소아용 의료기기 : 시장 점유율 분석, 업계 동향 및 통계, 성장 예측(2026-2031년)

According to Mordor Intelligence, the pediatric medical devices market size was valued at USD 43.62 billion in 2025 and estimated to grow from USD 46.11 billion in 2026 to reach USD 60.82 billion by 2031, at a CAGR of 5.70% during the forecast period (2026-2031).

This report Segments the Industry Into by Product (IVD Devices, Cardiology Devices, Anesthesia & Respiratory Care Devices, Neonatal ICU Devices, Monitoring Devices, Others), by End-User (Hospitals, Diagnostic Laboratories, Pediatric Clinics, Others), and Geography (North America, Europe, Asia-Pacific, Middle-East and Africa, South America).

Global Pediatric Medical Devices Market Trends and Insights

Rising Pre-term Birth Incidence

Preterm births reached 10.4% in the United States for the third straight year. India records roughly 1.5 million premature deliveries each year, driving sustained demand for incubators, tubes, and ventilators. Such statistics oblige manufacturers to miniaturize devices and extend durability for lengthier neonatal care cycles, directly fueling the pediatric medical devices market.

Expansion of Pediatric-Focused Hospital Infrastructure

China's "years of pediatric and mental health services" (2025-2027) program lists eight initiatives that strengthen dedicated children's wards and specialist centers. India's Rainbow Children's Medicare now runs 1,715 beds across 17 hospitals with occupancy up from 44.6% to 55.4% in two fiscal years, signaling faster throughput and procurement intensity. Multilateral lenders such as the Asian Infrastructure Investment Bank finance new pediatric towers in the Philippines, where bed density remains low at 0.89 per 1,000 residents. These bricks-and-mortar expansions translate into continuous capital-equipment refreshes that underpin the pediatric medical devices market.

Small Addressable Patient Pools Limit ROI

Humanitarian approvals cover devices that treat conditions faced by fewer than 200,000 US patients annually, such as SeaStar Medical's cartridge for pediatric acute kidney injury . OrthoPediatrics, focused solely on young patients, has installed 71 orthopedic systems yet still leans on premium pricing and acquisitions to scale. Limited volumes dilute R&D payback, slowing new-product launches that would otherwise enlarge the pediatric medical devices market.

Other drivers and restraints analyzed in the detailed report include:

1. Rapid Adoption of Minimally Invasive Cardiac Interventions
2. Home-Based Remote Monitoring Reimbursement Roll-Outs
3. Stringent FDA & EU Safety Evidence Requirements

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

Segment Analysis

IVD devices captured 22.40% of the pediatric medical devices market share in 2025, underlining their centrality in clinical decision-making. Monitoring devices are projected to clock a 6.15% CAGR through 2031 as care teams transition from episodic sampling to continuous data feeds. The AI-equipped plush toy that grades infant neuro-development underscores how ambient sensors migrate into child-friendly form factors. Cardiology devices keep benefitting from catheter-based breakthroughs such as the Minima Stent. Respiratory and anesthesia platforms hold steady given the high volume of premature births that need ventilatory support. Supply tightness in specialty polymers occasionally forces clinicians to repurpose adult lines, highlighting the importance of material innovation for the pediatric medical devices market.

Diagnostic imaging players add deep-learning modules to ultrasound and X-ray consoles, while ENT and mobility aids receive a boost from wearables such as the SONU Band. Collectively these innovations anchor the diversification that sustains the pediatric medical devices market size across hospital and home settings.

Hospitals controlled 53.70% of revenue in 2025 thanks to high-complexity procedures and integrated supply contracts. Yet homecare settings are set to rise 6.55% annually as reimbursement and technology converge to allow advanced interventions outside hospital walls. Laboratories face shrinking sample volumes as point-of-care analyzers and minimally invasive sensors redirect testing closer to patients. Children's clinics adopt compact ultrasound units that quicken triage and improve throughput. The pediatric medical devices market size for ambulatory surgeries inches up as transcatheter approaches remove the need for open repair. AI-supported wound vacuums and biosensors enable families to manage recovery at home, easing the inpatient load and reshaping demand patterns in the pediatric medical devices market.

Complete Report Scope:

• By Product Type
  • IVD Devices
  • Cardiology Devices
  • Anesthesia & Respiratory Care Devices
  • Neonatal ICU Devices
  • Monitoring Devices
  • Diagnostic Imaging Devices
  • Others (ENT, Ortho, Mobility Aids)
• By End-User
  • Hospitals
  • Diagnostic Laboratories
  • Pediatric Clinics
  • Ambulatory Surgical Centers
  • Homecare Settings
• By Care Setting
  • Inpatient Care
  • Outpatient Care
  • Home-based Care
  • Emergency & Critical Care
• By Technology
  • Conventional Devices
  • Wearable & Connected Devices
  • AI-Enabled Devices
  • 3D-Printed Patient-Specific Devices
  • Minimally-Invasive Catheter-Based
• By Geography
  • North America
    • United States
    • Canada
    • Mexico
  • Europe
    • Germany
    • United Kingdom
    • France
    • Italy
    • Spain
    • Rest of Europe
  • Asia-Pacific
    • China
    • Japan
    • India
    • Australia
    • South Korea
    • Rest of Asia-Pacific
  • Middle East & Africa
    • GCC
    • South Africa
    • Rest of Middle East & Africa
  • South America
    • Brazil
    • Argentina
    • Rest of South America

Geography Analysis

North America held 43.10% of the pediatric medical devices market in 2025, a position powered by reliable reimbursement and an active regulatory pipeline. The FDA's breakthrough label for the Minima Stent and the June 2025 green light for the SONU Band show how rapid clearances translate research into bedside tools fda.gov. CMS's 2025 payment rule further strengthens home-based adoption. Canada benefits from harmonized rules and cross-border device flows, while Mexico's infrastructure gap leaves headroom for foreign suppliers.

Asia-Pacific is forecast to grow at 7.08% through 2031, outpacing all other regions. China's 2025-2027 pediatric service drive sets a policy anchor, whereas India's pediatric segment, equal to 33% of national healthcare spending, should reach USD 33.5 billion by 2026. South Korea's escalating preterm costs and Japan's early adoption of catheter therapies create fertile ground for high-end devices. Regional research alliances are harmonizing practice standards and expanding the pediatric medical devices market size for multinational and domestic vendors alike.

Europe leverages EU MDR 2024/1860 to tighten safety while offering transition windows to 2028. Germany, France, and the United Kingdom spearhead R&D programs, whereas Spain and Italy scale pediatric ICUs. Lebanon's zero-mortality outcome in hybrid palliation of hypoplastic left heart syndrome underscores how clinical excellence can emerge beyond traditional hubs. South America and the Middle East & Africa record slower adoption but draw support from global lenders and multinational donations that gradually grow the pediatric medical devices market.

1. Abbott Laboratories
2. Medtronic
3. GE Healthcare
4. Koninklijke Philips
5. Johnson & Johnson (Ethicon & DePuy Synthes)
6. Siemens Healthineers
7. Boston Scientific
8. Becton Dickinson & Co.
9. Smiths Group
10. Cook Group
11. Edward Lifesciences
12. Atom Medical
13. Hamilton Medical
14. Phoenix Medical Systems
15. TSE Medical
16. David Medical
17. Fritz Stephan
18. Elektro-M
19. Trimpeks
20. Novonate
21. Stryker
22. Masimo
23. Hill-Rom

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 Overview
• 4.2 Market Drivers
  • 4.2.1 Rising Pre-Term Birth Incidence
  • 4.2.2 Expansion of Pediatric-Focused Hospital Infrastructure
  • 4.2.3 Rapid Adoption of Minimally-Invasive Cardiac Interventions
  • 4.2.4 Home-Based Remote Monitoring Reimbursement Roll-Outs
  • 4.2.5 New Reimbursement Codes in the US and Parts of Europe
  • 4.2.6 3D Printed Patient-Specific Implants for Rare Anomalies
• 4.3 Market Restraints
  • 4.3.1 Small Addressable Patient Pools Limit ROI
  • 4.3.2 Stringent FDA & EU Safety Evidence Requirements
  • 4.3.3 Scarcity of Large, High-Quality Pediatric Datasets
  • 4.3.4 Supply-Chain Shortages of Pediatric-Grade Biomaterials
• 4.4 Value / Supply-Chain Analysis
• 4.5 Regulatory Landscape
• 4.6 Technological Outlook
• 4.7 Porter's Five Forces Analysis
  • 4.7.1 Threat of New Entrants
  • 4.7.2 Bargaining Power of Buyers
  • 4.7.3 Bargaining Power of Suppliers
  • 4.7.4 Threat of Substitutes
  • 4.7.5 Competitive Rivalry

5 Market Size & Growth Forecasts (Value, USD Million)

• 5.1 By Product Type
  • 5.1.1 IVD Devices
  • 5.1.2 Cardiology Devices
  • 5.1.3 Anesthesia & Respiratory Care Devices
  • 5.1.4 Neonatal ICU Devices
  • 5.1.5 Monitoring Devices
  • 5.1.6 Diagnostic Imaging Devices
  • 5.1.7 Others (ENT, Ortho, Mobility Aids)
• 5.2 By End-User
  • 5.2.1 Hospitals
  • 5.2.2 Diagnostic Laboratories
  • 5.2.3 Pediatric Clinics
  • 5.2.4 Ambulatory Surgical Centers
  • 5.2.5 Homecare Settings
• 5.3 By Care Setting
  • 5.3.1 Inpatient Care
  • 5.3.2 Outpatient Care
  • 5.3.3 Home-based Care
  • 5.3.4 Emergency & Critical Care
• 5.4 By Technology
  • 5.4.1 Conventional Devices
  • 5.4.2 Wearable & Connected Devices
  • 5.4.3 AI-Enabled Devices
  • 5.4.4 3D-Printed Patient-Specific Devices
  • 5.4.5 Minimally-Invasive Catheter-Based
• 5.5 By Geography
  • 5.5.1 North America
    • 5.5.1.1 United States
    • 5.5.1.2 Canada
    • 5.5.1.3 Mexico
  • 5.5.2 Europe
    • 5.5.2.1 Germany
    • 5.5.2.2 United Kingdom
    • 5.5.2.3 France
    • 5.5.2.4 Italy
    • 5.5.2.5 Spain
    • 5.5.2.6 Rest of Europe
  • 5.5.3 Asia-Pacific
    • 5.5.3.1 China
    • 5.5.3.2 Japan
    • 5.5.3.3 India
    • 5.5.3.4 Australia
    • 5.5.3.5 South Korea
    • 5.5.3.6 Rest of Asia-Pacific
  • 5.5.4 Middle East & Africa
    • 5.5.4.1 GCC
    • 5.5.4.2 South Africa
    • 5.5.4.3 Rest of Middle East & Africa
  • 5.5.5 South America
    • 5.5.5.1 Brazil
    • 5.5.5.2 Argentina
    • 5.5.5.3 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 Abbott
  • 6.3.2 Medtronic plc
  • 6.3.3 GE Healthcare
  • 6.3.4 Philips Healthcare
  • 6.3.5 Johnson & Johnson (Ethicon & DePuy Synthes)
  • 6.3.6 Siemens Healthineers
  • 6.3.7 Boston Scientific
  • 6.3.8 Becton Dickinson & Co.
  • 6.3.9 Smiths Medical
  • 6.3.10 Cook Medical
  • 6.3.11 Edwards Lifesciences
  • 6.3.12 Atom Medical
  • 6.3.13 Hamilton Medical
  • 6.3.14 Phoenix Medical Systems
  • 6.3.15 TSE Medical
  • 6.3.16 David Medical
  • 6.3.17 Fritz Stephan GmbH
  • 6.3.18 Elektro-Mag
  • 6.3.19 Trimpeks
  • 6.3.20 Novonate Inc.
  • 6.3.21 Stryker Corp.
  • 6.3.22 Masimo Corporation
  • 6.3.23 Hill-Rom Holdings

7 Market Opportunities & Future Outlook

• 7.1 White-space & Unmet-need Assessment