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January 2025
The newborn imaging system market size is projected to reach USD 484.9 million by 2034, expanding from USD 323.5 million in 2025, at an annual growth rate of 4.6% during the forecast period from 2025 to 2034, as a result of the growing increasing prevalence of Retinopathy of Prematurity (ROP), and rising healthcare expenditure.
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Integrating artificial intelligence (AI) in eye imaging systems can revolutionize the way it perform, resulting in enhanced efficiency. It introduces automation and facilitates precise identification of retina and blood vessel features. It simplifies the task of radiologists, reducing manual errors. AI and machine learning (ML) algorithms can detect the presence of ROP or other eye-related disorders in newborns. This enables healthcare professionals to make timely clinical decisions and provide personalized treatment. AI-enabled wearable sensors can also aid in newborn and neonatal health monitoring. Additionally, AI and ML can detect the factors associated with the disease and the future potential of developing the disease.
The capacity to image the retina and create tools for picture analysis is quite interesting. Since its function needs the retina to see the outside world, the retinal structures involved in image creation must be optically transparent. Retinal imaging is referred to as a non-invasive screening technology that produces high-resolution pictures of the back of a patient’s eye undergoing diagnosis.
Retinal imaging is continuously developing, and innovative research findings are swiftly converted into therapeutic applications. Certain severe eye disorders, along with systemic diseases, appear in the human eye’s retina. This report majorly focuses on eye disorders associated with newborns.
Eye examination in the early phases of life is of most importance because if vision disorders are not detected in early childhood, it may result in long-term consequences. Most of the vision problems that cause adolescent blindness can be addressed if diagnosed early through comprehensive newborn screening. The most common eye disorders in newborn babies are retinopathy of prematurity, ocular development, refractive state, strabismus, visual acuity, color vision, visual functions, visual fields, and others. Retinal imaging assists in the diagnosis, follow-up, management, and assessment in all of these disorders. These disorders prominently require an eye imaging system to detect and manage such disorders. There have been great breakthroughs in both design and technology over the years. Such developments have applications in the majority of pediatric retinal illnesses, while the designs of new devices have often been limited to usage in adults.
The newborn eye imaging system market refers to the market for specialized imaging systems used to capture images of a newborn's eyes. These systems are designed to detect various eye disorders in newborns, such as retinopathy of prematurity (ROP), which can lead to blindness if not detected and treated early. The global newborn eye imaging system market is expected to experience significant growth in the coming years, driven by several factors. One key factor is the increasing incidence of ROP, which is often associated with premature birth and low birth weight. As the number of premature births continues to rise worldwide, the demand for newborn eye imaging systems is expected to increase as well.
Another factor driving market growth is the increasing awareness and adoption of early screening programs for ROP. Many countries have implemented screening programs to identify and treat ROP early, which has led to increased demand for newborn eye imaging systems. Additionally, advancements in technology and the introduction of new imaging systems are also expected to drive market growth. New imaging systems are being developed that provide higher-resolution images and more accurate diagnoses, which is expected to increase their adoption in hospitals and clinics.
According to the World Health Organization (WHO), cataract, retinopathy of prematurity (ROP), and vitamin A deficiency are among the leading causes of childhood blindness worldwide.
Retinopathy of Prematurity (ROP) is a potentially blinding eye disorder that affects preterm infants. It occurs when the blood vessels in the retina of the eye do not develop properly, leading to abnormal growth of new blood vessels that can cause scarring and retinal detachment. ROP can cause severe vision impairment or even blindness if left untreated. The incidence of ROP is increasing worldwide, particularly in low- and middle-income countries where access to high-quality neonatal care is limited. Factors that contribute to the development of ROP include prematurity, low birth weight, prolonged exposure to supplemental oxygen, and poor nutrition.
ROP causes irreversible vision impairment in about 32,300 infants worldwide each year, 20 percent of whom become blind or have a severe visual impairment.
Early detection and treatment of ROP are crucial for preventing severe visual impairment and blindness. Screening for ROP typically involves using an indirect ophthalmoscope to examine the retina, which can be challenging and time-consuming for clinicians. As a result, there is a growing need for new technologies to improve ROP screening and diagnosis.
One promising technology is the use of digital retinal imaging systems, which provide high-resolution images of the retina and can be used to identify signs of ROP. These systems are non-invasive and can be used at the bedside, making them particularly useful for screening preterm infants in neonatal intensive care units (NICUs).
Several companies are developing digital retinal imaging systems specifically designed for use in newborns, including the RetCam from Natus Medical Incorporated and the Pictor Plus from Volk Optical. These systems use advanced imaging technology to capture detailed images of the retina, which can then be analyzed by clinicians to identify signs of ROP.
The market for newborn eye imaging systems is expected to grow significantly in the coming years, driven by the increasing incidence of ROP and the need for more efficient and effective screening and diagnosis tools. Other factors contributing to market growth include advances in imaging technology, increasing awareness of the importance of early ROP detection and treatment, and rising demand for non-invasive diagnostic tools. ROP is a serious eye disorder that can cause lifelong vision impairment or even blindness if left untreated. Early detection and treatment are crucial for preventing severe visual impairment, and digital retinal imaging systems are emerging as promising technology for improving ROP screening and diagnosis. As such, the market for newborn eye imaging systems is expected to experience significant growth in the coming years.
The rising government support for newborn eye imaging systems is playing a crucial role in the growth of this market. Many governments across the world are focusing on improving their healthcare infrastructure, which includes the adoption of advanced technologies such as eye imaging systems for newborns. In addition, several government initiatives are being launched to promote the use of these systems, including the provision of funding for research and development, awareness campaigns, and incentives for healthcare providers to adopt these technologies.
For example, in the United States, the National Institutes of Health (NIH) provides funding for research into retinopathy of prematurity (ROP) and the development of new imaging technologies for the detection of ROP. Similarly, in India, the government has launched several initiatives to improve the healthcare infrastructure, including the implementation of the Rashtriya Bal Swasthya Karyakram (RBSK) program, which includes the provision of free eye screening for newborns. Thus, the rising government support for newborn eye imaging systems is expected to boost the adoption of these systems, particularly in developing countries where the burden of ROP is high, but healthcare resources are limited.
Furthermore, in many countries, government agencies or ministries of health play a key role in promoting and regulating healthcare practices, including those related to newborn care. As such, they can influence the adoption and utilization of new technologies like newborn eye imaging systems through policy and funding decisions.
The collaboration between government bodies, healthcare providers, and medical device manufacturers is crucial for the successful implementation of newborn eye imaging systems. The rising government support towards the betterment of neonatal care is contributing to the growth of the newborn eye imaging system market. Governments across the world are increasing their healthcare expenditure to improve the overall healthcare infrastructure and to reduce neonatal mortality rates.
According to a report by the World Health Organization (WHO), approximately 2.4 million neonatal deaths occurred globally within the first week of their lives.
This has led to an increase in government support towards better neonatal care, including the adoption of advanced medical technologies such as newborn eye imaging systems. Additionally, collaborations between healthcare providers and medical device manufacturers are driving the development of new and innovative newborn eye imaging systems. Medical device manufacturers are investing heavily in research and development activities to improve the accuracy and efficiency of newborn eye imaging systems.
Furthermore, healthcare providers are partnering with medical device manufacturers to integrate these advanced technologies into their neonatal care programs. These collaborations are resulting in the development of newborn eye imaging systems that offer advanced features such as high-resolution imaging, real-time analysis, and data management capabilities.
Moreover, the rising government support towards better neonatal care and collaborations between healthcare providers and medical device manufacturers are driving the growth of the newborn eye imaging system market. These factors are expected to continue to shape the market in the coming years, as governments and healthcare providers focus on improving neonatal care and reducing neonatal mortality rates.
Newborn eye imaging systems are highly specialized medical devices that require advanced technology and expertise for their design, manufacturing, and maintenance. As a result, they often come with a high price tag, which can be a major barrier to their adoption and utilization, especially in low-resource settings. In developing countries, where healthcare budgets are limited and there are competing priorities for healthcare spending, the high cost of newborn eye imaging systems can make it difficult for healthcare facilities to justify their purchase. In some cases, the cost may be prohibitive, leading to a lack of access to these systems and consequently, a failure to detect and treat retinopathy of prematurity in newborns.
In addition, even when newborn eye imaging systems are purchased, the high cost of maintenance and repairs can also be a challenge for healthcare facilities in low-resource settings. The lack of trained personnel and equipment can result in longer downtime and higher costs for repairs and replacements.
To address this restraint, there are various potential solutions that can be explored. One approach is to encourage collaboration between governments, healthcare providers, and manufacturers to reduce the cost of these systems. Governments can provide subsidies or tax breaks to manufacturers to reduce the cost of production, while healthcare providers can pool resources to purchase systems in bulk, thus benefiting from economies of scale.
Another approach is to develop innovative financing mechanisms, such as leasing or pay-per-use models, to make newborn eye imaging systems more accessible and affordable for healthcare facilities. This would allow facilities to pay for the systems over time, making it easier to manage their budgets and prioritize other healthcare needs.
Furthermore, there is a need for continued investment in research and development to improve the affordability and accessibility of newborn eye imaging systems. This could include the development of lower-cost systems that are easier to use and maintain, as well as the integration of artificial intelligence and other advanced technologies to improve the accuracy and efficiency of screening. Thus, addressing the high cost of newborn eye imaging systems is crucial for ensuring equitable access to this life-saving technology, particularly in low-resource settings where the burden of retinopathy of prematurity is highest.
The development of more efficient and cost-effective imaging systems could significantly increase the adoption rates of newborn eye imaging systems in low-resource settings. As technology continues to advance, there are opportunities to develop more compact and portable systems that are less expensive to manufacture and easier to transport to remote areas. This would make it easier for healthcare facilities in these regions to acquire and use the technology, potentially improving the diagnosis and treatment of retinopathy of prematurity.
Additionally, there is an opportunity to integrate the use of artificial intelligence (AI) into newborn eye imaging systems. AI-powered systems can analyze images in real-time and provide immediate results, reducing the need for specialized personnel to interpret the images. This can significantly reduce the cost of using the technology while also increasing efficiency and accuracy.
Furthermore, the development of telemedicine solutions can also create new opportunities for the adoption of newborn eye imaging systems. Telemedicine enables remote diagnosis and treatment, which can be especially important for healthcare facilities in low-resource settings that have limited access to specialized healthcare professionals. With the use of telemedicine, healthcare facilities can send images to specialists in other locations for interpretation, reducing the need for costly and time-consuming travel.
Moreover, technological advancements present significant opportunities for the growth and adoption of newborn eye imaging systems in low-resource settings, potentially improving the diagnosis and treatment of retinopathy of prematurity and other eye conditions in newborns.
By disease type, the ROP segment held a dominant presence in the newborn eye imaging systems market in 2024. Retinopathy of prematurity (ROP) is the most common ocular disorder in newborns. The prevalence rate of ROP globally is around 31.9%. The increasing number of premature births contributes to the segment’s growth. ROP leads to unwanted growth of blood vessels in the retina, causing serious eye and vision problems. The growing awareness of ROP screening and technological advancements boost the segment’s growth.
By disease type, the retinal disease segment is predicted to witness significant growth in the market over the forecast period. The rising number of newborn screening and favorable government policies augment the segment’s growth. Retinoblastoma and congenital eye diseases such as anophthalmia, coloboma, and aniridia are progressive and may lead to vision loss, potentiating the need for newborn eye screening. A Binocular indirect ophthalmoscope is most widely used to detect retinal diseases. However, the use of digital eye imaging in conjunction with telemedicine increases the accessibility of imaging systems to a larger population.
By device type, the wireless device segment is projected to expand rapidly in the market in the coming years. Wireless devices can continuously monitor the vital signs of premature babies. Advanced technologies and growing research and development led to the development of wireless devices. The increasing investments by government and private organizations also fuel the segment’s growth. The advent of sensors and high-definition cameras improves the overall functioning and efficiency of disease detection.
By end-user, the hospitals segment led the global newborn eye imaging systems market in 2024. The segmental growth is attributed to favorable infrastructure and suitable capital investments. Favorable reimbursement policies support the segment’s growth. Hospitals are also part of clinical trials, benefitting patients with enhanced diagnostic accuracy. The increasing number of hospitals and the need for advanced healthcare infrastructure propel the segment’s growth. Hospitals provide multidisciplinary expertise to diagnose and treat a particular disease.
By end-user, the ophthalmology & diagnosis center segment is anticipated to grow with the highest CAGR in the market during the studied years. The ophthalmology and diagnosis center contains specialized equipment and skilled professionals, providing advanced care to patients. Patients prefer diagnosis centers as they are more affordable and provide state-of-the-art facilities and services.
North America is the largest market for newborn eye imaging systems, owing to the presence of a large number of key players in the region, favorable government initiatives, and advanced healthcare infrastructure. The United States is the major contributor to the market in this region. The increasing number of newborn screenings due to growing awareness potentiates market growth. Around 4 million newborns are screened annually in the U.S. The increasing investments, collaborations, and mergers & acquisitions promote the development of eye imaging systems in North America.
Asia Pacific is expected to witness significant growth in the market, owing to the rising prevalence of retinopathy of prematurity and increasing healthcare expenditure in the region. Moreover, the increasing awareness about the benefits of early detection and treatment of retinopathy of prematurity is also contributing to market growth in this region. India reports around 3 million babies born prematurely annually. It is estimated that 25% to 40% of these babies have a risk of developing ROP.
Europe is projected to grow at the fastest rate in born-eye imaging systems, driven by the increasing prevalence of retinopathy of prematurity and government initiatives to promote neonatal care. The United Kingdom, Germany, and France are the major contributors to the market in this region. The increasing prevalence of retinopathy of prematurity (ROP) eye diseases significantly drives the growth of this region. Retinopathy of prematurity is a Vaso proliferative retinal condition that mostly affects newborn preterm babies. It is a completely preventable cause of childhood blindness. With the increased survival of preterm newborns, ROP has grown to become the major cause of preventable childhood blindness in this region. According to the Europe PMC Funders' Group, ROP is a blinding illness of preterm children that constitutes a substantial clinical concern, accounting for up to 40% of all childhood blindness.
Darius Moshfeghi, Founder of Pr3vent, commented that the company aims to build the future of AI in ophthalmology and change the way healthcare providers detect, diagnose, and treat eye disease in children. Their funding will help accelerate the development of their revolutionary imaging system for early detection of preventable vision loss in newborns.
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