Pipeline for prosthetic heart valves

GlobalData analyses growth prospects and key trends in the global market for prosthetic heart valves, which is expected to reach a value of $2.6 billion by 2017.


The implantation of prosthetic heart valves to treat valvular disease has become an increasingly common procedure. In the US, more than 60,000 patients undergo heart valve replacement surgery every year. Prosthetic heart valves are segmented into mechanical heart valves, tissue heart valves and transcatheter heart valves.

Heart valve replacement is a treatment procedure which requires the replacement of a diseased or damaged valve with a prosthetic heart valve. This is done in patients who suffer from valvular heart disease and the selection of the prostheses depends on the type of valve to be treated.

Mechanical valves are mostly used in younger patients with damaged valves, whereas the use of tissue heart valves is preferred in older patients with valvular heart disease.
A transcatheter heart valve is a new technology which has been launched in a few markets such as Europe, Australia and Brazil. These valves are minimally invasive, which makes them the preferred valve replacement among patients with valvular heart disease.

"The aging population and increasing patient population are expected to drive demand for prosthetic heart valve-based treatment in the future."

According to GlobalData's new report 'Prosthetic Heart Valves - Global Pipeline Analysis, Competitive Landscape and Market Forecasts to 2017', the global prosthetic heart valves market was valued at $1.5 billion in 2010 and is expected to grow at a compound annual growth rate (CAGR) of 8.2%, to reach a market value of $2.6 billion in 2017.

This growth will be contributed to by the growth of the global tissue heart valves market at a CAGR of 7.2% and the transcatheter heart valves market at a CAGR of 20% for the period 2010-2017. The mechanical heart valves market is expected to decline at a CAGR of -1% over the same seven-year period.

The aging population and increasing patient population are expected to drive demand for prosthetic heart valve-based treatment in the future. Moreover, technological advancements such as enhanced durability and improved haemodynamics of tissue heart valves will further drive the growth of the market. The launch of transcatheter heart valves in markets such as the US and Japan will lead to further substantial growth in the global prosthetic heart valves market in the future.

Market leaders

The global prosthetic heart valves market is dominated by Edwards Lifesciences Corporation, with a 38% share. Other players including Medtronic, St. Jude Medical and Sorin Group, Braile Biomédica, CryoLife and AorTech International make up 62% share of the global prosthetic heart valves market. Competition in the prosthetic heart valves market is intense and in order to maintain their competitiveness, companies are adopting strategies such as inorganic growth and product innovation. Product innovation continues to drive pricing, which acts as a huge barrier for new entrants in the medical devices market. Market players are also investing in expanding their product portfolios, resulting in their growing pipelines in the prosthetic heart valves market.

Transcatheter heart valves drive growth

The global transcatheter heart valves market has grown from $11.8 million in 2007 to $194.6 million in 2010 and is expected to grow at a CAGR of 20%, to reach a market value of $691 million in 2017. The launch of transcatheter heart valves in the US will lead to substantial growth in the market. The Medtronic Melody transcatheter heart valve is the first device to achieve FDA (Food and Drug Administration) approval under humanitarian device exemption (HDE) in the US in 2010.

The Edwards SAPIEN transcatheter heart valve, which is also expected to achieve premarket approval by the FDA in 2011, is expected to be used for the treatment of inoperable aortic stenosis patients in the US. The easy implantation of transcatheter heart valves has led to their fast adoption across Europe. Products such as the Edwards SAPIEN transcatheter heart valve and the Medtronic-CoreValve have been well accepted in Europe and also in Australia.

"The launch of transcatheter heart valves in the US market is also expected to lead to substantial growth in the market share of the US in the future"

Technological advancements are also being made which involve reducing the diameter of transcatheter heart valves so as to make their implantation easier and more efficient. Moreover, the growing patient population and the availability of reimbursement for transcatheter valve implantation procedures in Europe are expected to lead to the growth of the transcatheter heart valves market.

Market value

The global prosthetic heart valves market was valued at $1.5 billion in 2010. The prosthetic heart valves market in Europe accounted for $657 million and in the US it was valued at $501.7 million in 2010. The transcatheter heart valves market in Europe accounted for $170.6 million in 2010 and is responsible for Europe having a greater market share than the US. The launch of transcatheter heart valves in the US market is also expected to lead to substantial growth in the market share of the US in the future. Other regions, which include Asia-Pacific, the Middle East and Africa and South America, have a share of 23% of the global prosthetic heart valves market, amounting to $341.7 million in 2010.


Medical Device Developments
This article was first published in our sister publication Medical Device Developments.