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Dry Eye Syndrome: Global Drug Forecast and Market Analysis to 2026

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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.


Table Of Content


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

List Of Figure

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

List Of Table

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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Sun Pharmaceutical