미숙아 망막증: 시장 인사이트, 역학, 시장 예측(2032년)

Key Highlights:

• The total market size of Retinopathy of Prematurity (ROP) in the United States is approximately USD 8 million in 2022.
• The most important risk factor for developing Retinopathy of Prematurity is the baby's age and weight at birth. Especially children with gestational age at birth below 31 weeks or a birth weight of less than 1,500 g are prone to developing Retinopathy of Prematurity.
• In numerous European nations, the absence of a comprehensive registry detailing the incidence of Retinopathy of Prematurity has been evident. Instead, many of these countries rely on separate databases that are inconsistently published, further exacerbating the difficulty in establishing standardized data for specific timeframes. This lack of a unified registry hampers efforts to systematically analyze and compare Retinopathy of Prematurity incidence across different regions.
• Currently, the primary approach for Retinopathy of Prematurity screening relies on binocular indirect ophthalmoscopy. However, determining the presence of Retinopathy of Prematurity 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 Retinopathy of Prematurity does not signify the actual number of patients going for treatment as ~10% of the total Retinopathy of Prematurity patients, which represents the severe and treatable pool, in the US and the European countries, and ~30% of the total Retinopathy of Prematurity patients in Japan are estimated to undergo any kind of treatment.
• Laser therapy is a standard of care for treating Retinopathy of Prematurity and has emerged as a viable treatment option for Retinopathy of Prematurity. 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.
• 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.
• Regeneron is leveraging its experience in retinal diseases with EYLEA's label expansion in Retinopathy of Prematurity.
• Although preterm infant mortality is low, the proportion of patients with treatment-requiring retinopathy of prematurity (TR-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 Retinopathy of Prematurity. Additionally, in recent times, anti-vasoendothelial growth factor (anti-VEGF) antibody treatment has become widespread in many facilities in Japan.

DelveInsight's "Retinopathy of Prematurity (ROP) - Market Insights, Epidemiology and Market Forecast - 2032" report delivers an in-depth understanding of Retinopathy of Prematurity, historical and forecasted epidemiology as well as Retinopathy of Prematurity market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Retinopathy of Prematurity market report provides current treatment and prevention practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Retinopathy of Prematurity market size from 2019 to 2032. The report also covers current Retinopathy of Prematurity treatment practices/algorithms, prophylactic treatment, and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2019-2032

Retinopathy of Prematurity Disease Understanding and Treatment Algorithm

Retinopathy of Prematurity Overview

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

Retinopathy of Prematurity Diagnosis

Retinopathy of Prematurity 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.

Further details related to diagnosis are provided in the report…

Retinopathy of Prematurity Treatment

Many infants with Retinopathy of Prematurity have mild cases that improve on their own. However, some infants require treatment to prevent the progression of Retinopathy of Prematurity. 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 Retinopathy of Prematurity. 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 Retinopathy of Prematurity. 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 Retinopathy of Prematurity 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 Retinopathy of Prematurity is usually good with the disappearance of abnormal blood vessels from Retinopathy of Prematurity. However, even with good diagnosis and timely treatment, the Retinopathy of Prematurity sometimes worsens, and the retina pulls away from the back of the eye (a retinal detachment).

Retinopathy of Prematurity Epidemiology

As the market is derived using a patient-based model, the Retinopathy of Prematurity epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of preterm infants by birth weight (=1,500 g), total incident cases of Retinopathy of Prematurity and total treated cases (patients who went for initial treatment, patient who went for retreatment) of Retinopathy of Prematurity in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2019 to 2032.

• The total number of incident cases of preterm infants by birth weight (=1,500 g) in the 7MM was ~94,000 in 2022. As per the estimate, the incident cases of preterm infants by birth weight (=1,500 g) in the 7MM are anticipated to increase during the study period of 2019-2032.
• There is a decreasing trend in preterm births (=1,500 g) in Germany, Italy, and Spain.
• The total number of incident cases of Retinopathy of Prematurity in the US was ~18,000 in 2022 and is expected to increase during the forecast period.
• Among the EU4, Germany accounted for the highest number of incident cases of Retinopathy of Prematurity, followed by France, whereas Spain accounted for the lowest number of cases in 2022.
• The total number of incident cases of Retinopathy of Prematurity in Japan was ~5,000 in 2022 and is expected to increase during the forecast period.

Retinopathy of Prematurity Drug Chapters

The drug chapter segment of the Retinopathy of Prematurity report encloses a detailed analysis of the Retinopathy of Prematurity-marketed drugs. It also helps understand the Retinopathy of Prematurity pivotal clinical trial details, recent and expected market approvals, patent details, advantages and disadvantages of each included drug, the latest news, and recent deals and collaborations. The key players for Retinopathy of Prematurity are currently in the early stages of development.

Marketed Drug

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 Retinopathy of Prematurity. LUCENTIS is indicated in preterm infants for the treatment of Retinopathy of Prematurity 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 of EYLEA in the United States. Bayer has licensed exclusive marketing rights outside the United States, where the companies share equally the profits from sales of EYLE.

Emerging Drug

There are only a few candidates in the pipeline for Retinopathy of Prematurity 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 Retinopathy of Prematurity.

Note: Detailed therapies assessment will be provided in the final report.

Retinopathy of Prematurity Market Outlook

Currently, the standard of care for treating Retinopathy of Prematurity is laser treatment. The other important treatment for Retinopathy of Prematurity 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 Retinopathy of Prematurity 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 Retinopathy of Prematurity 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 Retinopathy of Prematurity. 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 Retinopathy of Prematurity 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 Retinopathy of Prematurity 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 Retinopathy of Prematurity through specialized surgery.

• The total market size of Retinopathy of Prematurity in the 7MM is approximately ~USD 13 million in 2032.
• Among EU4, Germany accounts for the largest market size in 2022, while Spain occupies the bottom of the ladder.
• In 2022, 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.
• FELIQS raised 2.5 USD million in 2022 to conduct a pre-IND meeting with FDA and manufacture the investigational drug (FLQ-101). FELIQS is expected to initiate the clinical trial of FLQ-101 for treating Retinopathy of Prematurity in the US by 2024.

Retinopathy of Prematurity Pipeline Development Activities

The report provides insights into therapeutic candidates in the different stages. It also analyzes key players involved in developing targeted therapeutics.

KOL Views

To keep up with current market trends, we take KOLs and SMEs' opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the Retinopathy of Prematurity evolving preventive treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along with challenges related to accessibility, including ophthalmologists, HCPs, Physicians, and others.

DelveInsight's analysts connected with 10+ KOLs to gather insights; however, interviews were conducted with 5+ KOLs in the 7MM. Centers such as National Eye Institute, National Institutes of Health, Bethesda, USA, Stanley Manne Children's Research Institute, United Kingdom, MD, Ophthalmology - Oakland, USA, North Shore University Health System, MD, Lurie Children's Hospital of Chicago, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Retinopathy of Prematurity market trends. This will support the clients in potential upcoming novel prophylactic treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Analyst views. In the SWOT analysis, 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. These pointers are based on the analyst's discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement is the price negotiation between the manufacturer and payer that allows the manufacturer access to that market. It is provided to reduce the high costs and make essential drugs affordable. In the US healthcare system, both Public and Private health insurance coverage are included. In addition, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs, including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces, are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), third-party organizations that provide services and educational programs to aid patients are also present. Ranibizumab is recommended to be available as a routine commissioning treatment option, where diode laser treatment is unsuitable, for neonates with Retinopathy of Prematurity within the criteria set out in this document.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of currently used therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

• The report covers key events, an executive summary, and a descriptive overview of Retinopathy of Prematurity, explaining its causes, signs, symptoms, pathogenesis, and currently used therapies.
• Comprehensive insight into the epidemiology segments and forecasts, disease progression, and treatment guidelines has been provided.
• Additionally, an all-inclusive account of the prominent therapies that will impact the current treatment landscape.
• A detailed review of the retinopathy of the prematurity market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind the 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 shape and drive the 7MM retinopathy of the prematurity market.

Retinopathy of Prematurity Report Insights

• Patient Population
• Therapeutic Approaches
• Retinopathy of Prematurity Pipeline Analysis
• Retinopathy of Prematurity Market Size and Trends
• Existing and Future Market Opportunity

Retinopathy of Prematurity Report Key Strengths

• Ten Years Forecast
• The 7MM Coverage
• Retinopathy of Prematurity Epidemiology Segmentation
• Key Cross Competition

Retinopathy of Prematurity Report Assessment

• Current Prophylactic Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT and Analyst Views)

FAQs

• What was the Retinopathy of Prematurity total market size, the market size by therapies, and market share (%) distribution in 2019, and what would it look like by 2032? What are the contributing factors for this growth?
• What are the pricing variations among different geographies of current treatment therapies?
• What are the disease risk, burdens, and unmet needs of Retinopathy of Prematurity? What will be the growth opportunities across the 7MM concerning the patient population with Retinopathy of Prematurity?
• Why are incident cases of preterm infants by birth weight (=1,500 g) declining in countries such as Germany, Italy, and Spain?
• What are the current guidelines for treating and preventing Retinopathy of Prematurity in the US, Europe, and Japan?
• What key designations have been granted for the emerging therapies for Retinopathy of Prematurity?
• What would be the impact of the biosimilar entry of LUCENTIS and EYLEA into the market of Retinopathy of Prematurity?
• Why is the treatment rate for Retinopathy of Prematurity so high in Japan as compared to the other 7MM?

Reasons to Buy:

• The report will help develop business strategies by understanding the latest trends and changing treatment dynamics driving the Retinopathy of Prematurity market.
• 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 opportunity in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Highlights of Access and Reimbursement policies of current therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders' perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet need of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. Key Insights

2. Report Introduction

3. Executive Summary of Retinopathy of Prematurity

4. Key Events

5. Epidemiology and Market Forecast Methodology

6. Retinopathy of Prematurity Market Overview at a Glance

• 6.1. Market Share (%) Distribution by Therapies in the 7MM in 2019
• 6.2. Market Share (%) Distribution by Therapies in the 7MM in 2032

7. Disease Background and Overview

• 7.1. Introduction
• 7.2. Causes
• 7.3. Sign and Symptoms
• 7.4. Pathophysiology
• 7.5. Pathogenesis
• 7.6. Diagnosis
• 7.7. Treatment Management of Retinopathy of Prematurity
• 7.8. Guidelines for Retinopathy of Prematurity
  • 7.8.1. American Academy of Pediatrics (AAP): 2018
    • 7.8.1.1. Screening Guidelines
    • 7.8.1.2. Treatment Guidelines
  • 7.8.2. Royal College of Pediatrics and Child Health (RCPCH): 2022
    • 7.8.2.1. Screening Guidelines
    • 7.8.2.2. Treatment Guidelines
  • 7.8.3. Screening Guidelines in England, Germany, France, and Italy
  • 7.8.4. Japanese Ophthalmological Society: 2020
    • 7.8.4.1. Guidelines for Follow-up after Intravitreal Injection of Ranibizumab

8. Epidemiology and Patient Population of the 7MM

• 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

10. Marketed Drugs

• 10.1. Key Competitors
• 10.2. LUCENTIS (ranibizumab): Novartis
  • 10.2.1. Product Description
  • 10.2.2. Regulatory Milestones
  • 10.2.3. Other Development Activities
  • 10.2.4. Pivotal Clinical Trial
  • 10.2.5. Product Profile
• 10.3. EYLEA (aflibercept): Regeneron/Bayer
  • 10.3.1. Product Description
  • 10.3.2. Regulatory Milestones
  • 10.3.3. Other Development Activities
  • 10.3.4. Pivotal Clinical Trial
  • 10.3.5. Product Profile

11. Key Competitors for Pre-clinical Assets

12. Retinopathy of Prematurity: 7MM Analysis

• 12.1. Key Findings
• 12.2. Key Market Forecast Assumptions
• 12.3. Market Outlook
• 12.4. Total Market Size of Retinopathy of Prematurity in the 7MM
• 12.5. United States Market Size
  • 12.5.1. Total Market Size of Retinopathy of Prematurity in the United States
  • 12.5.2. Market Size of Retinopathy of Prematurity by Current and Emerging Therapies in the United States
• 12.6. EU4 and the UK Market Size
  • 12.6.1. Total Market Size of Retinopathy of Prematurity in EU4 and the UK
  • 12.6.2. Market Size of Retinopathy of Prematurity by Current and Emerging Therapies in EU4 and the UK
• 12.7. Japan Market Size
  • 12.7.1. Total Market Size of Retinopathy of Prematurity in Japan
  • 12.7.2. Market Size of Retinopathy of Prematurity by Current and Emerging Therapies in Japan

13. Unmet Needs

14. SWOT Analysis

15. KOL Views

16. Market Access and Reimbursement

• 16.1. United States
  • 16.1.1. Centre for Medicare & Medicaid Services (CMS)
• 16.2. 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
  • 16.3.1. MHLW
• 16.4. Reimbursement of Retinopathy of Prematurity
  • 16.4.1. EYLEA (aflibercept): Regeneron Pharmaceuticals/Bayer
  • 16.4.2. LUCENTIS (ranibizumab): Novartis

17. Appendix

• 17.1. Bibliography
• 17.2. Report Methodology

18. DelveInsight Capabilities

19. Disclaimer