Aortic Valve Market Overview
The global aortic valve market generated $5.6 billion revenue in 2017 and is predicted to progress at a CAGR of 10.3% during 2018–2023. Increasing initiatives for creating awareness about valve replacement, rising prevalence of valvular heart diseases (VHDs), increasing preference for minimally invasive surgeries (MISs), and favorable reimbursement scenario are the major factors driving the market growth.
Based on product, the aortic valve market has been categorized in terms of valve type and suture type. On the basis of valve type, tissue/biological-based heart valves held larger share, in terms of value and volume, during the historical period. Moreover, on the basis of suture type, around 750,000 sutured aortic valves were sold, globally, in 2017.
On the basis of procedure, the aortic valve market has been bifurcated into MISs and open surgeries. Aortic valve replacement through MIS is majorly done using transfemoral approach, which is characterized by a wide diameter of artery allowing easy accessibility to catheter to pass through it. The aortic valves that are used in transfemoral MISs contributed $2,397.8 million revenue in 2017 and is expected to reach $4,897.5 million by 2023.
Moreover, open surgery for aortic valve replacement can be conducted with either a tissue/biological valve or a mechanical valve. Of the two, tissue/biological-based valves contributed larger revenue to the aortic valve market in 2017, accounting for more than 65.0% share, in terms of value. Patients implanted with mechanical heart valves require blood thinners to allow proper blood flow, which, to some extent, increase heart-related problems. Thus, the side-effects associated with mechanical valves have led to increase the adoption of tissue/biological-based valves in recent years.
Based on end user, the aortic valve market has been primarily classified into hospitals and ambulatory surgery centers (ASCs). The demand for artificial aortic valves in hospitals is expected to advance at a CAGR of 11.1% in the forecast period. Developed healthcare reimbursement structure and rising number of patients with cardiovascular and valvular diseases are the major factors driving the demand for aortic valves in this end user category.
Geographically, the European aortic valve market held the largest share in 2017. This growth is attributed to the high prevalence of aortic stenosis in the European countries, increasing product approvals leading to availability of technologically advanced treatment options, and growing initiatives to create awareness about valve replacement surgeries in the region.
Germany accounted for the largest share in the European aortic valve market in 2017, with 27.1% revenue contribution. According to the World Bank, life expectancy in Germany has grown at a steady pace and increased from 77 years in 1996 to 81 years in 2016. Increasing life expectancy indicates the surge in geriatric population with a high risk of CVDs, including aortic stenosis, which is further expected to support the demand for aortic valves in the country in the coming years.
Aortic Valve Market Dynamics
Growth Drivers and Restraints
The healthcare sector is continuously under pressure to improve quality, accessibility, and affordability of aortic valves and to provide technologically advanced surgical procedures. Due to several advantages offered by MISs, their demand is continuously increasing. MISs involve minimal incisions on patient and are performed through one or several small cuts.
Since its commercialization in 2007, the popularity of transcatheter aortic valve replacement (TAVR), a minimally invasive procedure and an alternative to surgical aortic valve replacement (SAVR), has grown exponentially. Moreover, approval of TAVR for new indications is expected to prove as a major opportunity for the aortic valve market players. According to the National Center for Biotechnology Information (NCBI), TAVR has potential to replace conventional ways for aortic valve replacement and will emerge as a new golden standard procedure for the treatment of aortic stenosis. Due to growing awareness about MISs and associated advantages, globally, the number of TAVR surgeries is expected to increase in the coming years.
On the other hand, favorable insurance policies and reimbursement scenario are closely linked with the adoption of aortic valves across the globe. For example, the adoption of TAVR has increased significantly across the European region where it is a well-established technology with proper coverage and reimbursement policies. For instance, on May 1, 2012, the Centers for Medicare and Medicaid Services (CMS) announced that it had issued coverage of TAVR under the Medicare National Coverage Determination (NCD) policy. The current NCD lays out requirements for TAVR procedures used for the treatment of symptomatic aortic stenosis according to a United States Food and Drugs Administration (USFDA)-approved indication.
However, product failures and recalls, and stringent regulatory norms pose a major threat on the aortic valve industry, declining its overall growth in the coming years.
Aortic Valve Market – Competitive Landscape
Key players in the global aortic valve market are investing in acquisitions, to gain larger share in the market. For instance, in May 2017, Boston Scientific Corporation (Boston) acquired Symetis SA (Symetis), a Swiss structural heart company focused on minimally invasive TAVI devices, for $435 million in cash. Post-acquisition, Symetis became a part of Boston’s interventional cardiology division and Boston started selling Symetis’s ACURATE TA and ACURATE neo/TF aortic valve systems in Europe and in other geographies outside of the U.S.
Some of the other key manufacturers in the aortic valve industry are Edwards Lifesciences Corporation, CryoLife Inc., Medtronic plc, Abbott Laboratories, LivaNova PLC, Venus Medtech (Hangzhou) Inc., and LifeNet Health.