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Market Overview
- The Global Transcatheter Aortic Valve Replacement (TAVR) Market is expected to grow at a CAGR of 14.8% during the forecasting period (2020-2027).
- Transcatheter aortic valve replacement (TAVR) is a minimally invasive surgical procedure for heart disease in which the valve is used to replace the old or damaged heart valve. This procedure helps to reduce severe degenerative aortic stenosis and upsurges the survival rate of patients.
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Market Dynamics
- The global transcatheter aortic valve replacement (TAVR) market is driven by several growth factors such as the rising prevalence of cardiovascular disorders such as heart failure (HF), coronary artery diseases (CAD), and hypertension. Cardiovascular diseases (CVDs) cause improper functioning of aortic valves, hence fuelling the demand for efficient valve replacement procedures. According to the National Health and Nutrition Examination Survey (NHANES) data (2016), an estimated 6.2 million American adults ≥20 years of age (2.2%) had heart failure between 2013 and 2016 compared with an estimated 5.7 million between 2009 and 2012. More than 5.7 million Americans suffer from heart failure, and there are approximately 915,000 new patients diagnosed with the disease annually. According to the World Health Organization (WHO), the number of people suffering from cardiovascular disorders will surge to 22.2 million by 2030 globally.
- Also, rising implementation of minimally intrusive processes over traditional surgical open-heart procedures, increasing studies on transcatheter aortic valve replacement (TAVR) for low risk of infection, minimal blood loss is further boosting the market growth. Transcatheter aortic valve replacement (TAVR) has been studied as an alternative to surgical aortic valve replacement in high and intermediate-risk surgical patients for more than five years. In May 2019, a new clinical trial, one of two studies on the topic presented at the American Association for Thoracic Surgery's 99th Annual Meeting, found the procedure to be equivalent or potentially preferable to surgical aortic valve replacement (SAVR) for low-risk patients.
- Increasing advancement in technology, new product launch, rising funding for research & development activities, increasing collaboration and mergers by major players are also some of the factors boosting the growth of the TAVR market globally. For instance, in March 2017, Boston Scientific Corporation acquired Symetis SA for US$ 435 million to sell the ACCURATE TA™ and ACCURATE neo™/TF™ valve systems in Europe and other geographies outside of the United States for the treatment of patients suffering from symptomatic aortic valve stenosis globally.
- In August 2017, Edwards Lifesciences Corporation focused on R&D to launch Edwards Sapien 3 Ultra System and Centera which include Axela sheath technology and on-balloon delivery design that make the procedure faster and reduce the possibility of any error.
- On August 16th, 2019, FDA approved Sapien 3, CoreValve Evolut TAVR valves for low-risk patients, TAVR now available for all patients with severe, symptomatic aortic stenosis.
Segment Analysis
- By type, the global transcatheter valve replacement (TAVR) market is segmented into transaortic implantation, transfemoral (TF) implantation, and transapical (TA) implantation. Among these, transfemoral (TF) implantation accounted for the largest market share in 2018 and estimated to grow at a significant growth rate during the forecast period. Transfemoral implantation is a standardized and consistent procedure in which an artificial valve is inserted through the femoral blood vessel with the minimally invasive procedure and negligible anesthesia. The transfemoral implantation procedure is the most common catheter-based approach and is performed in more than 80% of the transcatheter valve replacement (TAVR) cases, globally.
- Also, due to advanced technological systems and various platforms by key players, the segment is growing further during the forecast period. For instance, in September 2018, Israel's cardiovascular device developer Cardio valve launched both the Ahead US and Ahead EU multicenter studies of its Cardio valve transfemoral mitral valve replacement system. In September 2017, Integrum launched the OPRA Implant System Platform G for transfemoral patients. The new platform is CE labeled and approved by the FDA improves the mechanical performance of the system, simplifies the surgical procedure, and enhances osseointegration. In September 2014, Symetis SA, a European developer of transcatheter aortic valve implantation (TAVI) systems, launched ACCURATE neo™, its 15F compatible transfemoral TAVI system.
Geographical Analysis
- North America is dominating the transcatheter aortic valve replacement (TAVR) market in 2018 and estimated to hold the largest market size over the forecast period (2020-2027), owing to the rising prevalence of cardiovascular disease (CVD). It is one of the major causes of death, accounted for 840,678 deaths in the US in 2016, approx. 1 of every 3 deaths. Between 2013 and 2016, 121.5 million American adults had some form of cardiovascular disease. As per the American Heart Association, 2019, 116.4 million or 46% of the US adults are estimated to have hypertension. In 2016, Coronary Heart Disease was the leading cause (43.2%) of deaths attributable to cardiovascular disease in the US, followed by stroke (16.9%), High Blood Pressure (9.8%), Heart Failure (9.3%), diseases of the arteries (3.0%), and other cardiovascular diseases (17.7%).
- Also, the rising adoption of technologically advanced products, increasing mergers & acquisitions among major players, and favorable reimbursement policies are some of the factors leading to the growth of the TAVR market in this region. For instance, government organizations in the United States such as Centers for Medicare & Medicaid Services (CMS) help patients to opt for transcatheter aortic valve replacement procedure. According to the Journal of the American College of Cardiology, in the United States, 25 000 transcatheter valve implantation (TAVI) procedures were performed in 2015, and this figure is estimated to reach 100 000 procedures by 2020.
- Europe's transcatheter aortic valve replacement (TAVR) market is growing at the highest growth rate during the forecast period (2020-2027) due to the rising cases of severe aortic stenosis along with growing elderly population, and high adoption rate of advanced transcatheter aortic valves. In Germany, all transcatheter valve implantation (TAVI) and surgical aortic valve replacement (SAVR) procedures are registered within an obligatory quality assurance program led by the independent Institute for Applied Quality Improvement and Research in Health Care (AQUA). According to the AQUA reports, the annual number of SAVR procedures decreased from 11,205 in 2008 (mean age, 69.8 years) to 9,953 in 2014 (mean age, 68.5 years). On the other hand, the number of transcatheter valve implantation (TAVI) procedures has increased 20-fold, from 637 in 2008 (mean age, 81.6 years) to 13,264 in 2014 (mean age, 80.9 years) and has exceeded the annual numbers of isolated SAVR since 2013.
- In Europe, countries such as France, Germany, and Italy are leading markets for TAVR with rising aortic valve procedure, and technological advancement in the devices. For instance, in 2015, according to the National Center for Biotechnology Information (NCBI), around 31,000 aortic valve procedures were performed in Germany, owing to advancements in aortic valve replacement procedure, making it the most preferred destination for valve replacement implantation. In August 2016, Medtronic received CE mark approval for the self-expanding, recapturable and repositionable CoreValve Evolut R System to treat aortic stenosis patients who are at intermediate risk for open-heart surgery. The Evolut R System is the first transcatheter aortic valve replacement (TAVR or TAVI) device to obtain this expanded indication in Europe.
Competitive Landscape
- The Transcatheter Aortic Valve Replacement (TAVR) market is dominated by few major players including Medtronic plc, Boston Scientific Corporation, St. Jude Medical, Inc., Edwards Lifesciences Corporation, HLT, Inc., JenaValve Technology, Inc., Direct Flow Medical, Inc., Meril Life Sciences Pvt. Ltd., Transcatheter Technologies GmbH, SYMETIS SA, among others. The key players are also adopting various growth strategies such as mergers & acquisitions, partnerships, and collaborations which are contributing to the growth of the Transcatheter Aortic Valve Replacement (TAVR) market globally. The players are also focusing on product approvals and developing innovative products to strengthen their product portfolio that intensifies the market competition.
- In June 2019, Meril Life Sciences became the first Indian company to market and distribute its indigenously designed and patented TAVR technology, MyvalTM -THV system, to the European Union and other countries. The product has received the coveted CE approval in April 2019.
- In April 2019, the FDA approved Boston Scientific's LOTUS Edge Aortic Valve System in patients at high risk for surgical valve replacement via open-heart surgery.
- In August 2017, Edwards Lifesciences Corporation focused on R&D to launch Edwards Sapien 3 Ultra System and Center. These include Axela sheath technology and on-balloon delivery design that make the procedure faster and reduce the possibility of any error. This would enable the company to be more competitive with other players such as Medtronic, Boston Scientific Corporation, and Abbott.
- In July 2017, Medtronic plc launched the CoreValve Evolut PRO valve system in Europe for the treatment of aortic stenosis. The system will offer innovative medical technology for the surgical treatment of cardiovascular disease, which estimated to bolster the company’s growth in the field of cardiac surgeries.
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