The Macular Edema market reached a value of US$ 3.5 Billion across the top 7 markets (US, EU4, UK, and Japan) in 2023. Looking forward, the publisher expects the top 7 markets to reach US$ 5.8 Billion by 2034, exhibiting a growth rate (CAGR) of 5.77% during 2023-2034.
The Macular Edema market has been comprehensively analyzed in this report titled "Macular Edema Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Macular Edema refers to a condition characterized by the accumulation of fluid in the macula, which is the central portion of the retina responsible for sharp, detailed vision. This disease causes the macular tissue to swell, leading to distorted or blurred vision. The symptoms of the ailment can vary depending on the severity of the illness but may include impaired central vision, blank spots, decreased color perception, difficulty reading or performing detailed tasks, a sense of a dark or empty area in the center of vision, etc. The diagnosis of Macular Edema typically involves a comprehensive eye examination, along with a review of the patient's medical history and clinical features. The healthcare provider may also perform retinal imaging techniques, including optical coherence tomography (OCT), to obtain detailed cross-sectional pictures of the macula, which help to visualize any fluid accumulation and assess the severity of the ailment. Furthermore, indocyanine green angiography or fluorescein angiography is utilized to confirm a diagnosis by observing leakage or blockage in the retinal blood vessels.
The increasing cases of diabetic retinopathy, in which high blood sugar levels damage the retinal vessels, are primarily driving the Macular Edema market. In addition to this, the rising prevalence of trauma to the eye that can disrupt the normal structures and functions of the macula is creating a positive outlook for the market. Moreover, the widespread demand for intravitreal injections of anti-vascular endothelial growth factors to treat the ailment is further bolstering the market growth. These drugs inhibit the action of specific proteins that promote the development of abnormal blood vessels and increase vascular permeability in the retina, thereby reducing the leakage of fluid into the macula. Apart from this, the escalating application of laser therapy, since it delivers precise and controlled energy to the affected areas of the retina to stabilize vision and prevent the progression of the condition, is acting as another significant growth-inducing factor. Additionally, the emerging popularity of sustained-release implantable devices, which can slowly discharge medication over time and reduce inflammation in patients, is expected to drive the Macular Edema market during the forecast period.
This report provides an exhaustive analysis of the Macular Edema market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for Macular Edema and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the Macular Edema market in any manner.
Recent Developments:
In January 2024, Kyowa Kirin started the phase Ⅱ clinical trial of KHK4951 (generic name: tivozanib) for the treatment of diabetic Macular Edema in in Japan, North America, South Korea, and Australia. Kyowa Kirin has announced the enrollment of the first patient in its phase 2 trial evaluating Tivozanib eye drops (KHK4951) in patients with diabetic Macular Edema (DME).
In January 2024, EyePoint Pharmaceuticals, Inc., announced that the first patient had been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic Macular Edema (DME). EYP-1901 is an investigational sustained delivery therapy containing Vorolanib, a selective tyrosine kinase inhibitor.
In November 2023, Exonate Ltd., an mRNA therapy company focused on treatments for diabetic complications, announced its lead ophthalmology asset, EXN407, which has achieved its prespecified endpoints in a phase IB/IIA study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.
In October 2023, Genentech, a member of the Roche Group, received approval from the U.S. Food and Drug Administration (FDA) for Vabysmo (Faricimab-svoa) used for the treatment of Macular Edema following retinal vein occlusion (RVO).
In August 2023, Regeneron Pharmaceuticals, Inc received approval from the U.S. Food and Drug Administration (FDA) for Eylea (Aflibercept), used for the treatment of Macular Edema.
In April 2023, Chugai Pharmaceutical Co., Ltd. filed an additional application with the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo Intravitreal Injection 120 mg/mL Faricimab), for the treatment of Macular Edema associated with retinal vein occlusion (RVO) today.
Key Highlights:
The prevalence of Macular Edema was 5.47% and, overall, 5.81% in low-to-middle-income countries and 5.14% in high-income countries.
Lundeen et al. found a 62% rise in the yearly prevalence of Macular Edema. Additionally, they observed a higher prevalence of Macular Edema in men compared to women.
The prevalence of Macular Edema (ME) varies across diabetes types, ranging from 4.1% to 7.9% in type 1 diabetes and 1.4% to 12.8% in type 2 diabetes.
Drugs:
Lucentis (Ranibizumab) is an intravitreally administered drug, classified as a vascular endothelial growth factor (VEGF) inhibitor. It is approved for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). This monoclonal antibody fragment, belonging to the IgG1 kappa isotype, specifically targets human vascular endothelial growth factor A (VEGF-A), a glycoprotein implicated in the pathophysiology of AMD. Initially approved by the FDA in 2006 and the European Commission (EC) in 2007, Lucentis now has a biosimilar named BYOOVIZ, approved by Health Canada in March 2022. Other biosimilars, namely CIMERLI, RAIVISIO, and RANOPTO, were approved by the FDA, EC, and Health Canada in August 2022.
Eylea (Aflibercept), another VEGF inhibitor, is indicated for similar conditions as Lucentis and is also administered intravitreally. In addition to neovascular AMD, RVO-related macular edema, and DME, Eylea is approved for treating diabetic retinopathy and retinopathy of prematurity. The FDA approved Eylea for retinopathy of prematurity in preterm infants in February 2023 and for other conditions in August 2023. Yesafili, an aflibercept biosimilar, received approval for use in the EU in September 2023.
Faricimab, marketed as Vabysmo, is a bispecific antibody targeting both VEGF-A and Ang-2 for AMD and DME treatment. Like Lucentis and Eylea, it is administered intravitreally. Approved by the FDA in January 2022 and Canada in May 2022, Faricimab is catabolized similarly to endogenous immunoglobulins, with renal excretion following breakdown into smaller peptides and amino acids via cellular catabolism.
The Macular Edema market has been comprehensively analyzed in this report titled "Macular Edema Market: Epidemiology, Industry Trends, Share, Size, Growth, Opportunity, and Forecast 2024-2034". Macular Edema refers to a condition characterized by the accumulation of fluid in the macula, which is the central portion of the retina responsible for sharp, detailed vision. This disease causes the macular tissue to swell, leading to distorted or blurred vision. The symptoms of the ailment can vary depending on the severity of the illness but may include impaired central vision, blank spots, decreased color perception, difficulty reading or performing detailed tasks, a sense of a dark or empty area in the center of vision, etc. The diagnosis of Macular Edema typically involves a comprehensive eye examination, along with a review of the patient's medical history and clinical features. The healthcare provider may also perform retinal imaging techniques, including optical coherence tomography (OCT), to obtain detailed cross-sectional pictures of the macula, which help to visualize any fluid accumulation and assess the severity of the ailment. Furthermore, indocyanine green angiography or fluorescein angiography is utilized to confirm a diagnosis by observing leakage or blockage in the retinal blood vessels.
The increasing cases of diabetic retinopathy, in which high blood sugar levels damage the retinal vessels, are primarily driving the Macular Edema market. In addition to this, the rising prevalence of trauma to the eye that can disrupt the normal structures and functions of the macula is creating a positive outlook for the market. Moreover, the widespread demand for intravitreal injections of anti-vascular endothelial growth factors to treat the ailment is further bolstering the market growth. These drugs inhibit the action of specific proteins that promote the development of abnormal blood vessels and increase vascular permeability in the retina, thereby reducing the leakage of fluid into the macula. Apart from this, the escalating application of laser therapy, since it delivers precise and controlled energy to the affected areas of the retina to stabilize vision and prevent the progression of the condition, is acting as another significant growth-inducing factor. Additionally, the emerging popularity of sustained-release implantable devices, which can slowly discharge medication over time and reduce inflammation in patients, is expected to drive the Macular Edema market during the forecast period.
This report provides an exhaustive analysis of the Macular Edema market in the United States, EU4 (Germany, Spain, Italy, and France), United Kingdom, and Japan. This includes treatment practices, in-market, and pipeline drugs, share of individual therapies, market performance across the seven major markets, market performance of key companies and their drugs, etc. The report also provides the current and future patient pool across the seven major markets. According to the report, the United States has the largest patient pool for Macular Edema and also represents the largest market for its treatment. Furthermore, the current treatment practice/algorithm, market drivers, challenges, opportunities, reimbursement scenario, unmet medical needs, etc. have also been provided in the report. This report is a must-read for manufacturers, investors, business strategists, researchers, consultants, and all those who have any kind of stake or are planning to foray into the Macular Edema market in any manner.
Recent Developments:
In January 2024, Kyowa Kirin started the phase Ⅱ clinical trial of KHK4951 (generic name: tivozanib) for the treatment of diabetic Macular Edema in in Japan, North America, South Korea, and Australia. Kyowa Kirin has announced the enrollment of the first patient in its phase 2 trial evaluating Tivozanib eye drops (KHK4951) in patients with diabetic Macular Edema (DME).
In January 2024, EyePoint Pharmaceuticals, Inc., announced that the first patient had been dosed in the Phase 2 VERONA clinical trial of EYP-1901 for diabetic Macular Edema (DME). EYP-1901 is an investigational sustained delivery therapy containing Vorolanib, a selective tyrosine kinase inhibitor.
In November 2023, Exonate Ltd., an mRNA therapy company focused on treatments for diabetic complications, announced its lead ophthalmology asset, EXN407, which has achieved its prespecified endpoints in a phase IB/IIA study. During the trial, EXN407 met all safety and pharmacokinetic parameters and displayed encouraging signals of biological activity.
In October 2023, Genentech, a member of the Roche Group, received approval from the U.S. Food and Drug Administration (FDA) for Vabysmo (Faricimab-svoa) used for the treatment of Macular Edema following retinal vein occlusion (RVO).
In August 2023, Regeneron Pharmaceuticals, Inc received approval from the U.S. Food and Drug Administration (FDA) for Eylea (Aflibercept), used for the treatment of Macular Edema.
In April 2023, Chugai Pharmaceutical Co., Ltd. filed an additional application with the Ministry of Health, Labour and Welfare (MHLW) for anti-VEGF/anti-Ang-2 bispecific antibody Vabysmo Intravitreal Injection 120 mg/mL Faricimab), for the treatment of Macular Edema associated with retinal vein occlusion (RVO) today.
Key Highlights:
The prevalence of Macular Edema was 5.47% and, overall, 5.81% in low-to-middle-income countries and 5.14% in high-income countries.
Lundeen et al. found a 62% rise in the yearly prevalence of Macular Edema. Additionally, they observed a higher prevalence of Macular Edema in men compared to women.
The prevalence of Macular Edema (ME) varies across diabetes types, ranging from 4.1% to 7.9% in type 1 diabetes and 1.4% to 12.8% in type 2 diabetes.
Drugs:
Lucentis (Ranibizumab) is an intravitreally administered drug, classified as a vascular endothelial growth factor (VEGF) inhibitor. It is approved for treating neovascular (wet) age-related macular degeneration (AMD), macular edema following retinal vein occlusion (RVO), and diabetic macular edema (DME). This monoclonal antibody fragment, belonging to the IgG1 kappa isotype, specifically targets human vascular endothelial growth factor A (VEGF-A), a glycoprotein implicated in the pathophysiology of AMD. Initially approved by the FDA in 2006 and the European Commission (EC) in 2007, Lucentis now has a biosimilar named BYOOVIZ, approved by Health Canada in March 2022. Other biosimilars, namely CIMERLI, RAIVISIO, and RANOPTO, were approved by the FDA, EC, and Health Canada in August 2022.
Eylea (Aflibercept), another VEGF inhibitor, is indicated for similar conditions as Lucentis and is also administered intravitreally. In addition to neovascular AMD, RVO-related macular edema, and DME, Eylea is approved for treating diabetic retinopathy and retinopathy of prematurity. The FDA approved Eylea for retinopathy of prematurity in preterm infants in February 2023 and for other conditions in August 2023. Yesafili, an aflibercept biosimilar, received approval for use in the EU in September 2023.
Faricimab, marketed as Vabysmo, is a bispecific antibody targeting both VEGF-A and Ang-2 for AMD and DME treatment. Like Lucentis and Eylea, it is administered intravitreally. Approved by the FDA in January 2022 and Canada in May 2022, Faricimab is catabolized similarly to endogenous immunoglobulins, with renal excretion following breakdown into smaller peptides and amino acids via cellular catabolism.
Time Period of the Study
- Base Year: 2023
- Historical Period: 2018-2023
- Market Forecast: 2024-2034
Countries Covered
- United States
- Germany
- France
- United Kingdom
- Italy
- Spain
- Japan
Analysis Covered Across Each Country
- Historical, current, and future epidemiology scenario
- Historical, current, and future performance of the macular edema market
- Historical, current, and future performance of various therapeutic categories in the market
- Sales of various drugs across the macular edema market
Competitive Landscape:
This report also provides a detailed analysis of the current macular edema marketed drugs and late-stage pipeline drugs.In-Market Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
Late-Stage Pipeline Drugs
- Drug Overview
- Mechanism of Action
- Regulatory Status
- Clinical Trial Results
- Drug Uptake and Market Performance
Key Questions Answered in this Report:
Market Insights
- How has the macular edema market performed so far and how will it perform in the coming years?
- What are the markets shares of various therapeutic segments in 2023 and how are they expected to perform till 2034?
- What was the country-wise size of the macular edema market across the seven major markets in 2023 and what will it look like in 2034?
- What is the growth rate of the macular edema market across the seven major markets and what will be the expected growth over the next ten years?
- What are the key unmet needs in the market?
Epidemiology Insights
- What is the number of prevalent cases (2018-2034) of macular edema across the seven major markets?
- What is the number of prevalent cases (2018-2034) of macular edema by age across the seven major markets?
- What is the number of prevalent cases (2018-2034) of macular edema by gender across the seven major markets?
- How many patients are diagnosed (2018-2034) with macular edema across the seven major markets?
- What is the size of the macular edema patient pool (2018-2023) across the seven major markets?
- What would be the forecasted patient pool (2024-2034) across the seven major markets?
- What are the key factors driving the epidemiological trend of macular edema?
- What will be the growth rate of patients across the seven major markets?
Macular Edema: Current Treatment Scenario, Marketed Drugs and Emerging Therapies
- What are the current marketed drugs and what are their market performance?
- What are the key pipeline drugs and how are they expected to perform in the coming years?
- How safe are the current marketed drugs and what are their efficacies?
- How safe are the late-stage pipeline drugs and what are their efficacies?
- What are the current treatment guidelines for macular edema drugs across the seven major markets?
- Who are the key companies in the market and what are their market shares?
- What are the key mergers and acquisitions, licensing activities, collaborations, etc. related to the macular edema market?
- What are the key regulatory events related to the macular edema market?
- What is the structure of clinical trial landscape by status related to the macular edema market?
- What is the structure of clinical trial landscape by phase related to the macular edema market?
- What is the structure of clinical trial landscape by route of administration related to the macular edema market?
Table of Contents
1 Preface3 Executive Summary6 Patient Journey9 Macular Edema - Unmet Needs10 Macular Edema - Key Endpoints of Treatment13. Macular Edema - Attribute Analysis of Key Marketed and Pipeline Drugs16 Macular Edema - Recent Events and Inputs From Key Opinion Leaders18 Macular Edema Market - Strategic Recommendations19 Appendix
2 Scope and Methodology
4 Macular Edema - Introduction
5 Macular Edema - Disease Overview
7 Macular Edema - Epidemiology and Patient Population
8 Macular Edema - Treatment Algorithm, Guidelines, and Medical Practices
11 Macular Edema - Marketed Products
12 Macular Edema - Pipeline Drugs
14. Macular Edema - Clinical Trial Landscape
15 Macular Edema - Market Scenario
17 Macular Edema Market - SWOT Analysis
Methodology
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Table Information
| Report Attribute | Details |
|---|---|
| No. of Pages | 132 |
| Published | May 2024 |
| Forecast Period | 2023 - 2034 |
| Estimated Market Value ( USD | $ 3.5 Billion |
| Forecasted Market Value ( USD | $ 5.8 Billion |
| Compound Annual Growth Rate | 4.7% |
| Regions Covered | Global |
