Retinopathy of Prematurity Therapeutics Market: Early-Stage Pipeline and FDA Designations Signal Innovation Momentum, finds DelveInsight | Novartis, Regeneron, Bayer, FeliQS Corporation, Infant Bacterial Therapeutics

The Retinopathy of Prematurity treatment market is expected to witness significant growth in the coming years, primarily driven by advancements in diagnostic technologies and the development of novel therapeutics by key players such as Novartis, Regeneron, Bayer, FeliQS Corporation, and Infant Bacterial Therapeutics, among others. This growth trajectory is further supported by the rising awareness about Retinopathy of Prematurity management, improvements in neonatal care units, and increasing focus on preventive approaches for this potentially blinding condition that affects premature infants.

DelveInsight's "Retinopathy of Prematurity Market Insight, Epidemiology And Market Forecast - 2034" report delivers an in-depth understanding of ROP, historical and forecasted epidemiology, as well as the therapeutic market trends in the 7MM which include the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. The retinopathy of prematurity market size in the 7MM was approximately USD 13 million in 2023, with the US accounting for approximately USD 8 million of this value. The ROP market is expected to grow steadily during the forecast period (2024-2034), driven by the introduction of novel therapies, advancements in neonatal care, increasing awareness of the importance of early eye examinations for premature infants, and the rising prevalence of premature births.

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According to DelveInsight's analysis, the total number of incident cases of preterm infants by birth weight (≤1,500g) in the 7MM was approximately 94K in 2023, with these cases anticipated to increase during the study period of 2020-2034. Interestingly, there is a decreasing trend in preterm births (≤1,500g) in Germany, Italy, and Spain. Among the EU4 countries, Germany accounted for the highest number of incident cases of ROP, followed by France, whereas Spain had the lowest number of cases in 2023. Japan reported approximately 5K incident cases of ROP in 2023, with this number expected to rise during the forecast period.

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The report also explores the current and evolving retinopathy of prematurity treatment landscape. The current ROP treatment landscape primarily relies on laser therapy, which generated the highest revenue in the 7MM in 2023. Laser therapy has emerged as the standard of care aimed at countering the overproduction of vascular endothelial growth factor (VEGF) within the retina, a key factor contributing to the condition.

Anti-VEGF agents have become particularly valuable for infants for whom laser photocoagulation is difficult or impossible. Currently, there are only two retinopathy of prematurity approved drugs: EYLEA by Regeneron (NASDAQ: REGN)/Bayer (ETR: BAYN) and LUCENTIS by Novartis (SWX: NOVN). LUCENTIS is a humanized, high-affinity antibody fragment that binds to VEGF-A, while EYLEA is a VEGF inhibitor designed to block the growth of new blood vessels by targeting both VEGF-A and placental growth factor.

A notable treatment pattern observed is that only approximately 10% of the total ROP patients in the US and European countries, representing the severe and treatable pool, undergo any kind of treatment. In contrast, approximately 30% of ROP patients in Japan receive treatment, suggesting a more aggressive approach to management in this region. This difference highlights the variation in clinical practice across different healthcare systems, with Japanese ophthalmologists likely treating infants at an earlier stage of ROP compared to other countries.

The ROP pipeline is currently in the early stages of development, with most candidates focusing on preventive approaches rather than treatment. Key players such as FeliQS Corporation and Infant Bacterial Therapeutics (STO: IBT-B) are developing FLQ-101 and IBP-1118, respectively, both currently in preclinical stages for the retinopathy of prematurity prevention. In a significant development, the FDA granted Fast Track designation to FLQ-101 in November 2024, highlighting the recognition of unmet needs in this therapeutic area. FeliQS raised USD 2.5 million in 2022 to conduct pre-IND meetings with the FDA and manufacture the investigational drug, with a Phase 1b/2 study in both the US and Japan in the first quarter of 2025. In 2024, FLQ-101 also received Orphan Drug designation from the FDA.

Recent developments in the ROP market include the FDA's acceptance in February 2025 of Alvotech's biologics license application (BLA) for AVT06, a proposed biosimilar to EYLEA (Regeneron). Regulatory approval is expected to be completed in the fourth quarter of 2025, potentially expanding treatment options and improving accessibility.

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Looking ahead, the ROP market is expected to grow due to the development of better screening tools, the introduction of preventive treatments, and increased awareness about early detection. New treatment approaches for Retinopathy of Prematurity (ROP) aim to be faster and more efficient, allowing doctors to treat babies directly in local neonatal intensive care units (NICUs) without lengthy procedures or specialized anesthesia. These newer methods are expected to be more effective than traditional laser treatment, which, while helpful, can be stressful and time-consuming. Anti-VEGF drugs like EYLEA offer a quicker, FDA-approved alternative that can be given at the bedside without needing general anesthesia or costly laser equipment.

As research reveals more about the causes of ROP, new treatment options are likely to emerge, potentially changing how this serious eye condition is managed in vulnerable newborns.

Table of Contents
1. Key Insights
2. Report Introduction
3. Executive Summary of Retinopathy of Prematurity
4. Key Events
5. Retinopathy of Prematurity Epidemiology and Market Forecast Methodology
6. Retinopathy of Prematurity Market Overview at a Glance
7. Disease Background and Overview
8. Epidemiology and Patient Population of the 7MM
9. Retinopathy of Prematurity Patient Journey
10. Retinopathy of Prematurity Marketed Drugs
11. Key Competitors for Pre-clinical Assets
12. Retinopathy of Prematurity: 7MM Analysis
13. Retinopathy of Prematurity Unmet Needs
14. SWOT Analysis
15. KOL Views
16. Market Access and Reimbursement
17. Appendix
18. DelveInsight Capabilities
19. Disclaimer

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About DelveInsight
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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