Introduction to Heart Valves and Why They Fail

The heart contains four valves that open and close with each heartbeat to ensure blood flows in only one direction through the heart. The four valves are the mitral valve, tricuspid valve, pulmonary valve, and aortic valve. Valve disease occurs when one or more of these valves do not function properly, requiring them to be repaired or replaced. The two most common types of valvular heart disease that often necessitate valve replacement are aortic stenosis and mitral regurgitation. Aortic stenosis occurs when the aortic valve narrows and does not open fully, restricting blood flow from the heart. Mitral regurgitation occurs when the mitral valve does not close tightly, allowing blood to leak back into the left atrium.

Types of Prosthetic Heart Valves

There are three main types of prosthetic heart valves that can replace a diseased native valve: mechanical valves, biological valves, and tissue valves. Mechanical valves contain movable parts and last longer than other prosthetic valves, but require lifetime blood thinners. Biological valves are constructed from animal tissues but do not require long-term anticoagulation therapy and have a lower risk of bleeding complications compared to mechanical valves. Tissue valves, also known as stentless valves, are constructed from animal or human tissue mounted inside a stent but without any moving parts like mechanical valves.

Market Trends Favor Tissue Valves Over Mechanical Ones

For decades, mechanical heart valves were the most common type of prosthesis implanted due to their increased durability compared to early biological valves. However, in recent years the tide has shifted in favor of tissue valves due to advances that have increased their durability while eliminating the need for long-term anticoagulation therapy. As tissue valves now last 15-20 years on average, they are preferred for younger patients who wish to avoid a lifetime of blood thinners. The global prosthetic heart valve market was valued at $5 billion in 2021 and is projected to reach $8.5 billion by 2028, with tissue valves accounting for 65% of revenues.

Leading Tissue Valve Manufacturers Expanding Production

The three largest manufacturers of tissue heart valves worldwide are Edwards Lifesciences, Medtronic, and Boston Scientific. Edwards in particular has cornered over 50% of the global tissue heart valve market due to its dominance in the surgical aortic tissue valve segment with its popular Pericardial tissue valves. All three companies are expanding production to meet the growing demand for tissue valves. Edwards recently invested $80 million to expand its manufacturing facility in Irvine, California to double its tissue valve production capacity..

Shift towards Transcatheter Heart Valves

In addition to the shift towards tissue valves, another major trend is the rise of transcatheter heart valve replacement (TAVR) procedures where valves are implanted through catheters rather than open-heart surgery. TAVR procedures are less invasive, allowing high-risk patients who cannot undergo open-heart surgery to receive valve replacements.

Outlook Remains Bright on Growth of Prosthetic Valve Market

Favorable demographic trends including an aging population and increased life expectancies mean more people will develop valvular heart diseases requiring prosthetic replacements. Furthermore, advances continuing to make tissue valves and TAVR technologies even less invasive will drive greater adoption rates. The outlook remains strong for companies dominating the heart valve industry as the global market is estimated to grow over 40% in the next decade. Sustained investment in R&D, manufacturing expansion, and reimbursement coverage for newer technology will be critical for companies to capitalize on this lucrative market opportunity and stay ahead of the competition.