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Structural Heart Devices Global Market – Forecast To 2022

  • March 2016
  • -
  • IQ4I Research & Consultancy Pvt. Ltd
  • -
  • 233 pages

Structural heart devices has emerged as a new focus area of medical device manufacturers as the population of most developed and developing countries continue to become older and risk of cardiovascular diseases increase with aging. The cardiovascular diseases which also include structural heart diseases have become leading cause of death. It is projected that, with newfound prosperity due to globalization and industrialization has led to changing lifestyle increasing risk of younger people developing cardiovascular diseases. The increased interest has led to development of new technologies and devices that are less invasive and address the need of treatment of patients who are considered too weak to withstand the trauma of an open heart surgery.

According to IQ4I analysis, the structural heart devices global market is valued to be $XX million in 2015 and poised to grow at a double digit CAGR to reach $8,792.0 million by 2022. The structural heart device market is classified based on type, end-users and geography. The structural heart device market by type is segmented into repair and replacement markets base on the type of procedure performed. The repair segment is further sub segmented into annuloplasty, valvuloplasty and Transcatheter mitral valve repair (TMVR). The replacement segment is further segmented by technique into surgical valves and Transcatheter aortic valves replacement (TAVR). The surgical valve is sub-segmented as mechanical and tissue heart valves.

The structural heart devices end-user market is segmented into public and private hospitals based on location where the procedures are performed.
Finally, the structural heart devices market is classified by geographical regions into North America, Europe, Asia-pacific and Rest of the World.

Table Of Contents

Structural Heart Devices Global Market - Forecast To 2022

1 EXECUTIVE SUMMARY 19
2 INTRODUCTION 23
2.1 KEY TAKE AWAYS 23
2.2 REPORT DESCRIPTION 23
2.3 MARKETS COVERED 24
2.4 STAKEHOLDERS 25
2.5 RESEARCH METHODOLOGY 26
2.5.1 MARKET SIZE ESTIMATION 28
2.5.2 MARKET CRACKDOWN AND DATA TRIANGULATION 30
2.5.3 SECONDARY SOURCES 31
2.5.4 PRIMARY SOURCES 32
2.5.5 KEY DATA POINTS FROM SECONDARY SOURCES 32
2.5.6 KEY DATA POINTS FROM PRIMARY SOURCES 33
2.5.7 ASSUMPTIONS 33
3 MARKET ANALYSIS 35
3.1 INTRODUCTION 35
3.2 MARKET SEGMENTATION 36
3.3 FACTORS INFLUENCING MARKET 37
3.3.1 DRIVERS AND OPPORTUNTIES 38
3.3.1.1 Prevalence of heart valve disorders due to aging population 38
3.3.1.2 Technology advancements and growing healthcare budgetary
allocation 38
3.3.1.3 Demand for minimally invasive surgery 39
3.3.2 RESTRAINTS AND THREATS 39
3.3.2.1 Strict regulatory requirements with high cost of development 39
3.3.2.2 Lack of patient awareness and healthcare infrastructure in developing countries 40
3.3.2.3 High cost of devices and procedure 41
3.3.3 BURNING ISSUE 41
3.3.3.1 Lack of trained professionals 41
3.4 REGULATORY AFFAIRS 41
3.4.1 U.S. 42
3.4.2 EUROPE 42
3.4.3 CHINA 43
3.4.4 CANADA 44
3.4.5 INDIA 44
3.4.6 JAPAN 45
3.5 REIMBURSEMENT SCENARIO 46
3.6 CPT CODES 46
3.7 PATENT TRENDS 50
3.8 TECHNOLOGICAL ADVANCEMENTS 51
3.8.1 TISSUE ENGINEERING 51
3.8.2 POLYMERIC HEART VALVES 52
3.8.3 SUTURELESS AORTIC VALVE REPLACEMENT (SU-AVR) SYSTEM 53
3.8.4 CARDIAC OR VENTRICULAR REMODELING 53
3.8.5 ENDOSCOPIC AORTIC VALVE REPLACEMENT (TEAVR) SYSTEM 54
3.8.6 3-D PRINTED MODEL 54
3.9 UPCOMING TECHNOLOGIES 55
3.10 CLINICAL TRIALS 66
3.11 PORTER'S FIVE FORCE ANALYSIS 78
3.11.1 THREAT OF NEW ENTRANTS 79
3.11.2 THREAT OF SUBSTITUTES 79
3.11.3 BARGAINING POWER OF SUPPLIERS 79
3.11.4 BARGAINING POWER OF BUYERS 80
3.11.5 RIVALRY AMONG EXISTING COMPETITORS 80
3.12 MARKET SHARE ANALYSIS BY MAJOR PLAYERS 81
4 STRUCTURAL HEART DEVICES GLOBAL MARKET, BY TYPE 83
4.1 INTRODUCTION 83
4.2 STRUCTURAL HEART REPAIR DEVICES 86
4.2.1 ANNULOPLASTY 90
4.2.2 VALVULOPLASTY 93
4.2.3 TRANSCATHETER MITRAL VALVE REPAIR (TMVR) 96
4.3 STRUCTURAL HEART REPLACEMENT VALVES 99
4.3.1 INTRODUCTION 99
4.3.2 SURGICAL HEART VALVE REPLACEMENT 103
4.3.2.1 Mechanical replacement heart valves 107
4.3.2.2 Biological replacement heart valves (Tissue valves) 109
4.3.3 TRANSCATHETER AORTIC VALVE REPLACEMENT(TAVR) 112
4.3.4 TRANSCATHETER MITRAL VALVE REPLACEMENT (TMVR)** 115
5 STRUCTURAL HEART DEVICES GLOBAL MARKET, BY END-USERS 116
5.1 INTRODUCTION 116
5.2 PUBLIC HOSPITALS 119
5.3 PRIVATE HOSPITALS 120
6 REGIONAL ANALYSIS 121
6.1 INTRODUCTION 121
6.2 NORTH AMERICA 124
6.2.1 U.S. 124
6.3 EUROPE 131
6.4 ASIA PACIFIC 138
6.4.1 INDIA 138
6.4.2 CHINA 138
6.5 REST OF THE WORLD 145
7 COMPANY DEVELOPMENTS 151
7.1 INTRODUCTION 151
7.2 APPROVALS 152
7.3 MERGERS and ACQUISITIONS 161
7.4 NEW PRODUCT LAUNCHES 162
7.5 AGREEMENTS and COLLOBORATIONS 164
8 MAJOR COMPANIES 165
8.1 ABBOTT LABORATORIES 165
8.1.1 OVERVIEW 165
8.1.2 FINANCIALS 166
8.1.3 PRODUCT PORTFOLIO 168
8.1.4 KEY DEVELOPMENTS 169
8.1.5 BUSINESS STRATEGY 170
8.1.6 SWOT ANALYSIS 171
8.2 BOSTON SCIENTIFIC CORPOARTION 172
8.2.1 OVERVIEW 172
8.2.2 FINANCIALS 173
8.2.3 PRODUCT PORTFOLIO 176
8.2.4 KEY DEVELOPMENTS 177
8.2.5 BUSINESS STRATEGY 178
8.2.6 SWOT ANALYSIS 179
8.3 BRAILE BIOMEDICA 180
8.3.1 OVERVIEW 180
8.3.2 FINANCIALS 180
8.3.3 PRODUCT PORTFOLIO 181
8.3.4 KEY DEVELOPMENTS 181
8.3.5 BUSINESS STRATEGY 182
8.3.6 SWOT ANALYSIS 182
8.4 CRYOLIFE, INC. 183
8.4.1 OVERVIEW 183
8.4.2 FINANCIALS 184
8.4.3 PRODUCT PORTFOLIO 187
8.4.4 KEY DEVELOPMENTS 188
8.4.5 BUSINESS STRATEGY 190
8.4.6 SWOT ANALYSIS 190
8.5 EDWARDS LIFESCIENCES CORP. 191
8.5.1 OVERVIEW 191
8.5.2 FINANCIALS 192
8.5.3 PRODUCT PORTFOLIO 195
8.5.4 KEY DEVELOPMENTS 196
8.5.5 BUSINESS STRATEGY 198
8.5.6 SWOT ANALYSIS 199
8.6 JENAVALVE TECHNOLOGY 200
8.6.1 OVERVIEW 200
8.6.2 FINANCIALS 200
8.6.3 PRODUCT PORTFOLIO 201
8.6.4 KEY DEVELOPMENTS 201
8.6.5 BUSINESS STRATEGY 202
8.6.6 SWOT ANALYSIS 202
8.7 LEPU MEDICAL TECHNOLOGY(BEIJING) CO., LTD. 203
8.7.1 OVERVIEW 203
8.7.2 FINANCIALS 203
8.7.3 PRODUCT PORTFOLIO 204
8.7.4 KEY DEVELOPMENTS 204
8.7.5 BUSINESS STRATEGY 205
8.7.6 SWOT ANALYSIS 206
8.8 LIVANOVA PLC (SORIN GROUP) 207
8.8.1 OVERVIEW 207
8.8.2 FINANCIALS 208
8.8.3 PRODUCT PORTFOLIO 212
8.8.4 KEY DEVELOPMENTS 213
8.8.5 BUSINESS STRATEGY 215
8.8.6 SWOT ANALYSIS 215
8.9 MEDTRONIC, PLC 216
8.9.1 OVERVIEW 216
8.9.2 FINANCIALS 217
8.9.3 PRODUCT PORTFOLIO 221
8.9.4 KEY DEVELOPMENTS 222
8.9.5 BUSINESS STRATEGY 223
8.9.6 SWOT ANALYSIS 224
8.10 ST. JUDE MEDICAL, INC. 225
8.10.1 OVERVIEW 225
8.10.2 FINANCIALS 226
8.10.3 PRODUCT PORTFOLIO 229
8.10.4 KEY DEVELOPMENTS 230
8.10.5 BUSINESS STRATEGY 231
8.10.6 SWOT ANALYSIS 232

LIST OF TABLES

TABLE 1 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 22
TABLE 2 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY TYPE,
(2014-2022) ($MN) 84
TABLE 3 STRUCTURAL HEART REPAIR DEVICES GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 87
TABLE 4 STRUCTRAL HEART DEVICES REPAIR GLOBAL MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 88
TABLE 5 ANNULOPLASTY GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 91
TABLE 6 VALVULOPLASTY GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 94
TABLE 7 TMVR GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 97
TABLE 8 STRUCTURAL HEART REPLACEMENT DEVICES GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 100
TABLE 9 STRUCTURAL HEART DEVICES REPLACEMENT GLOBAL MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 101
TABLE 10 SURGICAL HEART VALVE REPLACEMENT GLOBAL MARKET REVENUE,
BY TYPE, (2014-2022) ($MN) 104
TABLE 11 SURGICAL VALVE REPLACEMENT GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 105
TABLE 12 MECHANICAL REPLACEMENT HEART VALVE GLOBAL MARKET REVENUE,
BY REGION, (2014-2022) ($MN) 108
TABLE 13 BIOLOGICAL REPLACEMENT HEART VALVE GLOBAL MARKET REVENUE,
BY GEOGRAPHY, (2014-2022) ($MN) 110
TABLE 14 TAVR GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 113
TABLE 15 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY END-USER, (2014-2022) ($MN) 117
TABLE 16 PUBLIC HOSPITALS GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 119
TABLE 17 PRIVATE HOSPITALS GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 120
TABLE 18 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 123
TABLE 19 NORTH AMERICAN STRUCTURAL HEART DEVICES MARKET REVENUE,
BY TYPE (2014-2022) ($MN) 125
TABLE 20 NORTH AMERICAN STRUCTURAL HEART DEVICES REPAIR MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 126
TABLE 21 NORTH AMERICAN STRUCTURAL HEART DEVICES REPLACEMENT MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 127
TABLE 22 NORTH AMERICAN STRUCTURAL HEART SURGICAL REPLACEMENT MARKET, BY TYPE, (2014-2022) ($MN) 128
TABLE 23 NORTH AMERICAN STRUCTURAL HEART DEVICES MARKET REVENUE,
BY END-USERS, (2014-2022) ($MN) 129
TABLE 24 EUROPEAN STRUCTURAL HEART DEVICES MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 132
TABLE 25 EUROPEAN STRUCTURAL HEART DEVICES REPAIR MARKET REVENUE,
BY TYPE, (2014-2022) ($MN) 133
TABLE 26 EUROPEAN STRUCTURAL HEART DEVICES REPLACEMENT MARKET, BY TYPE, (2014-2022) ($MN) 134
TABLE 27 EUROPEAN STRUCTURAL HEART SURGICAL REPLACEMENT MARKET,
BY TYPE, (2014-2022) ($MN) 135
TABLE 28 EUROPEAN STRUCTURAL HEART DEVICES MARKET REVENUE,
BY END-USERS, (2014-2022) ($MN) 136
TABLE 29 ASIA-PACIFIC STRUCTURAL HEART DEVICES MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 139
TABLE 30 ASIA-PACIFIC STRUCTURAL HEART DEVICES REPAIR MARKET REVENUE,
BY TYPE, (2014-2022) ($MN) 140
TABLE 31 ASIA-PACIFIC STRUCTURAL HEART REPLACEMENT MARKET, BY TYPE, (2014-2022) ($MN) 141
TABLE 32 ASIA-PACIFIC STRUCTURAL HEART DEVICES SURGICAL REPLACEMENT MARKET, BY TYPE, (2014-2022) ($MN) 142
TABLE 33 ASIA-PACIFIC STRUCTURAL HEART DEVICES MARKET REVENUE,
BY END-USERS, (2014-2022) ($MN) 143
TABLE 34 REST OF THE WORLD STRUCTURAL HEART DEVICES MARKET REVENUE,
BY TYPE (2014-2022) ($MN) 145
TABLE 35 REST OF THE WORLD STRUCTURAL HEART DEVICES REPAIR MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 146
TABLE 36 REST OF THE WORLD STRUCTURAL HEART REPLACEMENT MARKET,
BY TYPE, (2014-2022) ($MN) 147
TABLE 37 REST OF THE WORLD STRUCTURAL HEART DEVICES SURGICAL REPLACEMENT MARKET, BY TYPE, (2014-2022) ($MN) 148
TABLE 38 REST OF THE WORLD STRUCTURAL HEART DEVICES MARKET REVENUE,
BY END-USERS, (2014-2022) ($MN) 149
TABLE 39 APPROVALS (2013-2016) 153
TABLE 40 MERGERS and ACQUISTIONS (2013-2016) 161
TABLE 41 NEW PRODUCT LAUNCHES (2013-2016) 163
TABLE 42 AGREEMENT AND COLLABORATION (2013-2016) 164
TABLE 43 ABBOTT LABORATORIES: TOTAL REVENUE AND RandD EXPENSES,
(2013-2015) ($MN) 166
TABLE 44 ABBOTT LABORATORIES: TOTAL REVENUE BY SEGMENTS, (2013-15) ($MN) 167
TABLE 45 ABBOTT LABORATORIES: TOTAL REVENUE BY GEOGRAPHY,
(2013-2015) ($MN) 168
TABLE 46 BOSTON SCIENTIFIC CORPORATION: TOTAL REVENUE AND RandD EXPENSES, (2013-2015) ($MN) 173
TABLE 47 BOSTON SCIENTIFIC CORPORATION: TOTAL REVENUE BY SEGMENTS, (2013-2015) ($MN) 174
TABLE 48 BOSTON SCIENTIFIC CORPORATION: CARDIOVASCULAR, BY SEGMNETS, (2013-2015) ($MN) 175
TABLE 49 BOSTON SCIENTIFIC CORPORATION: TOTAL REVENUE BY GEOGRAPHY, (2013-2015) ($MN) 176
TABLE 50 CRYOLIFE, INC.: TOTAL REVENUE AND RandD EXPENSES, (2013-2015) ($MN) 184
TABLE 51 CRYOLIFE, INC.: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN) 185
TABLE 52 CRYOLIFE, INC.: PRESERVATION SERVICES, BY SUB-SEGMENTS,
(2013-2015) ($MN) 186
TABLE 53 CRYOLIFE, INC: TOTAL REVENUE, BY GEOGRAPHY (2013-2015) ($MN) 187
TABLE 54 EDWARDS LIFESCIENCES CORP.: TOTAL REVENUE AND RandD EXPENSES, (2013-2015) ($MN) 192
TABLE 55 EDWARDS LIFESCIENCES CORP.: TOTAL REVENUE, BY SEGMENTS,
(2013-2015) ($MN) 193
TABLE 56 EDWARDS LIFESCIENCES CORP.: TOTAL REVENUE, BY GEOGRAPHY,
(2013-2015) ($MN) 194
TABLE 57 LIVANOVA PLC: TOTAL REVENUE AND RandD EXPENSES (2013-2015) ($MN) 208
TABLE 58 LIVANOVA PLC: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN) 209
TABLE 59 LIVANOVA PLC: CARDIAC SURGERY REVENUE, BY SUB-SEGMENTS,
(2013-2015) ($MN) 210
TABLE 60 LIVANOVA PLC: TOTAL REVENUE, BY GEOGRAPHY, (2013-2015) ($MN) 211
TABLE 61 MEDTRONIC, PLC : TOTAL REVENUE AND RandD EXPENSES,
(2013-2015) ($MN) 217
TABLE 62 MEDTRONIC, PLC: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN) 218
TABLE 63 MEDTRONIC, PLC: CARDIAC and VASCULAR REVENUE, BY SUB-SEGMENTS, (2013-2015) ($MN) 219
TABLE 64 MEDTRONIC, PLC: TOTAL REVENUE, BY GEOGRAPHY, (2013-2015) ($MN) 220
TABLE 65 ST. JUDE MEDICAL: TOTAL REVENUE AND RandD EXPENSES,
(2013-2015) ($MN) 226
TABLE 66 ST. JUDE MEDICAL: TOTAL REVENUE BY SEGMENTS, (2013-2015) ($MN) 227
TABLE 67 ST. JUDE MEDICAL: TOTAL REVENUE BY GEOGRAPHY, (2013-2015) ($MN) 228
























LIST OF FIGURES


FIGURE 1 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY GEOGRAPHY, (2014-2022) ($MN) 21
FIGURE 2 STRUCTURAL HEART DEVICES GLOBAL MARKET: RESEARCH APPROACH 27
FIGURE 3 STRUCTURAL HEART DEVICES GLOBAL MARKET: TOP-DOWN AND BOTTOM-UP APPROACH 28
FIGURE 4 STRUCTURAL HEART DEVICES GLOBAL MARKET: FORECASTING MODEL 29
FIGURE 5 STRUCTURAL HEART DEVICES GLOBAL MARKET: MARKET CRACKDOWN AND DATA TRIANGULATION 30
FIGURE 6 STRUCTURAL HEART DEVICES GLOBAL MARKET: MARKET SEGMENTATION 36
FIGURE 7 MARKET DYNAMICS 37
FIGURE 8 STRUCTURAL HEART DEVICES GLOBAL MARKET: PATENT FILING BY MAJOR PLAYERS (2011-2015) 50
FIGURE 9 STRUCTURAL HEART DEVICES GLOBAL MARKET: PORTER'S ANALYSIS 78
FIGURE 10 STRUCTURAL HEART DEVICES GLOBAL MARKET SHARE ANALYSIS,
BY MAJOR PLAYERS, 2015 (%) 81
FIGURE 11 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY TYPE,
(2014-2022) ($MN) 85
FIGURE 12 STRUCTURAL HEART DEVICES REPAIR GLOBAL MARKET REVENUE,
BY TYPE, (2014-2022) 89
FIGURE 13 ANNULOPLASTY GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 92
FIGURE 14 VAVULOPLASTY GLOBAL MARKET REVENUE, BY REGION,
(2014-2022) ($MN) 95
FIGURE 15 TMVR GLOBAL MARKET REVENUE, BY REGION, (2015 V'S 2022) ($MN) 98
FIGURE 16 STRUCTURAL HEART DEVICES REPLACEMENT GLOBAL MARKET REVENUE, BY TYPE, (2014-2022) ($MN) 102
FIGURE 17 SURGICAL VALVE REPLACEMENT GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN) 106
FIGURE 18 BIOLOGICAL REPLACEMENT HEART VALVE REPLACEMENT GLOBAL MARKET REVENUE, BY REGION, (2015 V'S 2022) ($MN) 111
FIGURE 19 TAVR GLOBAL MARKET REVENUE, BY REGION, (2015 V'S 2022) ($MN) 114
FIGURE 20 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY END-USER, (2014-2022) ($MN) 118
FIGURE 21 STRUCTURAL HEART DEVICES GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN), CAGR (%) 122
FIGURE 22 NORTH AMERICAN STRUCTURAL HEART DEVICES MARKET SIZE, BY REPAIR, REPLACEMENT and END-USERS, (2014-2022) ($MN) 130
FIGURE 23 EUROPEAN STRUCTURAL HEART DEVICES MARKET SIZE, BY REPAIR, REPLACEMENT and END-USERS, (2014-2022) ($MN) 137
FIGURE 24 ASIA-PACIFIC STRUCTURAL HEART DEVICES MARKET SIZE, BY REPAIR, REPLACEMENT and END-USERS (2014-2022) ($MN) 144
FIGURE 25 REST OF THE WORLD STRUCTURAL HEART DEVICES MARKET SIZE,
BY REPAIR, REPLACEMENT and END-USERS, (2014-2022) ($MN) 150
FIGURE 26 KEY GROWTH STRATEGIES (2013-2016) 152
FIGURE 27 SWOT: ABBOTT LABORATORIES 171
FIGURE 28 SWOT: BOSTON SCIENTIFIC CORPORATION 179
FIGURE 29 SWOT: BRAILE BIOMEDICA 182
FIGURE 30 SWOT: CRYOLIFE, INC 190
FIGURE 31 SWOT: EDWARDS LIFESCIENCES 199
FIGURE 32 SWOT: JENAVALVE TECHNOLOGY 202
FIGURE 33 SWOT: LEPU MEDICAL TECHNOLOGY CO., LTD. 206
FIGURE 34 SWOT: LIVANOVA, PLC 215
FIGURE 35 SWOT: MEDTRONIC, PLC 224
FIGURE 36 SWOT: ST. JUDE MEDICAL 232

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