U.S. MARKETS FOR CURRENT AND EMERGING TECHNOLOGIES FOR THE TREATMENT OF HEART FAILURE
256 Pages | 54 Exhibits | 2012 Analysis | Forecasts Through 2016
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Demographics, the aging of the population, and accompanying rates of heart failure are the main drivers of the United States (U.S.) market for heart failure-specific diagnostic and therapeutic technologies. In the U.S., approximately 6.6 million adults age 18 and older (or 2.8% of the population) have heart failure, and it is estimated that by the year 2030, an additional 3.0 million people will have the disease, representing a 25.0% increase in prevalence. The condition is the most common Medicare diagnosis-related group (i.e., hospital discharge diagnosis), and more Medicare dollars are spent for the diagnosis and treatment of heart failure than for any other diagnosis.
In 2010, U.S. sales of heart failure-specific diagnostic and therapeutic technologies totaled approximately $3,193.8 million; over the forecast period covered by this report, this market is expected to increase in value at a compound annual rate of 2.8%, with sales reaching an estimated $3,683.6 million in the year 2016.
This dynamic new report from Medtech Insight includes analyses of products, markets, competitors, and opportunities in the area of heart failure-specific diagnostic and therapeutic technologies. The market segments that are covered by this report include B-type natriuretic peptide immunoassays, cardiac resynchronization therapy devices, mechanical circulatory support systems (including ventricular assist devices, intra-aortic balloon pumps, counterpulsation systems, and total artificial hearts), surgical ventricular restoration devices, and emerging cell and gene-based therapeutic technologies aimed at myocardial repair and regeneration.
EXECUTIVE SUMMARY i. Clinical Overview ii. B-Type Natriuretic Peptide Testing Products a. Market Forecast iii. Heart Failure Therapeutic Devices a. Cardiac Resynchronization Therapy Devices b. Mechanical Circulatory Support Devices c. Surgical Ventricular Restoration Products d. Market Forecast iv. Emerging Cell- and Gene-Based Myocardial Tissue Repair/Regeneration Products a. Cell-Based Myocardial Tissue Repair/Regeneration Technologies i. Market Forecast b. Gene-Based Myocardial Tissue Repair/Regeneration Technologies v. Combined Market Forecast Exhibit ES-1: United States Population, by Selected Ages, 1990-2050 Exhibit ES-2: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2010-2016 Exhibit ES-3: Heart Failure Therapeutic Devices, Market Forecast, 2010-2016 Exhibit ES-4: Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2010-2016 Exhibit ES-5: Heart Failure-Specific Diagnostic and Therapeutic Technologies, Combined Market Forecast, 2010-2016 1. OVERVIEW OF HEART FAILURE 1.1 Anatomy and Physiology of the Heart 1.2 Heart Failure Etiology 1.3 Diseases/Disorders Associated with the Development of Heart Failure 1.3.1 Coronary Artery Disease and Acute Myocardial Infarction 1.3.2 Hypertension 1.3.3 Cardiomyopathy 188.8.131.52 Dilated Cardiomyopathy 184.108.40.206 Hypertrophic Cardiomyopathy 220.127.116.11 Restrictive Cardiomyopathy 1.3.4 Valvular Heart Disease 1.3.5 Cardiac Dysrhythmias 18.104.22.168 Atrial Fibrillation 22.214.171.124 Bradycardia 126.96.36.199 Heart Block 188.8.131.52 Tachycardia 184.108.40.206 Ventricular Fibrillation 1.4 Epidemiology and Economic Impact of Heart Failure Exhibit 1-1: New York Heart Association Classification System for Heart Failure Exhibit 1-2: Summary, American College of Cardiology/American Heart Association Heart Failure Staging System Exhibit 1-3: Patient Breakdown Based on New York Heart Association and American College of Cardiology/American Heart Association Heart Failure Classifications Exhibit 1-4: Incidence, Prevalence, Mortality, and Hospital Discharges for Conditions Associated with the Onset of Heart Failure Exhibit 1-5: Heart Failure Facts and Figures 2. HEART FAILURE DIAGNOSIS 2.1 Initial Evaluation 2.1.1 Patient History and Physical Examination 2.1.2 Laboratory Testing 220.127.116.11 Natriuretic Peptide Testing 2.1.3 Electrocardiography 18.104.22.168 Resting Electrocardiography 22.214.171.124 Holter Monitoring 126.96.36.199 Exercise Stress Testing 2.2 Diagnostic Imaging 2.2.1 X-Ray-Based Imaging 188.8.131.52 Conventional X-Ray-Based Imaging 184.108.40.206 Angiography 2.2.2 Computed Tomography 2.2.3 Magnetic Resonance Imaging 2.2.4 Nuclear Medicine Imaging 2.2.5 Ultrasound Imaging Exhibit 2-1: Primary Clinical Goals of Heart Failure Diagnostic Modalities Exhibit 2-2: Medical Conditions Associated with Elevated B-Type Natriuretic Peptide Levels 3. B-TYPE NATRIURETIC PEPTIDE TESTING PRODUCTS MARKET 3.1 Approved Indications for B-Type Natriuretic Peptide Testing 3.2 Clinical Trials 3.3 Reimbursement 3.4 Guidelines for the Management of Heart Failure 3.5 Selected B-Type Natriuretic Peptide Testing Products for Heart-Failure Related Applications 3.6 Procedure Volumes Forecast 3.7 Market Forecast 3.7.1 Market Drivers 3.7.2 Market Limiters 3.8 Competitive Analysis Exhibit 3-1: Approved Clinical Applications for Heart Failure-Related Natriuretic Peptide Testing Exhibit 3-2: B-Type Natriuretic Peptide Cut-Off/Scaling Levels for the Differentiation of Heart Failure and Non-Heart Failure Patients Exhibit 3-3: Correlation of B-Type Natriuretic Peptide Levels with New York Heart Association Heart Failure Classes Exhibit 3-4: Proposed Algorithms for Interpretation of Natriuretic Peptide Levels in Patients Presenting with Acute Dyspnea Exhibit 3-5: 2012, Selected Heart Failure-Related B-Type Natriuretic Peptide Assays Exhibit 3-6: B-Type Natriuretic Peptide Testing, Procedure Volumes Forecast, 2010-2016 Exhibit 3-7: Heart Failure-Related B-Type Natriuretic Peptide Testing Products, Market Forecast, 2010-2016 Exhibit 3-8: 2010, Heart Failure-Related B-Type Natriuretic Peptide Testing Products Market, Share by Supplier 4. HEART FAILURE THERAPEUTIC DEVICES MARKET 4.1 Cardiac Resynchronization Therapy Devices 4.1.1 Clinical Trials 4.1.2 Indications and Contraindications 4.1.3 Products 4.1.4 Procedure Volumes 4.1.5 Market Forecast 4.1.6 Competitive Analysis 4.2 Mechanical Circulatory Support Systems 4.2.1 Ventricular Assist Devices 220.127.116.11 Device Types 18.104.22.168.1 External Ventricular Assist Devices 22.214.171.124.2 Internal Ventricular Assist Devices 126.96.36.199.3 Percutaneous Ventricular Assist Devices 188.8.131.52.4 Pulsatile Flow Ventricular Assist Devices 184.108.40.206.5 Continuous Flow VentricularAssist Devices 220.127.116.11 Indications 18.104.22.168 Device and Patient Selection 22.214.171.124 Products 126.96.36.199 Procedure Volumes 188.8.131.52 Market Forecast 184.108.40.206 Competitive Analysis 4.2.2 Intra-Aortic Balloon Pumps 220.127.116.11 Technology Overview 18.104.22.168 Indications and Contraindications 22.214.171.124 Products 126.96.36.199 Procedure Volumes 188.8.131.52 Market Forecast 184.108.40.206 Competitive Analysis 4.2.3 Counterpulsation Systems 220.127.116.11 Clinical Trials 18.104.22.168 Indications and Contraindications 22.214.171.124 Products 126.96.36.199 Procedure Volumes 188.8.131.52 Market Forecast 184.108.40.206 Competitive Analysis 220.127.116.11 Implantable Counterpulsation Systems 18.104.22.168.1 Implantable Intra-Aortic Counterpulsation Systems 22.214.171.124.2 Implantable Extra-Aortic Counterpulsation Systems 126.96.36.199.3 Plausible Market for Implantable Counterpulsation Systems 4.2.4 Total Artificial Hearts 188.8.131.52 Clinical Experience 184.108.40.206 Total Artificial Heart Indications and Potential Patient Caseloads 220.127.116.11 Products 18.104.22.168 Market Analysis 4.3 Surgical Ventricular Restoration 4.3.1 Products 4.3.2 Market Analysis 4.4 Combined Procedure Volumes Forecast 4.5 Combined Market Forecast Exhibit 4-1: Summary, Recommended Heart Failure Treatment Regimens, by Stage and Class Exhibit 4-2: Indications and Contraindications for Cardiac Resynchronization Therapy Exhibit 4-3: 2012, Selected Cardiac Resynchronization Therapy Devices Exhibit 4-4: Cardiac Resynchronization Therapy Device Implants, Procedure Volumes Forecast, 2010-2016 Exhibit 4-5: Cardiac Resynchronization Therapy Devices, Market Forecast, 2010-2016 Exhibit 4-6: 2010, Cardiac Resynchronization Therapy Devices Market, Share by Supplier Exhibit 4-7: Advantages and Disadvantages of Pulsatile and Continuous Flow Ventricular Assist Devices Exhibit 4-8: 2012, Selected Ventricular Assist Devices Exhibit 4-9: 2012, Selected Ventricular Assist Devices Under Development Exhibit 4-10: Ventricular Assist Device Placement, Procedure Volumes Forecast, 2010-2016 Exhibit 4-11: Ventricular Assist Devices, Market Forecast, 2010-2016 Exhibit 4-12: 2010, Ventricular Assist Devices Market, Share by Supplier Exhibit 4-13: Indications and Contraindications for Intra-Aortic Balloon Pump Therapy Exhibit 4-14: 2012, Selected Intra-Aortic Balloon Pump Consoles and Catheters Exhibit 4-15: Intra-Aortic Balloon Pump Therapy, Procedure Volumes Forecast, 2010-2016 Exhibit 4-16: Intra-Aortic Balloon Pump Systems, Market Forecast, 2010-2016 Exhibit 4-17: 2010, Intra-Aortic Balloon Pump Systems Market, Share by Supplier Exhibit 4-18: Indications and Contraindications for External Counterpulsation Therapy Exhibit 4-19: 2012, Selected External Counterpulsation Systems Exhibit 4-20: External Counterpulsation, Procedure Volumes Forecast, 2010-2016 Exhibit 4-21: External Counterpulsation Systems, Market Forecast, 2010-2016 Exhibit 4-22: 2010, External Counterpulsation Systems Market, Share by Supplier Exhibit 4-23: 2012, Selected Implantable Counterpulsation Systems Under Development Exhibit 4-24: 2012, Selected Total Artificial Heart Systems Exhibit 4-25: Total Artificial Heart Implantation,Procedure Volumes Forecast, 2010-2016 Exhibit 4-26: Total Artificial Heart Systems, Market Forecast, 2010-2016 Exhibit 4-27: 2012, Features of Chase Medicalâ€™s Surgical Ventricular Restoration Device Exhibit 4-28: Surgical Ventricular Reconstruction, Market and Procedure Volumes Forecast, 2010-2016 Exhibit 4-29: Device-Based Heart Failure Therapy, Combined Procedure Volumes Forecast, 2010-2016 Exhibit 4-30: Heart Failure Therapeutic Devices, Combined Market Forecast, 2010-2016 5. EMERGING CELL- AND GENE-BASED MYOCARDIAL TISSUE REPAIR/REGENERATION PRODUCTS MARKET 5.1 Cell-Based Myocardial Tissue Repair/Regeneration Technologies 5.1.1 Cell Graft Sources 5.1.2 Administration of Cell Therapy 5.1.3 Clinical Experience with Stem Cell-Based Myocardial Tissue Repair/Regeneration Technologies 5.1.4 Selected Cell-Based Myocardial Repair/Regeneration Technologies Under Development 22.214.171.124 Aastrom Biosciences 126.96.36.199 Advanced Cell Technology 188.8.131.52 Aldagen 184.108.40.206 Amorcyte/NeoStem 220.127.116.11 Baxter Healthcare/Baxter International 18.104.22.168 Bioheart 22.214.171.124 Cardio3 BioSciences 126.96.36.199 Cytori Therapeutics 188.8.131.52 Geron 184.108.40.206 Mesoblast 220.127.116.11 Osiris Therapeutics 5.2 Gene-Based Myocardial Tissue Repair/Regeneration Technologies 5.2.1 Gene Therapy Technologies Under Development for the Treatment of Heart Failure 18.104.22.168 AnGes MG 22.214.171.124 Cardium Therapeutics 126.96.36.199 Celladon 188.8.131.52 Center for Translational Medicine/Thomas Jefferson University 184.108.40.206 Southwestern Medical Center/University of Texas 220.127.116.11 University of Pittsburgh Medical Center 5.3 Emerging Market for Cell-Based Myocardial Repair/Regeneration Products Exhibit 5-1: Advantages and Disadvantages of Selected Cell Grafts for Myocardial Repair/Regeneration Exhibit 5-2: 2012, Selected Cell-Based Myocardial Repair/Regeneration Therapies Under Development Exhibit 5-3: 2012, Selected Gene-Based Myocardial Tissue Repair/Regeneration Therapies Under Development Exhibit 5-4: Cell-Based Myocardial Tissue Repair/Regeneration Products, Market Forecast, 2010-2016 6. COMPANY PROFILES 6.1 Alere, Inc. 6.2 Chase Medical, Inc. 6.3 Maquet GmbH/Getinge Group AB 6.4 Medtronic, Inc. 6.5 Mesoblast LTD 6.6 SynCardia Systems, Inc. 6.7 Thoratec Corporation 6.8 Vasomedical, Inc. APPENDIX: COMPANY LISTING
This report is listed in the following markets:
Biomaterials, Biotechnology, Cardiovascular, Diagnostics, Imaging, Surgery, Vascular and Wound Management