PharmaPoint: Macular Edema - Global Drug Forecast and Market Analysis to 2026

PharmaPoint: Macular Edema - Global Drug Forecast and Market Analysis to 2026

Summary

Macular Edema (ME) is a condition characterized by the thickening and swelling (edema) of the macula, which is the area of the retina that is responsible for central vision. The occurrence of ME is highly frequent in diabetics and usually manifests itself as DME, a complication of diabetic retinopathy, and is the most common cause of vision loss in patients affected by diabetes mellitus. In addition the risk for ME is also higher in patients with retinal vein occlusion, a common condition in the elderly, which consists of two types: branch retinal vein occlusion (BRVO) and central retinal vein occlusion (CRVO).

The current standard of care for macular edema focuses around the use of anti-VEGF therapies which are administered as intravitreal injections. There are currently two approved anti-VEGF therapies on the market for the treatment of both DME and ME-RVO, Roche/Novartis Lucentis and Regeneron/Bayers Eylea. Roches oncology anti-VEGF is also used off-label in many markets. Although anti-VEGF therapies represent an effective treatment for ME, many patients do not show an adequate response to such therapy. In the case of these patients, they are often moved onto second-line treatment with corticosteroids. Over the next ten years, GlobalData forecasts four novel therapies to enter the ME market: CLS-TA, Abicipar pegol, Luminate and Optina.

GlobalData estimates that drug sales for ME in 2016 were approximately $3.7 billion across the seven major markets covered in this report. Over the 10-year forecast period, the market is expected to grow to $7.0 billion at a CAGR of 6.7%. This growth will be driven by increased uptake of market leading therapy, Eylea, increased prevalence of diabetes and improved diagnosis and treatment rates. The launch of pipeline therapies will also be a driver of growth, with Allegro’s Luminate and Allergan’s Abicipar pegol forecast to be the highest selling pipeline agents in 2026.

Scope

- Overview of macular edema, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.
- Annualized macular edema therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in three patient segments (DME, ME-BRVO and ME-CRVO) forecast from 2016 to 2026.
- Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the macular edema therapeutics market
- Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for macular edema therapy. The most promising candidates in Phase III development are profiled.
- Analysis of the current and future market competition in the global macular edema 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.
- Develop business strategies by understanding the trends shaping and driving the global macular edema therapeutics market.
- Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global macular edema therapeutics market in the 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.
- Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents
1 Table of Contents 2
1.1 List of Tables 6
1.2 List of Figures 8
2 Executive Summary 10
2.1 Significant Growth Expected in the ME Market from 2016 to 2026 11
2.2 Eylea Will Dominate the ME Market Through to 2025 12
2.3 Future Players Are Unlikely to Rival the Might of Regeneron 14
2.4 Despite the Availability of Anti-VEGFs, Unmet Needs Remain 15
2.5 Late-Stage Pipeline Therapies Will Be a Driver of Growth, Especially in the US 16
2.6 What Do Physicians think? 17
3 Introduction 20
3.1 Catalyst 20
3.2 Upcoming Related Reports 20
4 Disease Overview 21
4.1 Etiology and Pathophysiology 22
4.1.1 DME 22
4.1.2 ME-RVO 25
4.2 Classification 28
4.2.1 DME 28
4.2.2 ME-RVO 28
4.3 Symptoms and Diagnosis 29
4.3.1 DME 29
4.3.2 ME-RVO 29
5 Epidemiology 31
5.1 Disease Background 31
5.2 Risk Factors and Comorbidities 32
5.3 Global and Historical Trends 32
5.4 Forecast Methodology 33
5.4.1 Sources 33
5.4.2 Forecast Assumptions and Methods 38
5.5 Epidemiological Forecast for Macular Edema (2016-2026) 48
5.5.1 Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 48
5.5.2 Age-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 49
5.5.3 Sex-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 50
5.5.4 Diagnosed Prevalent Cases of Clinically Significant DME Among the Diagnosed the DME Population 51
5.5.5 Total Prevalent Cases of ME following BRVO 52
5.5.6 Age-Specific Total Prevalent Cases of ME Following BRVO 53
5.5.7 Sex-Specific Total Prevalent Cases of ME Following BRVO 54
5.5.8 Total Prevalent Cases of ME Following CRVO 55
5.5.9 Age-Specific Total Prevalent Cases of ME Following CRVO 56
5.5.10 Sex-Specific Total Prevalent Cases of ME Following CRVO 56
5.6 Discussion 57
5.6.1 Epidemiological Forecast Insight 57
5.6.2 Limitations of Analysis 58
5.6.3 Strengths of Analysis 59
6 Disease Management 60
6.1 Diagnosis Overview 60
6.2 Treatment Overview 61
6.2.1 Treatment Guidelines and Leading Prescribed Drugs 61
6.2.2 Clinical Practice 62
6.3 US 64
6.4 France 68
6.5 Germany 70
6.6 Italy 73
6.7 Spain 76
6.8 UK 78
6.9 Japan 81
7 Competitive Assessment 84
7.1 Overview 84
7.2 Product Profiles - Anti-VEGF Therapies 85
7.2.1 Lucentis (Ranibizumab) 86
7.2.2 Eylea (Aflibercept) 96
7.2.3 Avastin (Bevacizumab) 104
7.3 Corticosteroid Implants 110
7.3.1 Ozurdex (Dexamethasone Acetate) 110
7.3.2 Iluvien (Fluocinolone Acetonide) 117
8 Unmet Need and Opportunity 123
8.1 Overview 123
8.2 More Efficacious First-Line Therapies 123
8.2.1 Unmet Need 123
8.2.2 Gap Analysis 124
8.2.3 Opportunity 126
8.3 Longer Duration of Action 127
8.3.1 Unmet Need 127
8.3.2 Gap Analysis 128
8.3.3 Opportunity 129
8.4 Alternative Route of Administration 129
8.4.1 Unmet Need 129
8.4.2 Gap Analysis 130
8.4.3 Opportunity 131
9 Pipeline Assessment 132
9.1 Overview 132
9.2 Clinical Trial Mapping 134
9.3 Promising Drugs in Clinical Development 135
9.3.1 CLS-TA (Triamcinolone Acetonide) 136
9.3.2 Abicipar Pegol 144
9.3.3 Luminate (ALG-1001) 150
9.3.4 Optina (Danazol) 157
9.4 Promising Drugs in Early-Stage Development 165
9.4.1 REGN910-3 (Nesvacumab + Aflibercept) 165
9.4.2 RG-7716 166
9.4.3 AKB-9778 167
9.4.4 Brolucizumab (RTH258) 170
9.5 Other Drugs in Development 171
9.6 Biosimilars 171
10 Current and Future Players 176
10.1 Overview 176
10.2 Trends in Corporate Strategy 179
10.3 Company Profiles 180
10.3.1 Roche/Genentech 180
10.3.2 Novartis 183
10.3.3 Regeneron 185
10.3.4 Bayer 187
10.3.5 Santen 189
10.3.6 Allergan 190
10.3.7 Alimera Sciences 193
10.3.8 Clearside BioMedical 195
10.3.9 Allegro Ophthalmics 197
11 Market Outlook 199
11.1 Global Market 199
11.1.1 Forecast 199
11.1.2 Drivers and Barriers - Global Issues 204
11.2 US 204
11.2.1 Forecast 204
11.2.2 Key Events 208
11.2.3 Drivers and Barriers 209
11.3 5EU 209
11.3.1 Forecast 209
11.3.2 Key Events 214
11.3.3 Drivers and Barriers 215
11.4 Japan 215
11.4.1 Forecast 215
11.4.2 Key Events 218
11.4.3 Drivers and Barriers 218
12 Appendix 219
12.1 Bibliography 219
12.2 Abbreviations 239
12.3 Methodology 242
12.3.1 Forecasting Methodology 243
12.3.2 Diagnosed Patients 243
12.3.3 Percent Drug-Treated Patients 243
12.3.4 Drugs Included in Each Therapeutic Class 243
12.3.5 Launch and Patent Expiry Dates 244
12.3.6 General Pricing Assumptions 244
12.3.7 Individual Drug Assumptions 245
12.3.8 Generic Erosion 250
12.3.9 Pricing of Pipeline Agents 250
12.4 Primary Research - KOLs Interviewed for this Report 252
12.5 Primary Research - Prescriber Survey 255
12.6 About the Authors 255
12.6.1 Analyst 255
12.6.2 Therapy Area Director 255
12.6.3 Epidemiologist 256
12.6.4 Managing Epidemiologist 256
12.6.5 Global Director of Therapy Analysis and Epidemiology 257
12.6.6 Global Head and EVP of Healthcare Operations and Strategy 257
12.7 About GlobalData 258
12.8 Contact Us 258
12.9 Disclaimer 258

List Of Tables

Table 1: Macular Edema: Key Metrics in the 7MM 10
Table 2: Risk Factors and Comorbidities for DME 32
Table 3: 7MM, Diagnosed Prevalence of DME in the Diagnosed Diabetic Retinopathy Population, 2016 33
Table 4: 7MM, Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Both Sexes, Ages ≥20 Years, N, Selected Years 2016-2026. 48
Table 5: 7MM, Diagnosed Prevalent Cases of Clinically Significant DME Among the Diagnosed DME Population, Both Sexes, Ages ≥20 Years, N, Selected Years 2016-2026 51
Table 6: 7MM, Total Prevalent Cases of ME Following BRVO, Both Sexes, Ages ≥20 Years, N, Selected Years 2016-2026 52
Table 7: 7MM, Total Prevalent Cases of ME following CRVO, Both Sexes, Ages ≥20 Years, N, Selected Years 2016-2026 55
Table 8: National and International Treatment Guidelines for ME 61
Table 9: Country Profile - US, 2017 67
Table 10: Country Profile - France, 2017 70
Table 11: Country Profile - Germany, 2017 72
Table 12: Country Profile - Italy, 2017 75
Table 13: Country Profile - Spain, 2017 78
Table 14: Country Profile - UK, 2017 80
Table 15: Country Profile - Japan, 2017 83
Table 16: The leading ME treatments in the 7MM, 2017 85
Table 17: Product Profile - Lucentis 87
Table 18: Efficacy Results from Key Phase II and Phase III Studies of Lucentis in DME 92
Table 19: Efficacy Results from Pivotal Phase III Trials of Lucentis in ME-RVO 94
Table 20: SWOT Analysis - Lucentis, 2017 95
Table 21: Product Profile - Eylea, 2017 97
Table 22: Efficacy Results from Pivotal Phase III Studies of Eylea in DME 100
Table 23: Efficacy Results from the Phase III trials COPERNICUS and GALILEO in ME-CRVO 101
Table 24: Efficacy Results from Phase III VIBRANT Study of Eylea in ME-BRVO 102
Table 25: Most Common Adverse Events (≥5%) of Eylea Across All Approved Indications 103
Table 26: SWOT Analysis - Eylea, 2017 103
Table 27: Product Profile - Avastin, 2017 105
Table 28: Efficacy Results from Phase III Study Comparing Avastin, Lucentis, and Eylea 108
Table 29: SWOT Analysis - Avastin, 2017 109
Table 30: Product Profile - Ozurdex, 2017 111
Table 31: Percentage of patients with a BCVA gain of ≥15 letters in Ozurdex’s Phase III studies 114
Table 32: Efficacy Results from Two Phase III Trials Investigating Ozurdex in DME 115
Table 33: SWOT Analysis - Ozurdex, 2017 116
Table 34: Product Profile - Iluvien 117
Table 35: Efficacy Results from the Phase III FAME Trial of Iluvien in DME 120
Table 36: Adverse Events Reported by ≥10%of Patients in the Phase III Trial, FAME 121
Table 37: SWOT Analysis - Iluvien, 2017 121
Table 38: Product Profile - CLS-TA, 2017 137
Table 39: Efficacy Results from the Phase II TANZANITE Study of CLS-TA for the Treatment of ME-RVO 141
Table 40: SWOT Analysis - CLS-TA, 2017 143
Table 41: Product Profile - Abicipar Pegol, 2017 144
Table 42: Summary of Efficacy Results from the Phase II PALM Study of Abicipar for the Treatment of DME 147
Table 43: SWOT Analysis - Abicipar pegol, 2017 149
Table 44: Product Profile - Luminate, 2017 150
Table 45: Summary of Efficacy Results from Stage I of the Phase IIB DEL MAR Study of Luminate in DME 154
Table 46: SWOT Analysis - Luminate, 2017 156
Table 47: Product Profile - Optina, 2017 157
Table 48: Efficacy Results from the Phase II/III OptimEyes Study in DME Patients with a BMI Between 27.7 and 31.3 161
Table 49: SWOT Analysis - Optina, 2017 164
Table 50: Clinical Trial Summary for Phase II Trial, RUBY 165
Table 51: Clinical Trial Summary for RG-7716 167
Table 52: Summary of the Clinical Trials Evaluating AKB-9778 in ME 168
Table 53: Efficacy Results from the Phase II TIME-2 Study of AKB-9778 in DME 169
Table 54: Early-Stage Drugs in Clinical Development for ME, 2017 171
Table 55: Ranibizumab Biosimilars in Development, 2017 172
Table 56: Bevacizumab Biosimilars in Development, 2017 174
Table 57: Key Companies in the ME Market in the 7MM, 2017 177
Table 58: Roche/Genentech, ME Portfolio Assessment, 2017 183
Table 59: Novartis, ME Portfolio Assessment, 2017 185
Table 60: Regeneron, ME Portfolio Assessment, 2017 187
Table 61: Bayer, ME Portfolio Assessment, 2017 189
Table 62: Santen, ME Portfolio Assessment, 2017 190
Table 63: Allergan’s ME Portfolio Assessment, 2017 193
Table 64: Alimera Science’s ME Portfolio Assessment, 2017 195
Table 65: Clearside BioMedical’s ME Portfolio Assessment, 2017 197
Table 66: Allegro Ophthalmic’s ME Portfolio Assessment, 2017 198
Table 67: ME Market - Global Drivers and Barriers, 2016-2026 204
Table 68: Key Events Impacting Sales for ME in the US, 2016-2026 208
Table 69: ME Market - Global Drivers and Barriers in the US, 2016-2026 209
Table 70: Key Events Impacting Sales for ME in the 5EU, 2016-2026 214
Table 71: ME Market - Global Drivers and Barriers in the 5EU, 2016-2026 215
Table 72: Key Events Impacting Sales for ME in Japan, 2016-2026 218
Table 73: ME Market - Global Drivers and Barriers in Japan, 2016-2026 218
Table 74: Key Historical and Projected Launch Dates for ME 244
Table 75: Key Historical and Projected Patent Expiry Dates for ME 244
Table 76: Average Number of Treatment Days of Lucentis per Eye per Year Across the 7MM 246
Table 77: Average Annual Cost of Lucentis Therapy for ME 246
Table 78: Average Number of Treatment Days of Eylea per Eye Across the 7MM 247
Table 79: Average Annual Cost of Eylea Therapy for ME 247
Table 80: Average Number of Treatment Days of Avastin per Eye per Year Across the 7MM 248
Table 81: Average Annual Cost of Avastin Therapy for ME 248
Table 82: Average Number of Treatment Days of Ozurdex per Eye per Year Across the 7MM 249
Table 83: Average Annual Cost of Ozurdex Therapy for ME 249
Table 84: Average Annual Cost of Iluvien Therapy for ME 249
Table 85: Average Annual Cost of CLS-TA Therapy for ME 250
Table 86: Average Annual Cost of Abicipar Pegol Therapy for ME 251
Table 87: High-Prescribing Physicians (non-KOLs) Surveyed, By Country 255

List Of Figures

Figure 1: Global Sales for ME by Country, 2016 and 2026 12
Figure 2: Trend of Drug Class Contribution to Global ME Sales, 2016-2026 13
Figure 3: Global ME Sales by Company, 2016-2026 15
Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in ME, 2016-2026 17
Figure 5: Structure of the Eye 21
Figure 6: Various Routes of Macular Edema Development 22
Figure 7: Pathophysiology of DME 23
Figure 8: Structure of a Healthy Eye and an Eye with DME 24
Figure 9: Comparison of a Healthy Eye and an Eye Suffering from CRVO 26
Figure 10: Representation of an Eye Suffering from BRVO 27
Figure 11: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of T2D Among the General Population 34
Figure 12: 7MM, Sources Used, Diagnosed Prevalent Cases of T1D Among the General Population 35
Figure 13: 7MM, Sources Used, Diagnosed Prevalent Cases of Diabetic Retinopathy Among the Diagnosed Diabetes Population 35
Figure 14: 7MM, Sources Used, Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population 36
Figure 15: 7MM, Sources Used, Diagnosed Prevalent Cases of Clinically-Significant DME Among the Diagnosed Diabetic Retinopathy Population 36
Figure 16: 7MM, Sources Used , Total Prevalent Cases of BRVO and CRVO Among the General Population 37
Figure 17: 7MM, Sources Used, Total Prevalent Cases of ME following BRVO 37
Figure 18: 7MM, Sources Used, Total Prevalent Cases of ME following CRVO 38
Figure 19: 7MM, Age-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Both Sexes, N, 2016 49
Figure 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Ages ≥20 Years, N, 2016 50
Figure 21: 7MM, Age-Specific Total Prevalent Cases of ME Following BRVO, Both Sexes, N, 2016 53
Figure 22: 7MM, Sex-Specific Total Prevalent Cases of ME Following BRVO, Ages ≥20 Years, N, 2016 54
Figure 23: 7MM, Age-Specific Total Prevalent Cases of ME Following CRVO, Both Sexes, N, 2016 56
Figure 24: 7MM, Sex-Specific Total Prevalent Cases of ME following CRVO, Ages ≥20 Years, N, 2016 57
Figure 25: Timeline for the Approval of Lucentis across the 7MM 88
Figure 26: Timeline for the Approval of Eylea Across the 7MM 98
Figure 27: Timeline for the Approval of Ozurdex across the 7MM 113
Figure 28: Unmet Needs for the Treatment of ME, 2017 123
Figure 29: Overview of the Development Pipeline in Macular Edema, 2017 133
Figure 30: ME Therapeutics - Clinical Trials by Indication and Development Stage, 2017 134
Figure 31: Macular Edema - Key Phase IIB-III Clinical Trials, 2017 135
Figure 32: Competitive Assessment of Late-Stage Pipeline Agents in ME, 2016-2026 136
Figure 33: Clinical and Commerical Positioning, CLS-TA 142
Figure 34: Clinical and Commerical Positioning, Abicipar Pegol 148
Figure 35: Clinical and Commerical Positioning, Luminate 155
Figure 36: Clinical and Commerical Positioning, Optina 163
Figure 37: Global Sales of Branded Products for ME by Company, 2016-2026 178
Figure 38: Company Portfolio Gap Analysis in ME, 2016-2026 179
Figure 39 : Global Sales for ME by Country, 2016 and 2026 200
Figure 40: Global Sales for ME by Drug Class, 2016 and 2026 202
Figure 41: Trend of Drug Class Contribution to Global ME Sales, 2016-2026 203
Figure 42: Sales for ME by Drug Class in the US, 2016 and 2026 206
Figure 43: Trend of Drug Contribution to US ME Sales, 2016-2026 207
Figure 44: Sales for ME in the 5EU, by Country, 2016 and 2026 211
Figure 45: Sales for ME in the 5EU, by Drug Class, 2016 and 2026 212
Figure 46: Trend of Drug Class Contribution to 5EU ME Sales, 2016-2026 213
Figure 47 : Sales for ME by Drug Class in Japan, 2016 and 2026 217

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