Report Detail

Medical Devices & Consumables Structural Heart Devices Global Market – Forecast To 2027

  • RnM2895587
  • |
  • 25 September, 2020
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  • Global
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  • 453 Pages
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  • IQ4I Research & Consultancy
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  • Medical Devices & Consumables

Structural heart devices consist of the various therapeutic interventional devices used to efficiently and economically close an abnormal communication between the heart chambers or to reconstruct or replace a diseased or degenerated heart valve through the adoption of a multidisciplinary remedial approach. Compared to the traditional highly invasive open heart surgical repair and replacement procedures, the current minimally invasive transcatheter therapeutic procedures with highly efficient, technologically advanced products assure patients and healthcare providers with improved efficiency, effectiveness and quicker restoration of the non coronary physical defects of the heart. Increased utilization of the various structural heart therapeutic products for the numerous and varied types of structural heart diseases among the patients, elevating inclination of the value centric global patient pool towards the minimally invasive, technologically advanced structural heart products with better therapeutic outcomes and the need to reduce hospitalization duration and ease and improve the patient’s condition quickly through durable structural heart interventional products are fuelling the structural heart devices global market.
As estimated by IQ4I Research, the structural heart devices global market is expected to reach $17,433.4 million by 2027 growing at a double digit CAGR from 2020 to 2027, due to elevating prevalence of various kinds of structural heart diseases, increasing expanded indication approval for various transcatheter structural heart products, persistently increasing geriatric population burdened with various kinds of degenerative valvular hear diseases, increasing demand for highly efficient, minimally invasive structural heart therapeutic products from the value centric patient population, increasing R&D spending for developing innovative and technologically advanced products, growing economies and increasing demand for better healthcare facilities in emerging markets. The structural heart devices market is segmented by product (product type), indication and geography.
Based on the product, the structural heart devices global market is segmented into structural heart repair and structural heart replacement devices. Among these products, structural heart replacement segment is the largest product segment in 2020 and is expected to grow at a double digit CAGR from 2020 to 2027. Structural heart repair devices segment is the fastest emerging segment growing at a low teen CAGR from 2020 to 2027. Among the various structural heart repair products like Annuloplasty repair devices, valvuloplasty devices, occluders, Transcatheter mitral valve repair devices and other repair devices like chordal implants, transcatheter mitral valve repair product segment accounted for the largest revenue in 2020 and is expected to grow at a mid teen CAGR from 2020 to 2027. Other structural heart repair device segment is the fastest emerging segment and is expected to exhibit exponential growth during the forecasted period. Among the structural heart replacement devices, Transcatheter valve replacement device segment accounted for the largest revenue in 2020 and is expected to grow at mid teen CAGR from 2020 to 2027. In the surgical valve replacement device global market by product type, tissue valve segment accounted for the largest revenue of in 2020. Among the Transcatheter valve replacement devices, Transcatheter aortic valve replacement (TAVR) device segment holds the largest share in 2020 and is expected to grow at low teen CAGR from 2020 to 2027 while Transcatheter mitral valve replacement (TMVR) product segment is the fastest emerging segment and is expected to show an exponential growth during the forecasted period.
Based on the indication, the structural heart devices global market is segmented into heart valve diseases, congenital heart diseases and other structural heart diseases. Among these, the heart valve disease segment commanded the largest revenue in 2020 and is expected to grow at a low teen CAGR from 2020 to 2027. Among the various heart valve diseases, aortic valve disease segment holds the largest share in 2020 and is expected to grow at a double digit CAGR from 2020 to 2027 while mitral valve disease segment is the fastest emerging segment and is expected to show mid teen CAGR during the forecasted period.
Based on the region, the structural heart devices global market is segmented into North America (U.S. and Rest of North America), Europe (Germany, France, Italy and Rest of Europe), Asia-Pacific (Japan, China, India, and Rest of APAC) and Rest of the world (Brazil, Turkey, Rest of Latin America and Middle East & Africa). North America accounted for the largest revenue in 2020 and is expected to grow at a double digit CAGR from 2020 to 2027 due to increasing prevalence of structural heart diseases, escalating geriatric population burdened with degenerative valvular heart diseases, increasing demand for highly efficient, durable, minimally invasive and technologically advanced structural heart therapeutic products from the value centric patient population, increasing R&D spending for developing innovative and technologically advanced products, substantial insurance coverage for the interventional procedures there.
The Asia-Pacific is the fastest growing region in structural heart devices market in 2020 and is expected to grow at a mid teen CAGR from 2020 to 2027 due to elevating structural heart disease burden in the region, escalating geriatric population, increasing demand for better healthcare facilities, increasing penetration of reimbursement schemes in developing countries, elevating demand for highly efficient and minimally invasive products from the value centric patient population, growing economies of the region, availability of various kinds of structural heart therapeutic products, increasing patient awareness of these products and increasing medical tourism prospects of the region.
The structural heart devices global market is consolidated with few companies dominating the market that offers fewer opportunities for entry for small and medium-sized companies with distinct products in the market. The top players in structural heart devices market are Edwards Lifesciences Corporation (U.S.), Medtronic PLC (Ireland), Abbott Laboratories (U.S.), Livanova PLC (U.K.), Boston Scientific Corporation (U.S.), Cryolife Inc. (U.S.), AtriCure, Inc. (U.S.), Venus Medtech (Hangzhou) Inc (China), Lifetech Scientific Corporation (China), NuMed Inc. (U.S.) and others.
The report provides an in-depth market analysis of the above-mentioned segments across the following regions:
• North America
o U.S.
o Rest of North America
• Europe
o Germany
o Italy
o France
o Rest of Europe
• Asia-Pacific
o Japan
o China
o India
o Rest of APAC
• Rest of the World (RoW)
o Brazil
o Turkey
o Rest of LATAM & MEA


1 EXECUTIVE SUMMARY 20

    2 INTRODUCTION 27

    • 2.1 KEY TAKEAWAYS 27
    • 2.2 SCOPE OF THE REPORT 28
    • 2.3 REPORT DESCRIPTION 28
    • 2.4 MARKETS COVERED 31
    • 2.5 STAKEHOLDERS 32
    • 2.6 RESEARCH METHODOLOGY 33
      • 2.6.1 MARKET SIZE ESTIMATION 34
      • 2.6.2 MARKET BREAKDOWN AND DATA TRIANGULATION 37
      • 2.6.3 SECONDARY SOURCES 38
      • 2.6.4 PRIMARY SOURCES 39
      • 2.6.5 KEY DATA POINTS FROM SECONDARY SOURCES 39
      • 2.6.6 KEY DATA POINTS FROM PRIMARY SOURCES 40
      • 2.6.7 ASSUMPTIONS 40

    3 MARKET ANALYSIS 44

    • 3.1 INTRODUCTION 44
    • 3.2 MARKET SEGMENTATION 46
    • 3.3 FACTORS INFLUENCING MARKET 48
      • 3.3.1 DRIVERS AND OPPORTUNITIES 49
        • 3.3.1.1 Increasing prevalence of structural heart diseases 49
        • 3.3.1.2 Increasing adoption of minimally invasive surgery for structural heart diseases 50
        • 3.3.1.3 Increasing expanded indication approval of tavr products 51
        • 3.3.1.4 Vast structural heart product pipeline and significant r&d investments 52
        • 3.3.1.5 Emergence of technologically advanced products 54
        • 3.3.1.6 Persistently escalating geriatric population with structural heart diseases 55
        • 3.3.1.7 Acquisitions to open an array of opportunities for the market to flourish 56
        • 3.3.1.8 Availability of advanced imaging techniques and increasing access to neonatal screening programs 57
      • 3.3.2 RESTRAINTS AND THREATS 58
        • 3.3.2.1 Lack of skilled and trained professionals 58
        • 3.3.2.2 High cost of the advanced structural heart devices 59
        • 3.3.2.3 Adverse effects of structural heart devices 60
        • 3.3.2.4 Unfavourable reimbursement policies in developing nations 61
        • 3.3.2.5 Stringent regulatory bodies guiding structural heart device manufacturers 62
    • 3.4 REGULATORY AFFAIRS 64
      • 3.4.1 INTERNATIONAL ORGANIZATION FOR STANDARDIZATION 64
        • 3.4.1.1 ISO 9001: 2015 quality management system 65
        • 3.4.1.2 ISO 14644-1 clean room standards 65
        • 3.4.1.3 ISO 13485 medical devices 65
        • 3.4.1.4 ISO 10993 biological evaluation of medical devices 66
        • 3.4.1.5 ISO 14971: risk management of medical devices 66
        • 3.4.1.6 ISO 5840 : heart valve validation 66
        • 3.4.1.7 IEC 60601-1 medical electrical equipment standard 67
        • 3.4.1.8 IEC 60601-1-11 home care safety 67
      • 3.4.2 ASTM INTERNATIONAL STANDARDS 67
      • 3.4.3 U.S. 67
      • 3.4.4 CANADA 69
      • 3.4.5 EUROPE 69
      • 3.4.6 JAPAN 70
      • 3.4.7 CHINA 71
      • 3.4.8 INDIA 73
    • 3.5 REIMBURSEMENT SCENARIO 74
    • 3.6 PATENT TRENDS 77
    • 3.7 TECHNOLOGICAL ADVANCEMENTS 78
      • 3.7.1 INTRODUCTION 78
      • 3.7.2 POLYMERIC HEART VALVES 79
      • 3.7.3 ULTRASOUND DEVICE FOR AORTIC STENOSIS 79
      • 3.7.4 BIODEGRADABLE OCCLUDERS 79
      • 3.7.5 VALVE IN VALVE PROCEDURE 80
      • 3.7.6 ADJUSTABLE ANNULOPLASTY RINGS 80
      • 3.7.7 SUTURELESS AORTIC VALVE SYSTEMS 81
    • 3.8 UPCOMING TECHNOLOGIES 81
      • 3.8.1 BIOENGINEERED LIVING OR REGENERATIVE HEART VALVES 81
      • 3.8.2 3-D BIOPRINTED HEART VALVE 82
    • 3.9 CLINICAL TRIALS 82
    • 3.10 FUNDING SCENARIO 87
    • 3.11 STRUCTURAL HEART DEVICES - PRODUCT PIPELINE ANALYSIS 90
    • 3.12 STRUCTURAL HEART DEVICE REGULATORY APPROVAL ANALYSIS 94
    • 3.13 PORTER’S FIVE FORCE ANALYSIS 100
      • 3.13.1 THREAT OF NEW ENTRANTS 101
      • 3.13.2 THREAT OF SUBSTITUTES 102
      • 3.13.3 BARGAINING POWER OF SUPPLIERS 103
      • 3.13.4 BARGAINING POWER OF BUYERS 103
      • 3.13.5 COMPETITIVE RIVALRY 104
    • 3.14 SUPPLY CHAIN ANALYSIS 105
    • 3.15 MARKET SHARE ANALYSIS BY MAJOR PLAYERS 110
      • 3.15.1 STRUCTURAL HEART DEVICES GLOBAL MARKET SHARE ANALYSIS 110
      • 3.15.2 MARKET SHARE ANALYSIS OF ANNULOPLASTY REPAIR DEVICES BY MAJOR PLAYERS 113
      • 3.15.3 MARKET SHARE ANALYSIS OF OCCLUDERS BY MAJOR PLAYERS 115
      • 3.15.4 MARKET SHARE ANALYSIS OF MECHANICAL VALVE REPLACEMENT DEVICES BY MAJOR PLAYERS 118
      • 3.15.5 MARKET SHARE ANALYSIS OF TISSUE VALVE REPLACEMENT DEVICES BY MAJOR PLAYERS 120
      • 3.15.6 MARKET SHARE ANALYSIS OF TRANSCATHETER AORTIC VALVE REPLACEMENT BY MAJOR PLAYERS 123
        • 3.15.6.1 Global TAVR devices market share analysis, by key players 2020 (%) 123
        • 3.15.6.2 Europe TAVR devices market share analysis, by key players 2020 (%) 126
        • 3.15.6.3 U.S. TAVR devices market share analysis, by key players 2020 (%) 129
      • 3.15.7 MARKET SHARE ANALYSIS OF VALVULOPLASTY REPAIR DEVICES BY MAJOR PLAYERS 131
    • 3.16 STRUCTURAL HEART DEVICES MARKET PENETRATION, PREVALENCE, OPPORTUNITY AND NUMBER OF PROCEDURES PERFORMED 133
    • 3.17 STRUCTURAL HEART DEVICES NUMBER OF UNITS BY REGION 141
      • 3.17.1 OCCLUDERS NUMBER OF UNITS BY REGION 141
      • 3.17.2 TRANSCATHETER MITRAL VALVE REPAIR DEVICES NUMBER OF UNITS BY REGION 142
      • 3.17.3 SURGICAL VALVE REPAIR - ANNULOPLASTY DEVICES NUMBER OF UNITS BY REGION 143
      • 3.17.4 TRANSCATHETER AORTIC VALVE REPLACEMENT (TAVR) DEVICES NUMBER OF UNITS BY REGION 144
      • 3.17.5 TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR) DEVICES NUMBER OF UNITS BY REGION 145
      • 3.17.6 TRANSCATHETER PULMONARY VALVE REPLACEMENT (TPVR) DEVICES NUMBER OF UNITS BY REGION 146
    • 3.18 TAVR CENTERS 147
    • 3.19 STRUCTURAL HEART DEVICES COMPANY COMPARISON TABLE BY PRODUCTS 148
      • 3.19.1 TRANSCATHETER HEART VALVE COMPANY COMPARISON TABLE BY PRODUCT AND INDICATION 148
      • 3.19.2 OCCLUDERS COMPANY COMPARISON TABLE BY PRODUCTS AND INDICATION 150
      • 3.19.3 VALVULOPLASTY COMPANY COMPARISON TABLE BY PRODUCTS AND INDICATION 154
      • 3.19.4 ANNULOPLASTY COMPANY COMPARISON TABLE BY PRODUCTS AND INDICATION 156
      • 3.19.5 MECHANICAL HEART VALVES COMPANY COMPARISON TABLE BY PRODUCTS AND INDICATION 158
      • 3.19.6 TISSUE HEART VALVES COMPANY COMPARISON TABLE BY PRODUCTS AND INDICATION 159

    4 STRUCTURAL HEART DEVICES GLOBAL MARKET, BY PRODUCT 161

    • 4.1 INTRODUCTION 161
    • 4.2 STRUCTURAL HEART REPAIR DEVICES 165
      • 4.2.1 ANNULOPLASTY REPAIR DEVICES 170
      • 4.2.2 VALVULOPLASTY 174
      • 4.2.3 OCCLUDERS 176
      • 4.2.4 TRANSCATHETER MITRAL VALVE REPAIR DEVICES 179
      • 4.2.5 OTHER STRUCTURAL HEART REPAIR DEVICES 182
    • 4.3 STRUCTURAL HEART VALVE REPLACEMENT DEVICES 185
      • 4.3.1 INTRODUCTION 185
      • 4.3.2 SURGICAL VALVE REPLACEMENT DEVICES 190
        • 4.3.2.1 Mechanical heart valves 194
        • 4.3.2.2 Tissue heart valves (biological valves) 197
      • 4.3.3 TRANSCATHETER VALVE REPLACEMENT DEVICES 199
        • 4.3.3.1 Transcatheter aortic valve replacement (TAVR) 203
        • 4.3.3.2 Transcatheter mitral valve replacement (TMVR) 206
        • 4.3.3.3 Transcatheter pulmonary valve replacement (TPVR) 208

      5 STRUCTURAL HEART DEVICES GLOBAL MARKET, BY INDICATION 210

      • 5.1 INTRODUCTION 210
      • 5.2 HEART VALVE DISEASES 213
        • 5.2.1 MITRAL VALVE DISEASES 218
        • 5.2.2 AORTIC VALVE DISEASES 221
        • 5.2.3 OTHER HEART VALVE DISEASES 224
      • 5.3 CONGENITAL HEART DISEASES 226
      • 5.4 OTHER STRUCTURAL HEART DISEASES 231

      6 REGIONAL ANALYSIS 234

      • 6.1 INTRODUCTION 234
      • 6.2 NORTH AMERICA 238
        • 6.2.1 U.S. 254
        • 6.2.2 REST OF NORTH AMERICA 258
      • 6.3 EUROPE 263
        • 6.3.1 GERMANY 280
        • 6.3.2 ITALY 284
        • 6.3.3 FRANCE 287
        • 6.3.4 REST OF EUROPE 290
      • 6.4 APAC 295
        • 6.4.1 JAPAN 312
        • 6.4.2 CHINA 316
        • 6.4.3 INDIA 321
        • 6.4.4 REST OF APAC 326
      • 6.5 ROW 331
        • 6.5.1 BRAZIL 347
        • 6.5.2 TURKEY 351
        • 6.5.3 REST OF LATAM & MEA 354

      7 COMPETITIVE LANDSCAPE 360

      • 7.1 INTRODUCTION 360
      • 7.2 PRODUCT APPROVALS 362
      • 7.3 ACQUISITIONS 368
      • 7.4 PRODUCT LAUNCH 370
      • 7.5 PARTNERSHIPS 371
      • 7.6 OTHER DEVELOPMENTS 372

      8 MAJOR COMPANIES 374

      • 8.1 ABBOTT LABORATORIES 374
        • 8.1.1 OVERVIEW 374
        • 8.1.2 FINANCIALS 375
        • 8.1.3 PRODUCT PORTFOLIO 379
        • 8.1.4 KEY DEVELOPMENTS 380
        • 8.1.5 BUSINESS STRATEGY 382
        • 8.1.6 SWOT ANALYSIS 383
      • 8.2 ATRICURE, INC. 384
        • 8.2.1 OVERVIEW 384
        • 8.2.2 FINANCIALS 385
        • 8.2.3 PRODUCT PORTFOLIO 388
        • 8.2.4 KEY DEVELOPMENTS 388
        • 8.2.5 BUSINESS STRATEGY 389
        • 8.2.6 SWOT ANALYSIS 390
      • 8.3 BOSTON SCIENTIFIC CORPORATION 391
        • 8.3.1 OVERVIEW 391
        • 8.3.2 FINANCIALS 392
        • 8.3.3 PRODUCT PORTFOLIO 396
        • 8.3.4 KEY DEVELOPMENTS 397
        • 8.3.5 BUSINESS STRATEGY 398
        • 8.3.6 SWOT ANALYSIS 399
      • 8.4 CRYOLIFE, INC. 400
        • 8.4.1 OVERVIEW 400
        • 8.4.2 FINANCIALS 401
        • 8.4.3 PRODUCT PORTFOLIO 405
        • 8.4.4 KEY DEVELOPMENTS 406
        • 8.4.5 BUSINESS STRATEGY 406
        • 8.4.6 SWOT ANALYSIS 407
      • 8.5 EDWARDS LIFESCIENCES CORPORATION 408
        • 8.5.1 OVERVIEW 408
        • 8.5.2 FINANCIALS 409
        • 8.5.3 PRODUCT PORTFOLIO 412
        • 8.5.4 KEY DEVELOPMENTS 413
        • 8.5.5 BUSINESS STRATEGY 415
        • 8.5.6 SWOT ANALYSIS 416
      • 8.6 LIFETECH SCIENTIFIC CORPORATION 417
        • 8.6.1 OVERVIEW 417
        • 8.6.2 FINANCIALS 418
        • 8.6.3 PRODUCT PORTFOLIO 421
        • 8.6.4 KEY DEVELOPMENTS 421
        • 8.6.5 BUSINESS STRATEGY 422
        • 8.6.6 SWOT ANALYSIS 423
      • 8.7 LIVANOVA PLC 424
        • 8.7.1 OVERVIEW 424
        • 8.7.2 FINANCIALS 425
        • 8.7.3 PRODUCT PORTFOLIO 429
        • 8.7.4 KEY DEVELOPMENTS 430
        • 8.7.5 BUSINESS STRATEGY 431
        • 8.7.6 SWOT ANALYSIS 432
      • 8.8 MEDTRONIC PUBLIC LIMITED COMPANY 433
        • 8.8.1 OVERVIEW 433
        • 8.8.2 FINANCIALS 434
        • 8.8.3 PRODUCT PORTFOLIO 438
        • 8.8.4 KEY DEVELOPMENTS 439
        • 8.8.5 BUSINESS STRATEGY 440
        • 8.8.6 SWOT ANALYSIS 441
      • 8.9 NUMED INC. 442
        • 8.9.1 OVERVIEW 442
        • 8.9.2 FINANCIALS 442
        • 8.9.3 PRODUCT PORTFOLIO 442
        • 8.9.4 KEY DEVELOPMENTS 444
        • 8.9.5 BUSINESS STRATEGY 444
        • 8.9.6 SWOT ANALYSIS 445
      • 8.10 VENUS MEDTECH (HANGZHOU) INC. 446
        • 8.10.1 OVERVIEW 446
        • 8.10.2 FINANCIALS 447
        • 8.10.3 PRODUCT PORTFOLIO 450
        • 8.10.4 KEY DEVELOPMENTS 450
        • 8.10.5 BUSINESS STRATEGY 451

    Summary:
    Get latest Market Research Reports on Structural Heart Devices . Industry analysis & Market Report on Structural Heart Devices is a syndicated market report, published as Structural Heart Devices Global Market – Forecast To 2027. It is complete Research Study and Industry Analysis of Structural Heart Devices market, to understand, Market Demand, Growth, trends analysis and Factor Influencing market.

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