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

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

Summary


Age-related macular degeneration (AMD) (ICD-10: H35.3) is one of the leading causes of vision loss among persons ages 50 years and over in developed countries and is the third leading cause of vision loss worldwide, after cataract and glaucoma (WHO, 2017). The exact cause of AMD is unknown; however, age is a major risk factor of AMD.

There are two major forms of AMD; “dry” (dAMD; nonexudative or atrophic) and “wet” (wAMD; exudative or neovascular) AMD. AMD is characterized by progression from early to intermediate and subsequently to the two major advanced forms of dAMD and wAMD: geographic atrophy (GA) and choroidal neovascularization (CNV), respectively.

The AMD market is about to enter an exciting phase over the next decade with the arrival of three novel therapies for dAMD, as well as the launches of two longer-duration anti-VEGF therapies and one adjunctive therapies to anti-VEGF for the treatment of wet AMD (wAMD). The AMD market is expected to increase from around $4.9B to $11.5B over the 10-year forecast period from 2016-2026. The launch of new drugs in both dAMD and wAMD will drive a significant market growth and the rapidly aging population will contribute to this growth. The population of wAMD patients in the seven major markets (7MM: US, France, Germany, Italy, Spain, UK, and Japan) covered in this report is expected to increase from 1.8 million people in 2016 to 2.4 million in 2026. GlobalData estimates the number of dry AMD (dAMD) patients with the late stage of the disease, called geographic atrophy (GA), at 1.5 million, which will increase to 2.1 million by 2026.The major drivers of growth in the AMD market during the forecast period include -

  • New product launches will be strong drivers in both the wAMD and dAMD markets.
  • The availability of therapies for GA will drive a sustained increase of treated GA cases, expanding this market.
  • The aging populations in the 7MM will contribute to the growth of AMD markets, together with an expected increase in the diagnosis of the disease.
  • The high annual cost of therapy (ACOT) for pipeline drugs means they will generate high sales and drive growth, curtailing the impact of the expiring patent protections of current therapies.


  • The report Age-Related Macular Degeneration: Global Drug Forecast and Market Analysis to 2026, provides overview Overview of AMD, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

    In particular, this report provides the following -
    • 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.
    Companies mentioned in this report: 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

    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.


    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
    1.1 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 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
    1.2 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 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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