Europe Pediatric Medical Device Market: Industry Analysis and Forecast (2024-2030)

  • The Europe Pediatric Medical Device Market size was valued at USD 8,903.02 Million in 2023 and the total Europe Pediatric Medical Device revenue is expected to grow at a CAGR of 7.13% from 2024 to 2030, reaching nearly USD 14,418.33 Million.

  • Format : PDF | Report ID : SMR_1664

Europe Pediatric Medical Device Market Overview

Pediatric medical devices are employed to treat or diagnose diseases in children under the age of 21. Paediatrics is a branch of medical treatment for newborns, kids, and teenagers. Pediatric medical devices take into account factors such as smaller body sizes, developmental stages, and the unique physiology of pediatric patients.


Paediatricians across Europe have voiced serious concerns about the evolving shortages of medical devices in the European Union (EU) that are essential for treating sick children. In 2023, the European Union revised its regulatory framework for medical devices, primarily to improve patient safety and public health. Germany dominated the European market with a major revenue share in 2023. As the medical device market for pediatrics grows, industry, academics, and clinicians have faced the formidable challenge of how to impact upon the hard-to-reach and vulnerable populations.


Addressing social determinants of child health and child health inequalities in large populations has been lighted by socioeconomic factors that limit technology reach. The substantial chronic disease burden, coupled with advanced healthcare infrastructure and easy access to services, continues to support the potential growth of the market. Additionally, caution is to be exercised as the Government, like many others in Europe, is controlling costs through various measures.


  1. In Europe, an average of approximately 11% of gross domestic product (GDP) is spent on healthcare. The spending on medical technology is estimated to vary significantly across European countries, ranging from around 5% to 12% of the total healthcare expenditure.

Europe Pediatric Medical Device Market


Europe Pediatric Medical Device Market Dynamics

Driving Factors in the Growth of the European Pediatric Medical Devices Market

The rise in the incidences of chronic disease or infectious diseases among the pediatric population such as diphtheria, leukemia, measles, mumps, anemia, asthma, chickenpox, tuberculosis, whooping cough, Lyme disease, and pneumonia acts as one of the major factors driving the growth of pediatric medical devices market. The generic drug market is growing robustly, with the government's cost-containment policy and a significant number of patent expiries driving the growth of the market. The increase in demographic and epidemiological profiles provides growth opportunities for manufacturers of chronic treatments that have influenced the European pediatric medical devices market growth.


The increasing demand for pediatric medical equipment, primarily driven by the growing global pediatric population, is one of the key factors propelling the market. Additionally, the rising prevalence of pediatric chronic conditions such as diabetes, asthma, cancer, and heart disease is contributing to the heightened need for pediatric medical equipment and has boosted the market growth.

Europe Pediatric Medical Device Market1

Challenges and Barriers Facing the European Pediatric Medical Devices Market

Paediatricians across Europe have voiced serious concerns about the evolving shortages of medical devices in the European Union (EU) that are essential for treating sick children. Pediatric medical devices are withdrawn from the market due to markedly increased regulatory requirements and high costs of certifying devices under the revised EU Medical Device Regulation. Despite numerous legislative, regulatory, and scientific efforts in recent years, innovative pediatric medical devices (PMDs) have yet to be made available at the same rate as adult medical devices. Many innovative medical devices approved for adult use have not been approved for pediatric use resulting in hindering the market growth.


Medical device development for pediatrics has remained relatively stagnant, as evidenced by premarket approvals (PMAs) and humanitarian device exemptions (HDEs) with labeling for pediatric usage. A major barrier to enabling the appropriate availability of medical devices for the pediatric age group is the very high financial cost of their assessment as a result it arises from the delegation of the conformity assessment in the EU to profit-making private enterprises that serve as notified bodies, with no prerequisites taken to encourage the certification of pediatric or orphan devices at low cost.


Europe Pediatric Medical Device Market Segment Analysis

Based on Product, In Vitro Diagnostic (IVD) Devices segment holds the highest share with a growing CAGR of 7.20% during the forecast period. In vitro diagnostics (IVDs) are non-invasive tests used on biological samples, for instance, blood, urine tissues, etc., to determine the status of a person’s health. Rising Awareness of preventative medicine and a robust regulatory framework that ensures the quality and efficacy of diagnostic tools have propelled the market growth. Medical technologies have improved the quality of care and the efficiency and sustainability of healthcare systems resulting in accelerating the market growth. There are over 40,000 different IVD products on the European market. The United Kingdom, Germany, France, Italy, and Spain play vital roles in the European in Vitro Diagnostic market.

Europe Pediatric Medical Device Market2

Europe Pediatric Medical Device Market Regional Insights

Germany dominated the Pediatric Medical Device Market with the highest market share accounting for 33.80% in 2023, the Country is expected to grow during the forecast period and maintain its dominance by 2030. Thanks to the increasing adoption of advanced medical treatments. The rapidly increasing pediatric healthcare market, as well as the advances in digital healthcare and data analytics, has provided an opportunity to collect large volumes of meaningful national and international data to provide clarity about childhood growth, development, and disease. Additionally, a sizable patient base with low birth weight and an uptick in preterm deliveries are expected to drive market growth in Europe.


The German pediatric medical devices market was attributed to holding the largest market share, and the UK pediatric medical devices market is estimated to be the fastest growing market in the Europe region. Additionally, growing parental awareness programs and an increase in investment in research and development activities are driving the France pediatric medical devices market.

Europe Pediatric Medical Device Market3

Europe Pediatric Medical Device Market Competitive Landscape

  • In 2023, Medtronic PLC, the global leader in healthcare technology announced it filed a complaint with the U.S. International Trade Commission (ITC), along with a parallel action in the U.S. District Court for the District of Delaware, to block Axonics from improperly importing and selling products that infringe two Medtronic patents related to the MRI compatibility of implantable medical devices.


  • In 2021, Stryker Corporation acquired Wright Medical Corporation for USD 5.4 Billion. Wright Medical has a strong presence in the pediatric orthopedics market and the acquisition increases Stryker's product portfolio in Europe.


Europe Pediatric Medical Device Market Scope

Market Size in 2023

USD 8,903.02 Bn.

Market Size in 2030

USD 14,418.33 Bn.

CAGR (2024-2030)


Historic Data


Base Year


Forecast Period


Segment Scope

By Product

  • In Vitro Diagnostic (IVD) Devices
  • Anesthesia & Respiratory Care Devices
  • Cardiology Devices
  • Diagnostic Imaging Devices
  • Neonatal ICU Devices


By End User

  • Hospitals
  • Pediatric Clinics
  • Ambulatory Surgical Centers


Country Scope

  • Germany
  • United Kingdom
  • Spain
  • France
  • Italy
  • Belgium
  • Sweden
  • Poland
  • Russia
































Europe Pediatric Medical Device Key Players

  • Medtronic PLC
  • Hamilton Medical AG (Hamilton Bonaduz AG)
  • TSE spol. s.r.o. (TSE Medical)
  • Atom Medical Corporation
  • F. Hoffmann-La Roche Ltd.
  • Fritz Stephan GmbH
  • General Electric Healthcare
  • Hamilton Medical
  • Koninklijke Philips N.V.
  • Siemens AG

Frequently Asked Questions

The rising burden of chronic diseases and congenital disabilities in children is expected to be the major driver for the market.

1.    Europe Pediatric Medical Device Market Introduction
1.1.    Study Assumption and Market Definition
1.2.    Scope of the Study
1.3.    Executive Summary 
1.4.    Emerging Technologies
1.5.    Market Projections
1.6.    Strategic Recommendations
2.    Europe Pediatric Medical Device Market Trends
2.1.    Market Consolidation
2.2.    Adoption of Advanced Technologies
2.3.    Pricing and Reimbursement Trends
3.    Europe Pediatric Medical Device Market Import Export Landscape
3.1.    Import Trends
3.2.    Export Trends
3.3.    Regulatory Compliance
3.4.    Major Export Destinations
3.5.    Import-Export Disparities
4.    Europe Pediatric Medical Device Market: Dynamics
4.1.1.    Market Drivers
4.1.2.    Market Restraints 
4.1.3.    Market Opportunities
4.1.4.    Market Challenges

4.2.    PORTER’s Five Forces Analysis
4.3.    PESTLE Analysis
4.4.    Regulatory Landscape
4.5.    Analysis of Government Schemes and Initiatives for the Europe Pediatric Medical Device Industry
5.    Europe Pediatric Medical Device Market Size and Forecast by Segments (by Value USD)
5.1.    Europe Pediatric Medical Device Market Size and Forecast, by Product (2024-2030)
5.1.1.    In Vitro Diagnostic (IVD) Devices
5.1.2.    Anesthesia & Respiratory Care Devices
5.1.3.    Cardiology Devices
5.1.4.    Diagnostic Imaging Devices
5.1.5.    Neonatal ICU Devices

5.2.    Europe Pediatric Medical Device Market Size and Forecast, by End-user (2023-2030)
5.2.1.    Hospitals
5.2.2.    Pediatric Clinics
5.2.3.    Ambulatory Surgical Centers

5.3.    Europe Pediatric Medical Device Market Size and Forecast, by Country (2023-2030)
5.3.1.    Germany
5.3.2.    United kingdom
5.3.3.    Spain
5.3.4.    France
5.3.5.    Italy
5.3.6.    Belgium
5.3.7.    Sweden
5.3.8.    Poland
5.3.9.    Russia 

6.    Europe Pediatric Medical Device Market: Competitive Landscape
6.1.    STELLAR Competition Matrix
6.2.    Competitive Landscape
6.3.    Key Players Benchmarking
6.3.1.    Company Name
6.3.2.    Service Segment
6.3.3.    End-user Segment 
6.3.4.    Revenue (2023)
6.3.5.    Company Locations

6.4.    Leading Europe Pediatric Medical Device Companies, by market capitalization
6.5.    Market Structure
6.5.1.    Market Leaders 
6.5.2.    Market Followers
6.5.3.    Emerging Players

6.6.    Mergers and Acquisitions Details
7.    Company Profile: Key Players
7.1.    Medtronic PLC
7.1.1.    Company Overview
7.1.2.    Business Portfolio
7.1.3.    Financial Overview
7.1.4.    SWOT Analysis
7.1.5.    Strategic Analysis
7.1.6.    Scale of Operation (small, medium, and large)
7.1.7.    Details on Partnership
7.1.8.    Regulatory Accreditations and Certifications Received by Them
7.1.9.    Awards Received by the Firm
7.1.10.     Recent Developments

7.2.    Abbott Laboratories
7.3.    Cardinal Health, Inc.
7.4.    GE HealthCare Technologies, Inc.
7.5.    Hamilton Medical AG (Hamilton Bonaduz AG)
7.6.    TSE spol. s.r.o. (TSE Medical)
7.7.    Fritz Stephan GmbH
7.8.    Phoenix Medical Systems Pvt. Ltd.
7.9.    Trimpeks
7.10.    Atom Medical Corporation
7.11.    F. Hoffmann-La Roche Ltd.
7.12.    Fritz Stephan GmbH
7.13.    General Electric Company
7.14.    Hamilton Medical
7.15.    Koninklijke Philips N.V.
7.16.    Medtronic
7.17.    Siemens AG
7.18.    TSE MEDICAL
8.    Key Findings
9.    Industry Recommendations

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