Ophthalmology Biosimilars Market Size, Share, Growth, Trends, and Global Industry Analysis: By Drug Type (Adalimumab, Aflibercept, Ranibizumab, Others), By Indication (Macular Degeneration, Diabetic Macular Edema, Retinal Detachment, Others), By Distribution Channel (Hospital Pharmacies, Retail Pharmacies & Drug Store, Online Pharmacies) and By Region Forecast 2020-2031

Ophthalmology Biosimilars Market size was valued at US$ xx billion in 2024 and is expected to reach US$ xx billion by 2031, growing at a significant CAGR of 14.5% from 2025-2031. The Global market is projected to grow at a CAGR of 16.5%. Moreover, the U.S. market is projected to grow at a CAGR of 17% over the forecast period. Ophthalmology biosimilars are biologic medical products that are highly similar to already approved reference biologics used in the treatment of various eye-related diseases, such as age-related macular degeneration (AMD), diabetic retinopathy, and retinal vein occlusion. These biosimilars are designed to match the reference product in terms of safety, efficacy, and quality, but they are generally offered at a lower cost. Developed once the patent protection for the original biologic expires, ophthalmology biosimilars aim to improve accessibility and affordability of advanced biologic therapies for vision-threatening conditions.

Regulatory agencies such as the FDA and EMA strictly evaluate biosimilars to ensure they meet rigorous standards before market approval. The market is witnessing significant growth, driven by the rising prevalence of chronic eye diseases and the increasing demand for cost-effective treatment alternatives. With healthcare systems under pressure to manage soaring pharmaceutical expenditures, biosimilars offer a viable solution to reduce treatment costs without compromising therapeutic outcomes. The market is further supported by favorable regulatory pathways, the expiration of patents for key biologics like Lucentis and Eylea, and growing acceptance among ophthalmologists. Biopharmaceutical companies are increasingly investing in biosimilar development and strategic collaborations to expand their product portfolios. As awareness and confidence in biosimilars continue to grow, the ophthalmology biosimilars market is poised to play a pivotal role in enhancing eye care access globally. 

Facts & Figures:

• In the United States, the Vision and Eye Health Surveillance System (VEHSS) estimates that among adults aged 40 and older, about 8.94 million people have diabetic retinopathy, with 1.71 million experiencing vision-threatening stages.
• According to studies, it is noted that between the age of 45-85 years the global prevalence of age-related macular degeneration was early age-related macular degeneration is projected to be 8.7% and late age macular degeneration is 0.4%.

Key Developments:

•  In May 2024, Formycon AG's licensee, Klinge Biopharma GmbH, partnered with MS Pharma to commercialize FYB203, a biosimilar candidate to Eylea® (Aflibercept), in the Middle East and North Africa (MENA) region. MS Pharma, leveraging its established presence in the region, plans to produce FYB203 locally in Saudi Arabia, aiming to enhance accessibility to cost-effective ophthalmic treatments across MENA.
• In May 2024, the U.S. FDA approved two biosimilars for Regeneron's Eylea: Biocon Biologics' Yesafili and Samsung Bioepis and Biogen's Opuviz. These approvals mark a significant milestone, introducing interchangeable biosimilar options for a widely used eye treatment, potentially increasing competition and reducing treatment costs in the U.S. market.
• In August 2024, Sandoz announced FDA approval for Enzeevu (aflibercept-abzv), further expanding the portfolio of approved aflibercept biosimilars. These developments underscore the growing interest and investment in ophthalmology biosimilars, aiming to enhance treatment accessibility and affordability for patients with retinal diseases. 

Ophthalmology Biosimilars Market Segmentation:

Based on the drug type:

• Adalimumab
• Aflibercept
• Ranibizumab
• Others

Among the drug types in the market, Ranibizumab biosimilars are currently leading the segment, driven by their widespread adoption and clinical efficacy in treating retinal disorders. One of the primary drivers behind Ranibizumab's dominance is the patent expiration of the reference biologic Lucentis, which opened the door for multiple biosimilar entries. Ranibizumab is extensively used for conditions such as age-related macular degeneration (AMD), diabetic macular edema (DME), and retinal vein occlusion (RVO), all of which are increasing in prevalence due to aging populations and rising diabetes rates globally. As healthcare systems across both developed and developing regions face pressure to contain costs, biosimilars of Ranibizumab offer a clinically equivalent but more cost-effective alternative.

Countries such as India, the U.S., and several EU nations have already approved and adopted these biosimilars, further boosting their market share. Moreover, regulatory agencies have streamlined approval processes, encouraging more pharmaceutical players to enter this space. Physician confidence in Ranibizumab biosimilars has grown significantly due to positive real-world outcomes and extensive post-marketing surveillance. This, coupled with favorable reimbursement policies and rising awareness among patients, has solidified Ranibizumab biosimilars as the leading segment in ophthalmology biosimilars, with robust prospects for continued growth. 

Based on the indication:

• Macular Degeneration
• Diabetic Macular Edema
• Retinal Detachment
• Others

Within the market, macular degeneration emerges as the leading indication segment, propelled by a significant increase in the global elderly population and the rising incidence of age-related macular degeneration (AMD). A major driver of this dominance is the growing demand for cost-effective therapies to manage chronic eye conditions, particularly in aging societies. AMD is one of the most common causes of vision loss in individuals over 60, and as life expectancy continues to rise globally, the patient pool requiring long-term treatment is expanding rapidly. Traditional biologics such as Lucentis and Eylea have proven effective in managing AMD, but their high costs have limited access in many regions.

The introduction of ophthalmology biosimilars targeting AMD has substantially improved affordability, leading to greater adoption among healthcare providers and patients alike. These biosimilars provide a comparable safety and efficacy profile, ensuring that quality of care is maintained while reducing the financial burden on healthcare systems. Furthermore, advancements in diagnostics and early screening have enabled earlier intervention, further fueling the demand for AMD therapies. With strong clinical support, favorable reimbursement policies, and an expanding elderly population, the macular degeneration segment is expected to maintain its lead and drive substantial growth in the biosimilars market.

Based on the distribution channel:

• Hospital Pharmacies
• Retail Pharmacies & Drug Store
• Online Pharmacies 

In the market, hospital pharmacies hold the leading position among distribution channels, primarily driven by the increasing number of hospital-based treatments and specialized care required for ophthalmic conditions. A key driver behind this dominance is the nature of biosimilar administration, which often involves intravitreal injections that must be administered by trained medical professionals within a controlled healthcare setting. Hospitals serve as central hubs for diagnosing and managing complex eye conditions like age-related macular degeneration (AMD) and diabetic macular edema (DME), both of which require consistent monitoring and follow-up. The presence of ophthalmologists and specialized retinal care units in hospitals makes them the preferred point of access for such therapies.

Moreover, hospitals often procure biosimilars in bulk through tenders and government-supported programs, allowing them to offer these treatments at reduced costs compared to other channels. This centralized procurement also supports better inventory management and ensures product authenticity. Additionally, healthcare policies in many regions favor reimbursement of biosimilars dispensed through hospital pharmacies, encouraging patients to seek treatment in these facilities. As the demand for efficient, high-quality, and affordable eye care continues to grow, hospital pharmacies are expected to remain the dominant distribution channel in the ophthalmology biosimilars landscape.