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Transcatheter Treatment: Procedures and Heart Valve Market

February 2021 | 144 pages | ID: T2239A6D05CEN
BCC Research

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Report Scope:

Transcatheter treatment includes procedure types such as TAVR, TAVI, TMVR and TMVI. Transcatheter procedure approaches include transfemoral, transapical and transaortic procedures. This report is an analytical business tool with the primary purpose of providing a thorough evaluation of the global market for transcatheter treatment for heart valve diseases. The format of this study includes the following -
  • Detailed description, including demographics and cost burden, of heart valve diseases (e.g., valvular stenosis and regurgitation) and transcatheter procedure approaches (e.g., transfemoral, transapical and transaortic).
  • Detailed description and analysis of transcatheter treatments devices including TAVR, TAVI, TMVR and TMVI devices.
  • Market characterization, unmet need, market size and segmentation (by region and treatment).
  • Market drivers and restraints.
  • Detailed market projections through 2025.
  • Competition and market shares.
  • Key marketed and pipeline (R&D) products along with information about their regulatory status.
  • Strategic landscape.
  • Regulatory structure.
  • Pricing and reimbursement.
  • Observations and conclusions on the future of transcatheter treatment.
  • Profiles of market participants and associations.
Report Includes -
  • 27 data tables and 26 additional tables
  • Descriptive overview of the global market for key transcatheter treatment procedures, heart valve systems, and techniques used for the treatment of valvular diseases
  • Analyses of the global market trends, with data from 2019-2020, and projections of five-year compound annual growth rates (CAGRs) through 2025
  • Estimation of the actual market size and revenue forecast for transcatheter treatment procedures, and their corresponding market share analysis based on product type, treatment procedure and other key market segments, with major geographic regions and countries involved
  • Identification of promising new transcatheter techniques and devices still in the development and testing stages, and the probability of their successful commercialization in the next five years
  • Market forecast and market potential for transcatheter treatment procedures based on pipeline devices, on account of their estimated probability of commercial launch
  • Assessment of the impact of demographic, economic, and other factors that will drive future demand for the transcatheter treatment devices and technologies market
  • Profile description of the market leading corporations within the industry, including Abbott Laboratories, Boston Scientific Corp., Edwards Lifesciences Corp., Medtronic Inc., and St. Jude Medical Inc.
Summary:

In 2019, the U.S. accounted for REDACTED of the global transcatheter treatment market, a value of REDACTED. The U.S. market should approach nearly REDACTED in 2020 and reach REDACTED by 2025, increasing at a CAGR of REDACTED from 2020 to 2025. 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.

In 2019, Europe, Asia-Pacific and ROW (Rest of the World) had shares of about REDACTED, REDACTED and REDACTED of the global market, or REDACTED, REDACTED and REDACTED, respectively. The Europe, Asia-Pacific and ROW markets should approach REDACTED, REDACTED and REDACTED in 2020 and reach REDACTED, REDACTED and REDACTED by 2025, increasing at CAGRs of REDACTED, REDACTED and REDACTED from 2020 through 2025, respectively.

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 a 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.
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
BCC Custom Research
Related BCC Research 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

COMPANIES MENTIONED

ABBOTT LABORATORIES
BIOTRONIK
BOSTON SCIENTIFIC CORP.
BRACCO SPA
BRAILE BIOMЙDICA
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.


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