Summary

The global Structural heart devices market is projected to reach USD 25.69 billion by 2029 from USD 16.31 billion in 2024, at a CAGR of 9.5% from 2024 to 2029. Drivers of growth in the market for structural heart devices include mounting incidence rates of valvular and congenital heart diseases, high advancement rates of minimally invasive technologies such as TAVR and TMVR, and rising adoption rates since global populations are aging and healthcare infrastructure is being enhanced.
“By product segment Heart Valve segment to account for the largest share during the forecast period”
The most paramount segment of the structural heart devices market is heart valves primarily due to the higher prevalence of valvular diseases such as aortic stenosis and mitral regurgitation, especially in the geriatric population. These have treatment requirements at the earlier stages, with the latest breakthroughs in minimally invasive techniques being TAVR and TMVR, which have drastically altered the approach to treating these diseases. The above techniques offer reduced recovery times, fewer surgical risks, and greater access to patients classified as high-risk or inoperable when compared to traditional open-heart surgery.
Technological upgrades, for example, next-generation valves with improved durability, better sealing, and optimized delivery mechanisms form one of this segment's most important demand drivers. Edwards Lifesciences, Medtronic, and Abbott companies are heavily investing in developing advanced transcatheter heart valves, thus further strengthening the dominancy of the segment. In addition, the growing adoption of these products in developed and emerging markets, supported by growth in reimbursement policies and demonstrated clinical success rates, further solidifies the heart valve segment as the largest and fastest-growing category in the structural heart market.
“APAC is estimated to register the highest CAGR during the forecast period.”
The Structural heart devices market is divided into Five regions: North America, Europe, Asia Pacific, Latin America, Middle East, and Africa. The Asia Pacific region witnessed the highest CAGR during the forecast period. Many APAC countries, including Japan, South Korea, and China, are witnessing demographic shifts as their populations age. The increasing diabetic population and increase in obesity due to sedentary lifestyles are also driving the growth of Structural heart devices in the APAC region.

The breakdown of the profile of primary participants in the Structural heart devices market:
• By Company Type: Tier 1- 35%, Tier 2- 45%, and Tier 3-20%
• By Designation: C-level Executives- 35%, Directors- 25% , and Others- 40%.
• By Region: North America - 40%, Europe – 30%, APAC –20%, Latin America – 5%, Middle East & Africa–5%

List of Companies Profiled in the Report
 Boston Scientific Corporation (U.S)
 Edwards Lifesciences Corporation (U.S)
 Medtronic (Ireland)
 Boston Scientific Corporation (U.S
 Abbott (U.S)
 Teleflex (U.S)
 Integer Holdings Corporation (U.S)
 Lepu Medical Technology Co.Ltd.(China)
 TTK (India)
 Artivion, Inc. (U.S)
 Venus Medtech, Inc. (China)
 Cook (U.S)
 SMT (India)
 Meril Lifesciences Pvt.Ltd (India)
 W.L Gore & Associates, Inc. (U.S)
 Cordis (U.S)
 Foldax (U.S)
 Micro Interventional Devices, Incorporated (U.S)
 Cardiac Dimensions (U.S)
 HighLife Medical (France)
 Mitralign (U.S)
 Braile Biomedica (Brazil)
 JenaValve (Germany)
 Corcym (Italy)
 Xeltis (Switzerland)
 Innovheart SRL (U.S)

Research Coverage
This report studies the Structural heart devices market based on product, procedure, end users and region. It also analyses factors (such as drivers, restraints, opportunities, and challenges) affecting market growth. It evaluates the market's opportunities and challenges for stakeholders and provides details of the competitive landscape for market leaders. The report also studies micro markets concerning their growth trends, prospects, and contributions to the total Structural heart devices market. The report forecasts the revenue of the market segments to five major regions.
Reasons to Buy the Report
This report also includes.
• Analysis of key drivers (technological advancements), restraints (Cost of the system), challenges (regulatory policies), and opportunities (Increase in minimally invasive procedures) contributing to the growth of the Structural heart devices market.
• Product Development/Innovation: Detailed insights on upcoming trends, research & development activities, in the Structural heart devices market.
• Market Development: Comprehensive information on the lucrative emerging markets type and region.
• Market Diversification: Exhaustive information about the growing geographies, recent developments, and investments in the Structural heart devices market.
• Competitive Assessment: In-depth assessment of market shares, growth strategies, product offerings, company evaluation quadrant, and capabilities of leading players in the global Structural heart devices market.

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Table of Contents

1 INTRODUCTION 29
1.1 STUDY OBJECTIVES 29
1.2 MARKET DEFINITION 29
1.3 STUDY SCOPE 30
1.3.1 MARKETS COVERED AND REGIONAL SCOPE 30
1.3.2 INCLUSIONS AND EXCLUSIONS 31
1.3.3 YEARS CONSIDERED 31
1.4 CURRENCY CONSIDERED 31
1.5 STAKEHOLDERS 32
1.6 SUMMARY OF CHANGES 32
2 RESEARCH METHODOLOGY 34
2.1 RESEARCH DATA 34
2.1.1 SECONDARY DATA 34
2.1.1.1 Key data from secondary sources 36
2.1.2 PRIMARY DATA 36
2.1.2.1 Key data from primary sources 38
2.1.2.2 Key industry insights 39
2.2 MARKET SIZE ESTIMATION 40
2.2.1 SUPPLY-SIDE ANALYSIS (REVENUE SHARE ANALYSIS) 40
2.2.2 TOP-DOWN APPROACH 41
2.2.3 COMPANY PRESENTATIONS AND PRIMARY INTERVIEWS 41
2.2.4 DEMAND-SIDE ANALYSIS 41
2.3 GROWTH FORECAST 42
2.4 MARKET BREAKDOWN AND DATA TRIANGULATION 44
2.5 MARKET SHARE ANALYSIS 45
2.6 RESEARCH ASSUMPTIONS 45
2.7 RISK ASSESSMENT 45
2.8 RESEARCH LIMITATIONS 46
3 EXECUTIVE SUMMARY 47
4 PREMIUM INSIGHTS 51
4.1 STRUCTURAL HEART DEVICES MARKET OVERVIEW 51
4.2 NORTH AMERICA: STRUCTURAL HEART DEVICES MARKET, BY PRODUCT AND COUNTRY 52
4.3 STRUCTURAL HEART DEVICES MARKET, BY COUNTRY 53
 
5 MARKET OVERVIEW 54
5.1 INTRODUCTION 54
5.2 MARKET DYNAMICS 54
5.2.1 DRIVERS 55
5.2.1.1 Growing geriatric population 55
5.2.1.2 Increasing preference for minimally invasive surgeries 56
5.2.1.3 Rising awareness about structural heart diseases 56
5.2.2 RESTRAINTS 58
5.2.2.1 High cost of devices and limited reimbursement 58
5.2.3 OPPORTUNITIES 58
5.2.3.1 Emergence of tissue-engineered heart valves 58
5.2.3.2 Expanding healthcare facilities in emerging economies 59
5.2.4 CHALLENGES 60
5.2.4.1 Regulatory and approval challenges 60
5.2.4.2 Intense competition among market players 61
5.2.4.3 Lack of skilled professionals 61
5.3 INDUSTRY TRENDS 62
5.3.1 MINIMALLY INVASIVE PROCEDURES 62
5.3.2 TECHNOLOGICAL ADVANCEMENTS IN DEVICE DESIGN 62
5.3.3 AI AND MACHINE LEARNING INTEGRATION 62
5.4 TRENDS/DISRUPTIONS IMPACTING CUSTOMER BUSINESSES 62
5.5 PRICING ANALYSIS 63
5.5.1 AVERAGE SELLING PRICE TREND, BY REGION 64
5.5.2 AVERAGE SELLING PRICE, BY KEY PLAYER 65
5.6 VALUE CHAIN ANALYSIS 65
5.7 SUPPLY CHAIN ANALYSIS 66
5.8 ECOSYSTEM ANALYSIS 67
5.9 INVESTMENT AND FUNDING SCENARIO 70
5.10 TECHNOLOGY ANALYSIS 71
5.10.1 KEY TECHNOLOGIES 71
5.10.1.1 Transcatheter aortic valve replacement 71
5.10.1.2 Transcatheter mitral aortic valve replacement 71
5.10.2 COMPLEMENTARY TECHNOLOGIES 72
5.10.2.1 3D printing 72
5.11 PATENT ANALYSIS 72
5.12 TRADE ANALYSIS 74
5.12.1 HS CODES 74
5.12.2 EXPORT DATA 75
5.12.3 IMPORT DATA 76
5.13 KEY CONFERENCES AND EVENTS, 2024–2025 77
5.14 CASE STUDY ANALYSIS 78
5.14.1 SAPIEN 3 TRANSCATHETER HEART VALVE FOR PRECISION PLACEMENT 78
5.14.2 MITRACLIP TRANSCATHETER EDGE-TO-EDGE REPAIR TO REDUCE HOSPITALIZATION 78
5.14.3 WATCHMAN FLX DEVICE FOR LEFT ATRIAL APPENDAGE 78
5.15 REGULATORY LANDSCAPE 79
5.15.1 REGULATORY ANALYSIS 79
5.15.1.1 North America 79
5.15.1.1.1 US 79
5.15.1.1.2 Canada 79
5.15.1.2 Europe 80
5.15.1.3 Asia Pacific 80
5.15.1.3.1 Japan 80
5.15.1.3.2 China 80
5.15.2 REGULATORY BODIES, GOVERNMENT AGENCIES, AND OTHER ORGANIZATIONS 81
5.16 PORTER’S FIVE FORCE ANALYSIS 83
5.16.1 THREAT OF NEW ENTRANTS 85
5.16.2 THREAT OF SUBSTITUTES 85
5.16.3 BARGAINING POWER OF SUPPLIERS 85
5.16.4 BARGAINING POWER OF BUYERS 85
5.16.5 INTENSITY OF COMPETITIVE RIVALRY 85
5.17 KEY STAKEHOLDERS AND BUYING CRITERIA 86
5.17.1 KEY STAKEHOLDERS 86
5.17.2 BUYING CRITERIA 87
5.18 REIMBURSEMENT ANALYSIS 87
5.19 UNMET NEEDS AND END-USER EXPECTATIONS 89
5.19.1 UNMET NEEDS 89
5.19.2 END-USER EXPECTATIONS 89
5.20 IMPACT OF AI/GEN AI ON STRUCTURAL HEART DEVICES MARKET 90
5.20.1 INTRODUCTION 90
5.20.2 KEY COMPANIES IMPLEMENTING AI 90
5.20.3 MARKET POTENTIAL OF AI IN STRUCTURAL HEART DEVICES MARKET 90
6 STRUCTURAL HEART DEVICES MARKET, BY PROCEDURE 91
6.1 INTRODUCTION 92
6.2 REPLACEMENT PROCEDURES 92
6.2.1 TAVR/TAVI REPLACEMENT PROCEDURES 93
6.2.1.1 Quicker recuperation and shorter hospital stays to promote growth 93
6.2.2 SAVR PROCEDURES 95
6.2.2.1 Wide adoption for treating valvular heart diseases to sustain growth 95
6.3 REPAIR PROCEDURES 96
6.3.1 CLOSURE PROCEDURES 97
6.3.1.1 Increasing prevalence of structural heart defects to boost market 97
6.3.2 ANNULOPLASTY 99
6.3.2.1 Growing focus on safety and efficacy to drive market 99
6.3.3 VALVULOPLASTY 100
6.3.3.1 Increasing cases of aortic stenosis and valvular regurgitation to fuel market 100
6.3.4 TMVR PROCEDURES 102
6.3.4.1 Growing preference over valve replacement to promote growth 102
6.3.5 TEER PROCEDURES 104
6.3.5.1 Global prevalence of mitral regurgitation to expedite growth 104
7 STRUCTURAL HEART DEVICES MARKET, BY PRODUCT 105
7.1 INTRODUCTION 106
7.2 HEART VALVE DEVICES 107
7.2.1 TRANSCATHETER HEART VALVES 108
7.2.1.1 Transcatheter mitral valve replacement 110
7.2.1.1.1 Growing use in treating age-related degeneration and heart diseases to boost market 110
7.2.1.2 Transcatheter aortic valve replacement 112
7.2.1.2.1 Increasing instances of aortic valve replacement to aid growth 112
7.2.2 SURGICAL VALVES 114
7.2.2.1 Mechanical valves 115
7.2.2.1.1 Higher durability and affordability to encourage growth 115
7.2.2.2 Biological valves 116
7.2.2.2.1 Need for reduced incidence of bleeding to accelerate growth 116
7.3 OCCLUDERS, CLOSURE SYSTEMS, AND DELIVERY SYSTEMS 118
7.4 ANNULOPLASTY RINGS 119
7.4.1 HIGH PREVALENCE OF MITRAL AND TRICUSPID VALVE REGURGITATION DISEASES TO PROMOTE GROWTH 119
7.5 ACCESSORIES 121
7.5.1 CATHETERS 122
7.5.1.1 Growing preference for minimally invasive procedures to fuel market 122
7.5.2 GUIDEWIRES 124
7.5.2.1 Need for precise navigation and placement of medical devices to augment growth 124
7.5.3 SHEATHS 125
7.5.3.1 Need for minimizing vascular trauma to promote growth 125
7.5.4 OTHER ACCESSORIES 127
 
8 STRUCTURAL HEART DEVICES MARKET, BY END USER 128
8.1 INTRODUCTION 129
8.1.1 HOSPITALS 129
8.1.1.1 Ability to handle large volume of patients to boost market 129
8.1.2 AMBULATORY SURGICAL CENTRES 130
8.1.2.1 Faster procedure time and lower infection rates to drive market 130
8.1.3 OTHER END USERS 132
9 STRUCTURAL HEART DEVICES MARKET, BY REGION 133
9.1 INTRODUCTION 134
9.2 NORTH AMERICA 134
9.2.1 MACROECONOMIC OUTLOOK FOR NORTH AMERICA 135
9.2.2 US 139
9.2.2.1 Favorable reimbursement scenario to augment growth 139
9.2.3 CANADA 143
9.2.3.1 Rising prevalence of target diseases to drive market 143
9.3 EUROPE 147
9.3.1 MACROECONOMIC OUTLOOK FOR EUROPE 147
9.3.2 GERMANY 151
9.3.2.1 Increase in geriatric and obese population to stimulate growth 151
9.3.3 UK 155
9.3.3.1 Increasing incidence of peripheral vascular diseases to support growth 155
9.3.4 FRANCE 159
9.3.4.1 Favorable government initiatives to drive market 159
9.3.5 ITALY 163
9.3.5.1 Increasing health expenditure and rising diabetes prevalence to boost market 163
9.3.6 SPAIN 166
9.3.6.1 Growing geriatric population to propel market 166
9.3.7 REST OF EUROPE 170
9.4 ASIA PACIFIC 175
9.4.1 MACROECONOMIC OUTLOOK FOR ASIA PACIFIC 175
9.4.2 JAPAN 180
9.4.2.1 Increasing healthcare expenditure to boost market 180
9.4.3 CHINA 184
9.4.3.1 Growing target patient population to drive market 184
9.4.4 INDIA 188
9.4.4.1 Increasing prevalence of diabetes to expedite growth 188
9.4.5 AUSTRALIA 191
9.4.5.1 Growing hospitalizations due to coronary artery diseases to fuel market 191
 
9.4.6 SOUTH KOREA 196
9.4.6.1 Increasing prevalence of hypertension to support growth 196
9.4.7 REST OF ASIA PACIFIC 200
9.5 LATIN AMERICA 203
9.5.1 MACROECONOMIC OUTLOOK FOR LATIN AMERICA 203
9.5.2 BRAZIL 207
9.5.2.1 Rising healthcare expenditure to aid growth 207
9.5.3 MEXICO 211
9.5.3.1 Increasing prevalence of cardiovascular diseases to spur growth 211
9.5.4 REST OF LATIN AMERICA 215
9.6 MIDDLE EAST & AFRICA 218
9.6.1 MACROECONOMIC OUTLOOK FOR MIDDLE EAST & AFRICA 218
9.6.2 GCC COUNTRIES 222
9.6.2.1 Rising cases of hypertension and associated cardiovascular diseases to drive market 222
9.6.3 REST OF MIDDLE EAST & AFRICA 225
10 COMPETITIVE LANDSCAPE 229
10.1 INTRODUCTION 229
10.2 KEY PLAYER STRATEGY/RIGHT TO WIN 229
10.2.1 OVERVIEW OF STRATEGIES ADOPTED BY KEY PLAYERS 229
10.3 REVENUE ANALYSIS, 2019–2023 230
10.4 MARKET SHARE ANALYSIS, 2023 231
10.5 COMPANY EVALUATION MATRIX: KEY PLAYERS, 2023 232
10.5.1 STARS 232
10.5.2 EMERGING LEADERS 232
10.5.3 PERVASIVE PLAYERS 233
10.5.4 PARTICIPANTS 233
10.5.5 COMPANY FOOTPRINT: KEY PLAYERS, 2023 234
10.5.5.1 Company footprint 234
10.5.5.2 Product footprint 235
10.5.5.3 Procedure footprint 236
10.5.5.4 End-user footprint 237
10.5.5.5 Region footprint 238
10.6 COMPANY EVALUATION MATRIX: STARTUPS/SMES, 2023 239
10.6.1 PROGRESSIVE COMPANIES 239
10.6.2 DYNAMIC COMPANIES 239
10.6.3 RESPONSIVE COMPANIES 239
10.6.4 STARTING BLOCKS 239
10.6.5 COMPETITIVE BENCHMARKING: STARTUPS/SMES, 2023 241
10.7 BRAND/PRODUCT COMPARISON 242
 
10.8 COMPANY VALUATION AND FINANCIAL METRICS 242
10.8.1 FINANCIAL METRICS 242
10.8.2 COMPANY VALUATION 243
10.9 COMPETITIVE SCENARIO 243
10.9.1 PRODUCT LAUNCHES AND APPROVALS 243
10.9.2 DEALS 245
11 COMPANY PROFILES 246
11.1 KEY PLAYERS 246
11.1.1 EDWARDS LIFESCIENCES CORPORATION 246
11.1.1.1 Business overview 246
11.1.1.2 Products offered 247
11.1.1.3 Recent developments 248
11.1.1.3.1 Deals 248
11.1.1.4 MnM view 249
11.1.1.4.1 Right to win 249
11.1.1.4.2 Strategic choices 249
11.1.1.4.3 Weaknesses and competitive threats 249
11.1.2 MEDTRONIC 250
11.1.2.1 Business overview 250
11.1.2.2 Products offered 252
11.1.2.3 Recent developments 252
11.1.2.3.1 Product launches and approvals 252
11.1.2.3.2 Deals 253
11.1.2.4 MnM view 253
11.1.2.4.1 Right to win 253
11.1.2.4.2 Strategic choices 253
11.1.2.4.3 Weaknesses and competitive threats 253
11.1.3 ABBOTT 254
11.1.3.1 Business overview 254
11.1.3.2 Products offered 255
11.1.3.3 Recent developments 256
11.1.3.3.1 Product launches and approvals 256
11.1.3.3.2 Deals 257
11.1.3.4 MnM view 257
11.1.3.4.1 Right to win 257
11.1.3.4.2 Strategic choices 257
11.1.3.4.3 Weaknesses and competitive threats 257
11.1.4 BOSTON SCIENTIFIC CORPORATION 258
11.1.4.1 Business overview 258
11.1.4.2 Products offered 259
11.1.4.3 Recent developments 260
11.1.4.3.1 Product launches and approvals 260
11.1.5 TELEFLEX 261
11.1.5.1 Business overview 261
11.1.5.2 Products offered 262
11.1.5.3 Recent developments 263
11.1.5.3.1 Product launches and approvals 263
11.1.5.3.2 Deals 263
11.1.6 INTEGER HOLDINGS CORPORATION 264
11.1.6.1 Business overview 264
11.1.6.2 Products offered 265
11.1.6.3 Recent developments 266
11.1.6.3.1 Deals 266
11.1.6.3.2 Expansions 266
11.1.7 LEPU MEDICAL TECHNOLOGY CO., LTD. 267
11.1.7.1 Business overview 267
11.1.7.2 Products offered 268
11.1.7.3 Recent developments 270
11.1.7.3.1 Product launches and approvals 270
11.1.8 TTK HEALTHCARE 271
11.1.8.1 Business overview 271
11.1.8.2 Products offered 272
11.1.9 ARTIVION, INC. 273
11.1.9.1 Business overview 273
11.1.9.2 Products offered 274
11.1.10 VENUS MEDTECH (HANGZHOU) INC. 276
11.1.10.1 Business overview 276
11.1.10.2 Products offered 277
11.1.10.3 Recent developments 277
11.1.10.3.1 Product launches and approvals 277
11.1.11 LIFETECH SCIENTIFIC CORPORATION 278
11.1.11.1 Business overview 278
11.1.11.2 Products offered 279
11.1.12 COOK 281
11.1.12.1 Business overview 281
11.1.12.2 Products offered 281
11.1.12.3 Recent developments 282
11.1.12.3.1 Deals 282
11.1.13 CORDIS 283
11.1.13.1 Business overview 283
11.1.13.2 Products offered 283
11.1.13.3 Recent developments 284
11.1.13.3.1 Product launches and approvals 284
11.1.14 SMT 285
11.1.14.1 Business overview 285
11.1.14.2 Products offered 285
11.1.14.3 Recent developments 286
11.1.14.3.1 Other developments 286
11.1.15 MERIL LIFE SCIENCES PVT. LTD. 287
11.1.15.1 Business overview 287
11.1.15.2 Products offered 288
11.1.16 W. L. GORE & ASSOCIATES, INC. 289
11.1.16.1 Business overview 289
11.1.16.2 Products offered 289
11.2 OTHER PLAYERS 291
11.2.1 FOLDAX 291
11.2.2 MICRO INTERVENTIONAL DEVICES, INCORPORATED 292
11.2.3 CARDIAC DIMENSIONS 292
11.2.4 BIOTRONIK 293
11.2.5 HIGHLIFE MEDICAL 294
11.2.6 MITRALIGN 294
11.2.7 BRAILE BIOMEDICA 295
11.2.8 JENAVALVE 295
11.2.9 CORCYM 296
11.2.10 XELTIS 296
11.2.11 INNOVHEART SRL 297
12 APPENDIX 298
12.1 DISCUSSION GUIDE 298
12.2 KNOWLEDGESTORE: MARKETSANDMARKETS’ SUBSCRIPTION PORTAL 301
12.3 CUSTOMIZATION OPTIONS 303
12.4 RELATED REPORTS 303
12.5 AUTHOR DETAILS 304