Summary

The Fetal Heart Rate Monitoring Device Market studied is expected to grow with an estimated CAGR of 6.70% over the forecast period.

With the emergence of COVID-19, the focus has shifted more towards patient care and comfort. With the rise in demand and compelling with the situation, regulatory authorities like USFDA have provided some relaxation in the regulations for the launch of medical devices to provide uninterrupted support and care to the mother and fetus during the tough situation of the pandemic. As soon as ease was provided in April 2020 by the USFDA, Philips had launched its wireless fetal heart rate monitoring device in June 2020 in the United States. Thus, COVID-19 is expected to positively impact the fetal heart rate monitoring device market.

The studied market growth is largely attributed to technological advancement in fetal monitoring devices, increasing birth rate and preterm births, and rising government and non-government initiatives to provide better maternal and fetal care. The technological advancement in monitoring devices is likely to drive the market growth as it has a prime focus on patient care and comfort. The wireless and in-home monitoring devices introduced in the market enabling data sharing with healthcare workers. Preterm birth means a baby is born before the completion of 37 weeks of pregnancy and lifestyle diseases such as diabetes and hypertension are the common cause of it. Further, the rate of preterm births has been increasing in the United States over the years. In 2019, there were 10.2% of live births were preterm i.e., 1 out of 10 babies born in the US. Preterm birth could lead to complications and even death, so vigorous heart rate monitoring helps determine the fetus's safety. Hence, owing to the rising number of preterm births and rising usages of these devices in fetal health monitoring, market is likely to grow with notable growth rate over upcoming period.

To ensure better facilities, various government and nongovernment agencies also participate. For instance, in September 2020, World Health Organization (WHO) was collaborated with ministries of health to strengthen and invest in care, particularly around the time of birth and the first week of life. These will encourage the participation of the organization and boost market growth. Given all the mentioned facts, the Fetal Heart Rate Monitoring Device Market is expected to witness significant growth over the forecast period.

However, stringent regulatory norms for medical devices and the high cost associated with fetal heart rate monitoring devices may act as restraining factors for the market studied.

Key Market Trends

Wireless Fetal Heart Rate Monitoring Devices Segment is Expected to Dominate the Market Over the Forecast Period

Wireless fetal heart rate monitoring devices are advanced diagnostic technology used to monitor the fetal heart rate to assure the fetus's health during high-risk pregnancies. The wireless fetal monitors come with either adhesive pads or patches or with the belt to ensure proper holding across the stomach of the mother. This new technology could be used for any method invasive or noninvasive without compromising the result in inpatient or outpatient settings.

Many technologically advanced medical device organizations are planning to launch such devices or be on the verge of launching them. These wireless or cableless monitoring devices have made prenatal care a better experience especially in developing countries where there is a shortage of obstetricians and gynecologists. Also, the use of a wireless fetal monitor that can transmit fetal heart rate data via Bluetooth, was piloted amongst healthy patients undergoing labor induction at term and allowed home monitoring for 24 hours. The use of wireless fetal monitoring technology in the home could be found feasible and acceptable to pregnant women. The instrument like HeraBEAT (smart fetal doppler with data sharing) by H-cube (Her Healthcare at home) enables the expected mother to hear and monitor the fetus's heart rate and share it with health practitioners. Thus, with the support of technologically advanced solutions for providing better prenatal care, the demand for wireless fetal heart rate monitoring devices is expected to grow in the future.

North America Dominates the Market and Expected to do Same in the Forecast Period

North America along with the United States and Canada, is found to have one of the very well-structured, developed, and advanced healthcare systems across the globe. With high research and development expenditure for fetal and neonatal care devices, the governments of the North American region are also promoting small setups for healthcare research. Therefore, many companies are encouraged to operate in this region, making North America dominating the market across the globe.

Moreover, According to the National Center for Science and Engineering Statistics (NCSES) report, the spending on Research and Development in the United States in healthcare has increased to 5.7% from 2018 to 2019. Also, the Canadian Government has launched about 73 projects under the Maternal, Newborn, and Child Health (MNCH) initiative aiming to improve the health of women and children. Further, high-risk pregnancies occur in around 6-8% of pregnancies in the United States. Monitoring of heart rate and vital during such conditions become extremely important for practitioners to prevent deaths. Thus, to overcome such scenarios and provide better health facilities to mother and fetus, the government is encouraging the participation by the various organization of industry and making the North American Market preferable choice by the industry players.

Competitive Landscape

The Fetal Heart Rate Monitoring market is moderately competitive with several global and regional players. In terms of market share, the major players currently dominate the market. With the rising patient awareness levels and high preterm birth rates, many regional players are expected to be part of the fetal heart rate monitoring devices market over the forecast period. The market's major players are GE Healthcare, Fujifilm Sonosite Inc, MedGyn Products Inc, Siemens Healthineers, Cooper Surgicals, Edan instruments, and Trismed Co Ltd.

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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 Technological Advancement in Fetal Monitoring Devices
4.2.2 Rising Number of Birth Rate and Preterm Births
4.2.3 Rising Government and Non Government Initiaves to Provide Better Maternal and Fetal Care
4.3 Market Restraints
4.3.1 Strigent Regulatory Norms for Medical Devices
4.3.2 High Cost Associated with Fetal Heart Rate Monitoring Devices
4.4 Porter's Five Force 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 Class
5.1.1 Internal Heart Rate Monitoring Device
5.1.2 External Heart Rate Monitoring Device
5.2 By Technology Type
5.2.1 Doppler Ultrasound Device
5.2.2 Electronic Fetal Monitoring Device
5.3 By Portablity of Device
5.3.1 Portable
5.3.2 Non Portable
5.4 By Geography
5.4.1 North America
5.4.1.1 United States
5.4.1.2 Canada
5.4.1.3 Mexico
5.4.2 Europe
5.4.2.1 Germany
5.4.2.2 United Kingdom
5.4.2.3 France
5.4.2.4 Italy
5.4.2.5 Spain
5.4.2.6 Rest of Europe
5.4.3 Asia-Pacific
5.4.3.1 China
5.4.3.2 Japan
5.4.3.3 India
5.4.3.4 Australia
5.4.3.5 South Korea
5.4.3.6 Rest of Asia-Pacific
5.4.4 Rest of the World

6 COMPETITIVE LANDSCAPE
6.1 Company Profiles
6.1.1 Philips Healthcare
6.1.2 GE Healthcare
6.1.3 Siemens Healthineers
6.1.4 Cooper Surgicals Inc
6.1.5 MedGyn Products, Inc
6.1.6 Edan Instruments
6.1.7 Sunray Medical Appratus Co.
6.1.8 Bionet America
6.1.9 Trismed CO, Ltd
6.1.10 Mindray Medicals
6.1.11 Fujifilm Sonosite, Inc
6.1.12 Natus Medical, Inc

7 MARKET OPPORTUNITIES AND FUTURE TRENDS