Pediatric Medical Devices Market Size, Share & Trends Analysis Report By Product (Cardiology Devices, In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices), By End-user, By Region, And Segment Forecasts, 2023 - 2030

Report Overview

The global pediatric medical devices market size was estimated at USD 28.4 billion in 2022 and is expected to expand at a compound annual growth rate (CAGR) of 7.8% from 2023 to 2030. The increasing demand for pediatric medical devices due to the rising chronic diseases among the children such as respiratory disorders and asthma is expected to propel the growth of the market over the forecast period. The COVID-19 pandemic significantly impacted the pediatric medical devices market initially. Medical device companies have manufacturing facilities worldwide and some have been closed due to this pandemic. Transportation of medical devices is being delayed due to the lockdown, creating a supply shortage for many critical medical devices. The need for medical devices increased, and the restriction on the supply and delivery of medical devices was lifted.

The need for medical devices in hospitals, clinics, and other COVID-19 centers has fueled the demand and market growth. The FDA has initiated many actions to help ensure that patients have continued access to high-quality medical devices. It includes allotting Emergency Use Authorizations (EUAs) and other documents to provide approvals and help increase the availability and capability for various medical devices in high demand during the COVID-19 public health emergency.

Most of the drugs and devices in pediatric patients are used for off-label indications. As per the report published in the National Library of Medicine, around 60-75% of medical drugs or devices are used for off-label indications for pediatric patients. This results in drawbacks including performance and safety concerns with a lack of proper instructions and education for the use of an adult medical device for children.

The barriers to pediatric medical device manufacturing arise from the small numbers of pediatric patients due to the low volume of patients. There is a smaller number of clinical trial enrollments of children than in adult trials. Parental approval and consent also complicate the admission of children in the clinical trial process.

Despite legislative and regulatory changes that have encouraged the development of pediatric medical devices, only a small number of medical devices are submitted to the FDA every year for approval. Until 2018, only larger-sized valves were available and were used for heart surgery that is often not suitable for children's hearts. In 2018, the U.S. FDA has approved a rotatable mechanical heart valve of 15 mm size, the smallest device that allows surgeons to treat infants and newborns in need of aortic or mitral valve replacement.

Product Insights

The in vitro diagnostic (IVD) devices segment held the largest revenue share of 22.4% in 2022. Based on product, the market is segmented into cardiology devices, anesthesia, and respiratory care devices, in vitro diagnostic (IVD) devices, diagnostic imaging devices, neonatal ICU devices, and others. IVD devices conduct tests to detect disease, condition, or infection. Approximately 70% of all clinical decisions are made using IVD products due to their precision and accuracy.

The anesthesia and respiratory care devices segment is expected to exhibit the highest growth of 8.8% over the forecast period. The growth can be attributed to the fact of CAGR number of respiratory disorders among the children such as chronic obstructive pulmonary disease (COPD) and obstructive sleep apnea (OSA). According to a report published in the Italian Journal of Pediatrics, respiratory diseases account for more than 25% of all pediatric consultations in which asthma accounts for 10% of the total cases.

End-user Insights

The hospitals segment held the largest revenue share of 40.6% as of 2022. The growing number of pediatric patient admissions and rising demand for advanced medical devices for better medical care are expected to propel the segment’s growth. According to a report published in the National Library of Medicine, more than 2 million children are admitted to hospitals in the U.S., incurring costs that represent 40% of pediatric healthcare expenditures.

The pediatric clinics segment is anticipated to witness a lucrative CAGR of 8.4% over the forecast period. The growth can be attributed to the fact that these clinics are focused mainly on pediatric care. The pediatric clinics provide the latest clinical information on health issues for children and adolescents. It offers a full range of services to ensure that a child grows up healthily. These clinics also provide a full schedule of check-ups, vaccinations, and the overall development of a child.

Regional Insights

North America dominated the market in terms of a revenue share of 38.3% in 2022. The increasing rate of pediatric chronic diseases in the region such as asthma, cancer, congenital heart disease, leukemia, etc., and advanced medical devices are the factors propelling the growth of the market. As per the statistics of the Centers for Disease Control and Prevention, more than 40% of school-going children and adolescents have at least one chronic disease.

The Asia Pacific region is expected to showcase the highest CAGR of 8.7% over the forecast period. The growth can be attributed to the large population with a high prevalence of diseases among children such as kidney disease and birth defects, etc. The factors responsible for the growth of chronic diseases are the wealth status for affording healthcare services and the shortage of professional medical services in rural areas.

Key Companies & Market Share Insights

The market players are involved in the strategies such as product launches, strategic collaboration, and acquisition & mergers. The pediatric medical devices market is surrounded by many large and small players that contribute to the overall growth of the industry.  Distribution channel improvement and collaboration with other industry players are some of the key initiatives undertaken by these market players.

For instance, in November 2022, GE Healthcare announced a $1 million donation of monitoring equipment and ultrasound to Ukraine as the war has a heavy toll on the country’s healthcare system. The company will be providing patient monitors devices, to monitor pediatric & adult patient vital signs. Some prominent players in the global pediatric medical devices market include:

• TSE MEDICAL

• Ningbo David Medical Device Co. Ltd

• Hamilton Medical

• GE Healthcare

• Fritz Stephan GmbH

• Phoenix Medical Systems Pvt Ltd

• Novonate Inc.

• Trimpeks

• Atom Medical Corporation

• Abbott

• Medtronic PLC

Pediatric Medical Devices Market Report Scope

Global Pediatric Medical Devices Market Segmentation

This report forecasts revenue growth at global, regional & country levels and provides an analysis of the latest industry trends in each of the sub-segments from 2018 to 2030. For this study, Grand View Research has segmented the global pediatric medical devices market report based on product, end-user, and region:

• Product Outlook (Revenue, USD Million, 2018 - 2030)

  • Cardiology Devices

  • In Vitro Diagnostic (IVD) Devices

  • Diagnostic Imaging Devices

  • Anesthesia & Respiratory Care Devices

  • Neonatal ICU Devices

  • Others

• End-user Outlook (Revenue, USD Million, 2018 - 2030)

  • Hospitals

  • Pediatric Clinics

  • Ambulatory Surgical Centers

  • Others

• Regional Outlook (Revenue, USD Million, 2018 - 2030)

  • North America

    • U.S.

    • Canada

  • Europe

    • U.K.

    • Germany

    • France

    • Italy

    • Spain

    • Denmark

    • Sweden

    • Norway

  • Asia Pacific

    • China

    • India

    • Japan

    • Australia

    • South Korea

    • Thailand

  • Latin America

    • Brazil

    • Mexico

    • Argentina

  • Middle East & Africa

    • South Africa

    • Saudi Arabia

    • UAE

    • Kuwait