Therapeutic Hypothermia Systems Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Product (Cooling Catheters, Water Blankets, Cool Caps, Others), By Application (Neurology, Cardiology, Neonatal Care, Others), By Region, and By Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 311.45 Million
CAGR (2026-2031)	6.61%
Fastest Growing Segment	Cooling Catheters
Largest Market	North America
Market Size (2031)	USD 457.27 Million

Market Overview

The Global Therapeutic Hypothermia Systems Market will grow from USD 311.45 Million in 2025 to USD 457.27 Million by 2031 at a 6.61% CAGR. Therapeutic hypothermia systems are medical devices engineered to lower a patient's body temperature to a specific therapeutic range, thereby reducing the risk of ischemic injury to the brain and other vital organs following periods of insufficient blood flow. The primary driver of this market is the growing prevalence of cardiac arrest and neonatal hypoxic-ischemic encephalopathy, necessitating reliable temperature management solutions to enhance patient survival and neurological recovery. According to the Sudden Cardiac Arrest Foundation, in 2025, data derived from the American Heart Association indicated that approximately 350,000 out-of-hospital cardiac arrests occur annually in the United States, underscoring the critical demand for effective post-resuscitation interventions.

However, a significant challenge impeding market expansion is the high acquisition cost of advanced cooling units combined with the requirement for specialized staff training to manage potential complications. These financial and operational barriers often limit the widespread adoption of these technologies, particularly in resource-constrained healthcare settings or smaller hospitals.

Key Market Drivers

The rising global incidence of cardiac arrest serves as a primary catalyst for the therapeutic hypothermia systems market, necessitating advanced targeted temperature management (TTM) to mitigate neurological damage. When spontaneous circulation is returned after cardiac arrest, patients often suffer from reperfusion injury, which cooling systems effectively counter by lowering cerebral metabolic rates. This clinical imperative is driving the deployment of intravascular and surface cooling units in intensive care settings to improve post-resuscitation care. Highlighting the scale of this critical requirement, according to the Sudden Cardiac Arrest Foundation, January 2025, in the 'Latest Statistics' report, 137,119 out-of-hospital cardiac arrest events were specifically reported to the CARES registry in the United States during 2024. This substantial volume of reported cases illustrates the immediate addressable market for reliable temperature management technologies aimed at maximizing patient survival.

Simultaneously, the growing prevalence of neonatal encephalopathy and birth asphyxia is mandating the widespread integration of specialized cooling devices in neonatal intensive care units. Therapeutic hypothermia has firmly established itself as the standard of care for newborns suffering from hypoxic-ischemic encephalopathy (HIE), as it significantly reduces the risk of long-term cognitive and motor disabilities. According to Hope for HIE, June 2025, in the 'State of Neonatal HIE' review, an estimated 1.2 million babies develop hypoxic-ischemic encephalopathy globally each year, creating sustained demand for precise neonatal cooling solutions. This clinical necessity is translating into tangible commercial expansion for device manufacturers. For instance, according to BrainCool AB, February 2025, the company delivered 39 BrainCool Systems in the fourth quarter of 2024 alone, generating record quarterly sales of SEK 12.0 million, reflecting the accelerating adoption of these life-saving systems in critical care environments.

Download Free Sample Report

Key Market Challenges

The high acquisition cost of advanced cooling units, combined with the necessity for specialized staff training, constitutes a formidable barrier to the expansion of the Global Therapeutic Hypothermia Systems Market. These financial and operational requirements limit the ability of healthcare facilities, particularly those with restricted budgets or in developing regions, to integrate these devices into their standard protocols. When hospitals are forced to prioritize expenditures, the substantial upfront investment for temperature management systems often leads to deferment in favor of more versatile or immediately critical equipment. This hesitation directly correlates with slower market penetration and reduced overall growth rates.

Furthermore, the economic environment for healthcare providers has intensified this reluctance to invest in capital-intensive technologies. According to the American Hospital Association, in 2025, a report revealed that 94% of health care administrators expected to delay equipment upgrades to manage ongoing financial strain. This statistic underscores the severity of the fiscal challenges facing hospitals, where rising operational costs and limited capital reserves necessitate a cautious approach to procurement. Consequently, even when the clinical benefits of therapeutic hypothermia are recognized, the combination of high device costs and the resource drain of required training programs effectively curtails widespread adoption.

Key Market Trends

The market is increasingly shifting toward non-invasive surface cooling modalities to minimize procedural risks associated with invasive intravascular catheters. Advanced surface systems allow clinicians to initiate temperature management immediately, bypassing the delays and infection hazards inherent to central venous access. This clinical preference for external methods is directly reflected in the financial performance of key manufacturers specializing in surface thermal regulation. According to Gentherm, February 2025, in the '2024 Fourth Quarter and Full Year Results' report, Medical segment revenue reached $49.8 million in 2024, an 8.1% increase year-over-year, driven largely by demand for its surface thermal management solutions. This growth indicates a sustained pivot toward non-invasive technologies for critical care environments.

Simultaneously, the proliferation of portable pre-hospital cooling systems is transforming early intervention protocols for cardiac arrest and stroke. Utilizing intranasal or battery-operated technologies, emergency personnel can now induce neuroprotective cooling prior to hospital arrival, significantly extending the therapeutic window. This trend is supported by advancing clinical research into mobile devices capable of delivering selective brain cooling in field settings. According to BrainCool AB, July 2024, in the 'First Patient Treated with RhinoChill System in Pivotal COTTIS 2 Study' press release, the first patient was enrolled in a pivotal trial evaluating the efficacy of the RhinoChill portable intranasal cooling system during thrombectomy procedures. These innovations are crucial for closing the therapeutic gap between ambulance transport and intensive care admission.

Segmental Insights

The Cooling Catheters segment is projected to register the fastest growth within the Global Therapeutic Hypothermia Systems Market due to the increasing adoption of intravascular temperature management methods. Clinicians prefer these internal systems over surface cooling alternatives because they provide more precise temperature control and faster cooling induction rates, which are critical for neuroprotection following cardiac arrest. Additionally, the expansion of this segment is supported by frequent product approvals from the U.S. FDA, which enhances the availability of these devices in intensive care units and validates their efficacy for managing patient temperature in critical scenarios.

Regional Insights

North America commands the leading position in the global therapeutic hypothermia systems market, driven by the widespread adoption of targeted temperature management protocols. The region benefits from established clinical guidelines by the American Heart Association that endorse hypothermia treatment for cardiac arrest patients, significantly influencing hospital practices. Additionally, the market is supported by extensive healthcare expenditure and a robust regulatory framework under the U.S. Food and Drug Administration, which facilitates the approval and commercialization of medical cooling devices. These factors collectively secure the region's primary status in the global landscape.

Recent Developments

• In July 2024, BrainCool AB announced the enrollment of the first patient in its pivotal COTTIS 2 clinical trial. This multi-center study evaluates the efficacy of the RhinoChill System combined with the BrainCool System in patients suffering from acute ischemic stroke who are undergoing thrombectomy. The research aims to demonstrate the neuroprotective benefits of early and rapid cooling initiated before the surgical removal of the blood clot. This milestone marks a significant step in validating the company's combined cooling approach, which seeks to minimize reperfusion injury and improve neurological outcomes for stroke patients by implementing cooling at the earliest possible stage of treatment.
• In April 2024, BrainCool AB signed an extended distribution agreement with ZOLL Medical Corporation to cover the Japanese market. This collaboration builds upon a previous partnership and grants ZOLL the rights to distribute the BrainCool System, marketed as the IQool System in the United States, within Japan. The agreement included a minimum order commitment from ZOLL valued at SEK 20 million, with deliveries scheduled to commence following regulatory approval of the system in the region. This expansion aims to leverage ZOLL's established commercial infrastructure to accelerate the adoption of BrainCool's targeted temperature management solutions in the Asian market.
• In March 2024, Haemonetics Corporation agreed to acquire Attune Medical, the manufacturer of the ensoETM esophageal cooling device, for an upfront cash payment of $160 million. The ensoETM is the only FDA-cleared temperature regulation device indicated for esophageal protection during radiofrequency cardiac ablation procedures. This strategic acquisition was intended to complement Haemonetics' existing electrophysiology portfolio and expand its presence in the interventional technologies market. The agreement also included provisions for additional payments contingent upon the achievement of specific sales growth and commercial milestones in the future, reflecting the potential for broader adoption of the esophageal temperature management technology.
• In January 2024, ZOLL Medical Corporation received FDA clearance and the CE Mark for a significant upgrade to its Thermogard Temperature Management System. This development established the platform as the first of its kind to offer both core and surface-based temperature management treatment options within a single system. The upgraded device was designed to provide clinicians with greater versatility in managing patient temperature, allowing for the use of either intravascular catheters or surface pads depending on the clinical scenario. The system aims to improve patient outcomes by offering precise temperature control and intelligent analytics, thereby streamlining the workflow for nursing staff in critical care settings.

Key Market Players

• Belmont Medical Technologies
• BrainCool AB
• ZOLL Medical Corporation
• Becton, Dickinson, and Company
• Stryker Corporation
• EM-MED Sp. z o.o.
• Life Recovery Systems
• Drägerwerk AG & Co. KGaA
• Terumo Cardiovascular Systems Corporation
• pfm medical gmbh

By Product	By Application	By Region
Cooling Catheters Water Blankets Cool Caps Others	Neurology Cardiology Neonatal Care Others	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Therapeutic Hypothermia Systems Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Therapeutic Hypothermia Systems Market, By Product:

• Cooling Catheters
• Water Blankets
• Cool Caps
• Others

• Therapeutic Hypothermia Systems Market, By Application:

• Neurology
• Cardiology
• Neonatal Care
• Others

• Therapeutic Hypothermia Systems Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE