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Neonatal Thermoregulation Market Size and Forecast, by Application (Hypothermia Management, Hyperthermia Management, Temperature Monitoring); Product Type; Modality; Distribution Channel, End user - Growth Trends, Key Players, Regional Analysis 2026-2035

  • Report ID: 7068
  • Published Date: Sep 18, 2025
  • Report Format: PDF, PPT

Neonatal Thermoregulation Market Outlook:

Neonatal Thermoregulation Market size was valued at USD 759.42 million in 2025 and is set to exceed USD 1.75 billion by 2035, expanding at over 8.7% CAGR during the forecast period i.e., between 2026-2035. In the year 2026, the industry size of neonatal thermoregulation is estimated at USD 818.88 million.

Neonatal Thermoregulation Market Size
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The increasing global incidence of preterm births has heightened the need for neonatal thermoregulation devices. According to a July 2020 NLM analysis, over 15 million babies are born prematurely each year worldwide, meaning that the global preterm birth rate is roughly 11%. Preterm infants, due to their underdeveloped body systems, often struggle to maintain body temperature, which can lead to serious health complications. To address this, devices such as incubators, radiant warmers, and warming blankets have become essential for stabilizing the temperature of these vulnerable infants. This rising number of preterm births globally directly contributes to the growing demand for the market.

Additionally, innovations in neonatal care, especially in thermoregulation, have greatly enhanced the management of preterm and critically ill infants. Smart incubators, equipped with sensors and automated systems, can adjust temperature, humidity, and oxygen levels in real time, providing optimal conditions for neonates. These technological advancements not only streamline neonatal care but also minimize the risk of complications such as hypothermia and infections, ultimately improving overall health outcomes and reducing long-term health issues for infants. This has accelerated the adoption of such devices, driving market growth.

Key Neonatal Thermoregulation Market Insights Summary:

  • Regional Highlights:

    • North America neonatal thermoregulation market will account for 33.70% share by 2035, fueled by advanced healthcare systems and substantial funding in neonatal care.
    • Asia Pacific market will exhibit the fastest growth during the forecast period 2026-2035, driven by rising preterm births and healthcare investments in neonatal care technologies.

  • Segment Insights:

    • The hypothermia management segment in the neonatal thermoregulation market is projected to hold a 57.20% share by 2035, attributed to increasing prevalence of preterm births and rising awareness about hypothermia prevention.

  • Key Growth Trends:

    • Rising awareness promoted by government organizations
    • Expansion of healthcare infrastructure in emerging markets

  • Major Challenges:

    • Upscale of advanced devices
    • Stringent regulatory norms

  • Key Players: GE Healthcare, Drägerwerk AG & Co. KGaA, Natus Medical Incorporated, Koninklijke Philips N.V., Fisher & Paykel Healthcare Limited, Atom Medical Corporation, Fanem Ltda., Inspiration Healthcare Group plc, International Biomedical, Ltd., Medtronic plc.

Global Neonatal Thermoregulation Market Forecast and Regional Outlook:

  • Market Size & Growth Projections:

    • 2025 Market Size: USD 759.42 million
    • 2026 Market Size: USD 818.88 million
    • Projected Market Size: USD 1.75 billion by 2035
    • Growth Forecasts: 8.7% CAGR (2026-2035)

  • Key Regional Dynamics:

    • Largest Region: North America (33.7% Share by 2035)
    • Fastest Growing Region: Asia Pacific
    • Dominating Countries: United States, Germany, Japan, China, United Kingdom
    • Emerging Countries: China, India, Japan, South Korea, Brazil

    • Last updated on : 18 September, 2025

Growth Drivers

  • Rising awareness promoted by government organizations: Governments and organizations globally are enhancing units and healthcare professional training, especially in developing regions. These efforts increase the availability of thermoregulation devices, fueling neonatal thermoregulation market expansion. At the same time, rising awareness among parents and healthcare providers about neonatal thermoregulation's importance is driving demand for these devices. Educational campaigns and early intervention programs further support this trend, contributing to greater adoption and improving outcomes in neonatal care.

  • Expansion of healthcare infrastructure in emerging markets: Improved healthcare infrastructure in emerging economies is significantly enhancing access to neonatal thermoregulation devices. As of October 2024, the World Bank’s USD 30 billion health portfolio supports 170+ projects enhancing primary care, public health, and digital health solutions globally. Expanding hospitals and clinics are investing in advanced neonatal care equipment, ensuring high-quality care for preterm infants, boosting demand for thermoregulation devices, and driving market growth.

Challenges

  • Upscale of advanced devices: Advanced thermoregulation devices, including smart incubators, and warming systems are designed to provide optimal care for newborns, particularly preterm infants. However, these devices often come with a high price tag, which can be a significant barrier for hospitals, particularly in low- and middle-income regions. The high cost limits the availability of such advanced technologies, making it difficult for healthcare facilities to provide the best possible care to vulnerable neonates, and affecting overall market growth in these regions.

  • Stringent regulatory norms: The process of obtaining regulatory approvals for neonatal thermoregulation devices can be time-consuming and complex, particularly in regions with stringent healthcare regulations, such as the U.S. and the E.U. These rigorous approval processes require extensive testing, documentation, and compliance with safety and efficacy standards, which can delay market entry for innovative products. As a result. New technologies may take longer to become available to healthcare providers, hindering the neonatal thermoregulation market.

Neonatal Thermoregulation Market Size and Forecast:

Report Attribute Details

Base Year

2025

Forecast Period

2026-2035

CAGR

8.7%

Base Year Market Size (2025)

USD 759.42 million

Forecast Year Market Size (2035)

USD 1.75 billion

Regional Scope

  • North America (U.S. and Canada)
  • Asia Pacific (Japan, China, India, Indonesia, South Korea, Malaysia, Australia, Rest of Asia Pacific)
  • Europe (UK, Germany, France, Italy, Spain, Russia, NORDIC, Rest of Europe)
  • Latin America (Mexico, Argentina, Brazil, Rest of Latin America)
  • Middle East and Africa (Israel, GCC North Africa, South Africa, Rest of the Middle East and Africa)
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Neonatal Thermoregulation Market Segmentation:

Application Segment Analysis 

The hypothermia management segment is expected to capture neonatal thermoregulation market share of over 57.2% by 2035. The segment’s growth is attributed to the increasing prevalence of preterm births, where infants struggle to maintain body temperature. Hypothermia can lead to severe complications, including organ dysfunction and developmental delays, making effective management critical. Advanced devices such as warming mattresses and incubators with precise temperature controls are widely adopted in hospitals and neonatal units. Rising awareness among healthcare providers about hypothermia prevention further drives demand, ensuring better survival rates and neonatal health outcomes.

Product Type Segment Analysis  

Based on product type, the neonatal incubators segment is poised to garner the majority of market share over the forecast period. The segment is growing in the neonatal thermoregulation market due to its critical role in providing a controlled environment for premature and low-birth-weight infants. Smart incubators with integrated monitoring systems maintain optimal conditions, reducing hypothermia and infections, and enhancing efficiency and care outcomes. For instance, in December 2021, the INVOS 7100 cerebral/somatic oximetry system aids neonatal care by improving hemodynamic management and resuscitation, contributing to the growth of neonatal incubators and thermoregulation devices.

Our in-depth analysis of the global market includes the following segments:

Application
  • Hypothermia Management
  •  Hyperthermia Management
  •  Temperature Monitoring

Product Type
  • Neonatal Incubators
  • Neonatal Warmers
  • Neonatal Cooling Systems
  • Others

Modality
  • Open Care Systems
  • Closed Care Systems

 

Distribution Channel
  • Hospital pharmacies
  • Retail Pharmacies
  • Online Stores

End user
  • Hospitals & Clinics
  • Neonatal Intensive Care Units (NICUs)
  • Homecare Settings
Vishnu Nair
Vishnu Nair
Head - Global Business Development

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Neonatal Thermoregulation Market Regional Analysis:

North America Market Insights

North America neonatal thermoregulation market is expected to dominate revenue share of over 33.7% by 2035. The region has an advanced healthcare system and specialized neonatal care centers benefit from substantial funding and resources, enabling the integration of state-of-the-art thermoregulation devices. In FY 2024, the U.S. allocated over USD 12.3 billion for global health through normal appropriations, according to a report released by the U.S. Government and Global Health in October 2024. Government policies, funding initiatives, and research support enhance access to advanced neonatal care technologies, improving outcomes and fuelling market growth across healthcare settings.

The U.S. faces a high number of preterm births annually. According to the March of Dimes, 373,902 preterm births occurred in the US in 2023, accounting for 10.4% of live births. This drives demand for advanced neonatal thermoregulation devices such as incubators and radiant warmers, which are crucial for supporting the survival and health of infants struggling to maintain body temperature. Additionally, growing awareness among parents about neonatal care and the importance of thermoregulation has increased the demand for high-quality devices. Educational campaigns further highlight the need for early intervention and advanced care solutions, boosting the neonatal thermoregulation market.

Canada has an advanced healthcare system, equipped with well-established hospitals and neonatal intensive care units (NICUs), enabling the adoption of modern thermoregulation technologies. Government investments in neonatal healthcare enhance infrastructure, supporting the adoption of advanced thermoregulation devices in hospitals and NICUs. For Instance, in September 2021 as per the government of Canada, the MNCH initiative with a USD 6.5 billion commitment, enhanced neonatal care, supporting the adoption of thermoregulation technologies and improving neonatal health outcomes.  This financial support ensures the availability of high-quality care for newborns, particularly preterm infants, further driving the growth of the market in Canada.

 Asia Pacific Market Insights

In APAC the neonatal thermoregulation market is expected to garner fastest CAGR over the forecast period. The region experiences a high number of preterm births due to factors such as maternal health issues, poor nutrition, and lack of prenatal care, driving demand for neonatal thermoregulation devices such as incubators and radiant Warners. Additionally, rising healthcare investments in countries such as China and India supporting the adoption of advanced neonatal care technologies, including thermoregulation devices. These investments aim to improve neonatal survival rates and reduce complications in both public and private healthcare facilities across the region.

Rapid improvements in the healthcare system in China, especially in neonatal intensive care units (NICUs), have increased access to advanced thermoregulation technologies. The expansion of healthcare infrastructure supports the widespread adoption of high-quality neonatal care devices. Additionally, substantial government investments in healthcare reforms, particularly neonatal care, provide funding for hospitals and healthcare facilities. The percentage of government spending on healthcare services rose to 58.2% in 2022, according to Frontiers Media S.A. in September 2024. This financial support enables the purchase of state-of-the-art thermoregulation devices, crucial for improving neonatal care outcomes and reducing complications in newborns.

The growing presence of private hospitals and healthcare facilities in India is accelerating the adoption of advanced neonatal care technologies, including thermoregulation devices, thus improving access to quality care. The hospital sector in India, which makes up 80% of the country's healthcare system overall, is projected to reach USD 132 billion by 2023, according to IBEF's January 2025 report. Additionally, the government of India has implemented various health schemes to enhance maternal and child health, providing funding for neonatal care. These initiatives are increasing the availability of advanced thermoregulation devices, further supporting the growth of the market in India.

Neonatal Thermoregulation Market Share
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Neonatal Thermoregulation Market Players:

    Key companies in the neonatal thermoregulation market are driving innovation through the development of advanced technologies such as smart incubators, radiant warmers, and non-invasive monitoring systems. These innovations focus on improving temperature control, enhancing monitoring capabilities, and reducing complications for neonates. Integration of artificial intelligence (AI) and data analytics in these devices enables real-time monitoring and automated adjustments, ensuring better care outcomes. Such innovations are improving efficiency, patient comfort, and overall neonatal survival rates. The key players are:

    • Medtronic PLC
      • Company Overview
      • Business Strategy
      • Key Product Offerings
      • Financial Performance
      • Key Performance Indicators
      • Risk Analysis
      • Recent Development
      • Regional Presence
      • SWOT Analysis
    • GE Healthcare
    • Drägerwerk AG & Co. KGaA
    • Fisher & Paykel Healthcare Corporation
    • Philips Healthcare
    • Radiometer Medical
    • NUA Surgical
    • Thermo Fisher Scientific Inc.
    • Stryker Corporation

Recent Developments

  • In March 2024, NUA Surgical MATTER’s 51 Labs support startups developing innovative solutions, including neonatal care technologies, enhancing thermoregulation, and reducing maternal and infant mortality rates.
  • In January 2023, Prapela FDA-designed mattress pad enhances respiratory rhythm in preterm infants, integrating seamlessly into neonatal thermoregulation devices such as incubators and warmers.
  • In December 2020, Medtronic launched Carpediem system advances neonatal care by providing CRRT for infants, supporting precise fluid management and temperature regulation in critical conditions.
  • Report ID: 7068
  • Published Date: Sep 18, 2025
  • Report Format: PDF, PPT
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Frequently Asked Questions (FAQ)

In the year 2026, the industry size of neonatal thermoregulation is estimated at USD 818.88 million.

The global neonatal thermoregulation market size crossed USD 759.42 million in 2025 and is likely to expand at a CAGR of more than 8.7%, surpassing USD 1.75 billion revenue by 2035.

North America neonatal thermoregulation market will account for 33.70% share by 2035, fueled by advanced healthcare systems and substantial funding in neonatal care.

Key players in the market include GE Healthcare, Drägerwerk AG & Co. KGaA, Natus Medical Incorporated, Koninklijke Philips N.V., Fisher & Paykel Healthcare Limited, Atom Medical Corporation, Fanem Ltda., Inspiration Healthcare Group plc, International Biomedical, Ltd., Medtronic plc.

Neonatal Thermoregulation Market Report Scope

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