Reportlinker Adds Cardiovascular Drug Delivery - Technologies, Markets and Companies
NEW YORK, Sept. 7 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:
Cardiovascular Drug Delivery - technologies, markets and companies
Summary
Drug delivery to the cardiovascular system is different from delivery to other systems because of the anatomy and physiology of the vascular system; it supplies blood and nutrients to all organs of the body. Drugs can be introduced into the vascular system for systemic effects or targeted to an organ via the regional blood supply. In addition to the usual formulations of drugs such as controlled release, devices are used as well. This report starts with an introduction to molecular cardiology and discusses its relationship to biotechnology and drug delivery systems.
Drug delivery to the cardiovascular system is approached at three levels: (1) routes of drug delivery; (2) formulations; and finally (3) applications to various diseases. Formulations for drug delivery to the cardiovascular system range from controlled release preparations to delivery of proteins and peptides. Cell and gene therapies, including antisense and RNA interference, are described in full chapters as they are the most innovative methods of delivery of therapeutics. Various methods of improving systemic administration of drugs for cardiovascular disorders are described including use of nanotechnology.
Cell-selective targeted drug delivery has emerged as one of the most significant areas of biomedical engineering research, to optimize the therapeutic efficacy of a drug by strictly localizing its pharmacological activity to a pathophysiologically relevant tissue system. These concepts have been applied to targeted drug delivery to the cardiovascular system. Devices for drug delivery to the cardiovascular system are also described.
Role of drug delivery in various cardiovascular disorders such as myocardial ischemia, hypertension and hypercholesterolemia is discussed. Cardioprotection is also discussed. Some of the preparations and technologies are also applicable to peripheral arterial diseases. Controlled release systems are based on chronopharmacology, which deals with the effects of circadian biological rhythms on drug actions. A full chapter is devoted to drug-eluting stents as treatment for restenosis following stenting of coronary arteries. Fifteen companies are involved in drug-eluting stents.
New cell-based therapeutic strategies are being developed in response to the shortcomings of available treatments for heart disease. Potential repair by cell grafting or mobilizing endogenous cells holds particular attraction in heart disease, where the meager capacity for cardiomyocyte proliferation likely contributes to the irreversibility of heart failure. Cell therapy approaches include attempts to reinitiate cardiomyocyte proliferation in the adult, conversion of fibroblasts to contractile myocytes, conversion of bone marrow stem cells into cardiomyocytes, and transplantation of myocytes or other cells into injured myocardium.
Advances in molecular pathophysiology of cardiovascular diseases have brought gene therapy within the realm of possibility as a novel approach to treatment of these diseases. It is hoped that gene therapy will be less expensive and affordable because the techniques involved are simpler than those involved in cardiac bypass surgery, heart transplantation and stent implantation. Gene therapy would be a more physiologic approach to deliver vasoprotective molecules to the site of vascular lesion. Gene therapy is not only a sophisticated method of drug delivery; it may at time need drug delivery devices such as catheters for transfer of genes to various parts of the cardiovascular system.
The cardiovascular drug delivery markets are estimated for the years 2009 to 2019 on the basis of epidemiology and total markets for cardiovascular therapeutics. The estimates take into consideration the anticipated advances and availability of various technologies, particularly drug delivery devices in the future. Markets for drug-eluting stents are calculated separately. Role of drug delivery in developing cardiovascular markets is defined and unmet needs in cardiovascular drug delivery technologies are identified.
Selected 96 companies that either develop technologies for drug delivery to the cardiovascular system or products using these technologies are profiled and 72 collaborations between companies are tabulated. The bibliography includes 200 selected references from recent literature on this topic. The report is supplemented with 27 tables and 6 figures
TABLE OF CONTENTS
0. Executive Summary 11
1. Cardiovascular Diseases 13
Introduction 13
History of cardiovascular drug delivery 13
Overview of cardiovascular disease 14
Coronary artery disease 14
Angina pectoris 14
Limitations of current therapies for myocardial ischemic disease 14
Cardiomyopathies 14
Cardiac arrhythmias 15
Congestive heart failure 15
Peripheral arterial disease 15
Current management 16
Atherosclerosis 16
The endothelium as a target for cardiovascular therapeutics 16
Molecular cardiology 17
Cardiogenomics 17
Cardioproteomics 17
Personalized cardiology 18
Pharmacogenomics of cardiovascular disorders 18
Modifying the genetic risk for myocardial infarction 19
Management of heart failure 19
Management of hypertension 20
Pharmacogenomics of diuretic drugs 20
Pharmacogenomics of ACE inhibitors 20
Management of hypertension by personalized approach 21
Pharmacogenetics of lipid-lowering therapies 21
Polymorphisms in genes involved in cholesterol metabolism 21
Role of eNOS gene polymorphisms 22
Important advances in cardiovascular therapeutics 22
Drug delivery, biotechnology and the cardiovascular system 23
Role of cardiovascular imaging in cardiovascular therapeutics 23
Chronopharmacotherapy of cardiovascular diseases 23
2. Methods for Drug Delivery to the Cardiovascular System 25
Introduction 25
Routes of drug delivery to the cardiovascular system 25
Local administration of drugs to the cardiovascular system 25
Intramyocardial drug delivery 25
Drug delivery via coronary venous system 26
Intrapericardial drug delivery 26
Formulations for drug delivery to the cardiovascular system 26
Sustained and controlled release 27
Programming the release at a defined time 27
Dosage formulation of calcium channel blockers 28
Sustained and controlled release verapamil 28
Methods of administration of proteins and peptides 28
Delivery of peptides by subcutaneous injection 29
Depot formulations and implants 29
Poly(ethylene glycol) technology 29
Microencapsulation for protein delivery 30
Localized delivery of biomaterials for tissue engineering 30
Oral delivery of proteins and peptides 30
DDS to improve systemic delivery of cardiovascular drugs 31
Nanotechnology-based drug delivery 32
Controlled delivery of nanoparticles to injured vasculature 33
Nanoparticles for cardiovascular imaging and targeted drug delivery 34
Nanofiber-based scaffolds with drug-release properties 34
Targeted drug delivery to the cardiovascular system 34
Immunotargeting of liposomes to activated vascular endothelial cells 35
PEGylated biodegradable particles targeted to inflamed endothelium 36
Devices for cardiovascular drug delivery 36
Local drug delivery by catheters 37
Microneedle for periarterial injection 38
Nanotechnology-based devices for the cardiovascular system 38
Liposomal nanodevices for targeted cardiovascular drug delivery 39
Nanotechnology approach to the problem of "vulnerable plaque" 39
Drug delivery in the management of cardiovascular disease 40
Drug delivery in the management of hypertension 40
Transnasal drug delivery for hypertension 40
Transdermal drug delivery for hypertension 41
Oral extended and controlled release preparations for hypertension 41
Long-acting hypertensives for 24 h blood pressure control 42
Drug delivery to control early morning blood pressure peak 42
Role of drug delivery in improving compliance with antihypertensive therapy 43
Drug delivery for congestive heart failure 43
Oral human brain-type natriuretic peptide 43
Nitric oxide-based therapies for congestive heart failure 43
Automated drug delivery system for cardiac failure 44
DDS in the management of ischemic heart disease 44
Intravenous emulsified formulations of halogenated anesthetics 45
Injectable peptide nanofibers for myocardial ischemia 45
Delivery of angiogenesis-inducing agents for myocardial ischemia 45
Drug delivery for cardioprotection 46
Drug delivery for cardiac rhythm disorders 47
Drug delivery in the treatment of angina pectoris 48
Sustained and controlled-release nitrate for angina pectoris 48
Transdermal nitrate therapy 48
Controlled release calcium blockers for angina pectoris 49
Vaccines for hypertension 50
Drug delivery in the management of pulmonary hypertension 50
Prostacyclin by inhalation 51
Endothelin receptor antagonist treatment of PAH 51
Anticoagulation in cardiovascular disease 51
Oral heparin 51
Low molecular weight heparin-loaded polymeric nanoparticles 52
Transdermal anticoagulants 52
Thrombolysis for cardiovascular disorders 52
Use of ultrasound to facilitate thrombolysis 52
Delivery of alteplase through the AngioJet rheolytic catheter 53
Drug delivery for peripheral arterial disease 53
Delivery of thrombolytic agent to the clot through a catheter 53
Delivery of growth factors to promote angiogenesis in ischemic limbs 54
Immune modulation therapy for PAD 54
NO-based therapies for peripheral arterial disease 54
Drug delivery in the management of hypercholesterolemia 55
Controlled/sustained release formulations of statins 55
Combinations of statins with other drugs to increase efficacy 55
Controlled release fenofibrate 56
Extended release nicotinic acid 57
Intravenous infusion of lipoprotein preparations to raise HDL 57
Innovative approaches to hypercholesterolemia 58
Single dose therapy for more than one cardiovascular disorder 58
3. Cell Therapy for Cardiovascular Disorders 61
Introduction 61
Inducing the proliferation of cardiomyocytes 61
Role of stem cells in repair of the heart 61
Cell-mediated immune modulation for chronic heart disease 61
Cell therapy for atherosclerotic coronary artery disease 62
Transplantation of myoblasts for myocardial infarction 62
MyoCell™ (Bioheart) 63
Transplantation of cardiac progenitor cells for revascularization of myocardium 64
Methods of delivery of cells to the heart 64
Cellular cardiomyoplasty 64
IGF-1 delivery by nanofibers to improve cell therapy for MI 65
Intracoronary infusion of bone marrow-derived cells for AMI 65
Non-invasive delivery of cells to the heart by Morph®guide catheter 65
Transplantation of stem cells for myocardial infarction 66
Transplantation of embryonic stem cells 66
Transplantation of hematopoietic stem cells 66
Transplantation of cord blood stem cells for myocardial infarction 66
Intracoronary infusion of mobilized peripheral blood stem cells 67
Human mesenchymal stem cells for cardiac regeneration 67
Cytokine preconditioning of human fetal liver CD133+ SCs 68
Transplantation of expanded adult SCs derived from the heart 68
Transplantation of endothelial cells 68
Transplantation of genetically modified cells 69
Transplantation of cells secreting vascular endothelial growth factor 69
Transplantation of genetically modified bone marrow stem cells 69
Cell transplantation for congestive heart failure 69
Myoblasts for treatment of congestive heart failure 69
Injection of adult stem cells for congestive heart failure 70
Role of cell therapy in cardiac arrhythmias 70
Atrioventricular conduction block 71
Ventricular tachycardia 71
ESCs for correction of congenital heart defects 72
Cardiac progenitors cells for treatment of heart disease in children 72
Stem cell therapy for peripheral arterial disease 72
Targeted delivery of endothelial progenitor cells labeled with nanoparticles 73
Clinical trials of cell therapy in cardiovascular disease 73
A critical evaluation of cell therapy for heart disease 75
Publications of clinical trials of cell therapy for CVD 75
Future directions for cell therapy of CVD 76
4. Gene Therapy for Cardiovascular Disorders 79
Introduction 79
Techniques of gene transfer to the cardiovascular system 80
Direct plasmid injection into the myocardium 80
Catheter-based systems for vector delivery 80
Ultrasound microbubbles for cardiovascular gene delivery 81
Vectors for cardiovascular gene therapy 81
Adenoviral vectors for cardiovascular diseases 81
Plasmid DNA-based delivery in cardiovascular disorders 82
Intravenous rAAV vectors for targeted delivery to the heart 82
Hypoxia-regulated gene therapy for myocardial ischemia 82
Angiogenesis and gene therapy of ischemic disorders 83
Therapeutic angiogenesis vs. vascular growth factor therapy 83
Gene painting for delivery of targeted gene therapy to the heart 84
Gene delivery to vascular endothelium 84
Targeted plasmid DNA delivery to the cardiovascular system with nanoparticles 84
Gene delivery by vascular stents 85
Gene therapy for genetic cardiovascular disorders 85
Genetic disorders predisposing to atherosclerosis 85
Familial hypercholesterolemia 86
Apolipoprotein E deficiency 87
Hypertension 88
Genetic factors for myocardial infarction 88
Acquired cardiovascular diseases 88
Coronary artery disease with angina pectoris 89
Ad5FGF-4 89
Ischemic heart disease with myocardial infarction 89
Angiogenesis for cardiovascular disease 90
Myocardial repair with IGF-1 therapy 90
Congestive heart failure 91
Rationale of gene therapy in CHF 91
-ARKct gene therapy 91
Intracoronary adenovirus-mediated gene therapy for CHF 92
AAV-mediated gene transfer for CHF 92
AngioCell gene therapy for CHF 92
nNOS gene transfer in CHF 93
Gene therapy for cardiac arrhythmias 93
Gene transfer for biological pacemakers 93
Management of arrhythmias due to myoblast transplantation 94
Genetically engineered cells as biological pacemakers 95
Gene therapy and heart transplantation 95
Gene therapy for peripheral arterial disease 96
Angiogenesis by gene therapy 96
HIF-1? gene therapy for peripheral arterial disease 96
HGF gene therapy for peripheral arterial disease 97
Ischemic neuropathy secondary to peripheral arterial disease 97
Maintaining vascular patency after surgery 97
Antisense therapy for cardiovascular disorders 98
Antisense therapy for hypertension 98
Antisense therapy for hypercholesterolemia 99
RNAi for cardiovascular disorders 99
RNAi for hypercholesterolemia 100
microRNA and the cardiovascular system 101
Role of miRNAs in angiogenesis 101
Role of miRNAs in cardiac hypertrophy and failure 101
Role of miRNAs in conduction and rhythm disorders of the heart 102
miRNA-based approach for reduction of hypercholesterolemia 102
miRNAs as therapeutic targets for cardiovascular diseases 102
Future prospects of miRNA in the cardiovascular therapeutics 103
Future prospects of gene therapy of cardiovascular disorders 103
Companies involved in gene therapy of cardiovascular disorders 104
5. Drug-Eluting Stents 105
Introduction 105
Percutaneous transluminal coronary angioplasty 105
Stents 105
Restenosis 105
Pathomechanism 106
Treatment 106
Nitric oxide-based therapies for restenosis 107
Carbon monoxide inhalation for preventing restenosis 107
Antisense approaches for prevention of restenosis after angioplasty 108
miRNA-based approach for restenosis following angioplasty 109
Gene therapy to prevent restenosis after angioplasty 109
Techniques of gene therapy for restenosis 110
NOS gene therapy for restenosis 111
Non-viral gene therapy to prevent intimal hyperplasia 111
HSV-1 gene therapy to prevent intimal hyperplasia 112
Drug delivery devices for restenosis 112
Local drug delivery by catheter 112
Absorbable metal stents 113
Drug-eluting stents 113
Various types of DES 113
CYPHER® sirolimus-eluting coronary stent 113
Sirolimus-eluting vs paclitaxel-eluting stents 114
Paclitaxel-eluting stents 115
Dexamethasone-eluting stents 115
NO-generating stents 115
Dexamethasone-eluting stents 116
Novel technologies for DES 116
Stents for delivery of gene therapy 116
Stem cell-based stents 116
Drug-eluting stents coated with polymer surfaces 117
Absorbable DES 117
Endeavour DES 118
Bio-absorbable low-dose DES 118
VAN 10-4 DES 119
Nanotechnology-based stents 119
Drugs encapsulated in biodegradable nanoparticles 119
Magnetic nanoparticle-coated DES 120
Magnetic nanoparticles encapsulating paclitaxel targeted to stents 120
Nanocoated DES 121
Nanopores to enhance compatibility of DES 121
The ideal DES 121
Companies developing drug-eluting stents 122
Clinical trials of drug-eluting stents 123
Measurements used in clinical trials of DES 123
TAXUS paclitaxel-eluting stents 123
XIENCE™ V everolimus-eluting coronary stent 124
COSTAR II clinical trial 125
Endeavor RESOLUTE zotarolimus-eluting stent system 126
CUSTOM I clinical trial 126
NOBORI CORE Trial 126
LEADERS trial 127
Comparison of DES in clinical trials 127
Comparison of DES with competing technologies 128
DES versus coronary artery bypass graft 128
DES versus bare metal stents 128
Guidelines for DES vs BMS 131
DES vs BMS for off-label indications 131
Role of DES in cases of bare-metal in-stent restenosis 131
DES versus balloon catheter coated with paclitaxel 132
DES versus intracoronary radiation therapy for recurrent stenosis 132
Cost-effectiveness of DES 133
Safety issues of DES 133
Adverse reactions to DES 133
Endothelial vascular dysfunction due to sirolismus 134
Risk of clotting with DES 134
Clopidogrel use and long-term outcomes of patients receiving DES 135
Effect of blood clot on release of drug from DES 136
Use of magnetized cell lining to prevent clotting of DES 136
Long-term safety studies of DES 136
Regulatory issues of DES 137
Future prospects for treatment of restenosis by DES 139
Future role of DES in management of cardiovascular diseases 139
Stent cost and marketing strategies 139
Improvements in stent technology 140
Bioabsorbale stent 140
6. Markets for Cardiovascular Drug Delivery 141
Introduction 141
Epidemiology of cardiovascular disease 141
Cost of care of cardiovascular disorders 142
Cardiovascular markets according to important diseases 143
Antithrombotics 143
Anticholesterol agents 143
Antihypertensive agents 144
Drugs for congestive heart failure 144
Markets for innovative technologies for cardiovascular disorders 144
Markets for cell therapy of cardiovascular disorders 144
Markets for gene therapy of cardiovascular disorders 145
Markets for drug-eluting stents 145
Major players in DES market 145
Impact of safety issues on future markets for DES 145
DES market in Asia 146
Patenting and legal issues of DES 147
The financial impact of DES on cardiovascular markets 147
Unmet needs for cardiovascular drug delivery 148
Role of DDS in developing cardiovascular markets 149
Markets for cardiovascular devices 149
Marketing of innovative cardiovascular drug delivery devices 149
Direct to consumer advertising of DES 150
Future trends in the integration of drug delivery with therapeutics 150
Future prospects of cardiovascular drug delivery 150
7. Companies involved in Cardiovascular Drug Delivery 153
Profiles of companies 153
Collaborations 256
8. References 260
Tables
Table 1 1: Landmarks in the historical evolution of cardiovascular drug delivery 13
Table 1 2: Gene polymorphisms that alter cardiovascular response to drugs 18
Table 2 1: Routes of drug delivery used for treatment of cardiovascular disorders 25
Table 2 2: Formulations for drug delivery to the cardiovascular system 26
Table 2 3: Improved methods of systemic drug delivery of cardiovascular drugs 32
Table 2 4: Targeted delivery of therapeutic substances to the cardiovascular system 35
Table 2 5: Classification of devices for drug delivery to the cardiovascular system 36
Table 2 6: Various methods of delivery of therapeutic agents for hypertension 40
Table 2 7: Marketed controlled/ extended release preparation for hypertension 42
Table 2 8: Drug delivery in ischemic heart disease 44
Table 2 9: Methods of delivery of nitrate therapy in angina pectoris 48
Table 2 10: Drug delivery for peripheral arterial disorders 53
Table 3 1: Clinical trials of cell therapy in cardiovascular disease 73
Table 4 1: Cardiovascular disorders for which gene therapy is being considered. 79
Table 4 2: Catheter-based systems for vector delivery to the cardiovascular system 80
Table 4 3: Potential applications of antisense in cardiovascular disorders 98
Table 4 4: Companies involved in gene therapy of cardiovascular diseases 104
Table 5 1: Treatment of restenosis 106
Table 5 2: Devices used for drug delivery in restenosis 112
Table 5 3: Companies involved in drug-eluting stents 122
Table 6 1: Prevalence of cardiovascular disorders in major markets: US 2009-2019 142
Table 6 2: Prevalence of cardiovascular disorders in major markets: Europe 2009-2019 142
Table 6 3: Prevalence of cardiovascular disorders in major markets: Japan 2009-2019 142
Table 6 4: Values of cardiovascular DDS in major markets 2009-2019 143
Table 6 5: Markets for innovative technologies for cardiovascular disorders 2009-2019 144
Table 7 1: Top 5 companies in cardiovascular drug delivery 153
Table 7 2: Collaborations in cardiovascular drug delivery 256
Figures
Figure 1 1: Drug delivery, biotechnology and cardiovascular diseases 23
Figure 2 1: Microneedle for periarterial injection 38
Figure 5 1: Vicious circle of vascular occlusion following angioplasty and stenting 107
Figure 5 2: Medtronic's Endeavour drug-eluting stent 118
Figure 5 3: Magnetic nanoparticle-coated stent 120
Figure 6 1: Unmet needs for cardiovascular drug delivery 148
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