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PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024

Summary

Dry Eye Syndrome (DES), also known as keratoconjunctivitis sicca, is a multifactorial disease of the tears and ocular surface. This ocular condition can cause ocular discomfort, visual disturbances, and tear film instability, which can potentially damage the ocular surface. The DES market has had few new therapeutics in the last decade with Japan seeing the most change in this time with the arrival of Diquas and Mucosta in 2010 and 2013, respectively. However, the lack of treatment options is about to change with the expected launch of numerous pipeline DES drugs during the forecast period, which will be a significant driver of growth in the 9MM. Indeed, this change has already been initiated with Ikervis’ recent arrival in Europe in 2015. Furthermore, additional marketing approvals are being sought for currently marketed DES drugs, Restasis and Diquas, in new countries in the 9MM, which will provide a source of growth in this market.

Highlights

Key Questions Answered

- The DES market has been dominated by artificial tears therapy and by Restasis (in the US) for many years, with little approved therapeutic options available in the 9MM. New classes of drugs are anticipated the reach the market within the forecast period. How will these change the market overall during the forecast period? Will Restasis maintain market dominance in 2024?
- The current late stage DES pipeline is varied, with first-in-class drugs in development with innovative modes of action. Which of these will have the biggest impact on the market? What strategies are developers undertaking to penetrate this chronically underserved market? Will these fulfil any unmet needs?
- Population aging is occurring in almost all countries worldwide, particularly in the 9MM. This is expected to have a significant impact on the prevalence of age-related diseases such as DES. How will epidemiological changes impact the growth of the future market?

Key Benefits

- The main driver of growth in the DES market will be the introduction of first-in-class drugs over the forecast period. The launch of these therapies will act as a stimulant for growth in this chronically underserved market.
- DES has been a high risk indication for developers, with numerous drugs failing in late stage development. This has acted as a significant barrier to growth in this market historically.
- The arrival of new therapies across the 9MM will increase treatment rates and provide alternative options for many patients.
- The largest unmet need in the DES market will remain the lack of additional safe and efficacious therapeutics with novel modes of action. In addition, simplifying dosing regimens is an important consideration for companies developing drugs to treat these patients.

Scope

- Overview of DES, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
- Annualized DES market revenue, annual cost of therapy and treatment usage pattern data from 2014 and forecast for ten years to 2024.
- Key topics covered include market characterization, unmet needs, R&D and clinical trials assessment, late stage clinical trial analysis and implications for the glaucoma therapeutics market.
- Pipeline analysis: focus on the four late-stage pipeline DES drugs discussing emerging trends as well as overview of earlier phase drugs.
- 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. 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 glaucoma 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 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 DES 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

PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024
1 Table of Contents
1 Table of Contents 8
1.1 List of Tables 14
1.2 List of Figures 17
2 Introduction 19
2.1 Related Reports 19
3 Disease Overview 21
3.1 Etiology and Pathophysiology 21
3.1.1 Etiology 21
3.1.2 Pathophysiology 24
3.2 Disease Classification 26
3.3 Symptoms 27
3.4 Prognosis 30
3.5 Quality of Life 31
4 Epidemiology 32
4.1 Risk Factors and Comorbidities 32
4.1.1 Risk of Dry Eye Syndrome Increases 35% Each Decade after Age 40 33
4.1.2 Women are twice as likely to have Dry Eye Syndrome as men 33
4.1.3 Use of certain medications may increase the risk of developing Dry Eye Syndrome 34
4.1.4 Diets rich in Omega-3 fatty acid may prevent dry eye syndrome 35
4.1.5 Certain environmental conditions can double the risk of Dry Eye Syndrome 35
4.2 Global Trends 36
4.2.1 US 36
4.2.2 5EU 36
4.2.3 Asia 37
4.3 Forecast Methodology 38
4.3.1 Sources used 39
4.3.2 Forecast Assumptions and Methods -Total Prevalent Cases of Dry Eye Syndrome 41
4.3.3 Sources Not Used 44
4.4 Epidemiology Forecast for Dry Eye Syndrome (2014-2024) 44
4.4.1 Total Prevalent Cases of Dry Eye Syndrome 44
4.4.2 Age-Specific Total Prevalent Cases 46
4.4.3 Sex-Specific Total Prevalent Cases 48
4.4.4 Age-Standardized Total Prevalence of Dry Eye Syndrome 50
4.4.5 Total Prevalent Cases of Dry Eye Syndrome by Severity 51
4.5 Discussion 52
4.5.1 Conclusions on Epidemiology Trends 52
4.5.2 Limitations of Analysis 53
4.5.3 Strengths of Analysis 54
5 Disease Management 55
5.1 Diagnosis and Treatment Overview 55
5.1.1 Diagnosis 55
5.1.2 Treatment Guidelines 58
5.1.3 Clinical Practice 59
5.2 US 65
5.3 5EU 69
5.4 Japan 74
5.5 China 76
5.6 India 78
6 Competitive Assessment 82
6.1 Overview 82
6.2 Product Profiles 83
6.2.1 Restasis (cyclosporine) 83
6.2.2 Diquas (diquafosol tetrasodium) 93
6.2.3 Mucosta ophthalmic solution (rebamipide) 99
6.2.4 Ikervis (cyclosporine) 104
6.2.5 Artificial Tears 111
6.2.6 Other therapies 119
7 Unmet Need and Opportunity 124
7.1 Overview 124
7.2 New Therapies for DES 126
7.2.1 Unmet Need 126
7.2.2 Gap Analysis 127
7.2.3 Opportunity 129
7.3 Better Diagnostic Tools 130
7.3.1 Unmet Need 130
7.3.2 Gap Analysis 131
7.3.3 Opportunity 133
7.4 Appropriate Clinical Trial Design to Secure Regulatory Approval 134
7.4.1 Unmet Need 134
7.4.2 Gap Analysis 136
7.4.3 Opportunity 137
7.5 Simplified Dosing 138
7.5.1 Unmet Need 138
7.5.2 Gap Analysis 139
7.5.3 Opportunity 140
7.6 Patient Education to Improve Tolerance and Compliance 140
7.6.1 Unmet Need 140
7.6.2 Gap Analysis 142
7.6.3 Opportunity 143
7.7 Improved Physician and Patient Disease Awareness 143
7.7.1 Unmet Need 143
7.7.2 Gap Analysis 145
7.7.3 Opportunity 145
8 Pipeline Assessment 146
8.1 Overview 146
8.2 Clinical Trial Mapping 147
8.2.1 Clinical Trial Design for DES 148
8.2.2 Ora for DES Drug Development 149
8.3 Promising Drugs in Clinical Development 150
8.3.1 Lifitegrast 152
8.3.2 Tavilermide 161
8.3.3 Visomitin 167
8.3.4 RGN-259 173
8.3.5 Cis-UCA 179
8.3.6 SI-614 181
8.4 Promising Drugs in Early-Stage Development 182
8.4.1 KPI-121 182
8.4.2 Ozagrel 183
8.4.3 P-321 184
8.4.4 Dextenza (OTX-DP) 185
8.5 Other Drugs in Development 186
9 Current and Future Players 187
9.1 Overview 187
9.2 Trends in Corporate Strategy 188
9.3 Company Profiles 189
9.3.1 Alcon 189
9.3.2 Allergan 190
9.3.3 Herantis 193
9.3.4 Mimetogen 194
9.3.5 Mitotech 195
9.3.6 Otsuka 196
9.3.7 RegeneRx 198
9.3.8 Santen 201
9.3.9 Shire 203
10 Market Outlook 206
10.1 Global Markets 206
10.1.1 Forecast 206
10.1.2 Drivers and Barriers - Global Issues 213
10.2 US 213
10.2.1 Forecast 213
10.2.2 Key Events 217
10.2.3 Drivers and Barriers 217
10.3 5EU 218
10.3.1 Forecast 218
10.3.2 Key Events 222
10.3.3 Drivers and Barriers 222
10.4 Japan 224
10.4.1 Forecast 224
10.4.2 Key Events 226
10.4.3 Drivers and Barriers 227
10.5 China 227
10.5.1 Forecast 227
10.5.2 Key Events 229
10.5.3 Drivers and Barriers 230
10.6 India 230
10.6.1 Forecast 230
10.6.2 Drivers and Barriers 233
11 Appendix 234
11.1 Bibliography 234
11.2 Abbreviations 267
11.3 Methodology 271
11.4 Forecasting Methodology 271
11.4.1 Diagnosed DES Patients 271
11.4.2 Percent Drug-Treated Patients 271
11.4.3 Launch Dates 272
11.4.4 General Pricing Assumptions 272
11.4.5 Individual Drug Assumptions 273
11.4.6 Pricing of Pipeline Agents 276
11.5 Primary Research - KOLs Interviewed for this Report 277
11.6 Primary Research - High-prescriber Survey 279
11.7 About the Authors 280
11.7.1 Analyst 280
11.7.2 Therapy Area Director 280
11.7.3 Epidemiologist 281
11.7.4 Global Head of Healthcare 281
11.8 About GlobalData 282
11.9 Disclaimer 282

1.1 List of Tables
Table 1: Symptoms of Dry Eye Syndrome 29
Table 2: Risk Factors and Comorbidities for Dry Eye Syndrome 33
Table 3: Sources of Epidemiology Data Used for the Forecast of Total Prevalent Cases of Dry Eye Syndrome in the 9MM 39
Table 4: 9MM, Total Prevalent Cases of Dry Eye Syndrome, Ages ?20 Years, Men and Women, N, Selected Years 2014-2024 45
Table 5: 9MM, Total Prevalent Cases of Dry Eye Syndrome, by Age Group, Men and Women, N (Row %), 2014 47
Table 6: 9MM, Total Prevalent Cases of Dry Eye Syndrome, by Sex, Ages ?20 Years, N, (Row %), 2014 49
Table 7: 9MM, Prevalent Cases of Dry Eye Syndrome, by Severity, Ages ?45 Years, N (Millions) (Row %), 2014 52
Table 8: National and International Treatment Guidelines for DES 59
Table 9: Country Profile - US 69
Table 10: Country Profile - 5EU 73
Table 11: Country Profile - Japan 76
Table 12: Country Profile - China 78
Table 13: Country Profile - India 81
Table 14: Leading Treatments for DES, 2015 83
Table 15: Product Profile - Restasis 89
Table 16: Restasis SWOT Analysis, 2015 91
Table 17: Global Sales Forecast ($m) for Restasis, 2014-2024 92
Table 18: Product Profile - Diquas 96
Table 19: Diquas SWOT Analysis, 2015 98
Table 20: Global Sales Forecast ($m) for Diquas, 2014-2024 99
Table 21: Product Profile - Mucosta 102
Table 22: Mucosta SWOT Analysis, 2015 103
Table 23: Global Sales Forecast ($m) for Mucosta, 2014-2024 104
Table 24: Product Profile - Ikervis 108
Table 25: Ikervis SWOT Analysis, 2015 110
Table 26: Global Sales Forecast ($m) for Ikervis, 2014-2024 111
Table 27: Artificial Tears SWOT Analysis, 2015 118
Table 28: Global Sales Forecast ($m) for Artificial Tears, 2014-2024 119
Table 29: Unmet Needs and Opportunities in DES 125
Table 30: Promising Drugs in Clinical Development for Dry Eye Syndrome, 2015 150
Table 31: Comparison of Drugs in Development for Dry Eye Syndrome, 2015 151
Table 32: Product Profile - Lifitegrast 157
Table 33: SWOT Analysis - Lifitegrast, 2015 160
Table 34: Global Sales Forecast ($m) for Lifitegrast, 2014-2024 161
Table 35: Product Profile - Tavilermide 164
Table 36: SWOT Analysis - tavilermide, 2015 166
Table 37: Global Sales Forecast ($m) for tavilermide, 2014-2024 167
Table 38: Product Profile - Visomitin 170
Table 39: SWOT Analysis - Visomitin, 2015 172
Table 40: Global Sales Forecast ($m) for Visomitin, 2014-2024 173
Table 41: Product Profile - RGN-259 176
Table 42: SWOT Analysis - RGN-259, 2015 178
Table 43: Global Sales Forecast ($m) for RGN-259, 2014-2024 178
Table 44: Product Profile - Cis-UCA 180
Table 45: Product Profile - SI-614 182
Table 46: Drugs in Development, 2015 186
Table 47: Key Companies in the Dry Eye Syndrome Market in the 9MM, 2014 187
Table 48: Allergan's DES Portfolio Assessment, 2015 193
Table 49: Herantis's DES Portfolio Assessment, 2015 194
Table 50: Mimetogen's DES Portfolio Assessment, 2015 195
Table 51: Mitotech's DES Portfolio Assessment, 2015 196
Table 52: Otsuka's DES Portfolio Assessment, 2015 198
Table 53: RegeneRx's DES Portfolio Assessment, 2015 201
Table 54: Santen's DES Portfolio Assessment, 2015 203
Table 55: Shire's DES Portfolio Assessment, 2015 205
Table 56: Global Sales Forecast ($m) for DES Therapies, 2014-2024 208
Table 57: DES Market - Drivers and Barriers, 2014-2024 213
Table 58: US Sales Forecast ($m) for DES Therapies, 2014-2024 215
Table 59: Key Events That Will Impact Sales for DES Therapies in the US, 2014-2024 217
Table 60: DES Market - Drivers and Barriers in the US, 2014-2024 217
Table 61: 5EU Sales Forecast ($m) for DES Therapies, 2014-2024 219
Table 62: Key Events Impacting Sales for DES Therapies in the 5EU, 2014-2024 222
Table 63: DES Market - Drivers and Barriers in the 5EU, 2014-2024 222
Table 64: National Healthcare Authorities and Governmental Drug Pricing Authorities in the 5EU Nations 223
Table 65: Japan Sales Forecast ($m) for DES Therapies, 2014-2024 225
Table 66: Key Events Impacting Sales for DES Therapies in Japan, 2014-2024 226
Table 67: DES Market - Drivers and Barriers in Japan, 2014-2024 227
Table 68: China Sales Forecast ($m) for DES Therapies, 2014-2024 228
Table 69: Key Events Impacting Sales for DES in China, 2014-2024 229
Table 70: DES Market - Drivers and Barriers in China, 2014-2024 230
Table 71: India Sales Forecast ($m) for DES, 2014-2024 231
Table 72: DES Market - Drivers and Barriers in India, 2014-2024 233
Table 73: Key Launch Dates 272
Table 74: Surveyed High-prescribing Physicians, by Country 279

1.2 List of Figures
Figure 1: Dry Eye Syndrome - Disease Etiology 22
Figure 2: The Tear Film in normal and dry eye 25
Figure 3: Varied Symptoms of Dry Eye Syndrome 30
Figure 4: 9MM, Total Prevalent Cases of Dry Eye Syndrome, Ages ?20 Years, Men and Women, N, 2014-2024 46
Figure 5: 9MM, Total Prevalent Cases of Dry Eye Syndrome, by Age Group, N, 2014 48
Figure 6: 9MM, Total Prevalent Cases of Dry Eye Syndrome, by Sex, Ages ?20 Years, N, 2014 50
Figure 7: 9MM, Age-Standardized Total Prevalence of Dry Eye Syndrome, Ages ?20 Years, by Sex, 2014 51
Figure 8: Dry Eye Syndrome Therapeutics - Phase II and II/III Clinical Trials in the 9MM, 2015 148
Figure 9: DES Phase II/Phase III Pipeline, 2015 151
Figure 10: Competitive Assessment of Late-Stage Pipeline Agents in DES, 2014-2024 152
Figure 11: Clinical and Commercial Positioning of lifitegrast 159
Figure 12: Clinical and Commercial Positioning of tavilermide 165
Figure 13: Clinical and Commercial Positioning of Visomitin 171
Figure 14: Clinical and Commercial Positioning of RGN-259 177
Figure 15: Company Portfolio Gap Analysis in Dry Eye Syndrome, 2014-2024 188
Figure 16: Global Sales for DES Therapies by Region, 2014 and 2024 209
Figure 17: Global Sales by Region for DES Therapies, 2014-2024 210
Figure 18: Global Sales for DES by Drug, 2014 and 2024 211
Figure 19: Global Sales by Drug for DES Therapies, 2014-2024 212
Figure 20: Drug Sales for DES Therapies in the US, 2014 and 2024 216
Figure 21: Drug Sales for DES Therapies in the 5EU, 2014 and 2024 220
Figure 22: Drug Sales by country for DES in the 5EU, 2014 and 2024 221
Figure 23: Drug Sales for DES Therapies in Japan, 2014 and 2024 226
Figure 24: Drug Sales for DES Therapies in China, 2014 and 2024 229
Figure 25: Drug Sales for DES Therapies in India, 2014 and 2024 232

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