Aortic Valve Market Overview
The global aortic valve market generated revenue of $5.9 billion in 2017 and is projected to showcase a CAGR of 10.8% during the forecast period, due to the increasing prevalence of valvular diseases, growing number of product launches and approvals, increasing number of clinical trials and surge in adoption of minimally invasive procedures. Transcatheter and sutureless valves are among the different type of valves used to perform the aortic valve replacement procedures. The demand for transcatheter valve is high, that led to a contribution of 58.8% share in the aortic valve market in 2017.
GLOBAL AORTIC VALVE MARKET, BY END USER, $M (2014–2025)
Based on surgery type, the aortic valve market is categorized into open surgery and minimally invasive surgery (MIS). Open surgery accounted for the largest share in 2017 and contributed 55.7% in the market. Hospitals, and other healthcare providers are the key end users in the aortic valve market, with hospitals being the largest end user in 2017. This leading position of the hospitals is mainly driven by increasing prevalence of valvular diseases and rising number of patient population in the hospitals.
Globally, North America attained the highest position in the aortic valve market, owing to increasing prevalence of valvular diseases, growing aging population, high healthcare expenditure, developed reimbursement structure, and presence of large number of medical device companies introducing advanced transcatheter valves.
Aortic Valve Market Dynamics
Minimally invasive procedures refer to the surgeries involving least surgical dissection to reduce trauma to the body and is performed using an endoscope for visual guidance, and thin needle. This procedure reduces pain and haemorrhaging due to minimal surgical incision, thereby reducing the recovery time post-surgery. Some of the other advantages of these surgeries include reduced exposure of internal organs to the external contaminants, less medication needed, reduced chances of blood transfusion and minimal post-operative scarring.
The advantages of MIS when compared to an open surgery include less trauma, decrease in hospitalization expenditures due to shorter hospital stay and quick post-operative recovery. Due to reduced prices and advantages, there is an increase in the adoption of minimally invasive procedures, including for valvular diseases, which in turn has led to a surge in the adoption of minimally invasive procedures for performing MIS, thereby leading to the growth of the aortic valve market.
Aortic stenosis and aortic regurgitation are the leading causes of heart valve replacement. The population at risk for aortic stenosis is rising. According to the estimates by John Muir Health, a non-profit integrated system for doctors, hospitals and other services, every year more than five million are diagnosed with heart valve disease such as aortic stenosis. It further reported that, approximately 1.5 million people in the U.S. diagnosed with aortic stenosis each year.
Aortic regurgitation is another valvular disease that requires aortic valve replacement surgery. Prevalence of this condition increases with age. Thus, rising geriatric population is a significant factor for market growth. The most common cause of aortic regurgitation is rheumatic heart disease. Rheumatic heart diseases are systematic inflammatory heart diseases. According to the WHO, approximately 2% of the population with CVDs have rheumatic heart diseases. Thus, growing incidence of rheumatic heart diseases is one of the key factors, which is anticipated to positively impact the aortic valve market in the following years.
Increasing number of clinical trials to study advanced aortic valves and existing valves to extend their indications is further fuelling the growth of the aortic valve market. For instance, in March 2018, LivaNova Plc announced the first patient enrolment in the Perceval Valve clinical study for Chinese Registration (“PERFECT”) TRIAL. This pre-market, prospective, single-arm trial study is being conducted to demonstrate the safety and effectiveness of Perceval sutureless aortic valve.
In January 2018, LivaNova Plc announced the enrolment of fist patient in the Behaviour of Valve Leaflets and the Incidence of Reduced Mobility Post-Surgical Aortic Valve Implant Study (“BELIEVE”). This post-market, prospective, international multicentre trial designed to study the overall incidence of reduced leaflet motion in patients receiving a commercially approved LivaNova bioprosthetic aortic heart valve in the U.S. and Canada.
Product recalls of aortic valves is a restraining factor for the aortic valve market. Product approval process is subject to strict regulations. As these devices are used in treating life-threatening conditions, safety is a major concern about these products. Boston Scientific Corporation announced product recall of its Lotus range of heart valves due to the problems associated with its locking mechanisms. Medtronic plc announced product recall of Medtronic 3f Enable Aortic Bioprosthesis owing to issues in instructions for use of the device. However, with changes in regulations, the process of approval might become stringent in the near future, which may reduce product recalls.
Aortic Valve Market – Competitive Landscape
With a number of technological advancements taking place in the aortic valve industry, the players are seeking approvals and introducing new and advanced valves to increase their market share. For instance, In March 2018, LivaNova Plc received CE Mark approval for its Bicarbon aortic valves for use with low-dose anticoagulant therapy. This expanded indication of the company’s Bicarbon family of mechanical valves is based on evidence and results from the LOWERING-IT trial.
In February 2018, Edwards Lifesciences Corporation received CE Mark for its self-expanding CENTERA valve for severe, symptomatic aortic stenosis patients at high risk of open surgery. In July 2017, Edwards Lifesciences Corporation received approval from USFDA for its INSPIRIS RESILIA aortic valve, the first in a new class of resilient heart valves for heart valve patients. Some of the other key players operating in the aortic valve industry are Medtronic plc, CryoLife Inc., Boston Scientific Corporation.