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Transcatheter Aortic Valve Implantation (TAVI) Market by Procedure (Transfemoral Implantation, Transapical Implantation, and Transaortic Implantation) - Global Opportunities and Forecasts, 2014-2022

Medical Devices & Supplies	LI_161675	Pages: 120	Sep 2016 \| 4023 Views
Author's : Deepa Tatkare	Tables: 36	Charts: 42	Formats*:

Transcatheter Aortic Valve Implantation Industry Overview:

Transcatheter Aortic Valve Implantation Market is expected to garner $5,962 billion by 2020, registering a CAGR of 16.5% during the forecast period 2016 - 2022. Transcatheter aortic valve implantation (TAVI), a minimally invasive procedure, is utilized to treat high-risk or inoperable aortic stenosis patients. This procedure involves implantation of specially designed transcatheter aortic valves that have the ability to regenerate the heart’s blood pumping function of the aortic valve. It is conducted through three approaches: transfemoral TAVI, transapical TAVI, and transaortic TAVI. Furthermore, the report provides market estimation on the basis of value as well as volume of TAVI devices.

Segment Review:

Transfemoral implantation is the standardized TAVI procedure, in which an artificial valve is implanted through the femoral artery with minimal anesthesia. Hence, this segment accounted for the highest market share in 2015 and is expected to maintain its dominance during the forecast period. However, this procedure has some complications due to higher distance from insertion to the aortic valve, which has led to the emergence of transapical TAVI and transaortic TAVI procedures.

Mexico TAVI Market Snapshot:
An increase in the percentage of the Mexican population, especially adults, prone to symptomatic aortic stenosis has been observed. As per the World Health Organization, deaths due to coronary heart diseases have reached to 76,043 or 14.72% of total deaths in 2014, and coronary heart disease and stroke ranked second and third in Mexico. Increase in incidence of aortic stenosis coupled with high-risk geriatric population boosts the growth of the Mexican TAVI market. In addition, medical tourism plays a vital role in market growth. Patients from developed countries such as the U.S., Canada, and Spain visit Mexico for heart-related treatments, owing to lower treatment cost and liberal regulatory framework in Mexico. The first TAVR procedure successfully completed in North America was performed in Mexico.

Top Impacting Factors

Rise in prevalence of aortic stenosis coupled with increase in geriatric population

According to a WHO report, around 524 million people were above the age of 65 years in 2010, which is expected to reach 1.5 billion by 2050, constituting about 16% of the total world population. The report estimated that 27% of the Japanese, 16% of the U.S., 24% of the UK, 17% of the Russian, and 14% of the Chinese population are expected to be above 65 years of age by 2020. An increase in vulnerability of severe aortic stenosis is observed with rise in age, which in turn increases the demand for TAVI systems. According to the Vanderbilt University Medical Center (U.S.), every year, around 200,000 people are diagnosed with aortic stenosis and about 75% of them are considered to be at high risk. An article of National Centre for Biotechnology Information (NCBI) stated that aortic valve stenosis is present in 2‐9% of the general population over 65 years of age. Furthermore, in a Euro heart survey program, it was reported that 29% of heart failure cases occur due to valve diseases. Older population of 75 years and above is at a higher risk to surgical aortic valve replacement (SAVR) procedure and hence they undergo TAVI.

Growth in adoption rate of transcatheter aortic valve implantation procedure

TAVI procedure aids to successfully treat high-risk aortic stenosis patients. The procedure is increasingly being adopted by patients who are not eligible for the SAVR procedure, as it is minimally invasive that has shown positive outcomes. The average length of stay was shorter during TAVR (8 days) procedure as compared to SAVR (11 days), as well as recovery after the surgery is much faster. These factors contribute to the increase in the adoption of TAVR procedures.

Increase in clinical evidence of safety & efficacy and new device approvals

Many novel TAVR devices are in the phase of clinical trials. The results of these studies are continuously supporting the safety & efficacy of these devices. Based on the encouraging results of Partner II trials, in August 2016, Edwards Lifesciences received FDA approval for the expansion of indications of SAPIEN 3 and SAPIEN XT for intermediate-risk patient population. The TAVI market has witnessed several FDA and CE mark approvals for transcatheter aortic valves in the last two years, thus driving the growth of the market. For instance, in June 2016, Medtronic plc received FDA approval for its recapturable, self-expanding CoreValve Evolut R system. In March 2016, Edwards Lifesciences Corporation received MHLW approval for its SAPIEN 3 transcatheter heart valve for the Japanese market. Moreover, the devices that are in clinical trials have displayed encouraging results. For instance, in a recent clinical trial, Boston Scientific’s Lotus valve system demonstrated lower paravalvular aortic regurgitation in patients who have undergone TAVI. There are significant number of transcatheter aortic valves under clinical trials, which are expected to receive regulatory approvals in the near future. These new approvals are anticipated to drive the market to grow at an even faster rate.

Increase in number of TAVR centers

The TAVI market growth is driven by the rise in number of centers providing transcatheter aortic valve replacement facility. This number has increased by approximately nine times from 37 in 2007 to 342 in 2011 in Europe. In the year 2015, Edwards Lifesciences stated that the TAVR procedure was available in 400 centers in the U.S. The company further plans to add additional National Coverage Determination (NCD) qualified centers in 2016 to increase its transcatheter aortic valves sales.

High cost of the device and unfavorable reimbursement policies

The cost associated with a TAVI procedure is high. Majority of the cost is due to the high pricing of the transcatheter aortic valves. The cost for CoreValve (Medtronic) was $23,663 (£14,800); however, the cost of a surgical valve is $3,198 (£2000), which makes transcatheter aortic valves to be seven times more costly than surgical valves. The price for Sapeins XT valves is around $30,000. Furthermore, reimbursement for TAVR decreased for transfemoral and transapical procedures in 2013 as compared to 2012 in the U.S. Thus, high cost of the TAVR procedure and unfavorable reimbursement policies hamper the growth of the market.

Stringent regulatory approval process

TAVI valves are highly specialized class III devices that are implanted in the body, and hence regulatory agencies have a stringent and time-consuming approval process for these devices. High investment is required to obtain an approval for a new transcatheter aortic valve system. According to the Advanced Medical Technology Association, it is estimated that about 77% and 80% of the total cost of commercializing a class II and class III medical device is expended at FDA-linked approval stages. Thus, this factor is set to hinder the market growth.

The key players profiled in this report include Boston Scientific Corporation, Direct Flow medical, Inc., Edwards Lifesciences Corporation, HLT, Inc., JenaValve Technology, Inc., Medtronic plc, Meril Life Sciences Pvt. Ltd., St. Jude Medical, Inc., SYMETIS SA, and Transcatheter Technologies GmbH.

Key Benefits

This report provides an extensive analysis of the current and emerging trends and dynamics in the global TAVI market.
In-depth analysis is conducted by constructing market estimations for the key segments between 2014 and 2022, which assist in identifying the prevailing opportunities
Comprehensive analysis of factors that drive and restrict the growth of the TAVI market is provided.
An in-depth analysis of current research and clinical developments within the market is provided.
Key players are profiled and their strategies are analyzed thoroughly, which interprets the competitive outlook of the market.

Transcatheter Aortic Valve Implantation (TAVI) Market Key Segments:

By Procedure

Transfemoral Implantation
Transapical Implantation
Transaortic Implantation

By Geography

North America
- U.S.
- Canada
- Mexico
Europe
- Germany
- France
- UK
- Italy
- Switzerland
- UK
- Rest of Europe
Asia-Pacific
- China
- Japan
- India
- Australia
- Rest of Asia-Pacific
LAMEA
- Brazil
- Israel
- South Africa
- Saudi Arabia
- Rest of LAMEA

Chapter: 1 INTRODUCTION

1.1 Report description
1.2 Key benefits
1.3 Key market segments
1.4 Research methodology

1.4.1 Secondary research
1.4.2 Primary research
1.4.3 Analyst tools and models

Chapter: 2 EXECUTIVE SUMMARY

2.1 CXO perspective

Chapter: 3 MARKET OVERVIEW

3.1 Market definition and scope
3.2 Key findings

3.2.1 Top investment pockets

3.3 Porter’s five forces analysis

3.3.1 Bargaining power of suppliers
3.3.2 Bargaining power of buyers
3.3.3 Threat of new entrants
3.3.4 Intensity of rivalry
3.3.5 Threat of substitutes

3.4 Market share analysis, 2015
3.5 Government regulations

3.5.1 U.S. FDA
3.5.2 Europe CE Mark
3.5.3 Ministry of Health, Labour and Welfare (MHLW)

3.6 Reimbursement scenario
3.7 Clinical trials
3.8 Market dynamics

3.8.1 Drivers

3.8.1.1 Rise in prevalence of aortic stenosis coupled with increase in geriatric population
3.8.1.2 Increase in adoption rate for transcatheter aortic valve implantation procedure
3.8.1.3 Increasing clinical evidence of safety and efficacy and new device approvals
3.8.1.4 Increase in number of TAVR Centers

3.8.2 Restraints

3.8.2.1 High cost of the device and unfavorable reimbursement policies
3.8.2.2 Stringent regulatory approval process

3.8.3 Opportunities

3.8.3.1 Use of TAVI systems for new indications
3.8.3.2 Rise in expenditure in healthcare and emergence in developing countries
3.8.3.3 Increase in interest of local to global players in the TAvi market

Chapter: 4 WORLD TRANSCATHETER AORTIC VALVE IMPLANTATION MARKET, BY PROCEDURE

4.1 Overview

4.1.1 Key market trends
4.1.2 Key growth factors and opportunities
4.1.3 Market size and forecast

4.2 Transfemoral (TF) Implantation

4.2.1 Market size and forecast

4.3 Transapical (TA) Implantation

4.3.1 Market size and forecast

4.4 Transaortic Implantation

4.4.1 Market size and forecast

Chapter: 5 WORLD TRANSCATHTER AORTIC VALVE IMPLANTATION MARKET, BY GEOGRAPHY, 2014-2022

5.1 Overview

5.1.1 Market size and forecast

5.2 North America

5.2.1 Key market trends
5.2.2 Key growth factors and opportunities
5.2.3 Market size and forecast
5.2.4 U.S. Market size and forecast
5.2.5 Canada Market Size and forecast
5.2.6 Mexico Market size and forecast

5.3 Europe

5.3.1 Key market trends
5.3.2 Key growth factors and opportunities
5.3.3 Market size and forecast
5.3.4 Germany Market size and forecast
5.3.5 France Market size and forecast
5.3.6 UK Market size and forecast
5.3.7 Italy Market size and forecast
5.3.8 Switzerland Market size and forecast
5.3.9 Rest of Europe Market size and forecast

5.4 Asia-Pacific

5.4.1 Key market trends
5.4.2 Key growth factors and opportunities
5.4.3 Market size and forecast
5.4.4 India Market size and forecast
5.4.5 China Market size and forecast
5.4.6 Japan Market size and forecast
5.4.9 Rest of Asia-Pacific Market size and forecast

5.5 LAMEA

5.5.1 Key market trends
5.5.2 Key growth factors and opportunities
5.5.3 Market size and forecast
5.5.4 Brazil Market size and forecast
5.5.5 Israel Market size and forecast
5.5.6 Saudi Arabia Market size and forecast
5.5.7 South Africa Market size and forecast
5.5.8 Rest of LAMEA Market size and forecast

Chapter: 6 COMPANY PROFILES

6.1 Boston Scientific Corporation

6.1.1 Company overview
6.1.2 Company snapshot
6.1.3 Operating business segments
6.1.4 Business performance
6.1.5 Key strategic moves & developments

6.2 Direct Flow Medical, Inc.

6.2.1 Company overview
6.2.2 Company snapshot
6.2.3 Operating business segments
6.2.4 Key strategic moves & developments

6.3 Edwards Lifesciences Corporation

6.3.1 Company overview
6.3.2 Company snapshot
6.3.3 Operating business segments
6.3.4 Business performance
6.3.5 Key strategic moves & developments

6.4 HLT, Inc.

6.4.1 Company overview
6.4.2 Operating business segments

6.5 JenaValve Technology, Inc.

6.5.1 Company overview
6.5.2 Company snapshot
6.5.3 Operating business segments

6.6 Medtronic plc

6.6.1 Company overview
6.6.2 Company snapshot
6.6.3 Operating business segments
6.6.4 Business performance
6.6.5 Key strategic moves & developments

6.7 Meril Life Sciences Pvt. Ltd.

6.7.1 Company overview
6.7.2 Company snapshot
6.7.3 Operating business segments

6.8 St. Jude Medical, Inc.

6.8.1 Company overview
6.8.2 Company snapshot
6.8.3 Operating business segments
6.8.4 Business performance
6.8.5 Key strategic moves & developments

6.9 Symetis SA

6.9.1 Company overview
6.9.2 Company snapshot
6.9.3 Operating business segments
6.9.4 Key strategic moves & developments

6.10 Transcatheter Technologies GmbH

6.10.1 Company overview
6.10.2 Company snapshot
6.10.3 Operating business segments
6.10.4 Key strategic moves & developments

List of Figures

FIGURE 1. WORLD TRANSCATHETER AORTIC VALVE IMPLANTATION (TAVI) MARKET SEGMENTATION
FIGURE 2. TOP INVESTMENT POCKETS
FIGURE 3. PORTER’S FIVE FORCES ANALYSIS
FIGURE 4. MARKET SHARE ANALYSIS, 2015
FIGURE 5. TOP IMPACTING FACTORS: TRANSCATHETER AORTIC VALVE IMPLANTATION MARKET, 2014-2022
FIGURE 6. AGE DISTRIBUTION OF TAVR PATIENTS, U.S., 2013
FIGURE 7. DISCHARGE DESTINATION FOR TAVR PATIENTS, U.S., 2013
FIGURE 8. WORLD TRANSFEMORAL IMPLANTATION MARKET, 2014 - 2022, ($MILLION)
FIGURE 9. WORLD TRANSAPICAL IMPLANTATION MARKET, 2014 - 2022, ($MILLION)
FIGURE 10. WORLD TRANSAORTIC IMPLANTATION MARKET, 2014 - 2022, ($MILLION)
FIGURE 11. U.S. TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 12. CANADA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 13. MEXICO TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 14. GERMANY TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 15. FRANCE TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 16. UK TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 17. ITALY TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 18. SWITZERLAND TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 19. REST OF EUROPE TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 20. INDIA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 21. CHINA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 22. JAPAN TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 23. REST OF ASIA-PACIFIC TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 24. BRAZIL TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 25. ISRAEL TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 26. SAUDI ARABIA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 27. SOUTH AFRICA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 28. REST OF LAMEA TAVI MARKET, 2014-2022 ($MILLION)
FIGURE 29. BOSTON SCIENTIFIC: NET SALES, 2013-2015 ($MILLION)
FIGURE 30. BOSTON SCIENTIFIC: REVENUE, BY BUSINESS SEGMENT, 2015 (%)
FIGURE 31. BOSTON SCIENTIFIC: CARDIOVASCULAR REVENUE, BY SUB-SEGMENT, 2015
FIGURE 32. BOSTON SCIENTIFIC: REVENUE, BY GEOGRAPHY, 2015 (%)
FIGURE 33. EDWARDS LIFESCIENCES: NET SALES, 2013-2015 ($MILLION)
FIGURE 34. EDWARDS LIFESCIENCES: REVENUE, BY BUSINESS SEGMENT, 2015 (%)
FIGURE 35. EDWARDS LIFESCIENCES: REVENUE, BY GEOGRAPHY, 2015 (%)
FIGURE 36. MEDTRONIC: NET SALES, 2014-2016 ($MILLION)
FIGURE 37. MEDTRONIC: REVENUE, BY SEGMENT, 2016 (%)
FIGURE 38. MEDTRONIC: CARDIAC AND VASCULAR GROUP REVENUE, BY SUB-SEGMENT, 2016
FIGURE 39. MEDTRONIC: REVENUE, BY GEOGRAPHY, 2016 (%)
FIGURE 40. ST. JUDE MEDICAL: NET SALES, 2013-2015, ($MILLION)
FIGURE 41. ST. JUDE MEDICAL: REVENUE BY PRODUCT CATEGORIES, 2015 (%)
FIGURE 42. ST. JUDE MEDICAL: REVENUE BY GEOGRAPHY, 2015 (%)

List of Tables

TABLE 1 MAJOR TAVI APPROVED DEVICES
TABLE 2 CLINICAL TRIALS, TAVI MARKET, 2012-2016
TABLE 3 WORLD TAVI MARKET, BY PROCEDURE, 2014-2022 ($MILLION)
TABLE 4 WORLD TAVI MARKET, BY PROCEDURE, 2014-2022 (UNITS)
TABLE 5 WORLD TAVI MARKET, BY GEOGRAPHY, 2014-2022 ($MILLION)
TABLE 6 WORLD TAVI MARKET, BY GEOGRAPHY, 2014-2022 (UNITS)
TABLE 7 NORTH AMERICA TAVI MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 8 NORTH AMERICA TAVI MARKET, BY COUNTRY, 2014-2022 (UNITS)
TABLE 9 NORTH AMERICA TAVI MARKET, BY PROCEDURE, 2014-2022 ($MILLION)
TABLE 10 NORTH AMERICA TAVI MARKET, BY PROCEDURE, 2014-2022 (UNITS)
TABLE 11 EUROPE: TAVI MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 12 EUROPE: TAVI MARKET, BY COUNTRY, 2014-2022 (UNITS)
TABLE 13 EUROPE: TAVI MARKET, BY PROCEDURE, 2014-2022 ($MILLION)
TABLE 14 EUROPE: TAVI MARKET, BY PROCEDURE, 2014-2022 (UNITS)
TABLE 15 ASIA-PACIFIC: TAVI MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 16 ASIA-PACIFIC: TAVI MARKET, BY COUNTRY, 2014-2022 (UNITS)
TABLE 17 ASIA-PACIFIC: TAVI MARKET, BY PROCEDURE, 2014-2022 ($MILLION)
TABLE 18 ASIA-PACIFIC: TAVI MARKET, BY PROCEDURE, 2014-2022 (UNITS)
TABLE 19 LAMEA: TAVI MARKET, BY COUNTRY, 2014-2022 ($MILLION)
TABLE 20 LAMEA: TAVI MARKET, BY COUNTRY, 2014-2022 (UNITS)
TABLE 21 LAMEA: TAVI MARKET, BY PROCEDURE, 2014-2022 ($MILLION)
TABLE 22 LAMEA: TAVI MARKET, BY PROCEDURE, 2014-2022 (UNITS)
TABLE 23 BOSTON SCIENTIFIC: COMPANY SNAPSHOT
TABLE 24 BOSTON SCIENTIFIC: PRODUCT CATEGORIES
TABLE 25 DIRECT FLOW MEDICAL: COMPANY SNAPSHOT
TABLE 26 EDWARDS LIFESCIENCES: COMPANY SNAPSHOT
TABLE 27 EDWARDS LIFESCIENCES: PRODUCT CATEGORIES
TABLE 28 JENAVALVE-COMPANY SNAPSHOT
TABLE 29 MEDTRONIC-COMPANY SNAPSHOT
TABLE 30 MEDTRONIC: PRODUCT CATEGORIES
TABLE 31 MERIL LIFE SCIENCES: COMPANY SNAPSHOT
TABLE 32 MERIL LIFE SCIENCES: PRODUCT CATEGORIES
TABLE 33 ST. JUDE MEDICAL: COMPANY SNAPSHOT
TABLE 34 ST. JUDE MEDICAL: PRODUCT CATEGORIES
TABLE 35 SYMETIS: COMPANY SNAPSHOT
TABLE 36 TRANSCATHETER TECHNOLOGIES -COMPANY SNAPSHOT