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미숙아 망막병증 : 시장 인사이트, 역학 및 시장 예측(2036년)

Retinopathy of Prematurity - Market Insight, Epidemiology, and Market Forecast - 2036

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 113 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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영문목차

미숙아 망막병증(ROP)에 대한 인사이트와 동향

  • DelveInsight의 분석에 따르면, 2025년 미국의 미숙아 망막병증(ROP) 시장 규모는 약 900만 달러에 달할 것으로 전망됩니다.
  • 현재 ROP 선별 검사에서 주로 사용되는 방법은 양안 간접 검안경 검사에 의존하고 있습니다. 그러나 ROP의 유무나 치료 필요성을 판단하기 위해서는 경험이 풍부한 안과 의사의 판단에 크게 의존하고 있습니다. 따라서 간편하고 정확하며 효율적인 진단법을 확립하는 것이 매우 중요합니다.
  • ROP의 전반적인 질병 부담은 실제로 치료를 받고 있는 환자 수를 반드시 반영하는 것은 아닙니다. 미국과 유럽 국가에서는 중증이지만 치료가 가능한 ROP 환자 전체의 약 10%, 일본에서는 전체 ROP 환자의 약 30%가 어떤 형태로든 치료를 받고 있는 것으로 추정됩니다.
  • 레이저 치료는 ROP 치료의 표준 요법이며, 효과적인 치료 옵션으로 자리 잡았습니다. 이 접근법은 이 질환의 주요 원인인 망막 내 VEGF의 과잉 생성을 억제하는 것을 목적으로 합니다. 항-VEGF 제제는 레이저 광응고 요법이 어렵거나 불가능한 영아의 치료에 유용합니다.
  • ROP 치료제로 FDA 승인을 받은 약품으로는 루센티스(라니비주맙)와 아이레아(아플라벨셉트)가 있습니다. 레제네론사는 망막 질환 분야에서 쌓아온 경험을 바탕으로, 아이레아의 적응증을 미숙아 망막병증(ROP)으로 확대하기 위해 노력하고 있습니다. 이는 2023년 FDA가 미숙아의 ROP에 대한 효과적인 치료법으로 아이레아를 승인한 데서 비롯되었습니다.
  • 신속하고 효율적이며, 장시간의 시술이나 특수한 마취를 필요로 하지 않고, 각지의 신생아 집중치료실(NICU) 병상 옆에서 치료가 가능한 요법은, 레이저 광응고 요법과 같이 스트레스가 많고 시간이 많이 소요되는 접근법에 비해 성공 가능성이 높을 것으로 생각됩니다.
  • 일본에서는 조산아의 사망률은 낮지만, 치료가 필요한 미숙아 망막병증(ROP) 환자의 비율은 높습니다. 따라서 다른 국가들에 비해 일본의 안과 의사들은 ROP의 더 초기 단계에서 영아 치료를 실시하고 있는 것으로 보입니다. 또한, 최근에는 항혈관내피성장인자(anti-VEGF) 항체 요법이 일본의 많은 의료기관에서 널리 보급되고 있습니다.

주요 7개국에서 미숙아 망막병증(ROP)의 시장 규모 및 전망

  • 2025년 ROP 시장 규모 : 약 1,400만 달러
  • 2036년 ROP 시장 규모 전망 : 약 2,000만 달러
  • ROP 성장률(2026-2036년) : 연평균 성장률(CAGR) 3%

본 ROP 시장 보고서에서는 표준 치료, 임상 실무, 진화하는 치료 알고리즘 등 현재의 치료 상황에 대한 종합적인 분석을 제공합니다. 이 보고서는 ROP 환자의 부담 동향, 수익 및 시장 점유율 동향, 피크 시기의 환자 점유율 및 치료 도입률 분석을 평가하는 한편, 전 세계 각 지역의 시장 규모에 대한 상세한 평가와 성장률 예측(과거 데이터 및 2022-2036년 예측)을 제시하고 있습니다. 본 보고서에서는 ROP 분야의 주요 미충족 요구 사항을 부각시키고, 경쟁 환경 및 임상 상황을 분석하여 고부가가치의 성장 기회를 도출함으로써, 향후 시장 성장 가능성에 대한 명확한 전망을 제시하고 있습니다.

미숙아 망막병증(ROP) 시장을 주도하는 주요 요인

ROP 발생률의 증가

특히 극저체중(1,500g 이하) 조산아에서 ROP 발생률이 증가하는 것은 ROP 시장의 확장을 이끄는 주요 요인입니다. 미국에서는 2025년에 약 1만 8,200건의 ROP 신규 사례가 보고되었으며, 2026년부터 2036년까지 연평균 성장률(CAGR) 3%로 더욱 증가할 것으로 전망됩니다.

ROP 치료 기회의 확대

항-VEGF제의 유효성과 안전성을 뒷받침하는 새로운 증거가 밝혀짐에 따라, 비정상적인 망막 신생혈관을 억제하고 장기적인 시기능 예후를 개선하는 표적 치료에 주력하는 제약 기업들에게 비즈니스 기회가 확대되고 있습니다.

미숙아 망막병증(ROP)에 대한 이해와 치료 알고리즘

미숙아 망막병증(ROP)의 개요와 진단

ROP는 조산아(예정일보다 일찍 태어난 아기)나 출생 시 체중이 1,500g 미만인 아기에게 발생할 수 있는 안과 질환입니다. ROP는 망막(안구 뒤쪽에 위치한 빛에 민감한 조직층)에 비정상적인 혈관이 형성되면서 발병합니다. ROP를 앓는 아기 중에는 증상이 경미하여 치료 없이 회복되는 경우도 있습니다. 하지만 시력을 보호하고 실명을 예방하기 위해 치료가 필요한 아기들도 있습니다.

미숙아 망막병증(ROP)의 진단

ROP 진단은 전문 안과 의사가 실시하는 종합적인 안과 검사를 통해 이루어집니다. 이 검사에서는 영아의 동공을 확장시켜 망막 혈관을 평가합니다. 이 질환은 중증도, 발생 부위, 그리고 비정상적인 혈관 증식의 범위에 따라 단계별로 분류됩니다. 망막 영상 검사는 경과 관찰에 도움이 됩니다. 증상의 중증도에 따라 레이저 치료나 약물 요법 등의 치료법이 고려됩니다. 적절한 시기에 개입하고 시력 상실을 예방하기 위해서는 정기적인 경과 관찰이 필수적입니다.

미숙아 망막병증(ROP)의 치료

ROP를 앓는 영아의 대부분은 증상이 경미하며, 자연적으로 호전됩니다. 그러나 일부 영아의 경우, ROP의 진행을 막기 위해 치료가 필요합니다. 치료법으로는 주로 레이저 치료, 항VEGF 주사, 그리고 안과 수술이 있습니다. 다만, 중증 ROP로 진단된 경우에는 주로 두 가지 치료법이 사용됩니다. 첫 번째는 망막의 미성숙하거나 미발달된 부위에 레이저를 조사하는 치료법입니다. 이 치료법은 ROP 치료의 현재 표준 치료법입니다. 두 번째 치료법은 안구 내 약물 주사(베바시주맙, 라니비주맙, 아프리벨셉트 등이 사용됩니다)입니다. 이 약물 주사는 ROP에서 비정상적인 혈관 형성을 유발하는 신호를 차단합니다. 이러한 약제는 레이저 치료의 대안으로, 혹은 레이저 치료와 병행하여 사용되기도 합니다. 주사 치료는 레이저 치료에 비해 비교적 새로운 치료법입니다. ROP에 대한 레이저 치료나 주사 치료의 효과는 대개 양호하며, ROP로 인한 비정상적인 혈관은 사라집니다. 그러나 정확한 진단과 적시의 치료가 이루어지더라도 ROP가 악화되어 망막이 안구의 후벽에서 떨어져 나가는(망막박리) 경우가 있습니다.

미숙아 망막병증(ROP)의 역학

미숙아 망막병증(ROP)의 역학적 분석 및 예측에 관한 주요 조사 결과

  • DelveInsight사의 추산에 따르면, 주요 7개국에서 출생 체중별(1,500g 이하) 조산아의 신규 사례 총수는 2025년에 약 9만 4,500건이었습니다. 이 추산에 따르면, 2026년부터 2036년까지의 예측 기간 동안 이러한 사례 수는 증가할 것으로 예상됩니다.
  • EU4 및 영국 중에서 2025년 ROP 신규 환자 수가 가장 많았던 나라는 프랑스였고, 그 다음은 독일이었으며, 스페인은 가장 적었습니다.
  • 주요 7개국 중 2025년 시점에서 ROP 치료를 받고 있는 환자 수가 가장 많은 나라는 미국이며, 그 다음으로 일본이 뒤를 잇고, 반면 스페인이 가장 적은 상황입니다.

미숙아 망막병증(ROP) 시장의 전망

현재 ROP 치료의 표준 치료법은 레이저 치료입니다. ROP의 또 다른 중요한 치료법은 항-VEGF 주사입니다. 현재 미숙아 망막병증 치료제로 승인된 약물은 EYLEA(아플라벨셉트)와 LUCENTIS(라니비주맙) 두 가지뿐입니다.

소아의 중증 ROP에 직면했을 경우, 일반적으로 두 가지 치료법이 있습니다. 첫 번째 방법은 레이저를 이용해 망막의 발달이 미흡한 부위를 조사하는 것입니다. 오랜 기간에 걸쳐 그 효과가 입증된 이 접근법은, 오랫동안 ROP의 주요 치료법으로 사용되어 왔습니다. 또 다른 치료법은 항VEGF 제제(베바시주맙, 아이레아, 루센티스)를 안구 내부에 직접 주사하는 방법입니다. 이러한 주사는 ROP에서 비정상적인 혈관 증식을 유발하는 신호를 차단합니다. 경우에 따라서는 이러한 약제가 레이저 치료와 병용되거나, 그 대안으로 사용되기도 합니다. 이미 확립된 레이저 치료와 달리, 약물 주사는 비교적 새로운 치료법입니다.

ROP에 대한 레이저 치료와 주사 치료 모두 대부분의 경우 좋은 결과를 가져오며, 이 질환에 수반되는 비정상적인 혈관의 퇴축으로 이어집니다. 레이저 광응고 요법은 효과적이지만, 환자에게 부담이 될 뿐만 아니라 시간이 오래 걸릴 수도 있습니다. 이에 비해 아프리벨셉트는 즉각적인 효과가 있으며, FDA 승인을 받은 치료법으로서 일부 환자들에게는 더 이용하기 쉬운 선택지가 될 가능성이 있습니다. 중요한 점은, 이번 승인으로 인해 전신 마취나 소아 마취 전문의, 레이저 치료 장비에 대한 투자가 필요 없이 지역 NICU(신생아 집중 치료실)에서 병상 치료를 실시할 수 있게 되어, 치료 접근성이 향상된다는 것입니다.

그러나 신속한 진단과 적시의 조치가 이루어졌더라도, ROP가 완고하게 지속되어 망막이 안구의 후벽에서 박리되는(망막박리로 알려진 상태) 경우가 있습니다. 이러한 우려스러운 경과는 시력의 현저한 저하를 초래할 가능성이 있습니다. 그렇긴 하지만, 희망은 있습니다. 숙련된 망막 외과 의사는 전문적인 수술을 통해 ROP로 인한 망막박리를 치료할 수 있는 능력을 갖추고 있습니다.

  • 주요 7개국의 미숙아 망막병증 시장 규모는 2025년에 약 1,400만 달러에 달할 것으로 전망됩니다.
  • EU4 국가 중에서는 2025년에 독일이 가장 큰 시장 규모를 차지하는 반면, 스페인은 최하위를 기록하고 있습니다.
  • 2025년, 주요 7개국에서 가장 높은 수익을 창출한 것은 레이저 치료였습니다.
  • 항-VEGF 제제 중에서는 베바시주맙이 가장 많이 사용되고 있으며(전체 VEGF 제제의 약 80%), 그 다음으로 유럽과 일본에서 승인되었으나 미국에서는 적응증 외 사용되고 있는 루센티스가 뒤를 잇습니다. 한편, 아이레아는 모든 국가에서 가장 최근에 승인된 의약품입니다. 비용 대비 효과 측면에서 볼 때, 베바시주맙이 가장 경제적인 선택지입니다.
  • 항-VEGF 제제인 아프리벨셉트는 비정상적인 망막 신생혈관 형성을 억제하는 VEGF 억제제로, 질환의 진행을 늦추며 ROP 치료의 주요 치료법으로서 약물 요법의 위상을 확립하고 있습니다.
  • 단일클론 항체인 라니비주맙은 VEGF-A를 선택적으로 억제하여 망막 예후를 개선하는 동시에 우수한 안전성 프로파일을 보여줌으로써, ROP 관리에서 표적 생물학적 제제의 역할을 입증하고 있습니다.
  • 새로운 신호 전달 경로를 표적으로 하는 치료법 : IGF-1 아날로그 및 신규 항염증제(예 : TREM-1 억제제)는 정상적인 혈관 발달을 회복시키고 염증을 완화하는 것을 목적으로 하며, ROP 관리에 있어 차세대 접근법으로 자리 잡고 있습니다.

생물학적 제제, 특히 항-VEGF 제제는 ROP 분야의 현재 혁신 동향을 특징짓고 있지만, 새로운 신호 전달 경로를 표적으로 하는 치료법은 향후 파이프라인 확대를 주도하고 장기적인 예후를 개선할 것으로 기대됩니다.

자주 묻는 질문

  • 미숙아 망막병증(ROP) 시장 규모는 어떻게 예측되나요?
  • 미숙아 망막병증(ROP) 치료에 사용되는 주요 약물은 무엇인가요?
  • 미숙아 망막병증(ROP)의 주요 치료법은 무엇인가요?
  • 미숙아 망막병증(ROP)의 발생률은 어떻게 되나요?
  • 미숙아 망막병증(ROP) 치료의 최신 동향은 무엇인가요?

목차

제1장 주요 인사이트

제2장 소개

제3장 주요 요약

제4장 주요 사건

제5장 역학 및 시장 예측 조사 방법

제6장 미숙아 망막병증 : 시장 개요

제7장 미숙아 망막병증(ROP) 배경과 개요

제8장 미숙아 망막병증(ROP) 역학 및 환자 인구

제9장 미숙아 망막병증(ROP) 환자 경과

제10장 시판 치료제

제11장 미숙아 망막병증(ROP)의 새로운 경쟁 구도

제12장 미숙아 망막병증(ROP) : 주요 7개국 해석

제13장 미충족 수요 : 미숙아 망막병증(ROP)

제14장 미숙아 망막병증(ROP) SWOT 분석

제15장 미숙아 망막병증(ROP)에 관한 KOL의 견해

제16장 미숙아 망막병증(ROP) 시장 진입과 상환

제17장 부록

제18장 DelveInsight의 서비스 내용

제19장 면책사항

제20장 DelveInsight 소개

KSM 26.07.20

Retinopathy of Prematurity (ROP) Insights and Trends

  • According to DelveInsight's analysis, the total market size of Retinopathy of Prematurity (ROP) in the United States is approximately USD 9 million in 2025.
  • Currently, the primary approach for ROP screening relies on binocular indirect ophthalmoscopy. However, determining the presence of ROP and the need for treatment heavily relies on experienced ophthalmologists. Hence, it is crucial to create a straightforward, precise, and efficient diagnostic method.
  • The overall disease burden of ROP does not signify the actual number of patients going for treatment, as ~10% of the total ROP patients, which represents the severe and treatable pool, in the US and European countries, and ~30% of the total ROP patients in Japan are estimated to undergo any kind of treatment.
  • Laser therapy is a standard of care for treating ROP and has emerged as a viable treatment option for ROP. This approach aims to counter the overproduction of VEGF within the retina, a key factor contributing to the condition. Anti-VEGF agents are useful in infants for whom laser photocoagulation is difficult or impossible.
  • 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.
  • Therapies that are both swift and efficient, enabling treatment at the bedside in local Neonatal Intensive Care Units (NICUs) without requiring lengthy procedures or specialized anesthesia, are more likely to achieve success compared to stressful and time-consuming approaches such as laser photocoagulation.
  • Although preterm infant mortality is low, the proportion of patients with treatment-requiring retinopathy of prematurity is high in Japan. Thus, it is likely that compared to other countries, ophthalmologists in Japan treat infants at an earlier stage of ROP. Additionally, in recent times, anti-vascular endothelial growth factor (anti-VEGF) antibody treatment has become widespread in many facilities in Japan.

Retinopathy of Prematurity (ROP) Market Size and Forecast in the 7MM

  • 2025 ROP Market Size: ~USD 14 million
  • 2036 Projected ROP Market Size: ~USD 20 million
  • ROP Growth Rate (2026-2036): 3% CAGR

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

The ROP market report delivers a comprehensive analysis of the current treatment landscape, including standards of care, clinical practices, and evolving therapeutic algorithms. It evaluates ROP patient burden trends, revenue & market share dynamics, peak patient share & therapy uptake analysis, and provides an in-depth market size assessment, and growth rate projections (Historical & Forecast 2022-2036) across global regions. The report highlights key unmet medical needs in ROP and maps the competitive and clinical landscape to uncover high-value opportunities, providing a clear outlook on future market growth potential.

Key Factors Driving the Retinopathy of Prematurity (ROP) Market

Rising ROP Incidence

The increasing incidence of ROP, particularly among preterm infants of very low birth weight (<=1,500 g), is a primary driver of ROP market expansion. In the US, in 2025, there were ~18,200 incident cases of ROP, which will further reach by 3% CAGR (2026-2036).

Rising Opportunities in ROP Therapies

Emerging evidence supporting the efficacy and safety of anti-VEGF agents highlights a growing opportunity for drug developers to focus on targeted therapies that inhibit abnormal retinal angiogenesis and improve long-term visual outcomes.

Emerging ROP Competitive Landscape

The ROP market is evolving with new therapies, advanced diagnostics, and a growing focus on early detection and prevention. Some of the ROP drugs in clinical trials include FLQ-101 (FeliQS Corporation), IBP-1118 (Infant Bacterial Therapeutics), and others.

Retinopathy of Prematurity (ROP) Understanding and Treatment Algorithm

Retinopathy of Prematurity (ROP) Overview and Diagnosis

ROP is an eye disease that can happen in premature babies (born early) or those who weigh less than 1,500 g at birth. ROP happens when abnormal blood vessels grow in the retina (the light-sensitive layer of tissue in the back of the eye). Some babies with ROP have mild cases and get better without treatment. However, some babies need treatment to protect their vision and prevent blindness.

Retinopathy of Prematurity (ROP) Diagnosis

ROP is diagnosed through a comprehensive eye exam by a specialized ophthalmologist. This exam involves dilating the infant's pupils to assess the retina's blood vessels. The disease is categorized into stages based on severity, location, and extent of abnormal vessel growth. Retinal imaging may aid in monitoring. Depending on the severity, treatment options such as laser therapy or medication are considered. Regular follow-up exams are crucial for timely intervention and to prevent vision loss.

Retinopathy of Prematurity (ROP) Treatment

Many infants with ROP have mild cases that improve on their own. However, some infants require treatment to prevent the progression of ROP. Treatment options primarily encompass laser therapy, anti-VEGF injections, and ocular surgery. However, mainly two options are used for treatment once it is confirmed that a child has severe ROP. The first treatment type is the laser, applied to the immature or undeveloped part of the retina. This treatment is the current standard of care for the treatment of ROP. The second type of treatment is an injection of medication (bevacizumab, ranibizumab, and aflibercept have been used) into the eye. This medication injection stops a signal causing the abnormal blood vessels in ROP to form. These medications may be used as an alternative to, or in addition to, laser treatment. The injection is a newer treatment than the laser treatment. The effect of laser or injection treatment for ROP is usually good, with the disappearance of abnormal blood vessels from ROP. However, even with good diagnosis and timely treatment, the ROP sometimes worsens, and the retina pulls away from the back of the eye (a retinal detachment).

Retinopathy of Prematurity (ROP) Unmet Needs

The section "unmet needs of Retinopathy of Prematurity (ROP)" outlines the critical gaps between the current state of patient care, diagnosis, and the ideal & effective management of the disease. It highlights the obstacles experienced by patients, clinicians, and researchers and identifies potential solutions for future progress.

1. Lack of emerging therapies in the pipeline

2. Long-term follow-up and monitoring

3. Lack of long-term safety effects of anti-VEGF agents in infants

4. Limited treatment options and others.....

Comprehensive unmet needs insights in Retinopathy of Prematurity (ROP) and their strategic implications are provided in the full report.

Retinopathy of Prematurity (ROP) Epidemiology

Key Findings from Retinopathy of Prematurity (ROP) Epidemiological Analysis and Forecast

  • 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.

Retinopathy of Prematurity (ROP) Drug Chapters & Competitive Analysis

The ROP drug chapter provides a detailed, market-focused review of approved therapies and the emerging pipeline across Phase I-III clinical trials. It covers the mechanism of action, clinical trial data, regulatory approvals, patents, collaborations, and strategic partnerships for each therapy, along with their advantages, limitations, and recent developments. This section offers critical insights into the ROP treatment landscape, supporting market assessment, competitive analysis, and growth forecasting for the ROP therapeutics market.

Approved Therapies for Retinopathy of Prematurity (ROP)

LUCENTIS (ranibizumab): Novartis

LUCENTIS (ranibizumab) is a humanized, high-affinity antibody fragment that binds to vascular endothelial growth factor A (VEGF-A), a protein that can cause the growth of blood vessels in the eye, potentially leading to vision loss. LUCENTIS is an anti-VEGF therapy that is injected into the eye. It is approved in the EU, JP, and other countries to treat patients with ROP. LUCENTIS is indicated in preterm infants for the treatment of ROP with Zone I (Stage 1+, 2+, 3 or 3+), Zone II (Stage 3+), or AP-ROP (aggressive posterior Retinopathy of Prematurity) disease.

EYLEA (aflibercept): Regeneron/Bayer

EYLEA is a VEGF inhibitor formulated as an injection for the eye. It is designed to block the growth of new blood vessels and decrease the ability of fluid to pass through blood vessels (vascular permeability) in the eye by blocking VEGF-A and placental growth factor (PLGF), two growth factors involved in ocular angiogenesis. Regeneron and Bayer are jointly developing EYLEA. The lead sponsors of the trials were Regeneron for BUTTERFLEYE and Bayer for FIREFLEYE. Bayer and Regeneron are collaborating on the global development of EYLEA. Regeneron maintains exclusive rights to EYLEA in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies share the profits from sales of EYLE equally.

Retinopathy of Prematurity (ROP) Pipeline Analysis

There are only a few candidates in the pipeline for ROP at the moment. Among them, the majority of candidates are in the preclinical stage of investigation, focusing on the preventive options of ROP. Key players, such as FeliQS Corporation (FLQ-101) and Infant Bacterial Therapeutics (IBP-1118), are developing therapies for the prevention of ROP.

Retinopathy of Prematurity (ROP) Key Players, Market Leaders and Emerging Companies

  • Regeneron Pharmaceuticals
  • Novartis
  • Bayer
  • Genentech
  • FELIQS Corporation, and others

Retinopathy of Prematurity (ROP) Drug Updates

  • 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.

Drug Class Insights

Retinopathy of Prematurity (ROP) Market Outlook

Currently, the standard of care for treating ROP is laser treatment. The other important treatment for ROP is the use of anti-VEGF injections. Currently, there are only two drugs, namely, EYLEA (aflibercept) and LUCENTIS (ranibizumab), approved for the treatment of Retinopathy of Prematurity.

When faced with severe ROP in a child, there are generally two avenues of treatment. The first method involves using a laser to target the underdeveloped regions of the retina. This time-tested approach has been the go-to solution for ROP for many years. Alternatively, the second treatment option involves injecting anti-VEGF injections (Bevacizumab, EYLEA, and LUCENTIS) directly into the eye. These injections intercept the signals that trigger abnormal blood vessel growth in ROP. Sometimes, these medications are used either in conjunction with or as an alternative to laser treatment. Unlike well-established laser therapy, medication injections are a relatively newer approach.

Both laser and injection treatments for ROP often yield positive outcomes, leading to the regression of the abnormal blood vessels associated with the condition. While effective, laser photocoagulation may not only be stressful but can also be time-consuming. In comparison, aflibercept works rapidly and provides an FDA-approved treatment that may be more accessible for some patients. Importantly, this approval improves access to care by allowing bedside treatment at the local NICU without the need for general anesthesia, pediatric anesthesia specialists, and investment in laser infrastructure.

However, even with swift diagnosis and timely intervention, there are instances where ROP stubbornly persists, and the retina detaches from the back of the eye-a condition known as retinal detachment. This distressing development can result in severely compromised vision. Nevertheless, there is hope: skilled retina surgeons are equipped to address retinal detachment caused by ROP through specialized surgery.

  • 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.

Drug Class/Insights into Leading Emerging and Marketed Therapies in Retinopathy of Prematurity (ROP) (2022-2036 Forecast)

The ROP market comprises anti-VEGF biologics and emerging targeted approaches alongside conventional laser therapy and supportive care, each addressing abnormal retinal angiogenesis and vascular dysregulation in premature infants.

  • Anti-VEGF: Aflibercept is a VEGF inhibitor that suppresses abnormal retinal neovascularization, reducing disease progression and establishing pharmacological intervention as a key treatment modality in ROP.
  • Monoclonal antibody: Ranibizumab selectively inhibits VEGF-A, improving retinal outcomes and supporting the role of targeted biologics in managing ROP with a favorable safety profile.
  • Emerging pathway-targeted therapies: IGF-1 analogs and novel anti-inflammatory agents (e.g., TREM-1 inhibitors) aim to restore normal vascular development and reduce inflammation, representing next-generation approaches in ROP management.

Biologics, particularly anti-VEGF agents, define the current innovation landscape in ROP, while emerging pathway-targeted therapies are expected to drive future pipeline expansion and improve long-term outcomes.

Retinopathy of Prematurity (ROP) Drug Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during the forecast period (2026-2036). The analysis covers the ROP market's uptake by drugs, patient uptake by therapy, and sales of each drug.

The uptake of therapies in ROP is expected to vary across anti-VEGF biologics, emerging pharmacological agents, and conventional laser-based interventions. Recently approved therapies such as Aflibercept demonstrate increasing uptake, while Ranibizumab is anticipated to show moderate but steady adoption, supported by strong clinical efficacy, targeted VEGF inhibition, and growing physician confidence in pharmacologic management of ROP. Their adoption is largely driven by the limitations of laser photocoagulation, particularly in preserving peripheral vision and reducing long-term complications in premature infants.

In comparison, other therapies such as off-label Bevacizumab are expected to maintain significant but variable uptake due to cost advantages and real-world experience, while next-generation approaches (including sustained-release anti-VEGF agents and IGF-1-targeted therapies) are projected to show gradual but progressive uptake as clinical evidence evolves and these therapies become integrated into neonatal care practices.

Retinopathy of Prematurity (ROP) Therapies Price Scenario & Trends

Pricing and analogue assessment of ROP therapies highlights evolving price dynamics structures. This section summarizes the cost of approved treatments, the closest and most appropriate analogue selection for emerging therapies, and the understanding of how pricing influences market access, adherence, and long-term uptake.

  • Pricing of Retinopathy of Prematurity (ROP) Approved Drugs

The recommended dose of EYLEA is 0.4 mg via intravitreal injection. Treatment begins with a single injection per eligible eye, which may be administered bilaterally on the same day. Assuming US pricing, EYLEA is estimated to cost approximately USD 1,850 to USD 2,000 per injection.

Further details are provided in the final report....

Industry Experts and Physician Views for Retinopathy of Prematurity (ROP)

To keep up with ROP market trends, we take Key Opinion Leaders (KOLs) and Subject Matter Experts (SMEs) opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on the ROP emerging therapies, evolving treatment landscape, patient adherence to conventional therapies, therapy switching trends, drug adoption and uptake, accessibility challenges, and epidemiology and real-world prescription patterns in ROP, including MD, PhD, Instructor, Postdoctoral Researcher, Professor, Researcher, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 6+ KOLs in the 7MM. Centers such as the Stanley Manne Children's Research Institute, Lurie Children's Hospital of Chicago, and National Eye Institute, National Institutes of Health, Bethesda, USA, etc., were contacted. Their opinion helps understand and validate current and emerging ROP therapies, highlight unmet medical needs, provide epidemiological context, and support strategic decisions for market access, therapy adoption, and pipeline prioritization in ROP.

Qualitative Analysis: SWOT and Conjoint Analysis

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and conjoint analysis.

In the SWOT analysis of Retinopathy of Prematurity (ROP), strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided

Conjoint analysis analyzes emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy.

The team of analysts analyzes promising emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. In efficacy, the trial's primary and secondary outcome measures are evaluated, whereas the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are mainly observed. In addition, the scoring is also based on the route of administration, order of entry, probability of success, and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, a descriptive overview of ROP, explaining its causes, signs and symptoms, pathogenesis, and currently available treatments.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, and disease progression along treatment guidelines.
  • Additionally, an all-inclusive account of both the current and emerging treatments, along with the elaborative profiles of late-stage and prominent therapies, will have an impact on the current treatment landscape.
  • A detailed review of the ROP market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
  • The report provides an edge while developing business strategies by understanding trends through SWOT analysis and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM ROP market.

Report Insights

  • Retinopathy of Prematurity (ROP) Patient Population Forecast
  • Retinopathy of Prematurity (ROP) Therapeutics Market Size
  • Retinopathy of Prematurity (ROP) Pipeline Analysis
  • Retinopathy of Prematurity (ROP) Market Size and Trends
  • Retinopathy of Prematurity (ROP) Market Opportunity (Current and forecasted)

Report Key Strengths

  • Epidemiology-based (Epi-based) Bottom-up Forecasting
  • Artificial Intelligence (AI)-enabled Market Research Report
  • 11-year forecast
  • Retinopathy of Prematurity (ROP) Market Outlook (North America, Europe, Asia-Pacific)
  • Patient Burden Trends (by geography)
  • Retinopathy of Prematurity (ROP) Treatment Addressable Market (TAM)
  • Retinopathy of Prematurity (ROP) Competitive Landscape
  • Retinopathy of Prematurity (ROP) Major Companies Insights
  • Retinopathy of Prematurity (ROP) Price Trends and Analogue Assessment
  • Retinopathy of Prematurity (ROP) Therapies Drug Adoption/Uptake
  • Retinopathy of Prematurity (ROP) Therapies Peak Patient Share Analysis

Report Assessment

  • Retinopathy of Prematurity (ROP) Current Treatment Practices
  • Retinopathy of Prematurity (ROP) Unmet Needs
  • Retinopathy of Prematurity (ROP) Clinical Development Analysis
  • Retinopathy of Prematurity (ROP) Emerging Drugs Product Profiles
  • Retinopathy of Prematurity (ROP) Market Attractiveness
  • Retinopathy of Prematurity (ROP) Qualitative Analysis (SWOT and Conjoint Analysis)

FAQs:

Market Insights

  • What was the Retinopathy of Prematurity (ROP) market size, the market size by therapies, market share (%) distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • What are the anticipated pricing variations among different geographies for the emerging therapies in the future?
  • What can be the future treatment paradigm of Retinopathy of Prematurity (ROP)?
  • What are the disease risks, burdens, and unmet needs of Retinopathy of Prematurity (ROP)? What will be the growth opportunities across the 7MM concerning the patient population with Retinopathy of Prematurity (ROP)?
  • Who is the major future competitor in the market, and how will the competitors affect their market share?
  • What are the current options for the treatment of Retinopathy of Prematurity (ROP)? What are the current guidelines for treating Retinopathy of Prematurity (ROP) in the US, Europe, and Japan?

Reasons to Buy:

  • The report will help in developing business strategies by understanding the latest trends and changing treatment dynamics driving the Retinopathy of Prematurity (ROP) market.
  • Bottom up forecasting builds from the affected population to product forecasts, delivering a robust, data driven approach ideal for new therapies and novel classes.
  • Insights on patient burden/disease incidence, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Detailed analysis and ranking of class-wise potential current and emerging therapies under the conjoint analysis section to provide visibility around leading classes.
  • To understand KOLs' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.
  • This Artificial Intelligence (AI) enabled report summarize and simplify complex datasets within the report into clear, actionable insights for stakeholders, investors, and healthcare providers, enabling faster, data driven decisions.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary

4. Key Events

  • 4.1. Upcoming Key Catalysts
  • 4.2. Key Transactions And Collaborations
  • 4.3. News Flow

5. Epidemiology and Market Forecast Methodology

6. ROP Market Overview at a Glance

  • 6.1. Emerging Landscape Analysis (By Phase, Molecule Type, and RoA)
  • 6.2. Market Share (%) Distribution of ROP By Therapies in the 7MM, in 2025
  • 6.3. Market Share (%) Distribution of ROP By Therapies in the 7MM, in 2036

7. Disease Background and Overview of Retinopathy of Prematurity (ROP)

  • 7.1. Introduction
  • 7.2. Causes
  • 7.3. Sign and Symptoms
  • 7.4. Pathophysiology
  • 7.5. Diagnosis
  • 7.6. Treatment Management of Retinopathy of Prematurity
    • 7.6.1. American Academy of Pediatrics (AAP)
      • 7.6.1.1. Screening Guidelines
      • 7.6.1.2. Treatment Guidelines
    • 7.6.2. Royal College of Pediatrics and Child Health (RCPCH)
      • 7.6.2.1. Screening Guidelines
      • 7.6.2.2. Treatment Guidelines
    • 7.6.3. Japanese Ophthalmological Society
      • 7.6.3.1. Guidelines for Follow-up after Intravitreal Injection of Ranibizumab

8. Epidemiology and Patient Population of Retinopathy of Prematurity (ROP)

  • 8.1. Key Findings
  • 8.2. Assumptions and Rationale
  • 8.3. Total Incident Cases of Retinopathy of Prematurity in the 7MM
  • 8.4. United States
    • 8.4.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in the United States
    • 8.4.2. Total Incident Cases of Retinopathy of Prematurity in the United States
    • 8.4.3. Total Treated Cases of Retinopathy of Prematurity in the United States
  • 8.5. EU4 and the UK
    • 8.5.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in EU4 and the UK
    • 8.5.2. Total Incident Cases of Retinopathy of Prematurity in EU4 and the UK
    • 8.5.3. Total Treated Cases of Retinopathy of Prematurity in EU4 and the UK
  • 8.6. Japan
    • 8.6.1. Total Incident Cases of Preterm Infants by Birth Weight (=1,500g) in Japan
    • 8.6.2. Total Incident Cases of Retinopathy of Prematurity in Japan
    • 8.6.3. Total Treated Cases of Retinopathy of Prematurity in Japan

9. Patient Journey of Retinopathy of Prematurity (ROP)

10. Marketed Therapies

  • 10.1. Marketed Competitive Landscape of Retinopathy of Prematurity (ROP)
  • 10.2. LUCENTIS (ranibizumab): Novartis
    • 10.2.1. Drug Description
    • 10.2.2. Regulatory Milestones
    • 10.2.3. Other Developmental Activities
    • 10.2.4. Summary of Pivotal Trials
    • 10.2.5. Clinical Development
      • 10.2.5.1. Clinical Trial Information
    • 10.2.6. Analyst's Views
  • 10.3. EYLEA (aflibercept): Regeneron/Bayer
    • 10.3.1. Drug Description
    • 10.3.2. Regulatory Milestones
    • 10.3.3. Other Developmental Activities
    • 10.3.4. Summary of Pivotal Trials
    • 10.3.5. Clinical Development
      • 10.3.5.1. Clinical Trial Information
    • 10.3.6. Analyst's Views

11. Emerging Competitive Landscape of Retinopathy of Prematurity (ROP)

12. Retinopathy of Prematurity (ROP): 7MM Analysis

  • 12.1. Key Findings
  • 12.2. Market Outlook of Retinopathy of Prematurity (ROP)
  • 12.3. Key Market Forecast Assumptions
    • 12.3.1. Cost Assumptions
  • 12.4. Conjoint Analysis of Retinopathy of Prematurity (ROP)
  • 12.5. Total Market Size of ROP in the 7MM
  • 12.6. Total Market Size of ROP by Therapies in the 7MM
  • 12.7. The United States
    • 12.7.1. Total Market Size of ROP in the United States
    • 12.7.2. Total Market Size of ROP by Therapies in the United States
  • 12.8. EU4 and the UK
    • 12.8.1. Total Market Size of ROP in EU4 and the UK
    • 12.8.2. Total Market Size of ROP by Therapies in EU4 and the UK
  • 12.9. Japan
    • 12.9.1. Total Market Size of ROP in Japan
    • 12.9.2. Total Market Size of ROP by Therapies in Japan

13. Unmet Needs of Retinopathy of Prematurity (ROP)

14. SWOT Analysis of Retinopathy of Prematurity (ROP)

15. KOL Views of Retinopathy of Prematurity (ROP)

16. Market Access and Reimbursement of Retinopathy of Prematurity (ROP)

  • 16.1. The United States
  • 16.1. EU4 and the UK
    • 16.2.1. Germany
    • 16.2.2. France
    • 16.2.3. Italy
    • 16.2.4. Spain
    • 16.2.5. United Kingdom
  • 16.3. Japan
  • 16.4. Summary and comparison of Market Access and Pricing Policy Developments in 2025
  • 16.5. Market Access and Reimbursement of ROP Therapies

17. Appendix

  • 17.1. Bibliography
  • 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer

20. About DelveInsight

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