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PharmaPoint: Macular Edema and Macular Degeneration - Japan Drug Forecast and Market Analysis to 2023

Summary

Macular Edema is a condition where fluid accumulates on the macula, leading to vision impairment or in severe cases even vision loss. The three main types of ME are diabetic macular edema (DME), and macular edema following either a central or branch retinal vein occlusion (ME-CRVO and ME-BRVO). Age-related macular degeneration (AMD) is a painless eye condition which leads to gradual, irreversible, loss of central vision, and is one of the leading causes of blindness among people aged 50 and over in the developed world. Currently the ME and AMD markets are dominated by the use of anti-VEGF monotherapy, however, in recent years, corticosteroid implants have been reaching the ME market which could challenge the stronghold these drugs have in this sector. The AMD market will see the arrival of the first therapies to treat dry AMD, fulfilling a huge unmet need in the management of this retinal disease, and these first-in-class therapies will strongly drive the market growth over the next ten years. The launch of wet AMD adjunctive therapies will also see a significant change in the treatment of AMD patients and have a positive impact on the market growth.

Japan has an increasingly aging society, which will act as a significant driver of growth in this market, along with the introduction of novel therapies for both wet and dry AMD. The wAMD drugs, Fovista and abicipar pegol, are expected to enter the Japanese AMD market in 2019 and 2023, respectively, while the dAMD drugs, lampalizumab and emixustat, are both expected to enter in 2018.

Scope

- Overview of Macular Edema and Macular Degeneration 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 Japan including product description, safety and efficacy profiles as well as a SWOT analysis.
- Sales forecast for the top drugs in Japan from 2013-2023.
- Analysis of the impact of key events as well the drivers and restraints affecting Japan Macular Edema and Macular Degeneration 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 Macular Edema and Macular Degeneration
- 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 Japan.

Table Of Contents

PharmaPoint: Macular Edema and Macular Degeneration - Japan Drug Forecast and Market Analysis to 2023
1 Table of Contents
2 Introduction 13
2.1 Related Reports 14
3 Disease Overview 16
3.1 Macular Degeneration Overview 16
3.1.1 Etiology and Pathophysiology 18
3.1.2 Classification 22
3.1.3 Symptoms and Diagnosis 24
3.2 Macular Edema Overview 27
3.2.1 Etiology and Pathophysiology 28
3.2.2 Classification 31
3.2.3 Symptoms and Diagnosis 32
4 Disease Management 35
4.1 Diagnosis and Treatment Overview 35
4.1.1 Macular Edema Diagnosis 35
4.1.2 Macular Degeneration Diagnosis 35
4.1.3 Treatment Guidelines and Leading Prescribed Drugs 36
4.1.4 Clinical Practice 37
4.2 Japan 50
5 Competitive Assessment 54
5.1 Overview 54
5.2 Product Profiles - Major Brands 55
5.2.1 Lucentis (ranibizumab) 55
5.2.2 Eylea (aflibercept) 65
5.2.3 Avastin (bevacizumab) 75
5.2.4 Macugen (pegaptanib sodium) 81
5.2.5 Visudyne (verteporfin) 84
6 Unmet Need and Opportunity 89
6.1 Overview 89
6.2 Treatment for Dry AMD 90
6.2.1 Unmet Need 90
6.2.2 Gap Analysis 92
6.2.3 Opportunity 94
6.3 Longer-Acting Anti-VEGF Drug Therapy 96
6.3.1 Unmet Need 96
6.3.2 Gap Analysis 98
6.3.3 Opportunity 98
6.4 Increased Efficacy of Anti-VEGF Therapy for wAMD 99
6.4.1 Unmet Need 99
6.4.2 Gap Analysis 100
6.4.3 Opportunity 101
6.5 Less Invasive Drug Formulations 101
6.5.1 Unmet Need 101
6.5.2 Gap Analysis 102
6.5.3 Opportunity 103
6.6 Awareness and Earlier Patient Diagnosis 104
6.6.1 Unmet Need 104
6.6.2 Gap Analysis 105
6.6.3 Opportunity 105
6.7 Home Monitoring of AMD Progression 106
6.7.1 Unmet Need 106
6.7.2 Gap Analysis 107
6.7.3 Opportunity 108
7 Pipeline Assessment 110
7.1 Overview 110
7.2 Promising Drugs in Clinical Development 111
7.2.1 Abicipar pegol 113
7.2.2 Fovista 119
7.2.3 Lampalizumab 127
7.2.4 Emixustat 133
7.2.5 DE-102 139
7.3 Promising Drugs in Early-Stage Development 143
7.3.1 Complement Inhibitors 143
7.4 Other Drugs in Development 145
7.5 Biosimilars 147
8 Market Outlook 149
8.1 Japan 149
8.1.1 Forecast 149
8.1.2 Key Events 154
8.1.3 Drivers and Barriers - Global Issues 154
8.1.4 Japan - Drivers and Barriers 158
9 Appendix 161
9.1 Bibliography 161
9.2 Abbreviations 183
9.3 Methodology 188
9.4 Forecasting Methodology 188
9.4.1 Diagnosed ME and AMD Patients 188
9.4.2 Percentage of Drug-Treated Patients 189
9.4.3 Drugs Included in Each Therapeutic Class 189
9.4.4 Launch and Patent Expiry Dates 189
9.4.5 General Pricing Assumptions 190
9.4.6 Individual Drug Assumptions 190
9.4.7 Pricing of Pipeline Agents 194
9.5 Primary Research - KOLs Interviewed for this Report 195
9.6 Primary Research - High-Prescribers Survey 196
9.7 About the Authors 197
9.7.1 Analyst 197
9.7.2 Therapy Area Director 197
9.7.3 Global Head of Healthcare 198
9.8 About GlobalData 199
9.9 Disclaimer 199

1.1 List of Tables

Table 1: ARM System Classification of AMD 23
Table 2: Symptoms of AMD 24
Table 3: National and International Treatment Guidelines for ME and AMD 37
Table 4: Most Prescribed Drugs for ME and AMD in the Japan Market, 2013 37
Table 5: ME and AMD Disease Management - Japan 53
Table 6: Leading Treatments for ME and AMD, 2014 55
Table 7: Product Profile - Lucentis 60
Table 8: Lucentis SWOT Analysis, 2014 65
Table 9: Approval Dates for Eylea 69
Table 10: Product Profile - Eylea 70
Table 11: Eylea — Common Adverse Reactions 74
Table 12: Eylea SWOT Analysis, 2014 75
Table 13: Product Profile - Avastin 79
Table 14: Avastin SWOT Analysis, 2014 81
Table 15: Product Profile - Macugen 83
Table 16: Product Profile - Visudyne 87
Table 17: Visudyne SWOT Analysis, 2014 88
Table 18: Unmet Needs and Opportunities in ME and AMD 90
Table 19: Promising Drugs in Clinical Development for ME and AMD 111
Table 20: Comparison of Drugs in Development for ME and AMD, 2014 112
Table 21: Product Profile - Abicipar pegol 115
Table 22: SWOT Analysis - Abicipar pegol, 2014 119
Table 23: Product Profile - Fovista 124
Table 24: SWOT Analysis - Fovista, 2014 127
Table 25: Product Profile - Lampalizumab 130
Table 26: SWOT Analysis - Lampalizumab, 2014 133
Table 27: Product Profile - Emixustat 136
Table 28: SWOT Analysis - Emixustat, 2014 139
Table 29: Product Profile - DE-102 141
Table 30: DE-102 SWOT Analysis, 2014 143
Table 31: Early-Stage Drugs in Clinical Development for ME and AMD, 2014 146
Table 32: Sales Forecast ($m) for ME in Japan, 2013-2023 150
Table 33: Sales Forecast ($m) for AMD in Japan, 2013-2023 152
Table 34: Key Events Impacting Sales for ME and AMD in Japan, 2013-2023 154
Table 35: ME and AMD Markets - Drivers and Barriers, 2013-2023 154
Table 36: ME and AMD Markets - Drivers and Barriers in Japan, 2013-2023 158
Table 37: Key Launch Dates 189
Table 38: Key Patent Expiries 190
Table 39: Surveyed High-Prescribing Physicians (Non-KOLs), by Country 196

1.2 List of Figures

Figure 1: Anatomy of the Eye and Macula 16
Figure 2: Amsler Grid viewed by Patient with Normal Vision and with wAMD 25
Figure 3: Color Fundus Photographs of Dry and Wet AMD 25
Figure 4: FAF Imaging of GA 26
Figure 5: Imaging of wAMD 27
Figure 6: CMT in DME 33
Figure 7: RVOs (BRVO and CRVO) on an FA 34
Figure 8: Increased CRT in ME-RVO 34
Figure 9: ME Clinical Treatment Flowchart 43
Figure 10: AMD Clinical Treatment Flowchart 50
Figure 11: Eylea's Clinical Development in DME and ME-BRVO 70
Figure 12: Competitive Assessment of Late-Stage Pipeline Agents in ME and AMD, 2013-2023 113
Figure 13: Abicipar Pegol's Clinical Development in wAMD and DME 116
Figure 14: Clinical and Commercial Positioning of abicipar pegol 118
Figure 15: Fovista's Clinical Development in wAMD 124
Figure 16: Clinical and Commercial Positioning of Fovista 126
Figure 17: Lampalizumab's Development in wAMD 130
Figure 18: Clinical and Commercial Positioning of lampalizumab 132
Figure 19: Emixustat Clinical Development in dAMD 136
Figure 20: Clinical and Commercial Positioning of emixustat 138
Figure 21: DE-102's Clinical Development in DME and ME-BRVO 141
Figure 22: Clinical and Commercial Positioning of DE-102 142
Figure 23: Individual Drug Sales for ME in Japan, 2013-2023 151
Figure 24: Individual Drug Sales for AMD in Japan, 2013-2023 153

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