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PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and
Market Analysis to 2022
On 8
th
July 2014

The Dry Eye Syndrome (DES) pipeline is strong, with 49 molecules in various phases of
development. More notably, the late-stage pipeline has three products with novel mechanisms
of action to treat the inflammation associated with the disease. That said, physicians suggest
that the largest unmet need for DES treatment is diagnosis.
Browse Full Report @ http://www.jsbmarketresearch.com/healthcare-medical/r-PharmaPoint-
Dry-Eye-Syndrome-Global-Drug-Forecast-and-Market-Analysis-118885
Scope

Annualized market revenues data for 9 key markets: US, France, Germany, Italy, Spain, UK,
Japan, China, and India

Annualized market revenues data from 2012 to 2022 and forecast from 2012 to 2022

Pipeline analysis data providing a split across the different phases, mechanisms of action being
developed and emerging trends by the 9 key markets. Pipeline candidates fall under major
therapeutic classes

Analysis of key recent licensing and partnership agreements in the DES Therapeutics market

Insightful review of the key industry drivers, restraints and challenges. Each trend is
independently researched to provide a qualitative analysis of its implications

Key topics covered include strategic competitor assessment, market characterization, unmet

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needs and implications.

Market Model Features

An interactive excel forecast model based on primary research interviews and surveys with
KOLs and high-prescribing physicians is included in this report*. This patient based model
provides diagnosis rates, patient segmentation, treatment rates, annual costs of therapy , and
indication-specific drug sales for the 10 year forecast period. The forecast model is robust, fully
transparent, and easy to navigate. Moreover, our models support data presented in the reports
and the complete methodology is outlined in the report and the model.

*Model only available with site and global license purchases.

Key Findings

The global DES therapeutics market is forecast to reach $5.47 billion by 2022 due to the launch
of novel pipeline drugs and an aging population.

The global push for increased physician and patient awareness will increase diagnosis and
treatment.

By 2022, the DES market will be significantly more competitive, but the current dearth of
treatment options leave much room for the coming pipeline therapies.

Other industries we cover:
Advertising and Media
Automotive and Parts
Consumer Goods
Healthcare and Medical
Finance and Banking
Food and Beverages
Travel and Tourism
Textiles and Clothing
SWOT Analysis

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Table of Content
2 Summary 8

2.1 Significant growth is expected in the DES market from 2012-2022. 8

2.2 Established players lack strong pipelines and will focus on filling this gap through
acquisitions 10

2.3 With only one drug on the market in the US and two in Japan, there is a significant void to
fulfill with pipeline products 10

2.4 The real opportunity for new players to market their new products and expand the patient
base relies on improved diagnosis. 11

2.5 Pipeline agents offer patients expansion into new markets, novel mechanisms of action and
longer-acting delivery systems. 11

2.6 What do the physicians think? 12

3 Introduction 14

3.1 Catalyst 14

3.2 Related Reports 14

4 Disease Overview 15

4.1 Etiology and Pathophysiology 15

4.1.1 Etiology 15

4.1.2 Pathophysiology 16

4.1.3 Classification 19

4.1.4 Prognosis 19

4.1.5 Quality of Life 20

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4.2 Symptoms 20

5 Epidemiology 21

5.1 Risk Factors and Comorbidities 21

5.1.1 Risk of dry eye syndrome increases 35% each decade after age 40 22

5.1.2 Women are twice as likely to have dry eye syndrome as men 22

5.1.3 Use of certain medications may increase the risk of developing dry eye syndrome 23

5.1.4 Diets rich in omega-3 fatty acids help prevent dry eye syndrome 24

5.1.5 Certain environmental conditions can double the risk of dry eye syndrome 24

5.2 Global Trends 24

5.2.1 US 24

5.2.2 5EU 25

5.2.3 Asia 25

5.3 Forecast Methodology 26

5.3.1 Sources Used 26

5.3.2 Forecast Assumptions and Methods 27

5.3.3 Sources Not Used 29

5.4 Epidemiology Forecast (20122022) 30

5.4.1 Prevalent Cases of Dry Eye Syndrome 30

5.4.2 Age-Specific Prevalent Cases 31

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5.4.3 Sex-Specific Prevalent Cases 34

5.4.4 Age-Standardized Prevalence of Dry Eye Syndrome 35

5.5 Discussion 36

5.5.1 Conclusions on Epidemiology Trends 36

5.5.2 Limitations of the Analysis 39

5.5.3 Strengths of the Analysis 39

6 Disease Management 39

6.1 Overview 39

6.1.1 Diagnosis Overview 39

6.1.2 Treatment Guidelines 43

6.1.3 Treatment Overview 47

6.2 US 50

6.2.1 Diagnosis 50

6.2.2 Clinical Practice 51

6.3 France 52

6.3.1 Diagnosis 52


6.4 Germany 54

6.4.1 Diagnosis 54


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6.5 Italy 54

6.5.1 Diagnosis 54


6.6 Spain 56

6.6.1 Diagnosis 56


6.7 UK 57

6.7.1 Diagnosis 57


6.8 Japan 57

6.8.1 Diagnosis 57


6.9 China 60

6.9.1 Diagnosis 60


6.10 India 61

6.10.1 Diagnosis 61


7 Competitive Assessment 62

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7.1 Overview 62

7.2 Strategic Competitor Assessment 62

7.3 Product Profiles Major Brands 63

7.3.1 Restasis (cyclosporine 0.05% ophthalmic emulsion) 63

7.3.2 Diquas (diquafosol tetrasodium) 69

7.3.3 Mucosta (rebamipide 2% ophthalmic suspension) 72

7.3.4 Additional Therapies 75

8 Opportunity and Unmet Need 78

8.1 Overview 78

8.2 Diagnostic tests are not specific enough to identify subgroups of patients 80

8.3 Frequent dosing and side effects limit compliance 81

8.4 Lack of physician and patient awareness 82

8.5 Trial design may be a factor in so few drugs being approved 83

8.6 Unmet Needs Gap Analysis 84

8.7 Comprehensive method for measuring dry eye signs and severity levels 85

8.8 Increase treatment rates among milder forms of the disease 86

9 Pipeline Assessment 86

9.1 Overview 86

9.2 Clinical Trial Mapping 87

9.2.1 Clinical Trials by Country 87

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9.2.2 Clinical Trials by Phase and Trial Status 88

9.3 Promising drugs in clinical development 88

9.3.1 Lifitegrast 90

9.3.2 CF-101 94

9.3.3 Cyclokat 97

9.3.4 EGP-437 101

9.3.5 RX-10045 105

9.3.6 MIM-D3 109

10 Current and Future Players 112

10.1 Overview 112

10.2 Trends in Corporate Strategy 114

10.3 Company Profiles 115

10.3.1 Allergan 115

10.3.2 Alcon (a wholly-owned subsidiary of Novartis AG) 117

10.3.3 Santen Pharmaceutical 118

10.3.4 Shire/SARcode Bioscience 123

10.3.5 Otsuka Holdings 124

10.3.6 Can-Fite Biopharma 126

10.3.7 Eyegate Pharma 128

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11 Market Outlook 129

11.1 Global Markets 129

11.1.1 Forecast 129

11.1.2 Drivers and Barriers Global Issues 131

11.2 United States 133

11.2.1 Forecast 133

11.2.2 Key Events 136

11.2.3 Drivers and Barriers 137

11.3 France 140

11.3.1 Forecast 140



11.4 Germany 144

11.4.1 Forecast 144



11.5 Italy 148

11.5.1 Forecast 148



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11.6 Spain 152

11.6.1 Forecast 152



11.7 United Kingdom 154

11.7.1 Forecast 154



11.8 Japan 159

11.8.1 Forecast 159



11.9 China 163

11.9.1 Forecast 163



11.10 India 167

11.10.1 Forecast 167


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12 Appendix 169

12.1 Bibliography 169

12.2 Abbreviations 177

12.3 Methodology 178

12.4 Forecasting Methodology 178

12.4.1 Diagnosed DES patients 178

12.4.2 Percent Drug-treated Patients 180

12.4.3 Drugs Included in Each Therapeutic Class 180

12.4.4 Launch and Patent Expiry Dates 180

12.4.5 General Pricing Assumptions 180

12.4.6 Individual Drug Assumptions 182

12.4.7 Generic Erosion 185

12.5 Physicians and Specialists Included in this Study 186

12.6 About the Authors 187

12.6.1 Author 187

12.6.2 Epidemiologist 188

12.6.3 Reviewers 189

12.6.4 Global Director of Epidemiology and Clinical Trials Analysis 190

12.6.5 Global Head of Healthcare 191

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12.7 About GlobalData 192

12.8 Contact Us 192

12.9 Disclaimer 192

List of Tables
Table 1: Dry Eye Syndrome: Key Metrics in the Major Pharmaceutical Markets, 2012 2022 7

Table 2: Symptoms of Dry Eye Syndrome 20

Table 3: Risk Factors and Comorbidities for DES 21

Table 4: 9MM, Sources of Epidemiology Data Used for the Dry Eye Syndrome Forecast 25

Table 5: 9MM, Prevalent Cases of Dry Eye Syndrome, Ages = 45 Years, Men and Women, N
(Millions), Selected Years, 20122022 29

Table 6: 9MM, Prevalent Cases of Dry Eye Syndrome, By Age, Men and Women, N (Row %),
2012 31

Table 7: 9MM, Prevalent Cases of Dry Eye Syndrome, By Sex, Ages = 45 Years, N (Millions) (Row
%), 2012 33

Table 8: Treatment Guidelines for Dry Eye Syndrome 46

Table 9: Commonly Prescribed Drugs for Dry Eye Syndrome by Class in the Global Markets,
2012 48

Table 10: Leading Treatments for Dry Eye Syndrome, 2012 62

Table 11: Product Profile Restasis 64

Table 12: Restasis SWOT Analysis, 2012 67

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Table 13: Global Sales Forecasts ($m) for Restasis, 20122022 68

Table 14: Product Profile Diquas 69

Table 15: Diquas SWOT Analysis, 2012 71

Table 16: Global Sales Forecasts ($m) for Diquas, 20122022 71

Table 17: Product Profile Mucosta 72

Table 18: Mucosta SWOT Analysis, 2012 73

Table 19: Global Sales Forecasts ($m) for Mucosta, 20122022 74

Table 20: Summary
of Minor Drug Classes, 2012 77

Table 21: Overall Unmet Needs Current Level of Attainment 79

Table 22: Clinical Unmet Needs Gap Analysis, 2012 84

Table 23: Dry Eye Syndrome Clinical Trials by Phase and Status, 2013 87

Table 24: Dry Eye Syndrome Phase Pipeline, 2012 87

Table 25: Comparison of Therapeutic Classes in Development for Dry Eye Syndrome, 2012 88

Table 26: Product Profile Lifitegrast 90

Table 27: Lifitegrast SWOT Analysis, 2012 92

Table 28: Global Sales Forecasts ($m) for Lifitegrast, 20122022 93

Table 29: Product Profile CF101 93

Table 30: CF101 SWOT Analysis, 2012 95

Table 31: Global Sales Forecasts ($m) for CF101, 20122022 96

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Table 32: Product Profile Cyclokat 97

Table 33: Cyclokat SWOT Analysis, 2012 98

Table 34: Global Sales Forecasts ($m) for Cyclokat, 20122022 99

Table 35: Product Profile EGP-437 100

Table 36: EGP-437 SWOT Analysis, 2012 103

Table 37: Global Sales Forecasts ($m) for EGP-437, 20122022 104

Table 38: Product Profile RX-10045 105

Table 39: RX-10045 SWOT Analysis, 2012 107

Table 40: Global Sales Forecasts ($m) for RX-10045, 20122022 108

Table 41: Product Profile MIM-D3 108

Table 42: MIM-D3 SWOT Analysis, 2012 109

Table 43: Global Sales Forecasts ($M) for MIM-D3, 20122022 111

Table 44: Key Companies in the Dry Eye Syndrome Market, 2012 112

Table 45: Allergans Dry Eye Syndrome Portfolio Assessment, 2012 115

Table 46: Allergan SWOT Analysis, 2012 115

Table 47: Alcons Dry Eye Syndrome Portfolio Assessment, 2012 117

Table 48: Alcons Dry Eye Syndrome Portfolio SWOT Assessment, 2012 117

Table 49: Santen Pharmaceuticals Dry Eye Syndrome Portfolio Assessment, 2012 119

Table 50: Santen Pharmaceuticals Dry Eye Syndrome Portfolio Assessment, 2012 121

Table 51: Santen Pharmaceuticals Dry Eye Syndrome Portfolio SWOT Analysis, 2012 122

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Table 52: Shires Dry Eye Syndrome Portfolio Assessment, 2013 123

Table 53: Shires Dry Eye Syndrome Portfolio SWOT Analysis, 2013 123

Table 54: Otsuka Pharmaceuticals Dry Eye Syndrome Portfolio Assessment, 2012 125

Table 55: Otsuka Pharmaceuticals Dry Eye Syndrome Portfolio SWOT Analysis, 2012 125

Table 56: Can-Fite Dry Eye Syndrome Portfolio Assessment, 2012 126

Table 57: Can-Fites Dry Eye Syndome Portfolio SWOT Analysis, 2012 126

Table 58: Eyegate Pharmas Dry Eye Syndrome Portfolio Assessment, 2012 127

Table 59: Eyegate Pharmas Dry Eye Syndrome Portfolio SWOT Analysis, 2012 127

Table 60: Global Sales Forecasts ($m) for Dry Eye Syndrome, 20122022 129

Table 61: Dry Eye Syndrome Global Market Drivers and Barriers, 20122022 130

Table 62: Sales Forecasts ($m) for Dry Eye Syndrome in the United States, 20122022 133

Table 63: Key Events Impacting Sales for Dry Eye Syndrome in the United States, 20122022
135

Table 64: United States, Dry Eye Syndrome Market Drivers and Barriers, 20122022 136

Table 65: Sales Forecasts ($m) for Dry Eye Syndrome in France, 20122022 139

Table 66: Key Events Impacting Sales for Dry Eye Syndrome in France, 20122022 140

Table 67: France, Dry Eye Syndrome Market Drivers and Barriers, 20122022 141

Table 68: Sales Forecasts ($m) for Dry Eye Syndrome in Germany, 20122022 144

Table 69: Key Events Impacting Sales for Dry Eye Syndrome in Germany, 20122022 145

Table 70: Germany, Dry Eye Syndrome Market Drivers and Barriers, 20122022 145

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Table 71: Sales Forecasts ($m) for Dry Eye Syndrome in Italy, 20122022 148

Table 72: Key Events Impacting Sales for Dry Eye Syndrome in Italy, 20122022 149

Table 73: Italy, Dry Eye Syndrome Market Drivers and Barriers, 20122022 149

Table 74: Sales Forecasts ($m) for Dry Eye Syndrome in Spain, 20122022 152

Table 75: Key Events Impacting Sales for Dry Eye Syndrome in Spain, 20122022 153

Table 76: Spain, Dry Eye Syndrome Market Drivers and Barriers, 20122022 153

Table 77: Sales Forecasts ($m) for Dry Eye Syndrome in the United Kingdom, 20122022 155

Table 78: Key Events Impacting Sales for Dry Eye Syndrome in the United Kingdom, 20122022
156

Table 79: United Kingdom, Dry Eye Syndrome Market Drivers and Barriers, 2012-2022 156

Table 80: Sales Forecasts ($M) for Dry Eye Syndrome in Japan, 20122022 159

Table 81: Key Events Impacting Sales for Dry Eye Syndrome Japan, 20122022 160

Table 82: Japan, Dry Eye Syndrome Market Drivers and Barriers, 2012-2022 160

Table 83: Sa

List of Figures
Figure 1: Sales for Dry Eye Syndrome by Region, 2012 2022 9

Figure 2: Company Portfolio Gap Analysis in Dry Eye Syndrome, 2012 2022 10

Figure 3: Competitive Assessment of Late-Stage Pipeline Agents in Dry Eye Syndrome, 2012
2022 12

Figure 4: Dry Eye Syndrome Disease Etiology 16

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Figure 5: Tear Film in Normal Eye and Dry Eye 17

Figure 6: 9MM, Prevalent Cases of Dry Eye Syndrome, Ages = 45 Years, Men and Women, N
(Millions), 20122022 31

Figure 7: 9MM, Prevalent Cases of Dry Eye Syndrome, By Age, N (Millions), 2012 33

Figure 8: 9MM, Prevalent Cases of Dry Eye Syndrome, By Sex, Ages = 45 Years, N (Millions),
2012 35

Figure 9: 9MM, Age-Standardized Prevalence of Dry Eye Syndrome, Ages = 45 Years, By Sex,
2012 36

Figure 10: Sequence of Diagnostic Tests Used to Diagnose Dry Eye Syndrome 40

Figure 11: Delphi Panel Treatment Recommendations for Dysfunctional Tear Syndrome Without
Lid Margin Disease, 2006 43

Figure 12: Delphi Panel Treatment Recommendations for Dysfunctional Tear Syndrome With Lid
Margin Disease and Abnormal Tear Distribution, 2006 44

Figure 13: Treatment Recommendations for Dry Eye Syndrome from the Management and
Therapy Subcommittee, Dry Eye Workshop, 2007 45

Figure 14: American Academy of Ophthalmology Preferred Practice Pattern for Dry Eye, 2011
46

Figure 15: Dry Eye Syndrome Therapeutics Clinical Trials by Country, 2013 87

Figure 16: Competitive Assessment of Late-Stage Pipeline Agents in Dry Eye Syndrome, 2012
2022 89

Figure 17: Company Portfolio Gap Analysis in Dry Eye Syndrome, 20122022 114

Figure 18: Global Sales for Dry Eye Syndrome by Region, 20122022 131

Figure 19: Sales for Dry Eye Syndrome in the United States by Drug Class, 20122022 136

Figure 20: Sales for Dry Eye Syndrome in France by Drug Class, 20122022 141

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Figure 21: Sales for Dry Eye Syndrome in Germany by Drug Class, 20122022 145

Figure 22: Sales for Dry Eye Syndrome in Italy by Drug Class, 20122022 149

Figure 23: Sales for Dry Eye Syndrome in Spain by Drug Class, 20122022 153

Figure 24: Sales for Dry Eye Syndrome in the United Kingdom by Drug Class, 20122022 156

Figure 25: Sales for Dry Eye Syndrome in Japan by Drug Class, 20122022 160

Figure 26: Sales for Dry Eye Syndrome in China by Drug Class, 20122022 164

Figure 27: Sales for Dry Eye Syndrome in India by Drug Class, 20122022 168

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To know more on PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market
Analysis to 2022
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Global-Drug-Forecast-and-Market-Analysis-118885

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