특히 신흥국 시장에서의 출생률의 상승이 태아 및 신생아 케어 디바이스 시장의 큰 촉진요인이 되고 있습니다. Verified Market Research의 분석가에 따르면, 태아 및 신생아 케어 디바이스 시장은 태아 및 신생아 케어 기기 시장은 2024년에 약 88억 달러에 달하고, 2031년까지 149억 3,000만 달러에 달한다고 추계되고 있습니다.
많은 정부가 임산부와 유아의 건강 상태 개선을 목적으로 한 정책과 프로그램을 실시했습니다. 이러한 노력에는 신생아 케어 시설과 장비에 대한 자금 지원이 포함되는 경우가 많으며, 2024년부터 2031년까지의 CAGR은 6.84%로 성장할 것으로 예상됩니다.
태아 및 신생아 케어 디바이스 시장 정의/개요
태아 및 신생아 케어 디바이스란, 임신 중의 태아나, 출생 후 28일간을 포함한 신생아기의 신생아를 모니터, 서포트, 치료하기 위해서 설계된 의료기기의 전문 카테고리를 가리킵니다. 이러한 의료기기는 특히 조산 및 복잡한 분만과 같은 위험이 높은 상황에서 어머니와 신생아의 건강과 안전을 보장하는 데 중요한 역할을합니다.
이러한 장비의 주요 유형은 태아의 심박수와 자궁 수축을 추적하고 분만 중 태아의 건강 상태를 평가하는 태아 모니터, 미숙아 및 질병 유아에 최적의 온도와 습도를 유지하면서 관리 되는 환경을 제공하는 인큐베이터, 자력으로 충분한 호흡을 할 수 없는 신생아의 호흡을 보조 또는 제어하는 인공 호흡기 등이 있습니다. 태아 및 신생아 케어 디바이스는 현대의 산과·소아과 의료에 있어서 빠뜨릴 수 없는 것이며, 발육의 중요한 단계에 있어서, 취약한 사람들의 건강 결과를 현저하게 개선하는 필수 불가결한 서포트를 제공합니다.
조산아와 관련된 과제에 대응하여 전문의료기기의 필요성이 높아지기 때문에 조산아의 유병률 증가는 신생아의료기기 수요에 크게 영향을 미칩니다. 2020년, 약 1,300만명의 신생아가 조산으로 태어나 전체 출생의 약 9.9%를 차지하며, 공중위생 문제의 규모를 돋보이게 하고 있습니다. 세계보건기구(WHO)는 조산은 신생아 사망의 주된 원인이며, 생존자에게 장기적인 건강 합병증을 일으킬 가능성이 있기 때문에 고급 신생아 케어 솔루션이 필요하다고 강조합니다.
미국에서는 2022년 조산률은 10.4%로 보고되고 있으며, 인종·민족간에 큰 격차가 있습니다. 이러한 통계는 조산아의 건강 관리에 필수적인 인큐베이터, 인공 호흡기, 모니터링 시스템과 같은 효과적인 신생아 케어 장비의 긴급한 필요성을 강조하고 있습니다. 이 분야 시장 성장과 기술 혁신을 촉진하고 있습니다.
신생아용으로 특별히 설계된 의료기기의 안전성과 효능을 입증하기 위한 광범위한 임상시험의 요건은 신생아의 생리학적 반응이 성인과는 상당히 다를 수 있기 때문에 태아 및 신생아 케어 디바이스 제조업체 FDA에 의하면 신생아용 의료기기는 안전성과 유효성을 보장하기 위해 신생아 임상시험에서 엄격한 연구를 받아야 하므로 승인 과정이 길어질 가능성이 있습니다. 게다가, 기존의 의료기기의 대부분은 당초는 성인용으로 설계되어 나중에 신생아용에 적합했던 것이며, 많은 경우, 이 취약한 집단에 대한 적합성을 보증하는 집단 특유의 시험이 무시되어 있습니다. 인구동태통계 보고에 따르면 2020년에는 미국에서 임신 20주 이상의 태아 사망 사고가 20,854건 가까이 보고되었으며, 효과적인 신생아 케어 솔루션이 긴급히 필요하다는 것이 밝혀졌습니다.
또한 제조업체는 FDA 및 WHO와 같은 기관이 정한 복잡한 규제 경로를 통과해야 합니다. 개발 프로세스 보다 복잡한 결과, 이러한 장애물은 혁신적인 태아 및 신생아 관리 장치 시장 진입 지연으로 이어지고 결국 신생아 결과를 개선하는 데 필요한 중요한 의료 기술의 사용 가능성에 영향을 미칩니다.
The rising birth rates, particularly in developing countries, are a significant driver of the fetal and neonatal care devices market. According to the analyst from Verified Market Research, the fetal and neonatal care devices market is estimated to reach a valuation of USD 14.93 Billion By 2031 over the forecast subjugating around USD 8.8 Billion valued in 2024.
Many governments are implementing policies and programs aimed at improving maternal and infant health outcomes. These initiatives often include funding for neonatal care facilities and equipment enabling the market to grow at a CAGR of 6.84% from 2024 to 2031.
Fetal And Neonatal Care Devices Market: Definition/ Overview
Fetal and neonatal care devices refer to a specialized category of medical equipment designed to monitor, support, and treat fetuses during pregnancy and newborns in the neonatal period, which encompasses the first 28 days after birth. These devices play a critical role in ensuring the health and safety of both mothers and their infants, particularly in high-risk situations such as premature births or complicated deliveries.
Key types of these devices include fetal monitors, which track fetal heart rate and uterine contractions to assess the well-being of the fetus during labor incubators that provide a controlled environment for premature or ill infants, maintaining optimal temperature and humidity and ventilators that assist or control breathing in newborns who are unable to breathe adequately on their own. Fetal and neonatal care devices are indispensable in modern obstetric and pediatric medicine, providing essential support that significantly improves health outcomes for vulnerable populations during critical stages of development.
Our reports include actionable data and forward-looking analysis that help you craft pitches, create business plans, build presentations and write proposals.
The increasing prevalence of preterm births significantly impacts the demand for neonatal care devices, as the need for specialized medical equipment rises in response to the challenges associated with premature infants. In 2020, an estimated 13.4 million newborns were born preterm globally, accounting for approximately 9.9% of all births, highlighting the scale of this public health issue. The World Health Organization emphasizes that preterm birth is the leading cause of neonatal mortality and can lead to long-term health complications for survivors, necessitating advanced neonatal care solutions.
In the United States, the preterm birth rate was reported at 10.4% in 2022, with significant disparities among racial and ethnic groups; for instance, the rate among African-American women was 14.6%, which is substantially higher than that of their white counterparts at 9.4%. These statistics underline the urgent need for effective neonatal care devices such as incubators, ventilators, and monitoring systems that are essential for managing the health of preterm infants. As healthcare systems strive to improve outcomes for these vulnerable populations, investments in neonatal care technologies are increasingly prioritized, driving market growth and innovation in this sector.
The requirement for extensive clinical testing to demonstrate the safety and efficacy of medical devices specifically designed for neonates, as their physiological responses can differ markedly from those of adults are the major challenges face by the manufacturers of fetal and neonatal care devices. According to the FDA, medical products for newborns must undergo rigorous studies in neonatal clinical trials to ensure they are safe and effective, which can prolong the approval process. Additionally, many existing medical devices are initially designed for adult populations and later adapted for use in neonates, often neglecting population-specific testing that guarantees their suitability for this vulnerable group. The National Vital Statistics Reports indicated that in 2020, nearly 20,854 fetal fatalities were reported in the U.S. at 20 weeks of gestation or more, underscoring the urgent need for effective neonatal care solutions.
Furthermore, manufacturers must navigate complex regulatory pathways established by agencies such as the FDA and WHO, which set stringent guidelines for device design and performance standards. These regulatory frameworks can be resource-intensive and may require specialized knowledge of pediatric medicine, further complicating the development process. As a result, these hurdles can lead to delays in bringing innovative fetal and neonatal care devices to market, ultimately affecting the availability of critical health technologies needed to improve outcomes for newborns.
The fetal care equipment segment has accounted for over 67% of the global market revenue. The increasing application of ultrasound devices to monitor fetal movement and health during pregnancy has been a major contributor to this dominance. According to a study published in 2020, the use of ultrasound in pregnancy more than doubled between 1980 and 1987, rising from 33.5% to 78.8% of pregnancies. Additionally, rising awareness, technological advancements, and ease of use have triggered the growing adoption of portable and do-it-yourself ultrasound devices for home use.
The fetal monitoring equipment segment, which includes devices such as Dopplers, intrapartum and antepartum monitors, and pulse oximeters, has also seen significant growth due to the increasing prevalence of obstetric complications and preterm births. In the U.S., the preterm birth rate reached 10.4% in 2022, with disparities among racial and ethnic groups. These factors have collectively driven the fetal care equipment segment to the forefront of the fetal and neonatal care devices market, underscoring the critical role these technologies play in monitoring and managing high-risk pregnancies.
Why do Hospitals Account for the Largest Share of the Fetal and Neonatal Care Devices Market?
Hospitals account for the largest share of the fetal and neonatal care devices market due to several critical factors that enhance their operational capabilities and patient care. In 2023, the hospital segment represented approximately 57.7% of the market revenue, reflecting the high demand for advanced medical technologies in these settings. The presence of Neonatal Intensive Care Units (NICUs) in hospitals facilitates the immediate access to specialized care required for high-risk pregnancies and premature births, which are increasingly prevalent; in the U.S., the preterm birth rate was reported at 10.4% in 2022.
Furthermore, hospitals are equipped with the latest and most technologically advanced equipment, which is essential for improving patient outcomes and ensuring effective monitoring and treatment of neonates. Government initiatives aimed at reducing infant mortality rates and increasing awareness about neonatal care have led to an increase in hospital admissions for neonatal care, further driving demand for fetal and neonatal devices. The combination of specialized healthcare professionals, comprehensive facilities, and a focus on maternal and child health positions hospitals as the primary users of fetal and neonatal care devices, thereby solidifying their dominant share in this market segment.
The strong presence of key market players in North America significantly contributes to the region's dominance in the fetal and neonatal care equipment market. According to a report, GE Healthcare holds the leading position in the overall fetal and neonatal care equipment market, with the company adopting several organic and inorganic growth strategies to sustain its leadership position and ensure future growth.
The presence of well-equipped Neonatal Intensive Care Units (NICUs) in the region, along with well-organized healthcare system, further solidifies North America's position as the largest market for fetal and neonatal care equipment. In the United States, the preterm birth rate was reported at 10.4% in 2022, with the percentage of newborn babies with low birth weight accounting for 8.24% in 2020. These statistics highlight the growing demand for advanced neonatal care equipment in the region.
The rapid growth of the fetal and neonatal care devices market in the Asia Pacific region is driven by the increasing rates of preterm births have been reported, with estimates indicating that approximately 11% of all live births in the region are preterm, necessitating specialized neonatal care equipment to improve survival outcomes. Government initiatives aimed at enhancing maternal and child health have played a crucial role, as evidenced by the establishment of over 450 Special Newborn Care Units (SNCUs) in India alone, which provide essential services to nearly 0.9 million neonates annually.
Furthermore, advancements in technology have facilitated the development of affordable and effective neonatal care devices, allowing for their widespread adoption even in rural and underserved areas. As a result, these combined factors are significantly contributing to the rapid expansion of the fetal and neonatal care devices market across the Asia Pacific region.
The Fetal And Neonatal Care Devices Market is characterized by a diversified set of competitors competing to innovate and fulfil the changing needs of healthcare providers and patients. Collaboration with healthcare institutions, strategic partnerships, and mergers and acquisitions all contribute to the competitive environment's dynamic nature, which drives ongoing innovation and growth.
Some of the prominent players operating in the fetal and neonatal care devices market include:
GE Healthcare
Philips Healthcare
Dragerwerk AG & Co. KGaA
Medtronic plc
Masimo Corporation
Natus Medical Incorporated
Phoenix Medical Systems (P) Ltd
Vyaire Medical
Atom Medical Corporation
Becton
Dickinson and Company
Koninklijke Philips NV
Mindray Medical International Limited
Siemens Healthineers AG
Hill-Rom Holdings, Inc.
GEA Group AG
Cerner Corporation
Stryker Corporation
Smith & Nephew plc
Zimmer Biomet Holdings, Inc.
Abbott Laboratories
In January 2024, GE Healthcare introduced the Novii+ Wireless Patch System, a beltless, wireless maternal/fetal monitoring solution. This innovative device non-invasively measures and displays fetal heart rate, maternal heart rate, and uterine activity, providing a comfortable option for antepartum monitoring and allowing freedom of movement during labor.
In April 2023, Dragerwerk AG & Co. KGaA launched the Babyroo TN300, an FDA-cleared device designed to provide supportive lung protection and temperature stability for newborn infants.