The Stent Market: Global and the United States

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The Stent MarketGlobal and the United States

• Stephan Bosshard
• Maritza Rodriguez

Prof John Essigmann Robert Langer
TA Ley Richardson
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We Will Discuss

• The 1st Stent
• Asian/European Markets
• American Market
• Comparisons
• Market Analysis
• Whats to Come

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Pioneers of Angioplasty

• January 1964 - Charles Dotter performs first
  percutaneous transluminal angioplasty

• September 1977 First percutaneous transluminal
  coronary angioplasty (PTCA) performed by Andreas
  Gruentzig in Zurich, Switzerland

• The concept of the stent grew directly out of the
  early interventional cardiologists' experience.

http//ptca.org/
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PTCAs Drawbacks

• Risk of artery collapse and restenosis (40-50)
  with conventional PTCA (balloon angioplasty)
  procedures

• Mid-80's radiologists and cardiologists start
  designing new devices in hopes of solving these
  problems

• Lasers, tiny "shavers", rotational "polishers" --
  many tools were miniaturized to be delivered via
  catheter.

http//ptca.org/
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The First Stents

• Stents are found to be most efficient method of
  reducing restenosis.

• Julio Palmaz and Richard Schatz work on stents in
  the United States in Europe others are
  developing own designs

• 1986 - Toulouse, France Jacques Puel and Ulrich
  Sigwart insert first stent into a human coronary
  artery.

• 1994 the first Palmaz-Schatz stent (Cordis
  Corporation) is approved by the FDA for use in
  the United States.

http//ptca.org/
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The Palmaz-Schatz Stent

• The Palmaz-Schatz stents are mounted on a balloon
  and can be opened once inside the coronary artery.

www.hgcardio.com
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The Evolution of Stents

• Stenting solved the problem of abrupt artery
  closure but restenosis rate still 20-30.

• Late 90s solution moves away from purely
  mechanical devices and toward pharmacology.

• Stents coated with immunosuppresant drugs
  (Sirolimus in Cypher) or chemotherapy agents
  (Paclitaxel in Taxus).

• Restenosis rate in drug-eluting stents is lt10.

http//ptca.org/
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Current Global MarketMedical Devices Industry

• Global sales - 175 billion in 2000
• - US 38 (66.5 billion)
• - Europe 26 (45.5 billion)
• - Japan 15 (26.3 billion)

• Industry with extremely high earnings growth

http//www.dlbabson.com
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Medical Devices Industry
http//www.dlbabson.com
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The Global Stent Market

• Current global market for stents 2.2 billion

• Projected global market for stents in 2005 5
  Billion

Banc of America
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Asian Markets

• Japan approval expected 6 months after FDA
  approvals

• India

-participant in BSCs Wisdom Program -Taxus
launched earlier this year -2003 Taxus Sales
15-20 Million
https//www.rbccmresearch.com India Business
Insight
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European Market

• Cypher stent (JJ) approved in April 2002
• -European market share 7-8 by end of 2002

• Taxus stent (Boston Scientific) approved in
  January 2003

• Taxus European Product Launch two weeks ago!

• End of 2003 40-45 of stents sold are
  drug-eluting stents

Boston Scientific
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The Conformite Europeenne (CE) Mark

• 4 Fundamental Principles of the EU
• -Freedoms of Persons, Services, Goods, Capital

• CE Mark
• -Issued by Notified Bodies

• Recent national decentralizing tendencies

• CE marking does not correlate to market share

-Johnson Johnson Cypher Stent
www.jacoti.com
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Reimbursement Hurdles in Europe

• Low rate of reimbursement by European Health
  Insurances

-Social Health Insurance Systems
-European Union Criteria

www.jacoti.com www.who.dk
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European Health Care Expenditures

www.who.dk
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Limited Coverage of Modern Technology

• Age-adjusted mortality rates per 100,000 for men
  from IHD 1990-1992

France142
Spain181
Portugal207
Italy 224
England Wales515
Scotland655

• UK has one of lowest rates of stenting procedures
  in Europe

University of Birmingham
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Stent Procedures in Europe and Great Britain

• PCI - percutaneous invasive intervention

• Stents are used in 70 of PCIs

European PCI rates
University of Birmingham
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European Health Care
www.who.dk
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The Future of the European Market

• Companies must overcome the reimbursement hurdles

• Health Care Technology Assessment (HCTA) Agencies

-Role of companies

• The influence of European Doctors and Medical
  Societies

• European Health Care in the future?
• -Privatization

www.jacoti.com
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PTCA Throughout Years
Percutaneous Transluminal Coronary
Angioplasty (PTCA)
Source Health Resources Utilization Branch,
CDC/NCHS AHA
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CVD Ops and Proc Years
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Year 1998 Procedures
Source AHA
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Year 2000 Procedures
Source AHA
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Price

• Current bare stents cost from about 900 - 1,200
  (The Wall Street Journal)
• New drug-coated stents to cost about 3,000 each
• (New York Times)
• Angioplasty costs 12,000
• Stenting costs 8,000
• Bypass costs about 27,000.

Source The Wall Street Journal, New York Times
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Calculations

• 70 to 90 of coronary angioplasties use stents

Using the number of stents used according to the
AHA
Stenting / PTCA Procedures Stents
Of Stents Sold x Stent Price Revenue
How much money does the US make?
Source AHA
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how me the Money

• In 1998, the US made 340 - 450 million
  dollars.
• In 2000, the US made 410 - 550 million dollars.

How much revenue was estimated?
Source AHA
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Future Stent Market

• Kurt Kruger from Bank of America predicts the
  global stent market to reach

• 3.2 billion in 2003

• 3.6 billion by 2004

• 5 billion by 2005

Lets find the future US market.
Source Bank of America
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Assuming drug coated stents replaces bare stents.
Source Boston Scientific
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Future Stent Market
What about drug coated stents?
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Effects

• About 20-40 of these patients who receive the
  traditional stents develop restinosis
• A study showed

• 17 of the patients with a bare stent had
• reclogged vessels which required a second
• procedure
• Only 5 of the patients who received the
• drug-coated stent.

Drug coated stents decrease restenosis.
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Drug Coated Stents Market

• Currently No US Market

• April 2003

• Released - lt ½ US Market

• Over Time Dominate US Stent Market

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Drug Coated Stents Revenue

• At First High Revenue

• High Cost (3,000)

• Drastic Revenue Increase

• Increase in use of Drug-coated vs. bare

• Slight Revenue Increase

• Competition (lower price)

• Increase in use of Drug-coated vs. bare

• Revenue to Stabilize or Increase Slightly

• Lower Prices

• Less Stent Replacement

• Continual need for Stents

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Conclusions US

• Drug coated stents will dominate the US market.

• United States will quickly increase its market
• share of the drug coated stent market

Why?
New technology catches on quicker in the US
Private insurances will pay for new technology.
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Future Work

• American Market

• Find more statistics

• Better model for future market

• Asian and European Markets

• Obtain numbers

• Obtain more information on Japan

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Questions???