Pediatric Medical Devices Market By Product Type (Diagnostic Devices, Therapeutic Devices, Surgical Instruments, Monitoring Devices, Infusion Therapy Devices, and Others), By Age Group (1 month - 2 years, 2-12 years, and 12-18 years), By End-user (Hospitals, Clinics, Home Care, and Ambulatory Surgical Centers), Global Market Size, Segmental analysis, Regional Overview, Company share analysis, Leading Company Profiles And Market Forecast, 2025 – 2035

Industry Outlook

The Pediatric Medical Devices market accounted for USD 34.5 Billion in 2024 and is expected to reach USD 82.1 Billion by 2035, growing at a CAGR of around 8.2% between 2025 and 2035.  The pediatric medical devices market represents a sub-market for the products of health care with specifically designed and oriented tools for children. They could include diagnostic, monitoring tools and devices, surgical devices and tools, respiratory, or even implantable products.

Some driving forces within the market include a steadily rising incidence of diseases related to pediatrics, innovative improvements in medical technologies, and ever-increasing demand for a specifically required special care system. It also focuses on the safety, comfort, and effectiveness of treatments for young patients. The innovations in technology, regulatory changes, and the growing awareness of pediatric healthcare needs are major factors influencing this market. With the growth of pediatric healthcare services worldwide, the demand for these devices is expected to grow further. 

Report Scope:

Market Dynamics

Rising Preterm Birth Rates Fuel Demand for Advanced Neonatal Care Devices

The neonatal care segment of the pediatric medical devices market is witnessing growth for specialized devices like incubators and oxygen support systems to maintain the health condition of preterm babies as well as newborns. The CDC estimated that almost 10 percent of all U.S.-born babies come into this world prematurely; most need intensive neonatal care. According to the WHO, preterm birth complications remain the leading cause of death for children under five years of age.

The rise in neonatal care has increased dependency on technology innovations such as new-generation incubators, CPAP machines, and oxygenators in trying to improve survival rates and results among these fragile infants. It is with the increasing incidence of preterm births coupled with technology innovations in neonatal care that the pediatric medical device market is being fueled.

Growing Need for Specialized Orthopedic Devices Drives Pediatric Market Expansion

The pediatric orthopedics segment in the pediatric medical devices market is developing because children have special anatomy that demands specific medical instruments for treating bone fractures and deformities. Unintentional injuries like fractures account for a huge morbidity in children. Pediatric bone fractures are one of the common types of emergency room visits every year. With increasing awareness of the requirement for specifically designed treatment, devices like pediatric casts, braces, and corrective orthopedic devices are becoming highly in demand.

The requirements are for safer, effective solutions in the treatment of pediatric musculoskeletal conditions. In addition, developments in material science and technological advancement have paved the way for producing lighter, softer devices suitable to the needs of children. This innovation further increases the adoption of pediatric orthopedic devices in healthcare settings.

Ethical Concerns Over Long-Term Safety and Necessity Restrain Pediatric Implantable Device Adoption

Ethical concerns relating to implantable devices, including pacemakers for children, have been one of the biggest restraints in this market of pediatric medical devices. Long-term safety and need were concerns with such implantable devices as children's bodies are always changing with time. Adjustment or replacement would frequently be needed for some of these implantable devices, leading to fears of possible complications and the fact that these may require several surgeries.

It further adds an ethical dimension of device implantation on young patients who are likely not to understand the implications of the procedure, thus making decision-making difficult. Risks have to be weighed against benefits for parents and healthcare providers especially if considering the long-term implications for the child's quality of life. All these can delay the integration of implantable devices in pediatric care.

3D Printing and Customization Unlock New Opportunities for Pediatric Medical Devices

Customizing pediatric medical devices with the use of 3D printing is one significant opportunity for the market. According to the U.S. Food and Drug Administration (FDA), 3D printing has been increasingly used in the creation of patient-specific implants and devices, and some pediatric applications have demonstrated promising results. The NIH emphasizes that 3D printing can offer solutions well-tailored to the anatomic needs of children, in which the fit of the device is improved for comfort and overall outcomes.

It also allows for speedier production, with reduced lead times and costs as well as increased personalization, especially in complex conditions. As healthcare systems continue to explore advanced solutions, 3D printing is expected to drive innovation in pediatric devices, allowing for greater precision and efficiency in treatments.

Development of Smart Inhalers Promises Improved Asthma Management for Pediatric Patients

Pediatric smart inhalers hold promising potential in the pediatric medical devices market, especially in asthma management. Asthma is experienced by about 6 million children in America, as estimated by the CDC and, therefore is a tremendous health issue. Smart inhalers, tracking the medication given and reminding of intake with regards to prescriptions, result in better adherence to their treatment, hence fewer acute exacerbations of asthma can be expected.

Poor adherence is said to be one of the top causes of hospitalizations due to asthma in children, as reported by the National Heart, Lung, and Blood Institute. In this smart inhalers could have a great deal of impact on asthma management and patient outcomes in pediatric health care.

Industry Experts Opinion

“The establishment of this new HCPCS code by CMS is a significant milestone for the adoption of pediatric in-office tympanostomy procedures. By expanding reimbursement, we are improving access to high-quality care for children and reducing a burden on families.”

• Dr. Shelagh Cofer, Associate Professor of Otolaryngology at Mayo Clinic

"Training and educating innovators with the unique skill set for pediatric device innovation is crucial to ensuring these patients are proactively included in the health technology development process, rather than left out, as they have been for decades. Our patients and children simply deserve better."

• Dr. Janene Fuerch, Assistant Director of the Stanford Biodesign Innovation Fellowship, and Neonatologist at Stanford University School of Medicine.

Segment Analysis

Based on the product type, the Pediatric Medical Devices market has been classified into diagnostic devices, therapeutic devices, surgical instruments, monitoring devices, infusion therapy devices, and others. Monitoring devices are currently leading the pediatric medical devices market due to their important functions in monitoring vital signs as well as chronic conditions in children. Given the non-invasive advances of technology, pulse oximetry, and temperature monitors, as well as wearable health trackers monitor children continuously and in real-time, allowing for early detection as well as better patient outcomes.

Based on the age group, the Pediatric Medical Devices market has been classified into 1 month - 2 years, 2-12 years, and 12-18 years. The market is dominated by 2-12 years because the prevalence of health issues like asthma, diabetes, and injury that require medical intervention in that age group is higher. The age group is highly active and prone to injury leading to a greater demand for diagnostic, therapeutic, and monitoring devices. In addition, treatments and devices designed especially for this age group coupled with greater awareness of early diagnosis and preventive care are driving up market demand.

Regional Analysis

North America is the leading market for pediatric medical devices, driven by an advanced healthcare infrastructure, high levels of healthcare spending, and intense focus on pediatric care. With a large number of pediatric hospitals, specialized clinics, and medical research institutions located in the U.S., the demand for pediatric devices prevails. In addition, the level of pediatric healthcare issues has become increasingly aware, especially due to government initiatives in this sector like the Affordable Care Act, making medical treatments to children easily accessible. The prevalence of chronic conditions such as asthma diabetes, and obesity in children increased the use of diagnostic, therapeutic, and monitoring devices.

The Asia Pacific region is growing fastest in pediatric medical devices, through increasing healthcare infrastructure, awareness toward pediatric health, and rising income levels. Countries such as China and India are witnessing rapid improvements in health access, with more hospitals focusing on pediatric care. Thus, the prevalence of increased diseases in children, such as respiratory problems, malnutrition, and infectious diseases further drives demand for medical appliances. Additionally, the increased government spending on healthcare and changing patterns in using modernized medical technology further enhance the growth pace of the pediatric medical devices market in the region.  

Competitive Landscape

The pediatric medical devices market is very competitive with key players in the field including Medtronic, Philips Healthcare, GE Healthcare, Johnson & Johnson, and Abbott Laboratories dominating the market. They have concentrated on innovation by designing products that are uniquely meant for pediatric care, from diagnostic tools, and monitoring devices to therapeutic instruments. Recent news includes Medtronic's addition to its pediatric portfolio with new advanced respiratory devices and Philips Healthcare's release of smart monitoring systems specifically designed for children.

GE Healthcare has also introduced ultrasound technology specifically designed for pediatrics, which is currently enhancing the capability to diagnose young patients. In response to the increasing demand for pediatric healthcare solutions, these companies are increasing their market share through technological advancement, partnerships, and regional expansion.

Pediatric Medical Devices Market, Company Shares Analysis, 2024

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Recent Developments:

• In August 2024, Renata Medical announced that the U.S. Food and Drug Administration (FDA) has approved the company’s first-of-its-kind Minima Growth Stent that is specifically tailored for neonates, infants, and young children, but also designed to be re-expanded throughout their growth period.
• In September 2024, CobiCure, LLC, a philanthropically funded nonprofit in the Advancium Health Network, announced the CobiCure Fellowship for Pediatric MedTech Innovation. The program is offered in collaboration with the five FDA Pediatric Device Consortiums (PDCs), as it looks to address a significant need for pediatric medical devices.

Report Coverage:

By Product Type

• Diagnostic Devices
• Therapeutic Devices
• Surgical Instruments
• Monitoring Devices
• Infusion Therapy Devices
• Others

By Age Group

• 1 month - 2 years
• 2-12 years
• 12-18 years

By End-user

• Hospitals
• Clinics
• Home Care
• Ambulatory Surgical Centers

By Region

North America

• U.S.
• Canada

Europe

• U.K.
• France
• Germany
• Italy
• Spain
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• Australia
• South Korea
• Singapore
• Rest of Asia Pacific

Latin America

• Brazil
• Argentina
• Mexico
• Rest of Latin America

Middle East & Africa

• GCC Countries
• South Africa
• Rest of the Middle East & Africa

List of Companies:

• Medtronic PLC
• Philips Healthcare
• GE Healthcare
• Siemens Healthineers
• Johnson & Johnson
• Becton, Dickinson and Company (BD)
• Stryker Corporation
• Abbott Laboratories
• Boston Scientific Corporation
• Fisher & Paykel Healthcare
• C.R. Bard, Inc.
• Smith & Nephew PLC
• 3M Health Care
• Terumo Corporation
• Cochlear Limited

Frequently Asked Questions (FAQs)