Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2026

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There are two clinical forms of age-related macular degeneration (AMD): dry and wet. Currently there are therapies available only for wet AMD. Drugs in late stages of development target the wet AMD segment and the late stage or atrophic form of dry AMD, called geographic atrophy (GA). The global markets are currently overwhelmingly dominated by anti-VEGFs for wAMD, including Lucentis, Eylea, and Avastin, which together accounted for 99.3% of AMD sales. Visudyne, photodynamic therapy (PDT), is used in a minority of patients usually combined with an anti-VEGF.

The AMD pipeline has two longer-acting anti-VEGF drugs (Novartis/Alcon’s brolucizumab and Allergan’s abicipar pegol) and one add-on therapy (Opthea’s OPT-302) in late-stage clinical development (Phase IIb/III) for wet AMD. Three drugs are in the late pipeline for GA, two complement inhibitors (Apellis’ APL-2 and Ophthotech’s Zimura) and a neuroprotective agent (Allergan’s Brimo DDS), which could launch within the forecast period.

GlobalData estimates the 2016 sales for AMD at approximately $4.9B across the 7MM covered in this report. The AMD market will experience a significant growth during the forecast period at a CAGR of 8.9%, with global sales of $11.5B in 2026. Such rapid growth is due primarily to the introduction of the new therapies for the previously untreatable dry AMD patients with GA, launching wet AMD drugs, and the increasing prevalence of AMD as a result of aging societies.

Key Questions Answered

What are the key drivers of significant growth of the AMD market?

How the sales of the current market leader, Bayer’s Eylea, will be affected by the launch of longer-acting anti-VEGF therapies (brolucizumab and abicipar pegol)?

How would physicians fit OPT-302 add-on therapy into the wet AMD treatment algorithm and what is its pricing and reimbursement prospect?

What are the market potentials of drugs developed for the treatment of GA associated with dry AMD, and would they fulfil the greatest unmet need in this space?

How will key patent expiries of anti-VEGF therapies and the use of Avastin impact sales of current and launching therapies in wet AMD?

Will there be opportunities remaining after the launch of late pipeline drugs in wet AMD and dry AMD?

Scope

Overview of AMD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

Annualized AMD therapeutics market revenue, cost of therapy per patient, and treatment usage patterns in two patient segments (GA due to dry AMD and wet AMD), forecast from 2016 to 2026.

Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping and implications for the AMD therapeutics market.

Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for AMD therapy. The most promising candidates in Phase IIb and Phase III developments are profiled.

Analysis of the current and future market competition in the global AMD 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 AMD therapeutics market.

Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global AMD 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.

Companies mentioned

Roche

Genentech

Novartis

Alcon

Regeneron

Bayer

Valeant

Allergan

Ohr

Ophthotech

Apellis

Opthea

Chugai

Pfizer

Santen

PanOptica

SciFluor Life Sciences

Tyrogenex

RXi Pharmaceuticals

Janssen

Astellas Pharma

Roche

Genentech

Novartis

Alcon

Regeneron

Bayer

Valeant

Allergan

Ohr

Ophthotech

Apellis

Opthea

Chugai

Pfizer

Santen

PanOptica

SciFluor Life Sciences

Tyrogenex

RXi Pharmaceuticals

Janssen

Astellas Pharma

Table of Contents

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Age-Related Macular Degeneration: Executive Summary

2.1 ...

Table of Contents

1 Table of Contents

1.1 List of Tables

1.2 List of Figures

2 Age-Related Macular Degeneration: Executive Summary

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

2.2 R&D and Corporate Strategies Within the AMD Market

2.3 Current Therapies for AMD Leave Abundant Unmet Needs

2.4 Opportunities Will Remain for New Entrants

2.5 Late-Stage Pipeline Drugs Entering the AMD Market Will Be a Key Driver of Growth

2.6 What Do Physicians Think?

3 Introduction

3.1 Catalyst

3.2 Related Reports

3.3 Upcoming Related Reports

4 Disease Overview

4.1 Etiology and Pathophysiology

4.1.1 Overview

4.1.2 dAMD

4.1.3 wAMD

4.1.4 Genetic Targets of Interest

4.2 Classification

4.3 Symptoms

4.4 Prognosis

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 Used

5.4.2 Forecast Assumptions and Methods

5.4.3 Total Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, Late Wet AMD, and Large Drusen

5.4.4 Diagnosed Incident Cases of AMD, Early AMD, Late AMD, Late Dry AMD, Late Wet AMD, and Large Drusen

5.5 Epidemiological Forecast for AMD (2016–2026)

5.5.1 Total Prevalent Cases of AMD

5.5.2 Age-Specific Total Prevalent Cases of AMD

5.5.3 Sex-Specific Total Prevalent Cases of AMD

5.5.4 Total Prevalent Cases of Early AMD

5.5.5 Total Prevalent Cases of Late AMD

5.5.6 Total Prevalent Cases of Late Dry AMD

5.5.7 Total Prevalent Cases of Late Wet AMD

5.5.8 Total Prevalent Cases of Large Drusen

5.5.9 Diagnosed Incident Cases of AMD

5.5.10 Age-Specific Diagnosed Incident Cases of AMD

5.5.11 Sex-Specific Diagnosed Incident Cases of AMD

5.5.12 Diagnosed Incident Cases of Early AMD

5.5.13 Diagnosed Incident Cases of Late AMD

5.5.14 Diagnosed Incident Cases of Late Dry AMD

5.5.15 Diagnosed Incident Cases of Late Wet AMD

5.5.16 Diagnosed Incident Cases of Large Drusen

5.6 Discussion

5.6.1 Epidemiological Forecast Insight

5.6.2 Limitations of the Analysis

5.6.3 Strengths of the 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

6.2.3 dAMD

6.2.4 wAMD

7 Competitive Assessment

7.1 Overview

7.2 Lucentis (Ranibizumab)

7.2.1 Overview

7.2.2 Efficacy

7.2.3 Safety

7.2.4 Forecast

7.3 Avastin (Bevacizumab)

7.3.1 Overview

7.3.2 Efficacy

7.3.3 Safety

7.3.4 SWOT Analysis

7.3.5 Forecast

7.4 Eylea (Aflibercept)

7.4.1 Overview

7.4.2 Efficacy

7.4.3 Safety

7.4.4 SWOT Analysis

7.4.5 Forecast

7.5 Macugen (Pegaptanib Sodium)

7.5.1 Overview

7.5.2 Efficacy

7.5.3 Safety

7.6 Visudyne (Verteporfin)

7.6.1 Overview

7.6.2 Efficacy

7.6.3 Safety

7.6.4 SWOT Analysis

7.6.5 Forecast

8 Unmet Needs and Opportunity Assessment

8.1 Overview

8.2 Treatment for Dry AMD

8.2.1 Unmet Need

8.2.2 Gap Analysis

8.2.3 Opportunity

8.3 Longer Acting Therapy

8.3.1 Unmet Need

8.3.2 Gap Analysis

8.3.3 Opportunity

8.4 Increased Anti-VEGF Efficacy

8.4.1 Unmet Need

8.4.2 Gap Analysis

8.4.3 Opportunity

8.5 Less Invasive Formulations

8.5.1 Unmet Need

8.5.2 Gap Analysis

8.5.3 Opportunity

8.6 Early Diagnosis and Disease Management

8.6.1 Unmet Need

8.6.2 Gap Analysis

8.6.3 Opportunity

9 Pipeline Assessment

9.1 Overview

9.2 Clinical Trial Mapping

9.2.1 Clinical Trials by Patient Population

9.3 Promising Drugs in Clinical Development

9.3.1 Brolucizumab

9.3.2 Abicipar pegol

9.3.3 OPT-302

9.3.4 APL-2

9.3.5 Zimura

9.3.6 Brimo DDS

9.4 Promising Drugs in Early-Stage Development

9.4.1 Complement Inhibitors

9.4.2 Anti-Angiogenic Agent

9.4.3 Anti-angiogenic (Topical)

9.4.4 Anti-angiogenic (Oral)

9.4.5 Anti-Fibrotic Agent

9.4.6 Stem Cell Therapy

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 Roche/Genentech

10.3.1 Overview

10.3.2 Portfolio Assessment

10.4 Novartis/Alcon

10.4.1 Overview

10.4.2 Portfolio Assessment

10.5 Regeneron

10.5.1 Overview

10.5.2 Portfolio Assessment

10.6 Bayer

10.6.1 Overview

10.6.2 Portfolio Assessment

10.7 Valeant

10.7.1 Overview

10.7.2 Portfolio Assessment

10.8 Allergan

10.8.1 Overview

10.8.2 Portfolio Assessment

10.9 Ohr Pharmaceutical

10.9.1 Overview

10.9.2 Portfolio Assessment

10.10 Apellis

10.10.1 Overview

10.10.2 Portfolio Assessment

10.11 Ophthotech

10.11.1 Overview

10.11.2 Portfolio Assessment

10.12 Opthea

10.12.1 Overview

10.12.2 Portfolio Assessment

11 Market Outlook

11.1 Global Markets

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 General Pricing Assumptions

12.3.6 Individual Drug Assumptions

12.3.7 Generic Erosion

12.3.8 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

List of tables

Table 1: AMD: Key Metrics in the 7MM

Table 2: Biological Pathways Associated with AMD Risk Genes

Table 3: The Four-Stage AREDS Classification of AMD ...

Table 1: AMD: Key Metrics in the 7MM

Table 2: Biological Pathways Associated with AMD Risk Genes

Table 3: The Four-Stage AREDS Classification of AMD

Table 4: Symptoms of AMD

Table 5: Severity Scale to Assess Five-Year Risk of Progression to Advanced AMD

Table 6: Risk Factors and Comorbid Conditions Associated with AMD

Table 7: Classification of AMD

Table 8: 7MM, Total Prevalent Cases of AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 9: 7MM, Total Prevalent Cases of Early AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 10: 7MM, Total Prevalent Cases of Late AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 11: 7MM, Total Prevalent Cases of Late Dry AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 12: 7MM, Total Prevalent Cases of Late Wet AMD, Both Sexes, N, Ages ≥50 Years, Selected Years 2016–2026

Table 13: 7MM, Total Prevalent Cases of Large Drusen, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 14: 7MM, Diagnosed Incident Cases of AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 15: 7MM, Diagnosed Incident Cases of Early AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 16: 7MM, Diagnosed Incident Cases of Late AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 17: 7MM, Diagnosed Incident Cases of Late Dry AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 18: 7MM, Diagnosed Incident Cases of Late Wet AMD, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 19: 7MM, Diagnosed Incident Cases of Large Drusen, Both Sexes, Ages ≥50 Years, N, Selected Years 2016–2026

Table 20: Treatment Guidelines for AMD

Table 21: AMD Disease Management – US

Table 22: AMD Disease Management – 5EU

Table 23: AMD Disease Management – Japan

Table 24: Most Prescribed Drugs for AMD in the Global Markets, 2017

Table 25: Product Profile – Lucentis

Table 26: Lucentis SWOT Analysis, 2017

Table 27: Product Profile – Avastin

Table 28: Avastin SWOT Analysis, 2017

Table 29: Product Profile – Eylea

Table 30: Eylea — Common Adverse Reactions

Table 31: Eylea SWOT Analysis, 2017

Table 32: Product Profile – Macugen

Table 33: Product Profile – Visudyne

Table 34: Visudyne SWOT Analysis, 2017

Table 35: Comparison of Therapeutic Classes in Development for AMD, 2016–2026

Table 36: Product Profile – Brolucizumab

Table 37: Brolucizumab and Eylea — Ocular Treatment-Emergent Adverse Events In the Study Eye

Table 38: Brolucizumab SWOT Analysis, 2017

Table 39: Product Profile – Abicipar Pegol

Table 40: Abicipar Pegol SWOT Analysis, 2017

Table 41: Product Profile – OPT-302

Table 42: OPT-302 SWOT Analysis, 2017

Table 43: Product Profile – APL-2

Table 44: APL-2 SWOT Analysis, 2017

Table 45: Product Profile – Zimura

Table 46: Mean Visual Acuity in a Subgroup of Anti-VEGF-Naïve wAMD patients who Received Lucentis and Zimura

Table 47: Zimura SWOT Analysis, 2017

Table 48: Product Profile – Brimo DDS

Table 49: Brimo DDS SWOT Analysis, 2017

Table 50: Innovative Early-Stage Approaches for AMD, 2017

Table 51: Product Profile – Squalamine

Table 52: CNTO-2476 — Ocular Adverse Events Reported for All Surgical Subjects in the CNTO-2476 Phase I/IIa Study

Table 53: Drugs in Development for AMD, 2017

Table 54: Ranibizumab Biosimilars in Phase III of Development Within the 7MM, 2017

Table 55: Bevacizumab Biosimilars in Phase III of Development Within the 7MM, 2017

Table 56: Key Companies in the AMD Market in the 7MM, 2017

Table 57: Roche/Genentech’s AMD Portfolio Assessment, 2017

Table 58: Novartis/Alcon’s AMD Disease Portfolio Assessment, 2017

Table 59: Regeneron’s AMD Portfolio Assessment, 2017

Table 60: Bayer’s AMD Portfolio Assessment, 2017

Table 61: Valeant’s AMD Portfolio Assessment, 2017

Table 62: Allergan’s AMD Disease Portfolio Assessment, 2017

Table 63: Apellis’ AMD Portfolio Assessment, 2017

Table 64: Ophthotech’s AMD Portfolio Assessment, 2017

Table 65: Opthea’s AMD Portfolio Assessment, 2017

Table 66: AMD Market – Global Drivers and Barriers, 2016–2026

Table 67: Key Events Impacting Sales for AMD in the US, 2016–2026

Table 68: AMD Market – Drivers and Barriers in the US, 2016–2026

Table 69: Key Events Impacting Sales for AMD in the 5EU, 2016–2026

Table 74: AMD Market – Drivers and Barriers in the 5EU, 2016–2026

Table 71: Key Events Impacting Sales for AMD in Japan, 2016–2026

Table 72: AMD Market – Drivers and Barriers in Japan, 2016–2026

Table 73: Key Projected Launch Dates for AMD

Table 74: Key Projected Patent Expiry Dates for AMD

Table 75: High-Prescribing Physicians (non-KOLs) Surveyed, by Country

List of figures

Figure 1: Global Sales Forecast by Country for AMD in 2016 and 2026

Figure 2: Company Portfolio Gap Analysis in AMD During the Forecast Period ...

Figure 1: Global Sales Forecast by Country for AMD in 2016 and 2026

Figure 2: Company Portfolio Gap Analysis in AMD During the Forecast Period

Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of AMD During the Forecast Period

Figure 4: Anatomy of the Eye and Macula: Healthy, dAMD, and wAMD

Figure 5: 7MM, Age-Standardized Total Prevalence of AMD (%), Men and Women, Ages ≥50 Years, 2016

Figure 6: 7MM, Sources Used, Total Prevalent Cases of AMD, Early AMD, Late AMD, Late Dry AMD, Late Wet AMD, and Large Drusen

Figure 7: 7MM, Sources Used, Diagnosed Incident Cases of AMD, Early AMD, Late AMD, Late Dry AMD, Late Wet AMD, and Large Drusen

Figure 8: 7MM, Age-Specific Total Prevalent Cases of AMD, Both Sexes, N, 2016

Figure 9: 7MM, Sex-Specific Total Prevalent Cases of AMD, Ages ≥50 Years, N, 2016

Figure 10: 7MM, Age-Specific Diagnosed Incident Cases of AMD, Both Sexes, N, 2016

Figure 11: 7MM, Sex-Specific Diagnosed Incident Cases of AMD, Ages ≥50 Years, N, 2016

Figure 12: Amsler Grid, as Viewed by Patients with Normal Vision and with wAMD

Figure 13: Color Fundus Photographs of Dry and Wet AMD

Figure 14: FAF Imaging of GA

Figure 15: Imaging of wAMD

Figure 16: AMD Clinical Treatment Flowchart

Figure 17: Unmet Needs and Opportunities in AMD

Figure 18: Overview of the Development Pipeline in AMD

Figure 19: Key Phase II/III Trials for Promising Pipeline Agents for wAMD

Figure 20: Key Phase II/III Trials for the Promising Pipeline Agents for dAMD

Figure 21: Competitive Assessment of the Late-Stage Pipeline Agents

Figure 22: Clinical and Commercial Positioning of Brolucizumab

Figure 23: Clinical and Commercial Positioning of Abicipar Pegol

Figure 24: Clinical and Commercial Positioning of OPT-302

Figure 25: Clinical and Commercial Positioning of APL-2.

Figure 26: Clinical and Commercial Positioning of Zimura

Figure 27: Clinical and Commercial Positioning of Brimo DDS

Figure 28: Global Sales of Branded Products for AMD, by Company, 2016 and 2026

Figure 29: Company Portfolio Gap Analysis in AMD, 2016–2026

Figure 30: Global (7MM) Sales Forecast for AMD, by Country, 2016 and 2026

Figure 31: Global (7MM) Sales Forecast for AMD, by Country, 2016 and 2026

Figure 32: Individual Drug Sales for AMD in 2016 and 2026

Figure 33: Sales Forecast for AMD in the US, by Drug, 2016 and 2026

Figure 34: Sales Forecast by Drugs for AMD in the 5EU in 2016 and 2026

Figure 35: Sales Forecast for AMD in Japan, by Drug, 2016 and 2026

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