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Forecast Period
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2025-2029
|
|
Market Size (2023)
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USD 6.81 Billion
|
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CAGR (2024-2029)
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8.64%
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Fastest Growing Segment
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TAVR
(Transcatheter Aortic Valve Replacement)
|
|
Largest Market
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North America
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|
Market Size (2029)
|
USD 11.22 Billion
|
Market OverviewGlobal
Structural Heart Devices Market was valued at USD 6.81 Billion in 2023 and is
expected to reach USD 11.22 Billion by 2029 with a CAGR of 8.64% during
forecast period. The market is primarily propelled by the significant
prevalence of target diseases. The global structural heart devices market has
been experiencing significant growth over recent years, driven by advancements
in medical technology, an aging population, and increasing prevalence of
structural heart diseases. Structural heart diseases (SHD) include a range of
conditions involving defects in the heart's structures, such as the heart
valves, walls, and chambers. As the global burden of SHD rises, so does the
demand for innovative and effective structural heart devices. As per the
National Institute of Health in 2020, roughly 60 million individuals in the
United States exhibit structural abnormalities in their hearts, comprising
approximately 20-25% of the adult population in the country. This underscores
the extensive potential for these devices in managing structural heart defects.
The treatment of structural heart disease (SHD) encompasses a broad range of
percutaneous interventions designed for patients with acquired heart disease
and congenital heart disease (CHD), which relate to functional and structural
irregularities in cardiac chambers, proximal major vessels, and heart valves.
Key Market Drivers
Rising Prevalence of Cardiovascular Diseases
Cardiovascular diseases have long held the
unenviable title of being the leading cause of death worldwide. According to
the World Health Organization, an estimated 17.9 million people die each year
due to cardiovascular diseases, accounting for nearly one-third of all global
deaths. This alarming statistic highlights the urgent need for advanced medical
interventions, and it's precisely this needs that has set the stage for the
remarkable growth of the global structural heart devices market. As global life expectancies increase, so does the
prevalence of cardiovascular diseases. Age is a well-established risk factor
for heart-related conditions, and as the world's population ages, more
individuals are at risk of developing heart problems. Modern lifestyles, characterized by sedentary
behavior, unhealthy diets, and increased stress, are taking a toll on heart
health. Smoking, excessive alcohol consumption, and poor dietary choices have
become common, contributing to the development of cardiovascular diseases. The worldwide obesity epidemic is strongly linked
to heart diseases. Obesity increases the risk of hypertension, diabetes, and
other conditions that strain the cardiovascular system, leading to a higher
prevalence of heart diseases.
With a growing number of individuals affected by
heart diseases, there's a larger patient pool in need of advanced treatment
options. Structural heart devices offer minimally invasive alternatives to
traditional open-heart surgeries, making them an attractive choice for both
patients and healthcare providers. The evolving landscape of medical technology has
brought about more effective and safer structural heart devices. These devices
are designed to address specific cardiovascular conditions, offering tailored
solutions for patients. Technological innovations have made procedures less
invasive, with shorter recovery times, attracting a broader range of patients. The rising prevalence of cardiovascular diseases is
not limited to developed nations. Emerging economies are experiencing a surge
in heart-related conditions as lifestyles and dietary habits change. This trend
has led to an increased demand for structural heart devices in these regions. Many governments and healthcare organizations
recognize the importance of cardiovascular care. As a result, they have
implemented reimbursement policies that support structural heart device
procedures, making them more accessible to patients. This financial assistance
encourages patients to choose these advanced treatments.
Advancements in Minimally Invasive Procedures
The landscape of healthcare is continually
evolving, with a notable shift towards less invasive treatment options. This
transformation is not only revolutionizing patient care but also propelling the
growth of the global structural heart devices market. Minimally invasive procedures involve techniques
that allow healthcare providers to perform medical interventions with less
trauma to the patient's body. These procedures typically require smaller
incisions, reduced hospital stays, and faster recovery times, making them an
attractive option for both patients and healthcare providers. In the realm of
cardiovascular care, minimally invasive procedures have made significant
strides, and structural heart devices are at the forefront of this
transformation. Minimally invasive procedures, which often use
structural heart devices, offer patients several advantages. These procedures
are associated with less pain, shorter hospital stays, and quicker recovery
times compared to traditional open-heart surgeries. Patients appreciate the
reduced physical and emotional burden, which is a crucial factor in the
increasing adoption of structural heart devices. Advancements in minimally invasive techniques have
expanded the range of applications for structural heart devices. Originally
developed to address heart valve defects, these devices are now used for a wide
array of cardiovascular conditions, including atrial septal defects, patent
foramen ovale closure, and left atrial appendage occlusion. This
diversification has broadened the market's scope, attracting a larger patient
base.
The rapid evolution of medical technology has led
to the development of increasingly sophisticated structural heart devices.
These innovations have made procedures safer, more efficient, and more
accessible. For example, transcatheter heart valves have undergone significant
improvements in terms of design, materials, and deployment techniques, ensuring
better outcomes and safety for patients. Minimally invasive procedures are often more
cost-effective than traditional open-heart surgeries. Shorter hospital stays
and quicker recoveries translate to lower healthcare costs for both patients
and providers. This cost-efficiency has made structural heart devices a more
attractive option for healthcare systems around the world. Patients today are more informed and proactive
about their healthcare choices. The reduced risks, pain, and downtime
associated with minimally invasive procedures align with patient preferences
for less invasive treatments. As patients become more involved in their
healthcare decisions, they are increasingly opting for procedures that offer
better post-operative experiences.
Growing Aging Population
The world is experiencing a significant demographic
shift with the rapid increase in the aging population. This demographic change
is not only transforming societies and healthcare systems but is also emerging
as a key factor fueling the growth of the global structural heart devices
market. The global population is aging at an unprecedented
rate. Several factors contribute to this phenomenon, including increased life
expectancy, declining birth rates, and advances in healthcare. This demographic
shift is especially pronounced in developed nations, but emerging economies are
also witnessing a gradual rise in their elderly populations.
Cardiovascular diseases and aging are intricately
linked. As individuals grow older, their risk of developing heart-related
conditions increases. Cardiovascular diseases such as heart valve defects,
atrial fibrillation, and other structural heart issues become more prevalent in
the elderly population. With this rise in heart-related ailments comes a
growing demand for innovative treatments, particularly structural heart
devices. The elderly are more susceptible to various
cardiovascular conditions due to factors like atherosclerosis, hypertension,
and valvular heart disease. As the aging population expands, the incidence of
heart diseases rises, necessitating advanced treatments. Advancements in medical technology have
revolutionized the treatment of cardiovascular diseases. Structural heart
devices, including transcatheter heart valves and occludes, have become
increasingly sophisticated and effective. These innovations cater to the unique
needs of elderly patients, ensuring better outcomes and safety.
As people age, they often prefer less invasive
treatment options that offer shorter recovery times and fewer complications.
Structural heart devices are instrumental in these minimally invasive
procedures, making them an appealing choice for elderly patients who seek both
effectiveness and a better quality of life. With healthcare systems worldwide adapting to the
changing demographic landscape, access to advanced treatments has improved.
Many healthcare providers are making structural heart devices readily
available, enabling aging populations to benefit from cutting-edge medical
interventions. Advancements in healthcare have not only increased
life expectancy but also improved the quality of life in old age. Structural
heart devices can prolong and enhance the lives of elderly individuals,
ensuring they can lead more active, fulfilling lives despite heart-related
conditions.
Expanding Awareness and Diagnosis
The global landscape of healthcare is constantly
evolving, with a growing emphasis on proactive health management, early
diagnosis, and patient awareness. These shifts in healthcare dynamics are
having a profound impact on the growth of the global structural heart devices
market.
Awareness about health and medical conditions has
increased significantly in recent years. Individuals are more informed about
the risk factors and symptoms associated with various diseases, including
cardiovascular issues. This heightened awareness has led to a paradigm shift in
healthcare, placing an emphasis on early diagnosis and timely intervention. Early diagnosis is often a critical factor in
improving health outcomes, especially in cases of cardiovascular diseases. For
structural heart conditions such as heart valve defects, atrial septal defects,
or patent foramen ovale, early detection is essential to prevent complications
and offer patients more treatment options. This increasing awareness and early
diagnosis are having several noteworthy impacts on the growth of the global
structural heart devices market. Patients are now more proactive about their health.
With greater awareness, they are more likely to seek medical attention when
they notice symptoms or risk factors. This proactive approach results in more
individuals receiving timely diagnoses of structural heart conditions,
ultimately driving the demand for structural heart devices.
Advances in diagnostic tools and techniques have
made it easier for healthcare providers to identify structural heart conditions
in their early stages. Non-invasive imaging, such as echocardiography and
cardiac MRI, has become more accessible and accurate, allowing for the timely
detection of heart abnormalities. Healthcare systems worldwide are implementing
screening programs and campaigns to identify individuals at risk of
cardiovascular diseases. This proactive approach to healthcare increases the
likelihood of detecting structural heart issues, creating a larger pool of
patients who may benefit from structural heart devices. Awareness and early diagnosis not only improve the
prognosis but also expand the range of treatment options. Structural heart
devices, particularly in the field of transcatheter interventions, offer less
invasive and more effective alternatives to traditional open-heart surgeries.
Early intervention can lead to better outcomes and quicker recovery for
patients. Patients who are aware of their heart condition and
the available treatment options often prefer less invasive procedures that
offer quicker recovery times and fewer complications. Structural heart devices
play a vital role in these minimally invasive procedures, making them an
attractive choice for those who are informed about their condition.
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Key Market Challenges
Regulatory Hurdles
Ensuring the safety and effectiveness of medical
devices is a paramount concern for regulators worldwide. Manufacturers of
structural heart devices must meet stringent regulatory requirements, which can
be a costly and time-consuming process. Obtaining approvals and certifications
for new devices and procedures can create significant barriers for market
entry.
Reimbursement Issues
Reimbursement policies and mechanisms for
structural heart procedures can be complex and vary from one region to another.
For both healthcare providers and patients, navigating the reimbursement
landscape can be challenging. Inconsistencies and ambiguities in reimbursement
policies can affect the adoption of these devices, especially in regions where
healthcare financing is a concern.
High Cost of Treatment
Structural heart devices are often associated with
significant costs. While these devices offer less invasive and more efficient
alternatives to traditional open-heart surgeries, the initial expense can be a
barrier for healthcare systems, providers, and patients. Cost-effectiveness is
a critical consideration in the adoption of these devices.
Key Market Trends
Expanding Indications
Structural heart devices were initially developed
to address heart valve defects. However, the market is witnessing a significant
expansion in the range of conditions they can treat. This includes conditions
such as atrial septal defects, patent foramen ovale closure, and left atrial
appendage occlusion, which have broadened the market's scope and patient base.
Transcatheter Techniques
Transcatheter techniques are becoming the go-to
approach for structural heart interventions. These procedures offer less
invasiveness, shorter recovery times, and a reduced risk of complications
compared to open-heart surgery. As technology continues to evolve, the range of
applications for transcatheter interventions will expand.
Bioresorbable Devices
Bioresorbable structural heart devices are on the
horizon. These devices are designed to gradually dissolve within the body after
fulfilling their intended function. This trend offers the advantage of reducing
the long-term presence of foreign materials in the body, potentially lowering
the risk of complications.
Segmental Insights
Type Insights
Based on the category of Type, the SAVR segment
emerged as the dominant force in the market in 2023, primarily because of its
proven effectiveness in medical treatments and the presence of well-established
reimbursement codes. Additionally, SAVR boasts clearly defined surgical
guidelines, making it the preferred choice for surgeons who can refer to these
guidelines during procedures. The market is categorized by device type,
including surgical aortic valve replacement (SAVR), transcatheter aortic valve replacement
(TAVR), mitral repair, and left atrial appendage closure (LAAC). On the other hand, the TAVR segment is expected to
experience the most rapid CAGR throughout the forecast period. This is due to
its minimally invasive nature, allowing the replacement of a narrowed aortic
valve without open-heart surgery. As the incidence of aortic stenosis (AS)
rises, there is a corresponding increase in demand for TAVR procedures.
Furthermore, TAVR is less invasive compared to traditional open-heart surgery,
making it an attractive option for high-risk patients who could experience complications
from open-heart procedures.The latest TAVR devices are more compact, flexible,
and easier to implant than their older counterparts, broadening their
suitability for a wider range of patients. In May 2023, a study published in
the Journal of the American College of Cardiology reported that minimally
invasive TAVR procedures consistently yielded superior clinical outcomes
compared to open-heart surgery over a 3-year follow-up period. This study
assessed the long-term results of aortic stenosis patients who underwent TAVR
as part of the Evolut Low Risk trial.
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Regional Insights
In 2023, North America took the lead in the global
market for structural heart devices, securing the largest share of revenue.
This was primarily due to the region's increased healthcare expenditure, a
surge in research and development initiatives, and a growing prevalence of
heart-related ailments, largely driven by the expanding elderly population.
Another significant factor contributing to North America's dominance is a
strong preference for less invasive medical procedures. Cedars-Sinai, in their January 2022 report,
revealed that the most common form of heart surgery in the United States is
coronary artery bypass graft surgery (CABG), also known as coronary artery
bypass or bypass surgery. Every year, more than 300,000 patients in the U.S.
undergo this successful bypass surgery, underscoring the rising incidence of
cardiovascular disorders in the nation.
Recent Developments
- In July 2024, Affluent Medical signed agreement with Edwards Lifesciences, resulting in an upfront payment of USD 16.35 million for its mitral valve technologies. Edwards has secured a global, non-exclusive license to Affluent’s intellectual property for a biomimetic cardiac mitral valve replacement technology, limited to open-heart surgery applications.
- In May 2024, an 82-year-old woman from Elliottsburg, PA, diagnosed with aortic valve stenosis, became the inaugural recipient worldwide of an advanced transcatheter aortic valve replacement (TAVR) procedure at UPMC Harrisburg. This groundbreaking surgery utilized the latest FDA-approved Evolut FX+ TAVR system to treat symptomatic severe aortic stenosis. Dr. Gada is the first interventional cardiologist globally to deploy this state-of-the-art Evolut FX+ TAVR system.
- In March 2023, Abbott revealed that its stented
tissue valve, Epic Max, had obtained approval from the U.S. FDA for the
treatment of patients dealing with stenosis or aortic regurgitation. This
addition to Abbott's Epic surgical valve platform, known for its positive
clinical track record and reliability, features an optimized design aimed at
improving valve circulation.
Key Market Players
·
Abbott Laboratories, Inc.
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Edwards Lifesciences Corporation
·
Medtronic Plc
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Boston Scientific Corporation
·
Lepu Medical Technology Holding Company
·
TTK Healthcare Limited
·
Biomerics, LLC
·
Braile Biomedic
·
Artivion, Inc.
·
JenaValve Technology Inc
|
By Type
|
By Region
|
- SAVR (Surgical Aortic Valve Replacement)
- TAVR (Transcatheter Aortic Valve Replacement)
- Mitral Repair (Annuloplasty)
- LAAC (Left Atrial Appendage Closure)
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- North America
- Europe
- Asia-Pacific
- South America
- Middle East & Africa
|
Report Scope:
In this report, the Global Structural Heart Devices
Market has been segmented into the following categories, in addition to the
industry trends which have also been detailed below:
- Structural Heart Devices Market, By Type:
o SAVR (Surgical Aortic Valve Replacement)
o TAVR (Transcatheter Aortic Valve Replacement)
o Mitral Repair (Annuloplasty)
o LAAC (Left Atrial Appendage Closure)
- Structural Heart Devices Market, By Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ Germany
§ United Kingdom
§ France
§ Italy
§ Spain
o Asia-Pacific
§ China
§ Japan
§ India
§ Australia
§ South Korea
o South America
§ Brazil
§ Argentina
§ Colombia
o Middle East & Africa
§ South Africa
§ Saudi Arabia
§ UAE
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the Global
Structural Heart Devices Market.
Available Customizations:
Global Structural Heart Devices market report
with the given market data, TechSci Research offers customizations according
to a company's specific needs. The following customization options are
available for the report:
Company Information
- Detailed analysis and profiling of additional
market players (up to five).
Global Structural Heart Devices Market is an
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report or want to confirm the date of release, please contact us at [email protected]