GDME1002FPR Bioabsorbable Stents - Current and Bioabsorbable Stents Future Outlook Bioabsorbable...
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Bioabsorbable Stents Current and Future Players
GDME1002FPR / Published December 2012
© GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 2 GDME1002FPR / Published DEC 2012
Bioabsorbable Stents, Key Metrics in the Major Markets
Coronary Artery Disease 4.5 million
Peripheral Artery Disease 4.1 million
2011 Market Sales ($m)
Coronary Market $0.39m
Peripheral Market $0.24m
Number of stents at preclinical phase 9
Number of stents at early clinical phase 5
Number of stent at late clinical phase 4
Stents for coronary artery disease 67%
Stents for peripheral artery disease 33%
Key events (2011-2018) Level of Impact
Commercial launch of DREAMS stent for coronary artery disease in 2014 in the EU
Commercial launch of ReZolve stent for coronary artery disease in 2014 in the EU
Commercial launch of Absorb BVS and DREAMS stent in the US in 2015
2018 Market Sales ($m)
5 EU $383m
Source: GlobalData Note: 5 EU = France, Germany, Italy, Spain and UK.
Sales for Bioabsorbable Stents by Region
We estimate 2012 Bioabsorbable Stent sales to be
$4.2m across the six regions covered in this report, which
are the US, France, Germany, Italy, Spain and the UK.
The coronary bioabsorbable stent market is expected to
have a larger market share than the peripheral
bioabsorbable stent market, with the stent sales in the
coronary market expected to be 15 times that of the
By the end of the forecast period, sales will grow to over
$702m with a CAGR of 172%.
The key drivers for the market in the forecast period are:
The rising prevalence of coronary and peripheral
artery disease in the major markets covered in this
The need for effective therapies that reduce the risk
of complications such as restenosis and thrombosis
associated with current drug-eluting and bare metal
The cost-savings for healthcare payers resulting from
reducing the need for repeat revascularization
FDA approval and launch of Absorb BVS and
Remedy in the US.
The launch of pipeline fully bioabsorbable stent
products such as the DREAMS stent developed by
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Companies Working to Get Their Stents Approved in the Bioabsorbable Stent Market
Bioabsorbable stent technology is in its infancy and has a
long road ahead before it is widely adopted into clinical
practice. This technology has the potential to
revolutionize the stent industry and improve treatment
outcomes for patients with coronary and peripheral artery
Germany is leading the way with bioabsorbable stenting
and has the largest market share in Europe; other
European countries such as France are not far behind.
The US will acquire market share steadily as
bioabsorbable stents receive approval.
Companies such as Biotronik and REVA Medical are also
developing fully bioabsorbable stents that will increase
the competition in the market. As these stents enter the
market, they will affect the current selling price and the
market share of Absorb BVS and Remedy.
Bioabsorbable Stents Total Revenue
2011 Total: $0.63m
US France Germany Italy Spain UK
2018 Total: $702m
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Unmet Needs Remain a Challenge
Stent technology has evolved over the years to address
the challenges of treating patients with coronary and
peripheral artery disease. Although stents such as drug-
eluting stents improve patient prognosis compared to
invasive cardiac surgeries, there still remain several
unmet needs and limitations with current therapies.
Complications such as restenosis and thrombosis remain
a concern. Effective therapies need to be developed to
reduce the number of stent-in-stent procedures that are
performed, where additional permanent stents are
implanted into patients. Additionally, physicians have
called for other treatment improvements such as
reducing or eliminating the need for dual anti-platelet
therapy that is administered when implanting bare metal
and drug-eluting stents.
A fully degradable and absorbable stent can lower the
risk of restenosis and thrombosis and ensure quality
long-term results for the patient.
Key Players in the Bioabsorbable Stent Market
Currently, the key players in the bioabsorbable stent
market are Abbott Vascular and Kyoto Medical Planning.
Abbott Vascular received CE approval for its Absorb BVS
for coronary artery disease, which is available for sale in
Europe, the Middle East, and parts of Asia-Pacific and
Kyoto Medical Planning received CE approval for its
Remedy stent, which is used to treat peripheral artery
disease and is available for sale in Europe and the
Middle East. These stents have yet to receive FDA
approval for use in the United States.
In the next few years as competitors such as Biotronik
enter the market, GlobalData believes that Abbott
Vascular and Kyoto Medical Planning will see a decrease
in market share of their bioabsorbable stent products.
Bioabsorbable Stents Future Outlook
Bioabsorbable stents provide temporary scaffolding to
the vessel and then disappear over time, leaving behind
a healed artery.
Although bioabsorbable stents offer several advantages,
adoption of this technology will be slow in the US and
Europe. The slow adoption can be attributed to the lack
of long-term clinical data and high selling prices. In the
European markets, the lack of integration of new stent
technologies into the existing reimbursement system will
slow the adoption of bioabsorbable stents.
Although the prevalence of peripheral artery disease is
high in the US and Europe, the market share of the
peripheral market is nine times lower than that of the
coronary market. The low market share can be attributed
to lack of data demonstrating clinical effectiveness of
stents such as drug-eluting stents for different peripheral
GlobalData believes that the bioabsorbable stent market
will steadily grow in the future as long-term clinical data
becomes available, appropriate reimbursement
guidelines are implemented and the selling price
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What do Physicians Think?
Physicians are cautiously optimistic and acknowledge the benefits of bioabsorbable stents.
“I think bioabsorbable stents are a very exciting
technology. The benefit of having a biodegradable stent
is that if and when it fails, you can go back and do it
Key Opinion Leader, November 2012
Physicians want to see long-term clinical data to evaluate the clinical effectiveness of bioabsorbable stents.
“Adoption of bioabsorbable stents depends on the clinical
data. If it is shown to be cost-effective, then I would
probably use it in 100% of my patients.”
Key Opinion Leader, October 2012
“There will be some adoption…. We still need to wait for
strong clinical data. We cannot replace drug-eluting and
bare metal stents that have thousands and thousands of
patients followed over five or 10 years.”
Key Opinion Leader, October 2012
The high selling price of bioabsorbable stents currently in the market will hinder widespread adoption.
“If the costs continue to be four times the cost of drug-
eluting stents, I cannot think of a hospital that can afford
Key Opinion Leader, October 2012
Bioabsorbable stents can potentially change the treatment paradigm for coronary artery disease.
“It is very possib