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LI_161675
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Pages: 120
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Sep 2016 | 4565 Views
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Author's :
Deepa Tatkare
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Tables: 36
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Charts: 42
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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.
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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.
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