Summary

The fetal and neonatal monitoring market is expected to register a CAGR of 6.8% over the forecast period.

The COVID-19 pandemic has had a significant impact on the fetal and neonatal monitoring market. According to the research article published in the Journal of Perinatology, 2020, low rates of perinatal transmission of the COVID-19 virus among neonates born to SARS-CoV-2 positive mothers were observed. However, as per the National Registry for Surveillance and Epidemiology of Perinatal COVID-19 Infection (NPC-19), 2020, an incidence of 44 COVID-19 positive cases were observed out of 2287 neonates born to mothers with confirmed SARS-CoV-2 infection. Additionally, as per the research article published in the European Journal of Pediatrics, 2020, neonates and children are less susceptible to COVID-19 due to the reduction in the functioning of angiotensin-converting-enzyme type 2 receptors. Though newborns are at lower risk of developing the infection, utmost care and monitoring are required in instances of COVID-19 infection among infants, which majorly involves continuous monitoring of blood oxygen levels and heartbeat. In this context, the studied market is expected to be significantly impacted during the pandemic.

Fetal monitoring devices are vital tools routinely used in gynecology and obstetrics interventions to examine fetal health during labor and delivery. Neonatal devices are extensively used in neonatal intensive care units (NICUs) where complex machines and monitoring devices are designed for the unique needs of newborn babies.

The prevalence of preterm births has increased in recent decades. According to the World Health Organization, 2018 fact sheet, approximately 15 million infants are born globally before the completion of 37 weeks of gestation, and the rate of preterm births ranges from 5% to 18% of all babies born across 184 countries worldwide. These preterm newborns are found prone to diseases and infections. Hence, these newborns are kept under surveillance using monitoring equipment. These factors have increased the demand for monitoring devices and equipment, which has also driven technological advancements in equipment. Moreover, many healthcare authorities in developing countries are also spreading awareness regarding these facilities to reduce the mortality rate of newborns. These factors have helped the growth of the market.

However, limited access to these facilities in under-developed and developing countries has hindered the further growth of the market. Also, the regulatory guidelines for market approval are very stringent, which dissuades many manufacturers from entering the market.

Key Market Trends

The Neonatal Monitoring Segment is Expected to Dominate the Market over the Forecast Period

A neonatal monitor is designed to continuously measure and display multiple vital physiological parameters of newborn and premature infants, especially those under critical care. The monitoring system is capable of monitoring parameters such as electrocardiogram, respiration rate, heart rate, blood pressure, peripheral capillary oxygen saturation (SpO2), and body temperature. Neonatal monitoring instruments are used in neonatal intensive care units (NICU), emergency rooms, and operating theatres at all levels of hospitals for continuous monitoring of neonates and infants.

Most of the babies admitted in the NICU are preterm babies, born before 37 weeks of gestational period or with a birth weight of less than 5.5 pounds. Preterm babies are more prone to infections and diseases and require more care. As per the Centers for Disease Control and Prevention (CDC), preterm births affected 1 in every 10 infants born in the United States in 2019. Additionally, preterm births among African-American women accounted for 14.4% of all preterm births in the United States, which was about 50% higher than the rate of preterm births among white (9.3%) or Hispanic women (10%).​ Premature babies in the NICU are fragile and at the risk of sudden changes in oxygenation and carbon dioxide levels, which can cause severe complications. With the neonatal monitoring devices, continuous measurement of blood gases, heart rate, and other vital parameters can be performed. Additionally, increasing product approvals are expected to drive the market growth. For instance, in June 2019, Masimo received the US FDA clearance for its O3 Regional Oximetry, which is indicated for use on neonatal and infant patients with less than 10 kg body weight. Thus, owing to the above-mentioned factors, the studied segment is expected to witness significant growth over the forecast period.

North America Holds the Major Share, and it is Expected to Dominate the Market Over the Forecast Period

North America is found dominating the market as the United States and Canada have well-structured and developed healthcare systems. These countries are found promoting research and development for fetal and neonatal medical devices and hence, have very high expenditures on healthcare. As a result of these policies, many companies globally are encouraged to operate in this region.

Moreover, most of the population in developed countries like the United States are covered under medical and health insurance and can afford these care units. Hence, the North American region is expected to cover a large share of the neonatal intensive care market. As per the data published by the Centers for Medicare & Medicaid Services (CMS), in the United States, national healthcare spending is projected to grow at an average rate of 5.5% per year during 2018-2027, to reach nearly USD 6.0 trillion by 2027. Healthcare spending is projected to grow 0.8% faster than the GDP per year over 2018-2027. As a result, the healthcare share of GDP is expected to rise from 17.9% in 2017 to 19.4% by 2027.​Additionally, according to the data from the National Center for Health Statistics, the percentage of preterm births in the United States increased from 9.57% in 2014 to 10.02% in 2018. The rise in preterm birth is expected to boost the demand for neonatal monitoring systems in the United States, as preterm babies are more susceptible to diseases like sepsis, pneumonia, etc. Hence, owing to the aforementioned factors, the studied market is expected to witness significant growth over the forecast period in the region.

Competitive Landscape

The fetal and neonatal monitoring market is moderately competitive. The majority of the fetal and neonatal monitoring equipment and devices are being manufactured by the global key players. Market leaders with more funds for research and better distribution systems have established their positions in the market. Moreover, Asia-Pacific is witnessing the emergence of some small players due to the increase in awareness, which helps in the growth of the market. The key players of the studied market comprise Medtronic PLC, Becton, Dickinson and Company, Koninklijke Philips NV, GE Company (GE Healthcare), and Siemens Healthineers, among others. The major players are evolving through strategies such as acquisitions, partnerships, and new product launches to secure their positions in the competitive landscape.

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Table of Contents

1 INTRODUCTION
1.1 Study Assumptions and Market Definition
1.2 Scope of the Study

2 RESEARCH METHODOLOGY

3 EXECUTIVE SUMMARY

4 MARKET DYNAMICS
4.1 Market Overview
4.2 Market Drivers
4.2.1 Increasing Number of Preterm and Low-weight Births
4.2.2 Advanced Technology in Fetal and Prenatal Monitoring
4.2.3 Growing Government Initiatives in Developing Countries Regarding Fetal Care
4.3 Market Restraints
4.3.1 Limited Accessibility in the Developing Regions
4.3.2 Stringent Regulatory Procedures
4.4 Porter's Five Forces Analysis
4.4.1 Threat of New Entrants
4.4.2 Bargaining Power of Buyers/Consumers
4.4.3 Bargaining Power of Suppliers
4.4.4 Threat of Substitute Products
4.4.5 Intensity of Competitive Rivalry

5 MARKET SEGMENTATION
5.1 By Product
5.1.1 Fetal Monitoring Devices
5.1.1.1 Heart Rate Monitors
5.1.1.2 Uterine Contraction Monitor
5.1.1.3 Pulse Oximeters
5.1.1.4 Other Fetal Monitoring Devices
5.1.2 Neonatal Monitoring Devices
5.1.2.1 Cardiac Monitors
5.1.2.2 Capnographs
5.1.2.3 Blood Pressure Monitors
5.1.2.4 Pulse Oximeters
5.1.2.5 Other Neonatal Monitoring Devices
5.2 By End User
5.2.1 Hospitals
5.2.2 Neonatal Care Centers
5.2.3 Other End Users
5.3 Geography
5.3.1 North America
5.3.1.1 United States
5.3.1.2 Canada
5.3.1.3 Mexico
5.3.2 Europe
5.3.2.1 Germany
5.3.2.2 United Kingdom
5.3.2.3 France
5.3.2.4 Italy
5.3.2.5 Spain
5.3.2.6 Rest of Europe
5.3.3 Asia-Pacific
5.3.3.1 China
5.3.3.2 Japan
5.3.3.3 India
5.3.3.4 Australia
5.3.3.5 South Korea
5.3.3.6 Rest of Asia-Pacific
5.3.4 Middle-East and Africa
5.3.4.1 GCC
5.3.4.2 South Africa
5.3.4.3 Rest of Middle-East and Africa
5.3.5 South America
5.3.5.1 Brazil
5.3.5.2 Argentina
5.3.5.3 Rest of South America

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Becton, Dickinson and Company
6.1.2 Fujifilm Holdings Corporation
6.1.3 Medtronic PLC
6.1.4 Draegerwerk AG & Co. KGaA
6.1.5 Huntleigh Healthcare Limited
6.1.6 CooperSurgical Inc.
6.1.7 Koninklijke Philips NV
6.1.8 Natus Medical Incorporated
6.1.9 GE Healthcare
6.1.10 Siemens Healthineers
6.1.11 Atom Medical Corporation
6.1.12 Cardinal Health
6.1.13 Edan Instruments Inc.
6.1.14 Masimo Corporation
6.1.15 Phoenix Medical Systems Pvt. Ltd

7 MARKET OPPORTUNITIES AND FUTURE TRENDS

8 IMPACT OF COVID-19 ON THE MARKET