Retinal Biologics Market

Market Overview

The global retinal biologics market was valued at USD 22.89 billion in 2023. It is estimated to reach USD 41.20 billion by 2032, growing at a CAGR of 6.75% during the forecast period (2024–2032). In recent years, a rise in the aging population and lifestyle changes has led to a subsequent surge in cases of retinal disorders like age-related macular degeneration and diabetic retinopathy globally, which is a significant driver for the retinal biologics market growth. Moreover, the emergence of personalized medicine and precision therapeutics presents a compelling opportunity for the global market

Retinal biologics are a class of drugs used to treat retinal diseases, which affect the retina, a critical layer of tissue at the back of the eye. Usually, these biologics are proteins or antibodies made to specifically target molecules implicated in the pathophysiology of the disease. They can then assist in the management of disorders such as diabetic retinopathy, age-related macular degeneration, and retinal vein occlusion.

Unlike traditional drugs, biologics are derived from living organisms and are often more complex in structure. They are administered via injections directly into the eye, targeting the affected area precisely. Retinal biologics offer the potential for more effective treatment with fewer side effects compared to conventional therapies, providing hope for patients with vision-threatening retinal conditions.

Highlights

• VEGF-A Antagonist dominates the drug class segment
• Macular degeneration dominates the disease indication segment
• Hospital pharmacies dominate the distribution channels segment
• North America held the largest market share

Market Dynamics

Global Retinal Biologics Market Drivers:

Growing Prevalence of Retinal Disorders 

The rising cases of retinal disorders, such as age-related macular degeneration (AMD) and diabetic retinopathy (DR), is a significant driver propelling the expansion of the retinal biologics market. According to an article published in PubMed, approximately 197 million people worldwide are affected by AMD, a number projected to increase to 288 million individuals by 2040 due to aging populations and lifestyle factors. 

Similarly, the International Diabetes Federation (IDF) reports that diabetic retinopathy affects approximately one-third of people with diabetes, making it the fifth-leading cause of vision loss globally. As the aging population continues to grow and the prevalence of chronic conditions like diabetes rises, the demand for effective treatments for retinal diseases escalates. This demographic shift, coupled with improved disease detection and healthcare access, underscores the urgent need for innovative biologic therapies to address the escalating burden of retinal disorders and improve patient outcomes.

Global Retinal Biologics Market Restraint:

High Cost of Retinal Biologics

The high cost of retinal biologics is a formidable restraint to retinal biologics market growth. These innovative therapies often involve intricate manufacturing processes and stringent quality control measures, resulting in elevated production expenses. The specialized nature of biologic treatments necessitates advanced equipment and expertise for administration, further increasing overall treatment costs. This financial burden poses significant challenges for healthcare systems, insurers, and patients, particularly in regions with limited access to healthcare resources or inadequate insurance coverage. Moreover, the high cost of retinal biologics may lead to disparities in treatment access, potentially disadvantaging economically disadvantaged patients and exacerbating healthcare inequalities. Thus, these factors are estimated to restrict the market expansion.

Global Retinal Biologics Market Opportunities:

Personalized Medicine

The evolving landscape of personalized medicine presents compelling opportunities for the retinal biologics market. Advancements in genomic profiling, biomarker identification, and precision therapeutics enable tailored treatment approaches, optimizing outcomes for patients with retinal disorders. By leveraging patient-specific genetic information and disease profiles, healthcare providers can customize treatment regimens, maximizing efficacy while minimizing adverse effects.

Furthermore, precision medicine fosters a shift towards proactive disease management and early intervention strategies, potentially reducing disease progression and healthcare costs in the long term. Enhanced patient stratification and targeted therapies not only improve treatment outcomes but also enhance patient satisfaction and adherence. As the field of precision medicine continues to expand, the retinal biologics market stands poised to capitalize on these opportunities, driving innovation and improving standards of care for individuals affected by retinal diseases.

Regional Analysis

Based on region, the global retinal biologics market share is bifurcated into North America, Europe, Asia-Pacific, Latin America, and the Middle East and Africa.

North America Dominates the Global Market

North America is the highest global retinal biologics market shareholder and is expected to expand substantially during the forecast period. North America dominates the retinal biologics industry, driven by robust healthcare infrastructure, high healthcare expenditure, and favorable reimbursement policies. The region is characterized by a strong emphasis on research and development, with leading pharmaceutical companies and academic institutions spearheading innovation in retinal therapies. In the United States, the prevalence of retinal disorders such as age-related macular degeneration and diabetic retinopathy is substantial, prompting increased demand for biologic treatments. For instance, as per the CDC, in 2021, an estimated 9.6 million individuals in the United States were affected with diabetic retinopathy.

Furthermore, there has been a rise in the approval of novel retinal biologics by regulatory bodies. For instance, in March 2022, Polpharma Biologics Group BV, Formycon AG, and Bioeq AG announced that the U.S. FDA had approved Cimerli (ranibizumab-eqrn). This biosimilar drug can be used interchangeably with Lucentis (ranibizumab injection). Cimerli received FDA approval for treating Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other severe retinal conditions, including Diabetic Macular Edema (DME), Macular Edema following Retinal Vein Occlusion (RVO), Diabetic Retinopathy (DR), and Myopic Choroidal Neovascularization (mCNV). Similarly, in May 2023, The FDA approved the supplemental Biologics License Application (sBLA) for faricimab-svoa to cure macular edema caused by retinal vein occlusion (RVO). Consequently, all these factors are estimated to drive the regional market growth.

Europe is a significant retinal biologics market characterized by a growing prevalence of retinal diseases and a robust healthcare infrastructure. Countries within the region, such as Germany, the United Kingdom, and France, are witnessing increasing investments in healthcare and research, driving innovation in the field of ophthalmology. Additionally, the aging population in Europe presents a demographic trend that fuels the demand for retinal treatments, particularly for age-related macular degeneration and diabetic retinopathy. Moreover, favorable regulatory frameworks and reimbursement policies further contribute to market growth, facilitating patient access to advanced biologic therapies.

Furthermore, regulatory bodies like the European Union approve novel drugs for treating retinal diseases. For instance, in September 2023, Biocon Biologics Ltd, a subsidiary of Biocon Ltd, achieved a critical milestone by receiving marketing approval from the European Commission (EC) for YESAFILI, a biosimilar of aflibercept. YESAFILI is a specialized ophthalmology product that targets various serious eye conditions, such as neovascular (wet AMD) age-related macular degeneration, visual impairment caused by macular oedema resulting from retinal vein occlusion (branch RVO or central RVO), visual impairment linked to diabetic macular oedema (DME), and visual impairment caused by myopic choroidal neovascularisation (myopic CNV). Thus, such factors are expected to boost the regional market expansion.

Segmental Analysis

The global retinal biologics market is segmented by drug class, disease indication, and distribution channel.

Based on drug class, the global retinal biologics market is segmented into TNF-a Inhibitors and VEGF-A Antagonists. 

The VEGF-A Antagonist segment owns the largest market share. A drug called a VEGF-A antagonist prevents the action of a protein called vascular endothelial growth factor A (VEGF-A), which is essential for angiogenesis or the development of new blood vessels. VEGF-A is involved in various physiological processes, including wound healing and embryonic development, but excessive VEGF-A expression is associated with pathological conditions such as cancer and retinal diseases. VEGF-A antagonists bind to VEGF-A molecules, preventing them from interacting with their receptors on endothelial cells and thereby blocking the signaling pathways that promote angiogenesis and vascular permeability. These antagonists assist in treating disorders, including age-related macular degeneration and diabetic retinopathy, by reducing aberrant blood vessel growth and leaking by blocking VEGF-A activity. This eventually preserves vision and stops more retinal damage.

Based on disease indication, the global retinal biologics market is bifurcated into macular degeneration, diabetic retinopathy, uveitis, and others. 

The macular degeneration segment is estimated to own the highest market share. Age-related macular degeneration (AMD) is a prominent segment within the retinal biologics industry, driven by the increasing prevalence of this debilitating condition, particularly among the elderly. AMD is characterized by a progressive degradation of the macula, which is the core portion of the retina that provides crisp, central vision. The cornerstone of AMD treatment is the use of anti-VEGF (vascular endothelial growth factor) medicines, such as ranibizumab and aflibercept, which target aberrant blood vessel growth and fluid leakage in the retina.

Moreover, these biologic treatments aim to protect residual eyesight, stop more vision loss, and, in certain situations, enhance visual acuity. Patients with AMD experience substantial reductions in quality of life, including reading, driving, and facial recognition challenges. The prevalence of AMD is predicted to increase as the world's population ages, highlighting the need for ongoing research and easy availability of potent retinal biologics in the treatment of this disorder that can cause blindness.

Based on the distribution channel, the global retinal biologics market is divided into retail pharmacies, hospital pharmacies, specialty clinics, and online pharmacies. 

The hospital pharmacies segment owns the largest market share. The segment plays a major role in the distribution of retinal biologics, serving as an essential hub for managing complex retinal disorders within hospital settings. These pharmacies ensure timely access to biologic therapies for inpatients and outpatients receiving specialized care from ophthalmologists and retinal specialists. With a focus on quality assurance and medication safety, hospital pharmacies adhere to stringent protocols for storing, handling, and administering retinal biologics, ensuring optimal efficacy and patient outcomes. 

Moreover, they collaborate closely with healthcare providers to coordinate treatment plans, monitor patient responses, and address adverse reactions or complications. By offering comprehensive pharmaceutical services and expertise in retinal therapeutics, hospital pharmacies contribute to the seamless integration of biologic therapies into the broader spectrum of retinal care, ultimately improving the quality of life for patients affected by retinal disorders.

Recent Developments

• March 2024- Sandoz, a prominent participant in the manufacturing of generic and biosimilar medications, successfully finalized the acquisition of Coherus' retinal disease drug division. This acquisition aims to establish Sandoz as a leader in the US market for biosimilar and ophthalmic products.
• March 2024- GenSight Biologics, a biopharmaceutical company specializing in gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announced that recent real-world data from early access programs (EAP) support the effectiveness of LUMEVOQ® in patients with Leber Hereditary Optic Neuropathy caused by the ND4 mutation (ND4-LHON), consistent with findings from clinical trials.