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

Pages: 119 Published: August 31, 2022 Report Code: GDHC250PIDR

The Diabetic Macular Edema (DME) market size was $5.05 billion in 2021 across the 7MM (seven major pharmaceutical markets). The market is forecast to achieve a CAGR of more than 8% during the forecast period.

Diabetic Macular Edema is a complication of type 1 and 2 diabetes with diabetic retinopathy. It is a leading cause of visual impairment and blindness in first-world countries, affecting over 28 million people (International Diabetes Federation, 2016; de Moura et al., 2020). The DME research report provides an overview of DME – including epidemiology, disease etiology, and management. The report will help 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.

Diabetic Macular Edema Market Size

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Key Regions in the DME Market

Seven major pharmaceutical markets (7MM) covered in this report are the US, 5EU (France, Germany, Italy, Spain, and the UK), and Japan. The US has the largest market share.

DME Market, by Regions

DME Market, by RegionsFor more regional insights, download a free report sample

DME Market Drivers

An increase in therapies with a longer duration of action, such as Kodiak Science’s KSI-301, means fewer treatment days, consequently improving patient compliance for DME patients who already experience heavy treatment burdens. In addition, the diabetic population is set to grow in line with the increased prevalence of risk factors such as obesity. Such factors will drive market growth in the coming years.

DME Market Barriers

Expensive therapies will face reimbursement challenges in markets where cost-conscious decisions are increasingly implemented. In addition, the inferior efficacy of pipeline agents will continue to leave many patients without adequate suppression of angiogenesis. This may hamper the growth of the market in focus in the coming years.

Classifications in the DME Market

DME is commonly classified as either focal (fDME) or diffuse (dDME). Diagnostic techniques used to diagnose DME subsets include optical coherence tomography (OCT) and fluorescein angiography (FA).

FDME

fDME involves fluid leaking from dilated capillaries and retinal microaneurysms. This is mainly associated with internal damage of BRB and presents as retinal fluid collection only in the outer retina. fDME may further be characterized by the presence of hard exudates.

DDME

DDME, on the other hand, consists of fluid leaking from the entire foveal circumference. This is mainly associated with external damage to the BRB; extensive capillary leakage leads to retinal fluid collection in the inner retina. dDME patients may also be susceptible to cystoid macular edema.

Key Pipeline Products in the DME Market

Diabetic Macular Edema has Ranibizumab, Aflibercept, Bevacizumab, Dexamethasone, Fluocinolone Acetonide, Triamcinolone Acetonide, Ranibizumab Biosimilar, and Nepafenac in the pipeline.

Key Players in the DME Market

Some of the key players in the Diabetic Macular Edema market are Novartis, Bayer, Alcon, Abbvie, and Regeneron.

Market Report Overview

Market size (2021 in 7MM) $5.05 billion
CAGR (2021 – 2031) >8%
Classifications FDME and DDME
Key Products Ranibizumab, Aflibercept, Bevacizumab, Dexamethasone, Fluocinolone Acetonide, Triamcinolone Acetonide, Ranibizumab Biosimilar, and Nepafenac
Key players Novartis, Bayer, Alcon, Abbvie, and Regenron

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.

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.

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.

Key Players

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

Table of Contents

| About GlobalData

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

13.1 Bibliography

13.2 Abbreviations

13.3 Methodology

13.3.1 Forecasting methodology

13.4 Primary research – KOLs interviewed for this report

13.4.1 KOLs

13.5 Primary research – prescriber survey

13.6 About the authors

13.6.1 Analyst

13.6.2 Therapy Area Director

13.6.3 Epidemiologist

13.6.4 Managing Epidemiologists/Reviewers

13.6.5 Vice President of Disease Analysis and Intelligence

13.6.6 Global Head and EVP of Healthcare Operations and Strategy

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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

Frequently Asked Questions

The Diabetic Macular Edema market size was $5.05 billion in 2021 across the 7MM.

The Diabetic Macular Edema market is forecast to achieve a CAGR of more than 8% during the forecast period.

The key classifications in the Diabetic Macular Edema market are FDME and DDME.

Ranibizumab, Aflibercept, Bevacizumab, Dexamethasone, Fluocinolone Acetonide, Triamcinolone Acetonide, Ranibizumab Biosimilar, and Nepafenac are in the pipeline in DME market.

 

Some of the key players in the Diabetic Macular Edema market are Novartis, Bayer, Alcon, Abbvie, and Regeneron.

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