The Global Transcatheter Heart Valve Market is Expected to reach $1,196m by 2017

Monday 20 February 2012, Amsterdam

The report provides market landscape, competitive landscape and information about market trends. The report provides comprehensive information on the key trends affecting the transcatheter heart valve market and key analytical content on the market dynamics. The report also reviews the competitive landscape and the profiles of companies operating on a global level. This report includes information only on transcatheter aortic heart valve market.

The Global Transcatheter Heart Valve Market is Expected to reach $1,196m by 2017

See figure: Transcatheter Heart Valve Market, Global Market Revenue ($m), 2010 - 2017

The global transcatheter heart valve market is expected to reach $1,196m in 2017. The market is forecast to grow with a Compounded Annual Growth Rate (CAGR) of 22% from $293.1m in 2010 to $1196m in 2017.

The market will be driven by the increasing elderly population as a proportion of the general population, as this is a group that is at particular risk of developing heart valve disease due to aortic stenosis. Degenerative calcified aortic stenosis is the most frequent heart valve disease in Europe and other Western countries. Calcification and thickening of the aortic valve is found to occur in 2-4% of adults over the age of 65. Transcatheter Aortic Valve Implantation (TAVI) provides elderly and high risk patients with a treatment option for heart valve replacement and the increasing elderly population is contributing to the growth of this market.

Competition Set to Increase with Promising Pipeline of Transcatheter Heart Valves in the Next Few Years

Currently, with more than 30 products in the pipeline, the transcatheter heart valve (THV) market is set to witness intense competition in the coming years. Though the first mover’s advantage will be there for Edwards Lifesciences and Medtronic, the products in the pipeline are promising and are being developed with advanced features that the current products lack. Features such as valve retrievability and repositioning will be a part of a new generation of THVs. There are promising products from Boston Scientific (Lotus Valve), St. Jude Medical (Portico) and Direct Flow Medical (Direct Floe Medical Valve) which are still undergoing clinical trials. Products from these companies are expected to be launched in Europe during 2012-2014, which will intensify the competition in this market. Recently, JenaValve and ACURATE TA from JenaValve Technologies and Symetis respectively have been approved for commercial use in Europe.

US FDA Approval of Sapien Transcatheter Heart Valve to be a Major Driver for the Market

The Sapien THV from Edwards Lifesciences was approved in November, 2011 by the US Food and Drug Administration (FDA). The approval was based on the evaluation of Cohort B of the Partner trial.

This approval paves for Edwards Lifesciences to market its THV in the US, where about 500,000 people suffer from severe aortic stenosis and about one third of this population will be ideal patients for a transcatheter heart valve replacement procedure. TAVR has already been adopted in Europe in a big way and the availability of this procedure in the US will increase the procedure volume in a big way. Also, once there is FDA approval, the procedure will gain acceptance in other parts of the globe where physicians and surgeons follow FDA recommendations.

Technological Advances in Transcatheter Heart Valve Replacement will Drive Greater Adoption Rates

Advancements in material, size and delivery systems have helped surgeons to refine the procedures, leading to better post-surgical outcomes. Improvements in delivery systems with reduced sheath size will reduce vascular complications.

Edwards Lifesciences has launched SAPIEN XT, which is an improved variant of the SAPIEN THV. This valve consists of a low profile delivery system and has several improved features when compared to the SAPIEN THV. Also driving better clinical outcomes are the advancements in imaging and fluoroscopy, which are an essential part of the procedure. Advancements in imaging software will enable greater precision and accuracy in valve insertion and offer better control in deployment and positioning. Improvements towards better valve and platform durability will enable expansion in indications for TAVI and this market will witness substantial growth in procedure volumes.

Favorable Reimbursement Leading to Widespread Adoption of Transcatheter Heart Valve Procedures in Europe

The availability of reimbursement for transcatheter heart valve replacement procedures has been a major driver for the adoption of this technique across Europe. The reimbursement scenario is different in countries across Europe. Germany has a universal system of reimbursement for TAVI, whereas France has conditional reimbursement. With many countries that previously did not have reimbursement in Europe now providing reimbursement, the adoption of TAVI is expected to increase.

Economic benefit analysis data from the PARTNER Cohort B trial and data on improved Quality of Life (QOL) has further increased the chances of several countries agreeing to provide reimbursement for TAVI. Favorable cost-effectiveness data along with the increasing clinical success of TAVI will be important factors that will drive further reimbursement coverage for TAVI, which in turn will drive the transcatheter heart valve market.