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2099356

경피적 대동맥판막 치환/이식 : 시장 인사이트, 경쟁 구도 및 시장 예측(2034년)

Transcatheter Aortic Valve Replacement/Implantation - Market Insights, Competitive Landscape, and Market Forecast - 2034

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 150 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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경피적 대동맥판막 치환/이식 시장 요약

개요:

  • 경피적 대동맥판막 치환/이식(TAVR/TAVI) 시장은 2025년에 85억 달러로 추산되며, 2034년까지 226억 달러에 달할 것으로 전망됩니다. 이러한 성장은 전 세계 대동맥판막 협착증 유병률의 증가, 최소침습적 구조적 심장 질환 치료의 급속한 확대, 그리고 적응증 환자군을 확대하는 규제 당국의 승인이 가속화되고 있는 데 힘입은 것입니다.
  • 전 세계 TAVR/TAVI 시장은 2026년부터 2034년까지의 예측 기간 동안 연평균 성장률(CAGR) 11.4%로 성장하고 있습니다.
  • 밸브 프레임 재질별로는 2025년 니치놀 부문이 TAVR/TAVI 시장에서 42%의 점유율을 차지하며 시장을 주도했습니다.
  • 벤야의 소재별로는 2025년에 소 유래 소재 부문이 TAVR/TAVI 시장에서 55%의 점유율을 차지하며 시장을 휩쓸었습니다.
  • 시술 유형별로는 2025년에 대퇴동맥 접근법이 TAVR/TAVI 시장에서 78%의 점유율을 차지하며 시장을 주도했습니다.
  • 적응증별로는 2025년에 대동맥판막협착증 부문이 TAVR/TAVI 시장에서 88%의 점유율을 차지하며 시장을 주도했습니다.
  • 최종사용자별로는 2025년에 병원 부문이 TAVR/TAVI 시장에서 68%의 점유율을 차지하며 시장을 주도했습니다.
  • 2025년, 북미는 전 세계 TAVR/TAVI 시장 매출에서 41%의 점유율을 차지하며, 전 세계 지역별 시장 점유율 중 가장 높은 수치를 기록했습니다.

경피적 대동맥판막 치환/이식(TAVR/TAVI)은 카테터를 통해 생체 판막을 삽입하여 병변이 있는 생체 대동맥판막을 치환하는 최소침습 수술입니다. 주로 중증 대동맥판막 협착증의 치료에 사용되며, 최근에는 대동맥판막 역류증의 치료에도 점점 더 널리 활용되고 있으며, 개흉 수술이 필요하지 않습니다. 판막 프레임은 생체 내 해부학적 구조 내에서 안전하게 확장 및 고정되어야 하며, 판막엽은 내구성이 뛰어나고 혈액과의 적합성이 우수한 판막 기능을 재현해야 하므로, TAVR 기기는 첨단 금속 공학, 생체 조직 공학 및 정밀한 전달 시스템을 결합하고 있습니다. 시장은 소재별(니치놀, 스테인리스강, 코발트-크롬 등)의 판막 프레임 소재 및(돼지 유래, 소 유래 등)의 판막 엽 소재, 시술 방법별(대퇴동맥 경로, 심첨부 경로, 대동맥 경로 등), 적응증별(대동맥판막 협착증, 대동맥판막 역류증 등), 최종사용자별(병원, 외래 수술 센터 등)로 분류됩니다. 세계적인 고령화, 무증상 및 저위험 환자에 대한 적응증 확대 가속화, 재수술 및 밸브-인-밸브(valve-in-valve) 적응증, 그리고 지속적인 기기 혁신에 힘입어 TAVR/TAVI는 중증 대동맥판막 질환에 대한 표준 치료법이 되었으며, 현대 구조적 심장 중재술의 초석이 되고 있습니다.

경피적 대동맥판막 치환/이식 시장의 주요 시장 촉진요인

  • 고령화 사회에서 대동맥판막협착증의 전 세계 유병률이 증가함에 따라 치료 대상이 되는 환자층이 확대되고 있으며, 중증 대동맥판막협착증은 65세 이상 미국인의 약 9%에게 영향을 미치는 것으로 추정됩니다.
  • EARLY TAVR 임상시험 결과를 바탕으로, FDA가 2025년에 에드워즈사의 SAPIEN 3 플랫폼에 대해 무증상 중증 대동맥판막 협착증에 대한 적응증을 승인한 것 등, 규제상의 적응증 확대로 인해 치료 대상이 되는 환자층이 확대되고 있습니다.
  • 개흉 수술을 통한 대동맥판막 치환술(SAVR)에 비해, 최소침습적 시술을 선호하는 의사와 병원이 늘어나고 있는 만큼, 모든 수술 위험 등급에서 TAVR의 도입이 가속화되고 있습니다.
  • 메드트로닉사의 'Evolut' 플랫폼에 대한 재-TAVR 적응증 확대와 관련하여, 2025년 8월 FDA가 승인한 사례를 포함하여, 재-TAVR 및 밸브-인-밸브(Valve-in-Valve) 시술의 적응증 확대로 인해 지속적이고 반복적인 시술 기반이 확대되고 있습니다.
  • JenaValve사의 'Trilogy' 시스템(증상을 동반한 중증 대동맥판막 역류증에 대해 FDA가 최초로 승인한 경피적 판막)을 필두로, 대동맥판막 역류증 전용 신형 의료기기가 그동안 충분한 치료를 받지 못했던 환자층에게 치료의 문을 열어주고 있습니다.
  • 폴리머 및 드라이 티슈 재질의 판막, AI 가이드형 전달 시스템, 기기의 소형화 등 지속적인 기술 발전으로 내구성이 향상되어, 더 젊은 연령층이나 저위험군 환자들에게도 치료가 가능해졌습니다.
  • 애보트, 메릴 라이프 사이언시스, 비너스 메드테크 등의 기업들 간의 경쟁 심화와 지리적 확대로 인해, 중등도 및 저위험 환자층과 신흥 시장에서 치료에 대한 접근성이 확대되고 있습니다.

경피적 대동맥판막 치환/이식 시장의 성장에 기여하는 요인

시장 촉진요인

고령화에 따른 대동맥판막 협착증 유병률의 증가

TAVR/TAVI 시장의 가장 근본적인 성장 요인은 인구 고령화에 따라 전 세계적으로 퇴행성 대동맥판막 질환의 유병률이 증가하고 있다는 점입니다. 중증 대동맥판막 협착증은 65세 이상 미국인의 약 9%에게 영향을 미치는 것으로 추정되며, 치료를 받지 않을 경우 증상이 있는 환자 10명 중 약 1명이 증상 발현 후 5주 이내에 사망할 가능성이 있습니다. 북미, 유럽, 아시아태평양에서 평균 수명이 늘어남에 따라 석회화 대동맥판막 협착증을 앓고 있는 고령 환자의 수가 꾸준히 증가하고 있으며, 심장초음파 검사를 통한 선별 검사 기술의 발전으로 인해 그동안 진단되지 않았던 많은 사례가 밝혀지고 있습니다. TAVR은 개흉 수술을 대체하는 최소침습적 치료법이며, 회복도 빠르기 때문에 점점 늘어나는 환자층에게 표준 치료법으로 자리 잡고 있으며, 2034년까지 시술 건수의 지속적인 증가를 뒷받침하는 요인이 되고 있습니다.

무증상 및 저위험 환자에 대한 적응증 확대

규제 당국의 일련의 승인으로 인해 TAVR의 대상 환자층이 직접 확대되고 있습니다. 2025년, FDA는 에드워즈사의 SAPIEN 3 플랫폼(SAPIEN 3, SAPIEN 3 Ultra, SAPIEN 3 Ultra RESILIA 포함)에 대해 무증상 중증 대동맥판막 협착증 환자에 대한 적응증을 승인했습니다. 이는 무증상 질환에 대한 최초의 승인이며, 지침에서 권장하는 임상 경과 관찰과 비교하여 더 우수한 예후를 보인 EARLY TAVR 임상시험의 결과를 바탕으로 한 것입니다. 메드트로닉사의 '에볼루트(Evolut)' 플랫폼은 현재 120개국 이상에서, 극고위험 및 고위험부터 중등도 및 저위험에 이르는 모든 외과적 위험 범주에 걸친, 증상이 동반된 중증 대동맥판막 협착증에 대해 승인되었습니다. 적격 위험 범주나 질환 단계가 확대될 때마다, 그동안 치료를 받지 못했거나 외과적 치료를 받았던 환자 중 일부가 TAVR의 적응증이 되어, 예측 기간 동안 수요가 더욱 증가할 것으로 예상됩니다.

시장 억제요인

강력한 성장세를 보이고 있음에도 불구하고, TAVR/TAVI 시장은 중대한 제약에 직면해 있습니다. TAVR 기기의 높은 비용과 관련 병원 수술 인프라의 구축 현황으로 인해, 가격에 민감한 시장이나 신흥 시장에서의 보급이 제한되고 있습니다. 이러한 시장에서는 북미나 서유럽에 비해 경피적 치료에 대한 보험 급여 제도가 여전히 미비한 상태이기 때문입니다. 특히, 현재 TAVR의 적용 대상이 되고 있는 젊은 층이나 저위험군 환자에 대한 장기 내구성 관련 데이터는 수십 년에 걸친 외과적 판막 치환술의 경험에 비하면 여전히 비교적 제한적이며, 장기 추적 조사에서 나타나는 판막의 구조적 열화에 대해서는 현재도 연구가 진행되고 있습니다. 심방 주위 누출, 혈관 접근 부위의 손상, 전도 장애로 인한 영구 심박조율기 이식의 필요성 등 시술 관련 합병증에 대해서는, 기기 및 시술법의 지속적인 개선이 요구되고 있습니다. 훈련을 받은 중재적 심장 전문의와 구조적 심장 질환 전문 팀의 부족으로 인해 많은 지역에서 시술 건수 증가가 제한되고 있는 반면, 이첨판이나 소동맥구와 같은 복잡한 해부학적 구조는 기존 기기 설계에 있어 여전히 과제로 남아 있습니다. FTC가 에드워즈사의 제나밸브사 인수를 문제 삼은 사례 등, 기업 통합에 대한 독점금지법상 심사를 포함한 규제 및 경쟁 측면에서의 마찰이 경쟁 구도에 불확실성을 더하고 있습니다. 이러한 비용, 근거, 임상, 인력, 규제상의 장벽이 복합적으로 작용하여, 고령화, 시술 선호도, 의료기기 혁신과 같은 근본적인 촉진요인이 여전히 견조함에도 불구하고 성장 속도가 둔화되고 있습니다.

지역별 해설

북미

2025년, 북미는 전 세계 TAVR/TAVI 시장 매출의 41%를 차지했습니다. 미국은 구조적 심장 질환 치료 인프라, 풍부한 임상시험 실적, 그리고 FDA의 명확한 규제를 강점으로 삼아 시장을 독점하고 있으며, 2025년에는 무증상 대동맥판막 협착증, 재TAVR, 그리고 대동맥판막 역류증으로의 적응증 확대로 인해 시술 건수가 지속적으로 증가할 것으로 전망됩니다.

유럽

유럽은 조기 CE 마크 승인, 확립된 구조적 심장 질환 교육 기반, 그리고 독일, 프랑스, 영국, 이탈리아, 스페인에 걸쳐 있는 광범위한 의료기기 포트폴리오에 힘입어 규모가 크고 임상적으로도 선진적인 지역 시장입니다. 애보트(Abbott)사의 'Navitor'에 대한 2025년 CE 마크 적용 확대와 제나밸브(JenaValve)사의 유럽 내 'Trilogy' 출시와 같은 규제 측면의 진전은, 이 지역이 차세대 TAVR 기기의 조기 도입 시장으로서 역할을 더욱 공고히 하고 있습니다.

아시아태평양

아시아태평양은 중국, 일본, 인도, 한국, 호주에서 심혈관질환의 부담이 증가하고, 카테터실 인프라가 확충되며, 의료 투자가 확대됨에 따라 가장 빠르게 성장하고 있는 지역입니다. 중국 내 Venus Medtech의 국내 시장 주도적 지위, 인도 내 Meril Life Sciences의 비용 경쟁력이 뛰어난 'Myval' 플랫폼, 그리고 일본 내 고령화에 따른 시술 건수 증가가 해당 지역에서의 TAVR 보급과 임상시험 활동을 가속화하고 있습니다.

세계의 기타 지역

라틴아메리카, 중동 및 아프리카를 아우르는 ‘세계의 기타 지역’은 신흥 성장 전진기지입니다. 심장 의료 인프라 확충, 대동맥판막 질환 진단 건수 증가, 그리고 경피적 치료에 대한 보험 급여 및 규제상 승인 절차 확대를 위한 노력에 힘입어, 치료 접근성이 점차 개선되고 있습니다. 여기에는 브라질의 Braile Biomedica와 같이 지역 내 제조 및 유통 체계를 구축한 제조업체들의 지원도 한몫하고 있습니다.

경피적 대동맥판막 치환술/이식 시장에서의 최근 개발 동향

2026년 5월, 애보트(Abbott)는 파리에서 개최된 EuroPCR 2026에서 Navitor TAVI의 실제 임상 데이터를 발표하며, 저위험 및 중위험 환자군에서 우수한 안전성과 성능이 확인되었다고 보고했습니다. 전략적 의의: 보다 광범위한 위험 범주에 적용하기 전에, Navitor의 밸브링 내 설계에 대한 임상적 신뢰성을 강화하기 위한 것입니다.

2026년 1월, 애보트사는 자사의 링 내 자가확장형 'Navitor' 판막에 관한 미국 내 초기 실제 임상 경험 데이터를 'JACC: Cardiovascular Interventions'지에 게재했습니다. 전략적 의의: 경쟁이 치열한 TAVR 시장에서 ‘Navitor’의 차별화된 설계를 뒷받침하는 임상적 근거 기반을 강화하는 것입니다.

자주 묻는 질문:

Q1. 경피적 대동맥판막 치환/이식 시장의 성장률은 어느 정도입니까?

경피적 대동맥판막 치환/이식 시장은 2026년부터 2034년까지의 예측 기간 동안 연평균 성장률(CAGR) 11.4%로 확대될 것으로 전망됩니다.

Q2. 경피적 대동맥판막 치환/이식 시장의 규모는 어느 정도입니까?

경피적 대동맥판막 치환/이식 시장 규모는 2025년에 85억 달러로 추정되며, 2034년까지 226억 달러에 달할 것으로 전망됩니다.

Q3. 경피적 대동맥판막 치환/이식(TAVR/TAVI) 시장을 주도하고 있는 지역은 어디입니까?

북미는 성숙한 구조적 심장질환 치료 생태계, 탄탄한 임상시험 인프라, 그리고 적격 환자층을 지속적으로 확대해 온 FDA의 명확한 규제 방침에 힘입어, 2025년에는 전 세계 매출의 41%를 차지하며 TAVR/TAVI 시장을 주도했습니다. 아시아태평양은 예측 기간 동안 가장 빠르게 성장할 지역입니다.

Q4. 경피적 대동맥판막 치환/이식 시장의 주요 성장 요인은 무엇입니까?

주요 촉진요인으로는 고령화에 따른 전 세계 대동맥판막협착증 유병률의 증가, FDA가 2025년에 무증상 중증 대동맥판막협착증에 대한 SAPIEN 3의 승인을 통해 적응증을 확대한 점, 외과적 대동맥판막 치환술을 대체하는 최소침습 시술에 대한 선호도 증가; 재TAVR 및 밸브-인-밸브(Valve-in-Valve) 적응증 확대; JenaValve사의 Trilogy 등, 대동맥판막 역류증 전용 신제품; 그리고 판막 설계 및 전달 시스템 분야의 지속적인 기술 발전 등이 있습니다.

Q5. 경피적 대동맥판막 치환/이식 시장의 주요 기업은 어디입니까?

주요 기업으로는 Medtronic, Edwards Lifesciences Corporation, Boston Scientific Corporation, Meril Life Sciences, Abbott, JenaValve Technology, Inc., Bracco SpA, Transcatheter Technologies GmbH, Braile Biomedica, Venus Medtech 등이 있으며, 그 외에도 '경쟁 현황' 섹션에서 소개된 활발한 공급업체가 다수 존재합니다. Edwards Lifesciences와 Medtroni는 각각 'SAPIEN' 및 'Evolut' 플랫폼을 통해 시장을 선도하고 있으며, Abbott의 'Navitor' 시스템이 그 격차를 좁혀가고 있습니다.

자주 묻는 질문

  • 경피적 대동맥판막 치환/이식 시장의 성장률은 어떻게 되나요?
  • 경피적 대동맥판막 치환/이식 시장의 규모는 어떻게 되나요?
  • 경피적 대동맥판막 치환/이식 시장을 주도하고 있는 지역은 어디인가요?
  • 경피적 대동맥판막 치환/이식 시장의 주요 성장 요인은 무엇인가요?
  • 경피적 대동맥판막 치환/이식 시장의 주요 기업은 어디인가요?

목차

제1장 경피적 대동맥판막 치환/이식 시장 보고서 소개

제2장 경피적 대동맥판막 치환/이식 시장 주요 요약

제3장 경피적 대동맥판막 치환/이식 시장의 주요 요인 분석

제4장 영향 분석 : AI, 지정학, 무역 및 경제 동향

제5장 규제 분석

제6장 경피적 대동맥판막 치환/이식 시장의 Porter's Five Forces 분석

제7장 경피적 대동맥판막 치환/이식 시장 평가

제8장 경피적 대동맥판막 치환/이식 시장 경쟁 구도

제9장 경피적 대동맥판막 치환/이식 시장 스타트업 자금 조달 및 투자 동향

제10장 경피적 대동맥판막 치환/이식 시장 : 기업 개요 및 제품 프로파일

제11장 KOL의 견해

제12장 프로젝트 접근법

제13장 DelveInsight 소개

제14장 면책사항 및 문의

KSM 26.07.30

Transcatheter Aortic Valve Replacement/Implantation Market Summary

Overview:

  • The Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI) market is estimated at USD 8.50 billion in 2025 and is projected to reach USD 22.60 billion by 2034. Growth is anchored in the rising global prevalence of aortic stenosis, rapid expansion of minimally invasive structural heart procedures, and accelerating regulatory approvals that broaden the eligible patient population.
  • The global TAVR/TAVI market is growing at a CAGR of 11.4% during the forecast period from 2026 to 2034.
  • By valve frame material, the nitinol segment dominated the TAVR/TAVI market with a 42% share in 2025.
  • By valve leaflet material, the bovine segment dominated the TAVR/TAVI market with a 55% share in 2025.
  • By procedure, the transfemoral approach segment dominated the TAVR/TAVI market with a 78% share in 2025.
  • By application, the aortic stenosis segment dominated the TAVR/TAVI market with an 88% share in 2025.
  • By end user, the hospitals segment dominated the TAVR/TAVI market with a 68% share in 2025.
  • North America dominated the global TAVR/TAVI market revenue with a 41% share in 2025, representing the highest regional market share globally.

Transcatheter Aortic Valve Replacement/Implantation (TAVR/TAVI) is a minimally invasive procedure that delivers a bioprosthetic valve through a catheter to replace a diseased native aortic valve, most commonly to treat severe aortic stenosis and, increasingly, aortic regurgitation, without the need for open-heart surgery. Because the valve frame must safely expand and anchor within the native anatomy while the leaflets replicate durable, blood-compatible valve function, TAVR devices combine advanced metallurgy, biological tissue engineering, and precision delivery systems. The market is organized by material across valve frame material, including nitinol, stainless steel, cobalt chromium, and others, and valve leaflet material, including porcine, bovine, and others; by procedure across transfemoral, transapical, and transaortic approaches; by application across aortic stenosis, aortic regurgitation, and others; and by end user across hospitals, ambulatory surgical centers, and others. Driven by an aging global population, accelerating label expansions into asymptomatic and lower-risk patients, redo and valve-in-valve indications, and continuous device innovation, TAVR/TAVI has become the standard of care for severe aortic valve disease and a cornerstone of modern structural heart intervention.

Transcatheter Aortic Valve Replacement/Implantation Market Key Growth Drivers

  • The rising global prevalence of aortic stenosis in an aging population is expanding the treatable patient pool, with severe aortic stenosis estimated to affect roughly 9% of Americans older than 65.
  • Regulatory label expansions, including the FDA's 2025 approval of Edwards' SAPIEN 3 platform for asymptomatic severe aortic stenosis based on the EARLY TAVR trial, are broadening eligible patient populations.
  • Growing physician and hospital preference for minimally invasive procedures over open surgical aortic valve replacement (SAVR) is accelerating TAVR adoption across all surgical risk categories.
  • Expanding indications for redo TAVR and valve-in-valve procedures, including Medtronic's August 2025 FDA approval of expanded Redo-TAVR for its Evolut platform, are enlarging the durable, recurring procedure base.
  • New dedicated devices for aortic regurgitation, led by JenaValve's Trilogy system, the first FDA-approved transcatheter valve for symptomatic severe aortic regurgitation, are opening previously underserved patient segments.
  • Continuous technological advancement, including polymer and dry-tissue leaflets, AI-guided delivery systems, and device miniaturization, is improving durability and enabling treatment of younger, lower-risk patients.
  • Rising competitive intensity and geographic expansion by companies such as Abbott, Meril Life Sciences, and Venus Medtech are increasing access in intermediate- and low-risk populations and in emerging markets.

Key Companies in Transcatheter Aortic Valve Replacement/Implantation Market

The competitive landscape is led by the following active device manufacturers:

  • Medtronic
  • Edwards Lifesciences Corporation
  • Boston Scientific Corporation
  • Meril Life Sciences
  • Abbott
  • JenaValve Technology, Inc.
  • Bracco SpA
  • Transcatheter Technologies GmbH
  • Braile Biomedica
  • Venus Medtech

Factors Contributing to the Growth of the Transcatheter Aortic Valve Replacement/Implantation Market

Market Drivers

Rising Prevalence of Aortic Stenosis in an Aging Population

The most fundamental driver of the TAVR/TAVI market is the rising global prevalence of degenerative aortic valve disease as populations age. Severe aortic stenosis is estimated to affect approximately 9% of Americans older than 65, and without treatment, roughly one in ten symptomatic patients may die within five weeks of symptom onset. As life expectancy rises across North America, Europe, and Asia-Pacific, the pool of elderly patients with calcific aortic stenosis expands steadily, and improved echocardiographic screening is uncovering substantial underdiagnosed disease burden. Because TAVR offers a minimally invasive alternative to open-heart surgery with faster recovery, it is increasingly the default therapy for this growing population, anchoring durable procedure-volume growth through 2034.

Regulatory Label Expansions into Asymptomatic and Lower-Risk Patients

A wave of regulatory approvals is directly enlarging the treatable population for TAVR. In 2025, the FDA approved Edwards' SAPIEN 3 platform, including SAPIEN 3, SAPIEN 3 Ultra, and SAPIEN 3 Ultra RESILIA, for patients with severe aortic stenosis who are without symptoms, the first such approval in asymptomatic disease, based on the EARLY TAVR trial demonstrating superior outcomes compared to guideline-recommended clinical surveillance. Medtronic's Evolut platform is now approved for symptomatic severe aortic stenosis across all surgical risk categories, from extreme and high risk to intermediate and low risk, in more than 120 countries. Each expansion of eligible risk categories and disease stages converts a segment of previously untreated or surgically managed patients into TAVR candidates, compounding demand across the forecast period.

Market Restraints

Despite strong momentum, the TAVR/TAVI market faces material constraints. The high cost of TAVR devices and associated hospital procedural infrastructure limits adoption in price-sensitive and emerging markets, where reimbursement frameworks for transcatheter therapies remain underdeveloped relative to North America and Western Europe. Long-term durability data, particularly for younger and lower-risk patients now becoming eligible for TAVR, remains comparatively limited next to decades of surgical valve experience, and structural valve deterioration over extended follow-up continues to be studied. Procedural complications, including paravalvular leak, vascular access injury, and the need for permanent pacemaker implantation due to conduction disturbances, require ongoing device and technique refinement. A shortage of trained interventional cardiologists and structural heart teams constrains procedure volume growth in many regions, while complex anatomies, including bicuspid valves and small annuli, continue to challenge existing device designs. Regulatory and competitive frictions, including antitrust scrutiny of consolidation such as the FTC's challenge to Edwards' acquisition of JenaValve, add uncertainty to the competitive landscape. Together, these cost, evidentiary, clinical, workforce, and regulatory barriers temper the pace of growth, even as the underlying drivers of an aging population, procedural preference, and device innovation remain firmly intact.

Transcatheter Aortic Valve Replacement/Implantation Market Segment Analysis

The Transcatheter Aortic Valve Replacement/Implantation by Material (Valve Frame Material [Nitinol, Stainless Steel, Cobalt Chromium, and Others] Valve Leaflet Material [Porcine, Bovine, and Others]), Procedure (Transfemoral, Transapical, Transaortic Approach), Application (Aortic Stenosis, Aortic Regurgitation, Others), End User (Hospitals, Ambulatory Surgical Centers, Others), and Geography (North America, Europe, Asia-Pacific, and Rest of World).

By Material

Dominant Subsegment: Nitinol. The Nitinol category is expected to dominate the market.

Dominant: Nitinol ~ 42%

The nitinol segment accounted for 42% of the TAVR/TAVI market in 2025. Nitinol is the leading valve frame material because its shape-memory and self-expanding properties allow devices such as Medtronic's Evolut and Venus Medtech's VenusA-Valve to conform precisely to the native annulus without balloon expansion, reducing the risk of annular injury and enabling repositionable, retrievable delivery. Self-expanding nitinol frames are especially favored in patients with irregular or heavily calcified anatomies and support lower-profile delivery systems that ease transfemoral access. While cobalt chromium is growing fastest as balloon-expandable platforms refine frame geometry for precise annular sizing, and stainless steel retains a smaller legacy footprint, the flexibility, recoverability, and broad anatomical applicability of nitinol secure its leadership across the forecast period.

By Procedure

Dominant Subsegment: Transfemoral Approach. The transfemoral approach category is expected to dominate the market.

Dominant: Transfemoral ~ 78%

The transfemoral approach segment accounted for 78% of the TAVR/TAVI market in 2025. Transfemoral access is the leading procedure route because it avoids thoracotomy or sternotomy entirely, is performed under conscious sedation in most centers, and enables shorter hospital stays with faster recovery than any alternative access route. Continuous reductions in delivery-system sheath size have extended transfemoral eligibility to patients with smaller or more diseased peripheral vasculature who previously required alternative access. Transapical and transaortic approaches remain clinically important for patients with prohibitive peripheral vascular disease, small stature, or prior cardiac surgery with dense adhesions, and transapical access is growing quickly as device iterations improve outcomes for these anatomically challenging cases, but the safety, recovery, and workflow advantages of transfemoral access secure its leadership across the forecast period.

Transcatheter Aortic Valve Replacement/Implantation Market Region Analysis

Dominant Region: North America

Dominant: North America ~ 41% (Largest)

North America accounted for 41% of the global TAVR/TAVI market revenue in 2025, representing the highest regional market share globally. The region's dominance reflects a mature structural heart ecosystem, dense hybrid cath-lab infrastructure, deep clinical-trial history led by pivotal trials such as EARLY TAVR, and clear FDA regulatory pathways that have repeatedly expanded eligible patient populations, most recently to asymptomatic severe aortic stenosis in 2025. The United States hosts the largest concentration of experienced structural heart programs and the broadest portfolio of approved devices, including SAPIEN, Evolut, Navitor, and Trilogy. Continued label expansions into redo TAVR, aortic regurgitation, and lower-risk patients, combined with an aging population and strong device reimbursement, anchor the region's continued leadership across the forecast period.

Fastest Growing Region: Asia-Pacific

Asia-Pacific is the fastest-growing region in the TAVR/TAVI market. The region's elevated CAGR is driven by rising cardiovascular disease burden, rapid expansion of cardiac catheterization infrastructure, and growing healthcare investment across China, Japan, India, South Korea, and Australia. China's Venus Medtech has built commanding domestic scale with its VenusA-Valve platform, Japan continues to expand transcatheter procedure volumes under an aging population, India benefits from Meril Life Sciences' indigenously developed, cost-competitive Myval platform, and Australia and South Korea are expanding structural heart training programs. Government healthcare investment, an expanding elderly population, and growing physician training in transcatheter techniques are accelerating adoption, while regional manufacturers scale production and pursue international regulatory approval, positioning Asia-Pacific as the principal source of incremental growth over the forecast period.

Regional Commentary

North America

North America accounted for 41% of the global TAVR/TAVI market revenue in 2025. The United States dominates on the strength of its structural heart infrastructure, deep clinical-trial base, and FDA regulatory clarity, while 2025 label expansions into asymptomatic aortic stenosis, redo TAVR, and aortic regurgitation reinforce continued procedural growth.

Europe

Europe is a large and clinically advanced regional market, supported by early CE Mark approvals, an established structural heart training base, and a broad device portfolio spanning Germany, France, the United Kingdom, Italy, and Spain. Regulatory momentum such as Abbott's 2025 CE Mark expansion for Navitor and JenaValve's European Trilogy activity reinforces the region's role as an early-access market for next-generation TAVR devices.

Asia-Pacific

Asia-Pacific is the fastest-growing region, propelled by rising cardiovascular disease burden, expanding cath-lab infrastructure, and growing healthcare investment across China, Japan, India, South Korea, and Australia. Venus Medtech's domestic leadership in China, Meril Life Sciences' cost-competitive Myval platform in India, and Japan's aging-population-driven procedure growth are accelerating regional TAVR adoption and clinical-trial activity.

Rest of World

The Rest of World region, spanning Latin America, the Middle East, and Africa, is an emerging growth frontier. Expanding cardiac care infrastructure, rising diagnosis of aortic valve disease, and efforts to broaden reimbursement and regulatory pathways for transcatheter therapies are gradually improving access, supported by manufacturers such as Braile Biomedica in Brazil that are building regional manufacturing and distribution capacity.

Transcatheter Aortic Valve Replacement/Implantation Market Competitive Landscape

The TAVR/TAVI market is classified as Highly Concentrated. Two integrated leaders, Edwards Lifesciences and Medtronic, together account for the substantial majority of global TAVR procedure volume through their SAPIEN and Evolut platforms, respectively, anchoring the top tier alongside Abbott's expanding Navitor system. Specialized and fast-scaling providers, including Meril Life Sciences, JenaValve Technology, Boston Scientific, Transcatheter Technologies GmbH, Braile Biomedica, and Venus Medtech, compete through regional manufacturing scale, dedicated aortic regurgitation devices, and cost-competitive platforms, increasing competition in emerging markets and underserved clinical segments.

The competitive landscape can be evaluated across the following dimensions:

  • Market concentration: Highly concentrated, with Edwards Lifesciences and Medtronic leading and a growing field of specialized challengers expanding in adjacent segments.
  • Leading players: Edwards Lifesciences and Medtronic anchor the top tier through their SAPIEN and Evolut platforms, with Abbott's Navitor system closing the gap.
  • Geographic reach: Leaders operate global commercial networks spanning the United States, Europe, and Asia-Pacific; Venus Medtech maintains commanding domestic scale in China while Meril Life Sciences expands across India and emerging markets.
  • Product portfolio strength: Top players offer multiple valve generations spanning balloon-expandable and self-expanding designs, redo TAVR indications, and, increasingly, dedicated aortic regurgitation devices.
  • Clinical evidence: Landmark trials, including EARLY TAVR and VANTAGE, and large post-approval registries are a decisive competitive advantage in expanding label indications.
  • Strategic partnerships and M&A: Active consolidation, including Edwards' 2024 acquisitions of JenaValve and JC Medical to expand its aortic regurgitation pipeline, and Boston Scientific's structural heart investments, continues to reshape the competitive field.
  • Manufacturing capabilities: Precision nitinol and cobalt-chromium frame fabrication, tissue processing and anti-calcification treatment, and low-profile delivery-system engineering are key competitive moats.
  • Innovation focus: Dry-tissue and polymer leaflets, fully retrievable delivery systems, AI-guided implantation, redo TAVR, and dedicated aortic regurgitation devices define the current innovation frontier.

Transcatheter Aortic Valve Replacement/Implantation Market Recent Developmental Activities

In May 2026, Abbott presented real-world Navitor TAVI outcomes data at EuroPCR 2026 in Paris, reporting favorable safety and performance in low- and intermediate-risk patients. Strategic significance: Reinforces clinical confidence in Navitor's intra-annular design ahead of broader risk-category adoption.

In January 2026, Abbott published early U.S. real-world experience data for its intra-annular, self-expanding Navitor valve in JACC: Cardiovascular Interventions. Strategic significance: Strengthens the clinical evidence base supporting Navitor's differentiated design in the competitive TAVR landscape.

Transcatheter Aortic Valve Replacement/Implantation Market Segmentation

Transcatheter Aortic Valve Replacement/Implantation Market by Material

  • Valve Frame Material
  • Nitinol
  • Stainless Steel
  • Cobalt Chromium
  • Others
  • Valve Leaflet Material
  • Porcine
  • Bovine
  • Others

Transcatheter Aortic Valve Replacement/Implantation Market by Procedure

  • Transfemoral Approach
  • Transapical Approach
  • Transaortic Approach

Transcatheter Aortic Valve Replacement/Implantation Market by Application

  • Aortic Stenosis
  • Aortic Regurgitation
  • Others

Transcatheter Aortic Valve Replacement/Implantation Market by End User

  • Hospitals
  • Ambulatory Surgical Centers
  • Others

Transcatheter Aortic Valve Replacement/Implantation Market by Geography

  • North America Transcatheter Aortic Valve Replacement/Implantation Market
  • United States Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Canada Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Mexico Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Europe Transcatheter Aortic Valve Replacement/Implantation Market
  • Germany Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • United Kingdom Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • France Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Italy Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Spain Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Rest of Europe Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Asia-Pacific Transcatheter Aortic Valve Replacement/Implantation Market
  • China Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Japan Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • India Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Australia Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • South Korea Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Rest of Asia-Pacific Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Rest of the World (RoW) Transcatheter Aortic Valve Replacement/Implantation Market
  • Middle East Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • Africa Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
  • South America Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)

Key Takeaways from the Transcatheter Aortic Valve Replacement/Implantation Market Report Study

  • Market size analysis for the current transcatheter aortic valve replacement/implantation market size (2025), and market forecast for 9 years (2026 to 2034).
  • Top key product/technology developments, mergers, acquisitions, partnerships, and joint ventures that happened over the last 3 years.
  • Key companies dominating the global transcatheter aortic valve replacement/implantation market.
  • Various opportunities available for competitors in the transcatheter aortic valve replacement/implantation market space.
  • What are the top-performing segments in 2025? How will these segments perform in 2034?
  • Which are the top-performing regions and countries in the current transcatheter aortic valve replacement/implantation market scenario?
  • Which are the regions and countries where companies should concentrate their opportunities for transcatheter aortic valve replacement/implantation market growth in the future?

Target audience who can benefit from this Transcatheter Aortic Valve Replacement/Implantation market report study

  • Transcatheter aortic valve replacement/implantation product providers
  • Research organizations and consulting companies
  • Transcatheter aortic valve replacement/implantation-related organizations, associations, forums, and other alliances
  • Government and corporate offices
  • Start-up companies, venture capitalists, and private equity firms
  • Distributors and traders dealing in transcatheter aortic valve replacement/implantation
  • Various end-users who want to know more about the transcatheter aortic valve replacement/implantation market and the latest technological developments in the transcatheter aortic valve replacement/implantation market.

Frequently Asked Questions:

Q1. What is the growth rate of the transcatheter aortic valve replacement/implantation market?

The transcatheter aortic valve replacement/implantation market is projected to expand at a CAGR of 11.4% during the forecast period from 2026-2034.

Q2. What is the market size of the transcatheter aortic valve replacement/implantation market?

The transcatheter aortic valve replacement/implantation market is estimated at USD 8.50 billion in 2025 and is projected to reach USD 22.60 billion by 2034.

Q3. Which region dominates the transcatheter aortic valve replacement/implantation market?

North America dominated the TAVR/TAVI market with a 41% share of global revenue in 2025, supported by a mature structural heart ecosystem, dense clinical-trial infrastructure, and FDA regulatory clarity that has repeatedly expanded eligible patient populations. Asia-Pacific is the fastest-growing region over the forecast period.

Q4. What are the key drivers of the transcatheter aortic valve replacement/implantation market?

The principal drivers are the rising global prevalence of aortic stenosis in an aging population; regulatory label expansions such as the FDA's 2025 approval of SAPIEN 3 for asymptomatic severe aortic stenosis; growing preference for minimally invasive procedures over surgical aortic valve replacement; expanding redo TAVR and valve-in-valve indications; new dedicated devices for aortic regurgitation such as JenaValve's Trilogy; and continuous technological advancement in valve design and delivery systems.

Q5. Who are the major players in the transcatheter aortic valve replacement/implantation market?

The major players include Medtronic, Edwards Lifesciences Corporation, Boston Scientific Corporation, Meril Life Sciences, Abbott, JenaValve Technology, Inc., Bracco SpA, Transcatheter Technologies GmbH, Braile Biomedica, and Venus Medtech, among other active providers profiled in the Competitive Landscape section. Edwards Lifesciences and Medtronic lead through their SAPIEN and Evolut platforms, with Abbott's Navitor system closing the gap.

Table of Contents

1. Transcatheter Aortic Valve Replacement/Implantation Market Report Introduction

  • 1.1 Scope of the Study
  • 1.2 Market Segmentation
  • 1.3 Market Assumptions

2. Transcatheter Aortic Valve Replacement/Implantation Market Executive Summary

  • 2.1 Market at a Glance

3. Transcatheter Aortic Valve Replacement/Implantation Market Key Factors Analysis

  • 3.1 Transcatheter Aortic Valve Replacement/Implantation Market Drivers
    • 3.1.1 Rising Prevalence of Aortic Stenosis
    • 3.1.2 Regulatory Label Expansions
    • 3.1.3 Preference for Minimally Invasive Procedures
    • 3.1.4 Expanding Redo TAVR and Valve-in-Valve Indications
  • 3.2 Transcatheter Aortic Valve Replacement/Implantation Market Restraints and Challenges
    • 3.2.1 High Device Cost and Reimbursement Constraints
    • 3.2.2 Durability Data and Procedural Complications
    • 3.2.3 Workforce, Anatomical, and Regulatory Complexity
  • 3.3 Transcatheter Aortic Valve Replacement/Implantation Market Opportunities
    • 3.3.1 Dedicated Aortic Regurgitation Devices
    • 3.3.2 Emerging-Market and Lower-Risk Patient Expansion

4. Impact Analysis: AI, Geopolitical, Trade, and Economic Developments

5. Regulatory Analysis

  • 5.1 United States
  • 5.2 Europe
  • 5.3 Japan
  • 5.4 China

6. Transcatheter Aortic Valve Replacement/Implantation Market Porter's Five Forces Analysis

  • 6.1 Bargaining Power of Suppliers
  • 6.2 Bargaining Power of Buyers
  • 6.3 Threat of New Entrants
  • 6.4 Threat of Substitutes
  • 6.5 Competitive Rivalry

7. Transcatheter Aortic Valve Replacement/Implantation Market Assessment

  • 7.1 By Material
    • 7.1.1 Valve Frame Material
    • 7.1.1 Nitinol
    • 7.1.2 Stainless Steel
    • 7.1.3 Cobalt Chromium
    • 7.1.4 Others
    • 7.1.2 Valve Leaflet Material
    • 7.2.1 Porcine
    • 7.2.2 Bovine
    • 7.2.3 Others
  • 7.2 By Procedure
    • 7.3.1 Transfemoral Approach
    • 7.3.2 Transapical Approach
    • 7.3.3 Transaortic Approach
  • 7.3 By Application
    • 7.4.1 Aortic Stenosis
    • 7.4.2 Aortic Regurgitation
    • 7.4.3 Others
  • 7.4 By End User
    • 7.4.1 Hospitals
    • 7.4.2 Ambulatory Surgical Centers
    • 7.4.3 Others
  • 7.5 By Geography
    • 7.5.1 North America
      • 7.5.1.1 United States Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.1.2 Canada Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.1.3 Mexico Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
    • 7.5.2 Europe
      • 7.5.2.1 Germany Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.2.2 United Kingdom Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.2.3 France Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.2.4 Italy Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.2.5 Spain Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.2.6 Rest of Europe Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
    • 7.5.3 Asia-Pacific
      • 7.5.3.1 China Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.3.2 Japan Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.3.3 India Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.3.4 Australia Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.3.5 South Korea Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.3.6 Rest of Asia-Pacific Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
    • 7.5.4 Rest of World
      • 7.5.4.1 Middle East Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.4.2 Africa Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)
      • 7.5.4.3 South America Transcatheter Aortic Valve Replacement/Implantation Market Size in USD million (2023-2034)

8. Transcatheter Aortic Valve Replacement/Implantation Market Competitive Landscape

  • 8.1 Market Concentration and Structure
  • 8.2 Competitive Positioning and Market Share Analysis (Premium Offering)

9. Transcatheter Aortic Valve Replacement/Implantation Market Startup Funding and Investment Trends

10. Transcatheter Aortic Valve Replacement/Implantation Market Company and Product Profiles

  • 10.1 Medtronic
    • 10.1.1 Company Overview
    • 10.1.2 Company Snapshot
    • 10.1.3 Financial Overview
    • 10.1.4 Service Portfolio
    • 10.1.5 Strategic Initiatives / Entropy
  • 10.2 Edwards Lifesciences Corporation
    • 10.2.1 Company Overview
    • 10.2.2 Company Snapshot
    • 10.2.3 Financial Overview
    • 10.2.4 Product Portfolio
    • 10.2.5 Strategic Initiatives / Entropy
  • 10.3 Boston Scientific Corporation
    • 10.3.1 Company Overview
    • 10.3.2 Company Snapshot
    • 10.3.3 Financial Overview
    • 10.3.4 Product Portfolio
    • 10.3.5 Strategic Initiatives / Entropy
  • 10.4 Meril Life Sciences
    • 10.4.1 Company Overview
    • 10.4.2 Company Snapshot
    • 10.4.3 Financial Overview
    • 10.4.4 Product Portfolio
    • 10.4.5 Strategic Initiatives / Entropy
  • 10.5 Abbott
    • 10.5.1 Company Overview
    • 10.5.2 Company Snapshot
    • 10.5.3 Financial Overview
    • 10.5.4 Product Portfolio
    • 10.5.5 Strategic Initiatives / Entropy
  • 10.6 JenaValve Technology, Inc.
    • 10.6.1 Company Overview
    • 10.6.2 Company Snapshot
    • 10.6.3 Financial Overview
    • 10.6.4 Product Portfolio
    • 10.6.5 Strategic Initiatives / Entropy
  • 10.7 Bracco SpA
    • 10.7.1 Company Overview
    • 10.7.2 Company Snapshot
    • 10.7.3 Financial Overview
    • 10.7.4 Product Portfolio
    • 10.7.5 Strategic Initiatives / Entropy
  • 10.8 Transcatheter Technologies GmbH
    • 10.8.1 Company Overview
    • 10.8.2 Company Snapshot
    • 10.8.3 Financial Overview
    • 10.8.4 Product Portfolio
    • 10.8.5 Strategic Initiatives / Entropy
  • 10.9 Braile Biomedica
    • 10.9.1 Company Overview
    • 10.9.2 Company Snapshot
    • 10.9.3 Financial Overview
    • 10.9.4 Product Portfolio
    • 10.9.5 Strategic Initiatives / Entropy
  • 10. Venus Medtech
    • 10.10.1 Company Overview
    • 10.10.2 Company Snapshot
    • 10.10.3 Financial Overview
    • 10.10.4 Product Portfolio
    • 10.10.5 Strategic Initiatives / Entropy

For illustrative purposes, only the top 10 companies are listed in the Table of Contents. The report may include analysis and references to additional companies where relevant to the market assessment.

11. KOL Views

12. Project Approach

13. About DelveInsight

14. Disclaimer and Contact Us

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