Retinopathy of Prematurity Market Positioned for Significant Commercial Growth by 2036 - DelveInsight

DelveInsight's "Retinopathy of Prematurity Market Insights, Epidemiology, and Market Forecast-2036′′ report offers an in-depth understanding of the Retinopathy of Prematurity, historical and forecasted epidemiology as well as the Retinopathy of Prematurity market trends in the United States, EU4 (Germany, Spain, Italy, France) the United Kingdom and Japan.

The latest healthcare forecast report provides an in-depth analysis of Retinopathy of Prematurity, offering comprehensive insights into the Retinopathy of Prematurity revenue trends, prevalence, and treatment landscape. The report delves into key Retinopathy of Prematurity statistics, highlighting the current and projected market size, while examining the efficacy and development of emerging Retinopathy of Prematurity therapies. Additionally, we cover the landscape of Retinopathy of Prematurity clinical trials, providing an overview of ongoing and upcoming studies that are poised to shape the future of Retinopathy of Prematurity treatment. This report is an essential resource for understanding the market dynamics and the evolving therapeutic options within the Retinopathy of Prematurity space.

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Some of the key facts of the Retinopathy of Prematurity Market Report:
• The Retinopathy of Prematurity market size was valued at approximately USD 14 million in 2025 and is projected to reach nearly USD 20 million by 2036, expanding at a compound annual growth rate (CAGR) of 3% during the forecast period from 2026 to 2036.
• In March 2026, SignaBlok announced that its TREM-1 peptide inhibitor received FDA Orphan Drug Designation for ROP.
• In February 2023, the FDA approved EYLEA (aflibercept) as the first drug for Retinopathy of Prematurity, a condition in premature infants where abnormal retinal blood vessel growth can cause retinal detachment and vision loss.
• The total market size of Retinopathy of Prematurity in the 7MM is approximately ~USD 14 million in 2025.
• Among EU4, Germany accounts for the largest market size in 2025, while Spain occupies the bottom of the ladder.
• In 2025, the highest revenue was generated by laser therapy in the 7MM.
• Among anti-VEGFs, bevacizumab is the most used therapy (approximately 80% of all VEGFs), followed by LUCENTIS as an approved therapy in Europe and Japan and off-label in the US. Whereas EYLEA is the most recent approval in all the countries. In terms of cost-effectiveness, bevacizumab is the most economical option.
• The FDA-approved drugs for treating ROP include LUCENTIS (ranibizumab) and EYLEA (aflibercept). Regeneron is leveraging its experience in retinal diseases with EYLEA's label expansion in Retinopathy of Prematurity. This stems from the FDA's recent approval of EYLEA as a feasible treatment for ROP in preterm infants in 2023.
• According to DelveInsight's estimates, the total number of incident cases of preterm infants by birth weight (≤1,500 g) in the 7MM was ~94,500 in 2025. As per the estimate, these cases are anticipated to increase during the forecast period of 2026-2036.
• Among the EU4 and the UK, France accounted for the highest number of incident cases of ROA, followed by Germany, whereas Spain accounted for the lowest number of cases in 2025.
• Among the 7MM, the United States has the highest number of patients undergoing treatment for ROP, followed by Japan, while Spain has the lowest in 2025.
• Key Retinopathy of Prematurity Companies: Novartis, Regeneron/Bayer, FeliQS Corporation, Infant Bacterial Therapeutics, Shire, OHB Neonatology, and others
• Key Retinopathy of Prematurity Therapies: LUCENTIS (ranibizumab), EYLEA (aflibercept), FLQ-101, IBP-1118, rhIGF-I/rhIGFBP-3, OHB-607, and others
• The Retinopathy of Prematurity market is expected to surge due to the disease's increasing prevalence and awareness during the forecast period. Furthermore, launching various multiple-stage Retinopathy of Prematurity pipeline products will significantly revolutionize the Retinopathy of Prematurity market dynamics.
• In 2023, the total number of preterm infant incident cases with a birth weight of ≤1,500 g in the 7MM was approximately 93,500. These cases are projected to rise throughout the study period from 2022 to 2036.
• In 2023, approximately 1,700 patients in the US underwent initial treatment for ROP, with around 600 requiring retreatment. In the UK, about 400 patients received initial treatment, while nearly 60 underwent retreatment. Similarly, in Japan, nearly 1,600 patients sought initial treatment for ROP, and approximately 260 required retreatment.
• In 2023, approximately 24,000 preterm infants in the EU4 with a body weight of ≤1,500 g were at risk for ROP.
• According to Guide-Vue.fr (2023), around 30% of premature infants born before 31 weeks of gestation in France and Europe develop retinopathy.
• In 2023, Germany had the highest number of incident cases of ROP among the EU4, followed by France, while Spain recorded the lowest number of cases.

Retinopathy of Prematurity Overview
Retinopathy of Prematurity (ROP) is a potentially blinding eye disorder that affects premature infants. It occurs when abnormal blood vessels grow and spread in the retina, the light-sensitive layer at the back of the eye. These abnormal vessels can leak or scar, potentially leading to retinal detachment and vision loss.

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Retinopathy of Prematurity Epidemiology
The epidemiology section provides insights into the historical, current, and forecasted epidemiology trends in the seven major countries (7MM) from 2022 to 2036. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. The epidemiology section also provides a detailed analysis of the diagnosed patient pool and future trends.

Retinopathy of Prematurity Epidemiology Segmentation:
The Retinopathy of Prematurity market report proffers epidemiological analysis for the study period 2022-2036 in the 7MM segmented into:
• Total incident cases of preterm infants by birth weight (≤1,500 g)
• Total incident cases of Retinopathy of Prematurity
• Total treated cases (patients who went for initial treatment, patients who went for retreatment)

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Retinopathy of Prematurity Drugs Uptake and Pipeline Development Activities
The drugs uptake section focuses on the rate of uptake of the potential drugs recently launched in the Retinopathy of Prematurity market or expected to get launched during the study period. The analysis covers Retinopathy of Prematurity market uptake by drugs, patient uptake by therapies, and sales of each drug.
Moreover, the therapeutics assessment section helps understand the drugs with the most rapid uptake and the reasons behind the maximal use of the drugs. Additionally, it compares the drugs based on market share.
The report also covers the Retinopathy of Prematurity Pipeline Development Activities. It provides valuable insights about different therapeutic candidates in various stages and the key companies involved in developing targeted therapeutics. It also analyzes recent developments such as collaborations, acquisitions, mergers, licensing patent details, and other information for emerging therapies.

Retinopathy of Prematurity Therapies and Key Companies
• LUCENTIS (ranibizumab): Novartis
• EYLEA (aflibercept): Regeneron/Bayer
• FLQ-101: FeliQS Corporation
• IBP-1118: Infant Bacterial Therapeutics
• rhIGF-I/rhIGFBP-3: Shire
• OHB-607: OHB Neonatology

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Retinopathy of Prematurity Market Drivers
• Rising incidence of preterm births worldwide, increasing the population at risk for retinopathy of prematurity (ROP).
• Improving survival rates of extremely premature and low-birth-weight infants due to advances in neonatal intensive care.
• Growing awareness of the importance of early ROP screening and timely intervention to prevent childhood blindness.
• Expansion of neonatal intensive care units (NICUs) and specialized ophthalmic screening programs, particularly in emerging markets.
• Increasing adoption of advanced retinal imaging technologies and telemedicine for remote ROP diagnosis and monitoring.

Retinopathy of Prematurity Market Barriers
• Limited awareness and inadequate screening infrastructure in low- and middle-income countries, leading to delayed diagnosis.
• Shortage of trained pediatric ophthalmologists and retinal specialists capable of diagnosing and treating ROP.
• High costs associated with advanced retinal imaging systems, laser equipment, and specialized neonatal eye care.
• Lack of standardized screening protocols and variability in clinical practices across different regions.
• Potential safety concerns and long-term efficacy uncertainties associated with intravitreal anti-VEGF therapy in premature infants.

Scope of the Retinopathy of Prematurity Market Report
• Study Period: 2022-2036
• Coverage: 7MM [The United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom), and Japan]
• Key Retinopathy of Prematurity Companies:Novartis, Regeneron/Bayer, FeliQS Corporation, Infant Bacterial Therapeutics, Shire, OHB Neonatology, and others
• Key Retinopathy of Prematurity Therapies: LUCENTIS (ranibizumab), EYLEA (aflibercept), FLQ-101, IBP-1118, rhIGF-I/rhIGFBP-3, OHB-607, and others
• Retinopathy of Prematurity Therapeutic Assessment: Retinopathy of Prematurity current marketed and Retinopathy of Prematurity emerging therapies
• Retinopathy of Prematurity Market Dynamics: Retinopathy of Prematurity market drivers and Retinopathy of Prematurity market barriers
• Competitive Intelligence Analysis: SWOT analysis, PESTLE analysis, Porter's five forces, BCG Matrix, Market entry strategies
• Retinopathy of Prematurity Unmet Needs, KOL's views, Analyst's views, Retinopathy of Prematurity Market Access and Reimbursement

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