2. Executive Summary
Transcatheter aortic valve replacement (TAVR) is a relatively new technology in the field of medical science. It is a minimally invasive
procedure to replace a narrowed aortic valve that fails to open properly (aortic stenosis). It is sometimes also called transcatheter aortic
valve implantation (TAVI). Aortic valve replacement typically requires open heart surgery, thus it disqualifies patients who are at high
risk for the process or are too weak to undergo a surgery. As a result, the market of heart valve surgical procedures is witnessing a
continuous decline as more and more patients requiring valve replacement are at risk for a surgical treatment. This shortcoming of the
traditional surgical method has paved way for the popularity and adoption of TAVR. It was first commercially launched in Europe in
2007 and later in the United States. The market for TAVR is regarded to be promising with immense growth opportunities and unmet
demand to cater to.
The key factors which are anticipated to drive market growth include ageing population, healthcare expenditure, increasing obese
population and gross domestic product apart from increasing prevalence of inoperable aortic stenosis. Some of the noteworthy
developments of this industry include advancement in technologies and favorable reimbursement in Europe. However, the industry
remains threatened by certain challenges which include regulatory issues, associated high risk and high cost of TAVR devices.
This report offers a comprehensive analysis of the global TAVR market, along with an in-depth study of the TAVR procedures and the
regional markets of the US, Europe and Japan. The global TAVR market is dominated by two major players, Edwards Lifesciences and
Medtronic which operate in a highly dynamic environment working in the direction of tapping maximum market share. Both the
companies in addition to St. Jude Medical have been profiled in the present report highlighting their key financials and business
strategies for growth.
By combining SPSS Inc.’s data integration and analysis capabilities with our relevant findings, we have predicted the future growth of
the industry. We employed various significant variables affecting this industry and created regression models with SPSS Base to
determine the future direction of the industry. Before deploying the regression model, the relationship between several independent or
predictor variables and the dependent variable was analyzed using standard SPSS output, including charts, tables and tests.
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3. Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure that repairs the
valve without removing the old, damaged valve.
•The TAVR market is highly concentrated in US and Europe. As of
2014, the US accounted for …% of the global market share
followed by Europe with …% of the market share. Japan makes up
about …% of market share and is expected to exhibit a market
potential of worth US$...million by 2019.
•The TAVR market has been increasing at a CAGR of …% for over
five years, increasing from a valuation of US$...million in 2009 to
US$...billion in 2013. It is estimated to be a US$...billion market in
2014.
•The average selling price of TAVR devices was US$... in the US in
2013, less than the previous year. Continuous developments and
innovations in TAVR devices along with increasing competition will
bring down the average selling prices of TAVR in years ahead.
Thus, the TAVR device price tag may begin to drop as the market
widens.
Average Selling Price of TAVR in the US (2011-2017E)Global TAVR Market Value (2009-2013)
TAVR Market by Region (2014)
2009 2010 2011 2012 2013
US$Million
2011 2012 2013 2014E 2015E 2016E 2017E
US$
U.S. Europe Japan R.O.W
4. Some of the noteworthy growth drivers of this industry include rising global healthcare expenditure,
increasing global ageing population, and increasing global obese population, among others.
•Global ageing population (over 65) was recorded to be … million
in 2013, compared to that of … million in 2012. This depicts an
increase of about …% in 2013. However, until now the overall
increase since 2009 is …%.
•TAVR market is expected to become more crowded with new
entries from St. Jude and Boston Scientific as well as smaller
players such as Direct Flow Medical, Symetis and Jena Valve.
Though, Edwards and Medtronic will remain market share leaders
with …% and …% of shares respectively.
• The US TAVR market is on the verge of moving from monopoly to
duopoly as Edwards and Medtronic are the only two companies in
the US with commercially available TAVR systems. Despite the
recent entry of competition into the TAVR market, Edwards grew
…% YOY holding majority market share of …% in 2013. Medtronic
accounts for …% of the market share.
The US TAVR Market Share by Company (2013)Global TAVR Market Share by Company (2013)
Global Ageing Population (2009-2013)
2009 2010 2011 2012 2013
Million
Edwards Lifesciences Medtronic
Edwards Lifesciences Medtronic Others
5. In 2013 worldwide, Edwards has performed higher number of implants than Medtronic
•As of 2013, the number of centers worldwide approved to replace the
aortic valve using the minimally invasive TAVR technique has
continued to increase when compared to 2011 from … to …, for
Edwards, and from … to …, for Medtronic. It is estimated to follow the
same trend in 2014, wherein Medtronic is expected show an impressive
growth of …%.
•In 2013, approximately ….. TAVR procedures were performed in the
US and ….. of them were from inoperable patients. The number of
TAVR procedures in the US is estimated to reach ….. by 2017, driven
by increasing prevalence of AS and growing adoption of TAVR
technology. Simultaneously, surgical heart valve replacement volumes
will begin to shrink slightly as TAVR devices replace them.
•Unlike US, Europe has many companies competing in TAVR products.
They include Boston Scientific, St. Jude and Direct Flow Medical. In
Europe, Edwards’ share is …% in 2013 followed by Medtronic with …%
of market share. Boston Scientific’s Lotus is expected to grab more
market share more meaningfully than its other smaller competitors.
European TAVR Market Share by Company (2013)The US TAVR Procedures (2011-2017E)
Global TAVR Market – Implanting Centers
by Company (2011–2014E)
2011 2012 2013 2014E 2015E 2016E 2017E
US$
2011 2012 2013 2014E
NumberofCenters
Edwards Lifesciences Medtronic St. Jude Medical Boston Scientific Others
6. The growth of TAVR market is hindered by the barrier for regulatory issues, associated high risk and high
cost of TAVR devices .
Between 2010 and 2012, more than …… patients received treatment through TAVR. The number of TAVR procedures reached ……. in 2013.
Following the similar increasing trend, number of procedures in the Europe/ROW is estimated to reach …… by 2017. Growth in TAVR
procedures is increasingly driven by a shift towards the treatment of lower-risk patients, which is happening in Germany for over last two years,
leading to an expanded treatable patient population.
Transcatheter aortic valve devices are priced at a premium level as compared to the conventional heart valve devices and will, therefore, spur
average selling price (ASP). As a whole, the global TAVR market is forecasted to reach US$..... million by 2017 from US$..... million in 2013.
The industry is expected to grow at a CAGR of …..% till 2017.
Several patients with severe symptomatic aortic stenosis are deemed inoperable for traditional open-heart surgery. TAVR precisely addresses
this issue and provides treatment to patients with severe symptomatic aortic stenosis who have an unacceptably high estimated surgical risk,
and who are not suitable candidates for surgery. For patients with high surgical risk, TAVR is the most preferred option due to its less invasive
nature and high accuracy rate. With time the technology will be rapidly adopted to treat patients who were previously not eligible or unable to
undergo surgical heart valve procedures. As a result of this increased adoption of TAVR procedures, surgical implantation of heart valves will
significantly decline and intensify market competition.
Note: Market attractiveness is inverse of penetration. Low penetration means high attractiveness and vice-versa
2010
2011
2012
2013
2014E
2015E
2016E
2017E
NumberofProcedures
Europe/ROW TAVR Procedures (2010-2017E)
2013
2014F
2015F
2016F
2017F
US$Million
Transcatheter Aortic Valve Replacement Market Forecast
(2013-2017F)
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