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Diabetic Macular Edema Market Size and Trend Report including Epidemiology and Pipeline Analysis, Competitor Assessment, Unmet Needs, Clinical Trial Strategies and Forecast, 2021-2031

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    Drug Pipelines

  • 119 Pages
  • August 2022
  • Region: Global
  • GlobalData
  • ID: 5661519
Diabetic macular edema (DME) is the leaking of blood vessels into the macula, located in the center of the retina, which consequently becomes swollen due to accumulation of excess fluid and results in impaired vision or even blindness. The loss of central vision can negatively impact patient's quality of life as everyday tasks such as reading, writing, driving, and recognizing faces and other objects becomes increasingly challenging.

Major drivers of growth in the DME market during the forecast period include the following:

  • The launches of longer-acting anti-vascular endothelial growth factor (VEGF) therapies to treat patients with DME
  • The launches of therapies with mechanisms of action which are new to the DME space.
  • An increase in the number of people with DME, in line with the growth of the diabetic population.

- Major barriers to growth in the DME market during the forecast period will include the following:

  • Products that are due to lose exclusivity within the forecast period, and the subsequent launch of biosimilars
  • Numerous anti-VEGF therapies on the market and in late-stage pipeline.
Key Questions Answered
  • What are the key unmet needs in DME? What do KOLs identify as the key unmet needs? Will the products in the current pipeline fill these unmet needs?
  • What were the key DME treatments in 2021?
  • When will the late stage pipeline products launch, and how will it affect drug sales and the overall DME market in the 7MM?

Key Highlights

  • DME market will grow significantly during the forecast period, at a CAGR of 8.2%.
  • Late-stage pipeline therapies are anticipated to drive growth in the DME market.
  • Reducing treatment burden is an important unmet need for DME.

Scope

  • Overview of DME - including epidemiology, disease etiology and management.
  • Topline DME drugs market revenue, annual cost of therapy, and anticipated sales for major late-stage pipeline drugs.
  • Key topics covered include assessment of marketed and pipeline therapies, unmet needs, current and future players and market outlook for the US, 5EU and Japan over the 10-year forecast period.
  • Pipeline analysis: Emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global DME therapeutics market. Insightful review of the key industry drivers and barriers.

Reasons to Buy

The report will enable you to:

  • Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
  • Develop business strategies by understanding the trends shaping and driving the global DME therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global DME 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.
  • Track drug sales in the global DME therapeutics market from 2021-2031.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

1 Diabetic Macular Edema: Executive Summary
1.1 The DME market will grow significantly during the forecast period, reaching sales of $11.08 billion in 2031
1.2 Development of longer-acting therapies for DME
1.3 Drugs with improved efficacy represent an important unmet need for DME
1.4 Less invasive formulations are an unmet need for DME
1.5 Late-stage pipeline therapies are anticipated to drive growth in the DME market
1.6 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
3.1.1 Overview
3.1.2 Etiology
3.1.3 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 Diagnosed prevalent cases of DME among the diagnosed DR population
4.4.4 Diagnosed prevalent cases of DME by involvement of the eye
4.4.5 Diagnosed prevalent cases of DME by type
4.5 Epidemiological Forecast for DME (2021-31)
4.5.1 Diagnosed prevalent cases of DME among the diagnosed DR population
4.5.2 Age-specific diagnosed prevalent cases of DME among the diagnosed DR population
4.5.3 Sex-specific diagnosed prevalent cases of DME among the diagnosed DR population
4.5.4 Diagnosed prevalent cases of DME by involvement of the eye
4.5.5 Diagnosed prevalent cases of DME by type
4.6 Discussion
4.6.1 Epidemiological Forecast Insight
4.6.2 COVID-19 impact
4.6.3 Limitations of Analysis
4.6.4 Strengths of 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 KOL insights on disease management
6 Competitive Assessment
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
8.1.3 Development of oral and topical agents
8.2 Clinical trials 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 Global markets
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
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 comorbid conditions associated with DME
Table 5: Treatment guidelines for DME
Table 6: Marketed drugs for DME in the 7MM, 2021
Table 7: Top 10 deals by value, 2016-21
Table 8: DME market - global drivers and barriers, 2021-31
Table 9: Key events impacting sales for DME in the US, 2021-31
Table 10: DME Market - drivers and barriers in the US, 2021-31
Table 11: Key events impacting sales for DME in the 5EU, 2021-31
Table 12: DME Market - drivers and barriers in the 5EU, 2021-31
Table 13: Key events impacting sales for DME in Japan, 2021-31
Table 14: DME market - drivers and barriers in Japan, 2021-31
Table 15: High-prescribing physicians (non-KOLs) surveyed, by country
List of Figures
Figure 1: Global sales forecast by country for DME in 2021 and 2031
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 GlobalData expects to be licensed for the treatment of DME during the forecast period
Figure 4: Pathogenic processes in DME
Figure 5: Pathogenic processes in DME
Figure 6: 7MM, diagnosed prevalence of DME (%), men and women, ages =20 years, 2021
Figure 7: 7MM, sources used and not used to forecast the diagnosed prevalent cases of DME
Figure 8: 7MM, sources used to forecast the diagnosed prevalent cases of DME by involvement of the eye
Figure 9: 7MM, sources used to forecast the diagnosed prevalent cases of DME by type
Figure 10: 7MM, diagnosed prevalent cases of DME, N, both sexes, ages =20 years, 2021
Figure 11: 7MM, diagnosed prevalent cases of DME by age group, N, both sexes, 2021
Figure 12: 7MM, diagnosed prevalent cases of DME by sex, N, ages =20 years, 2021
Figure 13: 7MM, diagnosed prevalent cases of DME by involvement of the eye, N, both sexes, ages =20 years, 2021
Figure 14: 7MM, diagnosed prevalent cases of DME by type, N, both sexes, ages =20 years, 2021
Figure 15: Treatment algorithm for DME
Figure 16: Unmet needs and opportunities in DME
Figure 17: Overview of the development pipeline in DME
Figure 18: Key late-stage trials for the promising pipeline agents that GlobalData expects to be licensed for DME in the 7MM during the forecast period
Figure 19: Competitive assessment of the late-stage pipeline agents that GlobalData expects to be licensed for the treatment of DME during the forecast period
Figure 20: Competitive assessment of the pipeline anti-VEGF inhibitor drugs benchmarked against the standard of care, Eylea, and of the pipeline corticosteroid drugs benchmarked against Ozurdex
Figure 21: Analysis of the company portfolio gap in DME during the forecast period
Figure 22: Global (7MM) sales forecast by country for DME in 2021 and 2031
Figure 23: Sales forecast by therapeutic class for DME in the 7MM, 2021 and 2031
Figure 24: DME sales forecast in the 7MM by drug, 2021 and 2031
Figure 25: Sales forecast by drug for DME in the US in 2021 and 2031
Figure 26: Sales forecast by drug for DME in the 5EU in 2021 and 2031
Figure 27: Sales forecast by drug for DME in Japan in 2021 and 2031

Companies Mentioned (Partial List)

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

  • Regeneron
  • Bayer
  • Roche
  • Novartis
  • AbbVie
  • Samsung Bioepis
  • Genentech
  • Outlook Therapeutics
  • Kodiak Sciences
  • Allergan
  • Alimera Sciences
  • Alcon
  • Wakamoto Pharmaceutical
  • Momenta Pharmaceuticals
  • Mylan NM
  • Xbrane Biopharma
  • STADA Arzneimittel AG
  • Oculis SA
  • Apexian Pharmaceuticals
  • Ocuphire Pharma
  • Bicycle Therapeutics
  • Oxurion