Structural Heart Devices Global Market is estimated to be worth $17.4 billion by 2027
Structural heart diseases (SHDs) consist of a wide spectrum of non coronary cardiac diseases characterized by the altered anatomy of the heart or its structures like valves, walls, chambers or pockets. Specifically, these are structural abnormalities in the heart’s chambers and valves that usually range from the congenital abnormal communications between the chambers of the heart to the acquired valvular diseases. The incorrectly shaped or damaged cardiac structures that alter blood flow and lead to various serious complications like stroke, cardiac arrest or heart failure warrant efficient structural heart interventions with various advanced and effective structural heart devices to efficiently treat SHDs and the associated complications non-traumatically, at reduced risk and at a faster recovery rate. These therapeutic interventions with technologically advanced devices ensure longer lifespan for structural heart disease patients, greater quality of life through enhanced autonomy, reduced strain on caregivers and healthcare spending. Incredible technological advancements in the rapidly evolving and growing structural heart disease field have made various previously unthinkable transcatheter procedures associated with reduced procedural risks, rapid recovery rates and improved patient satisfaction to become the norm for various life threatening structural heart diseases like -heart valve diseases and congenital heart diseases and in ensuring better therapeutic outcomes in high risk patients. Valvular heart diseases have affected approximately 209 million people across the globe in 2018. According to Centers for Disease Control and Prevention (CDC), approximately 2.5% of the U.S. population has valvular heart disease. According to American Heart Association, the birth prevalence of congenital heart diseases (CHDs) in the North America, Europe and Asia is 6.9, 8.2 and 9.3 per 1000 births respectively.
The structural heart devices global market is expected to reach $17,433.4 million by 2027 growing at a double digit CAGR from 2020 to 2027. Some of the factors such as increasing structural heart disease burden among the global population, increasing adoption and preference of minimally invasive surgical procedures for various kinds of structural heart diseases and persistently elevating geriatric population who are ineligible for open heart surgical interventions, availability of various technologically advanced and minimally invasive structural heart therapeutic products and advanced imaging techniques to finely elucidate, treat and diagnose the structural abnormalities of the heart are currently driving the market growth. Factors like increasing expanded indication approval of various transcatheter structural heart products for intermediate risk or low risk patients, increasing R&D spending for developing innovative and technologically advanced products, vast structural heart product pipeline, growing economies and increasing demand for better healthcare facilities in emerging markets are further substantiating enormous growth opportunities of the market. Insufficient number of trained and skilled healthcare professionals for handling the various innovative, advanced and sophisticated structural heart products, high cost of the more efficient, advanced structural heart products that impede their penetration especially in low-and middle-income countries, limited reimbursement policies especially in developing nations, stringent regulatory requisites for obtaining marketing approval for the structural heart devices and adverse effects associated with the use of various structural heart products are some of the factors that are hindering the market growth.
The structural heart devices global market is classified into various market segments such as Product, Indication and Geography. Based on the type of product, the market is segmented as Structural heart repair devices and structural heart replacement devices. The structural heart replacement devices segment accounted for the largest revenue in 2020 and is expected to grow at a double digit CAGR from 2020 to 2027 primarily due to the increasing prevalence of structural heart diseases across the globe, especially among the geriatric population and elevating demand for better, quicker, advanced and durable therapeutic options for these diseases from the value centric patient pool. The structural heart repair devices segment is the fastest emerging segment growing at a low teen CAGR from 2020 to 2027. The fastest growth rate of this segment is mainly due to increasing prevalence of structural heart diseases among the younger population of the world and the advantages associated with the repair procedures like reduced risk of infection, preservation of native heart structures and muscle strength and minimal requirement for anticoagulant medications.
Among the various structural heart repair products, Transcatheter mitral valve repair devices segment accounted for the largest revenue in 2020 and is expected to grow at a mid teen CAGR from 2020 to 2027 due to the increasing mitral valve disease burden among the world population and escalating demand for minimally invasive therapeutic procedures for these diseases. Other repair devices (like chordal implants, Transcatheter tricuspid repair devices) segment is the fastest emerging segment and is expected to exhibit exponential growth during the forecasted period due to the increasing prevalence of mitral regurgitation attributed to chordate tendineae rupture, ventricular remodeling associated with acute myocardial infarction among the global population and availability and development of various minimally invasive therapeutic options for these life threatening conditions. Among the structural heart replacement devices, Transcatheter valve replacement device segment accounted for the largest revenue in 2020 and is expected to grow at mid teen CAGR from 2020 to 2027 due to their highly efficient, minimally invasive therapeutic mechanism for structural heart diseases.
The structural heart devices global market, by indication has been grouped into heart valve diseases, congenital heart diseases and other structural heart diseases. Among these, the heart valve disease segment commanded the largest revenue in 2020 and is expected to grow at a low teen CAGR from 2020 to 2027 due to the large number of valvular heart disease patients throughout the globe in need of various efficient, durable, technologically advanced and non or minimally traumatizing therapeutic interventions.
The structural heart devices global market based on geography is segmented into North America, Europe, Asia-Pacific and the Rest of the world (ROW). North American region dominated the structural heart devices global market and accounted for the largest revenue in 2020 and is expected to grow at a double digit CAGR from 2020 to 2027, mainly due to increasing penetration and adoption of advanced therapeutic structural heart disease products for the highly prevalent structural heart diseases in the region, persistently escalating geriatric population with requisites of various durable and quicker structural heart disease therapeutic interventions, increasing research in structural heart disease field leading to the development of various innovative and technologically advanced products, increasing demand for efficient and technologically advanced, minimally invasive structural heart devices, elevating healthcare expenditure and increasing focus on healthcare. The Asia-Pacific region is the fastest growing region in structural heart devices market in 2020 and is expected to grow at a mid teen CAGR during the forecasted period owing to large structural heart disease patient base in these countries, increasing surgical procedures associated with various structural heart diseases, increasing per capita expenditure on healthcare needs, growing economies of this region, elevating demand for better and advanced structural heart therapeutic products, increasing income and affordability of the population here, high geriatric population demographics, increasing awareness and public spending in healthcare, increasing private investment in healthcare sector, increasing penetration of health insurance schemes, innovations promoted by public private partnership (PPP), and the growing medical tourism prospects of the region.
Technological advancements are rapidly revolutionizing the structural heart devices industry with various innovative and value based, patient friendly devices emerging in the market. Some of the major advancements in this field include development of polymeric heart valves with enhanced durability, reduced valve procedure associated thrombogenicity issues and substantially reduced medical care costs; real-time image-guided, non invasive, painless ultrasound therapeutic device for repairing diseased aortic valve leaflets; development of temporarily existing biodegradable occluders associated with fewer complications; valve in valve procedure as an alternative to the highly risky surgical redo procedures; adjustable annuloplasty rings that ensure optimal ring sizing and establishment of sufficient leaflet coaptation and sutureless valves that are easy to implant, ensure reduction in cardiopulmonary and aortic cross-clamp times and substantial reduction of future paravalvular leaks. Upcoming technologies like creation of durable, biocompatible and regenerative heart valves that overcome the limitations of the currently available mechanical or bioprosthetic valves and eliminate the need of future replacement surgeries; 3D bioprinted heart valves that aid in accurate valve sizing and selection as per the anatomical features of the patients are expected to drive the structural heart disease market in the coming years. Thus the current technological advancements and upcoming technologies that help in overcoming the budget constraints and limitations of the present innovations will help in reversing the scattered adoption and implementation rate of the highly efficient structural heart interventions.
Even though the structural heart devices market is consolidated the various underserved spaces and unmet needs of the structural heart diseases offer huge opportunity for existing players as well as the new entrants. The penetration data for various Transcatheter structural heart products and the procedures was estimated by considering the prevalence of various structural heart diseases among the population of different regions, number of eligible patients for various transcatheter procedures and open surgical procedures based on risk stratification and severity of the disease, the average selling price of the various Transcatheter structural heart products, number of units sold and the actual number of surgical and transcatheter procedures performed in these diseased population. According to IQ4I analysis, the global eligible severe, symptomatic aortic stenosis (SSAS) elderly patients (65 years and above) is estimated to be 3.4 million in 2020. The number of Transcatheter aortic valve replacement (TAVR) procedures for these patients is estimated to be xxx, indicating a penetration rate of xx% with an opportunity of xx% for TAVR product manufacturers in the market. The market penetration rate for TAVR is expected to reach x% by 2027. TAVR market has immense growth opportunities due to the various advantages of these procedures compared to the open surgical procedures. The number of Surgical aortic valve replacement (SAVR) procedures for these patients is estimated to be xxx indicating a penetration rate of x% with an opportunity of xx% for SAVR product manufacturers in the market. The market penetration rate for SAVR is expected to decrease to x% by 2027. SAVR market is gradually being displaced by the more advantageous TAVR procedures in developed nations but is still the most exercised therapeutic procedure for aortic stenosis in many of the developing nations due to the cost constraints. According to IQ4I analysis, global mitral regurgitation candidates’ eligible for Transcatheter mitral valve repair or replacement procedures is estimated to be xx million in 2020. The number of Transcatheter mitral valve repair or replacement procedures for these patients is estimated to be xxx indicating a penetration rate of only x% with an opportunity of x% for Transcatheter mitral valve product manufacturers in the market. The market penetration rate for Transcatheter mitral valve products is expected to reach x% by 2027.
To gain more market share by bringing innovative and differentiated products to the market and to stay abreast in the patient-driven market with smart and superior medical devices, the structural heart device companies are constantly striving for the approval or launch of innovative structural heart therapeutic devices especially in the potentially growing but untapped disease areas. For instance, in May 2020, Edwards PASCAL transcatheter valve repair system received CE mark approval for the treatment of patients with tricuspid regurgitation (TR). In April 2020, TriClip Transcatheter Tricuspid Valve Repair System, a minimally invasive, clip-based tricuspid valve repair device, of Abbott became the first to be commercially available in the world after receiving CE Mark approval for non-surgical treatment of tricuspid regurgitation (TR).
Most of the structural heart devices companies are trying to expand and enhance their product offerings to increase their market access and to perpetuate their leadership status in the market. To enhance their core capabilities and product offerings, companies are adopting the strategy of acquisition that helps them to expand their technology to address new sections of the market or provide them access to innovative products of small niche players in the market. For instance in August 2019, Atricure acquired SentreHEART, Inc., a privately held developer of percutaneous left atrial appendage management solutions to broaden its offerings in LAA management solutions.
The structural heart devices market is consolidated with the top five players occupying xx% of the market share and the remaining xx% of the market being occupied by other players. The top players in structural heart devices market are Edwards Lifesciences Corporation (U.S.), Medtronic PLC (Ireland), Abbott Laboratories (U.S.), Livanova PLC (U.K.), Boston Scientific Corporation (U.S.), Cryolife Inc. (U.S.), AtriCure, Inc. (U.S.), Venus Medtech (Hangzhou) Inc (China), Lifetech Scientific Corporation (China), NuMed Inc. (U.S.) and others.