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The global retinal biologics market size is currently valued at $ 25.65 billion and is poised to reach $ 57.47 billion by 2035, it is estimated to grow at a CAGR of 7.61%, during the forecast period.
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Retinal biologics refers to the bioengineered molecules that are particularly delivered inside the eyes of patients suffering from chronic retinal diseases. Over the decades, the pharmaceutical industry have been investigating various biologics that confer high bioavailability and targeted drug delivery in the eye. There has been a surge in the number of patients suffering from various back of the eye disorders, such as diabetic retinopathy, glaucomatous retinal degeneration and age-related macular degeneration. As per the World Health Organization, in 2023, nearly 2.2 billion people have near, or distance vision impairment and the leading cause are refractive errors. This increasing incidence of retinal diseases around the world has underscored the requirement of advanced treatment solutions to treat patients with vision impairment. These retinal biologics emerged as a potential class of therapeutics that target specific markers inside the patient's body to reduce the symptoms of ocular disorders in the eye. in May 2024, Biocon Biologics announced that the United States of Food and Drug Administration (USFDA) has first-to-file application for Yesafili(TM) a biosimilar of aflibercept.
In the field of retinal ophthalmology, the need for utilization of biological mechanisms in order to have target delivery has presented vast opportunities for the drug developers to explore, research and develop biological drugs. Furthermore, technological advancements, molecular biology and genetic engineering has further contributed to the identification and development of wide range of retinal biologic drugs. Notably, several cell therapies and gene therapies have also shown significant potential in the treatment of vision impairment, which is further opening pathways for industry leaders to drive innovation in this field. It is important to highlight here that VEGF-A antagonist treatment has been accepted in developing countries, such as China and India, which further shows the promising scope of retinal biologics in treating patients with ocular disorders. Considering the rising incidence of retinal diseases and ongoing research in the field, we believe that the retinal biologics market will continue to grow at a substantial pace during the forecast period, making this industry investible for long term.
The market report covers an in-depth analysis of the pipeline of retinal biologics and developers involved, the recent market activity and entry of biosimilars. This analysis is presented across various segments of the industry as mentioned in the table below.
| Key Report Attributes | Details | |
| Historical Trend | Since 2019 | |
| Forecast Period | Till 2035 | |
| Market Size 2035 | USD 57.47 billion | |
| CAGR (Till 2035) | 7.61% | |
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| Type of Drug Class |
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| End Users |
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| Distribution Channel |
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| Geographical Regions |
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| Key Companies Profiled |
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| PowerPoint Presentation (Complimentary) |
Available | |
| Customization Scope | 15% Free Customization | |
| Excel Data Packs (Complimentary) |
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One of the key objectives of market report was to estimate the current market size, opportunity and the market growth potential, over the forecast period, till 2035. We have provided informed estimates on the likely evolution of the market for the forecast period. The retinal biologics market analysis also features the likely distribution of the current and forecasted opportunity within the market across various segments, such as distribution by type of disease indication (macular degeneration, diabetic retinopathy, retinal veins and occlusions), type of drug class (VEGF-A Antagonists and TNF-alpha Inhibitors), end users (hospital pharmacies, homecare, specialty centers and other end users), distribution channels (hospital pharmacies, online pharmacies and retail pharmacies), and geographical regions (North America, Europe, Asia Pacific, Middle East and North Africa, and Latin America) and leading players. In order to account for future uncertainties associated with some of the key parameters and to add robustness to our model, we have provided three retinal biologics market forecast scenarios, namely conservative, base, and optimistic scenarios, representing different tracks of industry’s evolution.
All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. The financial figures mentioned in this market report are in USD, unless otherwise specified.
Based on the type of drug class, the global retinal biologics market is segmented into macular degeneration, diabetic retinopathy, retinal veins and occlusions. Presently, macular degeneration occupies the highest share (~35%) of the global market. This can be attributed to the growing incidence of such cases worldwide. Furthermore, the rise in approved biological drugs for the treatment of age-related macular degeneration (AMD) has further contributed to the growth of this segment. However, in the future, diabetic retinopathy will show substantial growth potential driven by the increasing incidence of diabetic patients across the globe. It is worth noting here that diabetic patients are at greater risk of vision impairment and likely to suffer from diabetic retinopathy, which becomes a primary reason for the highest growth rate during the forecast period. As per the report of Centers for Disease Control and Prevention (CDC), in 2021, 9.6 million people were suffering from diabetic retinopathy in the US; of which, 1.84 million patients have vision-threatening diabetic retinopathy.
The global market is categorized into different drug classes such as VEGF-A antagonists and TNF-alpha inhibitors. It is worth mentioning here that VEGF-A antagonists currently hold the highest retinal biologics market share (more than 65%). This dominance is primarily due to the widespread adoption of VEGF-A antagonists across the globe for the treatment of vision impairment (such as age-related macular degeneration). Lucentis (ranibizumab), Eylea (aflibercept), Beovu (brolucizumab) and Vabysmo (faricimab) are all anti-VEGF biologics that are approved for treatment of wet-AMD. Avastin (bevacizumab), another VEGF antagonist is used off-label for this indication. In August 2023, Regeneron Pharmaceuticals received FDA approval for Eylea HD 8mg for wet-AMD, diabetic retinopathy and diabetic macular edema. VEGF-A antagonists have also shown higher efficacy in the treatment of diabetic macular edema, and lead to growth of blood vessels inside the retina, which is further anticipated to boost the growth of this segment. In the future, TNF-alpha inhibitors will grow at a higher CAGR during the forecast period.
This segment highlights the distribution of global retinal biologics market across different end users such as hospitals, homecare, specialty centers, and other end users. Currently, hospitals account for the largest share of the market owing to the availability of advanced facilities and the high volume of treatments administered in the healthcare settings. The approved VEGF treatments are currently administered through intravitreal injection in ophthalmologist office. However, during the forecast period, specialty centers will grow at a higher CAGR driven by the growing demand for personalized care and targeted therapies (due to the growing preferences amongst the patients).
On the basis of the distribution channels, the global market is segmented into hospital pharmacies, online pharmacies, and retail pharmacies. Among these segments, hospital pharmacies hold the highest retinal biologics market share (close to 55%). This dominance is due to the fact that hospitals have centralized pharmacies to manage the procurement and distribution of biologics for the treatment. However, in the long run, online pharmacy is expected to grow at a substantial CAGR owing to the convenience of purchasing and increasing acceptance of online pharmacies for the distribution of biologics to manage chronic conditions.
The global retinal biologics market is distributed based on geographical region into North America, Europe, Asia Pacific, Middle East and North Africa, and Latin America. It is interesting to note here that currently, North America holds the highest share (43%) of the market. This highest share is likely to be the result of various strategic initiatives, such as acquisitions, collaborations and partnerships undertaken by the industry stakeholders for the development of advanced solutions to treat ocular disorders. Furthermore, in the US, there is a high prevalence of retinal diseases which has underscored the requirement of advanced therapeutic treatment in this region. In addition, supportive guidelines and advanced healthcare infrastructure have contributed to the growth of this segment. However, in the long run, Asia Pacific is expected to grow at a higher CAGR driven by the increasing research initiatives by the stakeholders for the development of advanced treatment options to correct vision impairment. Moreover, the growing awareness about the early detection of retinal conditions has contributed to the growth of the market in this region.
The “Global Retinal Biologics Market: Industry Trends and Global Forecasts, till 2035”; market report features an extensive study of the current market landscape, market size and future opportunities within the retinal biologics industry, during the given forecast period. The market report highlights the efforts of several stakeholders engaged in this rapidly emerging retinal biologic industry. Key takeaways of the market report have been briefly discussed below.
Currently, the market for retinal biologics is competitive and is characterized by the presence of several well-established and new entrants with required expertise. The market also has the presence of biosimilar manufacturers, in addition to originators. With respect to the approved biologics, there are at least four approved VEGF antagonists and a number of biosimilars have received approval in 2024. These have been covered in detail in the full report.
The industry stakeholders in this field are focusing on strategic alliance for the enhancement of product portfolio and to establish a strong foothold in the growing market. These companies are extensively engaged in research and development for the preclinical and clinical development of various types of retinal biologics, including VEGF-A antagonists and TNF-alpha inhibitors.
Rising incidence of vision impairment due to refractive errors, prolonged injuries and other injuries has heightened the demand for advanced therapeutic solutions. Further, sleep deprivation and rise in the digital screen time puts excessive strain on the eyes, thereby, resulting in numerous vision problems. With the introduction of retinal biologics, healthcare experts are able to treat vision impairment issues (including age-related macular degeneration and diabetic macular edema). Moreover, the need for the precise treatment of diabetic retinopathy in patients is likely to pace the market growth.
Drug developers are also investing in the development of biologics that can not only delay the progress of the disease, but also arrest and reverse the vision loss. One such company, India based Eyestem Research Private Limited received regulatory approval to begin clinical trials for their cell therapy Eyestem RPE in patients with dry AMD. The approval came in April 2024 and the first set of patients were injected with the drug in September 2024.
The development of retinal biologics (having a desired therapeutic concentration in an optimal drug delivery system) is exorbitant. Furthermore, the stringent regulatory compliance and complex manufacturing process further increase the cost of retinal biologics. High cost may create challenges in terms of broader acceptance and market expansion. Additionally, the lack of skilled personnel who are unaware of various treatment methods for treating retinal diseases with biologics may hinder the progress of the retinal biologics market. Moreover, some side effects associated with the retinal biologics, such as liver issue, itchiness, and light sensitivity, may affect the usage of biological drugs and impede the market growth during the projected period.
Despite the market challenges, the market for retinal biologics is growing at a steady pace during the forecast period. Some of the potential opportunities includes launch of new therapeutic drugs and increasing strategic initiatives of industrial stakeholder. Notably, in June 2024, Kemwell Biopharma entered into a collaboration with RevOpsis Therapeutics in order to accelerate the development of the latter company’s RO-104 (a tri-specific biologic) for the treatment of neovascular age-related macular degeneration. Earlier, in November 2023, EyeBio announced raising USD 65 million in the extension of Venture A series, to support the development of clinical therapy candidates for retinal diseases. More such strategic initiatives by the players in the retinal biologics industry are likely to continue and drive the growth in the future.
A number of biosimilars for Eylea have recently received approval both in the US and EU. The most recent approval was given to Sandoz’s Afqlir and Samsung Bioepis and Biogen’s Opuviz in September 2024 for the treatment of neovascular (wet) age-related macular degeneration, visual impairment due to macular edema secondary to branch or central retinal vein occlusion, visual impairment due to diabetic macular edema, and visual impairment due to myopic choroidal neovascularization. May 2024 also saw the US FDA provide approval to two Eylea biosimilars, Biocon Biologics’ Yesafili and Opuviz. The launch of biosimilars will help the market adoption by a wider population.
The global market is currently valued at USD 25.65 billion and is anticipated to reach USD 57.47 billion by 2035. Driven by the increasing demand for advanced therapeutic solutions to treat vision impairment, the market is estimated to grow at a compounded annual growth rate of 7.61% during the forecast period. The growing interest and incessant efforts of the stakeholder and researchers in this field are captivating, wherein various strategic collaborations / ventures are made to develop various biologics that can treat the prevailing retinal diseases. Recently, in September 2024, scientists from the University of Florida announced the completion of the first trial of gene therapy (developed by its spin-off Atsena Therapeutics) in the patients suffering from rare, inherited blindness.
Examples of key retinal biologics companies (which have also been profiled in this market report; the complete list of companies is available in the full report) include AstraZeneca, ABBVie, Amgen, Alimera Sciences, Allergan, Adverum Biotechnologies, Bayer, Bristol-Myers Squibb, Bausch & Lomb, Boehringer Ingelheim, Clearside Biomedical, Fresenius, Greybug Vision, Genentech, Janssen Biotech, Kodiak Sciences, Merck, MeiraGTx, Novartis, Neurotech Pharmaceuticals, Ocular Therapeutics, Oxurion, Opthea, Pfizer, Roche, Regeneron Pharmaceuticals, Sun Pharmaceuticals, Sanofi Genzyme, Santen Pharmaceutical, Teva pharmaceuticals and UCBCares. This market report includes an easily searchable excel database of all the companies engaged in the development of retinal biologics.
Several recent developments have taken place in the market, some of which have been outlined below. These developments, even though they took place post the release of our market report, substantiate the overall market trends that we have outlined in our analyses.