Retinopathy of Prematurity Market Size and Trends Analysis

The global retinopathy of prematurity market size is likely to be valued at US$2.9 billion in 2025, reaching US$4.3 billion by 2032, growing at a CAGR of 5.9% during the forecast period 2025-2032, driven by the increasing prevalence of preterm births, advancements in neonatal care, and the rising adoption of imaging-based diagnostic techniques. Growing awareness of early intervention and government-supported neonatal screening programs is also enhancing global ROP detection and treatment rates.

Key Highlights

• Leading Region: North America leads regionally with 35% share, due to advanced neonatal care infrastructure, high healthcare expenditure, and widespread awareness of early screening.
• Fastest-growing Region: Asia Pacific is the fastest-growing region, driven by rising preterm births and the expansion of telemedicine.
• Leading Treatment Type: Laser therapy leads the treatment type, accounting for over 40% of the market in 2025, offering high precision and a proven success rate in preventing retinal detachment.
• Dominating Diagnosis Method: Retinal examination dominates holding 45% of the market share, owing to its widespread use and reliability in early detection
• Leading End-use: Hospitals dominate end-use with a 55% share, driven by advanced neonatal units.
• Key Market Driver: The rising number of preterm births increases the risk of ROP, driving demand for early screening, diagnosis, and treatments like anti-VEGF drugs and laser therapy.
• Growth Opportunity: The adoption of AI-based screening, tele-ophthalmology, and novel therapies offers significant growth potential by improving early diagnosis, expanding access in underserved regions, and enhancing treatment outcomes for premature infants at risk of ROP.

Key Insights	Details
Retinopathy of Prematurity Market Size (2025E)	US$2.9 Bn
Market Value Forecast (2032F)	US$4.3 Bn
Projected Growth (CAGR 2025 to 2032)	5.9%
Historical Market Growth (CAGR 2019 to 2024)	5.0%

Market Factors - Growth, Barriers, and Opportunity Analysis

Rising Prevalence of Preterm Births

Rising premature births globally are a key driver of the Retinopathy of Prematurity Market. Studies show that approximately 15 million babies are born prematurely each year, and this number continues to increase due to factors such as maternal age, multiple pregnancies from assisted reproductive technologies, infections, and lifestyle-related complications. Advances in neonatal care have improved survival rates of these premature infants, but they remain at high risk of developing ROP because of incomplete retinal vascular development and exposure to supplemental oxygen therapy.

This growing population of at-risk infants directly increases the demand for early diagnosis and treatment of ROP. Consequently, healthcare systems worldwide are investing in advanced screening programs, teleophthalmology networks, and neonatal care infrastructure to detect the disease at its earliest stages. The trend highlights an urgent need for innovative therapeutic interventions, including anti-VEGF therapies and laser treatments, thereby fueling the expansion of the global ROP market.

Shortage of Skilled Ophthalmologists and Neonatal Specialists

The shortage of skilled ophthalmologists and neonatal specialists is a major restraint on the retinopathy of prematurity (ROP) market. Managing ROP requires timely diagnosis, specialized screening, and precise treatment, often involving delicate procedures such as laser photocoagulation or anti-VEGF injections in premature infants. However, there is a significant global deficit of trained paediatric ophthalmologists and neonatologists capable of performing these tasks.

In developing and rural regions, the situation is more severe, with limited access to qualified professionals and inadequate neonatal eye-care infrastructure. Many neonatal intensive care units (NICUs) lack dedicated ophthalmic staff, leading to delayed screening or missed diagnoses, which can result in permanent blindness. Even in developed nations, increasing preterm birth rates are straining the existing healthcare workforce. This shortage also limits the implementation of tele-ophthalmology programs and other screening initiatives aimed at expanding access to care.

Emergence of Novel Therapeutics and Drug Delivery Systems

The emergence of novel therapeutics and advanced drug delivery systems presents a significant opportunity in the retinopathy of prematurity (ROP) market. Current treatments, such as laser photocoagulation and intravitreal anti-VEGF injections, while effective, can be invasive and carry risks of retinal damage or systemic side effects. To address these limitations, researchers and pharmaceutical companies are developing next-generation anti-VEGF agents, gene therapies, and sustained-release formulations that offer safer, longer-lasting, and more targeted treatment options.

Innovative nanoparticle-based delivery systems and biodegradable implants are also gaining traction, designed to ensure controlled and localized drug release within the eye, minimizing the need for repeated injections in fragile, premature infants. Additionally, combination therapies that target multiple pathways involved in abnormal retinal vascularization are being explored to improve efficacy. These advancements not only promise better clinical outcomes but also enhance patient safety and convenience.

Category-wise Analysis

Type of Treatment Insights

Laser Therapy dominates the market, accounting for over 40% share in 2025, due to its high precision and proven effectiveness in halting disease progression. It helps prevent retinal detachment by sealing abnormal blood vessels, offering long-term vision preservation and making it the preferred treatment choice among ophthalmologists for advanced ROP cases.

Pharmaceuticals are anticipated to grow the fastest, driven by the increasing adoption of anti-VEGF drugs such as ranibizumab and bevacizumab. These minimally invasive therapies offer effective control of abnormal retinal vascularization, improving outcomes and reducing the need for surgical intervention in premature infants.

Age Group Insights

Premature Infants hold the largest share, representing 50% of the market share. Their underdeveloped retinal blood vessels make them highly susceptible to oxygen-induced retinal damage, increasing the need for early screening and treatment. This vulnerability drives the demand for specialized therapies and monitoring solutions, making premature infants the primary patient segment in ROP management.

Very Low Birth Weight Infants are projected to grow rapidly due to advances in neonatal care, which have increased their survival rates. Being highly susceptible to retinopathy of prematurity due to underdeveloped retinal vasculature, this group requires intensive screening and treatment, driving demand for targeted therapies, monitoring devices, and specialized neonatal care solutions.

Diagnosis Method Insights

Retinal Examination dominates, holding 45% of the market share, due to its widespread use and reliability in early detection of abnormal retinal vascularization. As a standard diagnostic procedure, it enables timely intervention, guiding treatment decisions such as laser therapy or anti-VEGF injections, and remains the preferred method among ophthalmologists for effective ROP management.

Imaging techniques, including fundus photography and AI-driven retinal analysis, are rapidly expanding. These technologies enhance diagnostic accuracy, enable early detection, and support remote screening in underserved areas. Their adoption is increasing due to the ability to monitor retinal development non-invasively, improving patient outcomes and expanding access to timely ROP care.

End-use Insights

Hospitals account for nearly 55% of total market revenue, driven by the presence of advanced neonatal intensive care units (NICUs) and ready access to ophthalmic specialists. These facilities offer comprehensive screening and treatment services, including laser therapy and anti-VEGF injections, making hospitals the primary point of care for managing premature infants at risk of ROP.

Research Institutes are experiencing strong growth driven by ongoing clinical trials and R&D in retinal regeneration therapies. Their focus on developing innovative treatments, such as gene therapy and advanced drug delivery systems, is driving advancements in early diagnosis and effective management, positioning research organizations as key contributors to future market expansion.

Regional Insights

North America Retinopathy of Prematurity Market Trends

North America accounts for approximately 35% of the global market share in 2025, driven by a combination of advanced neonatal care infrastructure, high awareness levels, and widespread adoption of ROP management protocols. The region benefits from well-established neonatal intensive care units (NICUs) equipped with sophisticated monitoring systems and imaging technologies, enabling early detection and timely intervention for premature infants at risk of ROP.

The United States leads North America, supported by high healthcare expenditure, advanced ophthalmic facilities, and structured ROP screening programs across hospitals and specialized clinics. Government initiatives, combined with private healthcare investments, have improved access to treatments such as laser therapy and anti-VEGF injections, ensuring effective disease management. Increasing awareness among neonatologists and parents regarding the importance of early screening contributes to the region’s strong market position.

Europe Retinopathy of Prematurity Market Trends

Europe holds around 30% market share, led by Germany, France, and the U.K., driven by strong healthcare infrastructure, advanced neonatal care, and proactive government initiatives. The region’s focus on stringent neonatal care guidelines ensures that premature infants receive timely monitoring and intervention, significantly reducing the risk of ROP-related blindness. Countries like Germany, France, and the U.K. are at the forefront, benefiting from well-equipped neonatal intensive care units (NICUs), widespread awareness programs, and specialized ophthalmic services.

In these countries, increased investments in tele-ophthalmology and AI-assisted retinal screening have expanded access to early diagnosis, particularly in rural and underserved areas. These technologies allow ophthalmologists to remotely assess retinal images and identify abnormal vascularization in preterm infants, enabling prompt treatment with laser therapy or anti-VEGF drugs. European governments and healthcare organizations have also implemented initiatives such as the European Screening Initiative for Preterm Infants, which standardizes screening protocols and promotes early intervention programs. Public-private partnerships and research collaborations are further accelerating the development of innovative diagnostics and therapies.

Asia Pacific Retinopathy of Prematurity Market Trends

Asia Pacific is the fastest-growing region, expected to grow at a CAGR exceeding 6.5% during 2025–2032. The region’s rapid market expansion is primarily driven by high birth rates and increasing preterm deliveries in countries such as India and China, which significantly raise the prevalence of ROP. Premature infants in these countries are at a higher risk of oxygen-induced retinal damage, creating strong demand for early screening, diagnosis, and treatment solutions.

Government initiatives and public health programs to improve neonatal care infrastructure are accelerating market growth. Investments in advanced neonatal intensive care units (NICUs) and widespread implementation of ROP screening guidelines are enhancing access to treatment. Additionally, the adoption of telemedicine and AI-assisted retinal imaging is helping reach underserved areas, enabling early detection and timely intervention even in remote regions. Rising awareness among healthcare providers and parents regarding the importance of early ROP management is further fueling demand.

Competitive Landscape

The global retinopathy of prematurity market is highly competitive, with key players emphasizing innovation in pharmacological and imaging-based treatments. Leading companies are focusing on the development of pharmacological therapies, particularly anti-VEGF drugs, and imaging-based diagnostics, including AI-assisted retinal screening and fundus photography, to improve early detection and therapeutic outcomes for premature infants.

To strengthen their market positions, these players are increasingly engaging in clinical trials, collaborating with hospitals, and entering into research partnerships with academic institutions and biotech firms. Such collaborations enable the testing of novel therapies, optimization of treatment protocols, and integration of cutting-edge technologies into clinical practice. Additionally, investments in biologics and sustained-release drug delivery systems are helping companies diversify their product portfolios and offer safer, more effective solutions.

Key Developments

• In February 2023, the U.S. FDA authorized EYLEA as the first pharmacological treatment for ROP, marking a significant milestone in ROP management.
• In February 2025, Alvotech announced that the U.S. FDA has accepted its biologics license application (BLA) for a biosimilar version of bevacizumab. This approval marks a crucial step toward providing a cost-effective treatment option for retinopathy of prematurity (ROP), a leading cause of vision impairment in premature infants.

Companies Covered in Retinopathy of Prematurity Market

• Pfizer
• Mylan
• Apellis Pharmaceuticals
• EyePoint Pharmaceuticals
• Hikma Pharmaceuticals
• Aerie Pharmaceuticals
• Roche
• Horizon Therapeutics
• Santen Pharmaceutical
• Bayer
• Novartis
• Allergan
• Regeneron Pharmaceuticals
• Alergan
• Eagle Pharmaceuticals