JSB Market Research: PharmaPoint: Dry Eye Syndrome

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PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Analysis to 2022 On 8th 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-PharmaPointDry-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 needs and implications.

Market Model Features Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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.

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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 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 4.2 Symptoms 20 5 Epidemiology 21 5.1 Risk Factors and Comorbidities 21 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 (2012–2022) 30 5.4.1 Prevalent Cases of Dry Eye Syndrome 30 5.4.2 Age-Specific Prevalent Cases 31 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 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 6.3.2 Clinical Practice 53 6.4 Germany 54 6.4.1 Diagnosis 54 6.4.2 Clinical Practice 54 6.5 Italy 54 6.5.1 Diagnosis 54 6.5.2 Clinical Practice 54 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


6.6 Spain 56 6.6.1 Diagnosis 56 6.6.2 Clinical Practice 56 6.7 UK 57 6.7.1 Diagnosis 57 6.7.2 Clinical Practice 57 6.8 Japan 57 6.8.1 Diagnosis 57 6.8.2 Clinical Practice 58 6.9 China 60 6.9.1 Diagnosis 60 6.9.2 Clinical Practice 60 6.10 India 61 6.10.1 Diagnosis 61 6.10.2 Clinical Practice 61 7 Competitive Assessment 62 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 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 9.2.2 Clinical Trials by Phase and Trial Status 88 9.3 Promising drugs in clinical development 88 9.3.1 Lifitegrast 90 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 11 Market Outlook 129 11.1 Global Markets 129 11.1.1 Forecast 129 11.1.2 Drivers and Barriers – Global Issues 131 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 11.3.2 Key Events 141 11.3.3 Drivers and Barriers 141 11.4 Germany 144 11.4.1 Forecast 144 11.4.2 Key Events 146 11.4.3 Drivers and Barriers 146 11.5 Italy 148 11.5.1 Forecast 148 11.5.2 Key Events 150 11.5.3 Drivers and Barriers 150 11.6 Spain 152 11.6.1 Forecast 152 11.6.2 Key Events 154 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


11.6.3 Drivers and Barriers 154 11.7 United Kingdom 154 11.7.1 Forecast 154 11.7.2 Key Events 157 11.7.3 Drivers and Barriers 157 11.8 Japan 159 11.8.1 Forecast 159 11.8.2 Key Events 161 11.8.3 Drivers and Barriers 161 11.9 China 163 11.9.1 Forecast 163 11.9.2 Key Events 165 11.9.3 Drivers and Barriers 165 11.10 India 167 11.10.1 Forecast 167 11.10.2 Key Events 168 11.10.3 Drivers and Barriers 168 12 Appendix 169 12.1 Bibliography 169 12.2 Abbreviations 177 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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 12.7 About GlobalData 192 12.8 Contact Us 192 12.9 Disclaimer 192 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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, 2012–2022 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 Table 13: Global Sales Forecasts ($m) for Restasis, 2012–2022 68 Table 14: Product Profile – Diquas 69 Table 15: Diquas SWOT Analysis, 2012 71 Table 16: Global Sales Forecasts ($m) for Diquas, 2012–2022 71 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 17: Product Profile – Mucosta 72 Table 18: Mucosta SWOT Analysis, 2012 73 Table 19: Global Sales Forecasts ($m) for Mucosta, 2012–2022 74 Table 20: Summary of Minor Drug Classes, 2012 77 Table 21: Overall Unmet Needs – Current Level of Attainment 79 Table 22: Clinical Unmet Needs – Gap Analysis, 2012 84 Table 23: Dry Eye Syndrome – Clinical Trials by Phase and Status, 2013 87 Table 24: Dry Eye Syndrome – Phase Pipeline, 2012 87 Table 25: Comparison of Therapeutic Classes in Development for Dry Eye Syndrome, 2012 88 Table 26: Product Profile – Lifitegrast 90 Table 27: Lifitegrast SWOT Analysis, 2012 92 Table 28: Global Sales Forecasts ($m) for Lifitegrast, 2012–2022 93 Table 29: Product Profile – CF101 93 Table 30: CF101 SWOT Analysis, 2012 95 Table 31: Global Sales Forecasts ($m) for CF101, 2012–2022 96 Table 32: Product Profile – Cyclokat 97 Table 33: Cyclokat SWOT Analysis, 2012 98 Table 34: Global Sales Forecasts ($m) for Cyclokat, 2012–2022 99 Table 35: Product Profile – EGP-437 100 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 36: EGP-437 SWOT Analysis, 2012 103 Table 37: Global Sales Forecasts ($m) for EGP-437, 2012–2022 104 Table 38: Product Profile – RX-10045 105 Table 39: RX-10045 SWOT Analysis, 2012 107 Table 40: Global Sales Forecasts ($m) for RX-10045, 2012–2022 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, 2012–2022 111 Table 44: Key Companies in the Dry Eye Syndrome Market, 2012 112 Table 45: Allergan’s Dry Eye Syndrome Portfolio Assessment, 2012 115 Table 46: Allergan SWOT Analysis, 2012 115 Table 47: Alcon’s Dry Eye Syndrome Portfolio Assessment, 2012 117 Table 48: Alcon’s Dry Eye Syndrome Portfolio SWOT Assessment, 2012 117 Table 49: Santen Pharmaceutical’s Dry Eye Syndrome Portfolio Assessment, 2012 119 Table 50: Santen Pharmaceutical’s Dry Eye Syndrome Portfolio Assessment, 2012 121 Table 51: Santen Pharmaceutical’s Dry Eye Syndrome Portfolio SWOT Analysis, 2012 122 Table 52: Shire’s Dry Eye Syndrome Portfolio Assessment, 2013 123 Table 53: Shire’s Dry Eye Syndrome Portfolio SWOT Analysis, 2013 123 Table 54: Otsuka Pharmaceutical’s Dry Eye Syndrome Portfolio Assessment, 2012 125 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 55: Otsuka Pharmaceutical’s Dry Eye Syndrome Portfolio SWOT Analysis, 2012 125 Table 56: Can-Fite Dry Eye Syndrome Portfolio Assessment, 2012 126 Table 57: Can-Fite’s Dry Eye Syndome Portfolio SWOT Analysis, 2012 126 Table 58: Eyegate Pharma’s Dry Eye Syndrome Portfolio Assessment, 2012 127 Table 59: Eyegate Pharma’s Dry Eye Syndrome Portfolio SWOT Analysis, 2012 127 Table 60: Global Sales Forecasts ($m) for Dry Eye Syndrome, 2012–2022 129 Table 61: Dry Eye Syndrome Global Market – Drivers and Barriers, 2012–2022 130 Table 62: Sales Forecasts ($m) for Dry Eye Syndrome in the United States, 2012–2022 133 Table 63: Key Events Impacting Sales for Dry Eye Syndrome in the United States, 2012–2022 135 Table 64: United States, Dry Eye Syndrome Market – Drivers and Barriers, 2012–2022 136 Table 65: Sales Forecasts ($m) for Dry Eye Syndrome in France, 2012–2022 139 Table 66: Key Events Impacting Sales for Dry Eye Syndrome in France, 2012–2022 140 Table 67: France, Dry Eye Syndrome Market – Drivers and Barriers, 2012–2022 141 Table 68: Sales Forecasts ($m) for Dry Eye Syndrome in Germany, 2012–2022 144 Table 69: Key Events Impacting Sales for Dry Eye Syndrome in Germany, 2012–2022 145 Table 70: Germany, Dry Eye Syndrome Market – Drivers and Barriers, 2012–2022 145 Table 71: Sales Forecasts ($m) for Dry Eye Syndrome in Italy, 2012–2022 148 Table 72: Key Events Impacting Sales for Dry Eye Syndrome in Italy, 2012–2022 149 Table 73: Italy, Dry Eye Syndrome Market – Drivers and Barriers, 2012–2022 149 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Table 74: Sales Forecasts ($m) for Dry Eye Syndrome in Spain, 2012–2022 152 Table 75: Key Events Impacting Sales for Dry Eye Syndrome in Spain, 2012–2022 153 Table 76: Spain, Dry Eye Syndrome Market – Drivers and Barriers, 2012–2022 153 Table 77: Sales Forecasts ($m) for Dry Eye Syndrome in the United Kingdom, 2012–2022 155 Table 78: Key Events Impacting Sales for Dry Eye Syndrome in the United Kingdom, 2012–2022 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, 2012–2022 159 Table 81: Key Events Impacting Sales for Dry Eye Syndrome Japan, 2012–2022 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 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), 2012–2022 31 Figure 7: 9MM, Prevalent Cases of Dry Eye Syndrome, By Age, N (Millions), 2012 33 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


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, 2012–2022 114 Figure 18: Global Sales for Dry Eye Syndrome by Region, 2012–2022 131 Figure 19: Sales for Dry Eye Syndrome in the United States by Drug Class, 2012–2022 136 Figure 20: Sales for Dry Eye Syndrome in France by Drug Class, 2012–2022 141 Figure 21: Sales for Dry Eye Syndrome in Germany by Drug Class, 2012–2022 145 Figure 22: Sales for Dry Eye Syndrome in Italy by Drug Class, 2012–2022 149 Figure 23: Sales for Dry Eye Syndrome in Spain by Drug Class, 2012–2022 153 Figure 24: Sales for Dry Eye Syndrome in the United Kingdom by Drug Class, 2012–2022 156 Email ID- contact@jsbmarketresearch.com Tel No- 91 2241236650 Published by- http:/www.jsbmarketresearch.com/


Figure 25: Sales for Dry Eye Syndrome in Japan by Drug Class, 2012–2022 160 Figure 26: Sales for Dry Eye Syndrome in China by Drug Class, 2012–2022 164 Figure 27: Sales for Dry Eye Syndrome in India by Drug Class, 2012–2022 168

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