Punjab Samachar

(Albany, New York) – October 12, 2026 – The market dynamics for Retinopathy of Prematurity (ROP) are expected to witness steady growth, driven by the increasing incidence of the condition among preterm infants, rising screening and diagnosis rates, growing adoption of anti-VEGF therapies, and the continued use of laser photocoagulation as a standard treatment approach. Additionally, the availability of approved therapies such as EYLEA (aflibercept) and LUCENTIS (ranibizumab), alongside emerging candidates such as FLQ-101 and IBP-1118, is expected to influence the Retinopathy of Prematurity market during the forecast period.

DelveInsight, a leading market research firm, announces the release of its latest report, “Retinopathy of Prematurity Market Insights, Epidemiology, and Market Forecast – 2036.” The report provides a comprehensive assessment of the disease, including historical and forecasted epidemiology, market trends, current treatment practices, emerging therapies, and competitive dynamics across the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.

Key Takeaways from the Retinopathy of Prematurity Market

• Market Size and Growth: The Retinopathy of Prematurity market across the seven major markets (7MM) was valued at approximately USD 14 million in 2025 and is projected to reach approximately USD 20 million by 2036, growing at a CAGR of around 3% during 2026–2036.

• US Market: The United States Retinopathy of Prematurity market was valued at approximately USD 9 million in 2025.

• Disease Burden: According to DelveInsight estimates, approximately 94,500 incident cases of preterm infants with a birth weight of 1,500 g or less were recorded across the 7MM in 2025.

• US Epidemiology: The United States recorded approximately 18,200 incident cases of Retinopathy of Prematurity in 2025.

• Treatment Population: Approximately 10% of total ROP patients in the United States and European countries represent the severe and treatable patient pool, while around 30% of total ROP patients in Japan are estimated to undergo treatment.

• Geographic Distribution: Among the EU4 and the UK, France accounted for the highest number of incident ROP cases in 2025, followed by Germany, while Spain recorded the lowest number.

• Approved Therapies: EYLEA (aflibercept) and LUCENTIS (ranibizumab) are the approved pharmacological therapies highlighted in the report.

• Emerging Therapies: FLQ-101, developed by FeliQS Corporation, and IBP-1118, developed by Infant Bacterial Therapeutics, represent emerging approaches under development for ROP prevention.

• Leading Companies: Key companies associated with the ROP treatment landscape include Regeneron Pharmaceuticals, Novartis, Bayer, Genentech, FeliQS Corporation, and Infant Bacterial Therapeutics.

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Key Factors Driving the Retinopathy of Prematurity Market

Rising Incidence of Retinopathy of Prematurity: The incidence of ROP among preterm infants, particularly those with very low birth weight of 1,500 g or less, is contributing to demand for neonatal eye screening, timely diagnosis, and appropriate treatment. DelveInsight estimates approximately 18,200 incident ROP cases in the United States in 2025, with the US incidence projected to increase at a CAGR of around 3% during 2026–2036. Improved survival among very preterm infants and greater attention to neonatal ophthalmic care are also important factors influencing the need for ROP management.

Increasing Adoption of Anti-VEGF Therapies: Anti-vascular endothelial growth factor (anti-VEGF) therapies have become an important pharmacological option for selected infants with ROP. These agents inhibit VEGF-mediated abnormal blood vessel growth in the retina. Aflibercept and ranibizumab are approved options in specific jurisdictions, while bevacizumab has also been used in clinical practice. Anti-VEGF treatment may be particularly useful in selected disease presentations where retinal vascular development and the risk of recurrence require careful management. However, treatment selection depends on disease characteristics, regulatory status, clinical guidance, and specialist assessment.

Continued Role of Laser Therapy: Laser photocoagulation remains a key treatment for severe or treatment-requiring ROP. The procedure targets the avascular peripheral retina to reduce the stimulus for abnormal blood vessel growth. According to DelveInsight’s estimates, laser therapy accounted for the highest revenue among ROP treatment approaches in the 7MM in 2025. Its established role in clinical management is expected to sustain demand throughout the forecast period, although treatment decisions vary according to disease severity and patient-specific factors.

Growing Need for Efficient Bedside Treatment: Premature infants often require specialized care in neonatal intensive care units (NICUs). Treatment approaches that can be delivered efficiently in these settings may help reduce procedural complexity and support timely intervention. Pharmacological treatments, including intravitreal anti-VEGF injections, offer an alternative to laser therapy in appropriate cases. Nevertheless, these treatments require specialized administration and follow-up because of the potential for recurrence and the need to monitor retinal vascular development over time.

Emerging Pipeline Therapies: The ROP pipeline remains relatively limited, creating opportunities for candidates designed to prevent or manage abnormal retinal development. FLQ-101, an investigational small molecule, and IBP-1118, an emerging candidate, are highlighted in DelveInsight’s report. Their future contribution will depend on clinical evidence, development progress, safety outcomes, and regulatory decisions.

Retinopathy of Prematurity Competitive Landscape

The Retinopathy of Prematurity market comprises established pharmacological therapies, laser-based treatment, and a limited pipeline of investigational candidates. The competitive landscape is shaped by the clinical use of anti-VEGF agents, the continued role of laser photocoagulation, and research into approaches that may prevent or reduce the severity of ROP.

Key companies and therapies include:

• Regeneron Pharmaceuticals/Bayer: EYLEA (aflibercept), an anti-VEGF therapy used for ROP in approved jurisdictions.

• Novartis/Genentech: LUCENTIS (ranibizumab), an anti-VEGF therapy approved for specific ROP indications in Europe and Japan.

• FeliQS Corporation: FLQ-101, an investigational small molecule being developed for ROP prevention.

• Infant Bacterial Therapeutics: IBP-1118, an emerging candidate included in the ROP development pipeline.

EYLEA and LUCENTIS inhibit VEGF-mediated pathways associated with abnormal retinal blood vessel growth. FLQ-101 is described in the report as a lipid peroxidation inhibitor, while IBP-1118 represents an investigational preventive approach. The commercial and clinical prospects of pipeline therapies will depend on further evidence of efficacy and safety, development milestones, and regulatory outcomes.

Discover more about therapies expected to shape the Retinopathy of Prematurity market

Retinopathy of Prematurity Treatment Landscape

The current treatment landscape for ROP primarily comprises laser photocoagulation and anti-VEGF injections, with vitreoretinal surgery used in advanced cases involving retinal detachment or other serious complications.

Laser photocoagulation remains a major treatment option for severe ROP, particularly when abnormal retinal vascular development requires intervention. Anti-VEGF agents provide a pharmacological alternative for selected patients by inhibiting the signaling pathways involved in abnormal blood vessel formation. These agents may be considered according to disease location, severity, and the treating specialist’s clinical judgment.

The treatment landscape also emphasizes the importance of ongoing retinal examinations following intervention. Recurrence, incomplete regression, and continued retinal vascular development can necessitate additional monitoring or retreatment. Long-term follow-up is particularly important after anti-VEGF therapy because the effects on peripheral retinal vascularization and potential longer-term outcomes must be carefully assessed.

Approved Therapies

LUCENTIS (Ranibizumab) – Novartis/Genentech

LUCENTIS (ranibizumab) is a humanized antibody fragment that binds to VEGF-A, inhibiting the signaling responsible for abnormal blood vessel growth. Administered by intravitreal injection, it is approved in Europe and Japan for specified ROP presentations, including certain forms of Zone I and Zone II disease and aggressive posterior ROP. Its use is governed by the relevant regional product information and clinical guidance.

EYLEA (Aflibercept) – Regeneron Pharmaceuticals/Bayer

EYLEA (aflibercept) is a VEGF inhibitor administered through intravitreal injection. It binds to VEGF-A and placental growth factor (PlGF), inhibiting growth-factor signaling involved in ocular angiogenesis. The therapy received US approval for ROP in February 2023, with approvals also reported in the European Union and Japan. Its role in the treatment landscape reflects growing interest in pharmacological approaches to abnormal retinal vascular development.

Emerging Therapies

FLQ-101 – FeliQS Corporation

FLQ-101 is an investigational small molecule being developed for the prevention of Retinopathy of Prematurity. According to DelveInsight, the candidate is in Phase I development and is administered intravenously. Its mechanism is described as a lipid peroxidation inhibitor. Further clinical evaluation will be required to establish its safety, efficacy, and potential role in preventing ROP.

IBP-1118 – Infant Bacterial Therapeutics

IBP-1118 is an emerging candidate included in DelveInsight’s ROP pipeline assessment. The report identifies the therapy as being in the preclinical stage of development for ROP prevention. Its potential contribution to future treatment strategies will depend on subsequent preclinical findings, clinical development, and regulatory review.

Recent Developments in the Retinopathy of Prematurity Market

• March 2026: SignaBlok announced that its TREM-1 peptide inhibitor received US FDA Orphan Drug Designation for Retinopathy of Prematurity.

• February 2023: EYLEA (aflibercept) received US FDA approval for the treatment of Retinopathy of Prematurity in preterm infants.

• December 2022: EYLEA received approval for ROP in the European Union, according to the supplied market information.

• September 2019: LUCENTIS (ranibizumab) received approval for ROP in the European Union, followed by approval in Japan in October 2019.

These developments highlight continued activity in pharmacological treatment and early-stage therapeutic research. Orphan Drug Designation is a regulatory designation and does not, by itself, establish that a therapy is approved for marketing or proven effective.

What Is Retinopathy of Prematurity?

Retinopathy of Prematurity is an eye disorder that affects some premature infants, particularly those born very early or with very low birth weight. It develops when retinal blood vessels do not mature normally and abnormal vessels grow in the retina, the light-sensitive tissue at the back of the eye. Mild cases may resolve without treatment, whereas severe disease can lead to retinal detachment, visual impairment, or blindness if not identified and managed appropriately.

ROP is diagnosed through retinal examinations conducted by a qualified ophthalmologist or other appropriately trained eye-care specialist. The infant’s pupils are dilated to allow assessment of retinal vascular development. Retinal imaging may also support documentation and monitoring. Disease severity is evaluated according to factors such as stage, zone, and the extent of abnormal vascular changes.

Treatment depends on the severity and clinical characteristics of the disease. Options include laser photocoagulation, intravitreal anti-VEGF injections, and surgery for advanced complications. Timely screening, appropriate treatment, and continued follow-up are essential to reduce the risk of adverse visual outcomes.

Retinopathy of Prematurity Epidemiology Segmentation

The Retinopathy of Prematurity epidemiology section provides insights into historical and forecasted patient populations across the seven major markets. The report covers the epidemiology study period from 2022 to 2036 and evaluates the following segments:

• Total incident cases of preterm infants by birth weight (≤1,500 g)

• Total incident cases of Retinopathy of Prematurity

• Total treated cases of Retinopathy of Prematurity

• Patients undergoing initial treatment

• Patients requiring retreatment

According to DelveInsight’s estimates, approximately 94,500 incident cases of preterm infants with a birth weight of 1,500 g or less were recorded across the 7MM in 2025. This population is anticipated to increase over the forecast period from 2026 to 2036.

Among the EU4 and the UK, France accounted for the highest number of incident ROP cases in 2025, followed by Germany, while Spain recorded the lowest number. The United States had the highest number of patients undergoing ROP treatment among the 7MM, followed by Japan.

The epidemiological assessment also considers differences in screening practices, disease identification, treatment eligibility, and follow-up requirements across countries. These factors influence the number of diagnosed and treated patients and are important when evaluating the addressable market for approved and emerging therapies.

Unmet Needs in Retinopathy of Prematurity

Despite advances in screening and treatment, several unmet needs remain in ROP management:

• Limited emerging therapies: The development pipeline remains relatively small, highlighting the need for additional preventive and therapeutic approaches.

• Long-term follow-up requirements: Infants require ongoing retinal monitoring to assess vascular development, detect recurrence, and identify potential complications.

• Long-term safety considerations: Further evidence is needed to understand the longer-term outcomes associated with anti-VEGF treatment in premature infants.

• Need for individualized treatment: Disease severity, retinal location, and patient-specific characteristics influence treatment selection and outcomes.

• Improved diagnostic approaches: More efficient screening, imaging, and monitoring may support timely identification and management.

• Efficient neonatal care: Treatment approaches that can be delivered safely and effectively in NICU settings remain an important area of clinical interest.

These unmet needs continue to create opportunities for innovation in preventive therapies, retinal imaging, screening protocols, and treatment strategies.

Scope of the Retinopathy of Prematurity Market Report

Therapeutic Assessment: Analysis of current ROP treatment approaches, including laser photocoagulation, anti-VEGF therapies, and emerging preventive candidates.

Market Dynamics: Evaluation of market drivers, barriers, treatment trends, therapy uptake, patient share, pricing considerations, and forecast assumptions.

Key Companies: Regeneron Pharmaceuticals, Novartis, Bayer, Genentech, FeliQS Corporation, Infant Bacterial Therapeutics, and other relevant market participants.

Key Therapies: EYLEA (aflibercept), LUCENTIS (ranibizumab), FLQ-101, IBP-1118, and other therapies relevant to the ROP treatment landscape.

Competitive Intelligence: Assessment of the competitive landscape, treatment preferences, key opinion leader insights, reimbursement considerations, and unmet medical needs.

Epidemiology Forecast: Assessment of preterm infant populations, incident ROP cases, treated patients, initial treatment, and retreatment across the 7MM.

Unmet Needs: Evaluation of limited pipeline options, long-term monitoring requirements, safety considerations, and opportunities for improved diagnostic and treatment approaches.

To learn more about companies developing therapies for Retinopathy of Prematurity

Retinopathy of Prematurity Clinical Trials and Therapeutic Assessment

DelveInsight’s report provides an assessment of emerging therapies and their development status, alongside the broader treatment landscape. Clinical and preclinical development programs are evaluated in the context of their proposed mechanisms, potential clinical value, and ability to address unmet needs in ROP prevention and management.

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Table of Contents

• Retinopathy of Prematurity Market Report Introduction

• Executive Summary for Retinopathy of Prematurity

• Key Events in Retinopathy of Prematurity

• SWOT Analysis of Retinopathy of Prematurity

• Retinopathy of Prematurity Patient Share Overview

• Retinopathy of Prematurity Market Overview

• Retinopathy of Prematurity Background and Overview

• Retinopathy of Prematurity Epidemiology and Patient Population

• Country-Specific Patient Population of Retinopathy of Prematurity

• Retinopathy of Prematurity Current Treatment and Medical Practices

• Retinopathy of Prematurity Unmet Needs

• Retinopathy of Prematurity Emerging Therapies

• Retinopathy of Prematurity Market Outlook

• Country-Wise Retinopathy of Prematurity Market Analysis (2022–2036)

• Retinopathy of Prematurity Market Access and Reimbursement

• Retinopathy of Prematurity Market Drivers

• Retinopathy of Prematurity Market Barriers

• Retinopathy of Prematurity Appendix

• Retinopathy of Prematurity Report Methodology

• DelveInsight Capabilities

• Disclaimer

About DelveInsight

DelveInsight is a leading market research and consulting firm specializing in the life sciences and healthcare industries. Founded in 2014, the company provides comprehensive market intelligence, epidemiology, and insights across pharmaceuticals, biotechnology, medical devices, and emerging therapies. DelveInsight helps healthcare organizations make informed strategic decisions through data-driven research and industry expertise.

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