Structural Heart Devices Global Market

–Forecast to 2027

Structural Heart Devices Global Market is estimated to be worth $17.4 billion

by 2027

IQ4I Research & Consultancy published a new report on “Structural Heart Devices
Global Market – Forecast To 2027” This report analyzes and studies the overall market,
major Drivers & Opportunities, Restraints & Threats in North America, Europe, Asia-Pacific
and Rest of the World.

IQ4I’s Report Contains 108 market data tables and 80 figures spread through 453
pages and an exhaustive TOC on “Structural Heart Devices Global Market”, [By
Products {Repair devices (Annuloplasty, Valvuloplasty, Occluders, Transcatheter
Mitral Valve Repair and Others), Replacement devices (Surgical Valve Replacement
(Mechanical valves and Tissue valves) and Transcatheter Valve Replacement (TAVR,
TMVR, TPVR)}; By Indication (Heart Valve Diseases (Mitral Valve Disease, Aortic Valve
Disease, Others), Congenital Heart Diseases, Other Structural heart diseases); By
Region (North America, Europe, Asia-Pacific and Rest of the World)]

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.

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Structural Heart Devices Global Market

–Forecast to 2027

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.

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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

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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

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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

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Structural Heart Devices Global Market

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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.

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Reasons for buying this report:

 Structural heart devices global market is expected to reach $17,433.4 million by 2027
at a double digit CAGR during the forecasting period.
 Identification and analysis of the structural heart devices market by identifying
various segments by product, product type, indication and geography.
 Revenue forecast of structural heart devices market and strategic analysis of each
sub-segment with respect to segmental growth trends.
 Identification of major market trends, Porter's model, and factors driving and
restraining structural heart devices market growth.
 Market penetration analysis of structural heart devices, analysis of structural heart
devices global market by number of units and their average selling prices, product
approval analysis, pipeline analysis, TAVR centers and company product and
indication matrix.
 Global individual market share of Annuloplasty repair devices, Valvuloplasty repair
devices, occluders, surgical mechanical valve replacement devices, surgical tissue
valve replacement devices and Transcatheter aortic valve replacement devices
(Global, Europe and U.S.)
 Analysis of the opportunities for stakeholders by identifying the high-growth
segments of the market.
 Identification of key technology developments and innovations driving the market.
 Funding scenario, Clinical trials, Reimbursement scenario, patent and supply chain of
the structural heart devices market by major players.
 Revenue forecast of the structural heart devices market with respect to North
America (U.S. and Rest of North America), Europe (Germany, Italy, France and Rest
of Europe), Asia-Pacific (Japan, China, India and Rest of APAC) and Rest of the
World (Brazil, Turkey and Rest of LATAM & MEA) regions.
 Profiles of major players in structural heart devices market and analysis of their
product offerings, financial revenue, business strategies, SWOTs and market shares.

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Structural Heart Devices Global Market

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FIGURE 1

STRUCTURAL HEART DEVICES GLOBAL MARKET SEGMENTATION

Structural Heart Devices Global Market

Product Indication Region

North
America
Replacement Heart Valve Congenital
Repair Device Others
Device Diseases Diseases
Europe

Annuloplasty Mitral Valve

Disease APAC
Surgical
TC Valve
Valve
Valvuloplasty Aortic Valve
Disease ROW
Mechanical
Occluders Valves TAVR
Others

TC Mitral Tissue Valves TMVR

Valve Repair

TPVR
Others

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