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시장보고서
상품코드
2082863
미숙아 망막병증 : 시장 인사이트, 역학 및 시장 예측(2036년)Retinopathy of Prematurity - Market Insight, Epidemiology, and Market Forecast - 2036 |
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DelveInsight
주요 7개국에서 미숙아 망막병증(ROP)의 시장 규모 및 전망
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.
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)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 역학적 분석 및 예측에 관한 주요 조사 결과
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.
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.
Retinopathy of Prematurity (ROP) Market Size and Forecast in the 7MM
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) 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.
Comprehensive unmet needs insights in Retinopathy of Prematurity (ROP) and their strategic implications are provided in the full report.
Key Findings from Retinopathy of Prematurity (ROP) Epidemiological Analysis and Forecast
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
Retinopathy of Prematurity (ROP) Drug Updates
Drug Class Insights
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.
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.
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.
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.
Market Insights