U.S. Markets for Invasive and Noninvasive Diagnostic Cardiology Products
U.S. Markets for Invasive and Noninvasive Diagnostic Cardiology Products
$4,750.00
Diagnostic interventional cardiology procedures covered by the scope of this report include electrocardiography (ECG); non-invasive imaging systems including computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine, ultrasound, and X-ray
Publisher: Medtech Insight
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In the next decade, the number of people living in the United States (U.S.) with diseases/disorders of the heart and vascular system is expected to continue to increase along with expansion in the elderly segment of the population and growth in the number of people with chronic conditions such as cardiovascular disease (CVD), diabetes, and obesity, which are exacerbated by unhealthful behaviors such as physical inactivity and tobacco smoking.
Diagnostic interventional cardiology procedures covered by the scope of this report include electrocardiography (ECG); non-invasive imaging systems including computed tomography (CT), magnetic resonance imaging (MRI), nuclear medicine, ultrasound, and X-ray; invasive diagnostic imaging systems including standard transcatheter coronary and peripheral angiography, electrophyiosology (EP) products, guidewire-based intravascular stenosis assessment, intracardiac echocardiography (ICE), intravascular ultrasound (IVUS), and optical coherence tomography (OCT); and in vitro diagnostics systems including cardiac markers, cholesterol testing products, and point-of-care/home coagulation monitoring systems. In the U.S. it is expected that the combined volume of these procedures will grow at a compound annual rate of 1.4% over the next half-decade, increasing from approximately 5.5 million in 2013 to an estimated 5.9 million in the year 2018. The total product sales for invasive and noninvasive diagnostic cardiology systems is expected to grow at a compound annual rate of 3.4% over the forecast period covered by this report, from approximately $3.8 billion in 2013 to an estimated $4.4 billion in the year 2018.
Table of Contents
1. CARDIOVASCULAR DISEASE OVERVIEW ………………………………………. 1-1
1.1 The Heart and Circulatory System…………………………………………….. 1-2
1.2 Selected Heart Diseases/Disorders…………………………………………… 1-6
1.2.1 Coronary Heart Disease……………………………………………. 1-6
1.2.1.1 Atherosclerosis………………………………………… 1-10
1.2.1.2 Angina Pectoris ……………………………………….. 1-13
1.2.1.3 Myocardial Infarction ………………………………… 1-17
1.2.2 Hypertension …………………………………………………………. 1-20
1.2.2.1 Systolic and Diastolic Pressures ………………… 1-22
1.2.2.2 Prehypertension ………………………………………. 1-22
1.2.3 Cardiomyopathy …………………………………………………….. 1-27
1.2.3.1 Dilated Cardiomyopathy ……………………………. 1-27
1.2.3.2 Hypertrophic Cardiomyopathy……………………. 1-28
1.2.3.3 Restrictive Cardiomyopathy ………………………. 1-29
1.2.4 Congenital Heart Defects ………………………………………… 1-30
1.2.4.1 Ventricular Septal Defects…………………………. 1-33
1.2.4.2 Atrial Septal Defects…………………………………. 1-34
1.2.4.3 Patent Ductus Arteriosus…………………………… 1-35
1.2.5 Cardiac Rhythm Disorders ………………………………………. 1-36
1.2.5.1 Bradycardia …………………………………………….. 1-36
1.2.5.2 Supraventricular Tachycardia…………………….. 1-38
1.2.5.2.1 Atrial Fibrillation ……………………. 1-38
1.2.5.3 Ventricular Tachycardia…………………………….. 1-41
1.2.5.3.1 Ventricular Fibrillation ……………. 1-41
1.2.6 Heart Failure………………………………………………………….. 1-42
1.2.6.1 Disease Development ………………………………. 1-43
1.2.6.2 Ejection Fraction Reduction ………………………. 1-44
1.2.6.3 Classification/Staging Systems ………………….. 1-45
1.3 Peripheral Vascular Disease Overview ……………………………………. 1-49
1.4 Anatomy and Physiology of the Circulatory System …………………… 1-49
1.5 Types of Peripheral Vascular Disease……………………………………… 1-49
1.5.1 Peripheral Artery Disease………………………………………… 1-49
1.5.1.1 Etiology ………………………………………………….. 1-49
1.5.1.2 Epidemiology…………………………………………… 1-53
1.5.2 Aneurysm ……………………………………………………………… 1-53
1.5.2.1 Etiology ………………………………………………….. 1-55
1.5.2.2 Epidemiology…………………………………………… 1-56
1.5.3 Deep Vein Thrombosis and Pulmonary Embolism ………. 1-58
1.5.3.1 Etiology ………………………………………………….. 1-60
1.5.3.2 Epidemiology…………………………………………… 1-60
1.5.4 Chronic Venous Insufficiency …………………………………… 1-61
1.5.4.1 Etiology ………………………………………………….. 1-63
1.5.4.2 Epidemiology…………………………………………… 1-66
1.6 Cerebrovascular Disease Overview ……………………………………….. 1-67
1.6.1 Stroke…………………………………………………………………… 1-67
1.6.1.1 Etiology ………………………………………………….. 1-69
1.6.1.2 Epidemiology…………………………………………… 1-70
Exhibit 1-1: Cross-Section Diagram of the Heart………………………………………….. 1-7
Exhibit 1-2: Statistics for Selected Coronary Heart Disease Risk Factors………… 1-9
Exhibit 1-3: Standard Angina Pectoris Classification………………………………….. 1-15
Exhibit 1-4: Angina Pectoris, Selected Statistics ………………………………………… 1-16
Exhibit 1-5: Clinical Classification of AMI …………………………………………………. 1-18
Exhibit 1-6: Myocardial Infarction, Selected Statistics …………………………………. 1-21
Exhibit 1-7: Percentage of Adults Who Have Been Told They Have High Blood
Pressure, by State………………………………………………………………… 1-23
Exhibit 1-8: Hypertension, Selected Statistics ……………………………………………. 1-26
Exhibit 1-9: Cardiomyopathy, Selected Statistics ……………………………………….. 1-31
Exhibit 1-10: Congenital Heart Defects, Selected Statistics …………………………… 1-37
Exhibit 1-11: Summary, New York Heart Association Heart Failure
Classification System ……………………………………………………………. 1-46
Exhibit 1-12: Summary, American College of Cardiology/American Heart
Association Heart Failure Staging System ………………………………. 1-48
Exhibit 1-13: Heart Failure, Selected Statistics ……………………………………………. 1-50
Exhibit 1-14: Peripheral Artery Disease, Facts and Figures …………………………… 1-54
Exhibit 1-15: Aortic Aneurysm, Facts and Figures………………………………………… 1-59
Exhibit 1-16: Deep Vein Thrombosis, Facts and Figures ………………………………. 1-62
Exhibit 1-17: Classification of Chronic Venous Insufficiency ………………………….. 1-65
Exhibit 1-18: Chronic Venous Insufficiency, Facts and Figures………………………. 1-68
Exhibit 1-19: 2014, Stroke, Facts and Figures …………………………………………….. 1-74
2. NONINVASIVE DIAGNOSTIC CARDIOLOGY PROCEDURES
AND PRODUCTS ……………………………………………………………………………. 2-1
2.1 Electrocardiography………………………………………………………………… 2-5
2.1.1 Resting Electrocardiography Examinations………………….. 2-5
2.1.2 Exercise Stress Testing…………………………………………….. 2-8
2.1.3 Ambulatory Electrocardiography ………………………………… 2-9
2.1.4 Procedure Volumes………………………………………………….. 2-9
2.1.5 Products ……………………………………………………………….. 2-11
2.1.6 Market Forecast …………………………………………………….. 2-11
2.1.7 Competitors…………………………………………………………… 2-13
2.2 Conventional X-Ray Imaging………………………………………………….. 2-17
2.2.1 Computed Radiography and Digital Radiography ……….. 2-21
2.2.2 General Radiology/Fluoroscopy ……………………………….. 2-22
2.2.3 Cardiovascular X-Ray Systems………………………………… 2-23
2.2.4 Procedure Volumes………………………………………………… 2-24
2.2.5 Products ……………………………………………………………….. 2-24
2.2.6 Market Forecast …………………………………………………….. 2-26
2.2.7 Competitors…………………………………………………………… 2-27
2.3 Computed Tomography…………………………………………………………. 2-31
2.3.1 Spiral Computed Tomography………………………………….. 2-33
2.3.2 Multislice Computed Tomography …………………………….. 2-34
2.3.3 Computed Tomography Angiography………………………… 2-35
2.3.4 Perfusion Computed Tomography…………………………….. 2-36
2.3.5 Cardiovascular-Related Applications of
Computed Tomography…………………………………………… 2-36
2.3.6 Procedure Volumes………………………………………………… 2-38
2.3.7 Products ……………………………………………………………….. 2-38
2.3.8 Market Forecast …………………………………………………….. 2-40
2.3.9 Competitors…………………………………………………………… 2-41
2.4 Magnetic Resonance Imaging ………………………………………………… 2-45
2.4.1 Magnetic Resonance Angiography……………………………. 2-48
2.4.1.1 Contrast-Enhanced Magnetic
Resonance Angiography …………………………… 2-49
2.4.1.2 Phase-Contrast Magnetic
Resonance Angiography …………………………… 2-49
2.4.1.3 Time-of-Flight Magnetic
Resonance Angiography …………………………… 2-49
2.4.2 Functional Magnetic Resonance Imaging…………………… 2-50
2.4.3 Proton Magnetic Resonance Spectroscopy………………… 2-50
2.4.4 Interventional Magnetic Resonance ………………………….. 2-51
2.4.5 Cardiovascular-Related Applications of Magnetic Resonance
Imaging Techniques ……………………………………………….. 2-51
2.4.6 Procedure Volumes………………………………………………… 2-52
2.4.7 Products ……………………………………………………………….. 2-52
2.4.8 Market Forecast …………………………………………………….. 2-54
2.4.9 Competitors…………………………………………………………… 2-55
2.5 Nuclear Medicine/Molecular Imaging……………………………………….. 2-58
2.5.1 Gamma Camera Imaging ………………………………………… 2-61
2.5.2 Positron Emission Tomography Scanner Imaging……….. 2-61
2.5.3 Fusion Imaging Techniques …………………………………….. 2-62
2.5.4 Cardiovascular-Related Applications of Nuclear
Medicine Imaging …………………………………………………… 2-63
2.5.5 Procedure Volumes………………………………………………… 2-64
2.5.6 Products ……………………………………………………………….. 2-65
2.5.7 Market Forecast …………………………………………………….. 2-65
2.5.8 Competitors…………………………………………………………… 2-67
2.6 Diagnostic Ultrasound …………………………………………………………… 2-72
2.6.1 Doppler Imaging…………………………………………………….. 2-75
2.6.2 Duplex Ultrasonography………………………………………….. 2-76
2.6.3 Echocardiography ………………………………………………….. 2-77
2.6.4 Cardiovascular-Related Applications of
Ultrasound Imaging ………………………………………………… 2-77
2.6.5 Procedure Volumes………………………………………………… 2-78
2.6.6 Products ……………………………………………………………….. 2-79
2.6.7 Market Forecast …………………………………………………….. 2-79
2.6.8 Competitors…………………………………………………………… 2-81
2.7 In Vitro Diagnostic Modalities …………………………………………………. 2-86
2.7.1 Cholesterol Testing ………………………………………………… 2-88
2.7.2 Cardiac Markers …………………………………………………….. 2-88
2.7.2.1 Creatine Kinase MB …………………………………. 2-89
2.7.2.2 Myoglobin……………………………………………….. 2-89
2.7.2.3 Cardiac Troponins……………………………………. 2-90
2.7.2.3.1 Biochemical Markers in Point-ofCare
Diagnostics of Heart Failure ………………………… 2-91
2.7.3 Coagulation Monitoring …………………………………………… 2-92
2.7.3.1 Activated Partial Thromboplastin Time Test ……………………………………………….. 2-93
2.7.3.2 Activated Clotting Time Test ……………………… 2-93
2.7.3.3 Bleeding Time Test ………………………………….. 2-94
2.7.3.4 Prothrombin Time Test……………………………… 2-94
2.7.3.5 Thrombin Clotting Time Test ……………………… 2-94
2.7.4 Procedure Volumes………………………………………………… 2-95
2.7.5 Products ……………………………………………………………….. 2-95
2.7.6 Market Forecast …………………………………………………….. 2-98
2.7.7 Competitors…………………………………………………………… 2-99
Exhibit 2-1: Noninvasive Diagnostic Cardiology, Combined Procedure
Volumes Forecast, 2013-2018 …………………………………………………. 2-3
Exhibit 2-2: Diagnostic Cardiology Products, Combined
Market Forecast, 2013-2018 ……………………………………………………. 2-6
Exhibit 2-3: Electrocardiography, Procedure Volumes Forecast, 2013-2018 ….. 2-10
Exhibit 2-4: Electrocardiography, Market Forecast, 2013-2018…………………….. 2-14
Exhibit 2-5: 2013, Coronary Electrocardiography Devices Market,
Share by Supplier…………………………………………………………………. 2-18
Exhibit 2-6: Coronary X-Ray, Procedure Volumes Forecast, 2013-2018 ……….. 2-25
Exhibit 2-7: Cardiac X-Ray Systems, Market Forecast, 2013-2018……………….. 2-28
Exhibit 2-8: 2013, Cardiac X-Ray Devices Market, Share by Supplier …………… 2-32
Exhibit 2-9: Computed Tomography, Procedure
Volumes Forecast, 2013-2018 ……………………………………………….. 2-39
Exhibit 2-10: Computed Tomography Systems, Market Forecast, 2013-2018 …. 2-42
Exhibit 2-11: 2013, Computed Tomography Devices Market,
Share by Supplier…………………………………………………………………. 2-46
Exhibit 2-12: Magnetic Resonance Imaging, Procedure
Volumes Forecast, 2013-2018 ……………………………………………….. 2-53
Exhibit 2-13: Magnetic Resonance Imaging Systems,
Market Forecast, 2013-2018 ………………………………………………….. 2-56
Exhibit 2-14: 2013, Magnetic Resonance Imaging Devices Market,
Share by Supplier…………………………………………………………………. 2-59
Exhibit 2-15: Nuclear Medicine Imaging, Procedure
Volumes Forecast, 2013-2018 ……………………………………………….. 2-66
Exhibit 2-16: Nuclear Medicine Imaging Systems,
Market Forecast, 2013-2018 ………………………………………………….. 2-68
Exhibit 2-17: 2013, Nuclear Medicine Imaging Devices Market,
Share by Supplier…………………………………………………………………. 2-73
Exhibit 2-18: Diagnostic Ultrasound Imaging, Procedure
Volumes Forecast, 2013-2018 ……………………………………………….. 2-80
Exhibit 2-19: Diagnostic Ultrasound Imaging Systems,
Market Forecast, 2013-2018 ………………………………………………….. 2-82
Exhibit 2-20: 2013, Diagnostic Ultrasound Imaging Devices Market,
Share by Supplier…………………………………………………………………. 2-87
Exhibit 2-21: In Vitro Diagnostic Testing, Procedure
Volumes Forecast, 2013-2018 ……………………………………………….. 2-96
Exhibit 2-22: Cardiovascular In Vitro Diagnostic Testing,
Market Forecast, 2013-2018 ………………………………………………… 2-100
Exhibit 2-23: 2013, Cholesterol Testing Devices Market, Share by Supplier…… 2-103
Exhibit 2-24: 2013, Near-patient Cardiac Marker Testing Devices Market,
Share by Supplier……………………………………………………………….. 2-104
Exhibit 2-25: 2013, Point-of-Care Coagulation Monitoring Devices Market,
Share by Supplier……………………………………………………………….. 2-106
3. INVASIVE DIAGNOSTIC CARDIOLOGY PROCEDURES AND
PRODUCTS……………………………………………………………………………………. 3-1
3.1 Angiography ………………………………………………………………………….. 3-6
3.1.1 Coronary Angiography ……………………………………………… 3-6
3.1.2 Peripheral Angiography…………………………………………….. 3-8
3.1.2.1 Peripheral Arterial Angiography……………………. 3-8
3.1.2.2 Peripheral Venous Agiography…………………….. 3-9
3.1.3 Procedure Volumes………………………………………………….. 3-9
3.1.4 Products ……………………………………………………………….. 3-10
3.1.5 Market Forecast …………………………………………………….. 3-10
3.1.6 Competitors…………………………………………………………… 3-13
3.2 Guidewire-Based Physiologic Intravascular
Stenosis Assessment ……………………………………………………………. 3-17
3.2.1 Technologies …………………………………………………………. 3-17
3.2.2 Procedure Volumes………………………………………………… 3-20
3.2.3 Products ……………………………………………………………….. 3-20
3.2.4 Market Forecast …………………………………………………….. 3-20
3.2.5 Competitors…………………………………………………………… 3-22
3.3 Intracardiac Echocardiography……………………………………………….. 3-25
3.3.1 Technologies …………………………………………………………. 3-27
3.3.2 Procedure Volumes………………………………………………… 3-27
3.3.3 Products ……………………………………………………………….. 3-28
3.3.4 Market Forecast …………………………………………………….. 3-30
3.3.5 Competitors…………………………………………………………… 3-30
3.4 Intravascular Ultrasound………………………………………………………… 3-33
3.4.1 Technologies …………………………………………………………. 3-35
3.4.2 Procedure Volumes………………………………………………… 3-36
3.4.3 Products ……………………………………………………………….. 3-36
3.4.4 Market Forecast …………………………………………………….. 3-38
3.4.5 Competitors…………………………………………………………… 3-41
3.5 Optical Coherence Tomography……………………………………………… 3-45
3.5.1 Products ……………………………………………………………….. 3-46
3.5.2 Procedure Volumes………………………………………………… 3-47
3.5.3 Market Forecast …………………………………………………….. 3-47
3.5.4 Competitors…………………………………………………………… 3-49
3.6 Electrophysiology …………………………………………………………………. 3-51
3.6.1 Conventional Electrophysiology Studies…………………….. 3-51
3.6.2 Advanced Electrophysiology Mapping……………………….. 3-52
3.6.3 Products ……………………………………………………………….. 3-53
3.6.4 Procedure Volumes………………………………………………… 3-53
3.6.5 Market Forecast …………………………………………………….. 3-54
3.6.6 Competitors…………………………………………………………… 3-56
Figure: Invasive Diagnostic Cardiology Products Market, Share by Segment, 2013 and 2018
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