|
Forecast
Period
|
2024-2028
|
|
Market
Size (2022)
|
USD
45.24 million
|
|
CAGR
(2023-2028)
|
15.29%
|
|
Fastest
Growing Segment
|
MeRes100
|
|
Largest
Market
|
United
States
|
Market Overview
North
America Bioresorbable Coronary Stents Market has valued at USD 45.24 million in
2022 and is anticipated to project robust growth in the forecast period with a
CAGR of 15.29% through 2028. The North America bioresorbable coronary stents
market represents a rapidly evolving segment within the broader medical device
and cardiovascular healthcare industry. Bioresorbable coronary stents, also
known as bioresorbable vascular scaffolds (BVS), are medical implants used to
treat coronary artery disease (CAD). These stents are designed to provide
temporary support to diseased coronary arteries and then gradually dissolve
over time, leaving no permanent implant behind. This approach differs from
traditional metallic stents, which remain in the body indefinitely.
Key Market Drivers
Clinical Benefits and Superior
Outcomes
Clinical
benefits and superior outcomes play a crucial role in driving the growth of the
North America bioresorbable coronary stents market. These benefits stem from
the unique characteristics and mechanisms of action of bioresorbable stents,
which differentiate them from traditional metallic stents. Bioresorbable coronary stents, or
bioresorbable vascular scaffolds (BVS), offer a significant advantage by
gradually dissolving in the body after serving their initial purpose of keeping
a coronary artery open. Unlike metallic stents, which remain in the body
permanently, bioresorbable stents are designed to be absorbed over time. This
dissolution eliminates the risk of late complications often associated with
metallic stents, such as in-stent restenosis (narrowing of the stented artery)
and stent thrombosis (blood clot formation within the stent). As a result,
patients who receive bioresorbable stents experience a lower incidence of these
complications, leading to improved long-term clinical outcomes.
Patients
who receive metallic stents are typically required to take dual antiplatelet
therapy (usually aspirin and a P2Y12 inhibitor) for an extended period, often
up to one year or more, to prevent blood clots around the stent. In contrast,
bioresorbable stents have the advantage of dissolving over time, eliminating
the need for prolonged DAPT. This is especially beneficial for patients who are
at a higher risk of bleeding complications associated with antiplatelet
therapy. The reduced duration of DAPT enhances patient compliance and overall
safety. Bioresorbable stents promote better vessel healing and restoration of
natural vessel function. Because they eventually dissolve, the artery can
return to its natural state, allowing for vasomotion (the ability of the artery
to constrict and dilate), which is not possible with permanent metallic stents.
This improved vessel healing and functionality can result in a reduction of
angina (chest pain) and improved overall cardiac function for patients,
contributing to superior clinical outcomes.
Patients
who receive bioresorbable coronary stents often report a better quality of life
compared to those with metallic stents. The absence of a permanent implant in
the body means that patients do not experience the discomfort or awareness of a
foreign object inside them. This can lead to improved overall well-being,
reduced anxiety, and increased satisfaction with their medical treatment. Bioresorbable
stents are particularly attractive to younger and more active patient
populations. These individuals may have concerns about the long-term
implications of metallic stents on their quality of life and ability to engage
in physical activities. The clinical benefits of bioresorbable stents, with
their potential for reducing late complications and the need for long-term
medication, make them an appealing choice for such patients.
Growing Prevalence of Coronary
Artery Disease
The
growing prevalence of coronary artery disease (CAD) is a significant driver for
the growth of the North America bioresorbable coronary stents market. Coronary
artery disease is a widespread cardiovascular condition that affects millions
of people worldwide, and the demand for effective treatment options has been on
the rise. Over the past few
decades, there has been a steady increase in the incidence of CAD, particularly
in developed and developing nations. This trend can be attributed to a range of
factors, including sedentary lifestyles, unhealthy diets, smoking, and an aging
population. CAD is a leading cause of morbidity and mortality North Americaly,
with significant economic and healthcare burdens.
The
aging of the North America population is a significant contributor to the
increasing prevalence of CAD. As people age, the risk of developing CAD rises
due to the cumulative effects of risk factors over time. The elderly population
often presents complex medical needs, making the treatment of CAD an important
part of healthcare systems worldwide. Lifestyle-related risk factors such as
obesity, diabetes, hypertension, and high cholesterol are becoming more
prevalent, leading to an increased risk of CAD. These risk factors are often
interrelated, compounding the problem and necessitating effective treatment
options for patients.
There
is a growing awareness of the importance of early diagnosis and treatment of
CAD. Advances in medical imaging and diagnostic techniques have made it easier
to identify CAD at an earlier stage, allowing for timely intervention and
treatment. As more individuals are diagnosed with CAD, the demand for effective
treatment options, including bioresorbable coronary stents, continues to rise. The
treatment landscape for CAD has seen significant advancements, including
innovations in percutaneous coronary intervention (PCI), which is the procedure
used to implant stents. Bioresorbable coronary stents have emerged as an
innovative option, and their adoption is likely to increase as the demand for
more advanced treatment modalities grows in response to the rising prevalence
of CAD.
Advancements in Technology and
Materials
Advancements
in technology and materials are significant drivers for the growth of the North
America bioresorbable coronary stents market. These advancements have led to
the development of more innovative and reliable bioresorbable stents, making
them an attractive option for both patients and healthcare providers. The choice of materials is a crucial
factor in the development of bioresorbable coronary stents. Advances in
biodegradable polymers and materials have allowed for the creation of stents
with enhanced strength, flexibility, and degradation properties.
Bioresorbable
stents are typically made from materials such as polylactic acid (PLA) or
polyglycolic acid (PGA), which gradually degrade in the body. Researchers have
made substantial progress in optimizing the properties of these materials to
ensure they provide sufficient mechanical support to the artery while also
allowing for controlled, predictable degradation. Technological advancements
have paved the way for more intricate and optimized stent designs. These
designs are tailored to improve deliverability and conformability during the
stent implantation procedure, minimizing complications and ensuring a more
successful outcome. Advanced computer-aided design (CAD) and simulation tools
have enabled the development of intricate stent architectures that balance
mechanical strength with biodegradability. Such designs are essential for
ensuring proper blood flow within the treated vessel.
Many
bioresorbable coronary stents incorporate drug-eluting capabilities to prevent
restenosis (re-narrowing of the treated vessel). Technological advancements in
drug-eluting stents have led to more precise and controlled drug release
profiles, reducing the risk of side effects and optimizing therapeutic
efficacy. Improved drug-eluting capabilities have also allowed for personalized
medicine approaches, tailoring drug delivery to individual patient needs based
on their specific vascular characteristics. Innovations in manufacturing
techniques have made it possible to produce bioresorbable stents with greater
precision, consistency, and quality. This is crucial for ensuring that each
stent meets rigorous safety and performance standards. Cutting-edge
manufacturing processes, such as laser cutting and 3D printing, have become
integral in producing stents with complex designs and the desired mechanical
properties. These techniques enable the production of stents that are highly
customizable to the patient's anatomy.
Regulatory Support and
Approvals
Regulatory
support and approvals are crucial drivers for the growth of the North America
bioresorbable coronary stents market. These factors create a foundation of
credibility and trust, facilitating the adoption of innovative medical devices
like bioresorbable stents. Regulatory
bodies, such as the U.S. Food and Drug Administration (FDA) in the United
States and the European Medicines Agency (EMA) in Europe, play a fundamental
role in evaluating and approving medical devices. Their stringent review
processes ensure that bioresorbable stents meet high safety and efficacy
standards before they can be marketed to healthcare professionals and patients.
Regulatory approvals provide assurance to healthcare providers that
bioresorbable stents have undergone rigorous testing, reducing concerns about
the safety and performance of these devices. This confidence is pivotal for
their acceptance and adoption in clinical practice.
Regulatory
approvals bestow credibility upon bioresorbable stents. When these stents
receive clearance or approval from major regulatory authorities, they gain
recognition as reliable and effective medical devices. This, in turn,
encourages healthcare providers to integrate them into their treatment
protocols. Regulatory support also reassures investors and stakeholders,
fostering financial backing and partnerships that are essential for research,
development, and market expansion. Bioresorbable stents that have gained
regulatory approval have a competitive edge in the market. They can
differentiate themselves from non-approved or less-regulated alternatives,
attracting a broader range of potential users. Regulatory support allows
manufacturers to market their products as safe and efficacious, which is a
significant selling point in the competitive landscape of medical devices.
International
recognition through regulatory approvals facilitates market expansion.
Manufacturers can access a broader customer base, including healthcare
providers and patients in different countries. The North America harmonization
of regulatory standards helps streamline the process of gaining approvals in
multiple regions, enabling companies to reach a wider audience and increase
market penetration. Regulatory approvals encourage healthcare professionals to
consider bioresorbable stents as a viable treatment option. They trust that the
devices have met the stringent requirements of regulatory agencies, which helps
drive clinical adoption. With the backing of regulatory support, clinicians are
more likely to recommend bioresorbable stents to their patients, increasing the
utilization of these devices in coronary artery disease treatment.
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Key Market Challenges
Limited Long-Term Clinical
Data
One
of the primary challenges facing bioresorbable coronary stents is the limited
long-term clinical data available. While these stents have demonstrated
promising results in terms of safety and short-to-medium-term efficacy, there
is a need for more extensive, long-term clinical evidence to support their use.
The dissolution process of bioresorbable stents, while intended to eliminate
long-term complications associated with metallic stents, has raised concerns
about the possibility of late scaffold discontinuity or late events after
complete bioresorption. This uncertainty can deter healthcare providers and
patients from fully embracing bioresorbable stents. Conducting long-term
clinical trials and monitoring patients for an extended period is
resource-intensive, and it takes time to accumulate meaningful data. This
challenge can slow down the market growth as stakeholders wait for more
comprehensive evidence of the long-term safety and efficacy of these devices.
Cost and Reimbursement
Challenges
Bioresorbable
coronary stents are often more expensive than traditional metallic stents. The
higher cost can present a barrier to adoption, especially in regions with
cost-conscious healthcare systems or where patients have limited access to
insurance coverage. Reimbursement challenges further compound this issue.
Healthcare reimbursement policies and reimbursement rates for bioresorbable
stents vary from one country to another. Uncertainty surrounding reimbursement
can deter healthcare providers from adopting these devices, as they may be
concerned about the financial implications. Manufacturers of bioresorbable
stents must work on cost-effective production methods to reduce the overall
cost and navigate the complexities of reimbursement policies to ensure market
access.
Technical and Procedural
Challenges
The
deployment of bioresorbable stents can be technically challenging. Their
thinner struts and different mechanical properties compared to metallic stents
require specialized training and expertise for interventional cardiologists.
This can limit the widespread adoption of bioresorbable stents, particularly in
regions where access to training and expertise is limited. Stent thrombosis,
though rare, remains a concern. Ensuring proper implantation technique and
addressing issues related to stent thrombosis are important to enhance safety.
These technical challenges need to be addressed through continuous medical
education and improved device design. Bioresorbable stents are also more
fragile than metallic stents and can be prone to damage during handling,
transport, and implantation. Ensuring the integrity of the stent throughout the
supply chain and during the procedure is critical.
Key Market Trends
Increasing Focus on
Personalized Medicine
One
significant trend in the bioresorbable coronary stents market is the growing
emphasis on personalized medicine. Healthcare providers are increasingly
recognizing that each patient's coronary anatomy and disease presentation are
unique. As a result, there is a shift toward tailoring treatment strategies,
including stent selection, to individual patient needs. Bioresorbable stents
offer the advantage of customization. Physicians can select the appropriate
stent size, length, and design based on a patient's specific coronary anatomy.
This trend toward personalized medicine ensures that patients receive the most
suitable treatment, optimizing outcomes and reducing the risk of complications.
Integration of Advanced
Imaging and Navigation Technologies
The
integration of advanced imaging and navigation technologies is another key
trend in the bioresorbable coronary stents market. Innovations in intravascular
imaging techniques, such as optical coherence tomography (OCT) and
intravascular ultrasound (IVUS), have enabled interventional cardiologists to
better assess coronary lesions and stent deployment. These imaging technologies
help ensure precise stent placement, reduce the risk of complications, and
support optimal patient outcomes. They also play a crucial role in assessing
vessel healing and confirming the gradual resorption of bioresorbable stents,
enhancing the safety and efficacy of these devices.
Rise of Drug-Eluting
Bioresorbable Stents
Drug-eluting
bioresorbable stents have gained prominence as a significant trend in the
market. These stents are designed to not only provide mechanical support but
also deliver therapeutic drugs that inhibit restenosis and promote healing of
the treated vessel. The development of innovative drug-eluting technologies has
led to more precise and controlled drug release profiles. As a result,
bioresorbable stents can address the challenge of in-stent restenosis
effectively, offering a solution to a common complication associated with
metallic stents. The combination of mechanical support and drug delivery in
bioresorbable stents represents a promising approach to improving patient
outcomes and has been driving interest in these devices.
Segmental Insights
Brand Insights
Based
on the category of Brand, the MeRes100 segment emerged as the dominant player
in the North America market for Bioresorbable Coronary Stents in 2022. MeRes100 is
celebrated for its clinical innovation. It has undergone rigorous clinical
trials to demonstrate its efficacy and safety. Clinical evidence supporting the
effectiveness of MeRes100 has been published, which has a positive impact on
its adoption by healthcare providers.
Its innovative design and controlled
degradation process contribute to better vessel healing and restoration of
natural vessel function, potentially reducing complications associated with
stent placement. This clinical efficacy positions MeRes100 as a compelling
choice for interventional cardiologists and their patients. MeRes100
incorporates unique technological advancements that set it apart from other
bioresorbable stents. Its proprietary polymer formulation and manufacturing
processes have been optimized to ensure controlled and predictable stent
degradation, addressing concerns about late scaffold discontinuity. These
technological advantages contribute to the appeal of MeRes100 as a
next-generation bioresorbable stent, which may attract healthcare providers and
patients looking for state-of-the-art treatment options.
MeRes100
has undergone regulatory approvals in various regions, including CE Mark
approval in Europe, which is essential for marketing and sales in the European
Union. Regulatory approvals help establish MeRes100 as a North Americaly
recognized and trusted medical device. As MeRes100 continues to gain regulatory
clearances in different markets, its availability and adoption are likely to
expand, contributing to its dominance in the North America bioresorbable
coronary stents market. The MeRes100 brand stands out through its
differentiation from other bioresorbable stents in the market. Its distinct
features, such as advanced imaging compatibility, excellent radial strength,
and gradual resorption profile, provide advantages in terms of safety and
efficacy. Market differentiation allows MeRes100 to address the unique needs of
both physicians and patients, potentially making it the preferred choice in a
competitive landscape. Meril Life Sciences has actively engaged in educational
initiatives and physician training programs to familiarize interventional
cardiologists with MeRes100. These efforts are crucial in promoting its
adoption and use in clinical practice. As more physicians become trained and
experienced in using MeRes100, its presence and dominance in the market are
likely to increase. These factors are expected to drive the growth of this
segment.
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Regional Insights
United
States emerged as the dominant player in the North America Bioresorbable
Coronary Stents market in 2022, holding the largest market share in terms of
value. The region boasts a sophisticated healthcare
infrastructure, encompassing hospitals, clinics, and specialized cardiac
centers. These facilities are equipped with state-of-the-art technology and
staffed by highly skilled healthcare professionals adept in performing coronary
procedures. Furthermore, the United States maintains a robust healthcare system
that actively fosters technological advancements and innovations. It serves as
the headquarters for several prominent medical device companies that make
substantial investments in research and development, thereby propelling the
progress of bioresorbable coronary stents. The presence of cutting-edge
technologies and a wealth of expertise in this region underpins its dominance
in the market. However, the United States lags behind, with limited prominence
in this sector.
The
Canada market is poised to be the fastest-growing market, offering lucrative
growth opportunities for Bioresorbable Coronary Stents players during the
forecast period. Factors such as the increasing numbers of coronary stenting
procedures due to the substantial patient population afflicted with
cardiovascular diseases, the area is also experiencing a swift uptake of CE and
FDA-approved devices. This, in turn, results in robust regional sales revenue
for bioresorbable coronary stents. Also, the region has made significant
investments in enhancing its healthcare infrastructure, which includes the
establishment of modern hospitals, cardiac centers, and catheterization
laboratories equipped with state-of-the-art medical technologies. These
developments empower healthcare providers to deliver high-quality treatments,
including the utilization of bioresorbable coronary stents, to their patients.
The presence of such facilities fosters the expansion of the market.
Recent Developments
- In
October 2023 - Boston Scientific Announces Results from the North America,
Randomized, Controlled EMBOLDEN Trial Demonstrating the Safety and
Effectiveness of the Watchman FLX Left Atrial Appendage Closure Device (LAAC
Device) for the Prevention of Stroke in Patients with Atrial Fibrillation Not
Suitable for Warfarin.
- In
August 2023, Medtronic presents new data from its Evolut Low Risk Trial at the
Transcatheter Cardiovascular Therapeutics (TCT) conference, showing that the
Evolut TAVR platform is superior to surgery for low-risk patients.
- In
October 2023, Cordis receives FDA approval for its new PROMUS Element+ stent,
the first stent to combine two different drug eluting technologies to reduce
the risk of restenosis, or blockages, in
the arteries after stenting.
Key Market Players
- Boston
Scientific Corporation
- Medtronic Inc.
- Cordis Corp
- Biotronik Inc.
- Meril Life Sciences Pvt. Ltd.
- Abbott Laboratories Ind.
- Elixir Medical Corp
- REVA Medical, LLC
- Arterial Remodeling Technologies SA
|
By
Brand
|
By
Region
|
- Magmaris
- Magnitude
- MeRes100
- DESolve
- Others
|
- United
States
- Canada
- Mexico
|
Report Scope:
In this report, the North America Bioresorbable
Coronary Stents Market has been segmented into the following categories, in
addition to the industry trends which have also been detailed below:
- North America Bioresorbable Coronary Stents Market, By Brand:
o Magmaris
o Magnitude
o MeRes100
o DESolve
o Others
- North America Bioresorbable Coronary Stents Market, By
Region:
o United States
o Canada
o Mexico
Competitive Landscape
Company Profiles: Detailed analysis of the major companies present in the North
America Bioresorbable Coronary Stents Market.
Available Customizations:
North America Bioresorbable Coronary Stents market
report with the given market data, Tech Sci 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).
North America Bioresorbable Coronary Stents Market
is an upcoming report to be released soon. If you wish an early delivery of
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