Analysis 74
6.2.1 Unmet Need: Safer Corticosteroids for Long-Term Use 74
6.2.2 Unmet Need: More Efficacious Medicines 75
6.2.3 Unmet Need: Increased Physician and Patient Awareness of Allergic Conjunctivitis 76
6.3 Opportunity Analysis 77
6.3.1 Opportunity: Effective Therapies that Would Target Allergic Conjunctivitis Subtypes 77
6.3.2 Opportunity: Drugs With an Improved Side Effect Profile 77
7 Research and Development Strategies 78
7.1 Overview 78
7.1.1 Reformulations of the Existing Therapies 78
7.1.2 Focus on Niche Patient Subgroups 81
7.1.3 Development of Novel Classes of Therapies 82
7.1.4 Clinical Trial Design 84
7.1.5 Trial Design 84
7.1.6 Recruiting Trial Participants 86
7.1.7 Future Trial Design 87
8 Pipeline Assessment 88
8.1 Overview 88
8.2 Promising Drugs in Clinical Development 89
8.2.1 Vekacia (cyclosporine) 90
8.2.2 SUN-1334H (antihistamine) 95
8.2.3 OTX-DP (dexamethasone) 97
8.2.4 RX-10045 (resolvin) 101
8.2.5 AC-170 (cetirizine) 105
8.3 Innovative Early-Stage Approaches 108
9 Pipeline Valuation Analysis 111
9.1 Clinical Benchmarking of Key Pipeline Drugs 111
9.2 Commercial Benchmark of Key Pipeline Drugs 114
9.3 Competitive Assessment 117
9.4 Top-Line Five-Year Forecast 119
9.4.1 US 120
9.4.2 5EU 122
10 Appendix 125
10.1 Bibliography 125
10.2 Abbreviations 133
10.3 Methodology 136
10.4 Forecasting Methodology 136
10.4.1 Diagnosed Allergic Conjunctivitis Patients 136
10.4.2 Percentage of Drug-Treated Patients 137
10.4.3 Drugs Included in Each Therapeutic Class 137
10.4.4 Launch Dates 137
10.4.5 General Pricing Assumptions 137
10.4.6 Individual Drug Assumptions 138
10.4.7 Generic Erosion 143
10.4.8 Pricing of Pipeline Agents 143
10.5 Physicians and Specialists Included in this Study 144
10.6 About the Authors 145
10.6.1 Authors 145
10.6.2 Reviewer 145
10.6.3 Epidemiologist 145
10.6.4 Global Head of Healthcare 146
10.7 About GlobalData 147
10.8 Disclaimer 147

1.1 List of Tables

Table 1: Characteristics of Allergic Conjunctivitis Subtypes 19
Table 2: Risk Factors and Comorbidities for Allergic Conjunctivitis 28
Table 3: 6MM, Sources of Allergic Conjunctivitis Prevalence Data Used in the Epidemiology Forecast 30
Table 4: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, All Ages, Both Sexes, N, 2013-2023 34
Table 5: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, by Age, Both Sexes, N (Row %), 2013 35
Table 6: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, by Sex, All Ages, N (Row %), 2013 37
Table 7: Leading Treatments for Allergic Conjunctivitis 42
Table 8: Product Profile -Antihistamines 43
Table 9: Antihistamines SWOT Analysis 45
Table 10: Product Profile - Mast Cell Stabilizers 46
Table 11: Mast Cell Stabilizers SWOT Analysis 47
Table 12: Product Profile - Dual-Acting Products 48
Table 13: Dual-Acting Products, SWOT Analysis 50
Table 14: Pataday SWOT Analysis 52
Table 15: Elestat SWOT Analysis 54
Table 16: Bepreve SWOT Analysis 56
Table 17: Lastacaft SWOT Analysis 57
Table 18: Product Profile - NSAIDs 59
Table 19: Topical Ocular NSAIDs SWOT Analysis 60
Table 20: Product Profile - Corticosteroids 62
Table 21: Corticosteroids SWOT Analysis 64
Table 22: Lotemax and Alrex SWOT Analysis 67
Table 23: Durezol SWOT Analysis 69
Table 24: Product Profile - Restasis 71
Table 25: Restasis SWOT Analysis 72
Table 26: Overall Unmet Needs - Current Levels of Attainment 73
Table 27: Allergic Conjunctivitis - Late-Stage Pipeline, 2014 89
Table 28: Product Profile - Vekacia 92
Table 29: Vekacia SWOT Analysis 94
Table 30: Product Profile - SUN-1334H 96
Table 31: SUN-1334H SWOT Analysis 97
Table 32: Product Profile - OTX-DP 99
Table 33: OTX-DP SWOT Analysis 100
Table 34: Product Profile - RX-10045 103
Table 35: RX-10045 SWOT Analysis 105
Table 36: Product Profile - AC-170 106
Table 37: AC-170 SWOT Analysis 108
Table 38: Early-Stage Pipeline Products for Allergic Conjunctivitis 110
Table 39: Clinical Benchmarking of Key Pipeline Drugs—Allergic Conjunctivitis First-Line 112
Table 40: Clinical Benchmarking of Key Pipeline Drugs—Allergic Conjunctivitis Second-Line 113
Table 41: Commercial Benchmark of Key Pipeline Drugs—Allergic Conjunctivitis First-Line 115
Table 42: Commercial Benchmark of Key Pipeline Drugs—Allergic Conjunctivitis Second-Line 117
Table 43: Top-Line Sales Forecasts ($) for Allergic Conjunctivitis, 2013-2018 119
Table 44: Key Events Impacting Sales of Allergic Conjunctivitis Therapies, 2013-2018 123
Table 45 Allergic Conjunctivitis- Drivers and Barriers, US and EU 124
Table 46: Key Launch Dates 137

1.2 List of Figures

Figure 1: Allergic Inflammatory Response 22
Figure 2: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, All Ages, Both Sexes, N, 2013-2023 34
Figure 3: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, by Age, Both Sexes, N, 2013-2023 36
Figure 4: 6MM, Total Prevalent Cases of Allergic Conjunctivitis, by Sex, All Ages, N, 2013 38
Figure 5: Competitive Assessment of Late-Stage Pipeline Agents in Allergic Conjunctivitis— First-Line, 2013-2018 118
Figure 6: Competitive Assessment of Late-Stage Pipeline Agents in Allergic Conjunctivitis- Second-Line, 2013-2018 118
Figure 7: Global Sales for Allergic Conjunctivitis by Region, 2013-2018 120

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