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Glaucoma-5EU Drug Forecast and Market Analysis to 2023

Glaucoma-5EU Drug Forecast and Market Analysis to 2023


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Executive Summary

Glaucoma-5EU Drug Forecast and Market Analysis to 2023

Summary

Glaucoma is a leading cause of preventable blindness globally. This chronic progressive optic neuropathy causes irreversible vision loss through damage to the optic nerve. There are currently no treatments that can directly prevent this damage, and all commercially available glaucoma therapies focus on lowering elevated intraocular pressure (IOP), a known risk factor for glaucoma development and progression. The launch of fixed-dose combination (FDC) products, which combine drugs from these various classes, will continue to be a source of significant growth in this market. The glaucoma market is about to enter a phase of new growth with the arrival of first-in-class drugs, such as Aerie's Rhopressa, Bausch & Lomb's Vesneo (latanoprost bunod), and Inotek's trabodenoson into the 7MM during the forecast period, which will generate additional growth in the global glaucoma market.

GlobalData estimates that drug sales for glaucoma in the 5EU reached USD 250m during the base year of 2013. After an initial period of minimal growth, GlobalData anticipates a moderate and steady growth trend from 2015 onwards. This can be partially attributed to the expected arrival of the recently approved FDC products Simbrinza and Taptiqom during 2015, and to the expected launch of five pipeline products during the forecast period.

*This is an on-demand report and will be delivered within 24 hrs. (excluding weekends) of the purchase.

Scope

Overview of Glaucoma including epidemiology, etiology, symptoms, diagnosis, pathology and treatment guidelines as well as an overview on the competitive landscape.

Detailed information on the key drugs in 5EU including product description, safety and efficacy profiles as well as a SWOT analysis.

Sales forecast for the top drugs in 5EU from 2013-2023.

Analysis of the impact of key events as well the drivers and restraints affecting 5EU Glaucoma market.

Reasons To Buy

Understand and capitalize by identifying products that are most likely to ensure a robust return

Stay ahead of the competition by understanding the changing competitive landscape for Glaucoma.

Effectively plan your M&A and partnership strategies by identifying drugs with the most promising sales potential

Make more informed business decisions from insightful and in-depth analysis of drug performance

Obtain sales forecast for drugs from 2013-2023 in 5EU.

1 Table of Contents

1 Table of Contents 2

1.1 List of Tables 6

1.2 List of Figures 9

2 Introduction 10

2.1 Catalyst 10

2.2 Related Reports 10

3 Disease Overview 12

3.1 Etiology and Pathophysiology 14

3.1.1 Etiology 14

3.1.2 Pathophysiology 17

3.2 Classification 20

3.3 Symptoms 21

3.4 Diagnosis 22

4 Disease Management 27

4.1 Diagnosis and Treatment Overview 27

4.1.1 Diagnosis 27

4.1.2 Treatment Guidelines 28

4.1.3 Leading Prescribed Drugs 30

4.1.4 Clinical Practice 30

4.2 5EU 32

5 Competitive Assessment 38

5.1 Overview 38

5.2 Product Profiles-Main Brands and Drug Classes 40

5.2.1 Xalatan (latanoprost) 40

5.2.2 Lumigan (bimatoprost) 46

5.2.3 Travatan (travoprost) 50

5.2.4 Tapros (tafluprost) 54

5.2.5 Beta Blockers 61

5.2.6 Carbonic Anhydrase Inhibitors 66

5.2.7 Alpha-Adrenergic Agonists 70

5.2.8 Simbrinza (brinzolamide + brimonidine) 73

5.2.9 Glanatec (ripasudil hydrochloride hydrate) 76

6 Unmet Need and Opportunity 82

6.1 Overview 82

6.2 Simplified Dosing Regimen 86

6.2.1 Unmet Need 86

6.2.2 Gap Analysis 87

6.2.3 Opportunity 90

6.3 Reminder Systems 91

6.3.1 Unmet Need 91

6.3.2 Gap Analysis 91

6.3.3 Opportunity 92

6.4 Long-Acting Therapy 93

6.4.1 Unmet Need 93

6.4.2 Gap Analysis 94

6.4.3 Opportunity 95

6.5 New Classes of IOP-Lowering Drugs 97

6.5.1 Unmet Need 97

6.5.2 Gap Analysis 99

6.5.3 Opportunity 100

6.6 Neuroprotective Drugs 101

6.6.1 Unmet Need 101

6.6.2 Gap Analysis 103

6.6.3 Opportunity 105

6.7 Improved Diagnosis and Monitoring 106

6.7.1 Unmet Need 106

6.7.2 Gap Analysis 107

6.7.3 Opportunity 108

7 Pipeline Assessment 109

7.1 Overview 109

7.2 Clinical Trials 109

7.2.1 Clinical Trial Mapping 109

7.2.2 Clinical Trial Design 110

7.3 Promising Drugs in Clinical Development 111

7.3.1 Rhopressa 113

7.3.2 Roclatan 125

7.3.3 Vesneo 133

7.3.4 Bimatoprost SR 142

7.3.5 Trabodenoson 150

7.3.6 OPC-1085EL 158

7.3.7 DE-117 162

7.3.8 OXT-TP 165

7.4 Promising Drugs in Early-Stage Development 167

7.4.1 ROCK Inhibitor AMA-0076 167

7.4.2 Sustained-Release PGA Products 168

7.5 Other Drugs in Development 171

8 Market Outlook 172

8.1 5EU 172

8.1.1 Forecast 172

8.1.2 Key Events 178

8.1.3 Drivers and Barriers 179

9 Appendix 180

9.1 Bibliography 180

9.2 Abbreviations 221

9.3 Methodology 226

9.4 Forecasting Methodology 226

9.4.1 Percent Drug-Treated Patients 226

9.4.2 Drugs Included in Each Therapeutic Class 227

9.4.3 Launch and Patent Expiry Dates 228

9.4.4 General Pricing Assumptions 228

9.4.5 Individual Drug Assumptions 229

9.4.6 Pricing of Pipeline Agents 238

9.5 Primary Research-KOLs Interviewed for this Report 239

9.6 Primary Research-High-prescriber Survey 241

9.7 About the Authors 242

9.7.1 Analyst 242

9.7.2 Therapy Area Director 242

9.7.3 Epidemiologist 243

9.7.4 Global Head of Healthcare 243

9.8 About GlobalData 244

9.9 Disclaimer 244

1.2 List of Figures

Figure 1: Open and Closed Iridocorneal Angles 13

Figure 2: The Aqueous Humor Cycle 16

Figure 3: Optic Nerve Damage-Cupping 18

Figure 4: Comparison of Healthy and Glaucomous Optic Nerves 26

Figure 5: Glaucoma Clinical Treatment Flowchart 32

Figure 6: Glaucoma-Number of Phase II and III/IIb Clinical Trials in Various Drug Classes in the 7MM 110

Figure 7: Competitive Assessment of Late-Stage Pipeline Agents in Glaucoma, 2013-2023 113

Figure 8: Rhopressa's Development in Glaucoma 121

Figure 9: Clinical and Commercial Positioning of Rhopressa 123

Figure 10: Roclatan's Development in Glaucoma 130

Figure 11: Clinical and Commercial Positioning of Roclatan 131

Figure 12: Vesneo Development in Glaucoma 138

Figure 13: Clinical and Commercial Positioning of Vesneo 140

Figure 14: Clinical and Commercial Positioning of Bimatoprost SR 148

Figure 15: Trabodenoson's Development in Glaucoma 154

Figure 16: Clinical and Commercial Positioning of Trabodenosen 156

Figure 17: OPC-1085EL's Development in Glaucoma 160

Figure 18: Clinical and Commercial Positioning of OPC-1085EL 161

Figure 19: DE-117's Development in Glaucoma 164

Figure 20: Drug Sales by Class for Glaucoma in the 5EU, 2013-2023 176

Figure 21: Drug Sales by Country for Glaucoma in the 5EU, 2013-2023 177

1.1 List of Tables

Table 1: Symptoms of Glaucoma 22

Table 2: Diagnostic Tests for Glaucoma. 22

Table 3: National and International Treatment Guidelines for Glaucoma 29

Table 4: Most Prescribed Drugs for Glaucoma in the Global Markets, 2013 30

Table 5: Country Profile-5EU 37

Table 6: Leading Treatments for Glaucoma, 2013 39

Table 7: Product Profile-Xalatan 43

Table 8: Xalatan SWOT Analysis, 2014 44

Table 9: Global Sales Forecast (USD m) for Xalatan, 2013-2023 45

Table 10: Global Sales Forecast (USD m) for Generic Latanoprost, 2013-2023 45

Table 11: Product Profile-Lumigan 48

Table 12: Lumigan SWOT Analysis, 2014 49

Table 13: Global Sales Forecast (USD m) for Lumigan, 2013-2023 50

Table 14: Product Profile-Travatan 52

Table 15: Travatan SWOT Analysis, 2014 53

Table 16: Global Sales Forecast (USD m) for Travatan/Travatan Z, 2013-2023 54

Table 17: Global Overview of Tafluprost 54

Table 18: Product Profile-Tapros Franchise 57

Table 19: Tafluprost Adverse Events 59

Table 20: Tafluprost SWOT Analysis, 2014 59

Table 21: Global Sales Forecast (USD m) for the Tapros Franchise, 2013-2023 60

Table 22: Beta Blockers Available in the 7MM 63

Table 23: Global Sales Forecast (USD m) for Beta Blocker Drugs, 2013-2023 66

Table 24: Carbonic Anhydrase Inhibitors Available in the 7MM 67

Table 25: Global Sales Forecast (USD m) for Carbonic Anhydrase Inhibitor Drugs, 2013-2023 70

Table 26: Alpha-Adrenergic Agonists available in the 7MM 71

Table 27: Global Sales Forecast (USD m) for Alpha-Adrenergic Agonist Drugs, 2013-2023 73

Table 28: Product Profile-Simbrinza 74

Table 29: Simbrinza SWOT Analysis, 2014 75

Table 30: Global Sales Forecast (USD m) for Simbrinza, 2013-2023 76

Table 31: Product Profile-Glanatec 79

Table 32: Glanatec SWOT Analysis, 2014 81

Table 33: Global Sales Forecast (USD m) for Glanatec, 2013-2023 81

Table 34: Unmet Needs and Opportunities in Glaucoma 85

Table 35: Promising Drugs in Clinical Development for Glaucoma 111

Table 36: Comparison of Drugs in Development for Glaucoma, 2014 112

Table 37: Product Profile-Rhopressa 121

Table 38: SWOT Analysis-Rhopressa, 2014 124

Table 39: Global Sales Forecasts (USD m) for Rhopressa, 2013-2023 125

Table 40: Product Profile-Roclatan 129

Table 41: SWOT Analysis-Roclatan, 2014 132

Table 42: Global Sales Forecasts (USD m) for Roclatan, 2013-2023 133

Table 43: Product Profile-Vesneo 138

Table 44: SWOT Analysis-Vesneo, 2014 141

Table 45: Global Sales Forecasts (USD m) for Vesneo, 2013-2023 142

Table 46: Product Profile-Bimatoprost SR 147

Table 47: SWOT Analysis-Bimatoprost SR, 2014 149

Table 48: Global Sales Forecasts (USD m) for Bimatoprost SR, 2013-2023 150

Table 49: Product Profile-Trabodenosen 154

Table 50: SWOT Analysis-Trabodenoson, 2014 157

Table 51: Global Sales Forecasts (USD m) for Trabodenosen, 2013-2023 158

Table 52: Product Profile-OPC-1085EL 159

Table 53: SWOT Analysis-OPC-1085EL, 2014 161

Table 54: Global Sales Forecasts (USD m) for OPC-1085EL, 2013-2023 162

Table 55: Product Profile-DE-117 164

Table 56: SWOT Analysis-DE-117, 2014 165

Table 57: Product Profile-OXT-TP 166

Table 58: SWOT Analysis-OTX-TP, 2014 167

Table 59: Drugs in Development, 2014 171

Table 60: 5EU Sales Forecast (USD m) for Glaucoma, 2013-2023 175

Table 61 Key Events Impacting Sales for Glaucoma in the 5EU, 2013-2023 178

Table 62: Glaucoma Market-Drivers and Barriers in the 5EU, 2013-2023 179

Table 63: Key Launch Dates 228

Table 64: Key Patent Expiries 228

Table 65: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 241

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