Global Drug-Eluting Stents Industry

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Global Drug-Eluting Stents Industry 

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This report analyzes the worldwide markets for Drug-Eluting Stents in US$ Million. The report provides separate comprehensive analytics for the US, Japan, Europe, and Rest of the World. Annual estimates and forecasts are provided for the period 2009 through 2017. Also, a six-year historic analysis is provided for these markets. The report profiles 39 companies including many key and niche players such as Abbott Vascular, Boston Scientific, Inc., Biosensors International Pte Ltd., Medtronic, Inc., and MIV Therapeutics Inc. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

I. INTRODUCTION, METHODOLOGY & PRODUCT DEFINITIONS Study Reliability and Reporting Limitations I-1Disclaimers I-2Data Interpretation & Reporting Level I-3Quantitative Techniques & Analytics I-3Product Definitions and Scope of Study I-3II. EXECUTIVE SUMMARY

1. MARKET OVERVIEW II-1

Recession Plummets Global DES Market II-1

Major Issues and Trends II-2

Recession Hits Cardiovascular Device Makers II-2

Changing Fortunes in the Global DES Industry II-2

Global Market Recovers From Safety Issue Shambles II-2

Competition Intensifies as New Products Make Way in to the

Market II-3

Drug-Eluting Stents Transforming the Face of Interventional

Cardiology Market II-3

Table 1: Global Stents Market by Type (2011): Percentage

Breakdown of Value Sales for Drug-Eluting Stents and

Bare-Metal Stents (includes corresponding Graph/Chart) II-4

Concerns over Adverse Effects Remain A Major Snag II-4

Potential Decline in Hospital Revenues II-4

Shift in Pricing Models to Increase Innovation Levels II-5

Glaring Lack of Health-Related Initiatives the World Over II-5

Bioabsorbable Stents - Abbott Makes a Headstart with Absorb II-5

2. COMPETITIVE LANDSCAPE II-7A Brief Introduction to DES II-7Suitable Patient Types for Drug-Eluting Stents II-7J&J Exit from DES Market Improves Prospects for Competitors II-7Drug-Eluting Stents - Competitive Landscape II-8World Drug-Eluting Stents Market (2002-2012): DES Brands Launched by Major Manufacturers- Abbott Vascular Inc. Boston Scientific Corp., Cordis (Johnson & Johnson),Medtronic Inc., and Intersect Ent II-9Boston Scientific Leads Global DES Market, Abbott Closes In II-9Table 2: World Drug Eluting Stents Market (2010): Market Share Breakdown of Value Sales by Leading Players - BostonScientific, Abbott, Medtronic, and Others (includes corresponding Graph/Chart) II-10Xience and Promus Take the Lead II-10Table 3: World Drug Eluting Stents Market (2010): Market Share Breakdown of Value Sales by Leading Brands - Xience V, Promus/Element, Taxus, Endeavor and Others (includes corresponding Graph/Chart) II-10Major DES Drugs Available in the Market II-11Sirolimus II-11Paclitaxel II-11Everolimus II-11Zotarolimus II-11Biolimus II-11Other Treatments Available for Treating In-Stent Restenosis II-12Select Leading Drug-Eluting Stent Products in the Market II-12XIENCE V (Abbott) II-12PROMUS® (Boston Scientific) II-12XIENCE PRIME (Abbott) II-12TAXUS® Liberte ® Atom™ (Boston Scientific) II-12ENDEAVOR (Medtronics) II-13TAXUS (Boston Scientific) II-13

3. CORONARY STENTING - AN INSIGHT II-14

Cardiovascular Diseases - A Brief Description II-14

Table 4: World Market for Cardiovascular Therapies (2011):

Percentage Share Breakdown of Value Sales by Product

Category-Drug-Eluting Stents, Cardiac Resynchronization

Therapy, Cardiac Markers, Portable Automated External

Defibrillators, and Angiogenesis/Gene Therapy (includes

corresponding Graph/Chart) II-14

Coronary Heart Disease II-15

Traditional Methods of Treating Blockage of Coronary Arteries II-15

Percutaneous Transluminal Coronary Angioplasty (PTCA) II-15

Coronary Artery Bypass Graft (CABG) II-15

Restenosis II-15

Evolution of Coronary Stents as a Replacement for Traditional

Methods II-15

What are Coronary Stents? II-16

How is Coronary Stenting Performed - Procedure II-16

Risks and Problems Associated with Placing a Stent II-16

Restenosis Still Pervasive Even after the Use of Stents II-16

Market Analysis for Coronary Stents II-16

By Region/Country II-17

Table 5: World Market for Coronary Stents (2011): Percentage

Share Breakdown of Value Sales by Region/Country -US, Japan,

Europe, Japan, and Rest of World (includes corresponding

Graph/Chart) II-17

In-Stent Restenosis - Outcome of Bare Metal Stents II-17

In-Stent Restenosis - Definition II-17

Causes of In-Stent Restenosis II-17

4. COST AND PRICE ECONOMICS II-18Cost Evaluation of DES II-18Initial Procedural Costs Remain High II-18Table 6: Average Price Per DES Unit for the Period 2004-2005 II-18

Table 7: Worldwide Average Stent Prices (2002-2005):

Breakdown of Regions by Drug Eluting Stents and Bare Metal

Stents II-18

Follow-Up Costs Provide Relief II-19

Table 8: A Comparative Presentation of Long-Term Costs of

DES and CABG II-19

Conversion of CABG Procedures to DES II-19

Impact of DES on Indirect Costs II-19

5. RESEARCH AND DEVELOPMENT INITIATIVES - A HISTORIC PERSPECTIVEBUILDER II-20Boston Completes European and Intercontinental Enrollment Phases II-20Medtronic To Start Clinical Study II-20Guidant Accomplishes Patient Enrollment II-20Abbott Receives FDA Approval for Initiation of ZoMaxx Clinical Trials II-20Medtronic Commences Endeavor III Clinical Trial II-21MIV Therapeutics Completes Drug-Eluting Stent Coating R&D Program II-21Guidant Conducts First Implant as Part of Drug Eluting Stent Trial II-21Medtronic's Endeavor Drug Eluting Stent Shows Positive Results II-21Cypher™ Coronary Stent Trials Show Restenosis Rates Decline by5.1% II-22Boston Scientific Demonstrates Positive Results for Taxus I Clinical Trial II-22Medtronic Initiates Endeavor II Clinical Trials for Endeavor Drug Eluting Stent II-22Guidant's Clinical Trials for Coronary Stent Demonstrates Positive Results II-22

6. CLINICAL TRIALS UNDERTAKEN FROM 2002-2007 II-23

MIV Commences Clinical Trials of HC Stent II-23

XTNT Voiced CUSTOM III Trial Program of NX™ DES System II-23

Dynatek Completes DES Coating Durability Trial II-23

STEALTH Trial II-23

SIROCCO Trial II-24

Cook Trial II-24

ZoMAXX Trial II-24

Ravel Trial II-24

Sirius Trial II-24

C - Sirius Trial II-25

E - Sirius Trial II-25

Taxus I through VI Clinical Trials II-25

Other Clinical Trials II-25

7. PRODUCT INNOVATIONS/INTRODUCTIONS II-26Abbott Receives European Clearance for Bioabsorbable Stent II-26NIMS Develops Am80 Drug Eluting Stent II-26Cook Medical Unveils New CE Marked Zilver PTX Drug-Eluting Peripheral Stent II-26Medtronic Rolls Out Driver Sprint RX Coronary Stent System II-27Boston Scientific Launches TAXUS Liberte DES In Japan II-27

8. PRODUCT INNOVATIONS/INTRODUCTIONS - A HISTORIC PERSPECTIVE BUILDER II-28

Medtronic Unveils Endeavor Sprint Drug-Eluting Stent in The US II-28

CeloNova Unveils CATANIA™ Stent System with NanoThin Polyzene®-F II-28

Abbott Launches Xience V Drug-Eluting Coronary Stent in Europe II-28

Boston Introduces Taxus(R) Express2(TM) in Japan II-28

Cordis Brings Advanced Drug-Eluting Stent II-29

Sorin Unveils Enhanced Janus Flex in Europe II-29

EUREKA Develops Latest Generation of Drug- Eluting Stent II-29

MIV Therapeutics Develops New Drug Eluting Coating Technology

in Canada II-30

Medtronic to Launch Endeavor DES in Europe II-30

DISA Vascular (Pty) Ltd Introduces ChromoFlex in Europe II-30

Boston Scientific Introduces Taxus Liberte Drug Eluting Stent

in Europe II-31

Boston Scientific Introduces Innovative Drug-Eluting Stent,

Taxus in the US Market II-31

9. RECENT INDUSTRY ACTIVITY II-32Boston Scientific Obtains CE Mark Approval for TAXUS Element™ II-32Biosensors Takes Over Cardiomind II-32Tryton Medical Implants First Tryton® in Austria and Portugal II-32Medtronic to Take Over Invatec II-32Abbott Obtains Approval for XIENCE V Stent System in Japan II-33Boston Scientific Obtains Approval for Promus Stent In Japan II-33Opto Circuits (India) Obtains CE Mark Approval for Taxcor Plus II-33Abbott Obtains Approval for Additional Indications of Xience Vand Xience Prime II-34Bayer Material Science to Acquire PolyBioMed II-34Boston Scientific Obtains Health Canada Approval for PROMUS® II-34Abbott Labs to Introduce XIENCE V Stent in China II-34Abbott Obtains Approval for XIENCE V® from Health Canada II-35Boston Scientific Obtains FDA Approval for TAXUS® Liberte® Atom™ Stent II-35Medtronic Obtains CE Mark Approval for Endeavor DES II-35Biosensors International Group Receives CE Mark Approval for BioMatrix II-36Medtronic Receives Approval for Endeavor Drug-eluting Stent in Japan II-36Boston Scientific Obtains Japanese Approval for TAXUS® Liberte® Atom™ II-36XTENT Receives CE Mark Approval for CUSTOM NX DES II-36Maxcor Lifescience Inks Strategic Cooperation Agreement with Micell Technologies II-37Boston Scientific Snaps Up Labcoat II-37

10. INDUSTRY ACTIVITY - A HISTORIC PERSPECTIVE BUILDER II-38

Medtronic Commences PROTECT Comparative Study in US II-38

B. Braun to Invest in its India based Operations II-38

Medtronic Secures TDP Approval for Endeavor Zotarolimus

Eluting Coronary Stent II-38

Medtronic Receives US FDA Approval for Endeavor Drug-Eluting

Stent II-39

Novation and Medtronic Ink National Agreement II-39

MIV Therapeutics Acquires Biosync Scientific II-39

J & J Acquires Conor Medsystems II-39

FDA Approves Boston Scientifis's Taxus Stent with Extended

Shelf Life II-40

Lombard Collaborates With S&N II-40

India Establishes Asia's first Catheter and Stent Unit. II-40

Abbott Requests FDA Approval for Xience II-40

Brookwood and TTV Start Joint Venture II-40

SurModics Acquires Brookwood Pharmaceuticals, Inc II-41

ARIAD Collaborates with ICON Medical II-41

Biosensors Acquires 50% Stake in JWMS II-41

Cordis' Cypher Select™ Plus Receives Approval in Europe II-41

Boston Scientific Acquires Guidant for $27 Billion, Abbott

Gets Guidant's Vascular and Cardiac Therapies Businesses as

Part of Deal II-42

Conor COSTAR II Receives US FDA Approval II-42

Abbott Expands Vascular Sites in Ireland II-42

Medtronic's Endeavor® Attains Reimbursement Approval in France II-42

SurModics Offers License for Hydrophilic Technology to Devax II-42

Conor obtains License for Novartis' Pimecrolimus II-43

Medtronics Makes Final PMA Submission for Endeavor II-43

Volcano Collaborates with CRF, Cardialysis and Stanford

University II-43

Boston's PROMUS Receives CE Mark Approval II-43

SurModics and X-Cell Inks Licensing Agreement II-44

Medtronic Receives Regulatory Approval for Endeavor (R) II-44

Medtronics' Endeavor Obtains Chinese Regulatory Approval II-44

Biosensors Collaborates with JW Medical II-44

Biosensors and Weigao To Consolidate Joint Venture II-44

Biotronik Enters Multi-Drug Deal with Novartis II-45

MIVT Enters Collaboration Deal with SMT II-45

SMT's Infinnium Paclitaxel System Receives CE Mark II-45

Guidant's Xience V Receives European Approval II-45

Medtronic Files Initial PMA Module TO US FDA II-46

Boston Scientific Receives European Approval for TAXUS(R) II-46

Biosensors Attains US Patent Covering DES Technology II-46

MediVas LLC and Estracure Inc Sign Agreement for Development

of DES II-46

Relisys Medical of India Finalizes Deal with Germany Based

Blue Membranes II-46

X-cell Medical Enrolls for Clinical Trial of ETHOS I Estradiol

Eluting Stent. II-47

Biosensors International Group Receives CE Approval for First

DES, Axxion II-47

Boston Scientific Corp Receives CE Mark Approval for Marketing

Larger Stent Sizes II-47

Medtronic Receives CE Mark Approval for Commercial Sale of

Endeavor DES in Europe II-47

Biosensors International Opens New Interventional Cardiology

Unit in Singapore II-48

Johnson & Johnson Recalls Cypher Drug-Eluting Stents II-48

Boston Scientific Buys Out Precision Vascular Systems II-48

Implant Sciences and CardioTech International enter into

Partnership with CorNova II-48

Avantec Vascular Corporation Signs Agreement with Novartis

Pharma AG II-48

Guidant and Cordis Enter into Promotion Agreement II-49

Genvec Collaborates with Cordis II-49

Cordis Receives Approval from Japanese Ministry of Health II-49

Boston Scientific Modifies Production of Taxus Drug-Eluting Stent II-49

Guidant Acquired CE Mark Approval for Multi-Link Bifurcation

Stent System II-50

Boston Scientific Receives Reimbursement Approval from French

Government II-50

Boston Scientific Withdraws Consortium of Drug-Coated Stents II-50

11. FOCUS ON SELECT GLOBAL PLAYERS II-51Abbott Vascular (USA) II-51Boston Scientific, Inc. (USA) II-51Biosensors International Pte Ltd. (Singapore) II-52Medtronic, Inc.(USA) II-52MIV Therapeutics, Inc. (Canada) II-52

12. GLOBAL MARKET PERSPECTIVE II-54

Table 9: World Recent Past, Current and Future Analysis for

Drug-Eluting Stents by Geographic Region - US, Japan, Europe

and Rest of the World Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2009 through

2017 (includes corresponding Graph/Chart) II-54

Table 10: World Historic Review for Drug-Eluting Stents by Geographic Region - US, Japan, Europe and Rest of the World Markets Independently Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart) II-55

Table 11: World 15-Year Perspective for Drug-Eluting Stents

by Geographic Region - Percentage Breakdown of Dollar Sales

for US, Japan, Europe and Rest of the World Markets for Years

2003, 2011, & 2017 (includes corresponding Graph/Chart) II-56

III. MARKET

1. THE UNITED STATES III-1

A. Market Analysis III-1

Issues and Trends III-1

US Healthcare Ideology III-1

The Important Role of Medicaid in the US III-1

Boston Leads the DES Market III-1

Table 12: US Drug Eluting Stents Market (2011): Market

Share Breakdown by Leading Players - Boston Scientific,

Abbott, Medtronic, and Johnson & Johnson (includes

corresponding Graph/Chart) III-2

Table 13: US Drug Eluting Stents Market (2011): Market Share Breakdown by Leading Brands - Xience V, Promus/Element, Taxus, Cypher, and Endeavor/Resolute(includes corresponding Graph/Chart) III-2Drug-Eluting Stents Launched in the US by Major Manufacturers (2003-2012) III-2Select Leading DES Products in the Market III-3Xience V - The Leader III-3Taxus and Promus- The Other Leading DES III-3Regulatory Environment III-3FDA Framework III-3FDA Approvals III-3B.Market Analytics III-6Table 14: The US Recent Past, Current and Future Analysis for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart) III-6

Table 15: The US Historic Review for Drug-Eluting Stents

Analyzed with Annual Sales Figures in US$ Million for Years

2003 through 2008 (includes corresponding Graph/Chart) III-7

2. JAPAN III-8A.Market Analysis III-8Healthcare System in Japan III-8Table 16: Japanese Market for Drug Eluting Stents(2005-2007): Market Share Breakdown of Sales Revenue by Major Players- Johnson & Johnson Boston Scientific, and Medtronic III-8B.Market Analytics III-9Table 17: Japanese Recent Past, Current and Future Analysis for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years 2009 through 2017 (includes corresponding Graph/Chart) III-9

Table 18: Japanese Historic Review for Drug-Eluting Stents

Analyzed with Annual Sales Figures in US$ Million for Years

2003 through 2008 (includes corresponding Graph/Chart) III-10

3. EUROPE III-11A.Market Analysis III-11Issues and Trends III-11Reimbursement Woes Continue in Europe III-11Reimbursement - A Major Hurdle in European Market Penetration of DES III-11Slow Market Penetration of New Medical Devices in Europe III-11Taxus - Leading the European Stent Market III-11Healthcare System in Europe III-11B.Market Analytics III-12Table 19: European Recent Past, Current and Future Analysis for Drug-Eluting Stents by Geographic Region - France, Germany, Italy, UK, Spain and Rest of the World Markets Independently Analyzed with Annual Sales Figures in US $ Million for Years 2009 through 2017 (includes corresponding Graph/Chart) (includes corresponding Graph/Chart) III-12

Table 20: European Historic Review for Drug-Eluting Stents

by Geographic Region - France, Germany, Italy, UK, Spain and

Rest of the Europe Markets Independently Analyzed with

Annual Sales Figures in US$ Million for Years 2003 through

2008 (includes corresponding Graph/Chart) III-13

Table 21: European 15-Year Perspective for Drug- Eluting Stents by Geographic Region - Percentage Breakdown of Dollar Sales for France, Germany, Italy, UK, Spain and Rest of Europe Markets for Years 2003, 2011 and 2017 (includes corresponding Graph/Chart) III-14

3a. FRANCE III-15

A. Market Analysis III-15

Healthcare System in France III-15

B. Market Analytics III-15

Table 22: French Recent Past, Current and Future Analysis

for Drug-Eluting Stents Analyzed with Annual Sales Figures

in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-15

Table 23: French Historic Review for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years2003 through 2008 (includes corresponding Graph/Chart) III-16

3b. GERMANY III-17

 Analysis III-17

Healthcare Policies in Germany III-17

Lower Market Penetration of DES III-17

B. Market Analytics III-18

Table 24: German Recent Past, Current and Future Analysis

for Drug-Eluting Stents Analyzed with Annual Sales Figures

in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-18

Table 25: German Historic Review for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years2003 through 2008 (includes corresponding Graph/Chart) III-19

3c. ITALY III-20

 Analysis III-20

Italian Healthcare System III-20

Local Healthcare Agencies III-20

National Health System in Italy III-20

B. Market Analytics III-21

Table 26: Italian Recent Past, Current and Future Analysis

for Drug-Eluting Stents Analyzed with Annual Sales Figures

in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-21

Table 27: Italian Historic Review for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years2003 through 2008 (includes corresponding Graph/Chart) III-22

3d. THE UNITED KINGDOM III-23

 Analysis III-23

National Health System in the UK III-23

B. Market Analytics III-23

Table 28: The UK Recent Past, Current and Future Analysis

for Drug-Eluting Stents Analyzed with Annual Sales Figures

in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-23

Table 29: The UK Historic Review for Drug- Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years2003 through 2008 (includes corresponding Graph/Chart) III-24

3e. SPAIN III-25

 Analysis III-25

Healthcare System in Spain III-25

B. Market Analytics III-25

Table 30: Spanish Recent Past, Current and Future Analysis

for Drug-Eluting Stents Analyzed with Annual Sales Figures

in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-25

Table 31: Spanish Historic Review for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years2003 through 2008 (includes corresponding Graph/Chart) III-26

3f. REST OF EUROPE III-27

Market Analytics III-27

Table 32: Rest of European Recent Past, Current and Future

Analysis for Drug-Eluting Stents Analyzed with Annual Sales

Figures in US$ Million for Years 2009 through 2017

(includes corresponding Graph/Chart) III-27

Table 33: Rest of European Historic Review for Drug-Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart) III-28

4. REST OF WORLD III-29

 Analysis III-29

Chinese Drug-Eluting Stents Market Witnesses Robust Growth III-29

B. Market Analytics III-29

Table 34: Rest of the World Recent Past, Current and Future

Analysis for Drug-Eluting Stents Analyzed with Annual Sales

Figures in US$ Million for Years 2009 through 2017 (includes

corresponding Graph/Chart) III-29

Table 35: Rest of World Historic Review for Drug- Eluting Stents Analyzed with Annual Sales Figures in US$ Million for Years 2003 through 2008 (includes corresponding Graph/Chart) III-30IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 39 (including Divisions/Subsidiaries - 46)

------------------------------------------Region/Country Players

------------------------------------------The United States 26Canada 3Japan 1Europe 11Germany 2The United Kingdom 3Italy 1Rest of Europe 5Asia-Pacific (Excluding Japan) 4Africa 1------------------------------------------

To order this report: Cardiovascular Devices Industry: Global Drug-Eluting Stents Industry

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