The Retinopathy of Prematurity (ROP) treatment market is poised for substantial growth in the coming years, fueled by advances in diagnostic technologies and the development of innovative therapies from leading companies like Novartis, Regeneron, Bayer, FeliQS Corporation, and Infant Bacterial Therapeutics.
DelveInsight’s “Retinopathy of Prematurity Market Insight, Epidemiology And Market Forecast – 2034” report provides a comprehensive analysis of ROP, covering historical and forecasted epidemiology and therapeutic market trends across the 7MM—the United States, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan. In 2023, the 7MM ROP market was valued at about USD 13 million, with the US accounting for roughly USD 8 million. The market is projected to grow steadily from 2024 to 2034, driven by novel therapies, improved neonatal care, increased awareness of early eye screenings for premature infants, and the rising incidence of premature births.
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DelveInsight’s analysis shows that the number of preterm infants (birth weight ≤1,500g) in the 7MM was about 94K in 2023, with cases expected to rise during 2020-2034. There is a declining trend in preterm births in Germany, Italy, and Spain. Among EU4 countries, Germany had the highest number of ROP cases in 2023, followed by France, while Spain had the lowest. Japan reported approximately 5K cases, with a forecasted increase.
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The current ROP treatment landscape is dominated by laser therapy, which generated the highest revenue in 2023 across the 7MM. Laser therapy is the standard of care to counter excessive vascular endothelial growth factor (VEGF) production in the retina. Anti-VEGF agents are valuable alternatives for infants who cannot undergo laser treatment. Presently, only two drugs are approved for ROP: EYLEA (Regeneron/Bayer) and LUCENTIS (Novartis). LUCENTIS targets VEGF-A, while EYLEA inhibits both VEGF-A and placental growth factor.
A noted treatment pattern is that only about 10% of total ROP patients in the US and Europe, representing severe cases, receive treatment. In contrast, approximately 30% of patients in Japan are treated, reflecting a more proactive approach. This difference highlights variations in clinical practices across these regions.
The ROP pipeline is in early development stages, focusing mainly on preventive therapies. FeliQS Corporation and Infant Bacterial Therapeutics are developing FLQ-101 and IBP-1118, respectively, both in preclinical phases for ROP prevention. The FDA granted Fast Track designation to FLQ-101 in November 2024, showing recognition of unmet needs. FeliQS raised USD 2.5 million in 2022 to advance FLQ-101 toward clinical trials, with a Phase 1b/2 study planned for 2025 in the US and Japan. FLQ-101 also received FDA Orphan Drug designation in 2024.
Recent progress includes the FDA’s acceptance in February 2025 of Alvotech’s biologics license application for AVT06, a proposed biosimilar to EYLEA. Regulatory approval is expected by late 2025, potentially expanding treatment access.
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Looking ahead, the ROP market growth will be supported by better screening technologies, preventive treatments, and increased awareness for early detection. New treatment approaches aim to provide faster, more efficient care in local NICUs without complex procedures or anesthesia. These alternatives may surpass traditional laser therapy, which is time-consuming and stressful. Anti-VEGF drugs like EYLEA offer quick, FDA-approved bedside options without the need for general anesthesia or expensive laser equipment.
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DelveInsight is a leading market research and consulting firm specializing in disease-specific insights and therapeutic market analysis. Their reports integrate real-world data, clinical trial findings, and expert interviews to deliver comprehensive industry intelligence.
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