Fetal And Neonatal Monitoring Devices Global Market Report 2024

The fetal and neonatal monitoring devices market size has grown strongly in recent years. It will grow from $8.22 billion in 2023 to $8.68 billion in 2024 at a compound annual growth rate (CAGR) of 5.6%. The growth in the historical period can be attributed to increased awareness of maternal and neonatal health, improved healthcare access, a rise in high-risk pregnancies, and the expansion of emerging markets.

The fetal and neonatal monitoring devices market size is expected to see strong growth in the next few years. It will grow to $10.57 billion in 2028 at a compound annual growth rate (CAGR) of 5.1%. The growth in the projected period can be attributed to the adoption of telemedicine and remote monitoring, the advancement of personalized medicine, an increase in premature birth rates, and the shift towards value-based healthcare. Major trends in the forecast period include the development of non-invasive monitoring methods, the use of wearable and home monitoring devices, the integration of artificial intelligence (AI) and machine learning, and a focus on data security and privacy.

The rising incidence of preterm births and low infant birth weight is a significant driver for the fetal and neonatal monitoring devices market. Preterm birth, characterized by babies born before completing 37 weeks of gestation, is associated with various health challenges, including developmental issues, cognitive impairments, and higher risks of disabilities. The World Health Organization (WHO) reports that preterm births are a leading cause of infant mortality, accounting for approximately 1 million infant deaths annually. WHO further estimates that nearly 15 million babies are born prematurely each year, with this number projected to continue increasing. The escalating need to address these challenges and improve infant survival rates through enhanced healthcare services fuels the growth of the fetal and neonatal monitoring devices market. For example, in 2021, the preterm birth rate among American women was reported to be 10.5% by the Centers for Disease Control and Prevention (CDC).

The equipment in the fetal and neonatal monitoring devices and equipment category can be categorized as either fetal or neonatal monitoring tools. Fetal monitoring equipment includes ultrasound devices, fetal dopplers, fetal MRI systems, fetal monitors, and fetal pulse oximeters. On the other hand, neonatal monitoring equipment encompasses infant warmers, incubators, convertible warmers, incubators, phototherapy equipment, respiratory devices, neonatal monitoring devices, and diagnostic imaging devices. These monitoring devices are utilized by various healthcare facilities, including hospitals, diagnostic centers, pediatric clinics, and ambulatory surgical centers, to ensure the health and safety of pregnant women and newborns throughout the childbirth process.

The fetal and neonatal monitoring devices and equipment market research report is one of a series of new reports that provides fetal and neonatal monitoring devices and equipment market statistics, including fetal and neonatal monitoring devices and equipment industry global market size, regional shares, competitors with a fetal and neonatal monitoring devices and equipment market share, detailed fetal and neonatal monitoring devices and equipment market segments, market trends and opportunities, and any further data you may need to thrive in the fetal and neonatal monitoring devices and equipment industry. This fetal and neonatal monitoring devices and equipment market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The growth of the fetal and neonatal monitoring device market is anticipated to be propelled by the increasing healthcare expenditure. Healthcare expenditure encompasses the total financial resources allocated to healthcare services and products, which include medical equipment, hospital services, physician services, prescription drugs, and public health activities. This financial commitment directly impacts the quality of maternal and neonatal care as it provides the essential resources for the development, deployment, and utilization of advanced fetal and neonatal monitoring devices. As an illustration, in May 2023, the Office for National Statistics in the UK reported a notable increase in healthcare spending. In nominal terms, healthcare spending surged by 9.4%, and in real terms, it rose by 9.7%. The UK's total healthcare expenditure in 2021 reached $367.25 billion (£280.7 billion), with pharmaceutical expenditure amounting to $51.84 billion (£39.6 billion) in the same year. Additionally, spending on preventive care reached $45.93 billion (£35.1 billion) in 2021, more than doubling from the previous year. Consequently, the upward trajectory in healthcare expenditure is a driving force behind the fetal and neonatal monitoring device market's growth.

The fetal and neonatal monitoring device market faces constraints due to stringent regulatory policies that govern this industry. Manufacturers of fetal and neonatal devices must undergo a series of tests and meet various requirements outlined by different regulatory bodies. Regulations from authorities like the FDA's Center for Devices and Radiological Health (CDRH), NMPA regulations, and EU directives impose rigorous standards on this equipment. Additionally, changes in regulations related to customer data protection, such as the European Union's General Data Protection Regulation (GDPR), modifications to equipment approval procedures, and other regulatory adjustments, contribute to increased healthcare expenditures. For instance, a report by Ernst and Young reveals that Fortune 500 companies are collectively investing $7.8 billion to ensure compliance with GDPR. GDPR is a European Union law that focuses on safeguarding the data protection and privacy of individuals residing within the European Union and the European Economic Area (EEA). Furthermore, the FDA's heightened demand for clinical data to substantiate claims has led to a more than 55% increase in the processing times of 510(k) applications over the past decade, thus prolonging the manufacturing cycle for companies in this market.

Leading companies in the fatty acid market are placing a strong emphasis on innovation by introducing cutting-edge devices like the Neonatal Care Warmer Babyroo TN300 to strengthen their market positions. The Neonatal Care Warmer, also known as an infant radiant warmer, is a medical apparatus designed to create a controlled and warm environment for newborn infants, especially those born prematurely or with specific medical needs. In a notable development, Dräger, a German-based company renowned for its gas detection and analysis systems, as well as respiratory and protective equipment, unveiled the Neonatal Care Warmer Babyroo TN300 in June 2023. The Babyroo TN300 represents a significant advancement in newborn care within labor and delivery rooms, as well as Neonatal Intensive Care Units (NICUs). This open-care warmer is equipped with resuscitation tools and offers a customizable design with state-of-the-art thermoregulation capabilities. The pre-warming function ensures that the mattress is prepared at the optimal temperature for newborns, underscoring the product's commitment to providing a secure and comfortable environment for these infants.

Manufacturers of fetal and neonatal monitoring devices are increasingly focusing on innovation and the integration of cutting-edge technologies, including wireless technology, into patient monitoring devices. This integration aims to enhance the diagnosis and monitoring of fetuses and newborns with greater efficiency. Among these innovative technologies, wireless sensor technology plays a crucial role, encompassing biosensor monitoring devices and wireless fetal heart rate monitoring devices. These wireless sensor systems are either implanted or embedded into the patient's skin, equipped with sensors that transmit real-time medical data for monitoring the patient's condition. For example, the National Institute of Neurological Disorders and Stroke has developed SARA, a scanning device capable of detecting fetal brain activity using flashes of light transmitted through the mother's abdomen. Similarly, Philips has introduced a cordless fetal monitoring device designed to ensure the safety of both the mother and child without any inconvenience or risk. These technological advancements address issues related to poor signal reception during observation and enable healthcare providers to monitor patients more efficiently and effectively.

The Department of Health in Hong Kong, which serves as the regulatory authority for fetal and neonatal monitoring devices in the region, issued a medical device safety alert to Guangzhou Sunray Medical Apparatus Co., Ltd., a medical device manufacturer. This alert was prompted by issues related to the maternal and fetal monitor produced by Guangzhou Sunray. The monitor was found to provide inaccurate ultrasound-derived fetal heart rate readings due to software-related problems. This inaccuracy had a detrimental impact on patients' health, potentially causing delayed medical intervention, which could result in severe harm or even the loss of the fetus. To address this issue and reduce associated risks, the regulatory body, MRHA, issued a medical device safety alert with instructions for correcting the device. In a similar vein, in January 2021, Medtronic PLC received a Class II recall notice from the Food and Drug Administration (FDA) for its Neonatal valves. This recall was initiated due to design-related problems with the valves, which led to issues with certain shunts, potentially causing shunt malfunction in specific cases. The recall aimed to address these device-related concerns and mitigate potential risks to patients.

Major companies operating in the fetal and neonatal monitoring devices market include GE Healthcare, Fisher & Paykel Healthcare Limited, Philips Healthcare, Atom Medical Corporation, Natus Medical Incorporated, Analogic Corporation, Phoenix Medical Systems (P) Ltd., Becton Dickinson and Company, Masimo Corporation, Drägerwerk AG & Co. KGAA, CareFusion Corporation, Nonin Medical, Koninklijke Philips N.V., Welch Allyn Inc., Spacelabs Healthcare, Smiths Medical Inc., Getinge AB, FUJIFILM SonoSite Inc., Siemens Healthcare GMBH, Incereb Ltd., Utah Medical Products Inc., OSI Systems, Lutech Industries Inc., Neoventa Medical AB, CardiacDirect, International Biomedical Ltd., Medtronic Plc, Abbott Laboratories, Hill-Rom, Edwards Lifesciences, OMRON, Shenzhen Mindray Bio-Medical Electronics Co. Ltd., CooperSurgical Inc., Huntleigh Healthcare Limited, Nihon Kohden Corporation, Arjohuntleigh Healthcare India Private Limited, Advanced Instrumentations, Dixion Vertrieb medizinischer Geräte GmbH, Mediana Co. Ltd., NCC Medical Co. Ltd.

Asia-Pacific was the largest region in the global fetal and neonatal monitoring devices and equipment market in 2023. North America was the second-largest region in the fetal and neonatal monitoring devices and equipment market. The regions covered in the fetal and neonatal monitoring devices market report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East, and Africa.

The countries covered in the fetal and neonatal monitoring devices market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Italy, Spain, Canada.

The fetal and neonatal monitoring devices market consists of sales of instruments such as ultrasound devices, fetal dopplers, fetal MRI systems, fetal monitors, and fetal pulse oximeters. Values in this market are factory gate values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD, unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.


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