Pediatric Medical Devices Market

Global Pediatric Medical Devices Market Size, Share & Industry Trends Analysis Report By Product, By End User (Hospitals, Clinics, Ambulatory Surgery Centers and Others), By Regional Outlook and Forecast, 2022 - 2028

Report Id: KBV-14036 Publication Date: February-2023 Number of Pages: 189
Special Offering:
Industry Insights | Market Trends
Highest number of Tables | 24/7 Analyst Support

Market Report Description

The Global Pediatric Medical Devices Market size is expected to reach $42 billion by 2028, rising at a market growth of 7.0% CAGR during the forecast period.

Medical equipment or tools used to diagnose or treat illnesses and problems in children under the age of 21 are referred to as pediatric devices. Infants, children, and adolescents are the focus of the medical specialty known as pediatrics, which deals with their health and medical care. Since children are more active and physically smaller than adults, these medical devices are built specifically with their needs in mind.

Pediatric Medical Devices Market - Global Opportunities and Trends Analysis Report 2018-2028

One of the main factors propelling the growth of the pediatric medical devices market is the increase in the prevalence of chronic diseases and infectious diseases among the pediatric population. The demand for pediatric medical devices is also influenced by the increased demand for anesthetic and respiratory equipment due to their efficiency in treating conditions like asthma and the rising occurrence of preterm births worldwide. Additionally, in recent times technical developments and new product launches in the field has grown significantly owing to the high demand.

Regulatory and legislative developments have aided in the development of pediatric medical devices, effects of which are also seen in the development of products. As a result, the FDA receives a number of applications for medical devices each year. For example, prior to 2018, only larger-sized valves could be utilized for heart surgery, which is frequently inappropriate for children's hearts. However, the tiniest device that enables surgeons to heal infants and neonates needing mitral or aortic valve replacement was approved by the U.S. FDA in 2018 and is a rotatable prosthetic mechanical heart valve of size 15 mm.

According to a UNICEF report, approximately 700,000 children under the age of five die from pneumonia each year, surpassing any other infectious ailment. Additionally, there have been more regulatory organization initiatives, more pediatric hospitals worldwide, technological advancements in pediatric equipment, and expanding parental awareness campaigns. The biggest players in the market have introduced new goods with enhanced capabilities. For example, Medtronic introduced a new pediatric monitor that warns medical professionals when a patient's airways might be blocked during breathing.

COVID-19 Impact Analysis

The FDA supported sponsors who wanted to make sure that these devices were set up to specifically cater to pediatric patients' needs. For instance, the FDA granted a EUA for a device that delivers continuous renal replacement treatment and can be used in patients with lower blood volumes or those with acute renal failure, fluid overload, or both. These patients were unable withstand a greater extracorporeal circuit volume in an acute care setting and weigh 8 to 20 kilograms. Despite the COVID-19 outbreak, the FDA emphasized how crucial it is to keep in mind the needs of pediatric patients. Therefore, the COVID-19 pandemic had a favorable impact on the pediatric medical devices market.

Market Growth Factors

Rising respiratory disorder and cancer incidences in children

According to the American Academy of Pediatrics, 15.4 million kids in the US tested COVID-19 positive in February 2023. As a result, the expansion of the pediatric medical devices market is driven by the increasing frequency of cancer and respiratory disorders among children. In addition, the rise in the number of premature babies is another important element driving the expansion of this industry. All these factors are promoting the growth of the market in the coming years.

Increasing birth rate and NICU availability

Many children require NICU facilities upon birth. Children who need NICU care are typically transferred there within 24 hours of birth due to difficulties during early birth, delivery, or health problems following birth. If a child is born before 37 weeks of pregnancy, it is considered preterm. Premature babies are more vulnerable to conditions like pneumonia, sepsis, etc. As a result, market participants have launched a number of devices that would broaden the selection of goods accessible in the neonatal ICU. Hence, the increasing birth rate and NICU devices are promoting the expansion of the market.

Pediatric Medical Devices Market Share and Industry Analysis Report 2021

Market Restraining Factors

Lack of clinical trials and problems in device manufacture

The danger to a manufacturer's reputation when pediatric medical devices malfunction may be too high for the business to bear. Even if the failure rate is low and parents or other carers are ready to take the chance in the hopes that their kid will benefit, this risk might acts as a significant barrier to entry into the market. In emerging markets, pediatric imaging, screening, and respiratory equipment are less common. Therefore, the leading players are raising the market's profile during the forecast period. However, the lack of market awareness during the forecast period impacts the market's total demand. All these factors significantly hamper the growth of the market.

Product Outlook

Based on product, the pediatric medical devices market is categorized into cardiology devices, in vitro diagnostic (IVD) devices, diagnostic imaging devices, anesthesia & respiratory care devices, neonatal ICU devices, and others. The neonatal ICU devices segment procured a considerable growth rate in the pediatric medical devices market in 2021. For the special requirements of little infants, complicated instruments and devices are used in neonatal intensive care units (NICUs). The increasing demand for NICU are accountable for the expansion of the segment. Heart or cardiorespiratory monitors, blood pressure monitors, temperature monitors, and pulse oximeters are a few of the instruments frequently utilized in the NICU.

End User Outlook

On the basis of end user, the pediatric medical devices market is divided into hospitals, clinics, ambulatory surgical centers, and others. The clinics segment witnessed a significant revenue share in the pediatric medical devices market in 2021. The fact that such clinics are primarily devoted to providing care for children can be accountable for the increase. The pediatric clinics offer the most recent clinical knowledge on children's and adolescents' health conditions. It provides a broad range of solutions to guarantee a child's healthy upbringing. These clinics also offer a comprehensive schedule of check-ups, vaccines, and a child's general growth.

Pediatric Medical Devices Market Report Coverage
Report Attribute Details
Market size value in 2021 USD 26.5 Billion
Market size forecast in 2028 USD 42 Billion
Base Year 2021
Historical Period 2018 to 2020
Forecast Period 2022 to 2028
Revenue Growth Rate CAGR of 7% from 2022 to 2028
Number of Pages 189
Number of Table 300
Report coverage Market Trends, Revenue Estimation and Forecast, Segmentation Analysis, Regional and Country Breakdown, Companies Strategic Developments, Company Profiling
Segments covered Product, End User, Region
Country scope US, Canada, Mexico, Germany, UK, France, Russia, Spain, Italy, China, Japan, India, South Korea, Singapore, Malaysia, Brazil, Argentina, UAE, Saudi Arabia, South Africa, Nigeria
Growth Drivers
  • Rising respiratory disorder and cancer incidences in children
  • Increasing birth rate and NICU availability
  • Lack of clinical trials and problems in device manufacture

Regional Outlook

Based on region, the pediatric medical devices market is analyzed across North America, Europe, Asia Pacific, and LAMEA. The North America segment garnered the maximum revenue share in the pediatric medical devices market in 2021. Advanced medical equipment and the rising prevalence of pediatric chronic disorders such as leukemia, asthma, cancer, and congenital heart disease are driving the market's expansion in this region. In America, more than 40% of adolescents and children in school have at least one chronic condition, according to figures from the Centers for Disease Control and Prevention (CDC).

Free Valuable Insights: Global Pediatric Medical Devices Market size to reach USD 42 Billion by 2028

The market research report covers the analysis of key stake holders of the market. Key companies profiled in the report include Medtronic PLC, Abbott Laboratories, Cardinal Health, Inc., GE HealthCare Technologies, Inc., Hamilton Medical AG (Hamilton Bonaduz AG), TSE spol. s.r.o. (TSE Medical), Fritz Stephan GmbH, Phoenix Medical Systems Pvt. Ltd., Trimpeks, and Atom Medical Corporation.

Strategies deployed in Pediatric Medical Devices Market

  • Sep-2022: Medtronic received an expanded FDA clearance for pediatric use of the LINQ II system, a wireless, small Insertable Cardiac Monitor system. The broadened indication consists of children aged two years and above, who have heart rhythm abnormalities and need continuous monitoring for a long period.
  • Apr-2022: Cardinal Health collaborated with Innara Health, a company engaged in feeding development for newborns and infants born prematurely. Under this collaboration, both companies would redesign the Ntrainer system. The Ntrainer system is an FDA-approved medical device for better prefeeding skills in newborns and preterm infants. Additionally, Cardinal Health would support the development and commercialization of the next-generation NTrainer.
  • Feb-2022: Medtronic plc got FDA approval for Freezor™ and Freezor™ Xtra Cardiac Cryoablation Focal Catheters, an ablation catheter to treat the growing prevalence of pediatric Atrioventricular Nodal Reentrant Tachycardia. The products are single-use, flexible devices used to block unnecessary electrical signals and freeze cardiac tissue within the heart.
  • May-2021: Medtronic introduced SonarMed™ airway monitoring system, a device that utilizes acoustic technology to check for endotracheal tube obstruction and confirm position at the same time, delivering clinicians critical information needed to make a better decision for the smallest patients. Additionally, the product is an FDA-approved airway monitoring system that delivers in-time notifications and particular measurements that help allow a structured response to address possible vital events including migration and ETT movement.
  • Dec-2020: Medtronic unveiled Carpedim, a cardio-renal pediatric dialysis emergency machine, across the United States. The Carpedim machine would deliver continuous renal replacement therapy (CRRT) to patients between 2.5 kg and 10 kg. Moreover, the product is intended to address challenges associated with current machines for neonatal patients.
  • Jan-2019: Abbott got FDA approval for The Amplatzer Piccolo Occluder, a medical device that can be implanted in babies weighing as little as 700 gm. The product's size is smaller than a pea, which provides hope to premature newborns and infants for corrective treatment. Moreover, the product is created to enable the physician to place it through the pulmonary or aortic artery and also to redeploy or retrieve the device for ideal placement.
  • Mar-2018: Abott got FDA approval for the Masters HPTM 15mm rotatable mechanical heart valve, the world's smallest mechanical heart valve. The Masters HPTM 15mm rotatable mechanical heart valve would allow doctors to treat toddlers and babies in need of aortic or mitral valve replacement.

Scope of the Study

Market Segments Covered in the Report:

By Product

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

By End User

  • Hospitals
  • Clinics
  • Ambulatory Surgery Centers
  • Others

By Geography

  • North America
    • US
    • Canada
    • Mexico
    • Rest of North America
  • Europe
    • Germany
    • UK
    • France
    • Russia
    • Spain
    • Italy
    • Rest of Europe
  • Asia Pacific
    • China
    • Japan
    • India
    • South Korea
    • Singapore
    • Malaysia
    • Rest of Asia Pacific
    • Brazil
    • Argentina
    • UAE
    • Saudi Arabia
    • South Africa
    • Nigeria
    • Rest of LAMEA

Key Market Players

List of Companies Profiled in the Report:

  • Medtronic PLC
  • Abbott Laboratories
  • Cardinal Health, Inc.
  • GE HealthCare Technologies, Inc.
  • Hamilton Medical AG (Hamilton Bonaduz AG)
  • TSE spol. s.r.o. (TSE Medical)
  • Fritz Stephan GmbH
  • Phoenix Medical Systems Pvt. Ltd.
  • Trimpeks
  • Atom Medical Corporation
Need a report that reflects how COVID-19 has impacted this market and its growth? Download Free Sample Now

Frequently Asked Questions About This Report

The global Pediatric Medical Devices Market size is expected to reach $42 billion by 2028.

Increasing birth rate and NICU availability are driving the market in coming years, however, Lack of clinical trials and problems in device manufacture restraints the growth of the market.

Medtronic PLC, Abbott Laboratories, Cardinal Health, Inc., GE HealthCare Technologies, Inc., Hamilton Medical AG (Hamilton Bonaduz AG), TSE spol. s.r.o. (TSE Medical), Fritz Stephan GmbH, Phoenix Medical Systems Pvt. Ltd., Trimpeks, and Atom Medical Corporation.

The expected CAGR of the Pediatric Medical Devices Market is 7.0% from 2022 to 2028.

The Hospitals segment acquired maximum revenue share in the Global Pediatric Medical Devices Market by End User in 2021 thereby, achieving a market value of $19.7 billion by 2028.



Call: +1(646) 600-5072


  • Buy Sections of This Report
  • Buy Country Level Reports
  • Request for Historical Data
  • Discounts Available for Start-Ups & Universities

Unique Offerings Unique Offerings

  • Exhaustive coverage
  • The highest number of Market tables and figures
  • Subscription-based model available
  • Guaranteed best price
  • Support with 10% customization free after sale

Trusted by over
5000+ clients

Our team of dedicated experts can provide you with attractive expansion opportunities for your business.

Client Logo