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  4. > The U.S. Market for Biodefense-Related Rapid Pathogen Identification and Treatments

Use this report to:
- Identify current trends and emerging technologies pertinent to biological rapid pathogen identification.
- Analyze treatment methods such as vaccines and pharmaceuticals in the U.S. biodefense-related rapid pathogen market.
- Learn about manufacturers of assays, sensors, vaccines and pharmaceuticals used in the identification and treatment of biological agents.Use this report to:
- Identify current trends and emerging technologies pertinent to biological rapid pathogen identification.
- Analyze treatment methods such as vaccines and pharmaceuticals in the U.S. biodefense-related rapid pathogen market.
- Learn about manufacturers of assays, sensors, vaccines and pharmaceuticals used in the identification and treatment of biological agents.

Highlights
- The U.S. market for biodefense-related rapid pathogen detection devices was valued at $214.2 million in 2015. The total market is projected to grow at a compound annual growth rate (CAGR) of 8% from 2016 through 2021 to reach $248 million by 2016 and $364 million by 2021.
- Detection devices are projected to grow at a CAGR of 5.2% from $155 million by 2016 to $200 million by 2021.
- The sensors devices market is projected to reach $93 million by 2016. It is projected to increase at a CAGR of 12% and reach $164 million by 2021.

Introduction & Scope

INTRODUCTION

REASONS FOR DOING THE STUDY
The U.S. found itself in the unusual position of being attacked by a foreign entity in 2001, and preparations for such an attack were woefully inadequate. Since then, the U.S. government has given priority to preparations for potential biological attacks by incentivizing industry and academia to develop pathogen identification and treatment products. Pathogenic agents can be viruses, bacteria, fungi, protozoa, parasites, or manufactured toxins. They are able to cause diseases in plants, animals and humans. Pathogens that are harmful to animals and plants are not covered unless they pose eminent danger to humans through consumption. Examples of infectious agents discussed include smallpox, anthrax, plague and tularemia. Another area of pathogen identification includes potentially harmful chemical toxins that are used in biological warfare situations. These include ricin and botulin.

The market for biodefense-related rapid pathogen identification products continues to expand with an emphasis on products that are more portable, easy to use, sensitive and accurate. Multiple assays are being field-tested and used by military personnel, first responders, industry and businesses. The purpose for this report is to provide an overview of the industry and its participants, and project the growth of the market through 2021.

STUDY GOALS AND OBJECTIVES
Biological substances that can be weaponized for either civilian or military destruction are considered biodefense related, and identifying these substances accurately and rapidly is at the heart of this report. Additionally, treatment methods such as vaccines and pharmaceuticals will be discussed. The report concentrates on the U.S. biodefense-related rapid pathogen identification and treatment markets.

This report is intended to:
- Provide an accurate overview of the biological warfare landscape and the infectious agents that could pose the most acute problems.
- Discuss the pathogen identification products currently on the market and their potential for growth.
- Identify current trends and emerging technologies pertinent to biological rapid pathogen identification.
- Provide an overview of recently issued patents related to biological rapid pathogen identification.
- Include a comprehensive directory of manufacturers of assays, sensors, vaccines and pharmaceuticals used

INTENDED AUDIENCE
This new report on the biodefense-related rapid pathogen identification and treatment market will be a valuable tool for decision makers and manufacturers in biodefense rapid pathogen diagnostic, vaccine and the pharmaceutical treatment industries. Individuals at research foundations, manufacturing companies and university laboratories will find valuable information on the U.S. biodefense market, and individuals involved in strategic planning, marketing and sales development will appreciate the specificity of the report. Additionally, emphasis on the type of disease, major players in the marketplace, market conditions, and current and projected revenues will be provided.

SCOPE AND FORMAT
The market report organizes information from diverse sources into a cohesive unit that includes an industry overview; overview of infectious agents with detection, vaccine and treatment information; biodefense-related diagnostic tools; current research and emerging industries related to rapid pathogen identification; biodefense-related pathogen identification product patents; and a comprehensive directory of assay,
sensor, vaccine and treatment companies.

Table Of Contents

The U.S. Market for Biodefense-Related Rapid Pathogen Identification and Treatments
TABLE OF CONTENTS
CHAPTER 1 INTRODUCTION 2
REASONS FOR DOING THE STUDY 2
STUDY GOALS AND OBJECTIVES 2
INTENDED AUDIENCE 3
SCOPE AND FORMAT 3
METHODOLOGIES AND INFORMATION SOURCES 3
ANALYST'S CREDENTIALS 3
RELATED BCC RESEARCH REPORTS 4
BCC RESEARCH WEBSITE 4
DISCLAIMER 4
CHAPTER 2 SUMMARY 6
DETECTION 6
HANDHELD DEVICES 7
TREATMENT 7
CONTRIBUTING FACTORS TO BIODEFENSE-RELATED PATHOGEN
IDENTIFICATION MARKET 7
U.S. MARKET FOR BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
PRODUCTS 7
SUMMARY TABLE U.S. MARKET FOR BIODEFENSE-RELATED RAPID PATHOGEN
IDENTIFICATION PRODUCTS, THROUGH 2021 ($ MILLIONS) 7
SUMMARY FIGURE BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
MARKET, BY TYPE OF DETECTION, IN 2016 AND 2021 (%) 7
CHAPTER 3 INDUSTRY OVERVIEW 10
HISTORY AND CURRENT STATE OF RAPID PATHOGEN IDENTIFICATION AND
TREATMENTS 10
DELIVERY AND DETECTION 11
AIRBORNE 11
EXPLOSIVES 11
FOOD AND WATER CONTAMINATION 11
ABSORPTION OR INJECTION 11
POTENTIAL BIOLOGICAL PATHOGENS 12
CLASS A 12
TABLE 1 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM
AGENTS/DISEASES: CLASS A 12
TABLE 2 CLASS A PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 13
CLASS B 13
TABLE 3 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM
AGENTS/DISEASES: CLASS B 13
TABLE 4 CLASS B PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 13
CLASS C 14
TABLE 5 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM
AGENTS/DISEASES: CLASS C 14
TABLE 6 CLASS C PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 15
RAPID IDENTIFICATION PRODUCTS 15
TABLE 7 LIMITATIONS OF SOME COMMON ANALYSIS METHODS 16
PCR 16
QPCR 16
MICROARRAY 16
MASS SPECTROMETRY 17
IMMUNOMAGNETIC SEPARATION (IMS) 17
SENSING TECHNOLOGY 17
TABLE 8 CHARACTERISTICS OF BIOSENSORS 18
FLUCTUATION-ENHANCING SENSING (FES) 18
SENSING OF PHAGE-TRIGGERED ION CASCADES (SEPTIC) 19
NANOPORE 19
IMMUNOASSAY 19
Enzyme-linked Immunosorbent Assay (ELISA) 19
Lateral Flow Tests 20
DETECT-TO-WARN SYSTEMS 21
TABLE 9 DETECT-TO-WARN MONITORING SYSTEMS 21
TREATMENTS 22
VACCINES 22
TABLE 10 VACCINES FOR PATHOGENS, BY DISEASE OR CONDITION, BRAND NAME
AND MANUFACTURER, 2014 22
PHARMACEUTICALS TO TREAT BIODEFENSE-RELATED PATHOGENS 22
TABLE 11 COMMON PHARMACEUTICALS TO TREAT BIODEFENSE-RELATED
PATHOGENS BY NAME, MANUFACTURER, DISEASE OR CONDITION, 2015 23
PLANNING AND RESPONSE TO BIOTERRORISM EVENT 23
FIGURE 1 FIVE COMPONENTS TO BIOLOGICAL DEFENSE (%) 24
BIOSURVEILLANCE 24
MICROBIAL FORENSICS 25
ROLE OF GOVERNMENT, UNIVERSITIES AND PRIVATE FUNDING IN PRODUCT
DEVELOPMENT 25
TABLE 12 MAJOR GOVERNMENT FUNDERS OF R andD WITH AMOUNT FUNDED,
2012-2014 ($ BILLIONS) 26
FIGURE 2 U.S. GENERAL R andD FUNDING SOURCES, 2014 (%) 26
FUNDING OPTIONS 27
U.S. GOVERNMENT FUNDING 27
Department of Homeland Security Project Biowatch 27
Department of Defense 27
UNIVERSITY/INDUSTRY FUNDING 27
INDUSTRY CHANGES 27
TABLE 13 SELECTED MERGERS AND ACQUISITIONS IN THE BIODEFENSE
IDENTIFICATION INDUSTRY, JANUARY 2013-JUNE 2015 27
CHAPTER 4 OVERVIEW OF INFECTIOUS AGENTS 30
TABLE 14 BIODEFENSE-RELATED PATHOGEN IDENTIFICATION WITH TEST AND
TEST RESULT TIME (MINUTES) 30
CATEGORY A BACTERIAL AGENTS 35
ANTHRAX 35
Signs and Symptoms 36
Detection Methods 36
TABLE 15 RAPID TESTS TO DETECT ANTHRAX 36
Vaccine Availability 37
Prevention/Treatment Protocols 37
PLAGUE (YERSINIA PESTIS) 38
Signs and Symptoms 38
Detection Methods 38
TABLE 16 RAPID TESTS TO DETECT YERSINIA PESTIS BACTERIA 38
Prevention/Treatment Protocols 39
TULAREMIA 39
Signs and Symptoms 39
Detection Methods 40
TABLE 17 RAPID TESTS TO DETECT FRANCISELLA TULARENSIS BACTERIA 40
Vaccine Availability 40
Prevention/Treatment Protocols 41
CATEGORY A VIRAL AGENTS 41
SMALLPOX 41
Signs and Symptoms 41
Detection Methods 41
TABLE 18 RAPID TESTS TO DETECT SMALLPOX 41
Vaccine Availability 42
Prevention/Treatment Protocols 42
INFLUENZA 43
Signs and Symptoms 43
Detection Methods 43
TABLE 19 RAPID TESTS TO DETECT PANDEMIC INFLUENZA 43
Vaccine Availability 44
Prevention/Treatment Protocols 44
VIRAL HEMORRHAGIC FEVERS 44
Ebola Virus 44
Signs and Symptoms 45
Detection Methods 45
TABLE 20 RAPID TESTS TO DETECT EBOLA HEMORRHAGIC FEVER 45
Vaccine Availability 45
TABLE 21 VACCINES IN TESTING FOR EBOLA HEMORRHAGIC FEVER 46
Treatment Protocols 46
TABLE 22 PHARMACEUTICALS IN TESTING FOR EBOLA HEMORRHAGIC FEVER 46
Marburg Virus 47
Signs and Symptoms 47
Detection Methods 47
TABLE 23 RAPID TEST TO DETECT MARBURG HEMORRHAGIC FEVER 47
Vaccine Availability 48
Treatment Protocols 48
CATEGORY B BACTERIAL AGENTS 48
BRUCELLOSIS 48
Signs and Symptoms 48
Detection Methods 48
TABLE 24 RAPID TESTS TO DETECT BRUCELLA 48
Vaccine Availability 49
Treatment Protocols 49
SALMONELLA 49
Signs and Symptoms 49
Detection Methods 49
TABLE 25 RAPID TESTS TO DETECT SALMONELLA 50
Vaccine Availability 50
Treatment Protocols 50
E. COLI 50
Signs and Symptoms 50
Detection Methods 50
TABLE 26 RAPID TESTS TO DETECT E. COLI 51
Vaccine Availability 51
Treatment Protocols 51
GLANDERS 51
Signs and Symptoms 51
Detection Methods 51
TABLE 27 RAPID TESTS TO DETECT GLANDERS 52
Vaccine Availability 52
Treatment Protocols 52
MELIOIDOSIS 52
Signs and Symptoms 52
Detection Methods 53
TABLE 28 RAPID TEST TO DETECT MELIOIDOSIS 53
Vaccine Availability 53
Treatment Protocols 53
PSITTACOSIS 53
Signs and Symptoms 53
Detection Methods 54
TABLE 29 RAPID TESTS TO DETECT PSITTACOSIS 54
Vaccine Availability 54
Treatment Protocols 54
Q FEVER 54
Signs and Symptoms 55
Detection Methods 55
TABLE 30 RAPID TESTS TO DETECT Q FEVER 55
Vaccine Availability 55
Treatment Protocols 55
STAPHYLOCOCCAL ENTEROTOXIN B (SEB) 55
Signs and Symptoms 56
Detection Methods 56
TABLE 31 RAPID TESTS TO DETECT SEB 56
Vaccine Availability 56
Treatment Protocols 56
TYPHOID FEVER 57
Signs and Symptoms 57
Detection Methods 57
TABLE 32 METHOD TO DETECT TYPHOID FEVER 57
Vaccine Availability 57
TABLE 33 VACCINES USED TO PREVENT TYPHOID INFECTIONS 57
Treatment Protocols 58
CHOLERA 58
Signs and Symptoms 58
Detection Methods 58
TABLE 34 RAPID TESTS TO DETECT CHOLERA 58
Vaccine Availability 58
Treatment Protocols 59
CRYPTOSPORIDIUM 59
Signs and Symptoms 59
Detection Methods 59
TABLE 35 METHODS TO DETECT CRYPTOSPORIDIUM 60
Vaccine Availability 60
Treatment 60
VIRAL ENCEPHALITIS 60
Signs and Symptoms 61
Detection Methods 61
TABLE 36 RAPID TESTS TO DETECT VIRAL ENCEPHALITIS 61
Vaccine Availability 61
Treatment Protocols 62
CATEGORY B TOXINS 62
RICIN 62
Signs and Symptoms 62
Inhalation 62
Ingestion 62
Skin/Eye Exposure 63
Detection Methods 63
TABLE 37 RAPID TESTS TO DIAGNOSE RICIN POISONING 63
Vaccine Availability 64
Treatment Protocols 64
BOTULISM 64
Signs and Symptoms 64
Detection Methods 64
TABLE 38 RAPID TESTS TO DETECT BOTULISM POISONING 64
Vaccine Availability 65
TABLE 39 VACCINES TO TREAT BOTULISM 65
Treatment Protocols 65
VACCINE STOCKPILING 66
TABLE 40 U.S. GOVERNMENT CONTRACTED MARKET FOR SNS VACCINES,
2013-2018 ($ MILLIONS) 66
BIODEFENSE-RELATED VACCINE MARKET 66
TABLE 41 BIODEFENSE-RELATED VACCINES BY INDICATION, NAME AND
MANUFACTURER 67
THERMOSTABLE VACCINES 67
CLASSES OF DRUGS THAT EFFECTIVELY TREAT BIODEFENSE-RELATED
PATHOGENS 67
AMINOGLYCOSIDES 68
QUINOLONES 68
TETRACYCLINES 68
TABLE 42 MEDICATIONS TO TREAT SELECTED BIODEFENSE-RELATED PATHOGENS
BY DISEASE, MEDICATION AND TYPE 68
FIGURE 3 ANTIBIOTICS USED TO TREAT BIODEFENSE-RELATED BACTERIAL
THREATS (%) 68
BARRIERS TO USING BIOLOGICAL WEAPONS 69
TABLE 43 BARRIERS TO USING BIOLOGICAL WEAPONS 70
CHAPTER 5 BIODEFENSE-RELATED PATHOGEN DETECTION DEVICES 72
TABLE 44 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED RAPID PATHOGEN
DETECTION DEVICES, THROUGH 2021 ($ MILLIONS) 72
PATHOGEN ID DEVICES BY TESTING METHOD 72
TABLE 45 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED DETECTION
DEVICES BY TESTING METHOD, THROUGH 2021 ($ MILLIONS) 72
FIGURE 4 SHARES OF BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
DEVICES BY TESTING METHOD, 2016 AND 2021 (%) 73
TYPE OF DEVICE 74
TABLE 46 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED DETECTION
DEVICES BY TYPE, THROUGH 2021 ($ MILLIONS) 74
FIGURE 5 SHARES OF BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
DEVICES BY TYPE, 2016 AND 2021 (%) 74
DIAGNOSTIC TOOLS 76
MASS SPECTROMETRY 76
TABLE 47 PROJECTED BIODEFENSE-RELATED MASS SPECTROMETRY DEVICE
MARKET, THROUGH 2021 ($ MILLIONS) 76
PCR 76
TABLE 48 PROJECTED BIODEFENSE-RELATED PCR DEVICE MARKET, THROUGH
2021 ($ MILLIONS) 77
IMMUNOLOGICAL ANALYSIS 77
TABLE 49 PROJECTED U.S. BIODEFENSE-RELATED IMMUNOLOGICAL DEVICE
MARKET, THROUGH 2021 ($ MILLIONS) 78
BIOLOGICAL SENSORS 78
CELLULAR ANALYSIS AND NOTIFICATION OF ANTIGEN RISKS AND YIELDS
(CANARY) 78
PHOTONIC SENSORS 78
FIBER-OPTIC BIOSENSORS 79
LAB-ON-CHIP BIOSENSORS 79
THE BIODEFENSE BIOSENSOR MARKET 80
TABLE 50 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED BIOLOGICAL
SENSORS, THROUGH 2021 ($ MILLIONS) 80
CHAPTER 6 CURRENT RESEARCH, EMERGING THERAPIES, PATENTS AND MARKET
OPPORTUNITIES 82
PHARMACEUTICAL TREATMENT PRODUCT PIPELINE 82
TABLE 51 PATHOGEN PHARMACEUTICAL PRODUCT PIPELINE 82
PHARMACEUTICAL RESEARCH 82
BACTERIAL INFECTIONS: PRODUCTS IN DEVELOPMENT 82
Rapid Test for Plague 82
BARDA's Antibacterial Program 83
TABLE 52 PHARMACEUTICALS IN BACTERIA BIOTHREAT PIPELINE BY COMPOUND
NAME, STAGE OF DEVELOPMENT, APPLICATION, AND DEVELOPER 83
VIRAL INFECTIONS: PRODUCTS IN DEVELOPMENT 83
BioCryst Pharmaceuticals 83
Toyama Chemical 84
TOXIN RESEARCH 84
Gene Therapy Treatment for Botulism 84
VACCINE RESEARCH 85
LAWRENCE LIVERMORE NATIONAL LABORATORY (LLNL) 85
ORGANIC VACCINES 85
PROFECTUS BIOSCIENCES 86
SOLIGENIX 86
TULANE UNIVERSITY (NEW ORLEANS, LA.) 86
PATHOGEN VACCINE PIPELINE 86
TABLE 53 PANDEMIC VACCINES UNDER DEVELOPMENT, 2015 87
VIRAL PRODUCT RESEARCH 87
AUTOIMMUNE TECHNOLOGIES 87
BIODEFENSE-RELATED DEVICE RESEARCH 88
OMNI ARRAY BIOTECHNOLOGY 88
NATIONAL CENTER FOR NANOSCIENCE AND TECHNOLOGY (BEIJING, CHINA) 88
BIOSENSORS USED IN SMARTPHONES 88
ANTHRAX DETECTION 89
I-DIAGNOSTICS AND TIRF LABS 89
GEORGIA TECH RESEARCH INSTITUTE 89
CARBON NANOTUBE THIN FILM BIOSENSORS FOR WHOLE VIRUS
DETECTION 90
MOLYBDENUM DISULFIDE BIOSENSORS 90
PATENTS 90
PATENTS BY NUMBER, COMPANY, TYPE OF DEVICE, DESCRIPTION, DATE
OF ISSUE 91
TABLE 54 RAPID PATHOGEN IDENTIFICATION PATENTS: NUMBER, COMPANY, TYPE
OF DEVICE, DESCRIPTION AND DATE OF ISSUE, AUGUST 2011-JUNE 2015 91
PATENTS BY MANUFACTURER 96
TABLE 55 NUMBER OF PATENTS BY MANUFACTURER, AUGUST 2011-JUNE 2015 96
TABLE 56 PATENTS BY FUNCTION AND COMPANY AUGUST 2011-JUNE 2015 96
PHARMACEUTICAL MARKET OPPORTUNITIES/CHALLENGES 97
VACCINE MARKET OPPORTUNITIES/CHALLENGES 97
DEVICE MARKET OPPORTUNITIES/CHALLENGES 97
CHALLENGES 97
OPPORTUNITIES 98
Rapid Assays 98
THE IMPACT OF GLOBAL POLITICAL/SOCIETAL CHANGES 98
SOCIETAL CHANGES 99
CHAPTER 7 U.S. AGENCIES AND THEIR PURPOSES 101
UNITED STATES DISEASE STRATEGY 101
TABLE 57 SELECTED EMERGING INFECTIOUS DISEASE SINCE 1975 BY NAME, YEAR
IDENTIFIED, ESTIMATED GLOBAL IMPACT AND MORTALITY PERCENTAGE 101
DEPARTMENT OF HEALTH AND HUMAN SERVICES (HHS) 102
PROJECT BIOSHIELD 102
FIGURE 6 PERCENTAGE OF PROJECT BIOSHIELD FUNDS USED TO ACQUIRE
COUNTERMEASURES, 2004-2014 (%) 102
PANDEMIC AND ALL-HAZARDS PREPAREDNESS REAUTHORIZATION 103
Pandemic and All-Hazards Preparedness Reauthorization Act of 2013 103
Title I: Strengthening Preparedness and Response for Public
Health Emergencies 104
Title II: Optimizing State and Local All-Hazards Preparedness and
Response 104
Title III: Enhancing Medical Countermeasure Review 104
Title IV: Accelerating Medical Countermeasure Advanced
Research and Development 105
BARDA 105
CENTERS FOR DISEASE CONTROL AND PREVENTION (CDC) 105
NATIONAL INSTITUTES OF HEALTH (NIH) 106
U.S. FOOD AND DRUG ADMINISTRATION (FDA) 106
FOOD SAFETY AND MODERNIZATION ACT (FSMA) 106
Key Initiatives of the Legislation 106
Prevention 107
Enhanced Partnerships 108
CHAPTER 8 COMPANY DIRECTORY 111
DIAGNOSTIC PRODUCTS 111
20/20 GENESYSTEMS, INC. 111
Business Overview 111
Product 111
TABLE 58 20/20 DIAGNOSTIC PRODUCT 111
ADVNT BIOTECHNOLOGIES 111
Business Overview 112
Products 112
TABLE 59 ADVNT DETECTION PRODUCTS 112
AETHLON MEDICAL 112
Business Overview 112
Products 113
TABLE 60 AETHLON MEDICAL PRODUCTS 113
ALERE 113
Business Overview 113
Products 113
TABLE 61 ALERE DIAGNOSTIC PRODUCTS 113
ALEXETER TECHNOLOGIES 114
Business Overview 114
Products 114
TABLE 62 ALEXETER TECHNOLOGIES DIAGNOSTIC PRODUCTS 114
ALPHA DIAGNOSTIC INTERNATIONAL 114
Business Overview 114
Products 115
TABLE 63 ALPHA DIAGNOSTIC INTERNATIONAL DIAGNOSTIC PRODUCTS 115
ANP TECHNOLOGIES 115
Business Overview 115
Products 116
TABLE 64 ANP TECHNOLOGIES DIAGNOSTIC PRODUCTS 116
ATLAS LINK BIOTECH CO., LTD 116
Business Overview 116
Products 117
TABLE 65 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 117
BATTELLE 117
Business Overview 117
Products 118
TABLE 66 BATTELLE DIAGNOSTIC PRODUCTS 118
BB DETECTION 118
Business Overview 118
Product 118
TABLE 67 BB DETECTION DIAGNOSTIC PRODUCT 118
BERTIN TECHNOLOGIES 119
Business Overview 119
Products 119
TABLE 68 BERTIN TECHNOLOGIES DIAGNOSTIC PRODUCTS 119
BIODETECTION INSTRUMENTS 119
Business Overview 119
Product 120
TABLE 69 BIODETECTION INSTRUMENTS DIAGNOSTIC PRODUCT 120
BIOFIRE DEFENSE 120
Business Overview 120
Products 121
TABLE 70 BIOFIRE DEFENSE PRODUCTS 121
BIOMEME 121
Business Overview 121
Product 121
TABLE 71 BIOMEME BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 121
BIOMERIEUX, INC. 122
Business Overview 122
Products 122
TABLE 72 BIOMERIEUX BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 122
BIOSEARCH TECHNOLOGIES 122
Business Overview 122
Product 123
TABLE 73 BIOSEARCH TECHNOLOGIES DIAGNOSTIC PRODUCT 123
BIOTECH INTERNATIONAL 123
Business Overview 123
Product 123
TABLE 74 BIOTECH INTERNATIONAL BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 123
BRUKER DETECTION 124
Business Overview 124
Product 124
TABLE 75 BRUKER BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 124
CANGENE CORP. (SEE EMERGENT BIOSOLUTIONS) 124
CERES NANOSCIENCES, INC. 124
Business Overview 124
CHEMRING DETECTION SYSTEMS 125
Business Overview 125
Product 125
TABLE 76 CHEMRING BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 125
CORGENIX MEDICAL CORP 125
Business Overview 126
Product 126
TABLE 77 CORGENIX DIAGNOSTIC PRODUCT 126
DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS INC. 126
Business Overview 126
TABLE 78 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC
PRODUCTS 126
DIATHERIX 127
Business Overview 127
Product 127
TABLE 79 DIATHERIX DIAGNOSTIC PRODUCT 127
ELECTRONIC SENSOR TECHNOLOGY, INC. 127
Business Overview 127
Product 128
TABLE 80 ELECTRONIC SENSOR TECHNOLOGY DIAGNOSTIC PRODUCT 128
ENVIRONICS OY 128
Business Overview 128
Products 128
TABLE 81 ENVIRONICS DIAGNOSTICS PRODUCTS 128
HAZTECH SYSTEMS 129
Business Overview 129
Products 129
TABLE 82 HAZTECH BIODEFENSE-RELATED PRODUCTS 129
INBIOS INTERNATIONAL, INC. 129
Business Overview 129
Products 130
TABLE 83 INBIOS DIAGNOSTICS PRODUCTS 130
INTEGRATED NANO-TECHNOLOGIES 130
Business Overview 130
Product 130
TABLE 84 INTEGRATED NANO-TECHNOLOGIES DIAGNOSTICS PRODUCT 130
MENON BIOSENSORS, INC. 131
Business Overview 131
Product 131
TABLE 85 MENON BIOSENSORS DIAGNOSTIC PRODUCT 131
MESO SCALE DEFENSE 131
Business Overview 131
Products 132
TABLE 86 MESO SCALE DEFENSE DIAGNOSTICS PRODUCTS 132
NANOLOGIX 132
Business Overview 132
Product 132
TABLE 87 NANOLOGIX DIAGNOSTICS PRODUCT 132
NEW HORIZON DIAGNOSTIC CORP. 133
Business Overview 133
Products 133
TABLE 88 NEW HORIZON DIAGNOSTICS PRODUCTS 133
OXFORD NANOPORE TECHNOLOGIES, LTD. 133
Business Overview 134
Products 134
TABLE 89 OXFORD NANOPORE TECHNOLOGIES DIAGNOSTIC PRODUCTS 134
PATHSENSORS, INC. 134
Business Overview 134
Products 135
TABLE 90 PATHSENSORS DIAGNOSTICS PRODUCTS 135
POSITIVE ID CORP. 135
Business Overview 135
Products 136
TABLE 91 POSITIVE ID DIAGNOSTICS PRODUCTS 136
PROENGIN, INC. 136
Business Overview 136
Product 137
TABLE 92 PROENGIN DIAGNOSTICS PRODUCT 137
QIAGEN N.V. 137
Business Overview 137
Products 137
TABLE 93 QIAGEN BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 137
QUANTUMDX GROUP 138
Business Overview 138
Product 138
TABLE 94 QUANTUMDX BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 138
RESEARCH INTERNATIONAL, INC. 138
Business Overview 139
Product 139
TABLE 95 RESEARCH INTERNATIONAL BIODEFENSE-RELATED DIAGNOSTIC
PRODUCT 139
REAL-TIME ANALYZERS, INC. 139
Business Overview 139
Product 140
TABLE 96 REAL-TIME ANALYZERS DIAGNOSTIC PRODUCT 140
RESPONSE BIOMEDICAL CORP. 140
Business Overview 140
Products 140
TABLE 97 RESPONSE BIOMEDICAL DIAGNOSTIC PRODUCTS 140
SANDIA NATIONAL LABORATORIES 141
Business Overview 141
Product 141
TABLE 98 SANDIA NATIONAL LABORATORIES DIAGNOSTIC PRODUCT 141
SMITHS DETECTION 141
Business Overview 141
Products 142
TABLE 99 SMITHS DETECTION BIODEFENSE-RELATED PRODUCTS 142
THERMO FISHER 142
Business Overview 142
Product 143
TABLE 100 THERMO FISHER BIODEFENSE-RELATED PRODUCT 143
TETRACORE 143
Business Overview 143
Products 143
TABLE 101 TETRACORE BIODEFENSE-RELATED PRODUCTS 143
VACCINES 144
BAVARIAN NORDIC A/S 144
Business Overview 144
Product 144
TABLE 102 BAVARIAN NORDIC BIODEFENSE VACCINE PRODUCT 144
CRUCELL HOLLAND B.V. 144
Business Overview 144
EMERGENT BIOSOLUTIONS 145
Business Overview 145
Products 145
TABLE 103 EMERGENT BIOSOLUTIONS VACCINE PRODUCTS 145
INOVIO PHARMCEUTICALS 145
Business Overview 145
Products 146
TABLE 104 INOVIO PHARMACEUTICALS VACCINE PRODUCTS 146
NOVAVAX 146
Business Overview 146
Products 146
TABLE 105 NOVAVAX VACCINE PRODUCTS 146
PHARMATHENE, INC. 147
Business Overview 147
Products 147
TABLE 106 PHARMATHENE VACCINE PRODUCTS 147
SOLIGENIX 147
Business Overview 147
TAPIMMUNE 148
Business Overview 148
PHARMACEUTICALS 148
GLAXOSMITHKLINE 148
Business Overview 148
Products 149
TABLE 107 GLAXOSMITHKLINE PHARMACEUTICAL PRODUCTS 149
MERCK 149
Business Overview 149
Products 150
TABLE 108 MERCK BIODEFENSE-RELATED PHARMACEUTICAL PRODUCTS 150
SAREPTA THERAPEUTICS 150
Business Overview 150
SIGA TECHNOLOGIES 150
Business Overview 150
Product 151
TABLE 109 SIGA BIODEFENSE-RELATED PRODUCT 151
NATIONAL LABORATORIES 151
LAWRENCE LIVERMORE NATIONAL LABORATORIES 151
Business Overview 151
SABIN VACCINE INSTITUTE 151
Business Overview 152

LIST OF TABLES
SUMMARY TABLE U.S. MARKET FOR BIODEFENSE-RELATED RAPID PATHOGEN
IDENTIFICATION PRODUCTS, THROUGH 2021 ($ MILLIONS) 7
TABLE 1 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM AGENTS/DISEASES:
CLASS A 12
TABLE 2 CLASS A PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 13
TABLE 3 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM AGENTS/DISEASES:
CLASS B 13
TABLE 4 CLASS B PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 13
TABLE 5 U.S. GOVERNMENT CLASSIFICATION OF BIOTERRORISM AGENTS/DISEASES:
CLASS C 14
TABLE 6 CLASS C PATHOGEN IDENTIFICATION BY TRANSMISSION METHOD 15
TABLE 7 LIMITATIONS OF SOME COMMON ANALYSIS METHODS 16
TABLE 8 CHARACTERISTICS OF BIOSENSORS 18
TABLE 9 DETECT-TO-WARN MONITORING SYSTEMS 21
TABLE 10 VACCINES FOR PATHOGENS, BY DISEASE OR CONDITION, BRAND NAME
AND MANUFACTURER, 2014 22
TABLE 11 COMMON PHARMACEUTICALS TO TREAT BIODEFENSE-RELATED
PATHOGENS BY NAME, MANUFACTURER, DISEASE OR CONDITION, 2015 23
TABLE 12 MAJOR GOVERNMENT FUNDERS OF R andD WITH AMOUNT FUNDED,
2012-2014 ($ BILLIONS) 26
TABLE 13 SELECTED MERGERS AND ACQUISITIONS IN THE BIODEFENSE
IDENTIFICATION INDUSTRY, JANUARY 2013-JUNE 2015 27
TABLE 14 BIODEFENSE-RELATED PATHOGEN IDENTIFICATION WITH TEST AND TEST
RESULT TIME (MINUTES) 30
TABLE 15 RAPID TESTS TO DETECT ANTHRAX 36
TABLE 16 RAPID TESTS TO DETECT YERSINIA PESTIS BACTERIA 38
TABLE 17 RAPID TESTS TO DETECT FRANCISELLA TULARENSIS BACTERIA 40
TABLE 18 RAPID TESTS TO DETECT SMALLPOX 41
TABLE 19 RAPID TESTS TO DETECT PANDEMIC INFLUENZA 43
TABLE 20 RAPID TESTS TO DETECT EBOLA HEMORRHAGIC FEVER 45
TABLE 21 VACCINES IN TESTING FOR EBOLA HEMORRHAGIC FEVER 46
TABLE 22 PHARMACEUTICALS IN TESTING FOR EBOLA HEMORRHAGIC FEVER 46
TABLE 23 RAPID TEST TO DETECT MARBURG HEMORRHAGIC FEVER 47
TABLE 24 RAPID TESTS TO DETECT BRUCELLA 48
TABLE 25 RAPID TESTS TO DETECT SALMONELLA 50
TABLE 26 RAPID TESTS TO DETECT E. COLI 51
TABLE 27 RAPID TESTS TO DETECT GLANDERS 52
TABLE 28 RAPID TEST TO DETECT MELIOIDOSIS 53
TABLE 29 RAPID TESTS TO DETECT PSITTACOSIS 54
TABLE 30 RAPID TESTS TO DETECT Q FEVER 55
TABLE 31 RAPID TESTS TO DETECT SEB 56
TABLE 32 METHOD TO DETECT TYPHOID FEVER 57
TABLE 33 VACCINES USED TO PREVENT TYPHOID INFECTIONS 57
TABLE 34 RAPID TESTS TO DETECT CHOLERA 58
TABLE 35 METHODS TO DETECT CRYPTOSPORIDIUM 60
TABLE 36 RAPID TESTS TO DETECT VIRAL ENCEPHALITIS 61
TABLE 37 RAPID TESTS TO DIAGNOSE RICIN POISONING 63
TABLE 38 RAPID TESTS TO DETECT BOTULISM POISONING 64
TABLE 39 VACCINES TO TREAT BOTULISM 65
TABLE 40 U.S. GOVERNMENT CONTRACTED MARKET FOR SNS VACCINES, 2013-2018
($ MILLIONS) 66
TABLE 41 BIODEFENSE-RELATED VACCINES BY INDICATION, NAME AND
MANUFACTURER 67
TABLE 42 MEDICATIONS TO TREAT SELECTED BIODEFENSE-RELATED PATHOGENS
BY DISEASE, MEDICATION AND TYPE 68
TABLE 43 BARRIERS TO USING BIOLOGICAL WEAPONS 70
TABLE 44 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED RAPID PATHOGEN
DETECTION DEVICES, THROUGH 2021 ($ MILLIONS) 72
TABLE 45 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED DETECTION DEVICES
BY TESTING METHOD, THROUGH 2021 ($ MILLIONS) 72
TABLE 46 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED DETECTION DEVICES
BY TYPE, THROUGH 2021 ($ MILLIONS) 74
TABLE 47 PROJECTED BIODEFENSE-RELATED MASS SPECTROMETRY DEVICE MARKET,
THROUGH 2021 ($ MILLIONS) 76
TABLE 48 PROJECTED BIODEFENSE-RELATED PCR DEVICE MARKET, THROUGH 2021
($ MILLIONS) 77
TABLE 49 PROJECTED U.S. BIODEFENSE-RELATED IMMUNOLOGICAL DEVICE MARKET,
THROUGH 2021 ($ MILLIONS) 78
TABLE 50 PROJECTED U.S. MARKET FOR BIODEFENSE-RELATED BIOLOGICAL
SENSORS, THROUGH 2021 ($ MILLIONS) 80
TABLE 51 PATHOGEN PHARMACEUTICAL PRODUCT PIPELINE 82
TABLE 52 PHARMACEUTICALS IN BACTERIA BIOTHREAT PIPELINE BY COMPOUND
NAME, STAGE OF DEVELOPMENT, APPLICATION, AND DEVELOPER 83
TABLE 53 PANDEMIC VACCINES UNDER DEVELOPMENT, 2015 87
TABLE 54 RAPID PATHOGEN IDENTIFICATION PATENTS: NUMBER, COMPANY, TYPE
OF DEVICE, DESCRIPTION AND DATE OF ISSUE, AUGUST 2011-JUNE 2015 91
TABLE 55 NUMBER OF PATENTS BY MANUFACTURER, AUGUST 2011-JUNE 2015 96
TABLE 56 PATENTS BY FUNCTION AND COMPANY AUGUST 2011-JUNE 2015 96
TABLE 57 SELECTED EMERGING INFECTIOUS DISEASE SINCE 1975 BY NAME, YEAR
IDENTIFIED, ESTIMATED GLOBAL IMPACT AND MORTALITY PERCENTAGE 101
TABLE 58 20/20 DIAGNOSTIC PRODUCT 111
TABLE 59 ADVNT DETECTION PRODUCTS 112
TABLE 60 AETHLON MEDICAL PRODUCTS 113
TABLE 61 ALERE DIAGNOSTIC PRODUCTS 113
TABLE 62 ALEXETER TECHNOLOGIES DIAGNOSTIC PRODUCTS 114
TABLE 63 ALPHA DIAGNOSTIC INTERNATIONAL DIAGNOSTIC PRODUCTS 115
TABLE 64 ANP TECHNOLOGIES DIAGNOSTIC PRODUCTS 116
TABLE 65 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 117
TABLE 66 BATTELLE DIAGNOSTIC PRODUCTS 118
TABLE 67 BB DETECTION DIAGNOSTIC PRODUCT 118
TABLE 68 BERTIN TECHNOLOGIES DIAGNOSTIC PRODUCTS 119
TABLE 69 BIODETECTION INSTRUMENTS DIAGNOSTIC PRODUCT 120
TABLE 70 BIOFIRE DEFENSE PRODUCTS 121
TABLE 71 BIOMEME BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 121
TABLE 72 BIOMERIEUX BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 122
TABLE 73 BIOSEARCH TECHNOLOGIES DIAGNOSTIC PRODUCT 123
TABLE 74 BIOTECH INTERNATIONAL BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 123
TABLE 75 BRUKER BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 124
TABLE 76 CHEMRING BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 125
TABLE 77 CORGENIX DIAGNOSTIC PRODUCT 126
TABLE 78 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC
PRODUCTS 126
TABLE 79 DIATHERIX DIAGNOSTIC PRODUCT 127
TABLE 80 ELECTRONIC SENSOR TECHNOLOGY DIAGNOSTIC PRODUCT 128
TABLE 81 ENVIRONICS DIAGNOSTICS PRODUCTS 128
TABLE 82 HAZTECH BIODEFENSE-RELATED PRODUCTS 129
TABLE 83 INBIOS DIAGNOSTICS PRODUCTS 130
TABLE 84 INTEGRATED NANO-TECHNOLOGIES DIAGNOSTICS PRODUCT 130
TABLE 85 MENON BIOSENSORS DIAGNOSTIC PRODUCT 131
TABLE 86 MESO SCALE DEFENSE DIAGNOSTICS PRODUCTS 132
TABLE 87 NANOLOGIX DIAGNOSTICS PRODUCT 132
TABLE 88 NEW HORIZON DIAGNOSTICS PRODUCTS 133
TABLE 89 OXFORD NANOPORE TECHNOLOGIES DIAGNOSTIC PRODUCTS 134
TABLE 90 PATHSENSORS DIAGNOSTICS PRODUCTS 135
TABLE 91 POSITIVE ID DIAGNOSTICS PRODUCTS 136
TABLE 92 PROENGIN DIAGNOSTICS PRODUCT 137
TABLE 93 QIAGEN BIODEFENSE-RELATED DIAGNOSTIC PRODUCTS 137
TABLE 94 QUANTUMDX BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 138
TABLE 95 RESEARCH INTERNATIONAL BIODEFENSE-RELATED DIAGNOSTIC PRODUCT 139
TABLE 96 REAL-TIME ANALYZERS DIAGNOSTIC PRODUCT 140
TABLE 97 RESPONSE BIOMEDICAL DIAGNOSTIC PRODUCTS 140
TABLE 98 SANDIA NATIONAL LABORATORIES DIAGNOSTIC PRODUCT 141
TABLE 99 SMITHS DETECTION BIODEFENSE-RELATED PRODUCTS 142
TABLE 100 THERMO FISHER BIODEFENSE-RELATED PRODUCT 143
TABLE 101 TETRACORE BIODEFENSE-RELATED PRODUCTS 143
TABLE 102 BAVARIAN NORDIC BIODEFENSE VACCINE PRODUCT 144
TABLE 103 EMERGENT BIOSOLUTIONS VACCINE PRODUCTS 145
TABLE 104 INOVIO PHARMACEUTICALS VACCINE PRODUCTS 146
TABLE 105 NOVAVAX VACCINE PRODUCTS 146
TABLE 106 PHARMATHENE VACCINE PRODUCTS 147
TABLE 107 GLAXOSMITHKLINE PHARMACEUTICAL PRODUCTS 149
TABLE 108 MERCK BIODEFENSE-RELATED PHARMACEUTICAL PRODUCTS 150
TABLE 109 SIGA BIODEFENSE-RELATED PRODUCT 151

LIST OF FIGURES
SUMMARY FIGURE BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
MARKET, BY TYPE OF DETECTION, IN 2016 AND 2021 (%) 7
FIGURE 1 FIVE COMPONENTS TO BIOLOGICAL DEFENSE (%) 24
FIGURE 2 U.S. GENERAL R andD FUNDING SOURCES, 2014 (%) 26
FIGURE 3 ANTIBIOTICS USED TO TREAT BIODEFENSE-RELATED BACTERIAL THREATS
(%) 68
FIGURE 4 SHARES OF BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
DEVICES BY TESTING METHOD, 2016 AND 2021 (%) 73
FIGURE 5 SHARES OF BIODEFENSE-RELATED RAPID PATHOGEN IDENTIFICATION
DEVICES BY TYPE, 2016 AND 2021 (%) 74
FIGURE 6 PERCENTAGE OF PROJECT BIOSHIELD FUNDS USED TO ACQUIRE
COUNTERMEASURES, 2004-2014 (%) 102

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