Heart Valves Market Size, Share & Industry Analysis, By Product Type (Replacement (Aortic, Mitral, and Others), and Repair), By Valve Type (Tissue Valve and Mechanical Valve), By Procedure (Surgical and Transcatheter), By End User (Hospitals, and Specialty Clinics & Others), and Regional Forecast, 2019-2032

The global Heart Valves Market size was valued at USD 6.58 billion in 2018 and is projected to reach USD 31.27 billion by 2032, exhibiting a CAGR of 11.8% during the forecast period.

Heart valve ensures that the blood flows in the correct direction and at an appropriate pressure. Valve regurgitation is the backward flow of blood through the valve rather than the normal unidirectional flow. According to the American Heart Association, bicuspid aortic valve defects occur in 13.7 per 1000 people in the U.S. This rising prevalence of cardiac valve disorder has surged the demand for prosthetic heart valves. According to the article “The Year in Cardiology 2017 - Valvular Heart Disease” published in the European Heart Journal, the total number of aortic valve replacement procedures are projected to reach 850,000 by 2020. Furthermore, the demand for minimally invasive procedures and technological advancement are compelling the major manufactures to introduce innovative products in the market, which, in turn, is positively impacting the industry.

MARKET TRENDS

Customized Heart Valves to Improve the Clinical Outcomes

One of the major challenges with cardiac valve surgery is that every patient has different heart valves anatomy, especially in the case of the mitral valve. Research and development of 3D printed personalized heart is emerging as the most important Heart Valves Market trend. Strait Access Technologies, a company in South Africa and scientists at ETH Zurich are developing customized cardiac valve made of silicone trough 3D printing technology. When compared to the conventional ones, the customized heart valves can be easily tailored as per to the patient’s anatomy within an hour and a half. This will also help to improve clinical outcomes. Thus, the development of these similar customized valves is likely to aid in the expansion of the market during the forecast period.

MARKET DRIVERS

Increase in Number of Heart Valves Surgery to Drive Market

The increasing number of replacement and repair heart surgeries, especially minimally invasive surgeries, are the key factors boosting the cardiac valve market growth. The increasing prevalence of aortic stenosis, cardiac valve vegetation, and other valvular stenosis diseases is multiplying the number of surgeries being performed worldwide. According to the German Heart Surgery Report, a total of 34,394 heart valve procedures were conducted in Germany in 2017. This is expected to drive the global Market growth during the forecast period. Furthermore, the gradual shift towards minimally invasive surgery, including transcatheter heart valve replacement, is poised to surge the market.

Launch of Innovative Products to Boost the Market

The cardiac valve market is anticipated to expand during the projected horizon owing to the introduction of new products in the market. Already, the introduction of tissue valves has revolutionized the prosthetic Heart Valves Market. Now, with the launch of products that are minimally invasive and sutureless, the market is expected to gain significant momentum. For example, in September 2019, Medtronic announced the launch of Evolut PRO+, a transcatheter aortic valve replacement (TAVR) system in the U.S. Apart from this, many manufacturers are carrying dedicated research and clinical trial for the development of innovative heart valves. For example, in September 2019, Abbott initiated the TRILUMINATE pivotal trial for the evaluation of TriClip, a transcatheter tricuspid valve repair for treating tricuspid regurgitation. Similar research by key manufacturers is likely to attract more Heart Valves Market revenue in the forthcoming years.

MARKET RESTRAINT

Complications Associated with Heart Valve Replacement may Hamper Market

Heart valve replacement, being an invasive procedure, is associated with potential risk and stands as a major factor limiting the cardiac valve market growth. The complications associated with this replacement surgery include excessive bleeding, arrhythmia, kidney problems, stroke, heart failure, blood clots, infection, and others. Although, minimally invasive procedures are available with less risk and complications; the cost of the surgery is very high when compared to invasive surgery. These complications can significantly affect the patient pool undergoing surgery, thereby, hampering the market size.

SEGMENTATION

By Product Type Analysis

Favorable Health Reimbursement to Favor the Replacement Segment

Based on product type, the market is segmented into replacement and repair. The replacement segment can be further classified into aortic, mitral, and others. The replacement segment is estimated to hold the major portion of this market share in 2018, owing to the significant increase in the number of valve replacement surgeries and favorable health reimbursement. Rising prevalence of valve disease and technological advancement in cardiac valve replacement procedures are anticipated to favor the expansion of the replacement segment. Among the replacement segment, the mitral sub-segment is estimated to witness remarkable business opportunities. This is owing to the huge unmet patient’s needs due to under treatment. A report by Edwards Lifesciences states that less than 2% of the patients with mitral valve disease receive interventions, leaving millions of patients in need of treatment. This highlights the growth opportunities present in the mitral sub-segment.

The repair segment is expected to grow during the forecast period owing to the increasing prevalence of mitral regurgitation and rise in research for the development of transcatheter repair products.

By Valve Type Analysis

Tissue Valve Segment to Witness Remarkable Growth

In terms of valve type, the market is segmented into tissue valve and mechanical valve. Introduction of bioprosthetic valves with advantages such as flexibility, strength, and less need of anticoagulants has resulted in dominant share of the tissue valves segment. This also hampered the demand for mechanical valves in the market. Moreover, mechanical valves were associated with thromboembolic complications, which rendered higher growth rate to the tissue valve segment.

The mechanical valve segment is poised to surge due to the high cost of tissue valves, increasing prevalence of valve regurgitation, and favorable health reimbursement.

By Procedure Analysis

Shift Towards Minimally Invasive Procedures to Forster the Transcatheter Segment

On the basis of procedure, the market is segment into surgical and transcatheter. With the increasing awareness among patients, there is a gradual shift towards minimally invasive procedures, which in turn is increasing the demand for transcatheter heart valve. Furthermore, technological advancement and the launch of new products are likely to augment the growth of the transcatheter segment. For example, in November 2019, Edward Lifesciences received CE mark for Edwards SAPIEN 3 to expand its use for the treatment of patients with aortic stenosis having lower risk for open heart surgery. Strategic collaborations between major manufacturers, rising number of replacement and repair procedures, and increasing geriatric population are factors attributable to the expansion of the surgical segment.

By End User Analysis

Hospital Segment to Account for Major Portion of the Market

In terms of end user, the market is segmented into hospitals, specialty clinics & others. Increasing number of procedures in hospitals, favorable health reimbursement, improving government guidelines for the management for vulvar diseases are primary reasons contributing to the expansion of the hospital segment. Growth of the specialty clinics & others segment is likely to rise owing to the increasing number of private practitioners and unmet patient needs.

REGIONAL ANALYSIS

The Market size in North America stood at USD 2.64 billion in 2018. Favorable health reimbursement, increasing number of valve repair and replacement procedures, and rising obese population are the primary factors responsible for North America’s dominance. According to the American Heart Association, 90,000 valve substitutes are implanted in the U.S. every year. This is poised to surge the demand for prosthetic heart valves in North America. In Europe, the market is estimated to expand owing to the increasing prevalence of cardiac valve disease and gradual shift towards minimally invasive procedures. According to the European Society of Cardiology, in 2017, the average proportion of male and female with elevated blood pressure in Europe were 28% and 20% respectively. This is expected to foster the prosthetic Heart Valves Market in Europe.

In Asia Pacific, the market is projected to grow, attributed to the rising geriatric and obese population, rapid adoption of tissue valves, and active government support. In Latin America and the Middle East & Africa, the demand for cardiac heart valve is anticipated to increase owing to rising cases of valve regurgitation and improving health infrastructure. According to Innovus, a technology transfer company owned by Stellenbosch University, an approximate of 1,400 aortic valve replacements are performed annually in South Africa. This is likely to favor the market in the Middle East and South Africa.

KEY INDUSTRY PLAYERS

Edwards Lifesciences and Abbott to have Leading Position Owing to their Diverse Product Portfolio

Edwards Lifesciences held the maximum share, which can be attributed to the diverse product portfolio of the company and increasing demand for their SAPIEN range of valves. The company is focused on developing new products to best suit the requirements of the patients. This is expected to strengthen the company’s position in the overall market. On the other hand, Abbott which entered the market by the acquisition of St. Jude Medical, Inc. and is now ranking second. The market position of Abbott is likely to expand owing to the increasing research investment, thereby increasing the heart valves market revenue.

LIST OF KEY COMPANIES PROFILED:

• Edwards Lifesciences Corporation


• Abbott


• Medtronic


• LivaNova PLC


• Boston Scientific Corporation


• CryoLife, Inc.


• Micro Interventional Devices, Inc.


• Others

KEY INDUSTRY DEVELOPMENTS:

• September 2019 –Medtronic announced the launch of Evolut PRO+, a transcatheter aortic valve replacement (TAVR) system in the U.S.


• September 2019 –Abbott initiated the TRILUMINATE pivotal trial for the evaluation of TriClip, a transcatheter tricuspid valve repair for treating tricuspid regurgitation.

REPORT COVERAGE

The Heart Valves Market report offers an elaborative analysis of numerous factors affecting the market. These include opportunities, growth drivers, threats, key developments, and restraints. In addition to this, it further helps in analyzing, segmenting, and defining the market based on different categories such as prosthetic heart valve types, procedure, product type, and end user. It analyzes several strategies such as product innovations, mergers, alliances, joint ventures, and acquisitions adopted by players in the industry.

Report Scope & Segmentation