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    US Pediatric Medical Device Market

    ID: MRFR/MED/15146-HCR
    100 Pages
    Garvit Vyas
    October 2025

    US Pediatric Medical Device Market Research Report By Product (Cardiology Devices, In Vitro Diagnostic (IVD) Devices, Diagnostic Imaging Devices, Telemedicine, Anesthesia & Respiratory Care Devices, Neonatal ICU Devices, Monitoring Devices, Others) and By End User (Hospitals, Pediatric Clinics, Ambulatory Surgical Centers, Research and Academic Institutes, Others) - Forecast to 2035

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    US Pediatric Medical Device Market Infographic
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    US Pediatric Medical Device Market Summary

    As per analysis, the US pediatric medical-device market size was estimated at 4500.0 USD Million in 2024.. The US pediatric medical-device market is projected to grow from 4802.4 USD Million in 2025 to 9200.0 USD Million by 2035, exhibiting a compound annual growth rate (CAGR) of 6.72% during the forecast period 2025 - 2035.

    Key Market Trends & Highlights

    The US pediatric medical-device market is experiencing robust growth driven by technological advancements and increasing healthcare expenditure.

    • Technological advancements are enhancing the efficacy and safety of pediatric medical devices.
    • The largest segment in the market is the diagnostic devices segment, while the fastest-growing segment is the therapeutic devices segment.
    • Regulatory support is fostering innovation and expediting the approval process for pediatric devices.
    • Key market drivers include the rising pediatric population and growing awareness of pediatric health issues.

    Market Size & Forecast

    2024 Market Size 4500.0 (USD Million)
    2035 Market Size 9200.0 (USD Million)

    Major Players

    Medtronic (US), Johnson & Johnson (US), Siemens Healthineers (DE), GE Healthcare (US), Philips (NL), Baxter International (US), Boston Scientific (US), Stryker (US), Abbott Laboratories (US)

    US Pediatric Medical Device Market Trends

    the pediatric medical device market is currently experiencing notable growth., driven by advancements in technology and an increasing focus on specialized healthcare for children. Innovations in design and functionality are enhancing the safety and efficacy of devices tailored for pediatric patients. This market is characterized by a diverse range of products, including diagnostic tools, therapeutic devices, and monitoring equipment, all aimed at addressing the unique needs of younger populations. Regulatory bodies are also playing a crucial role in ensuring that these devices meet stringent safety standards, which further supports market expansion. Moreover, the rising prevalence of chronic conditions among children is prompting healthcare providers to seek more effective solutions. As a result, there is a growing demand for devices that not only improve health outcomes but also enhance the overall patient experience. The integration of digital health technologies, such as telemedicine and mobile health applications, is likely to transform how pediatric care is delivered, making it more accessible and efficient. This trend suggests a promising future for the pediatric medical-device market, as stakeholders continue to innovate and adapt to the evolving healthcare landscape.

    Technological Advancements

    Recent innovations in technology are significantly influencing the pediatric medical-device market. Devices are becoming more sophisticated, incorporating features such as wireless connectivity and advanced imaging capabilities. These enhancements improve diagnostic accuracy and treatment effectiveness, catering specifically to the needs of younger patients.

    Regulatory Support

    Regulatory agencies are increasingly focused on the pediatric medical-device market, implementing guidelines that ensure safety and efficacy. This support fosters innovation, as manufacturers are encouraged to develop new products that meet stringent standards, ultimately benefiting pediatric patients.

    Increased Focus on Chronic Conditions

    There is a growing awareness of chronic health issues affecting children, leading to a heightened demand for specialized medical devices. This trend reflects a shift in healthcare priorities, as providers seek to address long-term health challenges with tailored solutions.

    US Pediatric Medical Device Market Drivers

    Technological Innovations

    Technological advancements play a crucial role in shaping the pediatric medical-device market. Innovations such as miniaturization, enhanced imaging techniques, and telemedicine solutions are transforming how pediatric care is delivered. For instance, the integration of artificial intelligence and machine learning in diagnostic tools is improving accuracy and efficiency in identifying pediatric conditions. The market for pediatric medical devices is projected to grow at a CAGR of around 8% over the next few years, driven by these technological innovations. As manufacturers continue to invest in research and development, the availability of cutting-edge devices tailored for children is expected to increase, further propelling market growth.

    Rising Pediatric Population

    The pediatric medical-device market is experiencing growth due to the increasing pediatric population in the United States. According to the U.S. Census Bureau, children aged 0-17 years represent approximately 22% of the total population. This demographic trend suggests a growing demand for medical devices tailored to children, as healthcare providers seek to address the unique needs of this age group. The rising number of pediatric patients necessitates the development of specialized devices, which could lead to innovations in design and functionality. Furthermore, as the population of children continues to expand, this market is likely to see a corresponding increase in investment and research aimed at improving health outcomes for younger patients..

    Increased Healthcare Expenditure

    The pediatric medical-device market is positively influenced by rising healthcare expenditure in the United States. According to the Centers for Medicare & Medicaid Services, national health spending is projected to grow at an average rate of 5.4% annually, reaching nearly $6 trillion by 2027. This increase in healthcare spending is likely to enhance access to advanced medical devices for pediatric patients. As hospitals and healthcare facilities allocate more resources towards pediatric care, the demand for specialized medical devices is expected to rise. This trend indicates a favorable environment for manufacturers in the pediatric medical-device market, as they can anticipate greater investment in innovative solutions that cater to the needs of children.

    Regulatory Support for Pediatric Devices

    Regulatory support for pediatric medical devices is a significant driver in the market. The U.S. Food and Drug Administration (FDA) has implemented initiatives aimed at facilitating the development and approval of medical devices for children. Programs such as the Pediatric Device Consortia Grant Program encourage innovation by providing funding and resources to support the creation of devices specifically designed for pediatric use. This regulatory environment fosters collaboration between manufacturers and regulatory bodies, potentially leading to a more efficient approval process. As a result, the pediatric medical-device market is likely to see an influx of new products that meet the unique needs of children, enhancing treatment options and improving health outcomes.

    Growing Awareness of Pediatric Health Issues

    There is a growing awareness of pediatric health issues among parents and healthcare providers, which is driving demand in the pediatric medical-device market. Increased education and advocacy surrounding childhood diseases and conditions have led to a heightened focus on early diagnosis and treatment. This awareness encourages parents to seek medical attention for their children, resulting in a higher utilization of medical devices designed specifically for pediatric patients. As healthcare professionals become more attuned to the unique challenges faced by children, the pediatric medical-device market is likely to benefit from an increase in the development and adoption of specialized devices that address these health concerns.

    Market Segment Insights

    By Product: Monitoring Devices (Largest) vs. Telemedicine (Fastest-Growing)

    In the US pediatric medical-device market, the distribution of market share among various product segments reflects the growing necessity for specialized healthcare solutions for children. Monitoring Devices, including various diagnostic and therapeutic tools, account for the largest segment due to their critical role in continuous patient assessment. Following closely are Anesthesia & Respiratory Care Devices and Diagnostic Imaging Devices, which also hold significant shares, while Telemedicine is rapidly gaining traction. The growth trends for this market highlight an increasing adoption of technologies that enhance patient care and accessibility. Telemedicine has emerged as the fastest-growing segment, driven by rising demand for remote consultations and monitoring tools due to convenience and access, particularly since the COVID-19 pandemic. In contrast, traditional segments like Neonatal ICU Devices maintain steady demand as advancements improve their efficacy.

    Monitoring Devices (Dominant) vs. Telemedicine (Emerging)

    Monitoring Devices are established as the dominant players in providing real-time health data, crucial for the effective management of pediatric patients. They encompass a range of technologies, including heart rate monitors, blood pressure cuffs, and pulse oximeters, which are vital for proactive healthcare intervention. Conversely, Telemedicine is an emerging segment, gaining momentum for its innovative approach to healthcare delivery. This segment leverages digital platforms to facilitate remote doctor-patient interactions, increased patient engagement, and compliance. The shift towards integrated healthcare solutions further boosts Telemedicine's appeal, making it increasingly relevant in the pediatric sector as it addresses both accessibility and efficiency.

    By End User: Hospitals (Largest) vs. Pediatric Clinics (Fastest-Growing)

    In the US pediatric medical-device market, hospitals capture the largest share among end users, indicating a strong reliance on advanced medical technologies for pediatric care. Pediatric clinics also hold a significant position but are increasingly gaining traction due to the rise in outpatient procedures and specialized care services. The growth of pediatric clinics is driven by factors such as increased awareness of pediatric health issues, advancements in telemedicine, and a shift towards outpatient care to enhance efficiency. Additionally, the demand for tailored medical solutions for children continues to expand, propelling both hospitals and clinics toward innovative device adoption and improving patient outcomes.

    Hospitals (Dominant) vs. Pediatric Clinics (Emerging)

    Hospitals dominate the US pediatric medical-device market due to their extensive resources, specialized staff, and comprehensive care capabilities. They invest heavily in state-of-the-art technologies that ensure the best medical outcomes for pediatric patients. In contrast, pediatric clinics, although smaller in scale, represent an emerging segment, focusing on personalized care and accessibility. They are adapting to trends like increased preventative care and minimal invasive procedures. Both segments complement each other; hospitals often rely on clinics for follow-up care, fostering a continuum of care that benefits patients and enhances overall health services for children.

    Get more detailed insights about US Pediatric Medical Device Market

    Key Players and Competitive Insights

    The pediatric medical-device market is characterized by a dynamic competitive landscape, driven by innovation, regulatory advancements, and increasing healthcare demands. Key players such as Medtronic (US), Johnson & Johnson (US), and Abbott Laboratories (US) are at the forefront, each adopting distinct strategies to enhance their market presence. Medtronic (US) focuses on technological innovation, particularly in minimally invasive devices, while Johnson & Johnson (US) emphasizes strategic partnerships to expand its product offerings. Abbott Laboratories (US) is leveraging its expertise in diagnostics to develop pediatric-specific solutions, thereby addressing unmet needs in this demographic. Collectively, these strategies contribute to a competitive environment that is increasingly focused on specialized, high-quality medical devices tailored for children.

    In terms of business tactics, companies are increasingly localizing manufacturing to reduce costs and improve supply chain efficiency. This approach appears to be particularly relevant in a moderately fragmented market where smaller players also vie for market share. The collective influence of major companies shapes the market structure, as they often set standards for quality and innovation that smaller firms strive to meet. This competitive structure fosters an environment where collaboration and strategic alliances are essential for growth and sustainability.

    In October 2025, Medtronic (US) announced a partnership with a leading pediatric hospital to develop a new line of wearable devices aimed at monitoring chronic conditions in children. This strategic move not only enhances Medtronic's product portfolio but also positions the company as a leader in pediatric healthcare technology. The collaboration is expected to yield significant advancements in patient monitoring, potentially improving outcomes for young patients.

    In September 2025, Johnson & Johnson (US) launched a new initiative focused on integrating artificial intelligence (AI) into its pediatric surgical devices. This initiative aims to enhance precision and reduce recovery times for pediatric surgeries. By investing in AI technology, Johnson & Johnson (US) is likely to set a new benchmark in surgical care for children, thereby reinforcing its competitive edge in the market.

    In August 2025, Abbott Laboratories (US) unveiled a groundbreaking diagnostic tool specifically designed for early detection of congenital heart defects in infants. This innovation is particularly crucial, as early diagnosis can significantly improve treatment outcomes. Abbott's commitment to addressing critical health issues in pediatrics not only strengthens its market position but also highlights the growing trend of developing specialized devices that cater to the unique needs of children.

    As of November 2025, current competitive trends in the pediatric medical-device market are increasingly defined by digitalization, sustainability, and the integration of AI technologies. Strategic alliances are becoming more prevalent, as companies recognize the value of collaboration in driving innovation and enhancing product offerings. Looking ahead, competitive differentiation is expected to evolve, with a notable shift from price-based competition to a focus on technological advancements, innovation, and supply chain reliability. This transition underscores the importance of developing high-quality, specialized medical devices that meet the unique needs of pediatric patients.

    Key Companies in the US Pediatric Medical Device Market market include

    Industry Developments

    The US Pediatric Medical Device Market has seen significant developments recently. In September 2023, Abbott Laboratories launched a new pediatric heart monitor aimed at improving early diagnosis and management of congenital heart disease. Meanwhile, Siemens Healthineers unveiled an innovative imaging device designed specifically for neonatal care, enhancing diagnostic capabilities in hospitals.

    Growth in the valuation of companies such as Medtronic and GE Healthcare has positively impacted the overall market, driven by increasing investments in pediatric healthcare technology. These companies have experienced a noticeable uptick in stock value, reflecting heightened demand for specialized medical devices.

    In terms of mergers and acquisitions, in July 2023, Boston Scientific acquired a smaller pediatric-focused medical device firm to expand its market presence. This acquisition aligns with the continuous trend of larger corporations, like Johnson and Johnson and Philips Healthcare, seeking to strengthen their portfolios in pediatric care.

    Recent statistics indicate a growing focus on innovation in the field, aiming to address the unique needs of pediatric patients, particularly driven by the increasing prevalence of chronic health issues among children. Overall, these developments underscore a dynamic and evolving landscape in the US Pediatric Medical Device Market.

    Future Outlook

    US Pediatric Medical Device Market Future Outlook

    The pediatric medical-device market is projected to grow at a 6.72% CAGR from 2024 to 2035, driven by technological advancements, increasing healthcare expenditure, and rising pediatric population.

    New opportunities lie in:

    • Development of telehealth platforms for remote monitoring of pediatric patients.
    • Investment in biodegradable medical devices to enhance sustainability.
    • Expansion of pediatric-specific training programs for healthcare professionals.

    By 2035, the market is expected to achieve substantial growth, reflecting evolving healthcare needs.

    Market Segmentation

    US Pediatric Medical Device Market Product Outlook

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

    US Pediatric Medical Device Market End User Outlook

    • Hospitals
    • Pediatric Clinics
    • Ambulatory Surgical Centers
    • Research and Academic Institutes
    • Others

    Report Scope

    MARKET SIZE 20244500.0(USD Million)
    MARKET SIZE 20254802.4(USD Million)
    MARKET SIZE 20359200.0(USD Million)
    COMPOUND ANNUAL GROWTH RATE (CAGR)6.72% (2024 - 2035)
    REPORT COVERAGERevenue Forecast, Competitive Landscape, Growth Factors, and Trends
    BASE YEAR2024
    Market Forecast Period2025 - 2035
    Historical Data2019 - 2024
    Market Forecast UnitsUSD Million
    Key Companies Profiled["Medtronic (US)", "Johnson & Johnson (US)", "Siemens Healthineers (DE)", "GE Healthcare (US)", "Philips (NL)", "Baxter International (US)", "Boston Scientific (US)", "Stryker (US)", "Abbott Laboratories (US)"]
    Segments CoveredProduct, End User
    Key Market OpportunitiesIntegration of digital health technologies enhances patient monitoring in the pediatric medical-device market.
    Key Market DynamicsTechnological advancements drive innovation in pediatric medical devices, enhancing treatment options and patient outcomes.
    Countries CoveredUS

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    FAQs

    What is the expected market size of the US Pediatric Medical Device Market in 2024?

    The US Pediatric Medical Device Market is expected to be valued at 4.5 billion USD in 2024.

    What is the projected market value for the US Pediatric Medical Device Market by 2035?

    The market is anticipated to reach 10.5 billion USD by 2035.

    What is the expected CAGR for the US Pediatric Medical Device Market from 2025 to 2035?

    The market is projected to grow at a CAGR of 8.007 percent from 2025 to 2035.

    Which product segment is expected to be the largest in the US Pediatric Medical Device Market in 2024?

    The Cardiology Devices segment is expected to be valued at 1.1 billion USD in 2024.

    What is the expected value of In Vitro Diagnostic (IVD) Devices in the US Pediatric Medical Device Market in 2024?

    In Vitro Diagnostic (IVD) Devices are projected to be valued at 1.0 billion USD in 2024.

    How much will the Diagnostic Imaging Devices segment be worth in 2035?

    The Diagnostic Imaging Devices segment is expected to reach a value of 2.8 billion USD in 2035.

    What is the expected value of the Telemedicine segment in 2035?

    The Telemedicine segment is anticipated to reach 2.0 billion USD in 2035.

    Who are the major players in the US Pediatric Medical Device Market?

    Key players include Siemens Healthineers, Smiths Medical, GE Healthcare, and Philips Healthcare, among others.

    What is the projected value of Anesthesia & Respiratory Care Devices in 2035?

    Anesthesia & Respiratory Care Devices are expected to be valued at 1.9 billion USD in 2035.

    What opportunities exist for growth in the US Pediatric Medical Device Market?

    The increasing prevalence of pediatric diseases and advancements in technology create significant growth opportunities in the market.

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