Medical Nanotechnology Markets

  • September 2008
  • -
  • TriMark Publications
  • -
  • 183 pages

Nanotechnology has reached critical mass. Nowhere is this more evident than in medicine. Rising medical costs, demands for less-invasive procedures and pressures for immediate feedback of medical conditions, all point to nanotechnology as offering a new approach in healthcare. This TriMark Publications report covers the specific segments of the medical nanotechnology markets, with particular emphasis on those segments where this emerging technology is or shows the potential to be most impactful. Nanotechnology, a field of science and technology that aims to control matter at the atomic, molecular and macromolecular level, potentially has far-reaching and paradigm-shifting implications for biology, drug discovery and medical technologies. The discipline has already yielded healthcare discoveries that have been used for drug delivery and diagnostic purposes. In this study, we describe various nanotechnologies under development for biological and medical purposes and assess their potential. Moreover, this analysis is arranged to provide an overview of the regulatory issues faced by the medical nanotechnology industry and focuses on how specific segments within the industry are poised for high future growth.

Table Of Contents

TABLE OF CONTENTS

1 Overview 6
1.1 Statement of Report 6
1.2 About This Report 6
1.3 Scope of the Report 8
1.4 Methodology 8
1.5 Executive Summary 10

2 Medical Products (Drugs, Devices and Nutraceuticals) Nanotechnology Markets 13
2.1 Background 13
2.2 Market Calculations 13
2.3 Market Demands 14
2.4 Market Overview 18
2.4.1 The Role of Nanotechnologies in Medicine 18
2.4.2 Nanotechnology Sector Challenges 21
2.4.3 Nanotechnology Sector Drivers 21
2.4.4 Nanotechnology Sector Restraints 21
2.5 Nanotechnology Medical Product Market Segments 21
2.5.1 Overview 21
2.5.2 World Markets 22
2.5.3 U.S. Market 24
2.5.4 European Market 25
2.5.5 Japanese Market 26
2.5.6 Asian Market 27
2.5.7 Middle East 29
2.5.8 ROW 30

3 Medical and Life Science Nanotechnology Markets 32
3.1 Nano-Particles 33
3.2 Market for Nano-Particles in Life Sciences and Medicine 34
3.2.1 Key Players 34
3.2.2 Application Manufacturers 36
3.3 Dendrimers 36
3.3.1 PAMAM Dendrimers 36
3.3.2 Market for Nanocapsules in Life Sciences and Healthcare 37
3.3.3 Key Players 37
3.4 Market for Nanoporous and Nanostructured Materials in Life Sciences and
Healthcare 37
3.4.1 Key Players 37
3.4.2 Nanofiltration 38
3.5 Nanodevices, Nanosensors and Quantum Dots 38
3.5.1 Sector Overview 38
3.5.2 Market for Quantum Dots in Life Sciences and Medicine 39
3.5.3 Commercial Applications for Quantum Dots 39
3.5.4 Key Players 40
3.5.5 Nanomaterials Suppliers 41
3.5.6 Application Manufacturers 41
3.6 Nanocoatings 42
3.7 Nanocomposites 42
3.8 Nanoarrays 42
3.8.1 Bead NanoArrays: A High-Sensitivity Detection System 43
3.9 Fullerenes 43
3.9.1 Key Applications and Market Opportunities 44
3.9.2 Medical Market Uses for Carbon Nanotubes 44
3.9.3 Key Players, Including Application Manufacturers, End Users and
Nanomaterials Suppliers 45
3.10 Liposome-like Nano-Particles 45
3.10.1 Nanostructured Lipid Carriers 46
3.10.2 DauxoXome Liposomal Formulation 46
3.11 Nanosensors 46
3.11.1 Microcantilever Sensors and Photonic Sensors 46
3.11.2 Field-Effect Nanoplate Devices 46
3.11.3 Electrochemical-Transducing Electrode Systems 47

4 Technology Issues 48
4.1 Nanotechnology in Drug Delivery and Development 48
4.1.1 Drug Delivery Using Nanotechnology 50
4.1.2 Design of Nanotechnology-Based Drug Delivery Systems 52
4.1.3 Using Magnetic Nano-Particles in Targeted Drug Delivery 53
4.1.4 Cancer Drug Delivery 53
4.1.5 Nano-Particle-Mediated Delivery of siRNA 55
4.1.6 Targeting Angiogenesis with Nano-Particles 55
4.1.7 Nanosystems and Inflammation 56
4.1.8 The Chiral Drug Development Process 56
4.1.9 Reasons Why the Drug Delivery Market is Rapidly Expanding 57
4.2 Categories of Medical Nanotechnology Products 57
4.2.1 Surgical Steel Devices 58
4.2.2 Contrast-Enhancing Agents for MRI (Magnetic Resonance Imaging) 58
4.2.3 Wound Dressings / Anti-Microbial Textiles 59
4.2.4 Nanocoated Surgical Blades 59
4.2.5 Suture Needles and Microneedles 59
4.2.6 Catheters for Minimally-Invasive Surgery 59
4.2.7 Optical Nanosurgery 59
4.2.8 Nanocoated or Nanocontoured Implant Surfaces 60
4.3 Biosensors and Biodetection 60
4.3.1 Cantilever Arrays 60
4.3.2 Nanosensors 60
4.3.3 Optical Sensors 60
4.3.4 Nano-Particle Sensors and Detectors 61
4.3.5 In Vitro Diagnostics 61
4.3.6 Imaging, In Vivo Diagnosis and Theranostics 64
4.4 Vaccines-Virus-Like Particles (VLPs) 65
4.5 Transdermal Drug Delivery 65
4.6 Phage Microarrays 65
4.7 Neuroscience 66
4.8 Nanotechnology Materials for Medical Products 67
4.8.1 Dental Materials 67
4.8.2 Bone Replacement 68
4.8.3 Contact Lenses 68
4.9 New Drug Development 68
4.10 Future Directions 69
4.10.1 Sources of Nano Development 69
4.10.2 Commercialization 70
4.10.3 Current/Pending Clinical Trials on New Products and Emerging Technologies
70
4.10.4 Future Directions 72
4.11 Key Technology Findings for Medical Uses of Nanotechnology 72

5 Business Trends 74
5.1 Market Forces 74
5.1.1 Market Drivers 74
5.1.2 Market Restraints 74
5.1.3 Medical / Clinical Studies 74
5.1.4 Demographics 75
5.2 Market Prospects 75
5.3 Marketing and Distribution 75
5.4 Competitive Landscape 76
5.5 Business Developments 76
5.5.1 Drug Pedigrees 76
5.6 Acquisitions and Partnerships 77
5.7 Key Players 77
5.8 Patent Climate 77
5.9 Investment Climate 78
5.9.1 U.S. Government 79
5.9.2 Europe 80
5.10 Venture Capital Environment 80
5.10.1 Medical and Health Nanotech Venture Companies 81
5.10.2 Pharma and Biotech Nanotech Venture Companies 83
5.11 Business Strategies for Medical Nanotechnology 88
5.12 Nanotechnology Questions 90
5.12.1 What Are the Near-Term Business Opportunities in the Medical
Nanotechnology Markets? 90
5.12.2 What Are the Business Models Currently Used by Companies in the Medical
Nanotechnology Markets? 90
5.12.3 How Will Manufacturers, Researchers, Physicians, Patients and Payers
Influence the Medical Nanotechnology Markets? 91
5.12.4 What Are the Drivers and Bottlenecks Influencing the Medical
Nanotechnology Markets? 91
5.12.5 What Are the Current and Emerging Technologies used in the Medical
Nanotechnology Markets? 91
5.12.6 Who Holds the Proprietary Rights to the Medical Nanotechnology Markets,
Especially in such a Multidisciplinary Environment? 92
5.12.7 What Are Current Applications of These Technologies? 92
5.12.8 What Regulatory Processes Must Medical Nanotechnology Undergo in the
U.S., Japan and Europe? 92
5.12.9 How Will New or Emerging Medical Nanotechnologies Change Treatment and
Payment Paradigms? 92
5.12.10 How Will Medical Nanotechnologies Reduce Adverse Clinical Reactions and
Decrease Total Patient Care Cost? 93
5.12.11 How Will Medical Nanotechnology Reduce Healthcare Expenditures? 93
5.12.12 How Will Medical Nanotechnology Decrease Patient Diagnostic Testing
Costs? 93
5.12.13 What is the Role of Nanotechnology in Drug Development? 93
5.12.14 Which Medical Nanotechnology Product Categories Are Driving Growth? 94
5.12.15 How Are Biomarkers Being Developed Using Nanotechnology? 94
5.12.16 What Companies Are Developing Nanotechnology Drug Delivery Systems? 94
5.12.17 How Are Nano-Optical Tagging Technologies Used in Animal Drug Safety
Assessment Studies? 94
5.12.18 What Nanotechnology Platforms Are Being Used in Point of Care Diagnostic
Testing? 95

6 Technology Assessment 96
6.1 Current Technologies for Nano 96
6.1.1 Nanodiagnostics 96
6.1.2 Competitive Analysis of Nano-Particle Assays 99
6.1.3 In Vivo Imaging 99
6.1.4 In Vitro Clinical Diagnostics 99
6.2 Future Technologies 101
6.3 Technology Accelerators, Roadblocks and Challenges 103
6.3.1 Technology Accelerators 103
6.3.2 Technology Roadblocks and Challenges 103
6.3.3 Public Awareness 104
6.4 Nanotechnology Product Trends and New Concepts for Medical Applications 106
6.4.1 Market Trends-Diagnostics 106
6.4.2 Market Trends-Therapies 115
6.4.3 Market Trends-Preventive and Other 120
6.4.4 Nanofibers in Medical Applications 124
6.4.5 Dental Applications 125
6.4.6 Optical Applications 126
6.5 Production Methods 126

7 Medical Nanotechnology Market Regulation and Reimbursement 128
7.1 Market Segments 128
7.1.1 Diagnostics 128
7.1.2 Therapies 128
7.1.3 Preventive 128
7.2 Customer Needs 128
7.3 Competitor Analysis 128
7.4 Pricing Pressures 129
7.5 U.S. Medicare and Other Government Agency Issues 129
7.6 Third-Party Reimbursement 129
7.7 Regulatory Trends 129
7.7.1 Regulatory Policy for Nanotechnology Drugs and Medical Devices 130
7.7.2 Current Good Manufacturing Practices (cGMPs) 133
7.7.3 Current Progress 134
7.7.4 Future Regulatory Trends 134
7.7.5 Key Issues 136
7.7.6 Labeling Requirements 136
7.8 Government Initiatives 136
7.8.1 NNI Research Centers 137
7.8.2 NNI Centers and Networks of Excellence 137
7.8.3 FDA's Nanotechnology Task Force 137
7.8.4 Dutch Government Nano Action Plan 138
7.8.5 Other Research Centers 138
7.9 Medical Regulatory and cGMPs Issues 139
7.10 New Technology Concerns 140
7.11 Use Environment 141
7.11.1 Cancer 141
7.11.2 Medical Review 141
7.12 Risk Assessment 141
7.12.1 Risk Management (ISO 14971:2007) 141
7.12.2 Toxicology Assessment 141
7.12.3 Safety Evaluation 142
7.13 Cautions for Medical Nanotechnology Platforms 144
7.13.1 ETUC Precautionary Principle Applied to Nanotechnologies 145
7.13.2 Possible Risks to Human Health from Nanotechnology Products 145

8 Corporate Profiles 146
8.1 Abbott Laboratories 146
8.2 Abraxis Biosciences 146
8.2.1 NDA Pipeline 147
8.3 Aduro BioTech 148
8.4 Advanced Magnetics (AMAG Pharmaceuticals) 148
8.5 Alnis BioSciences 149
8.6 APP Pharmaceuticals 149
8.7 Arrowhead Research Corporation 150
8.8 Baxter International 151
8.9 Bristol-Myers Squibb 151
8.10 Caliper 151
8.11 Capsulution NanoScience AG 152
8.12 CytRx Corporation 152
8.13 Dendritech, Inc. 152
8.14 Dendritic Nanotechnologies, Inc. 152
8.15 Dow Chemical 153
8.16 DuPont 153
8.16.1 The Framework 155
8.17 Elan Drug Delivery (see also Bristol-Myers Squibb) 156
8.18 Evident Technologies 157
8.19 Evolved Nanomaterial Sciences (ENS) 157
8.20 Flamel Technologies 157
8.21 General Electric 160
8.22 GlaxoSmithKline 160
8.23 Honeywell International 160
8.24 Invitrogen 161
8.25 Nano-C 162
8.26 Nanocyl SA 163
8.27 Nanogen, Inc. 163
8.28 Nanolab Systems 164
8.29 NanoPass Technologies, Ltd. 164
8.30 Nanophase Technologies Corporation 164
8.31 Nanospectra Biosciences 165
8.32 Nanosphere, Inc. 165
8.33 Nanosys 166
8.34 New England Precision Grinding (NEPG) 166
8.35 Novartis 167
8.36 Novavax 167
8.37 Nucryst (Westaim) Pharmaceuticals 168
8.38 Orthovita 168
8.39 Phillips 168
8.40 pSivida Corporation 169
8.41 Quantum Dot Corporation 169
8.42 Roche 170
8.43 Sandvik Bioline 170
8.44 Starpharma Holdings, Limited 171
8.45 Sigma Aldrich 172
8.46 Wyeth Pharmaceuticals 173

9 Appendix: Nanotechnology References 174

10 Appendix: Glossary of Terms in Nanotechnology 175
10.1 Bionanotechnology 175
10.1.1 Nanopore Sequencing 175
10.1.2 Cantilevers with Functionalized Tips 175
10.1.3 Microneedles 175
10.1.4 Microchips for Drug Delivery 175
10.1.5 Nucleic Acid Lattices and Scaffolds 176
10.1.6 Nanofibers as Biomaterials 176
10.1.7 Carbon Nanotubes 177
10.2 Definition of Nano-Particles with Biological and Medical Applications 177
10.2.1 Superparamagnetic Iron Oxide Crystals 177
10.2.2 Quantum Dots 178
10.2.3 Dendrimers 178
10.2.4 Polymeric Micelles 178
10.2.5 Liposomes 178
10.2.6 Nanospheres 179
10.2.7 Aquasomes (Carbohydrate-Ceramic Nano-Particles) 179
10.2.8 Polyplexes/Lipopolyplexes 179

11 Appendix: NNI Centers and Networks of Excellence 180
11.1 National Science Foundation 180
11.2 Department of Energy 181
11.3 Department of Defense 181
11.4 National Aeronautics and Space Administration (NASA) 182
11.5 National Institute for Occupational Safety and Health 182
11.6 National Institute of Standards and Technology 182
11.7 National Institutes of Health 182


LIST OF FIGURES

Figure 2.1: End-User Markets for Nanotechnology, 2007 15
Figure 2.2: Nanometer Scale 18
Figure 2.3: International Per Capita Healthcare Spending by Country, 2006 22
Figure 2.4: World Nanomedical Market Shares, 2007 23
Figure 2.5: Total Spending on Healthcare in the U.S., 1960 to 2007 24
Figure 3.1: Nanotechnology Applications 33
Figure 3.2: Carbon Nanotubes 44
Figure 4.1: Depiction of nab Technology 49
Figure 7.1: FDA Product Validation Chart 133
Figure 7.2: FDA Product Lifecycle Model 135
Figure 8.1: Sigma Aldrich Sales Distribution 172


LIST OF TABLES

Table 2.1: Global Market for Nanotechnology Products, 2005 to 2013 15
Table 2.2: Nanotechnology Materials for Consumer Products, 2005 to 2013 16
Table 2.3: Nanotechnology Markets Worldwide by Industry, 2002 to 2015 16
Table 2.4: Nanotechnology Development Worldwide by Region, 2002 to 2015 16
Table 2.5: Currently-Growing Nanofabrication Techniques 18
Table 2.6: Global Nanomedicine Market, 2004 to 2013 22
Table 2.7: Nanomedicine Market Revenues by Product Segment, 2007 23
Table 2.8: Global Nanomedicine Market by Geographic Segment, 2004 to 2013 23
Table 2.9: U.S. Nanomedicine Market, 2004 to 2013 24
Table 2.10: European Nanomedicine Market, 2004 to 2013 25
Table 2.11: Japanese Nanomedicine Market, 2004 to 2013 26
Table 2.12: Japanese Nanotechnology Product Market Forecast 27
Table 2.13: Government Funding for Nanotechnology Research and Development, 1997
to 2008 30
Table 2.14: Global Nanotechnology RandD Spending, 1997 to 2013 30
Table 2.15: Global Growth in Nanotechnology RandD, 1997 to 2013 31
Table 3.1: Global Market for Nanotechnology Applications in the Life Sciences,
2005 to 2012 32
Table 3.2: Market for Nano-Particles in Life Sciences and Medicine, 2004 to 2012
34
Table 3.2: Market for Nanostructured Materials in Life Sciences and Medicine,
2004 to 2012 37
Table 3.4: Market for Nanodevices in Life Sciences and Medicine, 2004 to 2012 39
Table 3.5: Commercial Applications of Quantum Dots 40
Table 3.6: Market for Nanocomposites in Life Sciences and Medicine, 2004 to 2012
42
Table 3.7: Liposomal Formulations Used in Nanotechnology 45
Table 3.8: Types of Nanoparticulate Drug Delivery Systems 47
Table 4.1: FDA-Approved Drugs Developed with Nanotechnology-Based Formulations
49
Table 4.2: Key Effectors of Drug Delivery Using Nanomaterials 50
Table 4.3: Nanoscale Applications for Drug Delivery in Pharmaceutical Drug
Development 51
Table 4.4: Drug Delivery Nanotechnology Market Drivers Ranked in Order of Impact
51
Table 4.5: Drug Delivery Nanotechnology Market Restraints Ranked in Order of
Impact 51
Table 4.6: Anti-Cancer Drugs Formulated Using Nanomaterials 54
Table 4.7: Nanomaterials for in vitro RNAi Delivery 54
Table 4.8: Use of Peptide-Based Nanotubes for Biological Active Targets 55
Table 4.9: Lab-on-Chip and Microfluidic Chip Technology Innovations 62
Table 4.10: Diagnostic Nanotechnology Market Drivers Ranked in Order of Impact
63
Table 4.11: Diagnostic Nanotechnology Market Restraints Ranked in Order of
Impact 63
Table 4.12: FDA-Approved In Vivo Imaging Materials Developed with
Nanotechnology-Based Formulations 64
Table 4.13: Application Areas for Phage Nanotechnology Platforms 66
Table 4.14: Application Areas for Neuroscience Nanotechnology Platforms 66
Table 4.15: Nanotechnology Application Areas for Medical Nanomaterials 67
Table 4.16: FDA-Approved Dental Biomaterials Developed with Nanotechnology-Based
Formulations 68
Table 4.17: Drug Discovery Nanotechnology Market Drivers Ranked in Order of
Impact 68
Table 4.18: Drug Discovery Nanotechnology Market Restraints Ranked in Order of
Impact 68
Table 4.19: Examples of Proposed U.S. NNI Interagency Collaborative Activities
70
Table 5.1: Medical Nanotechnology Market Drivers-Global, 2008 to 2016 75
Table 5.2: Medical Nanotechnology Market Restraints-Global, 2008 to 2016 75
Table 5.3: U.S. Nanotechnology Patents Issued per Year, 1996 to 2006 78
Table 5.4: Sources of Nanotechnology Funds 79
Table 5.5: National Government Funding Leaders for Nanotechnology, 2007 79
Table 5.6: Total Investments in Venture-Backed Nanotechnology Companies, 1997 to
2008 81
Table 5.7: Leading Nanotechnology Start-Up Companies 81
Table 6.1: Summary of Key Advantages for Nanotechnology 96
Table 6.2: Nanotechnology Platforms Used for Diagnostics and Imaging 96
Table 6.3: FDA-Approved In Vitro Diagnostics Developed with Nanotechnology-Based
Formulations 97
Table 6.4: Applications of Veridex Nanotechnology Platform for Diagnostic Assays
98
Table 6.5: Characteristics of Gold Nano-Particle Technology for Diagnostic
Testing 100
Table 6.6: Overview of Future Nanomedical Technology Development 101
Table 6.7: Recent Developments in Nanotechnology for Drug Delivery and Drug
Discovery 101
Table 6.8: Recent Developments in Nanomaterials and Nanotechnology-Based Devices
102
Table 6.9: Recent Nanotechnology Applications in Diagnostics 102
Table 6.10: Future Nanomedical Technology Platforms 102
Table 6.11: Additional Global Market Trends 127
Table 8.1: AMAG Nanotechnology Products and Candidates 149

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