Radiopharmaceuticals: Technologies and Global Markets

Radiopharmaceuticals: Technologies and Global Markets


Use this report to:
- Examine present and future strategies within the radiopharmaceuticals market, which includes radiopharmaceuticals for both diagnostic purposes and therapeutic purposes.
- Learn about the new developments in the market, including barriers and demand.
- Analyze the structure of the radiopharmaceuticals industry.


Highlights
- The global market radiopharmaceuticals were valued at nearly $5.1 billion and $5.7 billion in 2014 and 2015, respectively. This market is expected to increase from nearly $6.5 billion in 2016 to $11.6 billion in 2021 at a compound annual growth rate (CAGR) of 12.4% for 2016-2021.
- North American radiopharmaceuticals market is expected to grow from $3.5 billion in 2016 to $6.1 billion in 2021 at a CAGR of 11.8% from 2016 through 2021.
- European radiopharmaceuticals market is expected to grow from $1.7 billion in 2016 to $3.2 billion at a CAGR of 13.2% from 2016 through 2021.


INTRODUCTION

STUDY OBJECTIVES
Radiopharmaceuticals, also known as radioactive drugs, are used as diagnostic agents and therapeutic agents for various diseases such as cardiac and neurological conditions and to treat several types of cancers. Population growth, increasing life expectancy, population aging and improved diagnostic modalities are key factors in market growth for radiopharmaceuticals. BCC Research’s goal in conducting this study is to provide an overview of the current and expected future characteristics of the global market for radiopharmaceuticals.

This report examines present and future strategies within the radiopharmaceuticals market, which includes radiopharmaceuticals for both diagnostic purposes and therapeutic purposes. Radiopharmaceuticals for diagnostics are further categorized into radiopharmaceuticals used in positron emission tomography (PET), single photon emission computed tomography (SPECT) and other modalities such as two-dimensional scintigraphy and blood tests. Radiopharmaceuticals used for therapeutic purposes are further categorized into alpha emitters, beta emitters and brachytherapy seeds.

This report discusses new developments in the market, including barriers and demand. The classifications and comparisons of radiopharmaceuticals products are also included in this report. A detailed analysis of the structure of the radiopharmaceuticals industry is provided, and revenues are broken down by region. Sales figures are estimated for the five-year period from 2015 to 2021. The report also covers significant patents and their allotments in each category of radiopharmaceuticals.


REASONS FOR DOING THIS STUDY
Radiopharmaceuticals are medicinal formulations that contain radioisotopes. They are composed of a radioisotope and a carrier molecule and are generally molded according to the physiological function of the targeted organ. After administration, the radioisotope emits gamma radiation, which is used for either therapeutic or diagnostic purposes. In recent years, the market for diagnostic radiopharmaceuticals has shown growth due to the increasing incidence of cancer and neurological and cardiac diseases and the development of better imaging techniques for conditions such as Alzheimer's disease. Therapeutic radiopharmaceuticals account for a small proportion of the global radiopharmaceuticals market. However, the market for therapeutic radiop-harmaceuticals is expected to experience strong growth in the coming years due to increased demand.

R&D spending, along with increasing competition, expiration of related patent and new technologies, are giving a new direction to the market. Technology advancements, new product launches and changing lifestyles will influence future market growth. This study discusses how these factors will affect the market. Companies’ acquisition strategies and collaborations are also covered in this report. Further, the report discusses the strengths and weaknesses of each radiopharmaceuticals type in light of new technologies, growing competition and changing customer needs.


CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE
This study contributes information regarding market growth for radiopharmaceutical products, including manufacturers and users. Research centers, hospitals, various clinical settings, academic institutions, physicians, government and private laboratories, and pharmaceutical, diagnostic and biotechnology companies will find this study of interest.


SCOPE OF THE STUDY
This report focuses on the global market for radiopharmaceutical products. Radiopharmaceuticals provide actual mapping of the physiological functions and metabolic activity of organs. They provide highly specific information on organ function and dysfunction. Radiopharmaceuticals can also be used in radiotherapy to destroy dysfunctional cells.

In this report, BCC Research analyzes each global market in terms of applications, regulatory environment, new products and advancements, market projections and market shares. The geographical regions covered in the report are North America and Europe and an emerging markets category. The emerging markets category covers countries that include India, China, Japan, Korea, Taiwan, Africa, Australia, New Zealand and Canada.

This report also includes an analysis of relevant patent and comprehensive profiles of leading companies in the radiopharmaceuticals industry. Some of the major global players in the radiopharmaceuticals industry are Advanced Medical Isotope Corp., Advanced Accelerator Applications SA, Bayer AG (Bayer HealthCare Pharmaceuticals Inc.), Bracco S.p.A. (Bracco Imaging S.p.A.), Cardinal Health Inc., Eli Lilly and Co., Fujifilm RI Pharma Co. Ltd. (Fujifilm Corp.), General Electric Co. (GE Healthcare), Jubilant Life Sciences (Jubilant DraxImage Inc.), Lantheus Holdings Inc. (Lantheus Medical Imaging Inc.), Mallinckrodt PLC, Navidea Biopharmaceuticals Inc., Noridon Inc., Piramal Enterprises Ltd. (Piramal Imaging SA), Siemens AG (Siemens PETNET Solutions Inc.) and Triad Isotopes Inc.


METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search that included technical newsletters, journals and many other sources. Data was collected through interviews and correspondence with manufacturers and users of radiopharmaceutical products. Projections are based on estimates of the current number of end users, potential end users, mergers and acquisitions, and market trends.
INFORMATION SOURCES
Companies, including manufacturers and end users of radiopharmaceutical products, were surveyed to obtain data for this study. Data was gathered from various industry sources. BCC Research spoke with officials within the industry and consulted newsletters, company and product literature, and a host of technical articles, journals, indexes and abstracts. Exhaustive investigations of databases by key terminology were completed, and data were compiled from current financial, trade and government sources.

ANALYSTS’ CREDENTIALS

The study was carried out by a team of professionals in the biotechnology industry. The project manager was Shalini S. Dewan, who holds a master’s degree in pharmaceutical chemistry and has over 14 years of industry experience. She was awarded a Gold Medal by the Prime Minister of India for her work and has worked with top companies in India and the United States. Her other reports for BCC Research include:
- Global Markets for Reagents for Chromatography.
- Global Markets for Spectroscopy Equipment.
- Global Markets and Technologies for Advanced Drug Delivery Systems.
- Orthopedic Drugs, Implants and Devices.
- Global Markets for Medical Imaging Reagents and Analysis Equipment.
- The Pharmaceutical Regulatory Industry.
- Global Markets for Media, Sera and Reagents in Biotechnology.
- Global Markets for Contract Pharmaceutical Manufacturing, Research and Packaging.
- Global Markets for Chiral Technology.
- Autacoids and Related Drugs: Technologies and Global Markets.
- Contraceptives: Technologies and Global Markets.
- Liver Disease Treatments: The Global Market.
- Hormone Replacement Therapies and Other Hormone Therapies:
- Global Markets.
- Cardiovascular Medicine: Diagnostics, Drugs and Devices.
- Cancer Therapies: Technologies and Global Markets.
- Medical Imaging Reagents and Analysis Equipment.
The lead consultant for this project was Ms. Shalini Agarwal, who holds a master’s degree in business administration and a bachelor’s degree in science. She has authored many reports and other publications for various companies while serving as a market research analyst.
CHAPTER 1
INTRODUCTION 2
STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE 3
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 4
ANALYSTS' CREDENTIALS 4
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 5
DISCLAIMER 5
CHAPTER 2 EXECUTIVE SUMMARY 7
SUMMARY TABLE GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 8
SUMMARY FIGURE GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 8
CHAPTER 3 OVERVIEW 11
USES OF RADIOPHARMACEUTICALS 11
DIAGNOSTIC IMAGING 11
IN VIVO FUNCTION 11
IN VITRO STUDIES 12
THERAPEUTIC APPLICATIONS 12
DEFINITIONS 12
NUCLIDE 12
ISOTOPE 12
RADIATION 12
RADIOACTIVITY 12
ALPHA PARTICLES 13
BETA PARTICLES 13
GAMMA RAY 13
RADIOACTIVE DECAY 13
ISOMERIC TRANSITION 14
RADIOISOTOPE 14
RADIOPHARMACEUTICAL PRECURSOR 14
SPECIFIC ACTIVITY 15
LINEAR ENERGY TRANSFER 15
NEGATRON 15
POSITRON 15
TRANSMUTATION 15
HALF-LIFE 15
NUCLEAR MEDICINE 16
RADIOPHARMACY 16
PHARMACOKINETICS 16
MYELOSUPPRESSION 16
CRITICAL ORGAN 16
HISTORY AND BACKGROUND 16
TABLE 1 MILESTONES OF THE DISCOVERY OF RADIOACTIVITY AND NUCLEAR MEDICINE 17
ORIGIN OF RADIONUCLIDES 19
TYPES OF RADIONUCLIDES 20
Primordial Radionuclides 20
Secondary Radionuclides 20
Cosmogenic Radionuclides 20
METHODS OF PRODUCING RADIONUCLIDES 20
Nuclear Fission 20
Charged-particle Bombardment 21
Neutron Activation 21
Radionuclide Generator Systems 21
RADIONUCLIDES BY PRODUCTION TYPE 21
Particle Accelerator-Produced Radionuclides 21
Linear Particle Accelerators 22
Circular Particle Accelerators 22
TABLE 2 COMMON CYCLOTRON-PRODUCED RADIONUCLIDES/RADIOISOTOPES 22
Nuclear Reactor-Produced Radionuclides 24
TABLE 3 COMMON NUCLEAR REACTOR-PRODUCED RADIONUCLIDES/RADIOISOTOPES 24
RADIONUCLIDE GENERATORS 27
TABLE 4 COMMON RADIONUCLIDE PAIRS IN RADIONUCLIDE GENERATORS 27
COMMONLY USED RADIONUCLIDES IN MEDICINE 28
TECHNETIUM-99M 28
IODINE-123 29
IODINE-131 29
FLUORINE-18 29
INDIUM-111 29
THALLIUM-201 30
GALLIUM-67 30
PREPARATION OF RADIOPHARMACEUTICALS 30
RADIOPHARMACEUTICAL PREPARATION KITS 31
APPLICATIONS OF RADIOPHARMACEUTICALS 31
DIAGNOSTIC RADIOPHARMACEUTICALS 31
TABLE 5 COMMON ISOTOPES USED IN DIAGNOSTIC RADIOPHARMACEUTICAL DEVELOPMENT 32
TABLE 6 SELECTED COMMERCIALLY APPROVED DIAGNOSTIC RADIOPHARMACEUTICALS 32
TYPES OF DIAGNOSTIC RADIOPHARMACEUTICALS 34
PET Radiopharmaceuticals 34
SPECT Radiopharmaceuticals 35
THERAPEUTIC RADIOPHARMACEUTICALS 36
TABLE 7 COMMON ISOTOPSES USED IN THERAPEUTIC RADIOPHARMACEUTICAL DEVELOPMENT 36
Radioimmunotherapy 38
TABLE 8 SELECTED COMMERCIALLY APPROVED THERAPEUTIC RADIOPHARMACEUTICALS 38
Alpha Emitters 39
TAT/Alpha-immunotherapy 39
TABLE 9 ADVANTAGES AND DISADVANTAGES OF ALPHA EMITTERS 39
Beta Emitters 40
TABLE 10 ADVANTAGES AND DISADVANTAGES OF BETA EMITTERS 40
Brachytherapy 41
TABLE 11 COMMONLY USED RADIONUCLIDES (RADIATION SOURCES) FOR BRACHYTHERAPY 42
TABLE 12 ADVANTAGES AND DISADVANTAGES OF BRACHYTHERAPY 42
THERANOSTIC AGENTS 43
ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 43
TABLE 13 ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 44
CHAPTER 4 REGULATORY ASPECTS 46
NEW DRUG APPROVALS AND APPLICATIONS 46
INVESTIGATIONAL NEW DRUG 46
NEW DRUG APPLICATION 46
TABLE 14 APPROVALS OF NEW DRUG APPLICATIONS FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014 TO MAY 2016 47
ABBREVIATED NEW DRUG APPLICATION 47
TABLE 15 APPROVALS OF ABBREVIATED NEW DRUG APPLICATIONS FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014 TO MAY 2016 48
APPROVALS FOR RADIONUCLIDE BRACHYTHERAPY SOURCES 50
PREMARKET APPROVAL 51
PREMARKET NOTIFICATION 510(K) 51
TABLE 16 510K APPROVALS FOR RADIONUCLIDE BRACHYTHERAPY SOURCES, JANUARY 2014-MAY 2016 51
SAFETY ALERTS 53
TABLE 17 SAFETY ALERTS ISSUED FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014-MAY 2016 53
ADVERSE EVENT REPORTING 54
TABLE 18 ADVERSE EVENT REPORTING FOR RADIONUCLIDE BRACHYTHERAPY SOURCES, FROM JANUARY 2014-MAY 2016 55
DRUG SHORTAGES 56
TABLE 19 RADIOPHARMACEUTICAL SHORTAGES, THROUGH MAY 2016 57
CHAPTER 5 NEW DEVELOPMENTS 59
PIPELINE PRODUCTS 60
TABLE 20 CLINICAL TRIALS FOR RADIOPHARMACEUTICALS, THROUGH MAY 2016 60
OTHER SIGNIFICANT NEW DEVELOPMENTS IN RADIOPHARMACEUTICALS 66
GALLIUM-68 PET/CT SCANS 66
CHAPTER 6 MARKET ANALYSIS 71
MARKET BY RADIOPHARMACEUTICAL TYPE 72
MARKET OVERVIEW 73
MARKET REVENUE 77
TABLE 21 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY TYPE, THROUGH 2021 ($ MILLIONS) 78
FIGURE 1 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY TYPE, 2014-2021 ($ MILLIONS) 78
MARKET SHARES 78
TABLE 22 GLOBAL MARKET SHARES OF RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 79
FIGURE 2 GLOBAL MARKET SHARES OF RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 79
DIAGNOSTIC RADIOPHARMACEUTICALS 79
Diagnostic Radiopharmaceuticals Market by Type of Diagnostic Test 79
Market Overview 80
Market Revenue 83
TABLE 23 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, THROUGH 2021 ($ MILLIONS) 84
FIGURE 3 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2014-2021 ($ MILLIONS) 84
PET Radiopharmaceuticals 84
PET Radiopharmaceuticals Market by Region 86
Revenue of PET Radiopharmaceuticals Market by Region 87
TABLE 24 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 88
FIGURE 4 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 88
PET Radiopharmaceuticals Market by Type of Radionuclide 89
Revenue for PET Radiopharmaceuticals Market by Type of Radionuclide 91
TABLE 25 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 91
FIGURE 5 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 92
SPECT Radiopharmaceuticals 92
SPECT Radiopharmaceuticals Market by Region 93
Revenue of SPECT Radiopharmaceuticals Market by Region 95
TABLE 26 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 96
FIGURE 6 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 96
SPECT Radiopharmaceuticals Market by Type of Radionuclide 96
Revenue of SPECT Radiopharmaceuticals Market by Type of Radionuclide 99
TABLE 27 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 99
FIGURE 7 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 99
Other Diagnostic Radiopharmaceuticals 100
Other Diagnostic Radiopharmaceuticals Market by Region 100
Revenue of Other Diagnostic Radiopharmaceuticals
Market by Region 101
TABLE 28 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 102
FIGURE 8 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 102
Other Diagnostic Radiopharmaceuticals Market by Type of Radionuclide 102
Revenue of Other Diagnostic Radiopharmaceuticals Market by Type of Radionuclide 103
TABLE 29 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 104
FIGURE 9 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 104
Market Share of Diagnostics Radiopharmaceutical by Type 104
TABLE 30 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2015 (%) 105
FIGURE 10 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2015 (%) 105
THERAPEUTIC RADIOPHARMACEUTICALS 105
Therapeutic Radiopharmaceuticals by Type 106
Market Overview 107
Market Revenue 109
TABLE 31 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, THROUGH 2021 ($ MILLIONS) 110
FIGURE 11 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2014-2021 ($ MILLIONS) 110
Alpha Emitters 110
Alpha Emitters Market by Region 111
Revenue of Alpha Emitters Market by Region 112
TABLE 32 GLOBAL MARKET FOR ALPHA EMITTERS, BY REGION, THROUGH 2021 ($ MILLIONS) 113
FIGURE 12 GLOBAL MARKET FOR ALPHA EMITTERS, BY REGION, 2014-2021 ($ MILLIONS) 113
Alpha Emitters Market by Type of Radionuclide 113
Revenue of Alpha Emitters Market by Type of Radionuclide 115
TABLE 33 GLOBAL MARKET FOR ALPHA EMITTERS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 116
FIGURE 13 GLOBAL MARKET FOR ALPHA EMITTERS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 116
Beta Emitters 116
Beta Emitters Market by Region 117
Revenue of Beta Emitters Market by Region 119
TABLE 34 GLOBAL MARKET FOR BETA EMITTERS, BY REGION, THROUGH 2021 ($ MILLIONS) 120
FIGURE 14 GLOBAL MARKET FOR BETA EMITTERS, BY REGION, 2014-2021 ($ MILLIONS) 120
Beta Emitters Market by Type of Radionuclide 120
Revenue of Beta Emitters Market by Type of Radionuclide 122
TABLE 35 GLOBAL MARKET FOR BETA EMITTERS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 123
FIGURE 15 GLOBAL MARKET FOR BETA EMITTERS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 123
Brachytherapy Seeds 123
LDR Brachytherapy Seeds Market by Region 124
Revenue of LDR Brachytherapy Seeds Market by Region 125
TABLE 36 GLOBAL MARKET FOR LDR BRACHYTHERAPY SEEDS, BY REGION, THROUGH 2021 ($ MILLIONS) 125
FIGURE 16 GLOBAL MARKET FOR LDR BRACHYTHERAPY SEEDS, BY REGION, 2014-2021 ($ MILLIONS) 126
Brachytherapy Seeds Market by Type of Radionuclide 126
Revenue of Brachytherapy Seeds Market by Type of Radionuclide 127
TABLE 37 GLOBAL MARKET FOR BRACHYTHERAPY SEEDS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 127
FIGURE 17 GLOBAL MARKET FOR BRACHYTHERAPY SEEDS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 128
Market Shares of Therapeutic Radiopharmaceuticals by Type 128
TABLE 38 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 128
FIGURE 18 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 128
DIAGNOSTIC RADIOPHARMACEUTICALS MARKET BY REGION 129
MARKET OVERVIEW 129
MARKET REVENUE 130
TABLE 39 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 131
FIGURE 19 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 131
MARKET SHARES 132
TABLE 40 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 132
FIGURE 20 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 132
THERAPEUTIC RADIOPHARMACEUTICALS MARKET BY REGION 132
MARKET OVERVIEW 133
MARKET REVENUE 134
TABLE 41 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 135
FIGURE 21 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 135
MARKET SHARES 136
TABLE 42 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 136
FIGURE 22 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 136
RADIOPHARMACEUTICALS MARKET BY PRODUCTION METHOD 136
PARTICLE ACCELERATORS (CYCLOTRONS) 137
NUCLEAR REACTORS 137
RADIONUCLIDE GENERATORS 137
MARKET OVERVIEW 138
MARKET REVENUE 139
TABLE 43 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, THROUGH 2021 ($ MILLIONS) 140
FIGURE 23 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2014-2021 ($ MILLIONS) 140
MARKET SHARES 140
TABLE 44 MARKET SHARES OF RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2015 (%) 141
FIGURE 24 MARKET SHARES OF RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2015 (%) 141
CHAPTER 7 INDUSTRY STRUCTURE 143
DIAGNOSTIC RADIOPHARMACEUTICALS 143
PET RADIOPHARMACEUTICALS 143
Market Leaders 143
TABLE 45 LEADING MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 143
Market Shares 144
TABLE 46 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 (%) 145
FIGURE 25 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 (%) 145
SPECT RADIOPHARMACEUTICALS 146
Market Leaders 146
TABLE 47 LEADING MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 146
Market Shares 148
TABLE 48 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 (%) 148
FIGURE 26 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 (%) 148
OTHER DIAGNOSTIC RADIOPHARMACEUTICALS 149
Market Leaders 149
TABLE 49 LEADING MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 149
Market Shares 150
TABLE 50 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 (%) 150
FIGURE 27 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 (%) 150
THERAPEUTIC RADIOPHARMACEUTICALS 151
MARKET LEADERS 151
TABLE 51 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC RADIOPHARMACEUTICALS, 2015 151
MARKET SHARES 152
TABLE 52 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC RADIOPHARMACEUTICALS, 2015 (%) 152
CHAPTER 8 PATENT ANALYSIS 155
PATENTS BY YEAR 155
TABLE 53 NUMBER OF SIGNIFICANT PATENTS FOR RADIOPHARMACEUTICALS/ RADIONUCLIDES, JANUARY 2014-MAY 2016 156
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS FOR RADIOPHARMACAUTICALS/ RADIONUCLIDES, FROM JANUARY 2014-MAY 2016 156
PATENTS BY TYPE OF RADIONUCLIDE 156
TABLE 54 PATENTS BY TYPE OF RADIONUCLIDE, JANUARY 2014-MAY 2016 157
FIGURE 30 PATENTS BY TYPE OF RADIONUCLIDE, JANUARY 2014-MAY 2016 157
PATENTS BY COMPANY 157
TABLE 55 NUMBER OF PATENTS BY COMPANY, JANUARY 2014-MAY 2016 158
PATENTS BY COUNTRY 158
TABLE 56 NUMBER OF PATENTS BY COUNTRY, JANUARY 2014-MAY 2016 159
FIGURE 31 NUMBER OF PATENTS BY COUNTRY, JANUARY 2014-MAY 2016 159
TABLE 57 PATENT SHARES BY COUNTRY, JANUARY 2014-MAY 2016 (%) 160
FIGURE 32 PATENT SHARES BY COUNTRY, JANUARY 2014-MAY 2016 (%) 160
PATENTS BY ASSIGNEE TYPE 161
TABLE 58 NUMBER OF PATENTS BY ASSIGNEE TYPE, JANUARY 2014 -MAY 2016 161
FIGURE 33 NUMBER OF PATENTS BY ASSIGNEE TYPE, JANUARY 2014-MAY 2016 161
CHAPTER 9 CURRENT SITUATION 163
FACTORS AFFECTING THE RADIOPHARMACEUTICALS MARKET 163
DRIVERS OF THE RADIOPHARMACEUTICALS MARKET 163
Aging Population 163
Increasing Incidence of Life-threatening Diseases 163
Growing Focus on Early Diagnosis and Treatment 164
Launch of New Radiopharmaceuticals and Widening Applications 164
Growing Healthcare Spending in Emerging Regions 164
Increasing Number of Cyclotrons 164
Increasing Amount of Nuclear Imaging Equipment 165
Technological Advancements 165
RESTRAINTS AND CHALLENGES OF THE MARKET 165
Limited Global Supply of Medical Isotopes 165
Reimbursement Policies 165
Healthcare Reforms and Budgetary Constraints in Developed Countries 166
Regulatory Issues 167
COLLABORATIONS, MERGERS AND ACQUISITIONS 167
CHAPTER 10 COMPANY PROFILES 171
ACTINIUM PHARMACEUTICALS INC. 171
ADVANCED ACCELERATOR APPLICATIONS SA 171
ADVANCED MEDICAL ISOTOPE CORP. 173
ALLIANCE MEDICAL GROUP 173
ALSERES PHARMACEUTICALS INC. 174
AUSTRALIAN NUCLEAR ASSOCIATION AND TECHNOLOGY ORGANIZATION 175
AYTU BIOSCIENCE INC. 175
BARD MEDICAL 176
BAYER PHARMA AG 176
BLUE EARTH DIAGNOSTICS LTD. 177
BOARD OF RADIATION AND ISOTOPE TECHNOLOGY 178
BRACCO DIAGNOSTIC INC. 178
BTG INTERNATIONAL LTD. 179
CARDINAL HEALTH INC. 180
ELI LILLY AND COMPANY 181
FUJIFILM RI PHARMA CO. LTD. 182
GE HEALTHCARE 183
IBA MOLECULAR 184
ISORAY MEDICAL INC. 185
ISO-TEX DIAGNOSTICS INC. 185
JUBILANT DRAXIMAGE INC. 185
LANTHEUS MEDICAL IMAGING INC. 186
MALLINCKRODT PLC 187
NATIONAL CENTRE FOR NUCLEAR RESEARCH POLATOM 188
NATIONAL INSTITUTE FOR RADIOELEMENTS (IRE) 189
NAVIDEA BIOPHARMACEUTICALS INC. 189
NORDION INC. 190
NTP RADIOISOTOPES SOC LTD 191
PHARMALUCENCE INC. 191
PIRAMAL IMAGING SA 192
SIEMENS HEALTHCARE GMBH 193
SPECTRUM PHARMACEUTICALS INC. 194
TRIAD ISOTOPES INC. 195
ZEVACOR MOLECULAR 195
CHAPTER 11 ABBREVIATIONS 198
TABLE 59 ABBREVIATIONS 198


LIST OF TABLES

SUMMARY TABLE GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 8
TABLE 1 MILESTONES OF THE DISCOVERY OF RADIOACTIVITY AND NUCLEAR MEDICINE 17
TABLE 2 COMMON CYCLOTRON-PRODUCED RADIONUCLIDES/RADIOISOTOPES 22
TABLE 3 COMMON NUCLEAR REACTOR-PRODUCED RADIONUCLIDES/RADIOISOTOPES 24
TABLE 4 COMMON RADIONUCLIDE PAIRS IN RADIONUCLIDE GENERATORS 27
TABLE 5 COMMON ISOTOPES USED IN DIAGNOSTIC RADIOPHARMACEUTICAL DEVELOPMENT 32
TABLE 6 SELECTED COMMERCIALLY APPROVED DIAGNOSTIC RADIOPHARMACEUTICALS 32
TABLE 7 COMMON ISOTOPSES USED IN THERAPEUTIC RADIOPHARMACEUTICAL DEVELOPMENT 36
TABLE 8 SELECTED COMMERCIALLY APPROVED THERAPEUTIC RADIOPHARMACEUTICALS 38
TABLE 9 ADVANTAGES AND DISADVANTAGES OF ALPHA EMITTERS 39
TABLE 10 ADVANTAGES AND DISADVANTAGES OF BETA EMITTERS 40
TABLE 11 COMMONLY USED RADIONUCLIDES (RADIATION SOURCES) FOR BRACHYTHERAPY 42
TABLE 12 ADVANTAGES AND DISADVANTAGES OF BRACHYTHERAPY 42
TABLE 13 ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 44
TABLE 14 APPROVALS OF NEW DRUG APPLICATIONS FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014 TO MAY 2016 47
TABLE 15 APPROVALS OF ABBREVIATED NEW DRUG APPLICATIONS FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014 TO MAY 2016 48
TABLE 16 510K APPROVALS FOR RADIONUCLIDE BRACHYTHERAPY SOURCES, JANUARY 2014-MAY 2016 51
TABLE 17 SAFETY ALERTS ISSUED FOR RADIOPHARMACEUTICALS, FROM JANUARY 2014-MAY 2016 53
TABLE 18 ADVERSE EVENT REPORTING FOR RADIONUCLIDE BRACHYTHERAPY SOURCES, FROM JANUARY 2014-MAY 2016 55
TABLE 19 RADIOPHARMACEUTICAL SHORTAGES, THROUGH MAY 2016 57
TABLE 20 CLINICAL TRIALS FOR RADIOPHARMACEUTICALS, THROUGH MAY 2016 60
TABLE 21 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY TYPE, THROUGH 2021 ($ MILLIONS) 78
TABLE 22 GLOBAL MARKET SHARES OF RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 79
TABLE 23 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, THROUGH 2021 ($ MILLIONS) 84
TABLE 24 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 88
TABLE 25 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 91
TABLE 26 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 96
TABLE 27 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 99
TABLE 28 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 102
TABLE 29 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 104
TABLE 30 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2015 (%) 105
TABLE 31 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, THROUGH 2021 ($ MILLIONS) 110
TABLE 32 GLOBAL MARKET FOR ALPHA EMITTERS, BY REGION, THROUGH 2021 ($ MILLIONS) 113
TABLE 33 GLOBAL MARKET FOR ALPHA EMITTERS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 116
TABLE 34 GLOBAL MARKET FOR BETA EMITTERS, BY REGION, THROUGH 2021 ($ MILLIONS) 120
TABLE 35 GLOBAL MARKET FOR BETA EMITTERS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 123
TABLE 36 GLOBAL MARKET FOR LDR BRACHYTHERAPY SEEDS, BY REGION, THROUGH 2021 ($ MILLIONS) 125
TABLE 37 GLOBAL MARKET FOR BRACHYTHERAPY SEEDS, BY TYPE OF RADIONUCLIDE, THROUGH 2021 ($ MILLIONS) 127
TABLE 38 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 128
TABLE 39 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 131
TABLE 40 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 132
TABLE 41 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, THROUGH 2021 ($ MILLIONS) 135
TABLE 42 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 136
TABLE 43 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, THROUGH 2021 ($ MILLIONS) 140
TABLE 44 MARKET SHARES OF RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2015 (%) 141
TABLE 45 LEADING MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 143
TABLE 46 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 (%) 145
TABLE 47 LEADING MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 146
TABLE 48 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 (%) 148
TABLE 49 LEADING MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 149
TABLE 50 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 (%) 150
TABLE 51 LEADING MANUFACTURERS/SUPPLIERS OF THERAPEUTIC RADIOPHARMACEUTICALS, 2015 151
TABLE 52 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC RADIOPHARMACEUTICALS, 2015 (%) 152
TABLE 53 NUMBER OF SIGNIFICANT PATENTS FOR RADIOPHARMACEUTICALS/ RADIONUCLIDES, JANUARY 2014-MAY 2016 156
TABLE 54 PATENTS BY TYPE OF RADIONUCLIDE, JANUARY 2014-MAY 2016 157
TABLE 55 NUMBER OF PATENTS BY COMPANY, JANUARY 2014-MAY 2016 158
TABLE 56 NUMBER OF PATENTS BY COUNTRY, JANUARY 2014-MAY 2016 159
TABLE 57 PATENT SHARES BY COUNTRY, JANUARY 2014-MAY 2016 (%) 160
TABLE 58 NUMBER OF PATENTS BY ASSIGNEE TYPE, JANUARY 2014 -MAY 2016 161
TABLE 59 ABBREVIATIONS 198


LIST OF FIGURES

SUMMARY FIGURE GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 8
FIGURE 1 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY TYPE, 2014-2021 ($ MILLIONS) 78
FIGURE 2 GLOBAL MARKET SHARES OF RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 79
FIGURE 3 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2014-2021 ($ MILLIONS) 84
FIGURE 4 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 88
FIGURE 5 GLOBAL MARKET FOR PET RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 92
FIGURE 6 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 96
FIGURE 7 GLOBAL MARKET FOR SPECT RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 99
FIGURE 8 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 102
FIGURE 9 GLOBAL MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 104
FIGURE 10 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY TYPE OF DIAGNOSTIC TEST, 2015 (%) 105
FIGURE 11 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2014-2021 ($ MILLIONS) 110
FIGURE 12 GLOBAL MARKET FOR ALPHA EMITTERS, BY REGION, 2014-2021 ($ MILLIONS) 113
FIGURE 13 GLOBAL MARKET FOR ALPHA EMITTERS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 116
FIGURE 14 GLOBAL MARKET FOR BETA EMITTERS, BY REGION, 2014-2021 ($ MILLIONS) 120
FIGURE 15 GLOBAL MARKET FOR BETA EMITTERS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 123
FIGURE 16 GLOBAL MARKET FOR LDR BRACHYTHERAPY SEEDS, BY REGION, 2014-2021 ($ MILLIONS) 126
FIGURE 17 GLOBAL MARKET FOR BRACHYTHERAPY SEEDS, BY TYPE OF RADIONUCLIDE, 2014-2021 ($ MILLIONS) 128
FIGURE 18 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY TYPE, 2015 (%) 128
FIGURE 19 GLOBAL MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 131
FIGURE 20 MARKET SHARES OF DIAGNOSTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 132
FIGURE 21 GLOBAL MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2014-2021 ($ MILLIONS) 135
FIGURE 22 MARKET SHARES OF THERAPEUTIC RADIOPHARMACEUTICALS, BY REGION, 2015 (%) 136
FIGURE 23 GLOBAL MARKET FOR RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2014-2021 ($ MILLIONS) 140
FIGURE 24 MARKET SHARES OF RADIOPHARMACEUTICALS, BY PRODUCTION METHOD, 2015 (%) 141
FIGURE 25 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS, 2015 (%) 145
FIGURE 26 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT RADIOPHARMACEUTICALS, 2015 (%) 148
FIGURE 27 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC RADIOPHARMACEUTICALS, 2015 (%) 150
FIGURE 28 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC RADIOPHARMACEUTICALS, 2015 (%) 153
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS FOR RADIOPHARMACAUTICALS/ RADIONUCLIDES, FROM JANUARY 2014-MAY 2016 156
FIGURE 30 PATENTS BY TYPE OF RADIONUCLIDE, JANUARY 2014-MAY 2016 157
FIGURE 31 NUMBER OF PATENTS BY COUNTRY, JANUARY 2014-MAY 2016 159
FIGURE 32 PATENT SHARES BY COUNTRY, JANUARY 2014-MAY 2016 (%) 160
FIGURE 33 NUMBER OF PATENTS BY ASSIGNEE TYPE, JANUARY 2014-MAY 2016 161