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

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Published: November 30, 2017 Report Code: GDHC157PIDR-ST

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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/Bayer's Eylea. Roche's 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.

Roche/Genetech
Novartis
Regeneron
Bayer
Santen
Allergan
Alimera Sciences
Clearside Biomedical
Allegro Ophthalmics
Quark Pharmaceuticals
Boehringer Ingelheim
Stealth BioTherapeutics
OcuNexus Therapeutics
Taiwan Liposome Company
Senju Pharmaceuticals
Araim Pharmaceuticals
SciFlour Life Sciences
KalVista
Alcon
Formycon
Bioeq
Samsung Bioepis
Lupin
Aerpio Therapeutics
Ampio Pharmaceuticals
Sanofi
Avalanche Biotechnologies
Molecular Partners
Valeant
Actavis
pSivida
Hanmi Pharmaceutical

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Executive Summary

2.1 Significant Growth Expected in the ME Market from 2016 to 2026

2.2 Eylea Will Dominate the ME Market Through to 2025

2.3 Future Players Are Unlikely to Rival the Might of Regeneron

2.4 Despite the Availability of Anti-VEGFs, Unmet Needs Remain

2.5 Late-Stage Pipeline Therapies Will Be a Driver of Growth, Especially in the US

2.6 What Do Physicians think?

3 Introduction

3.1 Catalyst

3.2 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 DME

4.1.2 ME-RVO

4.2 Classification

4.2.1 DME

4.2.2 ME-RVO

4.3 Symptoms and Diagnosis

4.3.1 DME

4.3.2 ME-RVO

5 Epidemiology

5.1 Disease Background

5.2 Risk Factors and Comorbidities

5.3 Global and Historical Trends

5.4 Forecast Methodology

5.4.1 Sources

5.4.2 Forecast Assumptions and Methods

5.5 Epidemiological Forecast for Macular Edema (2016–2026)

5.5.1 Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population

5.5.2 Age-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population

5.5.3 Sex-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population

5.5.4 Diagnosed Prevalent Cases of Clinically Significant DME Among the Diagnosed the DME Population

5.5.5 Total Prevalent Cases of ME following BRVO

5.5.6 Age-Specific Total Prevalent Cases of ME Following BRVO

5.5.7 Sex-Specific Total Prevalent Cases of ME Following BRVO

5.5.8 Total Prevalent Cases of ME Following CRVO

5.5.9 Age-Specific Total Prevalent Cases of ME Following CRVO

5.5.10 Sex-Specific Total Prevalent Cases of ME Following CRVO

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of Analysis

5.6.3 Strengths of Analysis

6 Disease Management

6.1 Diagnosis Overview

6.2 Treatment Overview

6.2.1 Treatment Guidelines and Leading Prescribed Drugs

6.2.2 Clinical Practice

6.3 US

6.4 France

6.5 Germany

6.6 Italy

6.7 Spain

6.8 UK

6.9 Japan

7 Competitive Assessment

7.1 Overview

7.2 Product Profiles – Anti-VEGF Therapies

7.2.1 Lucentis (Ranibizumab)

7.2.2 Eylea (Aflibercept)

7.2.3 Avastin (Bevacizumab)

7.3 Corticosteroid Implants

7.3.1 Ozurdex (Dexamethasone Acetate)

7.3.2 Iluvien (Fluocinolone Acetonide)

8 Unmet Need and Opportunity

8.1 Overview

8.2 More Efficacious First-Line Therapies

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Longer Duration of Action

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Alternative Route of Administration

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Clinical Trial Mapping

9.3 Promising Drugs in Clinical Development

9.3.1 CLS-TA (Triamcinolone Acetonide)

9.3.2 Abicipar Pegol

9.3.3 Luminate (ALG-1001)

9.3.4 Optina (Danazol)

9.4 Promising Drugs in Early-Stage Development

9.4.1 REGN910-3 (Nesvacumab + Aflibercept)

9.4.2 RG-7716

9.4.3 AKB-9778

9.4.4 Brolucizumab (RTH258)

9.5 Other Drugs in Development

9.6 Biosimilars

10 Current and Future Players

10.1 Overview

10.2 Trends in Corporate Strategy

10.3 Company Profiles

10.3.1 Roche/Genentech

10.3.2 Novartis

10.3.3 Regeneron

10.3.4 Bayer

10.3.5 Santen

10.3.6 Allergan

10.3.7 Alimera Sciences

10.3.8 Clearside BioMedical

10.3.9 Allegro Ophthalmics

11 Market Outlook

11.1 Global Market

11.1.1 Forecast

11.1.2 Drivers and Barriers – Global Issues

11.2 US

11.2.1 Forecast

11.2.2 Key Events

11.2.3 Drivers and Barriers

11.3 5EU

11.3.1 Forecast

11.3.2 Key Events

11.3.3 Drivers and Barriers

11.4 Japan

11.4.1 Forecast

11.4.2 Key Events

11.4.3 Drivers and Barriers

12 Appendix

12.1 Bibliography

12.2 Abbreviations

12.3 Methodology

12.3.1 Forecasting Methodology

12.3.2 Diagnosed Patients

12.3.3 Percent Drug-Treated Patients

12.3.4 Drugs Included in Each Therapeutic Class

12.3.5 Launch and Patent Expiry Dates

12.3.6 General Pricing Assumptions

12.3.7 Individual Drug Assumptions

12.3.8 Generic Erosion

12.3.9 Pricing of Pipeline Agents

12.4 Primary Research – KOLs Interviewed for this Report

12.5 Primary Research – Prescriber Survey

12.6 About the Authors

12.6.1 Analyst

12.6.2 Therapy Area Director

12.6.3 Epidemiologist

12.6.4 Managing Epidemiologist

12.6.5 Global Director of Therapy Analysis and Epidemiology

12.6.6 Global Head and EVP of Healthcare Operations and Strategy

12.7 About GlobalData

12.8 Contact Us

12.9 Disclaimer

Table

Table 1: Macular Edema: Key Metrics in the 7MM

Table 2: Risk Factors and Comorbidities for DME

Table 3: 7MM, Diagnosed Prevalence of DME in the Diagnosed Diabetic Retinopathy Population, 2016

Table 4: 7MM, Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Both Sexes, Ages ≥20 Years, N, Selected Years 2016–2026.

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

Table 6: 7MM, Total Prevalent Cases of ME Following BRVO, Both Sexes, Ages ≥20 Years, N, Selected Years 2016–2026

Table 7: 7MM, Total Prevalent Cases of ME following CRVO, Both Sexes, Ages ≥20 Years, N, Selected Years 2016–2026

Table 8: National and International Treatment Guidelines for ME

Table 9: Country Profile – US, 2017

Table 10: Country Profile – France, 2017

Table 11: Country Profile – Germany, 2017

Table 12: Country Profile – Italy, 2017

Table 13: Country Profile – Spain, 2017

Table 14: Country Profile – UK, 2017

Table 15: Country Profile – Japan, 2017

Table 16: The leading ME treatments in the 7MM, 2017

Table 17: Product Profile – Lucentis

Table 18: Efficacy Results from Key Phase II and Phase III Studies of Lucentis in DME

Table 19: Efficacy Results from Pivotal Phase III Trials of Lucentis in ME-RVO

Table 20: SWOT Analysis – Lucentis, 2017

Table 21: Product Profile – Eylea, 2017

Table 22: Efficacy Results from Pivotal Phase III Studies of Eylea in DME

Table 23: Efficacy Results from the Phase III trials COPERNICUS and GALILEO in ME-CRVO

Table 24: Efficacy Results from Phase III VIBRANT Study of Eylea in ME-BRVO

Table 25: Most Common Adverse Events (≥5%) of Eylea Across All Approved Indications

Table 26: SWOT Analysis – Eylea, 2017

Table 27: Product Profile – Avastin, 2017

Table 28: Efficacy Results from Phase III Study Comparing Avastin, Lucentis, and Eylea

Table 29: SWOT Analysis – Avastin, 2017

Table 30: Product Profile – Ozurdex, 2017

Table 31: Percentage of patients with a BCVA gain of ≥15 letters in Ozurdex’s Phase III studies

Table 32: Efficacy Results from Two Phase III Trials Investigating Ozurdex in DME

Table 33: SWOT Analysis – Ozurdex, 2017

Table 34: Product Profile – Iluvien

Table 35: Efficacy Results from the Phase III FAME Trial of Iluvien in DME

Table 36: Adverse Events Reported by ≥10%of Patients in the Phase III Trial, FAME

Table 37: SWOT Analysis – Iluvien, 2017

Table 38: Product Profile – CLS-TA, 2017

Table 39: Efficacy Results from the Phase II TANZANITE Study of CLS-TA for the Treatment of ME-RVO

Table 40: SWOT Analysis – CLS-TA, 2017

Table 41: Product Profile – Abicipar Pegol, 2017

Table 42: Summary of Efficacy Results from the Phase II PALM Study of Abicipar for the Treatment of DME

Table 43: SWOT Analysis – Abicipar pegol, 2017

Table 44: Product Profile – Luminate, 2017

Table 45: Summary of Efficacy Results from Stage I of the Phase IIB DEL MAR Study of Luminate in DME

Table 46: SWOT Analysis – Luminate, 2017

Table 47: Product Profile – Optina, 2017

Table 48: Efficacy Results from the Phase II/III OptimEyes Study in DME Patients with a BMI Between 27.7 and 31.3

Table 49: SWOT Analysis – Optina, 2017

Table 50: Clinical Trial Summary for Phase II Trial, RUBY

Table 51: Clinical Trial Summary for RG-7716

Table 52: Summary of the Clinical Trials Evaluating AKB-9778 in ME

Table 53: Efficacy Results from the Phase II TIME-2 Study of AKB-9778 in DME

Table 54: Early-Stage Drugs in Clinical Development for ME, 2017

Table 55: Ranibizumab Biosimilars in Development, 2017

Table 56: Bevacizumab Biosimilars in Development, 2017

Table 57: Key Companies in the ME Market in the 7MM, 2017

Table 58: Roche/Genentech, ME Portfolio Assessment, 2017

Table 59: Novartis, ME Portfolio Assessment, 2017

Table 60: Regeneron, ME Portfolio Assessment, 2017

Table 61: Bayer, ME Portfolio Assessment, 2017

Table 62: Santen, ME Portfolio Assessment, 2017

Table 63: Allergan’s ME Portfolio Assessment, 2017

Table 64: Alimera Science’s ME Portfolio Assessment, 2017

Table 65: Clearside BioMedical’s ME Portfolio Assessment, 2017

Table 66: Allegro Ophthalmic’s ME Portfolio Assessment, 2017

Table 67: ME Market – Global Drivers and Barriers, 2016–2026

Table 68: Key Events Impacting Sales for ME in the US, 2016–2026

Table 69: ME Market – Global Drivers and Barriers in the US, 2016–2026

Table 70: Key Events Impacting Sales for ME in the 5EU, 2016–2026

Table 71: ME Market – Global Drivers and Barriers in the 5EU, 2016–2026

Table 72: Key Events Impacting Sales for ME in Japan, 2016–2026

Table 73: ME Market – Global Drivers and Barriers in Japan, 2016–2026

Table 74: Key Historical and Projected Launch Dates for ME

Table 75: Key Historical and Projected Patent Expiry Dates for ME

Table 76: Average Number of Treatment Days of Lucentis per Eye per Year Across the 7MM

Table 77: Average Annual Cost of Lucentis Therapy for ME

Table 78: Average Number of Treatment Days of Eylea per Eye Across the 7MM

Table 79: Average Annual Cost of Eylea Therapy for ME

Table 80: Average Number of Treatment Days of Avastin per Eye per Year Across the 7MM

Table 81: Average Annual Cost of Avastin Therapy for ME

Table 82: Average Number of Treatment Days of Ozurdex per Eye per Year Across the 7MM

Table 83: Average Annual Cost of Ozurdex Therapy for ME

Table 84: Average Annual Cost of Iluvien Therapy for ME

Table 85: Average Annual Cost of CLS-TA Therapy for ME

Table 86: Average Annual Cost of Abicipar Pegol Therapy for ME

Table 87: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

Figures

Figure 1: Global Sales for ME by Country, 2016 and 2026

Figure 2: Trend of Drug Class Contribution to Global ME Sales, 2016–2026

Figure 3: Global ME Sales by Company, 2016–2026

Figure 4: Competitive Assessment of Late-Stage Pipeline Agents in ME, 2016–2026

Figure 5: Structure of the Eye

Figure 6: Various Routes of Macular Edema Development

Figure 7: Pathophysiology of DME

Figure 8: Structure of a Healthy Eye and an Eye with DME

Figure 9: Comparison of a Healthy Eye and an Eye Suffering from CRVO

Figure 10: Representation of an Eye Suffering from BRVO

Figure 11: 7MM, Sources Used and Not Used, Diagnosed Prevalent Cases of T2D Among the General Population

Figure 12: 7MM, Sources Used, Diagnosed Prevalent Cases of T1D Among the General Population

Figure 13: 7MM, Sources Used, Diagnosed Prevalent Cases of Diabetic Retinopathy Among the Diagnosed Diabetes Population

Figure 14: 7MM, Sources Used, Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population

Figure 15: 7MM, Sources Used, Diagnosed Prevalent Cases of Clinically-Significant DME Among the Diagnosed Diabetic Retinopathy Population

Figure 16: 7MM, Sources Used , Total Prevalent Cases of BRVO and CRVO Among the General Population

Figure 17: 7MM, Sources Used, Total Prevalent Cases of ME following BRVO

Figure 18: 7MM, Sources Used, Total Prevalent Cases of ME following CRVO

Figure 19: 7MM, Age-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Both Sexes, N, 2016

Figure 20: 7MM, Sex-Specific Diagnosed Prevalent Cases of DME Among the Diagnosed Diabetic Retinopathy Population, Ages ≥20 Years, N, 2016

Figure 21: 7MM, Age-Specific Total Prevalent Cases of ME Following BRVO, Both Sexes, N, 2016

Figure 22: 7MM, Sex-Specific Total Prevalent Cases of ME Following BRVO, Ages ≥20 Years, N, 2016

Figure 23: 7MM, Age-Specific Total Prevalent Cases of ME Following CRVO, Both Sexes, N, 2016

Figure 24: 7MM, Sex-Specific Total Prevalent Cases of ME following CRVO, Ages ≥20 Years, N, 2016

Figure 25: Timeline for the Approval of Lucentis across the 7MM

Figure 26: Timeline for the Approval of Eylea Across the 7MM

Figure 27: Timeline for the Approval of Ozurdex across the 7MM

Figure 28: Unmet Needs for the Treatment of ME, 2017

Figure 29: Overview of the Development Pipeline in Macular Edema, 2017

Figure 30: ME Therapeutics – Clinical Trials by Indication and Development Stage, 2017

Figure 31: Macular Edema – Key Phase IIB-III Clinical Trials, 2017

Figure 32: Competitive Assessment of Late-Stage Pipeline Agents in ME, 2016–2026

Figure 33: Clinical and Commerical Positioning, CLS-TA

Figure 34: Clinical and Commerical Positioning, Abicipar Pegol

Figure 35: Clinical and Commerical Positioning, Luminate

Figure 36: Clinical and Commerical Positioning, Optina

Figure 37: Global Sales of Branded Products for ME by Company, 2016–2026

Figure 38: Company Portfolio Gap Analysis in ME, 2016–2026

Figure 39 : Global Sales for ME by Country, 2016 and 2026

Figure 40: Global Sales for ME by Drug Class, 2016 and 2026

Figure 41: Trend of Drug Class Contribution to Global ME Sales, 2016–2026

Figure 42: Sales for ME by Drug Class in the US, 2016 and 2026

Figure 43: Trend of Drug Contribution to US ME Sales, 2016–2026

Figure 44: Sales for ME in the 5EU, by Country, 2016 and 2026

Figure 45: Sales for ME in the 5EU, by Drug Class, 2016 and 2026

Figure 46: Trend of Drug Class Contribution to 5EU ME Sales, 2016–2026

Figure 47 : Sales for ME by Drug Class in Japan, 2016 and 2026

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