Retinal Vein Occlusion - Market Insight, Epidemiology and Market Forecast - 2034

The total Retinal Vein Occlusion market size in the 7MM was approximately USD 2.29 billion in 2022 and is projected to increase during the forecast period (2023-2034).

This report delivers an in-depth understanding of Retinal Vein Occlusion, historical and forecasted epidemiology, as well as the Retinal Vein Occlusion market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Retinal Vein Occlusion market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Retinal Vein Occlusion market size from 2020 to 2034. The report also covers Retinal Vein Occlusion treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Key Highlights

• The Retinal Vein Occlusion market size in the US was approximately USD 1.61 billion in 2022, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The Retinal Vein Occlusion market size in the EU4 and the UK was calculated to be approximately USD 453.9 million in 2022, which was nearly 20% of the total market revenue for the 7MM.
• In 2022, Japan with a revenue of approximately USD 231.7 million, accounted for the second-highest market size of Retinal Vein Occlusion among the 7MM, which is expected to increase significantly by 2034.
• The Retinal Vein Occlusion prevalence has been increasing due to the increase in the geriatric population and the surge in awareness about eye disorders.
• With the growing geriatric population, the disease prevalence is increasing, and so is disease awareness. There have been significant improvements in disease diagnosis, which is projected to improve further with technological advancements. The increasing prevalence of diabetes and other lifestyle conditions are major factors for the increasing implication of Retinal Vein Occlusion.
• The current treatment for Retinal Vein Occlusion includes the use of anti-VEGFs, corticosteroids, laser therapy, and several other off-labeled therapies. Intravitreal steroids and anti-VEGFs are used in cases of macular perfusion and macular ischemia, while, laser use is mostly in situations of neovascularization, and hard-to-treat cases with other therapies.
• Few drugs are approved by the US FDA for the treatment of Retinal Vein Occlusion, which include LUCENTIS (ranibizumab, Roche/Novartis), EYLEA (aflibercept, Regeneron Pharmaceutical/Bayer/Santen), OZURDEX (dexamethasone intravitreal implant, AbbVie), and the recently approved VABYSMO (faricimab, Roche/Chugai Pharmaceutical). Even AVASTIN (bevacizumab) and intravitreal triamcinolone are used as off-label therapies that help maintain or improve vision.
• The current treatment options only intend to minimize the damage, as there is no treatment to improve vision loss in the long term. The therapy aims to prevent further visual loss and deterioration due to complications, such as macular edema, ischemia, or neovascularization. However, most of the approved drugs are not effective in visual restoration and are not able to directly dissolve the blockage that causes the vein occlusion.
• The available treatment regime is as restrictive as it was a decade ago. It is long-term, and patients become non-compliant due to problematic treatment schedules, frequent visits to the doctor, high treatment costs, etc. A new effective therapy with a longer duration of action that can treat the actual cause of the disease, stop further progression, and potentially eliminate the need for long-term maintenance therapy is urgently needed.
• Retinal Vein Occlusion is the second most common retinal vascular disease after diabetic retinopathy. If left untreated, it typically leads to progressive deterioration of vision leading to permanent blindness. It is one of the most common causes of vision loss worldwide, and impaired vision affects quality of life and daily living.
• In 2022, the US had the largest market size of Retinal Vein Occlusion among the 7MM, accounting for approximately USD 1.61 billion. This is expected to increase further by 2034.
• Among the currently used anti-VEGF therapies, the majority of the market share was of EYLEA (aflibercept), with USD 852.9 million in 2022, in the 7MM. Competitive inroads by Regeneron’s EYLEA in the Retinal Vein Occlusion treatment landscape changed the market once dominated by Roche. With many anti-VEGF molecules losing their patent and the entry of biosimilars, the market dynamics are projected to witness some change.
• VABYSMO (faricimab) by Roche was recently approved in 2023 by the US FDA for Retinal Vein Occlusion. With improved dosing, and improvements in vision loss owing to a novel mode of action, in VABYSMO, Roche has found an excellent replacement for LUCENTIS, which lost its patent exclusivity and is losing its market shine. It will help Roche regain the lost market from Regeneron, and the drug is projected to generate significant revenue by 2034, in the US.
• Significant increases in research and development, a better understanding of the disease, and technological advancements have helped broaden clinical knowledge. Ongoing research has led to the discovery of potential therapies that aim to address unmet needs. Emerging therapies like Kodiak Sciences’ tarcocimab tedromer (KSI-301) and Outlook Therapeutics’ LYTENAVA (bevacizumab)/ONS-5010), are in late-stage development and are projected to enter the market during the forecast period, leading to the entry of new players in the treatment landscape.
• In addition to these emerging performers, there are a few early-stage drugs worth mentioning like ANXV by Annexin Pharmaceuticals, Autologous Bone Marrow CD34+ Stem Cells by The Emmes Company, and EYP-1901 (vorolanib) by EyePoint Pharmaceuticals which can change the entire market scenario if approved as they may provide the much-needed cure for Retinal Vein Occlusion.
• Tarcocimab tedromer (KSI-301) being developed by Kodiak Sciences, with enhanced therapeutic absorption and distribution in the eye and a novel design will maintain effective drug levels in ocular tissues for a longer period than the existing anti-VEGF agents. It will give tough competition to other similar therapies, upon its entry in the year 2027, in the US.
• LYTENAVA (bevacizumab)/ONS-5010, an investigational ophthalmic formulation of bevacizumab, is projected to be the first and only FDA-approved, on-label, responsibly priced bevacizumab for ophthalmic indication, is anticipated to generate a market share of USD 2.3 million in the first year of its launch (2027), in the US. It will not only dismiss AVASTIN in the Retinal Vein Occlusion space but will create significant trouble for other anti-VEGFs.
• However, the loss of patent exclusivity and the simultaneous approval of biosimilars, like BYOOVIZ (ranibizumab) co-developed by Samsung Bioepis and Biogen, ONGAVIA developed by Teva Pharmaceuticals, etc will create a wide sink in the already restricted market space, and this will also pose significant hurdles in market entry of emerging therapies.

Geographies Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020 to 2034

Forecast Period: 2024 to 2034

Retinal Vein Occlusion Market Size: USD 2.29 billion in 2022

Retinal Vein Occlusion Companies: AbbVie, Roche, Regeneron Pharmaceuticals, Taiwan Liposome Company, Aerie Pharmaceuticals, Graybug Vision, Outlook Therapeutics, Kodiak Sciences Inc, Chugai Pharmaceuticals, and others

Retinal Vein Occlusion Overview

Retinal Vein Occlusion, the second most common sight-threatening retinal vascular disorder after diabetic retinopathy, is characterized by blockage of the small veins that carry blood away from the retina. A degenerative disease often initiated by atherosclerosis and the formation of a blood clot, it is characterized by sudden vision change. However, the degree of vision change depends on the severity and location of the blockage. With blockage, pressure builds up in the capillaries, leading to hemorrhage and leakage of fluid and blood; this can lead to macular edema with leakage near the macula.

Risk factors include systemic conditions like hypertension, arteriosclerosis, diabetes mellitus, hyperlipidemia, cerebral vascular stroke, blood hyperviscosity, and thrombophilia. Individuals with end-organ damage have a substantially increased risk for Retinal Vein Occlusion. Ophthalmic risk factors 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 RVO (when only one of the macular venules is occluded).

Retinal Vein Occlusion is one of the most frequently occurring retinal vascular disorders in elderly patients that develops predominantly in individuals over age 65 years. Thus the most recognized risk factors for Retinal Vein Occlusion are age and systemic vascular disorders, with age being a key determinant in its intensity of progression. With an increase in the geriatric population, the prevalence is also projected to increase.

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 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. Optical coherence tomography angiography (OCTA) provides a non-invasive way to assess the extent of impaired capillary perfusion in retinal vascular occlusion without injection of contrast dye. Fundus autofluorescence can be perceived, in patients with recent-onset CRVO, a perivenular hypo autofluorescence with a fern-like appearance.

Retinal Vein Occlusion Treatment

The main goal of the treatment is to stabilize vision by sealing off leaking blood vessels and to manage complications of macular edema and neovascularization. Response to treatment is measured by improvement of visual acuity (as a measure of photoreceptor status) and retinal thickness (as a measure of leakage. The current treatment regime for Retinal Vein Occlusion includes the use of anti-VEGFs, corticosteroids, laser therapy, and several other off-labeled therapies.

Unfortunately, no treatment can reverse Retinal Vein Occlusion, though attempts have been made to create anastomoses through surgery and laser, to relieve the obstruction through thrombolytic administration and bypass the congestion via optic nerve sheathotomy.

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 RVO. 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, few products are approved by the US FDA for the treatment of Retinal Vein Occlusion, which includes LUCENTIS (ranibizumab, Roche/Novartis), EYLEA (aflibercept, Regeneron Pharmaceutical/Bayer/Santen), OZURDEX (dexamethasone intravitreal implant, AbbVie), besides the recently approved VABYSMO (faricimab, Roche/Chugai Pharmaceutical). AVASTIN (bevacizumab) and intravitreal triamcinolone are used as off-label therapies that help in maintaining or improving vision.

Retinal Vein Occlusion Epidemiology

As the market is derived using a patient-based model, the Retinal Vein Occlusion epidemiology chapter 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 in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

• In the 7MM, the total Retinal Vein Occlusion prevalent cases were estimated to be approximately 2,718,067 in 2022, of which the US accounted for around 57%, while EU4 and the UK accounted for nearly 30%, and Japan accounted for approximately 13% of the total prevalent cases. These cases are expected to increase by 2034.
• Among the 7MM, the US accounted for nearly 61% of the total diagnosed prevalent cases of Retinal Vein Occlusion, with nearly 935,343 cases in 2022. These cases are expected to increase during the study period (2020-2034).
• As per analysis, EU4 and the UK accounted for around 408,086 diagnosed prevalent cases of Retinal Vein Occlusion in 2022. These cases are expected to change during the study period (2020-2034).
• Among the EU4 and the UK, Germany accounted for the highest diagnosed prevalent cases of Retinal Vein Occlusion, representing nearly 28% of the cases, followed by Italy and France, while Spain had the least cases in 2022.
• According to estimates based on the epidemiology model, Retinal Vein Occlusion exhibits a higher female preponderance than males in the US. Of the total diagnosed prevalent cases in the US, nearly 48% were males and 52% were females, in 2022.
• In the US, the highest age-specific diagnosed prevalent cases of Retinal Vein Occlusion were for the age group 65-74 years, with nearly 334,051 cases, in 2022. As per the analysis, these cases are expected to increase, and the age group 65-74 years will contribute around 36% of the diagnosed prevalent cases, while the age groups <65 and =75 years will contribute 33% and 31%, respectively, by 2034.
• In 2022, among the 7MM, Japan had the second-highest cases of Retinal Vein Occlusion, contributing approximately 12% to the total diagnosed prevalent cases of Retinal Vein Occlusion.
• As per the epidemiology model, Retinal Vein Occlusion is classified into BRVO and CRVO. In 2022, of the total diagnosed Retinal Vein Occlusion cases, nearly 39,620 cases were classified as CRVO, while 139,612 cases were classified as BRVO, in Japan.

Retinal Vein Occlusion Drug Chapters

The drug chapter segment of the Retinal Vein Occlusion report encloses a detailed analysis of Retinal Vein Occlusion-marketed drugs and mid to late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the Retinal Vein Occlusion clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Retinal Vein Occlusion Drugs

VABYSMO (faricimab): Roche/Chugai Pharmaceutical

VABYSMO (faricimab) is a humanized bispecific immunoglobulin G1 (IgG1) antibody that binds both vascular endothelial growth factor A (VEGF-A) and angiopoietin-2 (Ang-2). The fragment crystallizable (Fc) region of faricimab was engineered by selected point mutations to abolish binding interactions with Fc? and FcRn receptors. Faricimab is a humanized bispecific antibody that acts through the inhibition of two pathways by binding to VEGF-A and Ang-2. 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. In October 2023, the US FDA approved VABYSMO (faricimab) for the treatment of macular edema following Retinal Vein Occlusion.

LUCENTIS (ranibizumab): Roche/Novartis

LUCENTIS (ranibizumab) 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. Ranibizumab binds to the receptor-binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. In August 2013, LUCENTIS was approved in Japan for the treatment of choroidal neovascularization in pathological myopia and macular edema associated with Retinal Vein Occlusion. In June 2011, the EMA approved LUCENTIS as a treatment for patients with visual impairment due to macular edema secondary to Retinal Vein Occlusion. In June 2010, the US FDA approved LUCENTIS for the treatment of macular edema secondary to Retinal Vein Occlusion.

EYLEA (aflibercept): Regeneron Pharmaceutical/Bayer/Santen

EYLEA (aflibercept) developed by Regeneron is a recombinant fusion protein consisting of portions of human VEGF 1 and VEGF 2 extracellular domains fused to the Fc portion of human IgG1 formulated as an iso-osmotic solution for intravitreal administration. Aflibercept is a dimeric glycoprotein produced in recombinant CHO cells. VEGF-A and PlGF are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. In June 2015, Bayer received approval for EYLEA from the MHLW in Japan for the treatment of patients with macular edema secondary to Retinal Vein Occlusion. In February 2015, the EC agreed to expand the indication for EYLEA to include macular edema secondary to BRVO, and in August 2013 for macular edema secondary to CRVO. In October 2014, the FDA approved EYLEA for the treatment of macular edema following Retinal Vein Occlusion.

OZURDEX (dexamethasone intravitreal implant): AbbVie

OZURDEX (dexamethasone intravitreal implant) developed by Allergan (now acquired by AbbVie) is an 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. In July 2010, EMA approved OZURDEX, the first treatment authorized in Europe for the treatment of macular edema due to Retinal Vein Occlusion, while in June 2009, was approved by the US FDA.

Emerging Retinal Vein Occlusion Drugs

Tarcocimab tedromer (KSI-301): Kodiak Sciences

Tarcocimab tedromer (KSI-301), an intravitreal injection being developed by Kodiak Sciences, 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 platform.

Kodiak Sciences has completed the Phase III BEACON study of KSI-301 in individuals with visual impairment due to treatment-naïve macular edema secondary to Retinal Vein Occlusion and plans to conduct one additional pivotal study in the first half of 2024, which, if successful, will serve as the basis for a BLA for macular edema following Retinal Vein Occlusion.

LYTENAVA (bevacizumab)/ONS-5010: Outlook Therapeutics

LYTENAVA (bevacizumab)/ONS-5010 is an investigational ophthalmic formulation of bevacizumab to be administered as an intravitreal injection. Bevacizumab is a recombinant humanized monoclonal antibody that selectively binds with high affinity to all isoforms of human VEGF and neutralizes VEGF’s biological activity through a steric blocking of the binding of VEGF to its receptors Flt-1 (VEGFR-1) and KDR (VEGFR-2) on the surface of endothelial cells.

Outlook Therapeutics has completed a Phase III trial to evaluate the safety of ophthalmic bevacizumab in subjects diagnosed with BRVO and is conducting another Phase III trial to compare the safety of ophthalmic bevacizumab in vials versus prefilled syringes in subjects with BRVO. Besides this, Outlook Therapeutics intends to initiate NORSE FOUR, a registration clinical trial that will evaluate ONS-5010 for use in treating BRVO. Further, the company has received agreement from the FDA on the protocols for NORSE FOUR.

Retinal Vein Occlusion Drug Class Insights

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. Anti-VEGF drugs are markedly more effective in the treatment of Retinal Vein Occlusion than any other treatment modality. Among all the available treatment choices, anti-VEGF drugs provide the greatest improvement in VA.

Intravitreal injection of corticosteroid drugs is to combat inflammation and edema. Corticosteroids have anti-inflammatory, antiangiogenic, and anti-permeability properties that make them an attractive therapeutic option for a variety of posterior segment diseases. The rationale for using a steroidal drug for the treatment of edematous and proliferative diseases is that abnormal proliferation of cells is often associated with and triggered by inflammation. Moreover, intraretinal accumulation of fluid is usually accompanied by a blood-retinal barrier dysfunction that can be restored with steroid therapy.

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.

LUCENTIS (ranibizumab), developed by Roche and marketed by Novartis and Chugai Pharmaceuticals in North America and Japan, respectively, is a VEGF inhibitor. Ranibizumab binds to the receptor-binding site of active forms of VEGF-A, including the biologically active, cleaved form of this molecule, VEGF110. VEGF-A causes neovascularization and leakage in models of ocular angiogenesis and vascular occlusion and contributes to the pathophysiology of wet AMD, mCNV, DR, DME, and macular edema following Retinal Vein Occlusion. The binding of ranibizumab to VEGF-A prevents the interaction of VEGF-A with its receptors (VEGFR1 and VEGFR2) on the surface of endothelial cells, reducing endothelial cell proliferation, vascular leakage, and new blood vessel formation.

Another drug EYLEA (aflibercept) developed by Regeneron was approved by the US FDA in October 2014, for the treatment of macular edema following Retinal Vein Occlusion. VEGF-A and PlGF are members of the VEGF family of angiogenic factors that can act as mitogenic, chemotactic, and vascular permeability factors for endothelial cells. VEGF acts via two receptor tyrosine kinases, VEGFR-1 and VEGFR-2, present on the surface of endothelial cells. PlGF binds only to VEGFR-1, which is also present on the surface of leucocytes. Activation of these receptors by VEGF-A can result in neovascularization and vascular permeability. Aflibercept acts as a soluble decoy receptor that binds VEGF-A and PlGF and thereby can inhibit the binding and activation of these cognate VEGF receptors.

Recently in 2023, VABYSMO, a faricimab, developed by Roche and Chugai with CrossMab technology targets two distinct pathways. Faricimab is a humanized bispecific antibody that acts through the inhibition of two pathways by binding to VEGF-A and Ang-2. 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. Ang-2 levels are increased in some patients with nAMD, DME, and Retinal Vein Occlusion.

OZURDEX, a dexamethasone intravitreal implant, developed by Allergan (now acquired by AbbVie) is an injectable, sustained-release, potent steroid implant for the treatment of macular edema due to Retinal Vein Occlusion. Dexamethasone, a corticosteroid, suppresses inflammation by inhibiting multiple inflammatory cytokines resulting in decreased edema, fibrin deposition, capillary leakage, and migration of inflammatory cells. It majorly blocks the production of VEGF and prostaglandins, which are involved in inflammation.

Retinal Vein Occlusion Market Outlook

Retinal Vein Occlusion is a common vascular disorder of the retina and one of the most common causes of vision loss worldwide. It is the second most common cause of blindness from retinal vascular disease after diabetic retinopathy. There is no treatment available to reverse Retinal Vein Occlusion. Most people with this condition will have permanent changes to their vision. The main goal of the treatment should be to stabilize vision by sealing off leaking blood vessels.

Unfortunately, there is no way actually to unblock retinal veins. However, the doctor can treat any health problems that seem to be related to Retinal Vein Occlusion. Vision may come back in some eyes that have had a Retinal Vein Occlusion. About one-third have some improvement, about one-third stay the same, and about one-third gradually improve, but it can take a year or more to learn the outcome. In some cases, the blocked vessels will lead to fluid accumulation in the retina while in others, may cause the formation of new blood vessels.

Currently, there are only few FDA-approved products for Retinal Vein Occlusion treatment, which include LUCENTIS (ranibizumab, Roche/Novartis), EYLEA (aflibercept, Regeneron Pharmaceutical/Bayer/Santen), OZURDEX (dexamethasone intravitreal implant, AbbVie), and the recently US FDA approved VABYSMO (faricimab, Roche/Chugai Pharmaceutical). While AVASTIN (bevacizumab) and intravitreal triamcinolone are used as an off-label therapy that helps in maintaining or improving vision.

LUCENTIS (ranibizumab) is a VEGF inhibitor, which is developed by Roche and marketed by Novartis and Chugai Pharmaceuticals in North America and Japan, respectively. In June 2010, the US FDA approved LUCENTIS (ranibizumab) for the treatment of macular edema following Retinal Vein Occlusion. 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. LUCENTIS is designed to bind to and inhibit VEGF-A, a protein that is believed to play a critical role in angiogenesis and the hyperpermeability of the vessels. Being the first approved VEGF inhibitor for Retinal Vein Occlusion, LUCENTIS enjoyed the pie alone for a long time due to its patent exclusivity, complemented by the piecemeal approval of EYLEA globally.

Another drug EYLEA (aflibercept) developed by Regeneron was approved by the US FDA in October 2014, for the treatment of macular edema following Retinal Vein Occlusion (both BRVO and CRVO). It is also an anti-VEGF inhibitor injection for the eye so designed to block the growth of new blood vessels and decrease vascular permeability in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in angiogenesis. Competitive inroads by Regeneron’s EYLEA in the Retinal Vein Occlusion treatment landscape changed the market once dominated by Roche.

Earlier the debate was only restricted to two of Roche’s star products LUCENTIS and AVASTIN, a cancer drug that was repackaged for doses small enough for use in the eye and much lighter on the pocket than the approved LUCENTIS. However, competitive inroads by Regeneron’s EYLEA since its approval by the US FDA in 2012 for the treatment of macular edema following CRVO has changed a lot for Roche.

However, recently in 2023, VABYSMO (faricimab) developed by Roche and Chugai with CrossMab technology targeting two distinct pathways (VEGF and angiopoietin inhibitor) that drive several retinal conditions received market approval by the US FDA, and is projected to show significant market presence by 2024, after anticipated approvals in Europe and Japan also. With improved dosing, reduced treatment burden, and improvements in vision loss owing to a novel mode of action, in VABYSMO, Roche has found an excellent replacement for LUCENTIS which loses its patent exclusivity and market shine.

In addition to this, the US FDA approved OZURDEX (dexamethasone intravitreal implant) in June 2009 for the treatment of macular edema following BRVO or CRVO. The drug is administered intravitreally. This lone approved drug in the separate corticosteroid niche with no significant competitor has secured for itself a significant place in the competitive Retinal Vein Occlusion market space. With a patent exclusivity till 2023, this second-line therapy for eyes with chronic edema that is poorly responsive to anti-VEGF injections has not much to fear. However off-label intravitreal triamcinolone cuts into this exclusive space with not much consequence.

Despite these advances in pharmacologic therapy, many eyes with Retinal Vein Occlusion continue to lose vision. The common final pathway appears to be photoreceptor cell death. Future research for Retinal Vein Occlusion treatments may focus on neuroprotective and photoreceptor regeneration therapies to improve sight in patients who have limited vision due to Retinal Vein Occlusion.

Various therapies are being developed and the pipeline for Retinal Vein Occlusion includes therapies like Kodiak Sciences’ tarcocimab tedromer (KSI-301), Outlook Therapeutics’ LYTENAVA (bevacizumab)/ONS-5010, Taiwan Liposome Company’s TLC399 (ProDex), Alcon’s AR-1105 (dexamethasone implant), and others.

The current market segmentation is based on the therapies prescribed and is further sub-segment based on the mechanism of action and their usage. The drugs that are being used in the present market include LUCENTIS (ranibizumab), EYLEA (aflibercept), and AVASTIN (bevacizumab), besides other therapies like OZURDEX (dexamethasone intravitreal implant) and intravitreal triamcinolone, etc. Even the recently US FDA-approved VABYSMO (faricimab) is included. These are the major segments covered in the forecast model.

• Several key players are evaluating their lead candidates in different stages of clinical development like tarcocimab tedromer (KSI-301) and LYTENAVA (bevacizumab)/ONS-5010. They aim to investigate their products to treat macular edema secondary to Retinal Vein Occlusion and BRVO, respectively.
• The total Retinal Vein Occlusion market size in the 7MM was approximately USD 2.29 billion in 2022 and is projected to increase during the forecast period (2023-2034).
• The market size of Retinal Vein Occlusion in the US was approximately USD 1.61 billion in 2022, which is anticipated to increase due to the increasing awareness of the disease and the launch of the emerging therapy.
• The total market size of EU4 and the UK was calculated to be approximately USD 453.9 million in 2022, which was nearly 20% of the total market revenue for the 7MM.
• According to estimates, among EU4 and the UK, Germany accounted for the highest market with approximately USD 127.1 million in 2022, followed by Italy with approximately USD 90.4 million in the respective year, while Spain accounted for the lowest market in 2022.
• According to analysis, in the US, among the currently used therapies, the majority of the market share was of EYLEA (aflibercept), with a revenue of approximately USD 629.5 million, in 2022, followed by other therapies that include OZURDEX, triamcinolone, etc.
• VABYSMO (faricimab) by Roche with CrossMab technology targeting two distinct pathways (VEGF and angiopoietin inhibitor) that drive several retinal conditions was recently approved in 2023 by the US FDA for Retinal Vein Occlusion. With improved dosing, reduced treatment burden, and improvements in vision loss owing to a novel mode of action, in VABYSMO, Roche has found an excellent replacement for LUCENTIS which lost its patent exclusivity and market shine. It will help Roche regain the lost market from Regeneron, and the drug is projected to capture nearly 21% of the total Retinal Vein Occlusion market, in the US, by 2034.
• In 2022, Japan with a revenue of approximately USD 231.7 million, accounted for the second-highest market size of Retinal Vein Occlusion among the 7MM, which is expected to increase significantly by 2034.
• Among the emerging therapies, tarcocimab tedromer (KSI-301) being developed by Kodiak Sciences, with enhanced therapeutic absorption and distribution in the eye and a novel design, will give tough competition to other similar therapies, upon its entry in the year 2027, and with a medium-fast uptake, is predicted to attain its peak by 6th year, in the US.
• LYTENAVA (bevacizumab)/ONS-5010, an investigational ophthalmic formulation of bevacizumab, is projected to be the first approved, on-label, responsibly priced bevacizumab for ophthalmic indication, and is anticipated to generate a market share of USD 1.5 million in its launch year (2028), in EU4 and the UK. It is projected to not only dismiss AVASTIN in the Retinal Vein Occlusion space but will create significant trouble for other anti-VEGFs.

Retinal Vein Occlusion Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2020-2034. For example, Outlook Therapeutics’ LYTENAVA (bevacizumab)/ONS-5010, an investigational ophthalmic formulation of bevacizumab, is projected to be the first and only FDA-approved, on-label, responsibly priced bevacizumab, with a slow-medium uptake, will enter the US market in 2027.

Retinal Vein Occlusion Pipeline Development Activities

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

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for emerging therapies for Retinal Vein Occlusion.

KOL Views on Evolving Retinal Vein Occlusion Market

To keep up with current market trends, we take KOLs and SMEs’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on Retinal Vein Occlusion evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/scientific writers, Medical Professionals, Professors, Directors, and Others.

The analysts connected with 50+ KOLs to gather insights; however, interviews were conducted with 15+ KOLs in the 7MM. Centers like the Royal College of Ophthalmologists, Johns Hopkins University School of Medicine, Charité University Medicine Berlin, Italian College of General Practitioners, University of Leicester, and the Kanagawa Children’s Medical Center were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Retinal Vein Occlusion market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Physician’s View on Highly Dynamic Retinal Vein Occlusion Market

According to our primary research analysis, various anti-VEGF therapies, are available in the market and prescribed. Anti-VEGF drugs are markedly more effective in the treatment of Retinal Vein Occlusion than any other treatment modality. Among all the available treatment choices, anti-VEGF drugs provide the greatest improvement in visual acuity. The current treatment choices for Retinal Vein Occlusion include anti-VEGF drugs, corticosteroids, laser therapy, and others. The anti-VEGF drugs include AVASTIN (bevacizumab), LUCENTIS (ranibizumab), EYLEA (aflibercept), and the recently US FDA-approved VABYSMO (faricimab), for the treatment of Retinal Vein Occlusion. Among these LUCENTIS, and EYLEA have been approved in the US, EU4 the UK, and Japan, but VABYSMO is still not approved in Europe and Japan, while bevacizumab is being used off-label in all countries.

According to a KOL in the US, anti-VEGF injection burden and frequency are lower, and visual outcomes are poorer in the real-world, tertiary care practice setting than in clinical trials that evaluate the monthly administration of injections, which reflects the presence of under treatment outside the controlled trial setting.

As per another KOL, an efficient treatment approach for addressing the underlying etiology of macular edema in Retinal Vein Occlusion is a therapy that suppresses VEGF. As a result, intravitreal anti-VEGF treatment has become the norm for treating this condition. The therapy can improve vision, but patients with significant retinal damage due to impaired blood flow often have poor outcomes.

Another KOL in Germany found that patient characteristics were similar for patients receiving ranibizumab or aflibercept at index. The disease is typically more prevalent in older, hypertensive, and cardiovascular disease individuals and its prevalence increases with age. BRVO is four times more prevalent than CRVO

The current pipeline contains stem cell therapies, tyrosine kinase inhibitors, and several small molecules that target different pathways in Retinal Vein Occlusion. The entry of these drugs will provide different options relating to patient-specific needs based on the type of occlusion and associated edema.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the Analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Conjoint Analysis analyzes multiple emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

In efficacy, the trial’s primary and secondary outcome measures are evaluated; for instance improvement in best-corrected visual acuity (BCVA) and ocular central subfield thickness (CST), and others.

Further, the therapies’ safety is evaluated wherein the adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials, which directly affects the safety of the molecule in the upcoming trials. It sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the route of administration, order of entry and designation, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Retinal Vein Occlusion Market Access and Reimbursement

Reimbursement of rare disease therapies can be limited due to lack of supporting policies and funding, challenges of high prices, lack of specific approaches to evaluating rare disease drugs given limited evidence, and payers’ concerns about budget impact. The high cost of rare disease drugs usually has a limited effect on the budget due to the small number of eligible patients being prescribed the drug. The US FDA has approved several rare disease therapies in recent years. From a patient perspective, health insurance and payer coverage guidelines surrounding rare disease treatments restrict broad access to these treatments, leaving only a small number of patients who can bypass insurance and pay for products independently.

The reimbursement challenges related to medical care and treatment for individuals with Retinal Vein Occlusion can be significant as it often requires specialized medical attention, covering the costs of diagnosis, treatment, and ongoing care. Health insurance plans may not fully cover limited coverage of some medical treatments, therapies, and devices specific to Retinal Vein Occlusion. This can result in high out-of-pocket expenses for families seeking the best care for their loved ones. Moreover, it requires specialized care from healthcare providers with expertise. Finding and accessing such specialists may be challenging, and the associated costs may not always be fully reimbursed by insurance.

The report provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenarios, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of Retinal Vein Occlusion, explaining its causes, signs and symptoms, pathogenesis, and currently available therapies.
• Comprehensive insight into the epidemiology segments and forecasts, the future growth potential of diagnosis rate, disease progression, and treatment guidelines have been provided.
• Additionally, an all-inclusive account of the current and emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current treatment landscape.
• A detailed review of the Retinal Vein Occlusion market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help shape and drive the 7MM Retinal Vein Occlusion market.

Retinal Vein Occlusion Market Report Insights

• Retinal Vein Occlusion Patient Population
• Retinal Vein Occlusion Therapeutic Approaches
• Retinal Vein Occlusion Pipeline Analysis
• Retinal Vein Occlusion Market Size and Trends
• Existing and Future Retinal Vein Occlusion Market Opportunity

Retinal Vein Occlusion Report Key Strengths

• Twelve years Forecast
• The 7MM Coverage
• Retinal Vein Occlusion Epidemiology Segmentation
• Key Cross Competition in the Retinal Vein Occlusion Market
• Attribute analysis

Retinal Vein Occlusion Drugs Uptake and Key Market Forecast Assumptions

• Retinal Vein Occlusion Market Report Assessment
• Current Retinal Vein Occlusion Treatment Practices
• Unmet Needs in the Retinal Vein Occlusion Market
• Retinal Vein Occlusion Pipeline Product Profiles
• Retinal Vein Occlusion Market Attractiveness
• Qualitative Analysis (SWOT and Conjoint Analysis)

Key Questions

Market Insights

• What was the total market size of Retinal Vein Occlusion, the market size of Retinal Vein Occlusion by therapies, and market share (%) distribution in 2020, and what would it look like by 2034? What are the contributing factors for this growth?
• How will VABYSMO (faricimab), tarcocimab tedromer (KSI-301), and LYTENAVA (bevacizumab)/ONS-5010 affect the treatment paradigm of Retinal Vein Occlusion?
• How will EYLEA (aflibercept compete with upcoming products and marketed therapies?
• Which drug is going to be the largest contributor by 2034?
• What are the pricing variations among different geographies for approved and marketed therapies?
• How would future opportunities affect the market dynamics and subsequent analysis of the associated trends?

Epidemiology Insights

• What are the disease risks, burdens, and unmet needs of Retinal Vein Occlusion? What will be the growth opportunities across the 7MM with respect to the patient population pertaining to Retinal Vein Occlusion?
• What is the historical and forecasted Retinal Vein Occlusion patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
• Out of the countries mentioned above, which country would have the highest diagnosed prevalent Retinal Vein Occlusion population during the forecast period (2023-2034)?
• What factors are contributing to the growth of Retinal Vein Occlusion cases?

Current Treatment Scenario, Marketed Drugs, and Emerging Therapies

• What are the current options for the treatment of Retinal Vein Occlusion? What are the current clinical and treatment guidelines for treating Retinal Vein Occlusion?
• How many companies are developing therapies for the treatment of Retinal Vein Occlusion?
• How many emerging therapies are in the mid-stage and late stage of development for treating Retinal Vein Occlusion?
• What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
• What is the cost burden of current treatment on the patient?
• Patient acceptability in terms of preferred treatment options as per real-world scenarios?
• What are the accessibility issues of approved therapy in the US?
• What is the 7MM historical and forecasted market of Retinal Vein Occlusion?

Reasons to Buy

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Retinal Vein Occlusion market.
• Insights on patient burden/disease prevalence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• The distribution of historical and current patient share is based on real-world prescription data in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying upcoming solid players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
• Highlights of Access and Reimbursement policies for Retinal Vein Occlusion, barriers to accessibility of approved therapy, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.