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TAVR Market Analysis, Size, Trends | COVID19 | 2020-2026 | MedCore

  • Year: 2020
  • Scope: 2016-2026
  • Region: United States
  • Published Date: 10/08/2020
  • Type: MedCore

In 2020, the U.S. Transcatheter Aortic Valve Replacement (TAVR) market size was valued at almost $2.4 billion, with over 75,000 TAVR procedures performed annually. In spite of COVID19, the market size is expected to increase at a cumulative growth rate of 8.7% to reach almost $5 billion in 2026.

Throughout this medical market research, we analyzed 10 TAVR companies and potential competitors across the United States and used our comprehensive methodology to understand the market sizes, unit sales, company market shares, and to create accurate forecasts.

Our analysts meticulously researched for up to 3 to 4 months to put together a Cardiac Surgery and Heart Valve Device MedSuite, which is a comprehensive analysis of a group of healthcare markets. This MedCore is one portion of that analysis that focuses on the TAVR market segment and provides further detailed segmentation to get a much more granular set of market data.

DATA TYPES INCLUDED

  • Unit Sales, Average Selling Prices, Market Value & Growth Trends
  • Procedure Volumes for the TAVR market
  • Market Forecasts Until 2026, and Historical Data to 2016
  • Competitive Analysis with Market Shares for Each Segment
  • Market Drivers & Limiters for the Transcatheter Heart Valve Replacement market
  • Recent Mergers & Acquisitions
  • COVID19 Impact on the TAVR Market in the US
  • Disease Overviews and Demographic Information
  • Company Profiles, Product Portfolios and SWOT for Top Competitors

TAVR Market Insights

For decades, open heart surgical aortic valve replacement (SAVR) has been the standard treatment for severe aortic stenosis, but recently TAVR has rapidly replaced SAVR in high-risk patients as well as patients at moderate risk for surgery. This is due to clinical evidence showing equal or better patient outcomes compared to SAVR. Some patients with heart valve problems are poor candidates for invasive valve replacement surgery due to advanced age or pre-existing conditions.

Number of Procedures in TAVR Market

TAVR was FDA approved for inoperable patients in 2011, high-risk patients in 2012, and followed by approval for intermediate-risk patients in 2017. The recent approval of low-risk patients is set to propel the market even further as the potential patient cohort is greatly increased. However, many physicians are concerned about the long-term durability of valves and some of the possible safety concerns. For this reason, products such as the Boston Scientific’s Sentinel™ cerebral embolic protection device (CEPD) are expected to be adopted into TAVR procedures as a means of reducing ischemic stroke, one of the possible adverse effects of the surgery.

COVID19 Impact on the TAVR Market

The COVID-19 pandemic had a significant impact on the U.S. cardiac surgery market in the first half of 2020. While the invasive cardiac surgery market is likely to be impacted the most severely by COVID-19, the non-invasive markets, such as TAVR, balloon valvuloplasty, cerebral embolic protection and preshaped guidewire markets, are expected to be minimally impacted due to the nature of underlying procedures. Particularly, the US TAVR market is expected to decline by around 13% in 2020 and get back to pre-COVID19 levels in early 2021.

TAVR Market Share Insights

TAVR Market Share Leaders

By 2020, Edwards Lifesciences was the leading competitor in the TAVR market and was the first company to develop a percutaneous aortic valve replacement device. The second leading player within the TAVR market was Medtronic. After FDA expanded indications for transcatheter heart valves to include low-risk patients, both Edwards SAPIEN 3® and Medtronic’s CoreValve Evolut R® systems received approval for this indication on the same day.

The third-leading competitor within the US TAVR market was Boston Scientific and holds less than 5% of the overall market share. The company entered the TAVR market in April 2019 with its LOTUS Edge™ aortic valve system. However, unlike Medtronic and Edwards Lifesciences,  Boston Scientific’s device is currently approved for high-risk patients only.

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For a Full Table of Contents, please contact iData.

TABLE OF CONTENTS FOR THE US CARDIAC SURGERY MARKET REPORT SUITE

TABLE OF CONTENTS I
LIST OF FIGURES XVI
LIST OF CHARTS XXVII
EXECUTIVE SUMMARY 1
U.S. CARDIAC SURGERY AND HEART VALVE DEVICE MARKET OVERVIEW 1
COMPETITIVE ANALYSIS 4
MARKET TRENDS 8
MARKET DEVELOPMENTS 13
PROCEDURE NUMBERS 14
PROCEDURE CODES INVESTIGATED 18
MARKETS INCLUDED 19
KEY REPORT UPDATES 23
VERSION HISTORY 24
RESEARCH METHODOLOGY 25
Step 1: Project Initiation & Team Selection 25
Step 2: Prepare Data Systems and Perform Secondary Research 28
Step 3: Preparation for Interviews & Questionnaire Design 30
Step 4: Performing Primary Research 31
Step 5: Research Analysis: Establishing Baseline Estimates 33
Step 6: Market Forecast and Analysis 34
Step 7: Identify Strategic Opportunities 36
Step 8: Final Review and Market Release 37
Step 9: Customer Feedback and Market Monitoring 38

DISEASE OVERVIEW

2.1 BASIC ANATOMY 39
2.2 DISEASE TREATMENTS & DIAGNOSTICS
2.2.1 Coronary Artery Disease 41
2.2.2 Myocardial Infarction 41
2.2.3 Angina Pectoris 42
2.2.4 Heart Valve Disease 43
2.2.5 Congestive Heart Failure 43
2.2.6 Aortic Stenosis 44
2.2.7 Degenerative/Functional Mitral Regurgitation 46
2.3 PATIENT DEMOGRAPHICS 47
2.3.1 General Statistics 47

PRODUCT ASSESSMENT

3.1 INTRODUCTION 48
3.2 PRODUCT PORTFOLIOS 48
3.2.1 Tissue Heart Valve Device 48
3.2.2 Mechanical Heart Valve Device 51
3.2.3 Annuloplasty Repair Device 53
3.2.4 Transcatheter Mitral Valve Repair Device 55
3.2.5 Transcatheter Heart Valve Replacement Device 56
3.2.6 Cerebral Embolic Protection Device 58
3.2.7 Balloon Valvuloplasty Device 59
3.2.8 On-Pump Coronary Artery Bypass Device 60
3.2.9 Off-Pump Coronary Artery Bypass Device 62
3.2.10 Autotransfusion Device 63
3.2.11 Endoscopic Vessel Harvesting Device 65
3.2.12 Anastomosis Assist Device 66
3.2.13 Transmyocardial Revascularization Device 67
3.2.14 Ventricular Assist Device 68
3.2.15 Intra-Aortic Balloon Pump Device 69
3.2.16 Artificial Heart Replacement Device 70
3.2.17 Remote Hemodynamic Monitoring System Device 71
3.2.18 Patent Foramen Ovale Device 72
3.2.19 Patent Ductus Arteriosus Closure Device 73
3.2.20 Atrial & Ventricular Septal Defect Device 75
3.2.21 Left Atrial Appendage Closure Device 76
3.2.22 Preshaped Guidewires 77
3.3 REGULATORY ISSUES AND RECALLS 78
3.4 CLINICAL TRIALS 101
3.4.1 Abbott 101
3.4.2 CryoLife 105
3.4.3 Edwards LifeSciences 106
3.4.4 Medtronic 111

IMPACT OF COVID-19 ON U.S. CARDIAC SURGERY AND HEART VALVE DEVICE MARKET

4.1 INTRODUCTION 112
4.2 MULTI-SCENARIO ANALYSIS 115
4.2.1.1 Best Case Scenario 115
4.2.1.2 Base Case Scenario 118
4.2.1.3 Worst Case Scenario 121

U.S. CARDIAC SURGERY AND HEART VALVE DEVICE MARKET BY SEGMENT MARKET OVERVIEW

5.1 INTRODUCTION 125
5.2 MARKET OVERVIEW 127
5.3 TREND ANALYSIS BY SEGMENT 134
5.4 DRIVERS AND LIMITERS 139
5.4.1 Market Drivers 139
5.4.2 Market Limiters 140
5.5 COMPETITIVE MARKET SHARE ANALYSIS 142
5.6 MERGERS AND ACQUISITIONS 150
5.7 COMPANY PROFILES 153
5.7.1 Abbott 153
5.7.2 Abiomed 155
5.7.3 AtriCure 156
5.7.4 Boston Scientific 157
5.7.5 CryoLife 158
5.7.6 Edwards LifeSciences 159
5.7.7 LivaNova 160
5.7.8 Getinge 161
5.7.9 Medtronic 162
5.7.10 Teleflex 162
5.7.11 Terumo 164
5.8 SWOT ANALYSIS 165
5.8.1 Abbott 166
5.8.2 Abiomed 167
5.8.3 AtriCure 168
5.8.4 Boston Scientific 169
5.8.5 CryoLife 170
5.8.7 Edwards LifeSciences 171
5.8.8 LivaNova 172
5.8.10 Getinge 173
5.8.11 Medtronic 174
5.8.12 Teleflex 175
5.8.13 Terumo 176

PROCEDURE NUMBERS

6.1 INTRODUCTION 177
6.2 CARDIAC SURGERY AND HEART VALVE PROCEDURES 178
6.3 SURGICAL HEART VALVE REPLACEMENT PROCEDURES 183
6.3.1 Tissue Heart Valve Procedures by Valve Type 185
6.3.2 Tissue Heart Valve Procedures by Device Type 187
6.3.3 Tissue Heart Valve Procedures by Tissue Type 189
6.3.4 Mechanical Heart Valve Replacement Procedures by Valve Type 191
6.3.5 Mechanical Heart Valve Replacement Procedures by Tissue Type 193
6.4 ANNULOPLASTY REPAIR PROCEDURES 195
6.4.1 Annuloplasty Repair Procedures by Valve Type 195
6.4.2 Annuloplasty Repair Procedures by Device Type 197
6.5 TRANSCATHETER MITRAL VALVE REPAIR PROCEDURES 199
6.5.1 Transcatheter Mitral Valve Procedures by Approach 200
6.5.2 Transcatheter Mitral Valve Repair Procedures by Disease 202
6.6 TRANSCATHETER HEART VALVE REPLACEMENT PROCEDURES 204
6.6.1 Transcatheter Heart Valve Replacement Procedures by Valve Type 204
6.6.1.1 Transcatheter Aortic Valve Replacement (TAVR) Procedures by Approach 206
6.6.1.2 Transcatheter Aortic Valve Replacement (TAVR) Procedures by Patient Risk Class 208
6.6.1.3 Transcatheter Aortic Valve Replacement (TAVR) Procedures by Embolic Protection 210
6.6.1.4 Transcatheter Aortic Valve Replacement (TAVR) Procedures by Therapy 212
6.6.1.5 Transcatheter Aortic Valve Replacement (TAVR) Procedures by Location 214
6.7 BALLOON VALVULOPLASTY PROCEDURES 216
6.8 CABG PROCEDURES 218
6.8.1 CABG Procedures by Support Type 220
6.8.2 CABG Vessel Harvesting Procedures by Type 222
6.8.3 CABG Procedures by Suture Type 224
6.8.4 CABG Procedures by Approach 226
6.9 TRANSMYOCARDIAL REVASCULARIZATION PROCEDURES 229
6.10 VENTRICULAR ASSIST DEVICE PROCEDURES 231
6.10.1 Ventricular Assist Procedures by Device Type 231
6.10.1.1 Percutaneous Ventricular Assist Procedures by Heart Side 233
6.10.1.2 Percutaneous Ventricular Assist Procedures by Indication 235
6.10.1.3 Implantable Ventricular Assist Procedures by Indication 237
6.10.1.4 Implantable Ventricular Assist Procedures by Area 239
6.10.1.5 External Ventricular Assist Procedures by Device Type 241
6.11 INTRA-AORTIC BALLOON COUNTERPULSATION PROCEDURES 243
6.11.1 Intra-Aortic Balloon Counterpulsation Procedures by Setting 243
6.11.2 Intra-Aortic Balloon Counterpulsation Procedures by Device Type 245
6.12 HEART TRANSPLANT PROCEDURES 247
6.13 REMOTE HEMODYNAMIC MONITORING DEVICE IMPLANTATION PROCEDURES 249
6.14 PATENT FORAMEN OVALE CLOSURE PROCEDURES 251
6.15 PATENT DUCTUS ARTERIOSUS CLOSURE PROCEDURES 253
6.16 SEPTAL DEFECT CLOSURE PROCEDURES 255
6.16.1 Septal Defect Closure Procedures by Anatomy 255
6.17 LEFT ATRIAL APPENDAGE CLOSURE PROCEDURES 257
6.17.1 Left Atrial Appendage Closure Procedures by Type 258
6.17.1.1 Epicardial Device Procedures by Device Type 260
6.17.1.1.1 Epicardial Clip Device Procedures by Approach 262

TISSUE HEART VALVE MARKET

7.1 INTRODUCTION 264
7.2 MARKET OVERVIEW 266
7.2.1 Tissue Heart Valve Market by Device Type 267
7.2.2 Tissue Heart Valve Market by Tissue Type 271
7.3 MARKET ANALYSIS AND FORECAST 275
7.3.1 Total Tissue Heart Valve Market 275
7.3.2 Tissue Heart Valve Market by Device Type 277
7.3.2.1 Stented Tissue Heart Valve Market 277
7.3.2.2 Sutureless/Rapid Deployment Tissue Heart Valve Market 279
7.3.2.3 Stentless Tissue Heart Valve Market 281
7.3.3 Tissue Heart Valve Market by Tissue Type 283
7.3.3.1 Xenograft Tissue Heart Valve Market 283
7.3.3.2 Allograft Tissue Heart Valve Market 285
7.4 DRIVERS AND LIMITERS 287
7.4.1 Market Drivers 287
7.4.2 Market Limiters 287
7.5 COMPETITIVE MARKET SHARE ANALYSIS 289

MECHANICAL HEART VALVE MARKET

8.1 INTRODUCTION 292
8.2 MARKET OVERVIEW 293
8.3 MARKET ANALYSIS AND FORECAST 297
8.3.1 Total Mechanical Heart Valve Market 297
8.3.2 Mechanical Heart Valve without Conduit Market 299
8.3.3 Mechanical Heart Valve with Conduit Market 301
8.4 DRIVERS AND LIMITERS 303
8.4.1 Market Drivers 303
8.4.2 Market Limiters 304
8.5 COMPETITIVE MARKET SHARE ANALYSIS 305

ANNULOPLASTY REPAIR DEVICE MARKET

9.1 INTRODUCTION 308
9.2 MARKET OVERVIEW 310
9.3 MARKET ANALYSIS AND FORECAST 314
9.3.1 Total Annuloplasty Repair Device Market 314
9.3.2 Ring Device Market 316
9.3.3 Band Device Market 318
9.4 DRIVERS AND LIMITERS 320
9.4.1 Market Drivers 320
9.4.2 Market Limiters 321
9.5 COMPETITIVE MARKET SHARE ANALYSIS 322

TRANSCATHETER MITRAL VALVE REPAIR DEVICE MARKET

10.1 INTRODUCTION 325
10.2 MARKET ANALYSIS AND FORECAST 326
10.3 DRIVERS AND LIMITERS 328
10.3.1 Market Drivers 328
10.3.2 Market Limiters 329
10.4 COMPETITIVE MARKET SHARE ANALYSIS 331
10.4.1 Potential Competitors 331

TRANSCATHETER HEART VALVE REPLACEMENT DEVICE MARKET

11.1 INTRODUCTION 335
11.2 MARKET OVERVIEW 337
11.3 MARKET ANALYSIS AND FORECAST 341
11.3.1 Total Transcatheter Heart Valve Replacement Device Market 341
11.3.2 Transcatheter Aortic Valve Replacement Device Market 343
11.3.3 Transcatheter Pulmonary Valve Replacement Device Market 346
11.4 DRIVERS AND LIMITERS 348
11.4.1 Market Drivers 348
11.4.2 Market Limiters 349
11.5 COMPETITIVE MARKET SHARE ANALYSIS 351
11.5.1 Potential Competitors 352

CEREBRAL EMBOLIC PROTECTION DEVICE MARKET

12.1 INTRODUCTION 355
12.2 MARKET ANALYSIS AND FORECAST 356
12.3 DRIVERS AND LIMITERS 358
12.3.1 Market Drivers 358
12.3.2 Market Limiters 358
12.4 COMPETITIVE MARKET SHARE ANALYSIS 360
The TAVR Market Analysis| United States | 2020-2026 | MedCore includes analysis on the following companies:

  • Edwards Lifesciences
  • Medtronic
  • Boston Scientific
  • Colibri Heart Valve
  • JenaValve
  • Abbott
  • Thubrikar Aortic Valve
  • Blue Sail
  • Venus Medtech
  • Meril Life Sciences

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  • Original primary research that consists of the most up-to-date market data
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Step 1: Project Initiation & Team Selection During this preliminary investigation, all staff members involved in the industry discusses the topic in detail.

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