Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026
Dry Eye Syndrome (DES) is a multifactorial disease of the tears and ocular surface that causes ocular discomfort, visual disturbances, and tear film instability, which can potentially damage the ocular surface. With a rapidly accelerating worldwide prevalence and the limited treatment options available, there is a growing pressure for new therapies and curative treatment for DES patients. Significant efforts are being made to develop a new treatment for DES, as current pharmacologic management is known to only provide temporary symptomatic relief.
GlobalData estimates the 2016 sales for DES at approximately USD 2.2B across the 8MM covered in this report.
The DES pipeline activity comprises 10 active Phase III (or Phase II/III) pipeline agents with novel mechanisms of action as well as cyclosporines with improved clinical profiles. Additionally, six of these late-stage pipeline drugs are expected to be first-in-class therapies. The most notable pipeline drugs include RegeneRx's thymosin beta-4 product RGN-259, Aldeyra's reproxalap which acts as an aldehyde trap, and Sylentis' TRPV1 inhibitor tivanisiran. Other late-phase novel drugs include Mitotech's mitochondrial antioxidant product visomitin, Kala Pharmaceuticals' corticosteroid KPI-121, and Novartis' and Dompe's recombinant human lubricin protein ECF-843. GlobalData expects these new drugs will expand the DES treatment options and contribute to overall market growth. Nevertheless, considerable opportunities remain within this severely underserved DES market.
Key Questions Answered
- What are the key unmet needs clinically and in research? What do KOLs identify as the key unmet needs? Will the products in the DES pipeline fill these unmet needs?
- When are the pipeline products expected to launch? What are the key features of the products in the pipeline?
- What are the threats for drugs currently on the market? How will the new pipeline products be incorporated into the current treatment algorithm?
- What are the key hurdles for manufacturers entering the DES market?
- Overview of DES: including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized DES market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (including mild DES, moderate DES, and severe DES), forecast from 2016 to 2026.
- Key topics covered: strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the DES therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for DES 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 DES 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 DES therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global DES 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.
1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 4
1.2 List of Figures 4
2 DES: Executive Summary 6
2.1 DES Therapeutics Market Will Grow to USD 5.6B by 2026 7
2.2 DES Is a High Risk Indication for Drug Development 9
2.3 While New Therapeutics Enter the DES Market, Unmet Needs Persist 10
2.4 Significant Opportunities Remain Within the DES Market to Fulfill Unmet Needs 11
2.5 Newly Approved Therapeutics Will Improve Treatment Options for DES Patients 11
2.6 What Do Physicians Think? 13
3 Introduction 15
3.1 Catalyst 15
3.2 Related Reports 15
3.3 Upcoming Related Reports 16
4 Disease Overview 17
4.1 Etiology and Pathophysiology 17
4.2 Disease Classification 22
5 Epidemiology 24
5.1 Disease Background 24
5.2 Risk Factors and Comorbidities 24
5.3 Global and Historical Trends 25
5.4 Forecast Methodology 26
5.5 Epidemiological Forecast for DES (2016-2026) 34
5.6 Discussion 39
6 Disease Management 42
6.1 Diagnosis and Treatment Overview 42
6.2 US 57
6.3 5EU 61
6.4 Japan 66
6.5 China 72
7 Competitive Assessment 76
7.1 Overview 76
7.2 Marketed Therapies and Artificial Tears for DES 78
7.3 Other Therapies 78
8 Unmet Needs and Opportunity Assessment 81
8.1 Overview 81
8.2 New Therapies for DES 82
8.3 Better Diagnostic Tools 88
8.4 Appropriate Clinical Trial Design 92
8.5 Simplified Dosing 96
9 Pipeline Assessment 99
9.1 Overview 99
9.2 Promising Drugs in Clinical Development 102
9.3 Promising Drugs in Early-Stage Development 105
10 Current and Future Players 110
10.1 Overview 110
10.2 Trends in Corporate Strategy 112
10.3 Allergan 114
10.4 Santen 117
10.5 Shire 119
10.6 RegeneRx 121
10.7 Aldeyra 123
10.8 Sylentis 124
10.9 Sun Pharmaceutical 125
10.10 Novartis 127
10.11 Dompe 128
11 Market Outlook 130
11.1 Global Markets 130
11.2 US 133
11.3 5EU 138
11.4 Japan 142
11.5 China 146
12 Appendix 150
12.1 Bibliography 150
12.2 Abbreviations 163
12.3 Methodology 166
12.4 Primary Research-Key Opinion Leaders Interviewed for This Report 178
12.5 Primary Research-Prescriber Survey 182
12.6 About the Authors 182
12.7 About GlobalData 185
12.8 Contact Us 186
12.9 Disclaimer 186
1.2 List of Figures
Figure 1: Global Sales Forecast by Country for DES in 2016 and 2026 9
Figure 2: Analysis of the Company Portfolio Gap in DES During the Forecast Period 10
Figure 3: Vicious Circle of DES 19
Figure 4: Tear Film Structure 22
Figure 5: Classification of DES 24
Figure 6: 8MM, Age-Standardized Total Prevalence of DES (%), Both Sexes, Ages ?20 Years, 2016 27
Figure 7: 8MM, Sources Used and Not Used to Forecast the Diagnosed Prevalent Cases of DES 29
Figure 8: 8MM, Total Prevalent Cases of DES, Both Sexes, Ages ?20 Years, N, 2016 35
Figure 9: 8MM, Age-Specific Total Prevalent Cases of DES, Both Sexes, Ages ?20 Years, N, 2016 36
Figure 10: 8MM, Sex-Specific Total Prevalent Cases of DES, Both Sexes, Ages ?20 Years, N, 2016 37
Figure 11: 8MM, Diagnosed Prevalent Cases of DES, Both Sexes, Ages ?20 Years, N, 2016 39
Figure 12: Unmet Needs and Opportunities in DES 83
Figure 13: Bullseye Diagram of Products in Clinical Development for DES, 2016 102
Figure 14: Key Phase IIb/III Trials for the Promising Pipeline Agents that GlobalData Expects be Licensed for DES in the 8MM During the Forecast Period 103
Figure 15: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of DES During the Forecast Period 104
Figure 16: Analysis of the Company Portfolio Gap in DES During the Forecast Period 113
Figure 17: Global (8MM) Sales Forecast by Country for DES in 2016 and 2026 133
Figure 18: Sales Forecast by Class for DES in the US in 2016 and 2026 137
Figure 19: Sales Forecast by Class for DES in the 5EU in 2016 and 2026 141
Figure 20: Sales Forecast by Class for DES in Japan in 2016 and 2026 145
Figure 21: Sales Forecast by Class for DES in China in 2016 and 2026 148
1.1 List of Tables
Table 1: DES: Key Metrics in the 8MM 7
Table 2: Risk Factors and Comorbid Conditions Associated with DES 26
Table 3: Diagnostic Tests for DES 44
Table 4: Popular Validated Questionnaires for DES 45
Table 5: Treatment Guidelines for DES 49
Table 6: Country Profile-US 62
Table 7: Country Profile-5EU 66
Table 8: Country Profile-Japan 73
Table 9: Country Profile-China 76
Table 10: Leading Treatments for DES, 2018 79
Table 11: Comparison of Therapeutic Classes in Development for DES, 2016-2026 105
Table 12: Key Companies in the DES Market in the 8MM, 2017 112
Table 13: Allergan's DES Portfolio Assessment, 2018 117
Table 14: Santen's DES Portfolio Assessment, 2018 120
Table 15: Shire's DES Portfolio Assessment, 2018 122
Table 16: RegeneRx's DES Portfolio Assessment, 2018 124
Table 17: Aldeyra's DES Portfolio Assessment, 2018 125
Table 18: Sylentis' DES Portfolio Assessment, 2018 126
Table 19: Sun Pharma's DES Portfolio Assessment, 2018 128
Table 20: Novartis' DES Portfolio Assessment, 2018 129
Table 21: Dompe's DES Portfolio Assessment, 2018 130
Table 22: DES Market-Global Drivers and Barriers, 2016-2026 134
Table 23: Key Events Impacting Sales for DES in the US, 2016-2026 138
Table 24: DES Market-Drivers and Barriers in the US, 2016-2026 139
Table 25: Key Events Impacting Sales for DES in the 5EU, 2016-2026 142
Table 26: DES Market-Drivers and Barriers in the 5EU, 2016-2026 143
Table 27: Key Events Impacting Sales for DES in Japan, 2016-2026 145
Table 28: DES Market-Global Drivers and Barriers in Japan, 2016-2026 146
Table 29: Key Events Impacting Sales for DES in China, 2016-2026 149
Table 30: DES Market-Global Drivers and Barriers in China, 2016-2026 150
Table 31: Key Historical and Projected Launch Dates for DES 170
Table 32: Key Historical and Projected Patent Expiry Dates for DES 171
Table 33: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 183
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