Targeted Temperature Management Market Set for Rapid Expansion as FDA Clearances, M&A Deals, and Regulatory Momentum in USA & Japan Drive Growth

Targeted Temperature management Market size was valued at USD 2,834.60 million in 2023 and is estimated to reach at a CAGR of 6.50% over the forecast period 2024-2031.

Targeted Temperature management Market report, published by DataM Intelligence, provides in-depth insights and analysis on key market trends, growth opportunities, and emerging challenges. Committed to delivering actionable intelligence, DataM Intelligence empowers businesses to make informed decisions and stay ahead of the competition. Through a combination of qualitative and quantitative research methods, it offers comprehensive reports that help clients navigate complex market landscapes, drive strategic growth, and seize new opportunities in an ever-evolving global market.

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The Targeted Temperature Management (TTM) Market refers to the healthcare sector focused on devices and therapies that regulate and maintain a patient's body temperature within a specific range to improve clinical outcomes, particularly after cardiac arrest, traumatic brain injury, stroke, or other critical conditions. This market includes surface cooling systems, intravascular cooling devices, and associated accessories designed to induce hypothermia or controlled normothermia.

Industry News of USA and Japan:

USA

• FDA clearance (Jun 17, 2025): 510(k) clearance granted for the EasiSlush Thermoregulation System (Bridge to Life), expanding temperature-control options for OR/ICU teams.

• Product launch (Jul 2025): Medline introduced the ComfortTemp patient warming/cooling system, enhancing peri-op and ICU normo/hypothermia workflows.

• M&A/portfolio move (Jun 2025): 3T Medical Systems acquired the Altrix Precision Temperature Management line from Stryker-keeping a leading precision warming/cooling platform active in the U.S. market.

• Regulatory landscape signal (Aug 11, 2025): FDA refreshed the Third-Party Review list confirming Thermal Regulating Systems remain eligible-useful for faster 510(k) throughput in this category.

• Post-market activity (May-Jun 2025): FDA posted a Class II recall notice for the Allon thermal regulating system (initiated May 13; posted Jun 12), underscoring ongoing quality vigilance in TTM devices.

Japan

• Regulatory momentum (May-Jul 2025): PMDA issued Spring updates and public comment notices, signaling active device policy work to accelerate market access for new med-tech solutions.

• PMD Act amendment (May 14, 2025; reported Jun 2): Japan amended the PMD Act-tightening oversight of Marketing Authorization Holders and streamlining approval pathways for medical devices, including TTM systems.

• Tech/field deployment (Jun-Jul 2025): Expo 2025 Osaka showcased Pocari Sweat Ice Slurry and wearable solar-powered cooling vests-spotlighting advanced portable cooling solutions with potential clinical crossover.

• Market-need signal (Jul 9, 2025): A severe heatwave sent over 10,000 people to hospitals for heatstroke in a single week-emphasizing strong demand for temperature-management technologies.

• Regulatory events pipeline (Jun-Jul 2025): PMDA announced IMDRF agendas and training seminars-important touchpoints for sponsors planning TTM-related device submissions or AI-assisted cooling protocols.

Key Players:

• Smiths Medical, Inc,

• Medtronic Plc,

• Stryker Corporation,

• 3M Health Care,

• Qool Therapeutics,

• Seiratherm GmbH,

• ZOLL Medical Corporation,

• Gentherm (Cincinnati Sub-Zero Products),

• Becton,

• Dickinson and Company,

• Drägerwerk AG & Co. KGaA,

• EMCOOLS Medical Cooling Systems GmbH,

• Attune Medical,

• BrainCool AB,

• Belmont Medical Technologies.

Growth Forecast Projected:

The Global Targeted Temperature management Market is anticipated to rise at a considerable rate during the forecast period, between 2024 and 2031. In 2023, the market is growing at a steady rate, and with the rising adoption of strategies by key players, the market is expected to rise over the projected horizon.

Research Process:

Both primary and secondary data sources have been used in the global Targeted Temperature management Market research report. During the research process, a wide range of industry-affecting factors are examined, including governmental regulations, market conditions, competitive levels, historical data, market situation, technological advancements, upcoming developments, in related businesses, as well as market volatility, prospects, potential barriers, and challenges.

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Market Segmentation:

➤ By Technique Type: Non-invasive, Invasive

➤ By Device Type: Patient Warming Systems, Patient Cooling Systems

➤ By Application: Neurology, Cardiology, Neonatal care, Orthopedics, Others

➤ By End-User: Hospitals, Emergency units, Ambulatory surgical centers, Others

Regional Analysis:

⇥ North America (U.S., Canada, Mexico)

⇥ Europe (U.K., Italy, Germany, Russia, France, Spain, The Netherlands and Rest of Europe)

⇥ Asia-Pacific (India, Japan, China, South Korea, Australia, Indonesia Rest of Asia Pacific)

⇥ South America (Colombia, Brazil, Argentina, Rest of South America)

⇥ Middle East & Africa (Saudi Arabia, U.A.E., South Africa, Rest of Middle East & Africa)

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Benefits of the Report:

➡ A descriptive analysis of demand-supply gap, market size estimation, SWOT analysis, PESTEL Analysis and forecast in the global market.

➡ Top-down and bottom-up approach for regional analysis

➡ Porter's five forces model gives an in-depth analysis of buyers and suppliers, threats of new entrants & substitutes and competition amongst the key market players.

➡ By understanding the value chain analysis, the stakeholders can get a clear and detailed picture of this Market

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