신생아 및 산전 진단 기기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the neonatal and prenatal devices market size is projected to expand from USD 8.36 billion in 2025 and USD 8.91 billion in 2026 to USD 12.19 billion by 2031, registering a CAGR of 6.47% between 2026 to 2031.

This report is Segmented by Product Type (Prenatal and Fetal Equipment, and Neonatal Equipment), Technology (Invasive Monitoring, and Non-Invasive Monitoring), End User (Hospitals, Maternity & Specialty Clinics, and More), and Geography (North America, Europe, Asia-Pacific, Middle East and Africa, South America). The Market Forecasts are Provided in Terms of Value (USD).

Global Neonatal And Prenatal Devices Market Trends and Insights

Rising Incidence of Preterm Births

Persistently high preterm delivery rates keep the neonatal and prenatal devices market under structural demand pressure. United States data show 373,902 preterm births in 2023, and rates remain highest among Black infants at 14.7% and American Indian or Alaska Native infants at 12.4%. Multiple pregnancies, which are seven times more likely to be preterm than singleton pregnancies, amplify equipment needs as fertility treatments rise. Hospitals, therefore, accelerate investment in advanced incubators, ventilators, and predictive analytics that can flag sepsis or necrotizing enterocolitis earlier than manual observation. Together, these factors translate into steady volume for life-support devices even as overall birth totals plateau in developed economies.

Growth in High-Risk Pregnancy & Prenatal Screening Volumes

Maternal age is rising in most high-income nations, lifting the proportion of pregnancies classified as high-risk and fueling demand for sophisticated prenatal imaging. Women aged 40 and older experienced 14.6% preterm birth rates in 2023, well above the national average. AI-based ultrasound now detects 95% of neural tube defects, while machine-learning classification algorithms reach 71.5% diagnostic accuracy in test datasets. Clinical uptake accelerates because remote ultrasound reviews allow specialists to serve community clinics, closing the gap created by the fall in first-trimester prenatal care coverage to 76.1% in 2023. Wearable maternal monitors combine heart-rate, blood-oxygen, and activity sensors to manage smoking and gestational diabetes risks in real time. Digital care pathways reduce unnecessary in-person visits without compromising outcomes, lowering system costs, and encouraging payer reimbursement for connected prenatal devices.

Declining Birth Rates in Developed Economies

Global fertility is projected to slide to 1.83 by 2050 and 1.59 by 2010, well below the replacement rate, cutting the underlying volume addressable by the neonatal and prenatal devices market in the wealthiest countries. The United States reported a 2% birth decline and 3% drop in the general fertility rate during 2023. Maternity unit closures compound access problems; more than 200 rural hospitals shut labor-and-delivery services, leaving 2.3 million women in "maternity care deserts". Socioeconomic factors-delayed marriage, higher education, and childcare expenses-continue to suppress birth numbers, and policy incentives have shown only modest success in France, South Korea, and Singapore. Lower absolute births mean suppliers must pivot toward higher acuity equipment and ancillary home monitoring services to sustain revenue growth in developed regions.

Other drivers and restraints analyzed in the detailed report include:

1. Expansion of NICU Capacity in Emerging Markets
2. AI-Enabled Remote Neonatal Monitoring Adoption in Home Settings
3. High Capital Cost & Reimbursement Hurdles

For complete list of drivers and restraints, kindly check the Table Of Contents.

Segment Analysis

Neonatal equipment revenue is expected to rise at a 9.53% CAGR through 2031, outstripping the prenatal and fetal category, even though prenatal devices held 62.88% of the neonatal and prenatal devices market in 2025. The neonatal and prenatal devices market size tied to incubators grows fastest because hospitals upgrade to portable, battery-powered units that cost a fraction of traditional models yet meet ISO temperature stability standards. Low-resource facilities in Bangladesh confront a 20,000-unit gap, and compact systems priced around GBP 250 reduce procurement barriers and stimulate government tenders. Phototherapy systems adopt longer-lasting LEDs that cut power consumption 60%, encouraging adoption in off-grid clinics. Ventilation platforms integrate predictive algorithms that flag respiratory distress minutes earlier than conventional alarms, which helps caregivers intervene before oxygen saturation drops to critical thresholds.

Prenatal and fetal equipment, while still the most significant contributor to the neonatal and prenatal devices market revenue, advances at a slower pace because penetration is already high among tertiary care centers. AI-enhanced ultrasound, typified by GE HealthCare's Voluson Signature line, reduces scan-to-report time by up to 40% without compromising diagnostic accuracy. Fetal MRI expands its role in central-nervous-system anomaly detection when ultrasound findings are inconclusive, creating a smaller but higher value subsegment. Remote fetal pulse oximeters link to telehealth portals so that obstetricians can watch high-risk pregnancies from afar, which is valuable in regions where 2.3% of mothers receive no prenatal care. However, market maturity and tightening hospital budgets temper growth relative to neonatology-focused devices, driving suppliers to focus R&D resources on postnatal applications.

Geography Analysis

North America commanded 36.88% of global revenue in 2025, anchored by large NICU footprints, robust private insurance coverage, and a regulatory environment that favors continuous innovation. Yet structural headwinds arise from a 2% annual birth decline, and more than 200 rural hospitals have shuttered labor wards, restricting access outside metro centers. Canada's single-payer model continues to buy premium equipment, but constrained budgets lengthen replacement cycles. Mexico's social-security hospitals adopt mid-range monitors as they balance cost and rising acuity.

Asia-Pacific is projected to expand at a 8.84% CAGR through 2031, making it the fastest-growing region within the neonatal and prenatal devices market. China alone commits billions of renminbi to neonatal infrastructure, while India's production-linked incentive scheme shifts device assembly onshore, lowering landed costs. Japanese and South Korean hospitals pursue AI imaging to manage aging clinical workforces, ensuring that premium segments continue to grow despite stagnant birth volumes. Southeast Asian nations, including Indonesia and Vietnam, open new maternal-child hospitals under public-private-partnership models, importing mid-tier incubators and monitors that balance feature sets with price.

Europe advances at a steadier clip as Medical Device Regulation deadlines prioritize compliance spending over green-field expansion, though unified rules simplify pan-EU launches for AI-driven software. Middle East and Africa, along with South America, remain nascent but strategically important because mobile-first infrastructure enables leapfrogging to cloud-connected devices without the legacy cost of wired networks. Portable incubators and solar-powered monitors see highest traction in these geographies, validating the global relevance of frugal innovation.

1. GE Healthcare
2. Koninklijke Philips
3. Dragerwerk
4. Atom Medical
5. Natus Medical
6. Getinge
7. Masimo
8. Medtronic
9. Vyaire Medical
10. Phoenix Medical Systems
11. Fanem Ltda
12. Fisher & Paykel Healthcare
13. Siemens Healthineers
14. Beckton Dickinson
15. Smiths Group
16. Hamilton Medical
17. Mindray Bio-Medical Electronics
18. Nihon Kohden
19. Edward Lifesciences
20. Butterfly Network, Inc.

Additional Benefits:

• The market estimate (ME) sheet in Excel format
• 3 months of analyst support

TABLE OF CONTENTS

1 Introduction

• 1.1 Study Assumptions & Market Definition
• 1.2 Scope of the Study

2 Research Methodology

3 Executive Summary

4 Market Landscape

• 4.1 Market Drivers
  • 4.1.1 Rising Incidence of Preterm Births
  • 4.1.2 Growth in High-Risk Pregnancy & Prenatal Screening Volumes
  • 4.1.3 Expansion of NICU Capacity in Emerging Markets
  • 4.1.4 Government-Supported Universal Fetal Monitoring Programs
  • 4.1.5 AI-Enabled Remote Neonatal Monitoring Adoption in Home Settings
  • 4.1.6 Development of Low-Cost Portable Incubators for Off-Grid Clinics
• 4.2 Market Restraints
  • 4.2.1 Declining Birth Rates in Developed Economies
  • 4.2.2 High Capital Cost & Reimbursement Hurdles
  • 4.2.3 Limited Skilled Neonatal Care Staff in Rural Hospitals
  • 4.2.4 Supply-Chain Disruptions for Critical Electronic Components
• 4.3 Technological Outlook
• 4.4 Porter's Five Forces Analysis
  • 4.4.1 Bargaining Power of Buyers
  • 4.4.2 Bargaining Power of Suppliers
  • 4.4.3 Threat of Substitutes
  • 4.4.4 Intensity of Competitive Rivalry
  • 4.4.5 Threat of New Entrants
• 4.5 Regulatory Landscape

5 Market Size & Growth Forecasts (Value in USD)

• 5.1 By Product Type
  • 5.1.1 Prenatal & Fetal Equipment
    • 5.1.1.1 Ultrasound & Ultrasonography Devices
    • 5.1.1.2 Fetal Doppler
    • 5.1.1.3 Fetal MRI
    • 5.1.1.4 Fetal Heart Monitors
    • 5.1.1.5 Fetal Pulse Oximeters
    • 5.1.1.6 Other Prenatal & Fetal Equipment
  • 5.1.2 Neonatal Equipment
    • 5.1.2.1 Incubators
    • 5.1.2.2 Neonatal Monitoring Devices
    • 5.1.2.3 Phototherapy Equipment
    • 5.1.2.4 Respiratory Assistance & Monitoring Devices
    • 5.1.2.5 Other Neonatal Care Equipment
• 5.2 By Technology
  • 5.2.1 Invasive Monitoring
  • 5.2.2 Non-Invasive Monitoring
• 5.3 By End User
  • 5.3.1 Hospitals
  • 5.3.2 Maternity & Specialty Clinics
  • 5.3.3 Home & Remote Care Settings
  • 5.3.4 Ambulatory Surgical Centers
• 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 Middle East & Africa
    • 5.4.4.1 GCC
    • 5.4.4.2 South Africa
    • 5.4.4.3 Rest of Middle East & Africa
  • 5.4.5 South America
    • 5.4.5.1 Brazil
    • 5.4.5.2 Argentina
    • 5.4.5.3 Rest of South America

6 Competitive Landscape

• 6.1 Market Concentration
• 6.2 Market Share Analysis
• 6.3 Company Profiles (includes Global Level Overview, Market Level Overview, Core Segments, Financials as Available, Strategic Information, Market Rank/Share for Key Companies, Products & Services, and Recent Developments)
  • 6.3.1 GE Healthcare
  • 6.3.2 Koninklijke Philips NV
  • 6.3.3 Dragerwerk AG & Co. KGaA
  • 6.3.4 Atom Medical Corporation
  • 6.3.5 Natus Medical Incorporated
  • 6.3.6 Getinge AB
  • 6.3.7 Masimo Corporation
  • 6.3.8 Medtronic
  • 6.3.9 Vyaire Medical
  • 6.3.10 Phoenix Medical Systems Pvt. Ltd
  • 6.3.11 Fanem Ltda
  • 6.3.12 Fisher & Paykel Healthcare
  • 6.3.13 Siemens Healthineers
  • 6.3.14 Becton, Dickinson and Company
  • 6.3.15 Smiths Medical (ICU Medical)
  • 6.3.16 Hamilton Medical AG
  • 6.3.17 Mindray Bio-Medical Electronics
  • 6.3.18 Nihon Kohden Corporation
  • 6.3.19 Edwards Lifesciences
  • 6.3.20 Butterfly Network, Inc.

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-Need Assessment