Global Cardiovascular Disease Diagnostics Industry

  • April 2012
  • -
  • Global Industry Analysts
  • -
  • 498 pages

This report analyzes the worldwide markets for Cardiovascular Disease Diagnostics in US$ Million by the following Two Broad Segments: In Vitro Diagnostics, and In Vivo Diagnostics. 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 provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia Pacific, Middle East, and Latin America. The report profiles 70 companies including many key and niche players worldwide such as AccuTech, LLC, Abbott Diagnostics, Alere Inc., Cholestech Corp., Ani Biotech Oy, Axis-Shield PoC, Beckman Coulter, Inc., biomérieux, Cambridge Heart, Inc., GE HealthCare, Home Access Health Corporation, LifeSign LLC, Liposcience, Inc., Nanosphere, Inc., Ortho-Clinical Diagnostics, Inc., Philips Healthcare, Polymer Technology Systems, Inc., Response Biomedical Corp., Roche Diagnostics, Siemens Healthcare Diagnostics, Inc., St. Jude Medical, Inc., and EP MedSystems. Market data and analytics are derived from primary and secondary research. Company profiles are primarily based upon search engine sources in the public domain.

Table Of Contents



I. INTRODUCTION, METHODOLOGY and PRODUCT DEFINITIONS
Study Reliability and Reporting Limitations I-1
Disclaimers I-2
Data Interpretation and Reporting Level I-3
Quantitative Techniques and Analytics I-3
Product Definitions and Scope of Study I-3
In Vitro Diagnostics I-3
In Vivo Diagnostics I-3


II. EXECUTIVE SUMMARY

1. INDUSTRY OVERVIEW II-1
Cardiovascular Diseases - Facts and Figures II-1
Cardiovascular Diseases: The Undying Challenge II-1

Table 1: Region-Wise Incidence and Prevalence of
Cardiovascular Diseases in 2006 II-2
Mounting Healthcare Costs - Calls for Early Diagnosis II-2
Cardiovascular Disease Diagnostics: Playing a Pivotal Role in
Early Disease Detection II-2
Fast and Accurate Diagnosis - Reduce Unnecessary Healthcare Costs II-3
POC Diagnostics Market Gains Momentum II-3
Cardiac Markers - Making Diagnosis Easier and Quicker II-4
Major Cardiac Markers and their Properties II-4
What’s New in POC Cardiac Markers Space? II-5
Leading Players II-5
List of Point of Care Cardiac Marker Testing Products II-6

2. IN-VIVO DIAGNOSTICS II-7
Novel Imaging Techniques Boost In vivo Diagnostics Market II-7
Non-Invasive Procedure Hogs the Limelight for Cardiovascular
Treatment II-7
Cardiology Diagnostic Imaging II-7
New Technologies Bring Diagnostics Closer to Patients II-8
Trends Cited in the Imaging Technologies Market II-8
CT Scanners II-8
MRI II-9
Move Towards Efficient Patient Data Management II-9

3. IN-VITRO DIAGNOSTICS II-10
A Quick Insight into the Global In-vitro Diagnostics Market II-10
Growth Trends II-10
Developed Countries Drive In-Vitro Diagnostics (IVD) Market II-10

Table 2: Leading In-Vitro Diagnostics Markets Worldwide
(2011): Percentage Breakdown for North America, Europe,
Japan, and Others (includes corresponding Graph/Chart) II-11
Established Players Dominate the Fragmented Market II-11

Table 3: Leading Players in the Global In-Vitro Diagnostics
Market (2011): Percentage Breakdown of Value Sales for Roche
Diagnostics, Bayer/Siemens, Abbott Diagnostics,
Ortho/LifeScan, Beckman Coulter, BD, and Others (includes
corresponding Graph/Chart) II-11
Point-of-Care In-Vitro Testing on the Roll II-12

Table 4: Global In vitro Diagnostics Market by Type of Test
(2011): Percentage Breakdown for Central Lab Testing,
Point-of-Care Testing, and Molecular Testing (includes
corresponding Graph/Chart) II-12
A Specific Focus on Global Cardiovascular In-Vitro Diagnostics
Market II-12
Aging Population Drives Home Testing Market II-13
Cholesterol and Other Cardiovascular Test Kits Offered by
Leading Companies II-13
Development of Home Cholesterol Testing Kits II-13

Table 5: Global Cholesterol Point-of-Care Rapid Tests Market
(2011): Market Shares of Leading Players by Value Sales for
Inverness Medical, Roche, Abaxis, and Others (includes
corresponding Graph/Chart) II-14
Strong Demand for Risk Assessment Markers II-14
Advancements in Alternate-Site Coagulation Monitoring II-14

4. CVD - CAUSE AND RISK FACTORS II-16
CVD - Global Facts II-16

Table 6: CVD Death Rates (per 100,000 population) Among Men
(Aged 35-74 years) by Select Country: 2007 (includes
corresponding Graph/Chart) II-16

Table 7: CVD Death Rates (per 100,000 population) Among Women
(Aged 35-74 years) by Select Country: 2007 (includes
corresponding Graph/Chart) II-17
Atherosclerosis - Leading Cause for CVD II-17
Risk Factors II-17
Irreversible Risk Factors II-18
Increasing age II-18
Sex (gender) II-18
Heredity (including Race) II-18
Risk Factors that can be controlled II-18
Tobacco Smoke II-18
High Blood Cholesterol II-18
LDL Cholesterol II-19
HDL Cholesterol II-19
Triglyceride levels II-19
Hypercholesterolemia - Conditions Associated with
Cholesterol Level II-20
High Blood Pressure II-20
BP - Leading Cause of Cardiovascular Disease in Young Adults II-21
Physical Inactivity II-21
Obesity and Overweight II-21
Diabetes Mellitus II-21
Cardiovascular Disease and Homocysteine Levels II-21
Measures for Reducing Cardiovascular Diseases II-22

5. CARDIOVASCULAR DISEASE AND CONDITIONS II-23
Angina Pectoris II-23
Arrhythmias II-23
Sudden Cardiac Death (SCD) II-23
Stroke II-24
Congestive Heart Failure II-24
Heart Failure Classification as per the NYHA and ACC/AHA II-24

Table 8: Prevalence Rates of Congestive Heart Failure in
Select Countries (per 10,000) (includes corresponding
Graph/Chart) II-25
Cardiovascular Disease Involving Transplant Patients II-25

6. DIAGNOSTIC TESTS FOR CARDIOVASCULAR DISEASES II-26
In-Vitro Cardiovascular Diagnostics II-26
Cholesterol Testing II-26
Use of Markers II-26
Creatine Kinase MB II-26
Troponin T and Troponin I II-27
C-Reactive Protein II-27
Plasminogen Activator Inhibitor-1 II-28
D-Dimer II-28
Thrombus Precursor Protein II-28
Other Cardiac Markers II-28
Increasing Popularity of Risk Assessment Markers II-28
A Step Forward in Cardiovascular Risk Assessment II-29
In Vivo Diagnostic Tests II-29
Computed Imaging / Tomography II-29
Electron Beam Computed Tomography (EBCT) II-29
Appropriate Conditions for EBCT Diagnosis II-30
Cardiac Positron Emission Tomography (PET) II-30
Digital Cardiac Angiography/ Digital Subtraction Angiography II-31
Magnetic Resonance Imaging (MRI) II-31
Single Photon Emission Computed Tomography (SPECT) II-32
Echocardiography II-32
Different Types of Echo-techniques II-32
M-mode (Motion mode, One-dimensional) II-32
Two-Dimensional (Cross-sectional) II-33
Stress Echocardiogram (Stress Echo) II-33
Transesophageal Echocardiogram (TEE) II-33
Risks II-33
Ultrasound Tests II-33
Doppler Ultrasound II-33
Intravascular Ultrasound II-34
Working II-34
Comparative Facts Related to Definitive Diagnosis of
Cardiovascular Disease II-34
Nuclear Cardiology Tests II-35
Applications II-35
Types of Nuclear Cardiology Tests II-35
Myocardial Perfusion Imaging II-35
Applications II-36
Risks II-36
Ventricular Function Test II-36
Testing Cardiac Stress II-37
Cardio Vascular Disease Diagnostics Tests in the Pipeline II-37
Aderis MRE-0470 II-37
CardioMEMS Novel Technology II-37
Technology Platform II-37

7. PRODUCT LAUNCHES AND DEVELOPMENTS II-38
Cardiac Science Launches Microvolt T-Wave Alternans Module II-38
Cleveland HeartLab to Extend Test Menu II-38
St. Jude Medical Introduces EnSite Derexi Module II-38
NorDiag Unveils NorDiags Arrow Instrument II-39
Biosense Webster Launches CARTO® 3 System II-39
McKesson Unveils New Variant of Horizon Cardiology
Cardiovascular Information System II-39
Correlagen Launches CardioGeneScan Test II-39
Royal Philips Electronics to Launch PageWriter TC50 Cardiograph II-40
Philips Introduces Xcelera R3.1 II-40
St. Jude Medical Launches Medical Devices for Heart Rhythms
Disorders II-40

8. PRODUCT LAUNCHES AND DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-42
TomTec and Medis Launches Cardiac Imaging and Analysis Product II-42
Royal Philips Electronics Launches PageWriter TC70 II-42
Philips Healthcare to Introduce CX50 CompactXtreme II-42
Royal Philips Electronics Introduces Xcelera R2.2 II-43
Toshiba America to Launch AplioTM Artida II-43
Philips Rolls Out 256-slice CT scanner, Brilliance iCT Scanner II-43
Royal Philips Launches Live 3D Transesophageal Echocardiogram
Probe II-44
GE Healthcare Launches Vivid e Ultrasound Systems II-44
Cardionetics Launches ECG Monitor for 24-Hour Real-Time
Cardiac Diagnosis II-44
Siemens Launches Imaging Release for the ACUSON Sequoia Platform II-44
GE Healthcare Launches Version 2.0 of Centricity Cardiology
CA1000 II-45
GE Healthcare Introduces New Capabilities to CardioSoft
Diagnostic Software II-45
GE Healthcare’s Lightspeed VCT Offers Imaging at 70% Lower
Exposure II-45
Roche Diagnostics Launches cobas h 232 Portable Cardiac Marker
System (Outside US) II-45
Royal Philips Launches New Imaging Tool for Complex Cardiac
Arrhythmias II-46
Siemens Medical Introduces syngo® US, New Echocardiography
Solution. II-46
Dade Behring Introduces CardioPhase® hsCRP Test for Multiple
Testing Platforms. II-46
Shimadzu Launches Two Models in Angiographic Imaging II-47
Omron Healthcare Introduces Non Invasive Vascular Profiling
System II-47
Abbott Launches XIENCE V, New Coronary Stent System II-47
Siemens Medical Introduces Acuson AcuNav 8F, an Advanced
Ultrasound Catheter II-47
BioMerieux Introduces High Performance VIDAS Troponin I Ultra II-48
Siemens Launches Acuson X300 Ultrasound Platform II-48
Siemens Releases Web-Enabled CT II-48
GE Introduces Latest Electrocardiograph Device, MAC 3500 II-49
GE Emphasizes on the Striking Features of New Vivid 7
Dimension ’06 II-49
GE Launches Latest Innova Digital Flat Panel Biplane Imaging
Devices II-49
Medtronic Introduces Latest Range of Implantable Cardiac
Defibrillators II-49
Philips Introduces Web Based Cardiac Tools II-50
Siemens Showcases Solutions for Cardiac Problems Through
Molecular Imaging II-50
Siemens Presents Advancements in Echocardiography II-50
Siemens Debuts syngo BEAT II-50
Siemens Combines syngo® Dynamics with Soarian® for
Cardiovascular EPR II-51
GE Healthcare Unveils CardIQ Fusion II-51
GE Introduces Discovery VCT II-51
GE Unveils Dynamic VUE II-51
GE Launches CardIQ Xpress II-52
GE Presents the Ventri for Cardiac Imaging II-52
GE Introduces High Definition Magnetic Resonance System II-52
Dade Behring Unveils CardioPhase(R) hsCRP Test II-52
Siemens Launches Encompass III on C512 Ultrasound Platform II-52
Siemens Launches Four New CT Clinical Engines II-53
Omron Launches HEM-9000AI Cardiovascular Diagnostic Tool II-53
Corgenix Introduces Predictive Cardiovascular Diagnostic Kit,
AtherOxâ„¢ II-53
Philips Introduces HD11 XE Cardiology Ultrasound System II-53
Siemens Introduces Biplane FD Cardiology System II-54
Siemens Introduces Syngo Circulation Software for CT Tomography II-54
Siemens Introduces SOMATOM Definition for Cardiac Imaging II-54
Dade Behring Unveils Homocysteine Test on BN (TM) Systems II-54
Roche Unveils Cardiac pro-BNP Test II-54
Philips Introduces HD11 XE II-55
Corgenix Unveils AtherOx(TM) II-55
GE Healthcare Unveils Breakthrough Imaging Technology II-55
Philips Launches Products to Detect Heart Problems II-55
Philips Unveils Computed Tomography and EP Planning package II-56
Philips Widens Magnetic Resonance Portfolio II-56
New Cardiac Monitoring Products from Philips II-56
Siemens Launches Image-Arena II-56
Siemens Announces New Procam-Calculator Combined with CT
Examination II-56
Siemens Medical Solutions Launches Axiom Artis dTA II-57
GE Healthcare Unveils Vivid i II-57
GE Healthcare Presents Fully Integrated 4D Cardiovascular
Ultrasound System II-58
GE Healthcare Debuts New Imaging System II-58
New Discovery PET/CT Systems from GE Healthcare II-58
SonoSite Presents SonoCalc IMT Software II-58
Dade Behring Introduces High Sensitivity Troponin I Assay II-59
Biosite Unveils New Diagnostic Test II-59
MDS Diagnostic Services Unveils New Test to Prevent Heart Disease II-59
diaDexus Develops PLAC Test II-60
Siemens Introduces New Nuclear Cardiology Imaging System II-60
Roche Diagnostics Receives U.S. Clearance and European CE Mark II-60
Camtronics Unveils Cardiovascular Screening Software II-61
Mayo Pioneers New Enzyme-Based Cardiovascular Risk Assessment
Test II-61

9. RECENT INDUSTRY ACTIVITY II-62
Danaher Acquires Beckman Coulter II-62
Inverness Changes Name to Alere II-62
Miraculins Acquires PreMD’s PREVU(i) Skin Cholesterol Test Assets II-62
Kardia Health Systems Partners with TomTec Imaging Systems II-63
TriLink and Biofortuna Ink Licensing Agreement II-63
Corgenix Enters into a Strategic Alliance with ELITech II-63
VaxGen to Merge with diaDexus II-64
St. Jude Medical to Take Over LightLab Imaging II-64
GE Healthcare and CardioDx Enter into Strategic Alliance II-64
bioMerieux and Knome Ink Strategic Partnership Agreement II-65
Merge Healthcare Acquires AMICAS II-65
Diamedix and Nova Ink Distribution Agreement II-65
Inverness Acquires Standard Diagnostics II-65
Quidel Acquires Diagnostic Hybrids II-66
bioMerieux Acquires Meikang Biotech II-66
Aurora Health Care Partners with Celera II-66
Mediscience Technology Corporation Acquires SensiVida Medical
Systems II-66
Volcano Acquires Axsun Technologies II-67
Thermo Fisher Takes Over B.R.A.H.M.S. II-67
SonoSite Acquires CardioDynamics International II-67
IntriCon Snaps Up Datrix II-68
ST. Jude Medical Receives US FDA and European Approval for
EnSite Velocityâ„¢ Cardiac Mapping System II-68

10. STRATEGIC CORPORATE DEVELOPMENTS - A HISTORIC PERSPECTIVE BUILDER II-69
Roche Inks Agreement with Response Biomedical II-69
Dynatek Dalta Scientific Inks Agreement with State Food and
Drug Administration II-69
Amic Inks Licensing Deal with Roche Diagnostics II-69
TRICARE Includes Atherotech’s VAP® Test II-69
PreMD Receives NSE Letter from US FDA for POC Skin Cholesterol
Test II-70
Amic Gains License for Roche’s Cardiac Marker II-70
diaDexus and Fisher HealthCare Sign Agreement II-70
Inverness Inks Distribution Agreement with PrognostiX II-71
GE Healthcare Enters into Collaboration with Boston Scientific II-71
St. Jude Medical Acquires EP MedSystems II-71
Inverness Takes Over Biosite II-72
Siemens Medical Acquires Dade Behring II-72
Inverness Medical Innovations Acquires Cholestech II-72
Acrongenomics, Pearson and Molecular Enter into Joint Venture II-73
Cholestech Teams Up with Onsite Health Diagnostics II-73
Lipomics to Collaborate with Agilent Technologies to Develop
Diagnostic Tests. II-73
Transgenomic and Fiuotecnica Renew Collaboration Agreement II-73
Alteon and BioRap Technologies Enter into an Agreement II-74
IM Medical Acquires New Technology for Detecting
Cardiovascular Diseases II-74
Medtronic Establishes New Business Entity II-74
Siemens Medical Acquires Bayer Healthcare’s Diagnostics Unit II-75
Inverness Medical Innovations Completes Acquisition of HemoSense II-75
Spacelabs Acquires Ferraris’ Cardiac Unit II-75
Global Immune Takes over Primedical International II-75
Siemens Acquires Diagnostics Products II-76
Cholestech and Life Line Enter into Collaboration II-76
LipoScience Signs an Agreement with ARUP II-76
Philips Acquires Witt Biomedical II-76
CardioDynamics Enters into an OEM Agreement with Shenzhen Mindray II-76
Biosense Enters into Strategic Partnership with Siemens
Medical Solutions II-77
Dade Behring Approved the Use of FSAP Antibodies by American
Diagnostica II-77
Abbott Receives Non-exclusive Sublicense for Diagnostic Use of
PIGF II-77
Nanogen Acquires Spectral’s Cardiac Test Division II-77
Varian Enters into Alliance with LipoScience to Jointly
Develop NMR System II-78
Cardiac Services Professionals Establish eCardio Diagnostics II-78
Response Biomedical Wins Nonexclusive License Rights for NT-
proBNP and Troponin T II-78
Biomerieux gains Nonexclusive License for NT-proBNP II-79
Philips and PMI Ink an Agreement for Outpatient Facility II-79
LipoScience Enters into an Agreement with LabCorp II-79
Abbott and Cleveland Clinic to Co-develop Myeloperoxidase
Cardiac Test II-79
Abbott Receives 510(k) Clearance from FDA for Myoglobin Test II-79
FDA Clears Additional Claim for Biosite’s Triage (R) BNP Test II-80
Biosite Inks an Agreement with University of Mainz II-80
Dade Behring Receives FDA Clearance for Advanced D-Dimer Assay II-80
Nanogen Acquires SYN•X Pharma II-80
GE Takes Over Amersham Plc II-80
St. Jude Medical Acquires Irvine Biomedical and Epicor II-80
SonoSite Snaps Up SonoMetric II-81
CardioDynamics Acquires Vermed II-81
Philips and EP MedSystems Announce an Alliance Involving
Electrophysiology Solutions II-81
Toshiba and ViTAL Enters into an Alliance with Johns Hopkins
University School of Medicine II-81
Response Biomedical Collaborates with Shionogi II-81
Terumo Signs Agreement with Spencer Technologies II-81
Spectral Diagnostics Announces Agreement with NGC Medical II-82
Philips Signs Agreement with Fletcher Allen Health Care II-82
Spectral Diagnostics Enters into an Agreement with Cardinal
Health II-82
Siemens Signs Agreement with MediGuide II-82
Biosite Enters into Agreement with DMI BioSciences II-83
Cambridge Heart Enters into Agreement with Del Mar Reynolds II-83
Cholestech Enters into an Agreement with Itamar Medical II-83
Siemens Enters into a Contract with HiPGraphics II-83
Abbott Announces US Clearance for Axis-Shield’s BNP Test for
Use on AxSYM II-83
Cholestech Announces FDA 510(k) Approval for hs-CRP Test II-84
Dade Behring Bags FDA Clearance NT-proBNP Test II-84
Dade Behring Receives FDA Clearance for N High Sensitivity CRP
Assay II-84
EP-4 Computerized Cardiac Stimulator Bags FDA Approval II-84
Biosite Adds two new offices II-84
Bayer Diagnostics Enhances BNP Assay Offering Globally II-84
EP MedSystems Garners CE Approval for ALERT Deflectable CS
Catheter in Europe II-85
Cambridge Heart Inc. and Quinton Cardiology Systems Renew Pact II-85
EPIX and Schering AG Extends Collaboration Agreement II-85
Siemens Ultrasound and TomTec Imaging Systems Announces Agreement II-86
FIT Biotech Plc Acquires Xenerate Ab to Develop Innovative
Cardiovascular Devices II-86
Beckman Coulter Enters into Agreement with Biosite II-86
Dade Behring Garners Non-exclusive Rights for a Key Cardiac
Marker II-86
Bracco Diagnostics Inc., Joins Hand with Eastern Isotopes Inc
to Develop CardioGen-82® II-86
New Lab Test from diaDexus Receives FDA Clearance II-87
Hypertension Diagnostics Receives SDA Approval in China II-87

11. FOCUS ON SELECT GLOBAL PLAYERS II-88
AccuTech, LLC (USA) II-88
Abbott Diagnostics (USA) II-88
Alere Inc. (USA) II-88
Cholestech Corp. (USA) II-90
Ani Biotech Oy (Finland) II-90
Axis-Shield PoC (UK) II-90
Beckman Coulter, Inc. (USA) II-91
biomerieux (France) II-91
Cambridge Heart, Inc. (USA) II-91
GE HealthCare (UK) II-92
Home Access Health Corporation (USA) II-92
LifeSign LLC (USA) II-92
Liposcience, Inc. (USA) II-93
Nanosphere, Inc. (USA) II-93
Ortho-Clinical Diagnostics, Inc. (USA) II-94
Philips Healthcare (USA) II-94
Polymer Technology Systems, Inc. (USA) II-94
Response Biomedical Corp. (Canada) II-95
Roche Diagnostics (Switzerland) II-95
Siemens Healthcare Diagnostics, Inc. (USA) II-96
St. Jude Medical, Inc. (USA) II-96
EP MedSystems (USA) II-97

12. GLOBAL MARKET PERSPECTIVE II-98

Table 9: World Recent Past, Current and Future Market Analysis
for Cardiovascular Disease Diagnostics by Geographic Region -
US, Canada, Japan, Europe, Asia- Pacific (excluding Japan),
Middle East and Latin American Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) II-98

Table 10: World Historic Review for Cardiovascular Disease
Diagnostics by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Middle East, and Latin
American Markets Independently Analyzed with Annual Sales
Figures in US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-99

Table 11: World 15-Year Perspective for Cardiovascular Disease
Diagnostics by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Middle East and Latin American Markets for
Years 2003, 2011 and 2017 (includes corresponding Graph/Chart) II-100

Table 12: World Recent Past, Current and Future Market Analysis
for Cardiovascular In Vitro Diagnostics by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Middle East and Latin American Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017(includes corresponding Graph/Chart) II-101

Table 13: World Historic Review for Cardiovascular In Vitro
Diagnostics by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Middle East and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008(includes corresponding
Graph/Chart) II-102

Table 14: World 15-Year Perspective for Cardiovascular In
Vitro Diagnostics by Geographic Region - Percentage Breakdown
of Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Middle East and Latin American Markets for
Years 2003, 2011 and 2017 (includes corresponding Graph/Chart) II-103

Table 15: World Recent Past, Current and Future Market Analysis
for Cardiovascular In Vivo Diagnostics by Geographic Region -
US, Canada, Japan, Europe, Asia-Pacific (excluding Japan),
Middle East and Latin American Markets Independently Analyzed
with Annual Sales Figures in US$ Million for Years 2009
through 2017 (includes corresponding Graph/Chart) II-104

Table 16: World Historic Review for Cardiovascular In Vivo
Diagnostics by Geographic Region - US, Canada, Japan, Europe,
Asia-Pacific (excluding Japan), Middle East and Latin American
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2003 through 2008 (includes
corresponding Graph/Chart) II-105

Table 17: World 15-Year Perspective for Cardiovascular In Vivo
Diagnostics by Geographic Region - Percentage Breakdown of
Dollar Sales for US, Canada, Japan, Europe, Asia-Pacific
(excluding Japan), Middle East and Latin American Markets for
Years 2003, 2011 and 2017 (includes corresponding Graph/Chart) II-106


III. MARKET

1. THE UNITED STATES III-1
A.Market Analysis III-1
US Diagnostic Market: An Insight III-1
Trends and Issues III-1
Innovations Drive the Usage of Cardiovascular Monitoring
Systems III-1
Cholesterol POCT Market: An Overview III-1
Table 18: US Cholesterol Point-of-Care Testing (2011):
Market Shares of Leading Players by Value Sales for
Inverness Medical, Polymer Technology Systems, and Roche
Diagnostics (includes corresponding Graph/Chart) III-2
Increasing Cardiovascular Ailments Drive Sales of Home Test
Devices III-2
CHF Biomarkers to Spearhead the US market III-2

Table 19: US Acute Myocardial Infarction (AMI) Diagnostics
Market (2006 - A Historic Perspective Builder): Market
Share by Revenue held by Major Players (Dade Behring,
Beckman Coulter, Bayer Diagnostics, and Others) in 2006
(includes corresponding Graph/Chart) III-3

Table 20: US Congestive Heart Failure (CHF) Diagnostics
Market (2006 - A Historic Perspective Builder): Market
Share by Revenue held by Major Players (Dade Behring,
Beckman Coulter, Bayer Diagnostics, and Others) in 2006
(includes corresponding Graph/Chart) III-3
Cardiovascular Disease Prevalence in the US III-4
Key Statistics on Cardiovascular Diseases III-4
Mortality Statistics III-4

Table 21: Prevalence of Cardiovascular Disease in the US
(includes corresponding Graph/Chart) III-5

Table 22: Percentage Breakdown of Deaths from
Cardiovascular Diseases in the US (includes corresponding
Graph/Chart) III-6

Table 23: Prevalence of Cardiovascular Diseases among
Americans by Age (Age 20 and Older) and Sex (includes
corresponding Graph/Chart) III-7

Table 24: A Factoid of CHD and MI (In Million) in the US III-7
Startling facts related to Stroke in US III-7

Table 25: A Factoid of Stroke (In Million) in the US III-8
Incidence of Coronary Heart Disease III-8
AHA Statistics for Coronary Heart Disease III-8
Mortality rates of CHD III-9

Table 26: Annual Number of Americans Having Diagnosed
Heart Attack by Age and Sex (includes corresponding
Graph/Chart) III-9

Table 27: Prevalence of CHD by Age and Sex (In %
population) (includes corresponding Graph/Chart) III-10
Arrhythmias III-10
CAD Diagnostics III-10
PVD Diagnostics III-11
Medicare Reimbursement Set for CPT Code 83704 III-11
Competitive Glance III-11
Point-of-Care (POC) Diagnostics Market in the US III-11

Table 28: Leading Players in the US POC Cardiac Market
(2004- A Historic Perspective Builder) - Percentage
Breakdown by Value Sales for Biosite, Dade Behring,
Spectral Diagnostics, Roche and Others (includes
corresponding Graph/Chart) III-12
B.Market Analytics III-12
Table 29: The US Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-12

Table 30: The US Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-13

Table 31: The US 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-14

2. CANADA III-15
A.Market Analysis III-15
Cardiovascular Disease Facts III-15
B.Market Analytics III-15
Table 32: Canadian Recent Past, Current and Future Analysis
for Cardiovascular Disease Diagnostics by Product Segment -
In Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-15

Table 33: Canadian Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-16

Table 34: Canadian 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-17

3. JAPAN III-18
Market Analytics III-18
Table 35: Japanese Recent Past, Current and Future Analysis
for Cardiovascular Disease Diagnostics by Product Segment -
In Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-18

Table 36: Japanese Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-19

Table 37: Japanese 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-20

4. EUROPE III-21
A.Market Analysis III-21
Cardiovascular Disease - Mortality Statistics III-21
Table 38: Leading Cause of Death Among Men in Europe
(2007): Percentage Breakdown for Cardiovascular Diseases,
Poisoning and Injuries, Respiratory Disease, Cancer, and
Others (includes corresponding Graph/Chart) III-21

Table 39: Leading Cause of Death Among Women in Europe
(2011): Percentage Breakdown for Cardiovascular Diseases,
Poisoning and Injuries, Respiratory Disease, Cancer, and
Others (includes corresponding Graph/Chart) III-22
Cardiovascular Disease - Risk Factor Profile III-22
The Cardiovascular Disease Cost Burden III-22
B.Market Analytics III-23
Table 40: European Recent Past, Current and Future Analysis -
for Cardiovascular Disease Diagnostics by Geographic Region
France, Germany, Italy, UK, Spain, Russia and Rest of Europe
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-23

Table 41: European Historic Review for Cardiovascular
Disease Diagnostics by Geographic Region - France, Germany,
Italy, UK, Spain, Russia and Rest of Europe Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008 (includes corresponding
Graph/Chart) III-24

Table 42: European Recent Past, Current and Future Analysis
for Cardiovascular Disease Diagnostics by Product Segment -
In Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017(includes corresponding
Graph/Chart) III-25

Table 43: European Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-26

Table 44: European 15-Year Perspective for Cardiovascular
Diagnostics by Geographic Region - Percentage Breakdown of
Dollar Sales for France, Germany, Italy, UK, Spain, Russia and
Rest of Europe Markets for Years 2003, 2011 and 2017 (includes
corresponding Graph/Chart) III-27

Table 45: European 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-28

4a. FRANCE III-29
Market Analytics III-29
Table 46: French Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-29

Table 47: French Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-30

Table 48: French 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-31

4b. GERMANY III-32
Market Analytics III-32
Table 49: German Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-32

Table 50: German Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-33

Table 51: German 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-34

4c. ITALY III-35
Market Analytics III-35
Table 52: Italian Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-35

Table 53: Italian Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-36

Table 54: Italian 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-37

4d. THE UNITED KINGDOM III-38
A.Market Analysis III-38
UK Cardiovascular Diseases Fact Sheet III-38
B.Market Analytics III-39
Table 55: The UK Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-39

Table 56: The UK Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-40

Table 57: The UK 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-41

4e. SPAIN III-42
Market Analytics III-42
Table 58: Spanish Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017(includes corresponding
Graph/Chart) III-42

Table 59: Spanish Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-43

Table 60: Spanish 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-44

4f. RUSSIA III-45
A.Market Analysis III-45
Major Players III-45
B.Market Analytics III-45
Table 61: Russian Recent Past, Current and Future Analysis for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2009 through 2017 (includes corresponding
Graph/Chart) III-45

Table 62: Russian Historic Review for Cardiovascular Disease
Diagnostics by Product Segment - In Vitro Diagnostics and In
Vivo Diagnostics Markets Independently Analyzed with Annual
Sales Figures in US$ Million for Years 2003 through 2008
(includes corresponding Graph/Chart) III-46

Table 63: Russian 15-Year Perspective for Cardiovascular
Disease Diagnostics by Product Segment - Percentage
Breakdown of Dollar Sales for In Vitro Diagnostics and In
Vivo Diagnostics Markets for Years 2003, 2011 and 2017
(includes corresponding Graph/Chart) III-47

4g. REST OF EUROPE III-48
Market Analytics III-48
Table 64: Rest of European Recent Past, Current and Future
Analysis for Cardiovascular Disease Diagnostics by Product
Segment - In Vitro Diagnostics and In Vivo Diagnostics
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2009 through 2017 (includes
corresponding Graph/Chart) III-48

Table 65: Rest of European Historic Review for
Cardiovascular Disease Diagnostics by Product Segment - In
Vitro Diagnostics and In Vivo Diagnostics Markets
Independently Analyzed with Annual Sales Figures in US$
Million for Years 2003 through 2008(includes corresponding
Graph/Chart) III-49

Table 66: Rest of European 15-Year Perspective for
Cardiovascular Disease Diagnostics by Product Segment -
Percentage Breakdown of Dollar Sales for In Vitro
Diagnostics and In Vivo Diagnostics Markets for Years 2003,
2011 and 2017 (includes corresponding Graph/Chart) III-50

5. ASIA-PACIFIC III-51
A.Market Analysis III-51
Cardiovascular Market in Asia-Pacific III-51
China III-51
Healthcare Expenditure to Grow Considerably by 2015 III-51
In vitro Diagnostics Market Poised for Strong Growth III-51
Domestic Manufacturers Pose a Threat for Overseas IVD
Manufacturers III-52
Leading Players III-52
Cardiovascular Disease Patients Overview III-52
Treatment Providers and Hospitals Overview III-53
Hospitals III-53

Table 67: Cardiovascular Special Treatment Hospitals in
China: 1991-2011(In numbers) (includes corresponding
Graph/Chart) III-53
Chinese Cardiovascular Disease Treatment as a Part of
Overall Health Care Industry III-53

Table 68: Cardiovascular Disease Treatment in China:
1991-2006 (includes corresponding Graph/Chart) III-54
India III-54
In-vitro Diagnostics Market: An Untapped Market III-54
Taiwan III-54
IVD Market: A Lucrative Market for Healthcare Services III-54
B.Market Analytics III-55
Table 69: Asia-Pacific Recent Past, Current and Future
Analysis for Cardiovascular Disease Diagnostics by Product
Segment - In Vitro Diagnostics and In Vivo Diagnostics
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) III-55

Table 70: Asia-Pacific Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-56

Table 71: Asia-Pacific 15-Year Perspective for
Cardiovascular Disease Diagnostics by Product Segment -
Percentage Breakdown of Dollar Sales for In Vitro
Diagnostics and In Vivo Diagnostics Markets for 2003, 2011 and
2017 (includes corresponding Graph/Chart) III-57

6. THE MIDDLE EAST III-58
Market Analytics III-58
Table 72: The Middle East Recent Past, Current and Future
Analysis for Cardiovascular Disease Diagnostics by Product
Segment - In Vitro Diagnostics and In Vivo Diagnostics
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2000 through 2010 (includes
corresponding Graph/Chart) III-58

Table 73: The Middle East Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-59

Table 74: The Middle East 15-Year Perspective for
Cardiovascular Disease Diagnostics by Product Segment -
Percentage Breakdown of Dollar Sales for In Vitro
Diagnostics and In Vivo Diagnostics Markets for 2003, 2011 and
2017 (includes corresponding Graph/Chart) III-60

7. LATIN AMERICA III-61
A.Market Analysis III-61
Brazil: A Growing Market for IVD III-61
Table 75: Brazilian IVD Market by Segment (2011):
Percentage Share Breakdown for Immunoassay, Hormone,
Microbiology, Biochemistry, Hematology, Molecular
Diagnostics, Cardiac markers, Hemostasis, and Cytology
(includes corresponding Graph/Chart) III-61
B.Market Analytics III-62
Table 76: Latin American Recent Past, Current and Future
Analysis for Cardiovascular Disease Diagnostics by Product
Segment - In Vitro Diagnostics and In Vivo Diagnostics
Markets Independently Analyzed with Annual Sales Figures in
US$ Million for Years 2007 through 2015 (includes
corresponding Graph/Chart) III-62

Table 77: Latin American Historic Review for Cardiovascular
Disease Diagnostics by Product Segment - In Vitro
Diagnostics and In Vivo Diagnostics Markets Independently
Analyzed with Annual Sales Figures in US$ Million for Years
2003 through 2008 (includes corresponding Graph/Chart) III-63

Table 78: Latin American 15-Year Perspective for
Cardiovascular Disease Diagnostics by Product Segment -
Percentage Breakdown of Dollar Sales for In Vitro
Diagnostics and In Vivo Diagnostics Markets for 2003, 2011 and
2017 (includes corresponding Graph/Chart) III-64


IV. COMPETITIVE LANDSCAPE

Total Companies Profiled: 70 (including Divisions/Subsidiaries - 82)

------------------------------------------
Region/Country Players
------------------------------------------
The United States 57
Canada 3
Japan 4
Europe 15
France 1
Germany 1
The United Kingdom 5
Italy 3
Rest of Europe 5
Asia-Pacific (Excluding Japan) 1
Middle-East 2
------------------------------------------

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