의료기기용 열가소성 엘라스토머 시장 : 시장 기회, 성장 촉진요인, 산업 동향 분석 및 예측(2026-2035년)

The Global Thermoplastic Elastomers in Medical Devices Market was valued at USD 3.3 billion in 2025 and is estimated to grow at a CAGR of 4.7% to reach USD 5.3 billion by 2035.

Thermoplastic elastomers have steadily evolved from niche materials into indispensable components within modern medical manufacturing. Their combination of elasticity, biocompatibility, and efficient processing supports the growing demand for durable, patient-friendly medical technologies. Healthcare providers increasingly prioritize solutions that deliver consistent performance while improving patient comfort, positioning TPEs as a preferred material class for next-generation device development. Sustainability and responsible material management have become central to the medical TPE landscape, driven by strict safety standards and environmental regulations. The shift toward recyclable materials with lower ecological impact and high sterilization resistance continues to accelerate adoption. Ongoing innovation addresses long-standing concerns related to conventional elastomers by improving formulation safety, mechanical stability, chemical resistance, and overall lifespan. Continuous clinical and environmental testing reflects the industry's commitment to advancing material science while supporting safer healthcare outcomes.

Thermoplastic Polyurethanes accounted for 52.4% share in 2025 and are forecast to grow at a CAGR of 5% through 2035. TPU remains the most widely adopted medical-grade TPE due to its balance of flexibility and strength, which allows precise control over softness without compromising structural reliability. These attributes support complex medical engineering requirements and contribute to consistent performance across a wide range of medical applications.

The catheters and tubing segment held a 28.7% share in 2025 and is anticipated to grow at a CAGR of 5.5% during 2026-2035. This dominance is supported by the material's ability to maintain biocompatibility, flexibility, and sterility throughout extended use cycles. TPEs ensure reliable performance across both routine medical procedures and advanced therapeutic systems, reinforcing their importance within this segment.

North America Thermoplastic Elastomers in Medical Devices Market held a 35% share in 2025. The region benefits from a mature healthcare infrastructure, rigorous regulatory oversight, and a strong concentration of medical device manufacturers. Continued investment in polymer research and compliance-focused innovation strengthens regional leadership by enhancing safety standards, device functionality, and patient experience.

Key companies operating in the Global Thermoplastic Elastomers in Medical Devices Market include Lubrizol Corporation, BASF SE, Covestro AG, Arkema, Dow Chemical, Kuraray, Kraiburg TPE, Teknor Apex, Hexpol/Elastron, RTP Company, Kraton, Evonik, Mitsubishi Chemical, Trinseo, and DSM Biomedical. Companies operating in the Thermoplastic Elastomers in Medical Devices Market focus on material innovation, regulatory alignment, and long-term partnerships to strengthen their competitive position. Manufacturers invest heavily in research to improve formulation safety, mechanical performance, and sterilization compatibility while meeting evolving compliance requirements. Strategic collaborations with medical device producers allow early integration of customized materials into product design cycles. Firms also prioritize sustainability initiatives by developing recyclable and low-impact elastomer solutions. Capacity expansion, geographic diversification, and portfolio optimization further support market penetration, while consistent quality assurance and clinical validation help build trust with healthcare providers and regulatory bodies.

Table of Contents

Chapter 1 Methodology & Scope

• 1.1 Market scope and definition
• 1.2 Research design
  • 1.2.1 Research approach
  • 1.2.2 Data collection methods
• 1.3 Data mining sources
  • 1.3.1 Global
  • 1.3.2 Regional/Country
• 1.4 Base estimates and calculations
  • 1.4.1 Base year calculation
  • 1.4.2 Key trends for market estimation
• 1.5 Primary research and validation
  • 1.5.1 Primary sources
• 1.6 Forecast model
• 1.7 Research assumptions and limitations

Chapter 2 Executive Summary

• 2.1 Industry 360° synopsis
• 2.2 Key market trends
  • 2.2.1 Regional
  • 2.2.2 TPE Chemistry
  • 2.2.3 Application
  • 2.2.4 Processing Method
• 2.3 TAM Analysis, 2026-2035
• 2.4 CXO perspectives: Strategic imperatives
  • 2.4.1 Executive decision points
  • 2.4.2 Critical success factors
• 2.5 Future Outlook and Strategic Recommendations

Chapter 3 Industry Insights

• 3.1 Industry ecosystem analysis
  • 3.1.1 Supplier landscape
  • 3.1.2 Profit margin
  • 3.1.3 Value addition at each stage
  • 3.1.4 Factor affecting the value chain
  • 3.1.5 Disruptions
• 3.2 Industry impact forces
  • 3.2.1 Growth drivers
    • 3.2.1.1 Shift from PVC to phthalate-free alternatives
    • 3.2.1.2 Growing demand for latex-free medical products
    • 3.2.1.3 Aging population & chronic disease prevalence
  • 3.2.2 Industry pitfalls and challenges
    • 3.2.2.1 Higher material cost vs. Commodity PVC
    • 3.2.2.2 Limited high-temperature resistance vs. Thermosets
  • 3.2.3 Market opportunities
    • 3.2.3.1 Sustainable & bio-based TPE formulations
    • 3.2.3.2 Antimicrobial & infection-prevention materials
• 3.3 Growth potential analysis
• 3.4 Regulatory landscape
  • 3.4.1 North America
  • 3.4.2 Europe
  • 3.4.3 Asia Pacific
  • 3.4.4 Latin America
  • 3.4.5 Middle East & Africa
• 3.5 Porter's analysis
• 3.6 PESTEL analysis
• 3.7 Price trends
  • 3.7.1 By region
  • 3.7.2 By TPE Chemistry
• 3.8 Future market trends
• 3.9 Technology and Innovation landscape
  • 3.9.1 Current technological trends
  • 3.9.2 Emerging technologies
• 3.10 Patent Landscape
• 3.11 Trade statistics (HS code)
  • 3.11.1 Major importing countries
  • 3.11.2 Major exporting countries
• 3.12 Sustainability and environmental aspects
  • 3.12.1 Sustainable practices
  • 3.12.2 Waste reduction strategies
  • 3.12.3 Energy efficiency in production
  • 3.12.4 Eco-friendly initiatives
• 3.13 Carbon footprint consideration

Chapter 4 Competitive Landscape, 2025

• 4.1 Introduction
• 4.2 Company market share analysis
  • 4.2.1 By region
    • 4.2.1.1 North America
    • 4.2.1.2 Europe
    • 4.2.1.3 Asia Pacific
    • 4.2.1.4 LATAM
    • 4.2.1.5 MEA
• 4.3 Company matrix analysis
• 4.4 Competitive analysis of major market players
• 4.5 Competitive positioning matrix
• 4.6 Key developments
  • 4.6.1 Mergers & acquisitions
  • 4.6.2 Partnerships & collaborations
  • 4.6.3 New Product Launches
  • 4.6.4 Expansion Plans

Chapter 5 Market Estimates and Forecast, By TPE Chemistry, 2022-2035 (USD Billion) (Kilo Tons)

• 5.1 Key trends
• 5.2 Thermoplastic Polyurethanes (TPU)
  • 5.2.1 Polyether-Based TPU
  • 5.2.2 Polyester-Based TPU
• 5.3 Styrenic Block Copolymers (TPE-S/SEBS)
  • 5.3.1 SEBS (Hydrogenated Styrenic)
  • 5.3.2 SBS & Other Styrenic Variants
• 5.4 Thermoplastic Vulcanizates (TPV)
  • 5.4.1 PP/EPDM Dynamic Vulcanizates
• 5.5 Thermoplastic Copolyester Elastomers (COPE/TPC-ET)
  • 5.5.1 Polyether Glycol/PBT Block Copolymers
• 5.6 Thermoplastic Polyamide Elastomers (PEBA/TPE-A)
• 5.7 Thermoplastic Olefin Elastomers (TPE-O/TPO)

Chapter 6 Market Estimates and Forecast, By Application, 2022-2035 (USD Billion) (Kilo Tons)

• 6.1 Key trends
• 6.2 Catheters & tubing
  • 6.2.1 Intravenous (iv) catheters
  • 6.2.2 Urological catheters
  • 6.2.3 Cardiovascular catheters & balloon catheters
  • 6.2.4 Single & multi-lumen medical tubing
  • 6.2.5 Drug delivery & infusion tubing
• 6.3 Medical equipment & devices
  • 6.3.1 Dental guards for bruxism disease
  • 6.3.2 Peristaltic pump tubes
  • 6.3.3 Urine catheter grips & components
  • 6.3.4 Respiratory face masks & seals
• 6.4 Disposable medical goods
  • 6.4.1 Throat swab brushes
  • 6.4.2 Examination gloves (non-latex)
  • 6.4.3 Disposable masks & garments
• 6.5 Medical films, bags & packaging
  • 6.5.1 Iv & saline bags
  • 6.5.2 Biopharmaceutical storage bags
  • 6.5.3 Enteral & parenteral nutrition bags
  • 6.5.4 Peritoneal & dialysis bags
• 6.6 Medical tips & gaskets
  • 6.6.1 Infusion bottle caps & closures
  • 6.6.2 Syringe gaskets & plunger tips
  • 6.6.3 Vial stoppers & septa
• 6.7 Surgical & diagnostic instruments
  • 6.7.1 Surgical instrument grips & handles
  • 6.7.2 Diagnostic equipment housings
• 6.8 Medical footwear
• 6.9 Implantable devices & components
  • 6.9.1 Surgical meshes (polymeric)
  • 6.9.2 Polymeric prostheses components
  • 6.9.3 Elastomeric implant blocks

Chapter 7 Market Estimates and Forecast, By Processing Method, 2022-2035 (USD Billion) (Kilo Tons)

• 7.1 Key trends
• 7.2 Injection Molding-Grade TPE
• 7.3 Extrusion-Grade TPE
• 7.4 Blow Molding-Grade TPE
• 7.5 Overmolding & Co-Injection Grade TPE

Chapter 8 Market Estimates and Forecast, By Region, 2022-2035 (USD Billion) (Kilo Tons)

• 8.1 Key trends
• 8.2 North America
  • 8.2.1 U.S.
  • 8.2.2 Canada
• 8.3 Europe
  • 8.3.1 Germany
  • 8.3.2 UK
  • 8.3.3 France
  • 8.3.4 Spain
  • 8.3.5 Italy
  • 8.3.6 Rest of Europe
• 8.4 Asia Pacific
  • 8.4.1 China
  • 8.4.2 India
  • 8.4.3 Japan
  • 8.4.4 Australia
  • 8.4.5 South Korea
  • 8.4.6 Rest of Asia Pacific
• 8.5 Latin America
  • 8.5.1 Brazil
  • 8.5.2 Mexico
  • 8.5.3 Argentina
  • 8.5.4 Rest of Latin America
• 8.6 Middle East and Africa
  • 8.6.1 Saudi Arabia
  • 8.6.2 South Africa
  • 8.6.3 UAE
  • 8.6.4 Rest of Middle East and Africa

Chapter 9 Company Profiles

• 9.1 BASF SE
• 9.2 Lubrizol Corporation
• 9.3 Covestro AG
• 9.4 Dow Chemical
• 9.5 Arkema
• 9.6 Teknor Apex
• 9.7 Kraiburg TPE
• 9.8 Hexpol/Elastron
• 9.9 Kuraray
• 9.10 RTP Company
• 9.11 Evonik
• 9.12 Kraton
• 9.13 DSM Biomedical
• 9.14 Trinseo
• 9.15 Mitsubishi Chemical