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Global Prosthetic Heart Valves Industry

  • June 2014
  • -
  • Global Industry Analysts
  • -
  • 203 pages

This report analyzes the worldwide markets for Prosthetic Heart Valves in US$ Million by the following Product Segments: Mechanical valves, and Biological/Tissue valves. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2013 through 2020. Also, a seven-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based on public domain information including company URLs. The report profiles 22 companies including many key and niche players such as -

Edwards Lifesciences Corporation
JenaValve Technology, Inc.
Medtronic, Inc.
On-X Life Technologies, Inc.
Sorin Group

Table Of Contents

Global Prosthetic Heart Valves Industry



I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS

Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-2
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3
Mechanical Heart Valves I-3
Biological/Tissue Heart Valves I-3


II. EXECUTIVE SUMMARY

1. OUTLOOK II-1
A Prelude II-1
Aortic Stenosis - An Underappreciated yet Growing Condition II-1
Market Overview II-2
Analysis by Region II-3
Market Prospects by Segment II-4
Major Growth Drivers and Issues II-4
Aging Demographics and Increasing Incidences of Cardiac Diseases II-4
Table 1: Global Population Statistics for the 65+ Age Group
(Male and Female) for Major Countries/Regions: 2013E (includes
corresponding Graph/Chart) II-5
Under-Treated Population II-6
Large Un-Treated Rheumatic Heart Disease Patient Population II-6
Developing Countries Face Accessibility Issues II-6

2. INDUSTRY OVERVIEW II-7
Developed Markets Move towards Bioprosthetic Valves II-7
Artificial Mechanical Heart Valves Come of Age II-7
Biological Valve Options - Better Yet Need Improvements II-8
Design and Function of Bio-Prosthesis Tissues II-9
Tissue Engineered Aortic Valves - The Future II-9
The Renaissance of Sutureless Valves II-9
Safety Concerns Shifts Focus towards Stentless Valves II-10
Metals Giving Way to Carbon Compounds and Polymers in
Mechanical Heart Valves II-10
BSE: A Potential Problem for Tissue Segment II-10
Transcatheter Aortic Valve Replacement Market Poised for Growth II-11
Market Upbeat for TAVI Devices II-11
TAVI/TAVR - A Review of Present, Present and Future Prospects II-11
Issues Confronting TAVI's Potential Indication Expansions II-12
The Two THVs Compared II-12
A Comparison of Key Design Features of Edwards SAPIEN XT and
Medtronic CoreValve II-13
A Comparison of Key Applications of Edwards SAPIEN XT and
Medtronic CoreValve II-13
Newer Valves on the Horizon II-13
Select Major First and Second Generation Transcatheter
Aortic Valve Replacement Products - Key Features and
Benefits II-14
Transcatheter Mitral Valve Regurgitation Treatment Faces Hurdles II-15

3. COMPETITIVE ANALYSIS II-17
A Peek into the Competitive Landscape of Heart Valves Market II-17
Table 2: Leading Players in Global Heart Valve Market (2012):
Percentage Breakdown of Value Sales for Edwards Lifesciences,
St. Jude Medical, Medtronic, Sorin Group and Others (includes
corresponding Graph/Chart) II-17
Key Players in the TAVI Market II-17
Table 3: Leading Players in the Global Transcatheter Aortic
Valve Replacement Market (2013): Percentage Breakdown of
Value Sales for Edwards, Medtronic and Others (includes
corresponding Graph/Chart) II-18
Medtronic Survives Patent Challenges, Settles Dispute with
Edwards II-18
Edwards's Sapien XT Carries Edge in Clinical Performance II-18
Edwards' TAVR Business Witnesses Robust Growth II-19
Sorin Group Eyes Mitral Valve Market II-19

4. PRODUCT OVERVIEW II-20
Human Heart - Morphology II-20
An Introduction to Heart Valves II-20
Heart Valve Disorders II-21
Probable Causes of Heart Valve Diseases II-21
Diagnosis II-21
Replacement or Repair? II-22
Heart Valve Replacement II-22
Prosthetic Heart Valves - An Introduction II-22
Chronology of Important Developments in Prosthetic Heart
Valve Market II-23
Designing Considerations for Prosthetic Heart Valves: II-23
Mechanical Valves II-24
Caged Ball Design II-24
Tilting Disc Heart Valve II-24
Bileaflet Valves II-24
Biological/Tissue Valves II-24
Stentless Tissue Valves: II-25
Stented Tissue Valves: II-25
Mechanical Vs. Biological II-25
Some Important Facts II-26
Valve Failure II-26
Symptoms of Malfunctioning Prosthetic Heart Valve II-27
Clinical Symptoms: II-27
Physical Symptoms: II-28
Sound: II-28
PHV Murmurs: II-28
Prosthetic Valve Endocarditis (PVE) II-29
Prosthetic Valve Thrombosis (PVT) II-30
Embolization II-30
Structural Breakdown of Bioprosthetic Valves II-30

5. PRODUCT LAUNCHES/REGULATORY APPROVALS II-31
Edwards Lifesciences Obtains FDA Approval for Sapien XT Valve II-31
Medtronic Obtains FDA Clearance for Expanded Indications II-31
Sorin Obtains CE Mark Approval for Extended Adult Age
Indication for its Percevalâ„¢ Sutureless Aortic Valve II-31
Edwards Lifesciences Secures CE Mark for Using SAPIEN XT in
Aortic Valve-in-Valve Procedures and Transcatheter Mitral II-31
Edwards Obtains CE Mark for Edwards SAPIEN 3 Valve II-31
Medtronic Secures FDA Approval for CoreValve® System II-31
On-X® Life Technologies Secures CE Mark for On-X® Prosthetic
Heart Valve II-31
Sorin Group Secures CE Mark Approval for XL VERSION of
PERCEVALâ„¢ Sutureless Aortic Valve II-32
Sorin Group Obtains CE Mark Approval for Solo Smart Aortic Valve II-32
Boston Scientific Obtains CE Mark Approval for Lotusâ„¢ Valve
System II-32
FDA Clears Revised Labeling for Edwards' Sapien TAVR Device
for Alternative Access Sites II-32
JenaValve Obtains Extended CE Mark for its TAVI System II-32
Medtronic Obtains CE Mark for Engagerâ„¢ Transcatheter Valve II-32
Edwards Obtains SFDA Approval for Carpentier- Edwards
Perimount Mitral Heart Valve II-33
Sorin Group Secures Approval for Mitroflow® Aortic Pericardial
Heart Valve in Japan II-33
St. Jude Medical Secures CE Mark for Porticoâ„¢ Transcatheter
Aortic Heart Valve and Transfemoral Delivery System II-33
On-X® Life Technologies Introduces On-X® Aortic Prosthetic
Valve and ePTFE Suture Chord-X® II-33
Medtronic Secures CE Mark for the CoreValve® Evolut™ 23mm Valve II-33
Sorin Group Secures CE Mark Approval for Extended Indications
of PERCEVALâ„¢ S II-33
St. Jude Medical Introduces New Trifecta Heart Valve in Japan II-33

6. RECENT INDUSTRY ACTIVITY II-34
Medtronic and Edwards Settle Patent Dispute II-34
Edwards Lifesciences Secures Reimbursement Approval for its
Sapien XT Valve in Japan II-34
Edwards Lifesciences Obtains IDE Approval from FDA to Begin
Clinical Trial of SAPIEN 3 Transcatheter Aortic Heart Valve II-34
Medtronic to Recommence Sales of CoreValve® System in Germany II-34
Sorin Group Inks Supply Agreement with Boston Scientific II-34

7. FOCUS ON SELECT PLAYERS II-35
Edwards Lifesciences Corporation (US) II-35
JenaValve Technology, Inc. (US) II-35
Medtronic, Inc. (US) II-36
On-X Life Technologies, Inc. (US) II-36
Sorin Group (Italy) II-37
St. Jude Medical, Inc. (US) II-37

8. GLOBAL MARKET PERSPECTIVE II-38
Table 4: World Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, Latin America and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Thousand for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-38

Table 5: World Historic Review for Prosthetic Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Thousand for Years 2006
through 2012 (includes corresponding Graph/Chart) II-39

Table 6: World 15-Year Perspective for Prosthetic Heart Valves
by Geographic Region - Percentage Breakdown of Dollar Sales
for US, Canada, Japan, Europe, Asia-Pacific, Latin America and
Rest of World Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) II-40

Table 7: World Recent Past, Current and Future Analysis for
Tissue Heart Valves by Geographic Region - US, Canada, Japan,
Europe, Asia-Pacific, Latin America and Rest of World Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2013 through 2020 (includes corresponding
Graph/Chart) II-41

Table 8: World Historic Review for Tissue Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Thousand for Years 2006
through 2012 (includes corresponding Graph/Chart) II-42

Table 9: World 15-Year Perspective for Tissue Heart Valves by
Geographic Region - Percentage Breakdown of Dollar Sales for
US, Canada, Japan, Europe, Asia-Pacific, Latin America and
Rest of World Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) II-43

Table 10: World Recent Past, Current and Future Analysis for
Mechanical Heart Valves by Geographic Region - US, Canada,
Japan, Europe, Asia-Pacific, Latin America and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Thousand for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-44

Table 11: World Historic Review for Mechanical Heart Valves by
Geographic Region - US, Canada, Japan, Europe, Asia-Pacific,
Latin America and Rest of World Markets Independently Analyzed
with Annual Sales Figures in US$ Thousand for Years 2006
through 2012 (includes corresponding Graph/Chart) II-45

Table 12: World 15-Year Perspective for Mechanical Heart
Valves by Geographic Region - Percentage Breakdown of Dollar
Sales for US, Canada, Japan, Europe, Asia-Pacific, Latin
America and Rest of World Markets for Years 2006, 2014 and 2020
(includes corresponding Graph/Chart) II-46

Table 13: World Recent Past, Current and Future Analysis for
Transcatheter Aortic Valve Implantation (TAVI) Systems by
Geographic Region - US, Japan, Europe and Rest of World
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2013 through 2020 (includes
corresponding Graph/Chart) II-47

Table 14: World 15-Year Perspective for Transcatheter Aortic
Valve Implantation (TAVI) Systems by Geographic Region -
Percentage Breakdown of Dollar Sales for US, Japan, Europe and
Rest of World Markets for Years 2014 and 2020 (includes
corresponding Graph/Chart) II-48


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
Current and Future Analysis III-1
Market Overview III-1
Valvular Disease Statistics III-2
Complications in Prosthetic Heart Valve III-2
Demographics Spur Growth III-2
Table 15: US Population Breakdown by Age Group (2012)
(includes corresponding Graph/Chart) III-3
Minimally Invasive Surgeries for Aortic Stenosis Treatment
Gains Popularity III-3
Competitive Landscape III-3
Prosthetic Heart Valves Approved by the FDA Since 2000 III-3
Edwards's Sapien Versus Medtronic's CoreValve III-4
CoreValve Could Make a Potential Impact III-4
FDA Regulations for Medical Devices III-5
New CPT Codes for TMVR and TAVR for Calendar Year 2014 III-6
Table 16: CPT Codes for Transcatheter Aortic Valve
Repair/Replacement Procedures and Non-Facility Payment
Rates for 2013 and 2014 III-6

Table 17: CPT Codes for Valve Repair/ Replacement
Procedures and Physician Payment Rates for 2013 and 2014 III-7
Product Launches/ Approvals III-8
Strategic Corporate Developments III-9
Key Players III-9
B.Market Analytics III-12
Table 18: US Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-12

Table 19: US Historic Review for Prosthetic Heart Valves by
Product Segment - Tissue and Mechanical Heart Valves Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-13

Table 20: US 15-Year Perspective for Prosthetic Heart Valves
by Product Segment - Percentage Breakdown of Dollar Sales
for Tissue and Mechanical Heart Valves Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-14

Table 21: US Recent Past, Current and Future Analysis for
Transcatheter Aortic Valve Implantation (TAVI) Systems
Market - Analyzed with Annual Sales Figures in US$ Million
for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-15

2. CANADA III-16
Market Analysis III-16
Table 22: Canadian Recent Past, Current and Future Analysis
for Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-16

Table 23: Canadian Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-17

Table 24: Canadian 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-18

3. JAPAN III-19
A.Market Analysis III-19
Current and Future Analysis III-19
Japanese Heart Valve Market to Grow III-19
Traditional Valves Market to Remain Strong III-19
Aging Population - A Key Growth Driver for Prosthetic Heart
Valves Market III-19
TAVR/TAVI Devices Debut in Japan III-19
Edwards to Boost Performance with SAPIEN XT III-20
Product Launches/Regulatory Approvals III-20
Strategic Corporate Development III-20
B.Market Analytics III-21
Table 25: Japanese Recent Past, Current and Future Analysis
for Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-21

Table 26: Japanese Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-22

Table 27: Japanese 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-23

Table 28: Japanese Recent Past, Current and Future Analysis
for Transcatheter Aortic Valve Implantation (TAVI) Systems
Market - Analyzed with Annual Sales Figures in US$ Million
for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-24

4. EUROPE III-25
A.Market Analysis III-25
Current and Future Analysis III-25
Market Overview III-25
Aging Population - A Key Market Driver III-26
Table 29: European Population Distribution by Region and
Age Group: 2013 (includes corresponding Graph/Chart) III-26
An Overview of Regional Adoption of Bioprosthetic Valves III-26
Table 30: Number of Biological Heart Valve Replacement
Procedures Performed in Select European Countries: 2013
(includes corresponding Graph/Chart) III-27
Central and Eastern Europe Markets Offer Growth Opportunities III-27
A Peek into the European TAVI Adoption Potential III-27
Major Players III-28
Table 31: Leading Players in the European Transcatheter
Heart Valve Market (2013): Percentage Breakdown of Value
Sales for Edwards Lifesciences, Medtronic and Others
(includes corresponding Graph/Chart) III-28
Product Launches/Approvals III-28
B.Market Analytics III-31
Table 32: European Recent Past, Current and Future Analysis
for Prosthetic Heart Valves by Geographic Region - France,
Germany, Italy, UK, Spain, Russia and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-31

Table 33: European Historic Review for Prosthetic Heart
Valves by Geographic Region - France, Germany, Italy, UK,
Spain, Russia and Rest of Europe Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2006 through 2012 (includes corresponding Graph/Chart) III-32

Table 34: European 15-Year Perspective for Prosthetic Heart
Valves by Geographic Region - Percentage Breakdown of Dollar
Sales for France, Germany, Italy, UK, Spain, Russia and Rest
of Europe Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-33

Table 35: European Recent Past, Current and Future Analysis
for Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-34

Table 36: European Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-35

Table 37: European 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-36

Table 38: European Recent Past, Current and Future Analysis
for Transcatheter Aortic Valve Implantation (TAVI) Systems
Market - Analyzed with Annual Sales Figures in US$ Million
for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-37

4a. FRANCE III-38
A.Market Analysis III-38
Current and Future Analysis III-38
Table 39: Percentage Distribution of French Population by
Age Group: 2012 (includes corresponding Graph/Chart) III-38
Leading TAVR Devices III-38
Table 40: Leading Devices in the French TAVR Market (2013):
Percentage Breakdown of Value Sales for Sapien XT,
CoreValve and Evolut (includes corresponding Graph/Chart) III-38
B.Market Analytics III-39
Table 41: French Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-39

Table 42: French Historic Review for Prosthetic Heart Valves
by Product Segment - Tissue and Mechanical Heart Valves
Markets Independently Analyzed with Annual Sales Figures in
US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-40

Table 43: French 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-41

4b. GERMANY III-42
A.Market Analysis III-42
Current and Future Analysis III-42
Reimbursements III-42
Leading TAVR Devices III-42
Table 44: Leading Devices in the German TAVR Market (2013):
Percentage Breakdown of Value Sales for Sapien XT,
CoreValve and Portico (includes corresponding Graph/Chart) III-42
Edwards and Medtronic Involve in Intense Patent Battle in
Germany III-43
Strategic Corporate Development III-43
B.Market Analytics III-44
Table 45: German Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-44

Table 46: German Historic Review for Prosthetic Heart Valves
by Product Segment - Tissue and Mechanical Heart Valves
Markets Independently Analyzed with Annual Sales Figures in
US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-45

Table 47: German 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-46

4c. ITALY III-47
A.Market Analysis III-47
Current and Future Analysis III-47
Leading TAVR Devices III-47
Table 48: Leading Devices in the Italian TAVR Market
(2013): Percentage Breakdown of Value Sales for Sapien XT
and CoreValve (includes corresponding Graph/Chart) III-47
Sorin Group - A Major Italy-Based Heart Valve Producer III-47
B.Market Analytics III-48
Table 49: Italian Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-48

Table 50: Italian Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-49

Table 51: Italian 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-50

4d. THE UNITED KINGDOM III-51
A.Market Analysis III-51
Current and Future Analysis III-51
Demographic Review III-51
Table 52: Percentage Distribution of UK Population by Age
Group: 2012 (includes corresponding Graph/Chart) III-51
Leading TAVR Devices III-51
Table 53: Leading Devices in the UK TAVR Market (2013):
Percentage Breakdown of Value Sales for Sapien XT,
CoreValve and Evolut (includes corresponding Graph/Chart) III-51
B.Market Analytics III-52
Table 54: UK Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-52

Table 55: UK Historic Review for Prosthetic Heart Valves by
Product Segment - Tissue and Mechanical Heart Valves Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2006 through 2012 (includes corresponding
Graph/Chart) III-53

Table 56: UK 15-Year Perspective for Prosthetic Heart Valves
by Product Segment - Percentage Breakdown of Dollar Sales
for Tissue and Mechanical Heart Valves Markets for Years
2006, 2014 and 2020 (includes corresponding Graph/Chart) III-54

4e. SPAIN III-55
Market Analysis III-55
Table 57: Spanish Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-55

Table 58: Spanish Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-56

Table 59: Spanish 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-57

4f. RUSSIA III-58
A.Market Analysis III-58
Current and Future Analysis III-58
Market Overview III-58
B.Market Analytics III-59
Table 60: Russian Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-59

Table 61: Russian Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-60

Table 62: Russian 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-61

4g. REST OF EUROPE III-62
Market Analysis III-62
Table 63: Rest of Europe Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Product Segment -
Tissue and Mechanical Heart Valves Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-62

Table 64: Rest of Europe Historic Review for Prosthetic
Heart Valves by Product Segment - Tissue and Mechanical
Heart Valves Markets Independently Analyzed with Annual
Sales Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-63

Table 65: Rest of Europe 15-Year Perspective for Prosthetic
Heart Valves by Product Segment - Percentage Breakdown of
Dollar Sales for Tissue and Mechanical Heart Valves Markets
for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-64

5. ASIA-PACIFIC III-65
A.Market Analysis III-65
Current and Future Analysis III-65
Potential for Growth in Asia III-65
Table 66: Over 65 Years Individuals as % of Total
Population in Select Asian Countries (2012) (includes
corresponding Graph/Chart) III-65
B.Market Analytics III-66
Table 67: Asia-Pacific Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Geographic Region -
China, India and Rest of Asia-Pacific Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-66

Table 68: Asia-Pacific Historic Review for Prosthetic Heart
Valves by Geographic Region - China, India and Rest of
Asia-Pacific Markets Independently Analyzed with Annual
Sales Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-67

Table 69: Asia-Pacific 15-Year Perspective for Prosthetic
Heart Valves by Geographic Region - Percentage Breakdown of
Dollar Sales for China, India and Rest of Asia-Pacific
Markets for Years 2006, 2014 and 2020(includes corresponding
Graph/Chart) III-68

Table 70: Asia-Pacific Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Product Segment -
Tissue and Mechanical Heart Valves Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-69

Table 71: Asia-Pacific Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-70

Table 72: Asia-Pacific 15-Year Perspective for Prosthetic
Heart Valves by Product Segment - Percentage Breakdown of
Dollar Sales for Tissue and Mechanical Heart Valves Markets
for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-71

5a. CHINA III-72
A.Market Analysis III-72
Current and Future Analysis III-72
A Market with Tremendous Potential III-72
Table 73: Percentage Distribution of Chinese Population by
Age Group: 2012 (includes corresponding Graph/Chart) III-72
Tissue Heart Valves to Outgrow Mechanical Versions III-73
Product Approval III-73
B.Market Analytics III-74
Table 74: Chinese Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-74

Table 75: Chinese Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-75

Table 76: Chinese 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-76

5b. INDIA III-77
A.Market Analysis III-77
Current and Future Analysis III-77
Indian Heart Valve Market on a Growth Spree III-77
India - A Large Attractive Market for Prosthetic Heart
Valves Device Manufacturers III-77
Select Recently Introduced Heart Valves in India III-78
Medical Tourism to Boost Market for Prosthetic Valves III-78
Competitive Landscape III-78
B.Market Analytics III-80
Table 77: Indian Recent Past, Current and Future Analysis for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chart) III-80

Table 78: Indian Historic Review for Prosthetic Heart Valves
by Product Segment - Tissue and Mechanical Heart Valves
Markets Independently Analyzed with Annual Sales Figures in
US$ Thousand for Years 2006 through 2012 (includes
corresponding Graph/Chart) III-81

Table 79: Indian 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-82

5c. REST OF ASIA-PACIFIC III-83
Market Analysis III-83
Table 80: Rest of Asia-Pacific Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Product Segment -
Tissue and Mechanical Heart Valves Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-83

Table 81: Rest of Asia-Pacific Historic Review for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2006 through
2012 (includes corresponding Graph/Chart) III-84

Table 82: Rest of Asia-Pacific 15-Year Perspective for
Prosthetic Heart Valves by Product Segment - Percentage
Breakdown of Dollar Sales for Tissue and Mechanical Heart
Valves Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-85

6. LATIN AMERICA III-86
Market Analysis III-86
Table 83: Latin American Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Geographic Region -
Brazil and Rest of Latin American Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-86

Table 84: Latin American Historic Review for Prosthetic
Heart Valves by Geographic Region - Brazil and Rest of Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-87

Table 85: Latin American 15-Year Perspective for Prosthetic
Heart Valves by Geographic Region - Percentage Breakdown of
Dollar Sales for Brazil and Rest of Latin American Markets
for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-88

Table 86: Latin American Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Product Segment -
Tissue and Mechanical Heart Valves Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-89

Table 87: Latin American Historic Review for Prosthetic
Heart Valves by Product Segment - Tissue and Mechanical
Heart Valves Markets Independently Analyzed with Annual
Sales Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-90

Table 88: Latin American 15-Year Perspective for Prosthetic
Heart Valves by Product Segment - Percentage Breakdown of
Dollar Sales for Tissue and Mechanical Heart Valves Markets
for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-91

6a. BRAZIL III-92
A.Market Analysis III-92
Current and Future Analysis III-92
Market Overview III-92
B.Market Analytics III-93
Table 89: Brazilian Recent Past, Current and Future Analysis
for Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2013 through
2020 (includes corresponding Graph/Chat) III-93

Table 90: Brazilian Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-94

Table 91: Brazilian 15-Year Perspective for Prosthetic Heart
Valves by Product Segment - Percentage Breakdown of Dollar
Sales for Tissue and Mechanical Heart Valves Markets for
Years 2006, 2014 and 2020 (includes corresponding Graph/Chart) III-95

6b. REST OF LATIN AMERICA III-96
Market Analysis III-96
Table 92: Rest of Latin American Recent Past, Current and
Future Analysis for Prosthetic Heart Valves by Product
Segment - Tissue and Mechanical Heart Valves Markets
Independently Analyzed with Annual Sales Figures in US$
Thousand for Years 2013 through 2020 (includes corresponding
Graph/Chart) III-96

Table 93: Rest of Latin American Historic Review for
Prosthetic Heart Valves by Product Segment - Tissue and
Mechanical Heart Valves Markets Independently Analyzed with
Annual Sales Figures in US$ Thousand for Years 2006 through
2012 (includes corresponding Graph/Chart) III-97

Table 94: Rest of Latin American 15-Year Perspective for
Prosthetic Heart Valves by Product Segment - Percentage
Breakdown of Dollar Sales for Tissue and Mechanical Heart
Valves Markets for Years 2006, 2014 and 2020 (includes
corresponding Graph/Chart) III-98

7. REST OF WORLD III-99
Market Analysis III-99
Table 95: Rest of World Recent Past, Current and Future
Analysis for Prosthetic Heart Valves by Product Segment -
Tissue and Mechanical Heart Valves Markets Independently
Analyzed with Annual Sales Figures in US$ Thousand for Years
2013 through 2020 (includes corresponding Graph/Chart) III-99

Table 96: Rest of World Historic Review for Prosthetic Heart
Valves by Product Segment - Tissue and Mechanical Heart
Valves Markets Independently Analyzed with Annual Sales
Figures in US$ Thousand for Years 2006 through 2012
(includes corresponding Graph/Chart) III-100

Table 97: Rest of World 15-Year Perspective for Prosthetic
Heart Valves by Product Segment - Percentage Breakdown of
Dollar Sales for Tissue and Mechanical Heart Valves Markets
for Years 2006, 2014 and 2020 (includes corresponding
Graph/Chart) III-101


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 22 (including Divisions/Subsidiaries - 23)

The United States (12)
Europe (8)
- Germany (3)
- The United Kingdom (1)
- Italy (1)
- Rest of Europe (3)
Asia-Pacific (Excluding Japan) (1)
Latin America (2)

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