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PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024
[Published by Global Data]

Published by Global Data: 05 Nov 2015 | 18076 | In Stock

Introduction

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
for PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024 [Published by Global Data]

  • 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

List Of Tables
in PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024 [Published by Global Data]

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

List Of Figures, Charts and Diagrams
in PharmaPoint: Dry Eye Syndrome - Global Drug Forecast and Market Assessment to 2024 [Published by Global Data]

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

Additional Details

Publisher

Global Data

Publisher Information

Reference

18076 | GDHC121PIDR

Number of Pages

283

Report Format

PDF

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