|
Forecast Period
|
2024-2028
|
|
Market Size (2022)
|
USD 450.07 million
|
|
CAGR (2023-2028)
|
10.30%
|
|
Fastest Growing Segment
|
Hospitals & Clinics
|
|
Largest Market
|
North America
|
Market Overview
The Global Bioresorbable Coronary Stents Market has
valued at USD 450.07 million in 2022 and is anticipated to project impressive
growth in the forecast period with a CAGR of 10.30% through 2028. The field of
cardiology has witnessed remarkable advancements in recent years, leading to
better patient outcomes and improved quality of life for individuals with
coronary artery disease (CAD). Among these advancements, bioresorbable coronary
stents have emerged as a promising innovation. These stents represent a
significant shift in the treatment of CAD, offering a solution that gradually
dissolves within the body after its purpose is served.
Coronary artery disease is
a prevalent cardiovascular condition characterized by the buildup of plaque
inside the coronary arteries, which can restrict blood flow to the heart
muscle. Left untreated, CAD can lead to chest pain (angina), heart attacks, and
even heart failure. Traditionally, CAD has been treated using metal stents,
which are implanted to keep the arteries open. However, these permanent
metallic implants have their limitations. Bioresorbable coronary stents, also known as bioresorbable vascular
scaffolds (BVS), are a game-changer in the field of interventional cardiology.
Unlike their metallic counterparts, bioresorbable stents are designed to be
gradually absorbed by the body over time. They are typically made from
materials such as polylactic acid, polyglycolic acid, or a combination of both.
The stent provides structural support to the artery during the initial stages
of healing and vessel remodeling, and then naturally dissolves, leaving behind
a healed artery.
The bioresorbable coronary
stents market has witnessed significant growth over the past decade, driven by
several factors. Clinical studies have
demonstrated the safety and efficacy of bioresorbable stents, showing
comparable outcomes to traditional metallic stents. Patients treated with
bioresorbable stents experience reduced long-term complications associated with
permanent metallic stents, such as in-stent restenosis and late stent
thrombosis. Ongoing research and
development efforts have led to the refinement of bioresorbable stent designs,
making them more suitable for a wider range of patients. Cardiologists and interventional radiologists are increasingly embracing
bioresorbable stents due to their patient-centric benefits and the potential
for improved clinical outcomes.
Key Market Drivers
Rising Prevalence of Coronary Artery Disease is
Driving the Global Bioresorbable Coronary Stents Market
Coronary artery disease (CAD) is a global health
concern affecting millions of people worldwide. It is a condition in which the
blood vessels that supply oxygen and nutrients to the heart become narrowed or
blocked, leading to reduced blood flow and potentially life-threatening
consequences. The management of CAD has seen significant advancements in recent
years, and one of the emerging technologies making waves in this field is
bioresorbable coronary stents. These innovative medical devices are becoming
increasingly popular due to their potential to address some of the limitations
of traditional metallic stents.
CAD remains one of the
leading causes of death worldwide. According to the World Health
Organization (WHO), cardiovascular diseases, including CAD, were responsible
for approximately 17.9 million deaths globally in 2019, making it the leading
cause of death. These alarming statistics highlight the pressing need for
effective treatments and interventions to manage CAD and reduce its impact on
public health. CAD often develops over many years, and its risk factors include
lifestyle choices such as smoking, unhealthy diet, physical inactivity, and
underlying conditions like hypertension, diabetes, and obesity. As these risk
factors continue to rise due to changing lifestyles and an aging population,
the prevalence of CAD is expected to increase further.
Coronary stents are small,
tube-like devices inserted into narrowed or blocked coronary arteries to keep
them open, allowing for improved blood flow to the heart muscle. Traditional
stents are typically made of metal, most commonly stainless steel or
cobalt-chromium alloys. While these metallic stents have been successful in
treating CAD, they have certain drawbacks, including the potential for
long-term complications such as in-stent restenosis and the interference they
pose with future diagnostic procedures like imaging. Bioresorbable coronary stents, often referred to as bioresorbable
vascular scaffolds (BVS), are designed to overcome some of these limitations.
These stents are made from biocompatible materials that gradually dissolve and
are absorbed by the body over time, leaving behind only the natural vessel. The
concept of bioresorbable stents has gained momentum in recent years, with the
promise of providing temporary support to the artery and then disappearing,
thus allowing the vessel to return to its normal function.
Rising Patient Preference for Minimally Invasive
Procedures Growth in Global Bioresorbable Coronary Stents
The preference for minimally invasive procedures
has been steadily growing among patients, and this trend is a significant
driver behind the increasing adoption of bioresorbable coronary stents. One of
the most compelling reasons patients opt for minimally invasive procedures is
the quicker recovery time. Compared to traditional open-heart surgeries,
procedures involving bioresorbable stents are less invasive and often require
shorter hospital stays. Minimally invasive procedures typically cause less pain
and discomfort compared to their invasive counterparts. Smaller incisions and
less tissue trauma contribute to a more comfortable post-operative experience. Minimally
invasive procedures carry a lower risk of complications, such as infection and
bleeding, which can be significant concerns with traditional surgeries. Patients
can return to their regular activities sooner after minimally invasive
procedures, leading to an overall improvement in their quality of life.
The patient preference for minimally invasive
procedures aligns perfectly with the unique benefits of bioresorbable coronary
stents. As more patients become aware of these advantages, there has been a
significant increase in demand for BRS, thereby driving market growth. Patients
are increasingly requesting bioresorbable stents, and healthcare providers are
responding to this demand by incorporating these devices into their treatment
options. Medical device manufacturers are investing in research and development
to improve bioresorbable stent designs and materials, further enhancing their
safety and effectiveness. Regulatory bodies are actively working to establish
guidelines and standards for bioresorbable stents, ensuring their safety and
efficacy, which in turn bolsters patient confidence.
Growing Surge in Healthcare Expenditure is Driving
the Global Bioresorbable Coronary Stents Market
Healthcare expenditure across the globe has been on
the rise for various reasons, including population growth, aging demographics,
and the increasing prevalence of chronic diseases like coronary artery disease.
Increased healthcare spending enables companies to invest in extensive research
and development efforts to create more advanced and effective bioresorbable
stents. This leads to the development of superior products with better patient
outcomes. The funds allocated for healthcare research often support large-scale
clinical trials that provide critical data on the safety and efficacy of
bioresorbable stents. These trials are essential for gaining regulatory
approvals and expanding market access. As healthcare expenditure increases,
more patients have access to advanced medical treatments, including
bioresorbable coronary stents. This expands the potential patient pool for
these devices and drives market growth. Intensified competition and investment
in the bioresorbable coronary stents market encourage innovation and the
development of next-generation stent technologies, further enhancing patient
care. The surge in healthcare expenditure is not limited to one region but is a
global phenomenon. This contributes to the widespread adoption of bioresorbable
coronary stents on a global scale.
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Key Market Challenges
Efficacy and Safety Concerns
One of the primary challenges in the bioresorbable
coronary stents market is ensuring the safety and efficacy of these devices.
Clinical trials have raised concerns about the rate of stent thrombosis, which
is the formation of blood clots within or around the stent. This issue can lead
to life-threatening complications and has prompted questions about the overall
safety of bioresorbable stents compared to traditional metallic stents.
Lack of Long-term Data
Long-term data on the performance of bioresorbable
coronary stents is limited. While they offer the advantage of being absorbed by
the body over time, questions remain about their long-term durability and
effectiveness in preventing restenosis (the re-narrowing of arteries).
Physicians and patients are often more comfortable with proven metallic stents
due to their extensive track record.
Manufacturing Complexity
The production of bioresorbable stents is more
complex than that of traditional stents. Ensuring consistency in stent
composition, strength, and resorption rates is challenging. Any variability in
these factors can impact patient outcomes and lead to regulatory hurdles.
Regulatory Hurdles
The regulatory approval process for bioresorbable
stents is rigorous and time-consuming. Manufacturers must demonstrate the
safety and effectiveness of these devices through extensive clinical trials.
Even minor issues can delay approvals or lead to recalls, which can
significantly impact market adoption.
Cost and Reimbursement
Bioresorbable coronary stents tend to be more
expensive than traditional metallic stents. This cost difference can be a
significant barrier to adoption, especially in regions with limited healthcare
budgets. Additionally, securing reimbursement from insurance providers can be
challenging, further hindering market growth.
Limited Market Penetration
The adoption of bioresorbable stents has been
slower than anticipated due to the challenges mentioned above. Many physicians
are hesitant to switch from proven metallic stents to bioresorbable
alternatives, and patient awareness about these newer options is often limited.
Competition with Drug-Eluting Stents
Bioresorbable coronary stents face competition from
drug-eluting stents, which are metallic stents coated with drugs that help
prevent restenosis. These drug-eluting stents have a proven track record and
are well-established in the market. Convincing physicians and patients to opt
for bioresorbable stents over these tried-and-true devices can be challenging.
Key Market Trends
Technological Advancements
The field of medical
technology has seen remarkable advancements in recent years, revolutionizing
the way we diagnose and treat various health conditions. One such innovation
that has gained significant attention is the development of bioresorbable coronary
stents. These innovative medical devices are transforming the way we manage
coronary artery disease, and their rapid adoption can be attributed to the
continuous technological advancements in the medical industry.
The choice of materials is
pivotal in the development of bioresorbable coronary stents. Continuous
research into biocompatible and bioresorbable materials has led to the creation
of stents that can maintain their mechanical integrity during the initial stages
of implantation while subsequently degrading harmlessly. Advancements in
material science have contributed significantly to the safety and efficacy of
these stents. Cutting-edge manufacturing techniques have enhanced
the precision and quality of bioresorbable stents. 3D printing and laser
cutting technologies allow for the production of stents with intricate designs
that optimize radial strength and conformability to the vessel wall. Many
bioresorbable stents are designed with drug-eluting properties. The controlled
release of drugs from these stents reduces the risk of restenosis and
inflammation, further improving patient outcomes. Technological advancements
have allowed for better drug-loading techniques and more efficient drug-release
profiles. Advances in imaging technologies such as intravascular ultrasound
(IVUS) and optical coherence tomography (OCT) have provided physicians with
detailed, real-time visualization of stent placement and expansion. This
enables precise deployment and ensures optimal stent positioning, ultimately
improving patient outcomes. Continuous research and clinical trials have played
a significant role in fine-tuning bioresorbable stent designs and assessing
their long-term safety and efficacy. These studies provide valuable data that
guide further technological developments in the field.
Segmental Insights
Brand Insights
Based on the brand, the MeRes-100 segment emerged
as the dominant player in the global market for Bioresorbable Coronary Stents in
2022. MeRes-100 is made from a biocompatible polymer called PLLA (Poly-L-Lactic
Acid), which has a long history of safe use in medicine. This material
gradually dissolves in the body over time, eliminating the need for a permanent
implant. After implantation, the MeRes-100 stent provides support to the artery
during the initial healing period. As the PLLA gradually breaks down, it allows
the artery to regain its natural flexibility and function. This process
typically takes about two to three years. Unlike metallic stents, which can
remain in the body indefinitely, MeRes-100 minimizes the risk of long-term
complications such as inflammation, thrombosis, and restenosis. Patients may
require a shorter duration of dual antiplatelet therapy, reducing the burden of
medication. MeRes-100 is designed with advanced features to aid in its
deployment and post-implantation assessment. Radiopaque markers help physicians
precisely position the stent, while the stent's thinner struts provide improved
visibility on imaging tests, ensuring proper placement and apposition. The
MeRes-100 stent has received regulatory approvals in various countries, making
it accessible to a broader range of patients around the world. Clinical studies
have shown promising results for the MeRes-100 stent. Patients who received
this bioresorbable stent experienced comparable clinical outcomes to those who
received traditional metallic stents. Moreover, the reduced need for long-term
antiplatelet therapy and the avoidance of potential complications associated
with permanent implants make it an appealing choice for both patients and
physicians.
End User Insights
The Hospitals & Clinics Based segment is projected
to experience rapid growth during the forecast period. Hospitals and clinics
are equipped with highly trained medical professionals, including cardiologists
and interventional radiologists, who are skilled in performing procedures
involving bioresorbable coronary stents. These medical experts are crucial for
diagnosing and treating coronary artery disease, which often requires stent
implantation. Hospitals and clinics have access to advanced medical equipment
and facilities necessary for performing stent implantation procedures. This
includes state-of-the-art catheterization labs, operating rooms, and
post-operative care units, ensuring safe and effective stent placement. Hospitals
and clinics serve as primary points of care for patients with coronary artery
disease. Patients often visit these facilities for diagnosis, treatment
planning, and follow-up care. This ensures a steady and reliable stream of
patients who may require bioresorbable coronary stents. Hospitals and clinics
collaborate closely with medical device manufacturers to stay updated on the
latest technological advancements and product offerings in the field of
bioresorbable coronary stents. They often participate in clinical trials and
research studies, helping to drive innovation in this market segment. ospitals,
in particular, are well-equipped to handle emergency cases of acute coronary
syndrome, where immediate intervention with stents may be necessary to save a
patient's life. The availability of 24/7 emergency services in hospitals makes
them indispensable for the treatment of such cases.
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Regional Insights
North America emerged as the dominant player in the
global Bioresorbable Coronary Stents market in 2022, holding the largest market
share in terms of value. North America, particularly the United States, boasts
a highly developed healthcare infrastructure with state-of-the-art medical
facilities, advanced research centers, and a well-established regulatory
framework. This infrastructure supports the development, clinical testing, and
adoption of innovative medical devices like bioresorbable coronary stents. North
American countries invest significantly in biomedical research and development
(R&D). This has led to the development of cutting-edge technologies and
medical devices, including bioresorbable coronary stents. Collaboration between
academic institutions, medical device companies, and healthcare providers
fosters innovation in this field. The United States Food and Drug
Administration (FDA) has stringent regulatory standards for medical devices,
including coronary stents. While this can pose challenges, it also ensures that
only safe and effective products reach the market. Companies that can meet
these rigorous standards gain a competitive edge and can tap into the large
patient population for clinical trials. North America has a well-trained and
experienced healthcare workforce, including interventional cardiologists who
are familiar with the latest medical technologies. They are more likely to
adopt and recommend bioresorbable coronary stents when they become available.
Recent Developments
- In January 2023, The FDA has granted approval for
Biosensors International's BioFreedom Drug Coated Coronary Stent (DCS) System –
P190020. This medical device is designed to address the narrowing of coronary
arteries resulting from coronary artery disease. The system comprises a
catheter delivery mechanism and a 316L stainless steel stent. The stent is
coated with Biolimus A9 medication and notably lacks any additional components
such as polymers or carriers to regulate drug release.
- In July 2023, Lifetech Scientific Corp.'s
three-year, first-in-humans trial demonstrated the safety and effectiveness of
their fully biodegradable iron-based absorbable coronary scaffold for treating
non-complex coronary lesions that had not been previously addressed with an
interventional device.
- In September 2022, Chandigarh's PGI has achieved a
groundbreaking milestone by conducting the world's inaugural robot-assisted
implantation of a bioresorbable stent with great success.
- In March 2020, the National Pharmaceutical Pricing
Authority (NPPA) granted a five-year exemption to Meril Life Sciences under the
"Drug Price Control Order 2013" clause, relieving them from price
restrictions. The authorities requested Meril Life Sciences to provide
information regarding the pricing they plan to set for the stent.
Key Market Players
- Boston Scientific Corporation
- Medtronic
plc
- Abbott
Laboratories ltd.
- STENTYS
S.A.
- Cordis
corporation
- Biotronik
inc.
- Lepu
Medical Technology (Beijing) Co., Ltd.
- Cook
India Medical Devices Pvt. Ltd
- XTENT
Inc.
- Kyoto
Medical Planning Co., Ltd
|
By Brand
|
By End User
|
By Region
|
- Magmaris
- Magnitude
- MeRes-100
- DESolve
- Others
|
- Hospitals
& Clinics
- Ambulatory Care Centers
- Others
|
- North
America
- Europe
- Asia Pacific
- South
America
- Middle East
& Africa
|
Report Scope:
In this report, the Global Bioresorbable Coronary
Stents Market has been segmented into the following categories, in addition to
the industry trends which have also been detailed below:
- Bioresorbable Coronary Stents Market, By Brand:
o Magmaris
o Magnitude
o MeRes-100
o DESolve
- Bioresorbable Coronary Stents Market, By End User:
o Hospitals & Clinics
o Ambulatory Care Centers
o Others
- Bioresorbable Coronary Stents Market, By
Region:
o North America
§ United States
§ Canada
§ Mexico
o Europe
§ France
§ United Kingdom
§ Italy
§ Germany
§ Spain
o Asia-Pacific
§ China
§ India
§ Japan
§ 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 Bioresorbable
Coronary Stents Market.
Available Customizations:
Global 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).
Global Bioresorbable Coronary Stents Market is an
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