Nanomaterials in Theranostics: Global Markets

  • July 2013
  • -
  • BCC Research
  • -
  • 170 pages



STUDY GOALS AND OBJECTIVES

This study provides a comprehensive analysis of the nanomaterial market for use in theranostics and personalized medicine. Theranostics is the fusion of therapy and diagnosis; it is the foundation of personalized medicine, which is a newly proposed model of highly customized healthcare. This study describes this model in detail and analyzes a large selection of nanomaterials that play various roles in the market, including proteins, monoclonal antibodies, nanoparticles, nanocrystals, liposomes and quantum dots.This market is increasing exponentially in size and revenues, and it is changing the standards of the healthcare model, thus imposing new marketing tactics, strategic alliances, innovative business models and research and development (R&D) outsourcing paradigms.This report addresses the drivers and limiters of this new model and offers an exhaustive analysis of the nanomaterials used in theranostics.


REASON FOR DOING THE STUDY

Theranostic and personalized medicine will be the ultimate transformation of modern healthcare to diagnose and treat diseases. Nanotechnology will be the toolbox used to execute this new approach to medicine. The report analyzes the market and includes historical sales of all the nanomaterials used in theranostics in 2011 and 2012. Sales are forecast through 2017.This study in an invaluable instrument for understanding the ways in which the pharmaceutical and medical device markets are rapidly changing by forming new paradigms and marketing strategies. The market is characterized by the creation of partnerships, collaborations and mergers and acquisitions (M&A) between pharmaceutical companies, the medical device industries, academics and small startups. Seventeen new emerging geographic markets, including Russia, India, China, Turkey, South Africa and Thailand, are also discussed.


SCOPE OF THE REPORT

Blockbuster and one–size-fits-all drugs are slowly exiting the market to make room for the era of personalized medicine. Theranostics, which is the fusion of therapeutics and diagnostics, is the foundation of personalized medicine in which specific therapies are tailored to patients to treat diseases based on their genetic makeups and/or to determine which therapies will have the fewest side effects. Nanotechnology will play a pivotal role in this revolution, and the global market for nanomaterials used in theranostics will be more than $187 billion in 2017, increasing at a compound annual growth rate (CAGR) of 10.8% Monoclonal antibodies will comprise the largest segment for the biologic nanomaterials, and liposome will be the largest segment for non-biologic nanomaterials. Other nanomaterials discussed in this report include fullerene C60, carbon nanotubes, quantum dots, gold nanoparticles and proteins.Profiles of key market players and small startups are also included. Major products that generate the largest revenues, as well as the most-valuable R&D products that will come on the market up to 2017 are provided.In-depth competitive market analysis is discussed, with examples of how new products will enter the market or how existing products will survive or perish. The report also includes a very detailed description of current and future technologies for the preparation of nanomaterials in theranostics.


INTENDED AUDIENCE

The report is intended for professionals in the medical, medical devices, pharmaceutical, nanotechnology, materials, chemical, biological, biotechnological and diagnostics fields. It allows readers to understand the paradigms of personalized medicine’s new business model. A discussion of the debate between the marketing of a drug with or without its companion diagnostic kit is included. Therefore, this report is valuable for both the pharmaceutical and the medical devices industries.Additional professionals who may benefit from reading this report include analysts, sales and marketing representatives, R&D personnel, business development personnel and corporate strategy developers. Investment firms will gain invaluable information concerning risks and opportunities encountered in the field.The report provides valuable insights and guidance for strategic marketing planning, driver and limiter understanding, and sales growth opportunities.


METHODOLOGY AND INFORMATION SOURCE

A bottom-up approached was used to calculate the global market size of nanomaterials for use in theranostics.Primary and secondary research was conducted using patent literature, paid and open-access academic literature, books, press (e.g., New York Times, Wall Street Journal) SEC filings, companies’ annual reports and press releases.Interviews with experts in the field were conducted, including analysts, heads of investor relations and professors.Additional statistical data and general information were obtained from the National Science Foundation, the National Institutes of Health (NIH), the World Health Organization (WHO), the U.S. Food and Drug Administration (FDA), IMS Health and the Congressional Budget Office.

Table Of Contents

CHAPTER 1 INTRODUCTION 2
STUDY GOALS AND OBJECTIVE 2
REASON FOR DOING THE STUDY 2
SCOPE OF THE REPORT 2
INTENDED AUDIENCE 3
METHODOLOGY AND INFORMATION SOURCE 3
ANALYST CREDENTIALS 4
RELATED REPORTS 4
BCC ON-LINE SERVICES 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
SUMMARY TABLE GLOBAL THERANOSTIC NANOMATERIAL MARKET, THROUGH 2017
($ MILLIONS) 6
SUMMARY FIGURE GLOBAL THERANOSTIC NANOMATERIAL MARKET, 2011-2017 ($
MILLIONS) 6
CHAPTER 3 OVERVIEW 9
THERANOSTICS AND PERSONALIZED MEDICINE OVERVIEW 9
TABLE 1 THERAPIES WITH DIAGNOSTIC COMPANION KITS 10
FIGURE 1 RISK OF CANCER FOR PATIENTS THAT CARRY A SPECIFIC GENETIC
MUTATION VS NON MUTATED (%) 11
NANOPARTICLES 14
PASSIVE TARGETING 15
ACTIVE TARGETING 15
NANOTECHNOLOGY OVERVIEW 16
NANOTECHNOLOGY PRODUCTS ON THE MARKET 17
SIZE DEFINITION 17
SHAPE 17
SURFACE AREA 18
QUANTUM DOTS 18
CARBON NANOTUBES 18
MULTIFUNCTIONAL NANOMATERIALS 18
TABLE 2 NANOMATERIAL TYPES 19
NANOTHERANOSTICS OVERVIEW 20
TABLE 3 MAJOR PLAYERS IN THE NANOPARTICLE DRUG FIELD 21
TABLE 4 NANOPARTICLE DRUG MARKET BY COMPANY, THROUGH 2017 ($
MILLIONS) 21
GOLD-BASED NANOMATERIALS 22
MAGNETIC NANOMATERIALS 22
POLYMERIC NANOMATERIALS 24
SILICA-BASED NANOMATERIALS 24
CARBON NANOMATERIALS 25
COMPOSITE NANOMATERIALS 25
BIOLOGIC NANOMATERIALS: ANTIBODY, PROTEINS AND DNA 25
OTHER NANOMATERIALS 26
DRUG DELIVERY 26
TABLE 5 MAJOR NANOMATERIAL APPLICATIONS IN THERANOSTICS 27
CHAPTER 4 GLOBAL NANOMATERIAL THERANOSTICS MARKET 29
TABLE 6 GLOBAL NANOMATERIAL THERANOSTIC MARKET, THROUGH 2017 ($
MILLIONS) 29
FIGURE 2 TITLE GLOBAL NANOMATERIAL THERANOSTIC MARKET, 2011-2017 ($
MILLIONS) 30
GLOBAL MONOCLONAL ANTIBODIES IN THERANOSTICS MARKET 30
TABLE 7 GLOBAL MONOCLONAL ANTIBODY MARKET, THROUGH 2017 ($ MILLIONS) 30
TABLE 8 GLOBAL PROTEIN MARKET, THROUGH 2017 ($ MILLIONS) 30
GLOBAL REVENUES FROM NANOPARTICLES IN DIAGNOSTICS IMAGING SYSTEMS 31
TABLE 9 GLOBAL DIAGNOSTIC IMAGING AND TESTING NANOPARTICLE MARKET,
THROUGH 2017 ($ MILLIONS) 31
GLOBAL REVENUES FOR DRUG DEVELOPMENT AND FORMULATION 32
TABLE 10 GLOBAL DRUG-DEVELOPMENT AND FORMULATION NANOPARTICLE
MARKET, THROUGH 2017 ($ MILLIONS) 32
GLOBAL MAGNETIC RESONANCE IMAGING REAGENT MARKET 32
TABLE 11 GLOBAL IRON-OXIDE NANOPARTICLES USED AS MAGNETIC RESONANCE
IMAGING CONTRAST AGENTS MARKET, THROUGH 2017 ($ MILLIONS) 32
GLOBAL IN VITRO OPTICAL IMAGING REAGENT MARKET 33
TABLE 12 GLOBAL NANOMATERIALS USED AS IN VITRO OPTICAL IMAGING
REAGENTS MARKET, THROUGH 2017 ($ MILLIONS) 33
GLOBAL GOLD-BASED MATERIALS USED AS NANOCARRIERS MARKET 33
TABLE 13 GLOBAL GOLD-BASED NANOMATERIALS USED AS CARRIERS MARKET,
THROUGH 2017 ($ MILLIONS) 33
GLOBAL LIPOSOMAL-BASED MATERIALS USED AS NANOCARRIERS MARKET 34
TABLE 14 GLOBAL LIPOSOME-BASED MATERIALS USED AS DRUG CARRIERS
MARKET, THROUGH 2017 ($ MILLIONS) 34
GLOBAL NANOCRYSTAL DRUG MARKET 34
TABLE 15 GLOBAL NANOCRYSTAL DRUG MARKET, THROUGH 2017 ($ MILLIONS) 34
GLOBAL BLOCKBUSTER ANTIBODY DRUG MARKET 35
TABLE 16 GLOBAL MONOCLONAL ANTIBODY BLOCKBUSTER DRUG MARKET,
THROUGH 2017 ($ MILLIONS) 35
CHAPTER 5 NANOTHERANOSTIC DRUG DELIVERY 37
INTRODUCTION 37
IN VIVO DRUG RELEASE STUDIES 38
DRUG EFFICACY 39
FUTURE DIRECTIONS 40
TABLE 17 EXAMPLES OF NANOMATERIALS USED IN THERANOSTICS 40
TABLE 18 IMAGING MODALITIES USED IN THERANOSTIC NANODEVICES 40
CHAPTER 6 NANOMATERIAL STRUCTURES, CHARACTERISTICS AND METHODS OF
PREPARATION 43
CARBON NANOTUBES 43
CARBON NANOTUBES AS CARRIERS OF IMMUNOACTIVE COMPOUNDS,
PROTEINS AND GENETIC MATERIALS 44
CANCER PHOTOTHERMAL THERAPY 45
CARBON NANOTUBES FOR OTHER THERAPEUTIC APPLICATIONS 45
FULLERENE C60 45
C60 TOXICITY 46
UPTAKE AND BIODISTRIBUTION 46
ANTIOXIDANT PROPERTIES 46
ENDOHEDRALS 47
MAGNETIC RESONANCE IMAGING 47
RADIONUCLIDES 48
PHOTODYANIMC THERAPY 48
DNA PHOTOCLEAVAGE 48
CANCER 49
INHIBITION OF ENZYMES, VIRUSES AND BACTERIA 50
DRUG AND GENE DELIVERY 50
PROTEINS 51
ENZYMES 52
TABLE 19 NON-MONOCLONAL ANTIBODY PROTEINS 52
MONOCLONAL ANTIBODIES 53
TABLE 20 MAJOR PLAYERS IN THE MONOCLONAL ANTIBODY MARKET 53
MONOCLONAL ANTIBODY THERAPY 54
TABLE 21 GLOBAL MONOCLONAL ANTIBODY MARKET 54
Mechanisms 55
NANOMATERIALS IN THERANOSTICS 56
TABLE 22 MAJOR PLAYERS IN NANOPARTICLE DRUG DEVELOPMENT 56
TABLE 23 NANOPARTICLE DRUG MARKET BY PRODUCT, THROUGH 2017 57
GOLD NANOPARTICLES 58
GOLD NANOCARRIERS 58
HYPERTHERMIA 59
CONTRAST ENHANCERS 59
RADIOTHERAPY 59
TABLE 24 U.S. FOOD AND DRUG ADMINISTRATION-APPROVED NANOPARTICLE
DRUG-DELIVERY SYSTEMS 60
MAGNETIC NANOPARTICLES 62
HYPERTHERMIA 63
MAGNETIC SEPARATION 64
IMAGING AND DELIVERY 64
BRAIN TUMOR DELIVERY 65
PROSTATE CANCER 65
BLADDER TUMOR 65
LIPOSOMES 66
TABLE 25 LIPOSOME ADVANTAGES 67
LIPOSOME CLASSIFICATION AND PREPARATION 67
Sonication 68
Extrusion 68
Freeze-Thawed Liposomes 68
Solvent Dispersion Method 69
Detergent-Removal Method 70
STEALTH LIPOSOME 70
ANTIBODY-LIPOSOME CONJUGATE 71
Liposome Application in Medicine and Pharmacology 71
Liposomes in Parasitic Diseases and Infections 72
Liposomes in Anti-Cancer Therapies 72
TABLE 26 LIPOSOME-BASED DRUGS 73
TABLE 27 MAJOR PLAYERS IN THE LIPOSOME MARKET 74
NANOCRYSTALS 74
TABLE 28 NANOCRYSTAL PROPERTIES 75
TABLE 29 NANOCRYSTAL DRUG FEATURES 76
NANOCRYSTALS FABRICATION 76
TABLE 29 NANOCRYSTAL DRUG FEATURES 76
Precipitation Methods 76
Milling 77
Homogenization Method 77
TABLE 30 NANOCRYSTAL MANUFACTURING TECHNOLOGIES 77
TABLE 31 NANOCRYSTAL DRUGS CURRENTLY ON THE MARKET 77
QUANTUM DOTS 78
QUANTUM DOTS NANOCARRIER 78
PHOTOPHYSICAL PROPERTIES: DRUG-DELIVERY AND DRUG-RELEASE
SENSING 79
Visualizing Intracellular Uptake In Vitro 80
Nanocarrier Biodistribution In Vivo 81
Short Interfering RNA and DNA delivery 81
MULTIFUNCTIONAL NANOPARTICLES 82
POLYMERIC NANOPARTICLES IN CANCER THERAPY 82
Polymer-Based Imaging Probes for Cancer Imaging 83
QUANTUM DOTS IN CANCER IMAGING AND THERAPY 84
QUANTUM DOTS IN PHOTODYNAMIC THERAPY AND IMAGING 84
MULTIFUNCTIONAL MAGNETIC NANOPARTICLES FOR CANCER IMAGING AND
THERAPY 84
MAGNETIC NANOPARTICLES FOR MAGNETIC RESONANCE IMAGING AND GENE
DELIVERY 85
MULTIFUNCTIONAL MAGNETO-POLYMERIC NANOHYBRIDS FOR CANCER
IMAGING AND THERAPY 85
GOLD NANOMATERIALS FOR PHOTOTHERMAL THERAPY 85
GOLD NANOSHELLS 85
GOLD NANORODS 86
MAGNETIC GOLD NANOSHELLS FOR PHOTOTHERMAL THERAPY AND IMAGING 86
CHAPTER 7 NANODEVICES AND NANOMATERIALS FOR DIAGNOSTICS 88
OVERVIEW 88
MOLECULAR RECOGNITION IN DIAGNOSIS 88
NANOPATTERNED DEVICES 89
PARTICLES 91
Magnetic Nanoparticles 91
Quantum Dots 91
Aptamer-Conjugated Nanoparticles 92
Nanoparticle-Based Bio-Bar Codes 92
Multiplex Dendrimers 92
Surface Enhanced Raman Spectropscopy 93
DIAGNOSTIC AND MEDICAL DEVICE INDUSTRY 93
CONCLUSIONS AND FUTURE TRENDS 93
TABLE 32 KEY PLAYERS IN THE IN VITRO DIAGNOSTIC MARKET 94
TABLE 33 KEY PLAYERS IN THE DIAGNOSTIC IMAGING MARKET 95
CHAPTER 8 NANOMATERIAL-BASED TREATMENTS FOR INFECTIONS ASSOCIATED
WITH MEDICAL DEVICES 97
INFECTIONS ASSOCIATED WITH MEDICAL DEVICES AND THEIR TREATMENTS 97
CATHETER-ASSOCIATED INFECTIONS 97
SOFT-TISSUE-IMPLANT-ASSOCIATED INFECTIONS 97
BIOFILM FORMATION 97
COMMON METHODS FOR PREVENTING AND TREATING MEDICAL
DEVICE-ASSOCIATED INFECTIONS 98
NANOMATERIALS IN MEDICAL APPLICATIONS 98
Antimicrobial Nanomaterials 98
Silver Nanoparticles 98
Zinc Oxide 99
Iron and Iron-Oxide Nanoparticles 99
Titanium Oxide 99
Carbon Nanotubes and Fullerenes 100
Chitosans 100
CYTOTOXICITY CONSIDERATION 101
CHAPTER 9 THERANOSTIC REGULATORY FRAMEWORKS 103
OVERVIEW 103
NANOPRODUCT PHYSICOCHEMICAL PROPERTY DIFFERENCES COMPARED
TO THEIR LARGER COUNTERPARTS 104
REGULATORY ISSUES IN NANOTECHNOLOGY 105
CHAPTER 10 COMPETITIVE ANALYSIS 108
INTRODUCTION 108
CONTRACT MANUFACTURING ORGANIZATIONS 109
INFORMATION TECHNOLOGY 109
ONCOLOGY 110
TABLE 34 GLOBAL BLOCKBUSTER MONOCLONAL ANTIBODIES IN THE ONCOLOGY
MARKET, THROUGH 2017 ($ MILLIONS) 111
TABLE 35 BLOCKBUSTER MONOCLONAL ANTIBODY PATENT EXPIRATION 111
BIOSIMILARS VERSUS GENERICS 111
Biosimilar: Competition and Improvement 113
ANTIRHEUMATICS MARKET 114
TABLE 36 BLOCKBUSTER MONOCLONAL ANTIBODIES FOR THE ANTIRHEUMATIC
MARKET, THROUGH 2017 114
EMERGING MARKETS 115
TABLE 37 KEY PLAYERS IN THE GENERIC MARKET 116
TABLE 38 COMPANY EVENTS IMPACTING THE THERANOSTIC MARKET 116
CHAPTER 11 COMPANY PIPELINES 132
TABLE 39 PROTEIN DRUGS 132
TABLE 40 NANOPARTICLES DRUGS 133
CHAPTER 12 THERAPY AND DIAGNOSTICS COMPANION KITS 135
CHAPTER 13 PATENT STATUS 139
TABLE 41 PATENTS BY TECHNOLOGY, 2001-2012 139
TABLE 42 QUANTUM DOT PATENT ASSIGNMENTS BY COMPANY 139
TABLE 43 GOLD NANOPARTICLE PATENT ASSIGNMENTS BY COMPANY 139
CHAPTER 14 DRIVERS AND LIMITERS 141
DRIVERS 141
TABLE 44 THERANOSTIC MARKET DRIVERS 141
LIMITERS 144
TABLE 45 THERANOSTIC MARKET LIMITERS 144
CHAPTER 15 COMPANY PROFILES 146
AFFYMETRIX 146
A.P. PHARMA INC. 146
ABRAXIS BIOSCIENCES INC. 146
PRODUCTS 147
ACUSPHERE INC. 147
PRODUCTS 147
STRATEGY 147
ACCUTHERANOSTICS 147
ADVANCED PROTEOME THERAPEUTICS INC. 148
ADVANCED RESEARCH TECHNOLOGIES INC. 148
PRODUCTS 149
STRATEGY 149
AFFIBODY AB 149
PRODUCTS 149
STRATEGY 149
AGENIX LTD. 149
PRODUCTS 150
STRATEGY 150
ALNYLAM PHARMACEUTICALS INC. 150
PRODUCTS 150
STRATEGY 150
ALSERES PHARMACEUTICALS INC. 150
PRODUCTS 151
STRATEGY 151
AMAG PHARMACEUTICALS INC. 151
PRODUCTS 152
STRATEGY 152
AMBRY GENETICS 152
APHIOS CORPORATION 152
PRODUCTS 153
STRATEGY 153



ALACRIS THERANOSTICS GMBH 153
ALZA CORP. 153
ARROWHEAD RESEARCH CORPORATION 154
PRIMARY OPPORTUNITIES 154
Improving Active Pharmaceutical Ingredients 154
Patient Population Enrichment Strategies 154
Improving Generics 155
LEAD PRODUCTS 155
PLATFORM TECHNOLOGIES 155
ASKLEPIOS BIOPHARMACEUTICAL INC. 155
PRODUCTS 156
STRATEGY 156
ASTELLA PAHRMA INC. 156
PRODUCTS 156
STRATEGY 156
ASTRAZENECA PHARMACEUTICALS PLC 157
PRODUCTS 157
STRATEGY 157
ATREUS PHARMACEUTICALS CORPORATION 157
PRODUCTS 157
STRATEGY 157
AXXAM SPA 158
BAYER HEALTHCARE AG 158
PRODUCTS 158
STRATEGY 158
BECKMAN COULTER 158
BIOMERIEUX 159
BIONKIT LTD. 160
BBI INTERNATIONAL 160
BIND BIOSCIENCES INC. 160
PRODUCTS 160
STRATEGY 161
BIOPAL 161
CERULEAN PHARMA INC. 161
PRODUCTS 161
STRATEGY 161
CYTIMMUNE 162
DEBIOTECH, S.A. 162
PRODUCTS 163
STRATEGY 163
ELAN PHARMACEUTICALS INC. 163
PRODUCTS 163
STRATEGY 163
EISAI 164
EPIGENOMICS AG 165
FLAMEL TECHNOLOGIES INC. 165
PRODUCTS 165



STRATEGY 166
FUJIFILM KYOWA KIRIN CO LTD. 166
GENOMIC HEALTH 166
GILEAD 166
GE GLOBAL RESEARCH 167
PRODUCTS 167
STRATEGY 167
GSK SMITHKLINE 168
INGEN BIOSCIENCES 168
INNOVA BIOSCIENCES 168
INSIGHT GENOMICS 168
IPSEN 169
IZON 169
JANSSEN BIOTECH INC. 169
JOHNSON and JOHNSON 170
LAB 21 170
LIQUIDIA TECHNOLOGIES INC. 171
MAGFORCE NANOTECHNOLOGIES AG 171
PRODUCTS 171
STRATEGY 172
MERCK 172
MONOGRAM BIOSCIENCES 172
NANOCS 172
NANOCARRIER CO. LTD. 173
PRODUCTS 173
STRATEGY 173
NANOCOMPOSIX 173
NANOPARTZ INC. 174
NANOPROBES INC. 174
NANOSPHERE INC. 174
PRODUCTS 174
STRATEGY 175
NANOSIGHT LTD. 175
NANOTHERAPEUTICS 175
NEKTAR 176
NOVARTIS INTERNATIONAL AG 176
PRODUCTS 176
STRATEGY 176
OCEAN NANOTECH 177
TECHNOLOGY 177
PACIFIC BIOMARKERS 178
PARTICLE SCIENCES 178
PFIZER 179
PHARNEXT 179
SANOFI 180
SELECTA BIOSCIENCE 180
SOLUBEST 181

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