GDME1002FPR Bioabsorbable Stents - Current and Bioabsorbable Stents Future Outlook Bioabsorbable...

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  • XX XX

    XXX / Published XXX

    Bioabsorbable Stents Current and Future Players

    GDME1002FPR / Published December 2012

  • Executive Summary

    © 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

    Diagnosed Prevalence

    Coronary Artery Disease 4.5 million

    Peripheral Artery Disease 4.1 million

    2011 Market Sales ($m)

    Coronary Market $0.39m

    Peripheral Market $0.24m

    Total $0.63m

    Pipeline Assessment

    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)

    US $319m

    5 EU $383m

    Total $702m

    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

    peripheral market.

    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

    report.

     The need for effective therapies that reduce the risk

    of complications such as restenosis and thrombosis

    associated with current drug-eluting and bare metal

    stents.

     The cost-savings for healthcare payers resulting from

    reducing the need for repeat revascularization

    procedures.

     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

    Biotronik.

  • Executive Summary

    © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 3 GDME1002FPR / Published DEC 2012

    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

    disease.

    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

    19%

    44%

    18%

    9%

    10%

    France

    Germany

    Italy

    Spain

    UK

    2011 Total: $0.63m

    45%

    9%

    27%

    7%

    4%

    8%

    US France Germany Italy Spain UK

    2018 Total: $702m

    Source: GlobalData

  • Executive Summary

    © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 4 GDME1002FPR / Published DEC 2012

    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

    Latin America.

    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

    lesions.

    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

    decreases.

  • Executive Summary

    © GlobalData. This report is a licensed product and is not to be copied, reproduced, shared or resold in any form. Page 5 GDME1002FPR / Published DEC 2012

    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

    again.”

    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

    that.”

    Key Opinion Leader, October 2012

     Bioabsorbable stents can potentially change the treatment paradigm for coronary artery disease.

    “It is very possib