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Radiopharmaceuticals: Technologies and Global Markets

  • September 2014
  • -
  • BCC Research
  • -
  • 126 pages

This BCC Research report covers present and future strategies within the radiopharmaceuticals market along with the invention of the market, the setbacks and the needs of the market. A detailed analysis of the radiopharmaceuticals industry structure has been conducted. CAGR projections are presented from 2014 through 2019.

Use this report to:
- Learn about the innovations in antibody engineering, recombinant DNA technology, conjugation chemistry and nanotechnology that are providing new approaches to the
delivery of radionuclides to cancer cells.
- Examine the invention of the market, the setbacks and the needs of the radiopharmaceuticals market.
- Gain information on the strengths and weaknesses of each type/technology in light of the new technologies, growing competition and changing customer needs in
radiopharmaceuticals market.

Highlights
- The global market for radiopharmaceuticals in 2012 was about $3.8 billion and $3.9 billion in 2013. The estimated market for the year 2014 is nearly $4.4 billion and this figure is forecast to expand through 2019 at a projected compound annual growth rate (CAGR) of 8%, approaching $6.4 billion.
- The North American market is expected to grow from $2.4 billion in 2014 to about $3.8 billion in 2019 at an estimated CAGR of 9.2% from 2014 to 2019.
- European market is expected to reach about $1.2 billion in 2014 and $1.6 billion by 2019, with a CAGR of 6.8% from 2014 to 2019.

INTRODUCTION

STUDY OBJECTIVES
Radiopharmaceuticals play an important role in the medical, pharmaceutical, diagnostic, biotechnology and life sciences industries. A radiopharmaceutical is a radioactive drug used in diagnostics as well as in the treatment of certain medical problems/diseases. The radiopharmaceuticals market is broadly segmented into two parts, namely, the diagnostic and therapeutic market. North America holds the largest share in the global radiopharmaceuticals market. The objective behind undertaking this study is to provide a synopsis of the current and future characteristics of the global market for radiopharmaceuticals. The notion behind the report is to present a comprehensive analysis of and the future direction for radiopharmaceuticals as an important tool for diagnostics as well as treatment for innumerable diseases.

The report reconnoiters present and future strategies within the radiopharmaceuticals market. The invention of the market, the setbacks and the needs of the market are
discussed in this report. A detailed analysis of the radiopharmaceuticals industry structure has been conducted. Revenues are broken down by the region. Sales figures
are given for 2012 and 2013, estimated for 2014, and projected for 2019.

REASONS FOR DOING THIS STUDY
Radiopharmaceuticals are used extensively in medicine, biotechnology and pharmaceutical research. Over the past few years, a number of techniques have been developed utilizing radiopharmaceuticals for the treatment and diagnosis of aliments. Extensive research in the field of this type of drugs has exposed specific functionality in modern medicine. Newer treatments for various maladies have now begun to explore the advantages of radiopharmaceuticals. This has led to the steady market for them.

R&D spending along with increasing competition, patent expiries and new technologies are directing this market. Advancements and new product launches have influenced
market growth in the near future. This study looks at almost all the systems affected by these factors. Acquisition strategies and collaborations by companies are also covered in this report. This study also discusses the strength and weaknesses of each type/technology in light of the new technologies, growing competition and changing customer needs.

CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE
This study contributes to the areas of market growth in radiopharmaceuticals manufacturers/generators and users. Pharmaceutical biotechnical companies, research
institutes and physicians will find this study to be of interest.

SCOPE OF THE STUDY
The scope of this study encompasses radiopharmaceuticals in pharmaceutical markets. BCC Research analyzes each market and its applications, regulatory environment,
technology, market projections and market shares. The report also covers the brachytherapy seeds. Technological issues include the latest trends and developments. The emerging market for radiopharmaceuticals includes countries like India, China, Japan, Korea, Taiwan, Canada, Africa, Australia and New Zealand.

METHODOLOGY
Both primary and secondary research methodologies were used in preparing this study. BCC Research conducted a comprehensive literature search, which included technical
newsletters and journals and many other sources. Data were collected through interviews and correspondence with manufacturers of radiopharmaceutical technical
experts. Projections were based on estimates such as the current number of end users, potential end users, mergers and acquisitions, and market trends.

Table Of Contents

Radiopharmaceuticals: Technologies and Global Markets
TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2
STUDY OBJECTIVES 2
REASONS FOR DOING THIS STUDY 2
CONTRIBUTIONS OF THE STUDY AND INTENDED AUDIENCE 2
SCOPE OF THE STUDY 3
METHODOLOGY 3
INFORMATION SOURCES 3
ANALYSTS' CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
SUMMARY TABLE GLOBAL REVENUE OF RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 7
SUMMARY FIGURE GLOBAL REVENUE OF RADIOPHARMACEUTICALS BY REGION,
2012-2019 ($ MILLIONS) 7
CHAPTER 3 OVERVIEW 9
TERMINOLOGY 9
RADIOPHARMACEUTICAL 9
RADIONUCLIDE 9
RADIOACTIVITY 9
RADIOACTIVE DECAY 9
NEGATRON 9
POSITRON 9
ELECTRON CAPTURE 10
ISOMERIC TRANSITION 10
TRANSMUTATION 10
HALF-LIFE 10
RADIATION 10
NUCLEAR MEDICINE 10
MYELOSUPPRESSION 10
LINEAR ENERGY TRANSFER (LET) 10
FISSION 10
HISTORICAL BACKGROUND 11
TABLE 1 DISCOVERY OF RADIOACTIVITY AND NUCLEAR MEDICINE 11
ORIGIN OF RADIONUCLIDES 13
PARTICLE ACCELERATOR-PRODUCED RADIONUCLIDES 13
TABLE 2 CYCLOTRON RADIONUCLIDE/RADIOISOTOPES 14
NUCLEAR REACTOR-PRODUCED RADIONUCLIDES 15
TABLE 3 NUCLEAR REACTOR RADIONUCLIDES/RADIOISOTOPES 15
RADIONUCLIDE GENERATORS 16
TABLE 4 RADIONUCLIDE GENERATORS 17
MODES OF DECAY 17
COMMONLY USED RADIONUCLIDES IN MEDICINE 18



TECHNETIUM-99M 18
IODINE-123 18
THALLIUM-201 19
GALLIUM-67 19
APPLICATIONS OF RADIOPHARMACEUTICALS 19
DIAGNOSTIC USE OF RADIOPHARMACEUTICALS 19
TABLE 5 EXAMPLES OF DIAGNOSTIC RADIOPHARMACEUTICALS 20
TYPES OF DIAGNOSTIC RADIOPHARMACEUTICALS 21
PET Radiopharmaceuticals 21
SPECT Radiopharmaceuticals 21
THERAPEUTIC RADIOPHARMACEUTICALS 22
TABLE 6 EXAMPLES OF THERAPEUTIC RADIOPHARMACEUTICALS 23
Alpha Emitters 24
TABLE 7 EXAMPLES OF ALPHA EMITTERS 24
TABLE 8 ADVANTAGES AND DISADVANTAGES OF ALPHA EMITTERS 25
Beta Emitters 25
TABLE 9 ADVANTAGES AND DISADVANTAGES OF BETA EMITTERS 26
Brachytherapy 26
TABLE 10 COMMONLY USED RADIONUCLIDES (RADIATION SOURCES) FOR
BRACHYTHERAPY 26
TABLE 11 ADVANTAGES AND DISADVANTAGES OF BRACHYTHERAPY 27
ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 27
TABLE 12 ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 27
CHAPTER 4 REGULATORY ASPECTS 30
NEW DRUG APPROVALS AND APPLICATIONS 30
TABLE 13 NEW DRUG APPROVALS (FROM 2011- MARCH 2014) 30
NEW DRUG APPLICATIONS 31
TABLE 14 NEW DRUG APPLICATIONS (FROM 2010-MARCH 2014) 31
SAFETY ALERTS 32
TABLE 15 SAFETY ALERTS FOR RADIOPHARMACEUTICALS (FROM 2010-MARCH
2014) 32
ADVERSE EVENT REPORTING 33
TABLE 16 ADVERSE EVENT REPORTING (FROM 2010-MARCH 2014) 33
DRUG SHORTAGE 33
TABLE 17 RESOLVED DRUG SHORTAGE IN 2013 33
510K APPROVALS FOR RADIONUCLIDE BRACHYTHERAPY SOURCE 34
TABLE 18 510K APPROVALS (FROM 2010-MARCH 2014) 34
CHAPTER 5 NEW DEVELOPMENTS 36
PIPELINE PRODUCTS 36
TABLE 19 PIPELINE PRODUCTS IN RADIOPHARMACEUTICALS 36
OTHER SIGNIFICANT NEW DEVELOPMENTS IN RADIOPHARMACEUTICALS 38
CHAPTER 6 MARKET ANALYSIS OF RADIOPHARMACEUTICALS 41
MARKET BY TYPES OF RADIOPHARMACEUTICALS 41
GLOBAL RADIOPHARMACEUTICALS MARKET 42



TABLE 20 MARKET FOR RADIOPHARMACEUTICALS BY CATEGORY, THROUGH 2019
($ MILLIONS) 43
FIGURE 1 MARKET FOR RADIOPHARMACEUTICALS BY CATEGORY, 2012-2019 ($
MILLIONS) 43
Market Share 43
TABLE 21 MARKET SHARE OF RADIOPHARMACEUTICALS BY CATEGORY IN 2013 (%) 44
FIGURE 2 MARKET SHARE OF RADIOPHARMACEUTICALS BY CATEGORY IN 2013 (%) 44
DIAGNOSTIC RADIOPHARMACEUTICALS MARKET BY TYPE OF DIAGNOSTIC
TEST 44
Market Overview 45
Market Revenue 46
TABLE 22 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST, THROUGH 2019 ($ MILLIONS) 47
FIGURE 3 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST, 2012-2019 ($ MILLIONS) 47
PET Radiopharmaceuticals 48
PET Radiopharmaceuticals Market by Region 48
Market Overview 48
Market Revenue 50
TABLE 23 MARKET FOR PET RADIOPHARMACEUTICALS BY REGION, THROUGH 2019
($ MILLIONS) 51
FIGURE 4 MARKET FOR PET RADIOPHARMACEUTICALS BY REGION, THROUGH 2019
($ MILLIONS) 51
PET Radiopharmaceuticals Market by Type of Radionuclide 52
Market Overview 52
Market Revenue 53
TABLE 24 MARKET FOR PET RADIOPHARMACEUTICALS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 53
FIGURE 5 MARKET FOR PET RADIOPHARMACEUTICALS BY TYPE OF RADIONUCLIDE,
2012-2019 ($ MILLIONS) 53
SPECT Radiopharmaceuticals 54
SPECT Radiopharmaceuticals Market by Region 54
Market Overview 55
Market Revenue 55
TABLE 25 MARKET FOR SPECT RADIOPHARMACEUTICALS BY REGION, THROUGH
2019 ($ MILLIONS) 56
FIGURE 6 MARKET FOR SPECT RADIOPHARMACEUTICALS BY REGION, THROUGH
2019 ($ MILLIONS) 56
SPECT Radiopharmaceuticals Market by Type of Isotope 57
Market Overview 57
Market Revenue 59
TABLE 26 MARKET FOR SPECT RADIOPHARMACEUTICALS BY TYPE OF
RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 59
FIGURE 7 MARKET FOR SPECT RADIOPHARMACEUTICALS BY TYPE OF
RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 59
Other Diagnostic Radiopharmaceuticals 60
Other Diagnostic Radiopharmaceuticals Market by Region 60
Market Overview 61
Market Revenue 61



TABLE 27 MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 62
FIGURE 8 MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 62
Other Diagnostic Radiopharmaceuticals Market By Type of
Radionuclide 62
Market Overview 63
Market Revenue 63
TABLE 28 MARKET FOR OTHERS DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE
OF RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 64
FIGURE 9 MARKET FOR OTHERS DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE
OF RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 64
MARKET SHARE OF DIAGNOSTICS RADIOPHARMACEUTICAL BY TYPE 64
TABLE 29 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST IN 2013 (%) 64
FIGURE 10 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST IN 2013 (%) 65
THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE 65
Market Overview 66
Market Revenue 66
TABLE 30 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE,
THROUGH 2019 ($ MILLIONS) 67
FIGURE 11 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE,
THROUGH 2019 ($ MILLIONS) 67
Alpha Emitters 68
Alpha Emitters Market by Region 68
Market Overview 69
Market Revenue 69
TABLE 31 MARKET FOR ALPHA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 70
FIGURE 12 MARKET FOR ALPHA EMITTERS BY REGION, THROUGH 2019 ($
MILLIONS) 70
Alpha Emitters Market by Type of Radionuclide 71
Market Overview 71
Market Revenue 72
TABLE 32 GLOBAL MARKET FOR ALPHA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 72
FIGURE 13 GLOBAL MARKET FOR ALPHA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 72
Beta Emitters 73
Beta Emitters Market by Region 73
Market Overview 74
Market Revenue 74
TABLE 33 MARKET FOR BETA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 75
FIGURE 14 MARKET FOR BETA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 75
Beta Emitters by Type of Radionuclide 76
Market Overview 76
Market Revenue 77
TABLE 34 GLOBAL MARKET FOR BETA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 77



FIGURE 15 GLOBAL MARKET FOR BETA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 78
Brachytherapy Seeds 78
Brachytherapy Seeds Market by Region 78
Market Overview 79
Market Revenue 79
TABLE 35 MARKET FOR BRACHYTHERAPY SEEDS BY REGION, THROUGH 2019 ($
MILLIONS) 80
FIGURE 16 MARKET FOR BRACHYTHERAPY SEEDS BY REGION, THROUGH 2019 ($
MILLIONS) 80
Brachytherapy Seeds Market by Type of Radioisotope 80
Market Overview 81
Market Revenue 81
TABLE 36 MARKET FOR BRACHYTHERAPY BY TYPE OF RADIONUCLIDE, THROUGH
2019 ($ MILLIONS) 81
FIGURE 17 MARKET FOR BRACHYTHERAPY BY TYPE OF RADIONUCLIDE, THROUGH
2019 ($ MILLIONS) 81
MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICAL BY TYPE 82
TABLE 37 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE IN
2013 (%) 82
FIGURE 18 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE IN
2013 (%) 82
MARKETS BY REGION FOR DIAGNOSTIC RADIOPHARMACEUTICALS 83
MARKET OVERVIEW 83
MARKET REVENUE 84
TABLE 38 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 85
FIGURE 19 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 86
MARKET SHARE 86
TABLE 39 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION
IN 2013 (%) 86
FIGURE 20 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION
IN 2013 (%) 86
MARKETS BY REGION FOR THERAPEUTIC RADIOPHARMACEUTICALS 87
MARKET OVERVIEW 87
MARKET REVENUE 89
TABLE 40 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 90
FIGURE 21 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 90
MARKET SHARE 90
TABLE 41 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY REGION
IN 2013 (%) 91
FIGURE 22 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY REGION
IN 2013 (%) 91
RADIOPHARMACEUTICALS MARKET BY PRODUCTION METHOD 91
PARTICLE ACCELERATORS (CYCLOTRONS) 92
NUCLEAR REACTORS 92
RADIONUCLIDE GENERATORS 92



MARKET OVERVIEW 92
MARKET REVENUE 93
TABLE 42 MARKET FOR RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
THROUGH 2019 ($ MILLIONS) 94
FIGURE 23 MARKET FOR RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
THROUGH 2019 ($ MILLIONS) 94
MARKET SHARE 94
TABLE 43 MARKET SHARE OF RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
2013 (%) 95
FIGURE 24 MARKET SHARE OF RADIOPHARMACEUTICALS BY PRODUCTION
METHOD, 2013 (%) 95
CHAPTER 7 INDUSTRY STRUCTURE FOR BIOPHARMACEUTICALS 97
DIAGNOSTIC RADIOPHARMACEUTICALS 97
PET DIAGNOSTIC RADIOPHARMACEUTICALS 97
Market Leaders 97
TABLE 44 GLOBAL MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS,
2013 97
Market Share 98
TABLE 45 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET
RADIOPHARMACEUTICALS, 2013 (%) 98
FIGURE 25 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET
RADIOPHARMACEUTICALS, 2013 (%) 98
SPECT DIAGNOSTIC RADIOPHARMACEUTICALS 99
Market Leaders 99
TABLE 46 GLOBAL MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 99
Market Share 100
TABLE 47 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 (%) 101
FIGURE 26 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 (%) 101
OTHER DIAGNOSTIC RADIOPHARMACEUTICALS 102
Market Leaders 102
TABLE 48 GLOBAL MANUFACTURERS/ SUPPLIERS OF OTHER DIAGNOSTIC
RADIOPHARMACEUTICALS, 2013 102
Market Share 102
TABLE 49 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER
DIAGNOSTIC RADIOPHARMACEUTICALS, 2013 (%) 103
FIGURE 27 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER
DIAGNOSTIC RADIOPHARMACEUTICALS, 2013 (%) 103
THERAPEUTIC RADIOPHARMACEUTICALS 104
MARKET LEADERS 104
TABLE 50 GLOBAL MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 104
MARKET SHARE 104
TABLE 51 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 (%) 104
FIGURE 28 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 (%) 105



CHAPTER 8 PATENT ANALYSIS 107
PATENTS BY YEAR 107
TABLE 52 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-APRIL 2014 107
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-APRIL 2014 107
PATENTS BY TYPE/CATEGORY 108
TABLE 53 PATENTS BY CATEGORY, JANUARY 2010-APRIL 2014 108
FIGURE 30 PATENTS BY CATEGORY, JANUARY 2010-APRIL 2014 108
PATENTS BY COMPANY 109
TABLE 54 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-APRIL 2014 109
FIGURE 31 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-APRIL 2014 109
PATENTS BY COUNTRY 110
TABLE 55 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-APRIL 2014 110
FIGURE 32 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-APRIL 2014 110
TABLE 56 PATENT SHARES, BY COUNTRY, JANUARY 2010-APRIL 2014 (%) 111
FIGURE 33 PATENT SHARES BY COUNTRY, JANUARY 2010-APRIL 2014 (%) 112
PATENTS BY ASSIGNEE 112
TABLE 57 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2010-APRIL 2014 112
FIGURE 34 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2010-APRIL 2014 112
CHAPTER 9 CURRENT SITUATION 115
REGULATORY ISSUES 115
BABY-BOOMER GENERATION 115
INCREASING INCIDENCE OF LIFE THREATENING DISEASES 115
RISING AWARENESS 116
COMPETITION 116
TECHNOLOGICAL ADVANCEMENTS 116
SETBACKS IN INDUSTRY 116
MERGERS, ACQUISITIONS AND COLLABORATIONS 116
FUNDING FOR RESEARCH 117
CHAPTER 10 COMPANY PROFILES 119
ACTINIUM PHARMACEUTICALS INC. 119
ADVANCED MEDICAL ISOTOPE CORP. 119
ALSERES PHARMACEUTICALS INC. 120
AUSTRALIAN NUCLEAR ASSOCIATION AND TECHNOLOGY ORGANIZATION
(ANSTO) 120
AVID RADIOPHARMACEUTICALS INC. 121
BARD MEDICAL 121
BAYER HEALTHCARE PHARMACEUTICALS 121
BOARD OF RADIATION AND ISOTOPE TECHNOLOGY (BRIT) 122
BRACCO DIAGNOSTICS INC. 123
CARDINAL HEALTH INC. 123
ELI LILLY AND COMPANY 124
ERIGAL LIMITED 125
FUJIFILM IR PHARMA CO. LTD. 125
GE HEALTHCARE (SUBSIDIARY OF GENERAL ELECTRIC COMPANY) 126
ISOTEX DIAGNOSTICS INC. 126



IBA MOLECULAR 127
ISORAY MEDICAL 127
JAZZ PHARMACEUTICALS 128
JUBILANT DRAXIMAGE INC. 128
LANTHEUS MEDICAL IMAGING INC. 129
MALLINCKRODT 129
NATIONAL CENTRE FOR NUCLEAR RESEARCH POLATOM 130
NATIONAL INSTITUTE OF RADIOELEMENT (IRE) 130
NAVIDEA BIOPHARMACEUTICALS INC. 131
NORDION INC. 131
NTP RADIOISOTOPES (PTY) LTD. 132
PHARMALUCENSE INC. 132
PIRAMAL IMAGING 133
SIEMENS AG 133
TRIAD ISOTOPES INC. 134
CHAPTER 11 ABBREVIATIONS 136


LIST OF TABLES

SUMMARY TABLE GLOBAL REVENUE OF RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 7
TABLE 1 DISCOVERY OF RADIOACTIVITY AND NUCLEAR MEDICINE 11
TABLE 2 CYCLOTRON RADIONUCLIDE/RADIOISOTOPES 14
TABLE 3 NUCLEAR REACTOR RADIONUCLIDES/RADIOISOTOPES 15
TABLE 4 RADIONUCLIDE GENERATORS 17
TABLE 5 EXAMPLES OF DIAGNOSTIC RADIOPHARMACEUTICALS 20
TABLE 6 EXAMPLES OF THERAPEUTIC RADIOPHARMACEUTICALS 23
TABLE 7 EXAMPLES OF ALPHA EMITTERS 24
TABLE 8 ADVANTAGES AND DISADVANTAGES OF ALPHA EMITTERS 25
TABLE 9 ADVANTAGES AND DISADVANTAGES OF BETA EMITTERS 26
TABLE 10 COMMONLY USED RADIONUCLIDES (RADIATION SOURCES) FOR
BRACHYTHERAPY 26
TABLE 11 ADVANTAGES AND DISADVANTAGES OF BRACHYTHERAPY 27
TABLE 12 ADVANTAGES AND DISADVANTAGES OF RADIOPHARMACEUTICALS 27
TABLE 13 NEW DRUG APPROVALS (FROM 2011- MARCH 2014) 30
TABLE 14 NEW DRUG APPLICATIONS (FROM 2010-MARCH 2014) 31
TABLE 15 SAFETY ALERTS FOR RADIOPHARMACEUTICALS (FROM 2010-MARCH 2014) 32
TABLE 16 ADVERSE EVENT REPORTING (FROM 2010-MARCH 2014) 33
TABLE 17 RESOLVED DRUG SHORTAGE IN 2013 33
TABLE 18 510K APPROVALS (FROM 2010-MARCH 2014) 34
TABLE 19 PIPELINE PRODUCTS IN RADIOPHARMACEUTICALS 36
TABLE 20 MARKET FOR RADIOPHARMACEUTICALS BY CATEGORY, THROUGH 2019 ($
MILLIONS) 43
TABLE 21 MARKET SHARE OF RADIOPHARMACEUTICALS BY CATEGORY IN 2013 (%) 44
TABLE 22 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST, THROUGH 2019 ($ MILLIONS) 47
TABLE 23 MARKET FOR PET RADIOPHARMACEUTICALS BY REGION, THROUGH 2019
($ MILLIONS) 51
TABLE 24 MARKET FOR PET RADIOPHARMACEUTICALS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 53
TABLE 25 MARKET FOR SPECT RADIOPHARMACEUTICALS BY REGION, THROUGH
2019 ($ MILLIONS) 56
TABLE 26 MARKET FOR SPECT RADIOPHARMACEUTICALS BY TYPE OF
RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 59
TABLE 27 MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 62
TABLE 28 MARKET FOR OTHERS DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 64
TABLE 29 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST IN 2013 (%) 64
TABLE 30 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE, THROUGH
2019 ($ MILLIONS) 67
TABLE 31 MARKET FOR ALPHA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 70
TABLE 32 GLOBAL MARKET FOR ALPHA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 72
TABLE 33 MARKET FOR BETA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 75
TABLE 34 GLOBAL MARKET FOR BETA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 77



TABLE 35 MARKET FOR BRACHYTHERAPY SEEDS BY REGION, THROUGH 2019 ($
MILLIONS) 80
TABLE 36 MARKET FOR BRACHYTHERAPY BY TYPE OF RADIONUCLIDE, THROUGH
2019 ($ MILLIONS) 81
TABLE 37 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE IN
2013 (%) 82
TABLE 38 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 85
TABLE 39 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION IN
2013 (%) 86
TABLE 40 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 90
TABLE 41 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY REGION IN
2013 (%) 91
TABLE 42 MARKET FOR RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
THROUGH 2019 ($ MILLIONS) 94
TABLE 43 MARKET SHARE OF RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
2013 (%) 95
TABLE 44 GLOBAL MANUFACTURERS/SUPPLIERS OF PET RADIOPHARMACEUTICALS,
2013 97
TABLE 45 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET
RADIOPHARMACEUTICALS, 2013 (%) 98
TABLE 46 GLOBAL MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 99
TABLE 47 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 (%) 101
TABLE 48 GLOBAL MANUFACTURERS/ SUPPLIERS OF OTHER DIAGNOSTIC
RADIOPHARMACEUTICALS, 2013 102
TABLE 49 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER DIAGNOSTIC
RADIOPHARMACEUTICALS, 2013 (%) 103
TABLE 50 GLOBAL MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 104
TABLE 51 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 (%) 104
TABLE 52 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-APRIL 2014 107
TABLE 53 PATENTS BY CATEGORY, JANUARY 2010-APRIL 2014 108
TABLE 54 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-APRIL 2014 109
TABLE 55 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-APRIL 2014 110
TABLE 56 PATENT SHARES, BY COUNTRY, JANUARY 2010-APRIL 2014 (%) 111
TABLE 57 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2010-APRIL 2014 112


LIST OF FIGURES

SUMMARY FIGURE GLOBAL REVENUE OF RADIOPHARMACEUTICALS BY REGION,
2012-2019 ($ MILLIONS) 7
FIGURE 1 MARKET FOR RADIOPHARMACEUTICALS BY CATEGORY, 2012-2019 ($
MILLIONS) 43
FIGURE 2 MARKET SHARE OF RADIOPHARMACEUTICALS BY CATEGORY IN 2013 (%) 44
FIGURE 3 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST, 2012-2019 ($ MILLIONS) 47
FIGURE 4 MARKET FOR PET RADIOPHARMACEUTICALS BY REGION, THROUGH 2019
($ MILLIONS) 51
FIGURE 5 MARKET FOR PET RADIOPHARMACEUTICALS BY TYPE OF RADIONUCLIDE,
2012-2019 ($ MILLIONS) 53
FIGURE 6 MARKET FOR SPECT RADIOPHARMACEUTICALS BY REGION, THROUGH
2019 ($ MILLIONS) 56
FIGURE 7 MARKET FOR SPECT RADIOPHARMACEUTICALS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 59
FIGURE 8 MARKET FOR OTHER DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 62
FIGURE 9 MARKET FOR OTHERS DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
RADIONUCLIDE, THROUGH 2019 ($ MILLIONS) 64
FIGURE 10 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY TYPE OF
DIAGNOSTIC TEST IN 2013 (%) 65
FIGURE 11 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE,
THROUGH 2019 ($ MILLIONS) 67
FIGURE 12 MARKET FOR ALPHA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 70
FIGURE 13 GLOBAL MARKET FOR ALPHA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 72
FIGURE 14 MARKET FOR BETA EMITTERS BY REGION, THROUGH 2019 ($ MILLIONS) 75
FIGURE 15 GLOBAL MARKET FOR BETA EMITTERS BY TYPE OF RADIONUCLIDE,
THROUGH 2019 ($ MILLIONS) 78
FIGURE 16 MARKET FOR BRACHYTHERAPY SEEDS BY REGION, THROUGH 2019 ($
MILLIONS) 80
FIGURE 17 MARKET FOR BRACHYTHERAPY BY TYPE OF RADIONUCLIDE, THROUGH
2019 ($ MILLIONS) 81
FIGURE 18 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY TYPE IN
2013 (%) 82
FIGURE 19 MARKET FOR DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 86
FIGURE 20 MARKET SHARE OF DIAGNOSTIC RADIOPHARMACEUTICALS BY REGION IN
2013 (%) 86
FIGURE 21 MARKET FOR THERAPEUTIC RADIOPHARMACEUTICALS BY REGION,
THROUGH 2019 ($ MILLIONS) 90
FIGURE 22 MARKET SHARE OF THERAPEUTIC RADIOPHARMACEUTICALS BY REGION
IN 2013 (%) 91
FIGURE 23 MARKET FOR RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
THROUGH 2019 ($ MILLIONS) 94
FIGURE 24 MARKET SHARE OF RADIOPHARMACEUTICALS BY PRODUCTION METHOD,
2013 (%) 95
FIGURE 25 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF PET
RADIOPHARMACEUTICALS, 2013 (%) 98
FIGURE 26 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF SPECT
RADIOPHARMACEUTICALS, 2013 (%) 101



FIGURE 27 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF OTHER
DIAGNOSTIC RADIOPHARMACEUTICALS, 2013 (%) 103
FIGURE 28 MARKET SHARES OF MANUFACTURERS/SUPPLIERS OF THERAPEUTIC
RADIOPHARMACEUTICALS, 2013 (%) 105
FIGURE 29 NUMBER OF SIGNIFICANT PATENTS BY YEAR, JANUARY 2010-APRIL 2014 107
FIGURE 30 PATENTS BY CATEGORY, JANUARY 2010-APRIL 2014 108
FIGURE 31 NUMBER OF U.S. PATENTS BY COMPANY, JANUARY 2010-APRIL 2014 109
FIGURE 32 NUMBER OF U.S. PATENTS BY COUNTRY, JANUARY 2010-APRIL 2014 110
FIGURE 33 PATENT SHARES BY COUNTRY, JANUARY 2010-APRIL 2014 (%) 112
FIGURE 34 NUMBER OF PATENTS BY ASSIGNEE, JANUARY 2010-APRIL 2014 112

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