Frost: Mature U.S. Artificial Heart Valve Industry Seeks New Opportunities

February 19, 2007 // Published as a news service by IHS

According to Frost & Sullivan, this is strengthening the applicability of tissue-based devices where doctors previously were more reliant on mechanical valves.

These advances in valve replacement, along with product innovations in heart valve repair, are likely to bolster future growth of the U.S. artificial heart valve market.

Analysis from Frost & Sullivan found revenues in this market totaled $519M in 2005, with estimates to reach $867M in 2012.

"Recent advances in catheter technology have renewed focus on repair over replacement," said Frost & Sullivan research analyst Venkat Rajan. "Therefore, given the added physiological limitations of certain replacement valves, the majority of start-up activity has been focused on the development of tissue valve repair products."

Improvements to minimally invasive technologies and the rising prevalence of congestive heart failure and valve regurgitation have spurred a rise in the number of entrepreneurial annuloplasty designers.

Analysts said in the past, an open heart procedure for heart valve was almost as risky as performing a valve replacement, therefore limiting application. However, with the introduction of minimally invasive beating heart products, heart valve repair has become a more feasible option.

Analysts said one of the biggest challenges to grow in a mature industry is executing strategies with enough magnitude to instigate a significant shift in the market. In nascent or developing medical device fields, a new product with advanced features or improved procedural efficiency is enough to warrant rapid market adoption. In mature markets such as this one, the opportunities to shift market perception about one's brand name or a technology are limited.

"Growth in the U.S. heart valve market is being restrained by the absence of any recent paradigm-shifting technologies that could otherwise facilitate market expansion," said Rajan. "Another common barrier for growth is the regulatory and reimbursement requirements for defining qualified patients for interventional therapy."

Given the importance placed on evidence-based medicine, it is crucial that market participants be able to profile their devices with detailed, early stage and post-market launch clinical data. Analysts said device thrombosis and durability are the biggest factors that affect device selection among clinicians, and being able to show low rates of complications requiring follow-up procedures is critical to persuading device adoption.

In established markets where there are no external threats, such as those for heart valves, analysts said head-to-head trials versus market competitors' devices can be effective in shifting market share within a short time period.

Source: Frost & Sullivan.