Diabetic Macular Edema: Disease Analysis and Forecast

Summary

This report covers the 7MM (US, France, Germany, Italy, Spain, UK, Japan) and provides an Excel-based forecast model for the diabetic macular edema market through 2033.

Drug sales in the DME pharmacotherapy market are expected to grow by a significant margin between 2024 and 2034, with an overall compound annual growth rate (CAGR) of 3.4% over the forecast period. In 2024, the analyst estimated the total DME market to be valued at $4.42 billion across the 7MM, with the US accounting for 55.6% of the market. The 5EU accounted for 41.4% of the global DME market with an estimated value of $1.83 billion, and Japan’s DME market accounted for 2.8% of the market, with an estimated value of $127.5 million in 2024.

Major drivers of DME market growth over the forecast period are the:

The launch of longer-acting anti-vascular endothelial growth factor (VEGF) therapies to treat patients with DME, most notably Roche’s Susvimo and Bayer/Regeneron’s high-dose Eylea
Optimism from key opinion leaders (KOLs) that these therapies could increase the interval between treatments for DME
An increase in the number of people with DME
Drugs with a new mechanism of action and/or new route of administration entering the DME market, particularly Oculis’ dexamethasone acetate, which introduces the topical route of administration to the DME space

Major barriers that will restrict the growth of the DME market during the forecast period are the:

Products that are due to lose exclusivity within the forecast period and the subsequent biosimilar launches of gold-standard therapies
The DME market already being crowded with anti-VEGF inhibitor therapies, providing competition for new therapies that employ the same mechanism of action

Scope

Overview of diabetic macular edema, including epidemiology, symptoms, diagnosis, and disease management.
Annualized diabetic macular edema therapeutics market revenue, cost of therapy per patient, and treatment usage patterns forecast from 2024 to 2034.
Key topics covered include strategic competitor assessment, market characterization, unmet needs, clinical trial mapping, and implications of these factors for the diabetic macular edema therapeutics market.
Pipeline analysis: comprehensive data assessing emerging trends and mechanisms of action under development for diabetic macular edema treatment. The most promising candidates in late-stage development are profiled.
Analysis of the current and future market competition in the global diabetic 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

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Develop business strategies by understanding the trends shaping and driving the 7MM diabetic macular edema therapeutics market.
Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the 7MM diabetic macular edema therapeutics market in the future.
Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing 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 Executive Summary

1.1 Market overview
1.2 The DME market will grow modestly during the forecast period, reaching sales of $6.18 billion in 2034
1.3 Development of longer-acting therapies for DME
1.4 Drugs with improved efficacy represent an important unmet need for DME
1.5 Less invasive formulations are an unmet need for DME
1.6 Late-stage pipeline therapies are anticipated to drive growth in the DME market
1.7 What do physicians think?

2 Introduction

2.1 Catalyst
2.2 Related reports
2.3 Upcoming reports

3 Disease Overview

3.1 Etiology and pathophysiology
3.2 Classification or staging systems

4 Epidemiology

4.1 Disease background
4.2 Risk factors and comorbidities
4.3 Global and historical trends
4.4 7MM forecast methodology
4.4.1 Sources
4.4.2 Forecast assumptions and methods
4.4.3 Forecast assumptions and methods: diagnosed prevalent cases of DME in diabetes - 7MM
4.4.4 Forecast assumptions and methods: diagnosed prevalent cases of DME by involvement of the eye - 7MM
4.5 Epidemiological forecast for DME (2024-34)
4.5.1 Diagnosed prevalent cases of DME in diabetes
4.5.2 Age-specific diagnosed prevalent cases of DME in diabetes
4.5.3 Sex-specific diagnosed prevalent cases of DME in diabetes
4.5.4 Diagnosed prevalent cases of DME by involvement of the eye
4.6 Discussion
4.6.1 Epidemiological forecast insight
4.6.2 Limitations of the analysis
4.6.3 Strengths of the analysis

5 Disease Management

5.1 Diagnosis and treatment overview
5.1.1 Diagnosis overview
5.1.2 Treatment overview
5.1.3 Pharmacotherapy treatments for DME
5.1.4 Surgical treatment options for DME
5.2 Key opinion leader insights on disease management

6 Current Treatment Options

6.1 Overview

7 Unmet Needs and Opportunity Assessment

7.1 Overview
7.2 Drug safety and efficacy
7.3 Less invasive formulations
7.4 Longer-acting therapy
7.5 Other mechanisms of action
7.6 Earlier diagnosis of patients

8 R&D Strategies

8.1 Overview
8.1.1 Development of novel targets
8.1.2 Longer-acting drugs
8.2 Clinical trial design
8.2.1 Clinical endpoints for DME
8.2.2 Inclusion and exclusion criteria for DME

9 Pipeline Assessment

9.1 Overview
9.2 Promising drugs in clinical development

10 Pipeline Valuation Analysis

10.1 Overview
10.2 Competitive assessment

11 Current and Future Players

11.1 Overview
11.2 Deal-making trends

12 Market Outlook

12.1 7MM
12.1.1 Forecast
12.1.2 Drivers and barriers - global issues
12.2 US
12.2.1 Forecast
12.2.2 Key events
12.2.3 Drivers and barriers
12.3 5EU
12.3.1 Forecast
12.3.2 Key events
12.3.3 Drivers and barriers
12.4 Japan
12.4.1 Forecast
12.4.2 Key events
12.4.3 Drivers and barriers

13 Appendix

13.1 Bibliography
13.2 Abbreviations
13.3 Methodology
13.3.1 Forecast methodology
13.4 Primary research - key opinion leaders interviewed for this report
13.4.1 Key opinion leaders
13.5 Primary research - prescriber survey
13.6 About the authors
13.6.1 Senior Analyst
13.6.2 Therapy Area Director
13.6.3 Epidemiologists
13.6.4 Vice President of Disease Intelligence and Epidemiologists
13.6.5 Global Head of Pharma Research, Analysis, and Competitive Intelligence

About the Analyst
Contact Us

List of Tables

Table 1: DME - key metrics in the 7MM
Table 2: Classifications of DME as distinguished via FA
Table 3: Classifications of DME as outlined by the International Council of Ophthalmology
Table 4: Risk factors and comorbidities for DME
Table 5: Treatment guidelines for DME
Table 6: Marketed drugs for DME in the 7MM, 2024
Table 7: Top 10 DME deals by value, 2019-2026
Table 8: DME market - global drivers and barriers, 2024-34
Table 9: Key events impacting sales for DME in the US, 2024-34
Table 10: DME Market - drivers and barriers in the US, 2024-34
Table 11: Key events impacting sales for DME in the 5EU, 2024-34
Table 12: DME Market - drivers and barriers in the 5EU, 2024-34
Table 13: Key events impacting sales for DME in Japan, 2024-34
Table 14: DME market - drivers and barriers in Japan, 2024-34
Table 15: High-prescribing physicians (non-KOLs) surveyed, by country

List of Figures

Figure 1: Global DME sales forecast by country in 2024 and 2034
Figure 2: Analysis of the company portfolio gap in DME during the forecast period
Figure 3: Competitive assessment of the late-stage pipeline agents that the Analyst expects to be licensed for the treatment of DME during the forecast period
Figure 4: Etiology of DME
Figure 5: Pathogenic processes in DME
Figure 6: 7MM, diagnosed prevalence of DME in diabetes (%), both sexes, ages =20 years, 2024
Figure 7: 7MM, sources used and not used to forecast the diagnosed prevalent cases of DME in diabetes
Figure 8: 7MM, sources used to forecast the diagnosed prevalent cases of DME by involvement of the eye
Figure 9: 7MM, diagnosed prevalent cases of DME in diabetes, N, both sexes, ages =20 years, 2024
Figure 10: 7MM, diagnosed prevalent cases of DME in diabetes by age, N, both sexes, 2024
Figure 11: 7MM, diagnosed prevalent cases of DME in diabetes by sex, N, ages =20 years, 2024
Figure 12: 7MM, diagnosed prevalent cases of DME by involvement of the eye, N, both sexes, ages =20 years, 2024
Figure 13: Treatment algorithm for DME
Figure 14: Unmet needs and opportunities in DME
Figure 15: Overview of the development pipeline in DME
Figure 16: Key late-stage trials for the promising pipeline agents that the Analyst expects to be licensed for the treatment of DME in the 7MM during the forecast period
Figure 17: Competitive assessment of recently approved and late-stage pipeline agents that the Analyst expects to be licensed for the treatment of DME during the forecast period
Figure 18: Competitive assessment of the pipeline drugs benchmarked against the standard of care
Figure 19: Analysis of the company portfolio gap in DME during the forecast period
Figure 20: 7MM sales forecast by country for DME in 2024 and 2034
Figure 21: 7MM sales forecast by drug class for DME in 2024 and 2034
Figure 22: Sales forecast by class for DME in the US in 2024 and 2034
Figure 23: Sales forecast by class for DME in the 5EU in 2024 and 2034
Figure 24: Sales forecast by class for DME in Japan in 2024 and 2034

Companies Mentioned (Partial List)

A selection of companies mentioned in this report includes, but is not limited to:

Regeneron
Pfizer
Bayer
Oculis
Outlook Therapeutics
Eyepoint

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