Retinal Vein Occlusion - Market Insight, Epidemiology and Market Forecast - 2032

This ‘Retinal vein occlusion (RVO) - Market Insights, Epidemiology, and Market Forecast-2032' report delivers an in-depth understanding of the Retinal vein occlusion, historical and forecasted epidemiology as well as the Retinal vein occlusion market trends in the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan.

The Retinal vein occlusion market report provides current treatment practices, emerging drugs, market share of the individual therapies, and current and forecasted 7MM Retinal vein occlusion market size from 2019 to 2032. The Report also covers current Retinal vein occlusion treatment practice, market drivers, market barriers, SWOT analysis, reimbursement, market access, and unmet medical needs to curate the best of the opportunities and assesses the underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain, and the United Kingdom)
• Japan

Study Period: 2019-2032

Retinal vein occlusion Disease Understanding and Treatment Algorithm

Retinal vein occlusion Overview

Retinal vein occlusion is one of the most frequently occurring retinal vascular disorders in elderly patients that develop predominantly in individuals over the age of 65 years. The main risk factor for Retinal vein occlusion includes age. With the increase of the geriatric population, as of now, the prevalence of retinal vein occlusion is also supposed to be on the high rise.

Further risk factors include systemic conditions like hypertension, arteriosclerosis, diabetes mellitus, hyperlipidemia, cerebral vascular stroke, blood hyperviscosity, and thrombophilia. A strong risk factor for Retinal vein occlusion is metabolic syndrome (hypertension, diabetes mellitus, and hyperlipidemia). Individuals with end-organ damage caused by diabetes mellitus and hypertension have a substantially increased risk for retinal vein occlusion. Ophthalmic risk factors for Retinal vein occlusion are ocular hypertension and glaucoma, higher ocular perfusion pressure, and changes in the retinal arteries
Retinal vein occlusion is categorized into central Retinal vein occlusion (CRVO) and branch retinal vein occlusion (BRVO) according to the site of blockage in the retinal vein. CRVO is divided further into nonischemic and ischemic types according to the perfusion status based on fluorescein angiography. BRVO consists of major branch Retinal vein occlusion (when one of the major branch retinal veins is occluded, usually near, or rarely at, the optic disc) and macular branch Retinal vein occlusion (when only one of the macular venules is occluded).

Macular edema is the major complication of significant visual loss in patients with CRVO and BRVO, and various treatments have been used to improve macular edema and cause regression of intraocular neovascularization.

Retinal vein occlusion Diagnosis

The initial examination of a patient with a Retinal vein occlusion includes all relevant aspects of the comprehensive adult medical eye evaluation, with particular attention to those aspects related to retinal vascular disease. Several tests are being used for the diagnosis of Retinal vein occlusion such as Optical coherence tomography (OCT), and Fluorescein angiography (FA). Apart from this, Systemic evaluation is often performed in patients with CRVO and is directed by the patient's age, coexisting risk factors, and medical history.

Retinal vein occlusion Treatment
The current market for Retinal vein occlusion is dependent on the use of anti-VEGF, corticosteroids, laser therapy, and several other off-labeled therapies. Among the present treatment option, anti-VEGF occupies the maximum market share. Current treatment within Retinal vein occlusion is aimed at the secondary outcome i.e., macular edema Retinal vein occlusion. Anti-VEGF drugs have proven efficacy in the treatment of retinal vein occlusion, hence are used most. Anti-VEGF drugs make the injured blood vessels less leaky, thereby decreasing macular edema.

The anti-VEGF molecules that are being used in the present market include ranibizumab, aflibercept, and bevacizumab. Aflibercept and ranibizumab are anti-VEGF drugs approved by the US FDA for the treatment of Retinal vein occlusion-associated macular edema. Bevacizumab is the FDA-approved biologic for treating cancer but is frequently used off-label to treat conditions of the eye, including CRVO. Bevacizumab is a less expensive anti-VEGF drug as compared to aflibercept, hence is used mostly as off-labeled therapy.

Among corticosteroid therapy, Ozurdex is used mostly in Retinal vein occlusion management. In June 2009, the US FDA approved it for the treatment of macular edema following BRVO or CRVO. It represents the first injectable, sustained-release, potent steroid implant that provides prolonged efficacy and a favorable safety profile.

Retinal vein occlusion Epidemiology

The disease epidemiology covered in the report provides historical as well as forecasted epidemiology segmented by Total Prevalent Cases of Retinal vein occlusion, Total Diagnosed Prevalent Cases of Retinal vein occlusion, Gender-specific Diagnosed Prevalent Cases of Retinal vein occlusion, Age-specific Diagnosed Prevalent Cases of Retinal vein occlusion, and Type-specific Diagnosed Prevalent Cases of Retinal vein occlusion scenario of Retinal vein occlusion in the 7MM covering the United States, EU5 countries (Germany, France, Italy, Spain, and the United Kingdom) and Japan from 2019 to 2032.

Key Findings

• In the year 2021, the total prevalent cases of Retinal vein occlusion were approximately 2,708,118 cases in the 7MM, which are expected to increase by 2032 at the CAGR of 1.0% during the study period (2019-2032).
• Among EU-5 countries, the highest number of prevalent cases of Retinal vein occlusion were in Germany, (approximately 225,397 cases), in the year 2021, which are expected to increase by 2032. The lowest number of cases were observed in Spain.
• In 2021, the total diagnosed prevalent cases of Retinal vein occlusion in the 7MM were approximately 1,518,208 cases, which are estimated to increase by 2032.
• In the 7MM, total gender-specific diagnosed prevalent cases of Retinal vein occlusion were approximately 715,167 cases for males and 803,041 cases for females in the year 2021. As per the analysis, these cases are expected to increase by the year 2032.
• Retinal vein occlusion is more frequent in the older age population. The age-specific diagnosed prevalent cases in the 7MM were approximately 454,378, 572,552, and 491,279 cases for the age group less than 65 years, 65-74 years, and ≥75 years, in 2021.
• In the 7MM, total type-specific diagnosed prevalent cases of Retinal vein occlusion were approximately 298,789 cases for CRVO and approximately 1,219,419 cases for BRVO in the year 2021. As per the analysis, these cases are expected to increase by the year 2032.

Retinal vein occlusion Epidemiology

The epidemiology segment also provides the Retinal vein occlusion epidemiology data and findings across the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan.

Retinal vein occlusion Drug Chapters

The drug chapter segment of the Retinal vein occlusion report encloses the detailed analysis of Retinal vein occlusion marketed drugs, mid-phase, and late-stage pipeline drugs. It also helps to understand the Retinal vein occlusion clinical trial details, expressive pharmacological action, agreements and collaborations, approval, and patent details of each included drug, and the latest news and press releases.

Retinal vein occlusion Marketed Drugs
Lucentis (ranibizumab): Roche
Lucentis developed by Roche is a recombinant humanized IgG1 kappa isotype monoclonal antibody fragment designed for intraocular use which binds to and inhibits the biological activity of human VEGF-A. It binds with high affinity to the VEGF-A isoforms (e.g. VEGF110, VEGF121, and VEGF165), thereby preventing the binding of VEGF-A to its receptors VEGFR-1 and VEGFR-2. VEGF-A is a protein that has a critical role in angiogenesis and the hyperpermeability of the vessels.

The drug is a prescription medication given by injection into the eye. It has been associated with a detached retina and serious eye infection and should not be used in patients who have an infection in or around the eye. It was first approved by the US FDA for the treatment of wet-AMD in 2006. Besides Retinal vein occlusion it is also approved for diabetic macular edema, diabetic retinopathy in patients with diabetic macular edema, and myopic choroidal neovascularization
Product's detail in the report…
Ozurdex (dexamethasone): AbbVie
Ozurdex developed by Allergan (now acquired by AbbVie) is the first injectable, sustained-release, potent steroid implant with a prolonged efficacy and a favorable safety profile. It is a dissolving implant that is injected directly into the vitreous humor of the eye to treat swelling that may occur when there is a blockage of certain blood vessels in the eyes. Ozurdex contains dexamethasone in the Novadur solid polymer sustained-release drug delivery system and is preloaded into a single-use, DDS applicator to facilitate direct injection of the implant into the vitreous. The Novadur system contains poly (D, L-lactide-co-glycolide) PLGA intravitreal polymer matrix without any preservative. It is also approved for the treatment of non-infectious posterior uveitis and diabetic macular edema.

Product's detail in the report…
List of products to be continued in the report…

Retinal vein occlusion Emerging Drugs

KSI-301: Kodiak Sciences
KSI-301, an intravitreal injection being developed by Kodiak Sciences Inc., is a novel anti-VEGF biologic designed to have an extended ocular half-life. It consists of a custom-built antibody inhibiting VEGF, a potent cytokine known to contribute to the pathology of retinal vascular diseases, conjugated with a phosphorylcholine biopolymer. The drug is designed to maintain potent and effective drug levels in ocular tissues for longer than the existing agents and is based on the Antibody Biopolymer Conjugate (ABC) Platform. Kodiak Sciences is currently conducting a Phase III BEACON study of KSI-301 in individuals with macular edema due to treatment-naïve Retinal vein occlusion. These studies are anticipated to form the basis of the company's initial BLA to support potential approval and commercialization. The results of the BEACON study are anticipated to be announced in 2022.

Product's detail in the report…
Vabysmo (faricimab): Roche/Chugai Pharmaceuticals
Vabysmo (faricimab) being developed by Roche is a bispecific antibody developed with CrossMab technology to tightly bind VEGF-A on one arm and angiopoietin (Ang)-2 on the other arm, targeting two distinct pathways that drive several retinal conditions. Ang-2 and VEGF-A contribute to vision loss by destabilizing blood vessels, causing new leaky blood vessels to form and increasing inflammation. By inhibiting VEGF-A, faricimab suppresses endothelial cell proliferation, neovascularization, and vascular permeability. By inhibiting Ang-2, faricimab is thought to promote vascular stability and desensitize blood vessels to the effects of VEGF-A. Therefore by simultaneously blocking both pathways involving Ang-2 and VEGF-A, faricimab stabilizes blood vessels, potentially improving vision outcomes for longer for people living with retinal conditions. Roche is currently conducting Phase III trials to evaluate the efficacy and safety of Faricimab in patients with macular edema secondary to BRVO and CRVO and based on its results is expected to file for approval by 2023.

Product's detail in the report…
TLC399 (ProDex): Taiwan Liposome Company
TLC399 is a multilamellar and multivesicular proprietary BioSeizer formulation of dexamethasone sodium phosphate (DSP), intended as an intravitreal, or in-eye, injection for the treatment of macular edema due to retinal vein occlusion. TLC399 in preclinical models has been shown to provide therapeutic levels of DSP in the eye for at least 6 months after a single administration and has also demonstrated its potential to decrease the thickness of the retina and improve vision. TLC399 through its sustained release technology will provide benefits for a much longer duration at reduced administration frequency. In the phase, I/II safety trial the formulation demonstrated an effective reduction in retinal central subfield thickness and improvements in visual acuity. Successful Phase II trial results were published and a further update is awaited. The company is also evaluating the opportunities to develop TLC399 in diabetic macular edema in combination with intravitreal anti-VEGF drugs.

Product's detail in the report…
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Retinal vein occlusion Market Outlook

The current treatment options for Retinal vein occlusion intend to minimize the damage, as there is no treatment to improve vision loss in the long term. The therapies aim to prevent further visual loss and its complications, such as macular edema, ischemia, or neovascularization.

The mainstay treatment for Retinal vein occlusion includes intravitreal injection of anti-VEGF drugs. These drugs target VEGF, an important growth factor that causes macular edema. Intravitreal injection of corticosteroid drugs is to combat inflammation and edema. Intraocular injections of steroids are another potential treatment for eyes that do not respond to anti-VEGF drugs. While intraocular steroids can have some side effects such as an increase in eye pressure and cataract progression, in most cases, these side effects can be controlled.

Laser treatment may be used along with anti-VEGF therapy in hard-to-treat cases. Laser therapy for macular edema involves applying light laser pulses to the macula in a grid pattern. Pan-retinal photocoagulation therapy is a treatment option used when patients have new blood vessel formation following the Retinal vein occlusion. While Focal laser therapy is used to treat associated edema. Several other treatment strategies focus on the surgical treatment of the occluded retinal vein. Some of the approaches include radial optic neurotomy, chorioretinal venous anastomosis, vitrectomy with or without internal limiting membrane peeling, and others.

Currently, there are only three FDA-approved products for Retinal vein occlusion treatment, including Lucentis (ranibizumab, Roche), Eylea (aflibercept, Regeneron), Ozurdex (dexamethasone intravitreal implant, AbbVie) while Avastin (bevacizumab) and intravitreal triamcinolone are used as an off-label therapy that help in maintaining or improving the vision.

Apart from the approved and off-label therapies, various emerging therapies are being evaluated in clinical trials for the treatment of Retinal vein occlusion and its types. The emerging therapies include ONS-5010/Lytenava (Outlook Therapeutics), KSI-301 (Kodiak Sciences), TLC399/ProDex (Taiwan Liposome Company), AR-1105 (Aerie Pharmaceuticals), and GB-102 (Graybug Vision), and Vabysmo (faricimab/RG7716) (Roche/ Chugai Pharmaceutical). However, most of these are being developed for associated complications of macular edema secondary to Retinal vein occlusion except ONS-5010/Lytenava. Also, most in the pipeline have anti-VEGF agonist mechanisms of action or are corticosteroids, and hence they will be competing with the other already approved therapies of this type. However, Roche's Vabysmo (faricimab/RG7716) targeting two distinct pathways and with expected approval by 2024 may get an early mover advantage over others in the category.

According to the publisher, the overall dynamics of the Retinal vein occlusion market are anticipated to change in the coming years owing to the expected launch of emerging therapies.

Key Findings

• The market size of Retinal vein occlusion in seven major markets was USD 2,378.1 million in 2021, which is further expected to increase by 2032 at a Compound Annual Growth Rate (CAGR) of 5.8% for the study period (2019-2032).
• The expected launch of potential therapies may increase market size in the coming years, assisted by an increase in the prevalent population of Retinal vein occlusion.
• Upcoming therapies such as KSI-301, Vabysmo, ONS-5010, and others have the potential to create a significant positive shift in the Retinal vein occlusion market size.
• The United States accounts for the largest market size of Retinal vein occlusion, in comparison to EU5 (Germany, Italy, France, Spain, and the United Kingdom) and Japan.
• Among the EU5 countries, Germany had the highest market size with USD 141.0 million in 2021.

The United States Market Outlook

This section provides the total Retinal vein occlusion market size and market size by therapies in the United States.

EU-5 Market Outlook

The total Retinal vein occlusion market size and market size by therapies in Germany, France, Italy, Spain, and the United Kingdom are provided in this section.

Japan Market Outlook

The total Retinal vein occlusion market size and market size by therapies in Japan are provided.

Retinal vein occlusion Drugs Uptake

This section focuses on the rate of uptake of the potential drugs recently launched in the Retinal vein occlusion market or expected to get launched in the market during the study period 2019-2032. The analysis covers the Retinal vein occlusion market uptake by drugs; patient uptake by therapies; and sales of each drug.

This helps in understanding the drugs with the most rapid uptake, and reasons behind the maximal use of new drugs and allows, the comparison of the drugs based on market share and size which again will be useful in investigating factors important in market uptake and in making financial and regulatory decisions.

Retinal vein occlusion Development Activities

The report provides insights into different therapeutic candidates in phase II, and phase III stages and also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers detailed information on collaborations, acquisitions, and mergers, licensing, and patent details for Retinal vein occlusion emerging therapies.

Reimbursement Scenario in Retinal vein occlusion

Approaching reimbursement proactively can have a positive impact both during the late stages of product development and well after product launch. In the report, we consider reimbursement to identify economically attractive indications and market opportunities. When working with finite resources, the ability to select the markets with the fewest reimbursement barriers can be a critical business and price strategy.

Competitive Intelligence Analysis

The publisher performs competitively and market Intelligence analysis of the Retinal vein occlusion market by using various competitive intelligence tools that include-SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies, etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers the descriptive overview of Retinal vein occlusion, explaining its etiology, signs and symptoms, pathophysiology, genetic basis, and currently available therapies.
• Comprehensive insight has been provided into the Retinal vein occlusion epidemiology and treatment.
• Additionally, an all-inclusive account of both the current and emerging therapies for Retinal vein occlusion is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of the Retinal vein occlusion market; historical and forecasted is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the 7MM Retinal vein occlusion market.

Report Highlights

• The robust pipeline with novel MOA and topical ROA and increasing prevalence will positively drive the Retinal vein occlusion market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Retinal vein occlusion R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Retinal vein occlusion. The launch of emerging therapies will significantly impact the Retinal vein occlusion market.
• Our in-depth analysis of the pipeline assets across different stages of development (phase III and phase II), different emerging trends, and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Retinal vein occlusion Report Insights

• Patient Population
• Therapeutic Approaches
• Retinal vein occlusion Pipeline Analysis
• Retinal vein occlusion Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Retinal vein occlusion Report Key Strengths

• 11-Years Forecast
• The 7MM Coverage
• Retinal vein occlusion Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Retinal vein occlusion Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers
• SWOT analysis

Key Questions

Market Insights:

• What was the Retinal vein occlusion market share (%) distribution in 2019 and how it would look like in 2032?
• What would be the Retinal vein occlusion total market size as well as market size by therapies across the 7MM during the forecast period (2022-2032)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Retinal vein occlusion market size during the forecast period (2022-2032)?
• At what CAGR, the Retinal vein occlusion market is expected to grow at the 7MM level during the forecast period (2022-2032)?
• What would be the Retinal vein occlusion market outlook across the 7MM during the forecast period (2022-2032)?
• What would be the Retinal vein occlusion market growth till 2032 and what will be the resultant market size in the year 2032?
• How would the market drivers, barriers, and future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights:

• What is the disease risk, burden, and unmet needs of Retinal vein occlusion?
• What is the historical Retinal vein occlusion patient pool in the United States, EU5 (Germany, France, Italy, Spain, and the UK), and Japan?
• What would be the forecasted patient pool of Retinal vein occlusion at the 7MM level?
• What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Retinal vein occlusion?
• Out of the above-mentioned countries, which country would have the highest prevalent population of Retinal vein occlusion during the forecast period (2022-2032)?
• At what CAGR the population is expected to grow across the 7MM during the forecast period (2022-2032)?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies:

• What are the current options for the treatment of Retinal vein occlusion along with the approved therapy?
• What are the current treatment guidelines for the treatment of Retinal vein occlusion in the US and Europe?
• What are the Retinal vein occlusion marketed drugs and their MOA, regulatory milestones, product development activities, advantages, disadvantages, safety, and efficacy, etc.?
• How many companies are developing therapies for the treatment of Retinal vein occlusion?
• How many emerging therapies are in the mid-stage and late stages of development for the treatment of Retinal vein occlusion?
• What are the key collaborations (Industry-Industry, Industry-Academia), Mergers and acquisitions, and licensing activities related to the Retinal vein occlusion therapies?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Retinal vein occlusion and their status?
• What are the key designations that have been granted for the emerging therapies for Retinal vein occlusion?
• What are the 7MM historical and forecasted market of Retinal vein occlusion?

Reasons to Buy

• The report will help in developing business strategies by understanding trends shaping and driving Retinal vein occlusion.
• To understand the future market competition in the Retinal vein occlusion market and an Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Retinal vein occlusion in the US, Europe (Germany, Spain, Italy, France, and the United Kingdom), and Japan.
• Identification of strong upcoming players in the market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for the Retinal vein occlusion market.
• To understand the future market competition in the Retinal vein occlusion market.