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

  • ID: 4459366
  • Report
  • Region: Global
  • 258 pages
  • GlobalData
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FEATURED COMPANIES

  • Alimera Sciences
  • Allegro Ophthalmics
  • Allergan
  • Bayer
  • Clearside BioMedical
  • Novartis
  • MORE
PharmaPoint: Macular Edema - Global Drug Forecast and Market Analysis to 2026

Summary

Macular edema (ME) is a condition where fluid and protein deposits accumulate on the macula, causing it to swell, leading to vision deterioration and loss. There are three main types of ME that warrant pharmacological treatment: diabetic macular edema (DME), macular edema following branch retinal vein occlusion (ME-BRVO), and macular edema following central retinal vein occlusion (ME-CRVO). The arrival of anti-vascular endothelial growth factor (VEGF) therapy revolutionized the treatment of ME and has quickly established itself as the gold standard of care.

Pharmaceutical sales within the diabetic macular edema (DME) and macular edema following retinal vein occlusion (ME-RVO) markets are expected to see significant growth, with an overall Compound Annual Growth Rate (CAGR) of over 6.5% over the forecast period from 2016-2026.With about 65% of the overall ME market, the US is clearly the most dominant market within the 7MM, generating around $2.4B in sales in 2016. This trend is expected to continue, and by the end of the forecast period, the US will account for around 70% of the 7MM market, generating over $4.5B in pharmaceutical sales.

We forecasts four pipeline drugs to launch in the ME market during the forecast period. Despite all four launching in the US, only two will launch in the 5EU and none are expected to become available in Japan within the next 10 years. Of the pipeline drugs expected to launch in the US, Luminate, a novel integrin peptide being developed by Allegro in combination with Avastin, is forecast to generate the highest in sales in the DME market, with a 2026 value of over $600M. Its high sales will be attributed to its first-in-class status and high cost of therapy.

Anti-VEGF therapies represent the gold standard of care for ME across the 7MM, amassing $3.5B in global sales in 2016. Eylea was responsible for 63% of anti-VEGF sales and 60% of total global sales, with a 2016 value of over $2 Billion. Eylea’s hold over the market is expect to continue as physicians favor this drug over rival anti-VEGF therapy Lucentis due to its perceived higher efficacy, easier dosing schedule, and lower treatment cost in certain markets. Sales of this blockbuster drug are forecast to peak at around $4.2B in 2025, after which sales will decline due the likely entry of cheaper biosimilars across the 7MM.

The report "PharmaPoint: Macular Edema - Global Drug Forecast and Market Analysis to 2026", provides the overview of macular edema, including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and disease management.

In particular, this report provides the following:
  • 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.
Companies mentioned in this report: Roche/Genetech, Novartis, Regeneron, Bayer, Santen Allergan.

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.
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Note: Product cover images may vary from those shown
2 of 4

FEATURED COMPANIES

  • Alimera Sciences
  • Allegro Ophthalmics
  • Allergan
  • Bayer
  • Clearside BioMedical
  • Novartis
  • MORE
1 Table of Contents

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
4.2 Classification
4.3 Symptoms and Diagnosis

5 Epidemiology
5.1 Disease Background
5.2 Risk Factors and Comorbidities
5.3 Global and Historical Trends
5.4 Forecast Methodology
5.5 Epidemiological Forecast for Macular Edema (2016-2026)
5.6 Discussion

6 Disease Management
6.1 Diagnosis Overview
6.2 Treatment Overview
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
7.3 Corticosteroid Implants

8 Unmet Need and Opportunity
8.1 Overview
8.2 More Efficacious First-Line Therapies
8.3 Longer Duration of Action
8.4 Alternative Route of Administration

9 Pipeline Assessment
9.1 Overview
9.2 Clinical Trial Mapping
9.3 Promising Drugs in Clinical Development
9.4 Promising Drugs in Early-Stage Development
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

11 Market Outlook
11.1 Global Market
11.2 US
11.3 5EU
11.4 Japan

12 Appendix
12.1 Bibliography
12.2 Abbreviations
12.3 Methodology
12.4 Primary Research - KOLs Interviewed for this Report
12.5 Primary Research - Prescriber Survey
12.6 About the Authors
12.7 About
12.8 Contact Us
12.9 Disclaimer

List of Tables
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

List of 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
Note: Product cover images may vary from those shown
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  • Roche/Genentech
  • Novartis
  • Regeneron
  • Bayer
  • Santen
  • Allergan
  • Alimera Sciences
  • Clearside BioMedical
  • Allegro Ophthalmics
Note: Product cover images may vary from those shown
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Note: Product cover images may vary from those shown
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