Transcatheter Treatment: Procedures and Heart Valve Market

Table of Contents

Chapter 1 Introduction

• Study Goals and Objectives
• Reasons for Doing This Study
• Scope of Report
• Information Sources
• Methodology and Information Sources
• Geographic Breakdown
• Analyst's Credentials
• Custom Research
• Related Reports

Chapter 2 Summary and Highlights

Chapter 3 Structural Heart Valve Disease

• Disease Overview
• Spectrum of Structural Heart Disease
• Valvular Heart Disease
• Symptoms and Risk Factors of Structural Heart Disease
• Causes of Structural Heart Disease
• Rheumatic Fever
• Mitral Valve Prolapse
• Peripheral Artery Disease
• Cardiovascular Disease
• Aortic Aneurysm
• Obesity
• Diagnosis of Structural Heart Disease
• Treatment of Structural Heart Disease
• Management Through Medication
• Surgical Intervention: Heart Valve Repair and Replacement
• Tobacco Smoking and Heart Disease
• Aging, Gender and Structural Heart Diseases
• Global Demographics
• U.S. Demographics
• European Demographics
• Japanese Demographics
• Current Challenges and Future Directions

Chapter 4 Aortic Valve Disease

• Disease Overview
• Types of Aortic Stenosis
• Acquired Aortic Stenosis
• Congenital Aortic Stenosis
• Mild and Moderate Aortic Stenosis
• Severe Aortic Stenosis
• Asymptomatic Aortic Stenosis
• Symptomatic Aortic Stenosis
• Causes, Risk Factors and Symptoms
• Causes
• Symptoms
• Risk Factors
• Epidemiology and Economic Burden
• Diagnosis
• Standard Doppler Echocardiography
• Multimodality Imaging
• Other Techniques
• Treatment
• Open Surgical Treatment (SAVR)
• Transcatheter Treatment (TAVR/TAVI)
• Aortic Valve Repair Versus Aortic Valve Replacement
• Types of Transcatheter Approaches
• Open Surgical Repair (SAVR) versus Transcatheter Treatment (TAVR/TAVI)
• TAVR and TAVI Complications
• Key Marketed and Pipeline Products
• Key Marketed Products
• Key Pipeline/R&D Products
• Unmet Need
• Current Challenges and Future Developments

Chapter 5 Mitral Valve Disease

• Disease Overview
• Types of Mitral Regurgitation
• Disease Origin
• Disease Stage
• Disease Symptoms
• Causes, Risk Factors and Symptoms
• Causes
• Symptoms
• Risk Factors
• Epidemiology and Economic Burden
• Diagnosis
• Standard Echocardiography
• Multimodality Imaging
• Other Techniques
• Treatment
• Open Surgical Treatment (SMVR)
• Transcatheter Treatment (TMVR and TMVI)
• Mitral Valve Repair Versus Mitral Valve Replacement
• Types of Transcatheter Approaches
• Open Surgery (SMVR) Versus Transcatheter Treatment (TMVR/TMVI)
• TMVR Complications
• Key Marketed and Pipeline Products
• Key Marketed Products
• Key Pipeline/R&D Products
• Other Less-Invasive (MIS) Mitral Valve Technologies
• Unmet Need
• Current Challenges and Future Developments

Chapter 6 Tricuspid Valve Disease

• Disease Overview
• Types of Tricuspid Regurgitation
• Primary Tricuspid Regurgitation
• Secondary Mitral Regurgitation
• Causes, Risk Factors and Symptoms
• Causes
• Symptoms
• Epidemiology
• Diagnosis
• Echocardiography and Grading
• Other Techniques
• Treatment
• Medical Treatment
• Tricuspid Valve Surgery
• Key Marketed and Pipeline Products
• Key Marketed Products
• Key Pipeline/R&D Products

Chapter 7 Market Size and Growth Analysis

• Overview
• Market Size and Growth Analysis by Region
• Market Size and Growth Analysis by Segment
• Market Size and Growth Analysis by Procedure Approach
• Market Size and Growth Analysis by Procedure (TAVR/TAVI, TMVR and TTVR)
• Heart Valve Market: Traditional versus Transcatheter Heart Valves
• Market Growth Drivers and Restraints
• Market Growth Drivers
• Market Restraints

Chapter 8 Competitive Landscape

• Overview

Chapter 9 Company Market Strategies

• Market Consolidation in Cardiovascular Device Market
• Mergers and Acquisitions in the Transcatheter Treatment Device Market
• Key Observations Regarding Transcatheter Device Industry
• Future Strategic Landscape

Chapter 10 Regulatory Structure: Medical Devices

• Regulatory Background
• Regulatory Systems for Medical Devices by Region
• U.S.
• European Union (EU)
• Japan

Chapter 11 Pricing and Reimbursement: Medical Devices

• Pricing and Reimbursement Background
• Pricing and Reimbursement for Medical Devices by Region
• United States
• Europe
• Japan

Chapter 12 Conclusions: Outlook for Transcatheter Treatment Devices

• Major Developments Influencing the Market
• Technological Developments
• Demographic and Economic Trends
• Changing Structure of the Healthcare Industry
• Long-Term Outlook for Transcatheter Treatments

Chapter 13 Company Profiles

• Abbott Laboratories
• Biotronik
• Boston Scientific Corp.
• Bracco Spa
• Braile Biomedica
• Cardiac Dimensions Inc.
• Colibri Heart Valve Llc
• Direct Flow Medical Inc.
• Edwards Lifesciences Corp.
• Gorman Cardiovascular Research Group
• Hansen Medical Inc. (Subsidiary Of Auris Health Inc.)
• Highlife Sas
• Jenavalve Technology Inc.
• Medtronic Inc.
• Micro Interventional Devices Inc.
• Microport Scientific
• Mitrassist Ltd.
• MVRX Inc.
• Navigate Cardiac Structures Inc.
• Neovasc Inc.
• St. Jude Medical Inc. (Subsidiary Of Abbott Laboratories)
• Venus Medtech Inc.

Chapter 14 Appendix A: List of Acronyms

Chapter 15 Appendix B: Professional Organizations

• American Heart Association
• Center for Drug Evaluation and Research (CDER)
• Center for Devices and Radiological Health (CDRH)
• Centers for Medicare & Medicaid Services (CMS)
• European Databank for Medical Devices (EUDAMED)
• Food and Drug Administration (FDA or USFDA)
• Hormone Foundation
• International Diabetes Federation (IDF)
• International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
• Network for Excellence in Health Innovation (NEHI)
• National Center for Biotechnology Information (NCBI)
• National Institute of Aging (NIA)
• Pharmaceuticals and Medical Devices Agency (PMDA)
• World Cancer Research Fund International
• World Health Organization (WHO)

List of Tables
Summary Table: Global Market for Transcatheter Treatment Devices, by Region, Through 2025
Table 1: Scope of Structural Heart Diseases
Table 2: Leading Peripheral Vascular Disease Conditions
Table 3: Global Prevalence of Peripheral Artery Disease, Through 2021
Table 4: Global Incidence of Hypertension, by Patient Group, 2019
Table 5: Global Prevalence of Angina Pectoris and Stroke, by Number of Survivors, Through 2030
Table 6: Global Prevalence of Congestive Heart Failure and Stroke, Through 2030
Table 7: Epidemiology, AAA vs. TAA
Table 8: Global vs. U.S. Prevalence of AAA, Through 2025
Table 9: BMI Calculation
Table 10: BMI Categories Based on Increasing Health Risks
Table 11: Trends in Obesity in the World’s Population, by Segment, Through 2021
Table 12: U.S. Obesity and Severe Obesity vs. General Population, by Segment, Through 2021
Table 13: Structural Heart Disease: Management Through Medication
Table 14: Structural Heart Valve Disease Treatment Through Surgical Intervention
Table 15: Estimated World Population and Annual Growth, by Age Group, Through 2030
Table 16: World Population, by Region, Through 2030
Table 17: U.S. Population Estimates and Projections, by Age Group, Through 2030
Table 18: Estimates of Anticipated U.S. Life Expectancy at Birth, by Gender, Through 2020
Table 19: European Population Estimates and Projections, by Age Group, Through 2030
Table 20: Japanese Population Estimates and Projections, by Age Group, Through 2030
Table 21: Aortic Valve Area and Calcification Score, by Stage of Aortic Stenosis
Table 22: Global vs. U.S. Prevalence of Aortic Stenosis, Through 2025
Table 23: Global vs. U.S. Prevalence of Severe/Symptomatic Aortic Stenosis, Through 2025
Table 24: Imaging Techniques for Aortic Stenosis Diagnosis
Table 25: Types of Aortic Valve and Repair Techniques
Table 26: Advantages and Challenges of TAVI vs. TAVR
Table 27: TAVR Access Routes for Aortic Stenosis
Table 28: Key Marketed Products in Transcatheter Aortic Valve Treatment
Table 29: Key Pipeline/R&D Products in Transcatheter Aortic Valve Treatment
Table 30: Mitral Valve Area, by Stage of Mitral Stenosis
Table 31: Global vs. U.S. Prevalence of Mitral Regurgitation, Through 2025
Table 32: Global vs. U.S. Prevalence of Severe/Symptomatic Mitral Regurgitation, Through 2025
Table 33: Imaging Techniques for the Diagnosis of Mitral Valve Disease
Table 34: Types of Mitral Valve Repairs
Table 35: Types of Mitral Valve Repairs and Techniques
Table 36: TMVI vs. TMVR: Advantages and Challenges
Table 37: Key Marketed Products, Transcatheter Mitral Valve Treatment
Table 38: Key Pipeline/R&D Products, Transcatheter Mitral Valve Treatment
Table 39: Transcatheter Mitral Valve Treatment, Other Less-Invasive (MIS) Mitral Valve Technologies
Table 40: Global vs. U.S. Prevalence of Tricuspid Regurgitation, Through 2025
Table 41: Imaging Techniques for the Diagnosis of Tricuspid Valve Disease
Table 42: Clinical Trials for Treating Tricuspid Regurgitation Using Transcatheter Technique
Table 43: Global Market for Transcatheter Treatment Devices, by Region, Through 2025
Table 44: Global Market for Transcatheter Treatment Devices, by Segment, Through 2025
Table 45: Global Market for Transcatheter Treatments, by Procedure (TAVR/TAVI and TMVR), Through 2025
Table 46: Global Market for Heart Valves, by Type of Valve, Through 2025
Table 47: Global Market for Transcatheter Treatment Devices, by Leading Company, 2019
Table 48: Differences between Regulatory Approvals in the U.S. and Europe
Table 49: Transcatheter Aortic Valve Procedures, Billing and Reimbursement, U.S.
Table 50: Operations on Aortic Valve, ICD-10 Procedure Code
Table 51: Hospital Inpatient Procedures Utilizing MS-DRGs, National Average Reimbursements, CMS
Table 52: List of Acronyms

List of Figures
Summary Figure: Global Market for Transcatheter Treatment Devices, by Region, 2019-2025
Figure 1: Global Prevalence of Peripheral Artery Disease, 2000-2021
Figure 2: Global Incidence of Hypertension, by Patient Group, 2019
Figure 3: Global Prevalence of Angina Pectoris and Stroke, by Number of Survivors, 2004-2030
Figure 4: Global Prevalence of Congestive Heart Failure and Stroke, 2004-2030
Figure 5: Global vs. U.S. Prevalence of AAA, 2019-2025
Figure 6: Trends in Obesity in the World’s Population, by Segment, 2012-2021
Figure 7: U.S. Obesity and Severe Obesity vs. General Population, by Segment, 2016 and 2021
Figure 8: Estimated World Population and Annual Growth, by Age Group, 2000-2030
Figure 9: World Population, by Region, 2000-2030
Figure 10: U.S. Population Estimates and Projections, by Age Group, 2000-2030
Figure 11: Estimates of Anticipated U.S. Life Expectancy at Birth, by Gender, 2005-2020
Figure 12: European Population Estimates and Projections, by Age Group, 2000-2030
Figure 13: Japanese Population Estimates and Projections, by Age Group, 2000-2030
Figure 14: Global vs. U.S. Prevalence of Aortic Stenosis, 2019-2025
Figure 15: Global vs. U.S. Prevalence of Severe/Symptomatic Aortic Stenosis, 2019-2025
Figure 16: Global vs. U.S. Prevalence of Mitral Regurgitation, 2019-2025
Figure 17: Global vs. U.S. Prevalence of Severe/Symptomatic Mitral Regurgitation, 2019-2025
Figure 18: Global vs. U.S. Prevalence of Tricuspid Regurgitation, 2019-2025
Figure 19: Global Market for Transcatheter Treatment Devices, by Region, 2019-2025
Figure 20: Global Market Shares of Transcatheter Mitral Valve Repair, by Disease Condition, 2019
Figure 21: Global Market Shares of Transcatheter Treatment Devices, by Valve Type, 2019
Figure 22: Global Market Shares of Transcatheter Aortic Valve Repair Market, by Procedure Approach, 2019
Figure 23: Global Market for Transcatheter Treatments, by Procedure (TAVR/TAVI and TMVR), 2019-2025
Figure 24: Global Market for Heart Valves, by Type of Valve, 2019-2025
Figure 25: Global Heart Valve Repair Market Share, by Type of Surgery, 2019
Figure 26: Global Market Shares of Transcatheter Treatment Devices, by Leading Company, 2019

Samples

Executive Summary

By region, the U.S. is expected to maintain dominance in the global transcatheter treatment market. This is due to the growing geriatric population, increasing prevalence of structural heart diseases, continuous technological advancements, increasing investment in R&D, incentives for new product development, increasing adoption of transcatheter techniques, positive reimbursement, and other healthcare reforms.

Europe is the second-largest market after the U.S., and there are many established and early-stage companies that are working to enter the European TAVR market by developing improved transcatheter heart valve devices. Although a few products are already approved and available in the market, new features and more advanced technologies are expected to further expand the eligible patient population. Germany currently has the largest volume of TAVR procedures among Western European nations. With regard to the European transcatheter treatment device market, it is growing mainly due to improved healthcare infrastructure, increasing prevalence of heart disease, improving diagnosis rates, and growing demand for minimally invasive and catheter-based treatment options.

The Asian market for transcatheter treatment devices is expected to experience the highest growth among all four regions during the next five years for various reasons: a growing aging (greater than 60 years) population, increasing availability and affordability of treatment, increasing acceptance of transcatheter procedures and advanced technology-enabled products and solutions. Additionally, the increased patient population and improving diagnosis rate are likely to increase the demand for TAVR/TAVI and TMVR procedures within the region. Japan is an established market in Asia-Pacific, while China and India are emerging markets that are growing rapidly.

Companies Mentioned

• Abbott Laboratories
• American Heart Association
• Biotronik
• Boston Scientific Corp.
• Bracco Spa
• Braile Biomedica
• Cardiac Dimensions Inc.
• Center for Devices and Radiological Health (CDRH)
• Center for Drug Evaluation and Research (CDER)
• Centers for Medicare & Medicaid Services (CMS)
• Colibri Heart Valve Llc
• Direct Flow Medical Inc.
• Edwards Lifesciences Corp.
• European Databank for Medical Devices (EUDAMED)
• Food and Drug Administration (FDA or USFDA)
• Gorman Cardiovascular Research Group
• Hansen Medical Inc. (Subsidiary Of Auris Health Inc.)
• Highlife Sas
• Hormone Foundation
• International Diabetes Federation (IDF)
• International Federation of Pharmaceutical Manufacturers & Associations (IFPMA)
• Jenavalve Technology Inc.
• Medtronic Inc.
• Micro Interventional Devices Inc.
• Microport Scientific
• Mitrassist Ltd.
• MVRX Inc.
• National Center for Biotechnology Information (NCBI)
• National Institute of Aging (NIA)
• Navigate Cardiac Structures Inc.
• Neovasc Inc.
• Network for Excellence in Health Innovation (NEHI)
• Pharmaceuticals and Medical Devices Agency (PMDA)
• St. Jude Medical Inc. (Subsidiary Of Abbott Laboratories)
• Venus Medtech Inc.
• World Cancer Research Fund International
• World Health Organization (WHO)