Global Markets and Technologies for Pandemic Control

  • March 2013
  • -
  • BCC Research
  • -
  • 172 pages

REPORT SCOPE

INTRODUCTION

REASONS FOR DOING THE STUDY

The spread of human immunodeficiency virus (HIV), hepatitis B and C, evolving influenza strains and antibiotic-resistant organisms have put healthcare agencies on guard to avert pending pandemics from these diseases. They have also alerted healthcare professionals to the possibility of the use of viruses and bacteria in bioterrorism threats.
The problem of antimicrobial resistance poses a global threat to the effective treatment of many bacterial diseases. Additionally, the emergence of drug-resistant strains of HIV and hepatitis have jolted the healthcare community out of its relative complacency about the threat of infectious diseases and prompted diagnostic and pharmaceutical manufacturers to bolster their infectious disease pipelines.
Multidrug-resistant tuberculosis is no longer confined to any one country or to those individuals who are co-infected with HIV. A number of multidrug resistant microbes such as methicillin-resistant Staphalococcus auerus (MRSA) and vancomycin-resistant Enterococcus (VRE) that were once found only in hospitals or nursing homes are now active in the community at large.
The rate of HIV infection combined with resistance to existing HIV and acquired immunodeficiency syndrome (AIDS) drugs and the obstacles encountered in developing an AIDS vaccine have resulted in a full-blown pandemic. Further, drug resistance in the treatment of HIV/AIDS necessitates the use of complex dosage protocols with unpleasant side effects that often further debilitate patients.
Solutions to the dilemma of drug resistance involve management approaches on a worldwide scale (such as the implementation of rigorous surveillance of resistant organisms), better education of healthcare workers about appropriate use of antibiotics and closer monitoring of antibiotics used in animal and plant crops.
Combined with these organizational activities is the need for new and effective drugs. New drugs to treat bacterial diseases and HIV/AIDS are being developed, but a new class of drugs to treat bacterial infections has not been developed since 2003, underscoring the need for more development in this area.

SCOPE OF REPORT

This report provides an in-depth look at the emerging pandemic of antibiotic resistance and the established viral pandemic of HIV/AIDS. It also provides historical, epidemiological and market information on hepatitis B and C, tuberculosis and malaria. This report also investigates bacterial and viral diseases that are emerging as health threats because of inadequate or nonexistent preventive and/or therapeutic products to combat them.
Antibiotic-resistant organisms wreak havoc with international healthcare systems as methicillin-resistant Staphylococcus aureus (MRSA), vancomycin-resistant Enterococci (VRE) and Clostridium difficile (C. diffile) become more pervasive. These infections represent future pandemics if no suitable antibiotics are developed to counteract them. At present, each is problematic, but remains at an epidemic level, primarily within healthcare institutions and nursing facilities. Consequently, these infections are covered descriptively within the report, but are not yet classified as pandemics, nor measured quantitatively as part of the overall market for pandemics.
The report outlines the available preventative and diagnostic products used to combat current and future pandemic infections and projects markets for these products. Forecasts are provided for the diagnostic and pharmaceutical markets for products to treat HIV/AIDS, hepatitis B and C, malaria and tuberculosis. Forecasts and trends are gleaned from industry sources as well as from an assessment of emerging products and technologies.
The causes, the extent of impact and strategies to monitor, treat and prevent resistant diseases are assessed. The mechanisms by which drugs function to combat resistant microbes are described. Drugs that show promise of long-term activity (i.e., low likelihood of resistance) and their effects on the market are assessed.

METHODOLOGY/INFORMATION SOURCES

The data for this report were gathered from primary and secondary sources, including information obtained from industry analysts, manufacturer and company reports, industry trade journals, medical journals and industry associations. Additional information was obtained through the U.S. Patent and Trademark Office (USPTO), U.S. Securities and Exchange Commission (SEC) filings, The World Health Organization (WHO), the Organisation for Economic Cooperation and Development (OECD), the Mayo Clinic, the Pharmaceutical Research and Manufacturing Association and the Joint United Nations Programme on HIV/AIDS (UNAIDS).
Where precise information was not available, projections were made using reasonable assumptions and estimates based on historical data. Market data are based on manufacturers' sales.

INTENDED AUDIENCE

This updated version of the pandemic market and technologies will be a valuable tool for decision makers, marketing personnel and manufacturers in both the diagnostic and pharmaceutical treatment industries. Individuals at research foundations, manufacturing companies and university laboratories will find valuable information on the global diagnostic product and pharmaceutical industries.

ANALYST CREDENTIALS

Peggy S. Lehr is the BCC Research analyst of this report. Ms. Lehr holds a BS in Journalism from the University of Colorado, Boulder, and a MS in Communication from the University of Denver. Ms. Lehr has worked as a researcher, editor and publisher within the publishing industry for both for-profit and not-for-profit organizations.

REPORT HIGHLIGHTS

The report provides:
• An overview of the products in development to treat bacterial diseases, especially those caused by drug-resistant organisms, and HIV/AIDS
• Analyses of market trends, with data from 2011 and 2012, and projections of compound annual growth rates (CAGRs) through 2017
• Clarification of the HIV/AIDS pandemic and ongoing efforts to control it
• Discussion of emerging threats, such as multidrug-resistant tuberculosis, West Nile virus and other serious viral diseases
• Trends based on projected sales through 2017 for new products, including supporting analyses for projections.
• Comprehensive company profiles of major players.

Table Of Contents

TABLE OF CONTENTS

CHAPTER 1 INTRODUCTION 2

REASONS FOR DOING THE STUDY 2
SCOPE OF REPORT 2
METHODOLOGY/INFORMATION SOURCES 3
INTENDED AUDIENCE 3
ANALYST CREDENTIALS 3
RELATED BCC REPORTS 4
BCC ONLINE SERVICES 4
DISCLAIMER 4

CHAPTER 2 SUMMARY 6

SUMMARY TABLE PROJECTED MARKET FOR PANDEMIC INFECTIOUS
DISEASE PRODUCTS, BY DISEASE TYPE, THROUGH 2017 ($ MILLIONS) 7
SUMMARY FIGURE PROJECTED MARKET FOR PANDEMIC INFECTIOUS
DISEASE PRODUCTS, BY REGION, 2012 AND 2017 (%) 7

CHAPTER 3 OVERVIEW 10

PATHOGENIC MICROBES AND INFECTIOUS DISEASES RECOGNIZED
BETWEEN 1973 AND 2009 10
TABLE 1 DISEASE-CAUSING BACTERIA, PARASITES, AND VIRUSES
IDENTIFIED BETWEEN 1973 AND 2009 10
FACTORS IN THE EMERGENCE OF INFECTIOUS DISEASES 11
HUMAN DEMOGRAPHICS AND BEHAVIOR 12
TECHNOLOGY 12
THE ROLE OF NEEDLES 12
ECONOMIC DEVELOPMENT AND LAND USE 12
INTERNATIONAL TRAVEL 13
MICROBIAL ADAPTATION 13
ANTIBIOTIC DEVELOPMENT 13
TABLE 2 HISTORY OF ANTIBIOTIC DISCOVERY AND APPROVAL, 1935-2003 13
CLASSIFYING VIRAL OUTBREAKS, EPIDEMICS AND PANDEMICS 14
TABLE 3 CDC’S SIX PHASES OF CLASSIFICATION OF VIRAL PANDEMICS 14
CURRENT AND POTENTIAL EPIDEMICS WITH PANDEMIC POTENTIAL 14
TABLE 4 MAJOR INFECTIOUS DISEASES WITH TYPE OF DISEASE, NUMBER
OF CASES, AND POTENTIAL AS A PANDEMIC, 2011 15
CURRENT AND POTENTIAL PANDEMICS 16
CURRENT TECHNOLOGIES FOR ADDRESSING POTENTIAL PANDEMIC
THREATS 16
TABLE 5 TECHNOLOGIES TO ADDRESS POTENTIAL PANDEMIC THREATS 17
BIOLOGICAL WEAPONS FOR TERRORISM 17
TABLE 6 DISEASES THAT COULD BE OR HAVE BEEN WEAPONIZED 18
THE NEXT PANDEMIC 18
TYPES OF ZOONOTIC VIRUSES 19
A BRIEF HISTORY OF GLOBAL PANDEMICS 19
BUBONIC PLAGUE (1300 TO PRESENT) 19
CHOLERA (1916 TO 1966) 20
THE SPANISH INFLUENZA PANDEMIC (1918) 20
ASIAN FLU PANDEMIC (1957 TO 1958) 20
HIV/AIDS PANDEMIC (1980 TO PRESENT) 21
INFLUENZA A-H1N1 (2009 TO PRESENT) 21
MALARIA (2700 BC TO PRESENT) 21
SEVERE ACUTE RESPIRATORY SYNDROME (SARS) (2002 TO 2003) 22
SMALLPOX (15TH CENTURY TO 1979) 22
TUBERCULOSIS (4000 BC TO PRESENT) 22
TREATMENTS FOR INFECTIOUS DISEASES 23
PREVENTION 23
VACCINATION 23
PHARMACEUTICAL TREATMENTS 23
OPPORTUNITIES TO FIGHT POTENTIAL PANDEMIC INFECTIOUS
DISEASES 24
BIOINFORMATION AND REMOTE SENSING MARKET 24
MERGERS AND ACQUISITIONS 24
TABLE 7 SELECTED MERGERS AND ACQUISITIONS, 2008-2012 ($ MILLIONS) 25

CHAPTER 4 VACCINES, DIAGNOSTIC TESTING, AND PHARMACEUTICAL

MARKETS FOR INFECTIOUS DISEASES 27
VACCINES 27
TABLE 8 MAJOR MANUFACTURERS OF VACCINES FOR CURRENT AND
POTENTIAL PANDEMICS 28
TYPES OF DIAGNOSTIC TESTING 28
FLUORESCENT IMMUNOASSAY (FIA) 29
Direct Fluorescent Antibody Testing 29
Indirect Fluorescent Antibody Testing 29
Chemiluminescent Microparticle Immunoassay (CIA) 29
Chemiluminescent Microparticle Immunoassay (CIA) 29
ENZYME IMMUNOASSAY 30
Basic EIA 30
Enzyme-linked Immunosorbent Assay (ELISA) 30
GENE PROBE ANALYSIS 31
Polymerase Chain Reaction Amplification 31
Nucleic Acid Amplification Test (NAT) 31
Transcription-Mediated Amplification (TMA) 32
Nucleic Acid Sequence-Based Amplification (NASBA) 32
MARKET ANALYSIS, BY DISEASE 32
HEPATITIS B AND C 32
Diagnostic Product Market 33
TABLE 9 HEPATITIS B AND C DIAGNOSTIC PRODUCT MARKET BY TYPE OF
TEST, 2011 ($ MILLIONS/%) 33
TABLE 10 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HEPATITIS
B AND C, 2012 33
Automated Infectious Disease Testing for Hepatitis 35
Treatment Market 35
TABLE 11 HEPATITIS B AND C TREATMENT MANUFACTURER MARKET
STANDING, BY REVENUE, 2011 ($ MILLIONS) 36
FIGURE 1 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS
MARKET AND THEIR MARKET SHARE, 2011 (%) 36
Vaccines and Medications for Hepatitis 37
TABLE 12 VACCINES AND MEDICATIONS FOR THE TREATMENT OF
HEPATITIS, 2012 37
HIV/AIDS 38
Diagnostic Market 38
TABLE 13 HIV DIAGNOSTIC PRODUCT MARKET SHARE, 2011 ($ MILLIONS/%) 38
TABLE 14 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HIV/AIDS,
2012 38
Treatments 39
TABLE 15 HIV LIFE CYCLE 40
Nucleoside Reverse Transcriptase Inhibitors (NRTI) 40
Non-nucleoside Reverse Transcriptase Inhibitors (NNRTI) 40
Protease Inhibitors (PI) 40
Entry Inhibitors 41
Integrase Inhibitors 41
Multi-class Combination 41
Generic Treatments 41
TABLE 16 FDA-APPROVED GENERIC DRUGS FOR TREATMENT OF HIV, 2004
TO 2012 41
Brand Name HIV Treatments 42
TABLE 17 CURRENTLY APPROVED PHARMACEUTICAL PRODUCTS FOR
TREATMENT OF HIV/AIDS, 2012 43
BRANDED TREATMENT MARKET, BY MAJOR MANUFACTURER 44
TABLE 18 HIV TREATMENT MARKET BY MANUFACTURER, 2011 ($ MILLIONS) 44
FIGURE 2 MARKET SHARE FOR BRANDED HIV DRUGS BY MANUFACTURER,
2011 (%) 44
INFLUENZA 45
Pandemic Influenza (H1N1) 46
Diagnostic Products 46
TABLE 19 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF
PANDEMIC INFLUENZA, 2012 46
Pharmaceutical Products 46
TABLE 20 CURRENT PHARMACEUTICALS APPROPRIATE FOR TREATMENT OF
PANDEMIC INFLUENZA 47
MALARIA 47
Mosquito Netting 47
TABLE 21 WHO RECOMMENDED MOSQUITO NETTING, 2012 48
Diagnosis of Malaria 48
TABLE 22 AVAILABLE MALARIA DIAGNOSTIC METHODS 49
Diagnostic Tests of Malaria 49
TABLE 23 CURRENT RAPID DIAGNOSTIC TESTS FOR DETECTION OF
MALARIA 49
Pharmaceutical Treatments for Malaria 50
TABLE 24 PHARMACEUTICAL PRODUCTS USED TO TREAT MALARIA, 2012 51
TUBERCULOSIS 51
Diagnostic Products 51
TABLE 25 CURRENT DIAGNOSTIC TESTS FOR DETECTION OF
TUBERCULOSIS, 2012 52
Pharmaceutical Products 52
TABLE 26 DRUGS USED TO TREAT TB 52

CHAPTER 5 DISEASE OVERVIEW 55

TABLE 27 CAUSATIVE ORGANISMS FOR PANDEMIC DISEASES 55
ANTHRAX 55
OVERVIEW 55
RISK FACTORS 55
INCIDENCE 56
DIAGNOSTIC PROCEDURES 56
TREATMENTS 56
TABLE 28 VACCINES AND MEDICATIONS FOR THE TREATMENT OF
ANTHRAX, 2012 56
CHOLERA 57
OVERVIEW 57
RISK FACTORS 57
INCIDENCE 57
DIAGNOSTIC PROCEDURES 57
TABLE 29 CURRENT DIAGNOSTIC TESTS FOR CHOLERA 57
TREATMENT 58
HEPATITIS B AND C 58
OVERVIEW 58
RISK FACTORS 59
INCIDENCE 59
Hepatitis in the U.S. 59
Hepatitis C in the U.S. 59
Hepatitis in Canada 59
Hepatitis B and C in EMRA 59
Hepatitis in Africa 60
Hepatitis in Russia, Eurasia 60
Hepatitis in Japan 61
Hepatitis in China 61
Hepatitis in India 61
Hepatitis in Australia 61
TREATMENTS 61
HIV/AIDS 61
OVERVIEW 61
TABLE 30 CDC CLASSIFICATION OF HIV INFECTION 62
RISK FACTORS 63
INCIDENCE/MORTALITY 63
HIV in the U.S. 63
HIV and Women in the U.S. 64
HIV in Canada 64
HIV in Latin and South America 64
HIV Treatment in Central/South America 64
HIV/AIDS in the EMRA 65
HIV in Africa 65
Access to Therapeutics in Africa 65
Russia, Eastern Europe, Central Asia 66
HIV Treatments in the Region 66
HIV in the Middle East 66
HIV in Sub-Saharan Africa 66
HIV/AIDS in Asia 67
HIV in Japan 67
HIV in India 67
HIV Testing/Treatment in India 67
HIV in China 68
HIV Testing and Treatment in China 68
Estimated Active Pharmaceutical Ingredients Needed 69
TABLE 31 PROJECTED NEED FOR API TO MEET CORE ARV PRODUCT
REQUIREMENTS, 2011 AND 2015 69
INFLUENZA 69
OVERVIEW 69
Vaccines 69
New Production Techniques for Developing Influenza Vaccines 70
H1N1 70
H5N1 70
Mutations that Transform H5N1 into Pandemic Influenza 70
Pandemic Risk 71
Risk Factors 71
Incidence/Mortality 72
MALARIA 72
OVERVIEW 72
RISK FACTORS 72
Biological Characteristics 72
INCIDENCE/MORTALITY 73
TREATMENT MARKET 73
SEVERE ACUTE RESPIRATORY SYNDROME (SARS) 73
OUTBREAK LOCALES 73
INFECTION AND TRANSMISSION 74
TREATMENT 74
TUBERCULOSIS 74
OVERVIEW 74
RISK FACTORS 74
INCIDENCE/MORTALITY 75
HEMORRHAGIC FEVERS 75
ARENAVIRUSES 76
BUNYAVIRUSES 76
FILOVIRUSES 76
FLAVIVIRUSES 77
RISK 77
PANDEMIC POTENTIAL FOR HEMORRHAGIC VIRUSES 77

CHAPTER 6 VIRAL PANDEMIC THREATS AND TREATMENTS 80

WHAT IS A VIRUS? 80
PROJECTED GLOBAL MARKET FOR VACCINES, DIAGNOSTICS AND
PHARMACEUTICALS 80
TABLE 32 PROJECTED GLOBAL MARKET FOR VIRAL HIV AND HEPATITIS
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($
MILLIONS)
80
GLOBAL DIAGNOSTIC MARKET FOR HIV AND HEPATITIS 81
MARKET FOR VIRAL DISEASE DIAGNOSTIC PRODUCTS 81
TABLE 33 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED
TO DETECT HIV AND HEPATITIS PANDEMIC DISEASES, THROUGH 2017 ($
MILLIONS)
81
FIGURE 3 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED
TO DETECT HIV AND HEPATITIS PANDEMIC DISEASES, 2012 AND 2017 (%) 81
VIRAL PANDEMIC PHARMACEUTICAL PRODUCTS, BY DISEASE 82
TABLE 34 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC
PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 83
FIGURE 4 GLOBAL MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS, 2012 AND 2017 (%) 83
HEPATITIS 84
TABLE 35 HEPATITIS CHARACTERISTICS BY TYPE 84
TABLE 36 PROJECTED GLOBAL MARKET FOR HEPATITIS DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 85
TABLE 37 PROJECTED GLOBAL MARKET FOR HEPATITIS VACCINE AND
PHARMACEUTICALS, THROUGH 2017 ($ MILLIONS) 86
HEPATITIS A 86
TABLE 38 PROJECTED REVENUE FROM HEPATITIS A TREATMENTS,
THROUGH 2017 ($ MILLIONS) 86
HEPATITIS B 87
TABLE 39 PROJECTED GLOBAL REVENUE FROM HEPATITIS
PHARMACEUTICALS AND VACCINATIONS, THROUGH 2017 ($ MILLIONS) 87
HEPATITIS C 87
TABLE 40 PROJECTED GLOBAL REVENUE FROM HEPATITIS C
PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($ MILLIONS) 87
FIGURE 5 MARKET SHARES FOR HEPATITIS C TREATMENTS, 2010 (%) 88
REGIONAL ANALYSIS 88
TABLE 41 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, BY REGION, THROUGH 2017 ($
MILLIONS)
89
PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS, BY REGION 89
TABLE 42 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 89
FIGURE 6 GLOBAL PANDEMIC VIRAL INFECTIOUS DISEASE DIAGNOSTIC
MARKET, 2012 AND 2017 (%) 89
TABLE 43 PROJECTED GLOBAL MARKET FOR PANDEMIC PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 91
FIGURE 7 GLOBAL PANDEMIC PHARMACEUTICAL MARKET, 2012 AND 2017
(%) 91
AMERICAS 92
TABLE 44 PROJECTED AMERICAS MARKET FOR VIRAL PANDEMIC
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($
MILLIONS)
92
TABLE 45 PROJECTED MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) 93
TABLE 46 PROJECTED MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) 93
EMRA 93
TABLE 47 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 94
DIAGNOSTIC MARKET IN EMRA 94
TABLE 48 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 94
TABLE 49 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC
PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 95
ASIA 95
TABLE 50 PROJECTED ASIAN MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 95
DIAGNOSTIC PRODUCTS IN ASIA 95
TABLE 51 PROJECTED MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS IN ASIA, THROUGH 2017 ($ MILLIONS) 96
FIGURE 8 MARKET FOR PANDEMIC DIAGNOSTIC PRODUCTS IN ASIA 2012
AND 2017 (%) 96
TABLE 52 PROJECTED MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS IN ASIA, THROUGH 2017 ($ MILLIONS) 97
OPPORTUNITIES IN THE VIRAL PANDEMIC INFECTIOUS DISEASE
DIAGNOSIS AND TREATMENT MARKET 97
OPPORTUNITIES IN THE HIV/AIDS MARKET 97
Diagnostics 97
Pharmaceuticals 98
Immediate Term Priorities 99
Medium Term Priorities 99
OPPORTUNITIES IN THE HEPATITIS MARKET 100
Pharmaceutical Opportunities in the Hepatitis Market 100

CHAPTER 7 BACTERIAL PANDEMIC THREATS AND TREATMENTS 102

ANTIBACTERIAL RESISTANCE 102
THE MICROBIOLOGY OF BACTERIAL RESISTANCE 102
MECHANISMS OF RESISTANCE 103
METHODS OF RESISTANCE 103
Beta-Lactamase Production 103
Importing Resistance from Other Organisms 104
Alteration of Binding Sites to Circumvent Anti-Infective
Effectiveness 105
Antibiotic Discharge 105
PRIMARY REASONS FOR ANTIBIOTIC RESISTANCE 105
BROAD-SPECTRUM PRESCRIPTIONS 105
PATIENT PRESSURE 106
SURVEILLANCE OF MICROBIAL RESISTANCE TO ANTIBIOTICS 106
RESISTANCE BY CLASS OF ANTIBIOTIC 106
TABLE 53 ANTIBIOTIC RESISTANT ORGANISMS AND DRUG CLASSES
AFFECTED 106
INCIDENCES OF ANTIBIOTIC RESISTANCE 107
ANTIBIOTIC RESISTANCE IN EUROPE 107
MRSA INFECTIONS IN MALAYSIA 107
ANTIBIOTIC RESISTANCE IN THE U.S. 107
VANCOMYCIN-RESISTANT ENTEROCOCCUS (VRE) 107
METHICILLIN-RESISTANT STAPHYLOCOCCUS AUREUS (MRSA) 108
CLOSTRIDIUM DIFFICILE (C. DIFFICILE) 108
TUBERCULOSIS (TB) 108
TABLE 54 PROJECTED GLOBAL MARKET FOR TB DIAGNOSTIC AND
PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($ MILLIONS) 108
EPIDEMIOLOGY OF TB 109
GEOGRAPHIC PREVALENCE 109
FINANCING CONTROL EFFORTS 110
DIAGNOSING TB 110
Smear Microscopy 110
Phage-based Diagnostics 110
Nucleic Acid Amplification Technologies (NAAT) 110
TABLE 55 PROJECTED GLOBAL MARKET FOR TB DIAGNOSTIC TESTS,
THROUGH 2017 ($ MILLIONS) 111
PHARMACEUTICAL TREATMENTS FOR TB 111
TABLE 56 CURRENTLY AVAILABLE TREATMENTS FOR TB WITH BRAND
NAME, GENERIC NAME AND MANUFACTURER, 2012 111
MARKET FOR TB PHARMACEUTICAL TREATMENTS 112
TABLE 57 PROJECTED GLOBAL MARKET FOR TB PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 112
REGIONAL ANALYSIS 112
TABLE 58 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC TB PRODUCTS BY
REGION, THROUGH 2017 ($ MILLIONS) 113
TABLE 59 PROJECTED GLOBAL MARKET FOR TB PHARMACEUTICAL
PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) 113
AMERICAS 113
TABLE 60 PROJECTED AMERICAS MARKET FOR TB DIAGNOSTIC PRODUCTS
THROUGH 2017 ($ MILLIONS) 114
TABLE 61 PROJECTED AMERICAS MARKET FOR TB PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 114
EMRA 114
TABLE 62 PROJECTED EMRA MARKET FOR TB DIAGNOSTIC PRODUCTS,
THROUGH 2017 ($ MILLIONS) 115
TABLE 63 PROJECTED EMRA MARKET FOR TB PHARMACEUTICAL PRODUCTS,
THROUGH 2017 ($ MILLIONS) 115
ASIA 115
TABLE 64 PROJECTED ASIAN MARKET FOR TB DIAGNOSTIC PRODUCTS,
THROUGH 2017 ($ MILLIONS) 116
TABLE 65 PROJECTED ASIAN MARKET FOR TB PHARMACEUTICAL PRODUCTS,
THROUGH 2017 ($ MILLIONS) 116
OPPORTUNITIES IN THE TUBERCULOSIS MARKET 116
PREVENTION 116
TABLE 66 CURRENT TB VACCINES IN DEVELOPMENT 117
DIAGNOSTICS 117
TREATMENT 117
TABLE 67 PHARMACEUTICALS IN DEVELOPMENT FOR THE TREATMENT OF
TB, 2012 118

CHAPTER 8 PARASITIC PANDEMIC THREATS AND TREATMENTS 120

CLIMATE CHANGE AND VECTOR-BORNE DISEASES 120
MALARIA 120
TABLE 68 ESTIMATED 2010 GLOBAL MALARIA CASES AND DEATHS, WITH
RATE OF DECREASE OF MALARIA DEATHS BY REGION* SINCE 2000 120
Cause of Malaria 121
TABLE 69 PROJECTED GLOBAL MARKET FOR MALARIA PREVENTION,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($
MILLIONS)
121
Interventional Techniques to Minimize Exposure to Malarial Vectors 122
TABLE 70 PROJECTED GLOBAL MARKET FOR INSECTICIDE-TREATED NETS,
THROUGH 2017 ($ MILLIONS) 122
Diagnosis of Malaria 122
TABLE 71 PROJECTED GLOBAL MARKET FOR MALARIAL DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 123
Treatment of Malaria 123
TABLE 72 PROJECTED GLOBAL MARKET FOR MALARIA DRUG TREATMENTS,
THROUGH 2017 ($ MILLIONS) 123
Regional Analysis 123
TABLE 73 PROJECTED GLOBAL MARKET FOR MALARIAL PANDEMIC
PREVENTION, DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS BY REGION,
THROUGH 2017 ($ MILLIONS)
124
The Americas 124
TABLE 74 PROJECTED AMERICAS MARKET FOR MALARIA PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS THROUGH 2017 ($
MILLIONS)
124
TABLE 75 MALARIAL PREVENTION PRODUCT MARKET IN THE AMERICAS BY
REGION, THROUGH 2017 ($ MILLIONS) 125
TABLE 76 MALARIAL DIAGNOSTIC PRODUCT MARKET IN THE AMERICAS BY
REGION, THROUGH 2017 ($ MILLIONS) 125
TABLE 77 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN THE
AMERICAS BY REGION, THROUGH 2017 ($ MILLIONS) 126
EMRA 126
TABLE 78 PROJECTED EMRA MARKET FOR MALARIAL PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS THROUGH 2017 ($
MILLIONS)
126
TABLE 79 MALARIAL PREVENTATIVE PRODUCT MARKET IN THE EMRA BY
REGION, THROUGH 2017 ($ MILLIONS) 127
TABLE 80 MALARIAL DIAGNOSTIC PRODUCT MARKET IN THE EMRA BY
REGION, THROUGH 2017 ($ MILLIONS) 127
TABLE 81 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN THE EMRA
BY REGION, THROUGH 2017 ($ MILLIONS) 128
Asia 128
TABLE 82 PROJECTED ASIA MARKET FOR MALARIA PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($
MILLIONS) 128
TABLE 83 MALARIAL PREVENTION PRODUCT MARKET IN ASIA BY REGION,
THROUGH 2017 ($ MILLIONS) 129
TABLE 84 MALARIAL DIAGNOSTIC PRODUCT MARKET IN ASIA BY REGION,
THROUGH 2017 ($ MILLIONS) 129
TABLE 85 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN ASIA BY
REGION, THROUGH 2017 ($ MILLIONS) 130
OPPORTUNITIES IN THE MALARIAL DISEASE MARKET 130
Diagnostic Testing 130
Pharmaceutical Products 130

CHAPTER 9 REGULATIONS 132

CREATING DRUG TREATMENTS 132
TABLE 86 PROCESS OF CREATING DRUG TREATMENTS IN THE U.S. 132
REGIONAL REGULATIONS 133
THE AMERICAS 133
Canada 133
EMA 134
Diagnostic Products in EU 134
ASIA 134
Japan 134
Diagnostic Regulations 135
Pharmaceutical Regulations 135
China 135
India 135

CHAPTER 10 PHARMACEUTICAL TREATMENT PIPELINE 138

EMERGING TRENDS IN DIAGNOSTIC PRODUCTS 138
ANTIBIOTIC-RESISTANT INFECTIONS 138
EMERGING TRENDS IN PHARMACEUTICAL PRODUCTS 138
HIV/AIDS 138
Gilead Sciences 139
GlaxoSmithKline 139
HEPATITIS 139
Gilead Sciences 139
Janssen Pharmaceuticals/Tibotec Pharmaceuticals 140
Merck 140
Roche 140
Boehringer Ingelheim 140
Vertex Pharmaceuticals 141
INFLUENZA 141
VaxInnate 141
PHARMACEUTICAL TREATMENT PRODUCT PIPELINE 141
TABLE 87 PANDEMIC DISEASE PHARMACEUTICAL PRODUCT PIPELINE, 2012 141

CHAPTER 11 PATENT ANALYSIS 149

PHARMACEUTICAL PATENTS ISSUED BY COMPANY, APPROVAL DATE AND
DISEASE 149
TABLE 88 PANDEMIC PHARMACEUTICAL AND VACCINE PATENTS
(FEBRUARY 2006-DECEMBER 2012) 150
DIAGNOSTIC PATENTS ISSUED BY COMPANY, APPROVAL DATE AND
DISEASE 154
TABLE 89 PANDEMIC DIAGNOSTIC PATENTS (MARCH 2005 THROUGH
DECEMBER 2012) 154
PATENTS ISSUED BY COMPANY 155
TABLE 90 PANDEMIC PHARMACEUTICAL AND VACCINE PRODUCT PATENTS
(JANUARY 2005 THROUGH DECEMBER 2012) 155
TABLE 91 PANDEMIC DIAGNOSTIC PRODUCT PATENTS (JANUARY 2005
THROUGH DECEMBER 2012) 156
PATENTS ISSUED BY COUNTRY 157
TABLE 92 PANDEMIC PRODUCT DIAGNOSIS AND TREATMENT PATENTS, BY
COUNTRY (JANUARY 2005 THROUGH DECEMBER 2012) 157
PATENTS ISSUED, BY DISEASE 157
TABLE 93 PATENTS ISSUED FOR DIAGNOSIS AND TREATMENT OF
PANDEMIC DISEASES (MARCH 2005 THROUGH OCTOBER 2012) 158
FIGURE 9 DIAGNOSTIC AND PHARMACEUTICAL PATENTS ISSUED
(BETWEEN MARCH 2005 AND DECEMBER 2012) (%) 158

CHAPTER 12 COMPANY DIRECTORY 161

ABBOTT LABORATORIES 161
TABLE 94 ABBOTT PHARMACEUTICAL PRODUCTS 161
TABLE 95 ABBOTT DIAGNOSTIC PRODUCTS 161
ALERE 161
TABLE 96 ALERE DIAGNOSTIC PRODUCTS 162
ALFA SCIENTIFIC DESIGNS 162
TABLE 97 ALFA SCIENTIFIC DESIGNS DIAGNOSTIC PRODUCTS 163
ANADYS PHARMACEUTICALS (SEE ROCHE) 163
ATLAS LINK BIOTECH CO, LTD 163
TABLE 98 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 163
BAXTER HEALTHCARE 163
TABLE 99 BAXTER PHARMACEUTICAL PRODUCTS 164
BAYER AG 164
TABLE 100 BAYER PHARMACEUTICAL PRODUCTS 164
BIO-RAD LABORATORIES 164
TABLE 101 BIO-RAD DIAGNOSTIC PRODUCTS 165
BOEHRINGER INGELHEIM GMBH 165
TABLE 102 BOEHRINGER INGELHEIM PHARMACEUTICAL PRODUCTS 165
BRISTOL-MYERS SQUIBB COMPANY 166
TABLE 103 BRISTOL-MYERS SQUIBB PHARMACEUTICAL PRODUCTS 166
CREATIVE DIAGNOSTICS 166
TABLE 104 CREATIVE DIAGNOSTICS DIAGNOSTIC PRODUCTS 167
DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS, INC 167
TABLE 105 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC
PRODUCTS 167
DIASORIN 168
TABLE 106 DIAGNOSTIC PRODUCTS 168
EMERGENT BIOSOLUTIONS 168
TABLE 107 PHARMACEUTICAL PRODUCTS 169
ENANTA PHARMACEUTICALS 169
ENZO BIOCHEM 169
TABLE 108 ENZO BIOCHEM DIAGNOSTIC PRODUCTS 169
FIRST DIAGNOSTIC LLC 170
TABLE 109 DIAGNOSTIC PRODUCT 170
GILEAD SCIENCES, INC. 170
TABLE 110 GILEAD SCIENCES PHARMACEUTICAL PRODUCTS 171
GLAXOSMITHKLINE 171
TABLE 111 GSK PHARMACEUTICAL PRODUCTS 171
HOME ACCESS HEALTH, INC 172
TABLE 112 HOME ACCESS HEALTH DIAGNOSTIC PRODUCTS 172
HUMAN GENOME SCIENCES (SEE GLAXOSMITHKLINE) 172
IDENIX PHARMACEUTICALS 172
IMMUNOSTICS 173
TABLE 113 IMMUNOSTICS DIAGNOSTIC PRODUCTS 173
IND DIAGNOSTIC, INC. 173
TABLE 114 IND DIAGNOSTIC PRODUCTS 173
INVERNESS MEDICAL INNOVATIONS (SEE ALERE) 174
JANSSEN THERAPEUTICS (FORMERLY TIBOTEC THERAPEUTICS) 174
TABLE 115 JANSSEN THERAPEUTICS PHARMACEUTICAL PRODUCTS 174
MERCK and COMPANY, INC. 174
TABLE 116 MERCK PHARMACEUTICAL PRODUCTS 175
NOVARTIS PHARMACEUTICAL CORPORATION 175
TABLE 117 NOVARTIS DIAGNOSTIC PRODUCTS 176
ORASURE TECHNOLOGIES, INC. 176
TABLE 118 ORASURE DIAGNOSTIC PRODUCTS 176
ORTHO CLINICAL DIAGNOSTICS 176
TABLE 119 ORTHO DIAGNOSTIC PRODUCTS 177
PFIZER, INC. 177
TABLE 120 PFIZER PHARMACEUTICAL PRODUCTS 177
PRINCETON BIOMEDITECH CORPORATION 178
TABLE 121 PRINCETON BIOMEDITECH DIAGNOSTIC PRODUCTS 178
PROTEIN SCIENCES CORPORATION 178
ROCHE LABORATORIES (HOFFMANN-LA ROCHE INC) 179
TABLE 122 ROCHE PHARMACEUTICAL PRODUCTS 179
RIB-X PHARMACEUTICALS 179
ROMARK LABORATORIES 180
SANOFI PASTEUR 180
TABLE 123 SANOFI PASTEUR PHARMACEUTICAL PRODUCTS 180
SCICLONE PHARMACEUTICALS 181
TABLE 124 SCICLONE PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 181
SHANGHAI KEHUA BIO-ENGINEERING CO, LTD 181
TABLE 125 SHANGHAI KEHUA BIO-ENGINEERING DIAGNOSTIC PRODUCTS 181
STANDARD DIAGNOSTICS, INC 182
TABLE 126 STANDARD DIAGNOSTICS DIAGNOSTIC PRODUCTS 182
TRINITY BIOTECH PLC 183
TABLE 127 TRINITY BIOTECH DIAGNOSTIC PRODUCTS 183
VERTEX PHARMACEUTICALS 183
TABLE 128 VERTEX PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 183
VIIV HEALTHCARE 184
TABLE 129 VIIV HEALTHCARE PHARMACEUTICAL PRODUCTS 184



LIST OF TABLES

SUMMARY TABLE PROJECTED MARKET FOR PANDEMIC INFECTIOUS DISEASE
PRODUCTS, BY DISEASE TYPE, THROUGH 2017 ($ MILLIONS) 7
TABLE 1 DISEASE-CAUSING BACTERIA, PARASITES, AND VIRUSES IDENTIFIED
BETWEEN 1973 AND 2009 10
TABLE 2 HISTORY OF ANTIBIOTIC DISCOVERY AND APPROVAL, 1935-2003 13
TABLE 3 CDC’S SIX PHASES OF CLASSIFICATION OF VIRAL PANDEMICS 14
TABLE 4 MAJOR INFECTIOUS DISEASES WITH TYPE OF DISEASE, NUMBER OF
CASES, AND POTENTIAL AS A PANDEMIC, 2011 15
TABLE 5 TECHNOLOGIES TO ADDRESS POTENTIAL PANDEMIC THREATS 17
TABLE 6 DISEASES THAT COULD BE OR HAVE BEEN WEAPONIZED 18
TABLE 7 SELECTED MERGERS AND ACQUISITIONS, 2008-2012 ($ MILLIONS) 25
TABLE 8 MAJOR MANUFACTURERS OF VACCINES FOR CURRENT AND
POTENTIAL PANDEMICS 28
TABLE 9 HEPATITIS B AND C DIAGNOSTIC PRODUCT MARKET BY TYPE OF
TEST, 2011 ($ MILLIONS/%) 33
TABLE 10 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HEPATITIS
B AND C, 2012 33
TABLE 11 HEPATITIS B AND C TREATMENT MANUFACTURER MARKET
STANDING, BY REVENUE, 2011 ($ MILLIONS) 36
TABLE 12 VACCINES AND MEDICATIONS FOR THE TREATMENT OF HEPATITIS,
2012 37
TABLE 13 HIV DIAGNOSTIC PRODUCT MARKET SHARE, 2011 ($ MILLIONS/%) 38
TABLE 14 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF HIV/AIDS,
2012 38
TABLE 15 HIV LIFE CYCLE 40
TABLE 16 FDA-APPROVED GENERIC DRUGS FOR TREATMENT OF HIV, 2004 TO
2012 41
TABLE 17 CURRENTLY APPROVED PHARMACEUTICAL PRODUCTS FOR
TREATMENT OF HIV/AIDS, 2012 43
TABLE 18 HIV TREATMENT MARKET BY MANUFACTURER, 2011 ($ MILLIONS) 44
TABLE 19 CURRENT DIAGNOSTIC PRODUCTS FOR DETECTION OF PANDEMIC
INFLUENZA, 2012 46
TABLE 20 CURRENT PHARMACEUTICALS APPROPRIATE FOR TREATMENT OF
PANDEMIC INFLUENZA 47
TABLE 21 WHO RECOMMENDED MOSQUITO NETTING, 2012 48
TABLE 22 AVAILABLE MALARIA DIAGNOSTIC METHODS 49
TABLE 23 CURRENT RAPID DIAGNOSTIC TESTS FOR DETECTION OF MALARIA 49
TABLE 24 PHARMACEUTICAL PRODUCTS USED TO TREAT MALARIA, 2012 51
TABLE 25 CURRENT DIAGNOSTIC TESTS FOR DETECTION OF TUBERCULOSIS,
2012 52
TABLE 26 DRUGS USED TO TREAT TB 52
TABLE 27 CAUSATIVE ORGANISMS FOR PANDEMIC DISEASES 55
TABLE 28 VACCINES AND MEDICATIONS FOR THE TREATMENT OF ANTHRAX,
2012 56
TABLE 29 CURRENT DIAGNOSTIC TESTS FOR CHOLERA 57
TABLE 30 CDC CLASSIFICATION OF HIV INFECTION 62
TABLE 31 PROJECTED NEED FOR API TO MEET CORE ARV PRODUCT
REQUIREMENTS, 2011 AND 2015 69
TABLE 32 PROJECTED GLOBAL MARKET FOR VIRAL HIV AND HEPATITIS
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($
MILLIONS) 80
TABLE 33 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED
TO DETECT HIV AND HEPATITIS PANDEMIC DISEASES, THROUGH 2017 ($
MILLIONS) 81
TABLE 34 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC
PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 83
TABLE 35 HEPATITIS CHARACTERISTICS BY TYPE 84
TABLE 36 PROJECTED GLOBAL MARKET FOR HEPATITIS DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 85
TABLE 37 PROJECTED GLOBAL MARKET FOR HEPATITIS VACCINE AND
PHARMACEUTICALS, THROUGH 2017 ($ MILLIONS) 86
TABLE 38 PROJECTED REVENUE FROM HEPATITIS A TREATMENTS, THROUGH
2017 ($ MILLIONS) 86
TABLE 39 PROJECTED GLOBAL REVENUE FROM HEPATITIS
PHARMACEUTICALS AND VACCINATIONS, THROUGH 2017 ($ MILLIONS) 87
TABLE 40 PROJECTED GLOBAL REVENUE FROM HEPATITIS C
PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($ MILLIONS) 87
TABLE 41 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, BY REGION, THROUGH 2017 ($ MILLIONS) 89
TABLE 42 PROJECTED GLOBAL MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 89
TABLE 43 PROJECTED GLOBAL MARKET FOR PANDEMIC PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 91
TABLE 44 PROJECTED AMERICAS MARKET FOR VIRAL PANDEMIC
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($
MILLIONS) 92
TABLE 45 PROJECTED MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) 93
TABLE 46 PROJECTED MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS IN THE AMERICAS, THROUGH 2017 ($ MILLIONS) 93
TABLE 47 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 94
TABLE 48 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 94
TABLE 49 PROJECTED EMRA MARKET FOR VIRAL PANDEMIC
PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 95
TABLE 50 PROJECTED ASIAN MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
AND PHARMACEUTICAL PRODUCTS, THROUGH 2017 ($ MILLIONS) 95
TABLE 51 PROJECTED MARKET FOR VIRAL PANDEMIC DIAGNOSTIC
PRODUCTS IN ASIA, THROUGH 2017 ($ MILLIONS) 96
TABLE 52 PROJECTED MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS IN ASIA, THROUGH 2017 ($ MILLIONS) 97
TABLE 53 ANTIBIOTIC RESISTANT ORGANISMS AND DRUG CLASSES
AFFECTED 106
TABLE 54 PROJECTED GLOBAL MARKET FOR TB DIAGNOSTIC AND
PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($ MILLIONS) 108
TABLE 55 PROJECTED GLOBAL MARKET FOR TB DIAGNOSTIC TESTS,
THROUGH 2017 ($ MILLIONS) 111
TABLE 56 CURRENTLY AVAILABLE TREATMENTS FOR TB WITH BRAND NAME,
GENERIC NAME AND MANUFACTURER, 2012 111
TABLE 57 PROJECTED GLOBAL MARKET FOR TB PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 112
TABLE 58 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC TB PRODUCTS BY
REGION, THROUGH 2017 ($ MILLIONS) 113
TABLE 59 PROJECTED GLOBAL MARKET FOR TB PHARMACEUTICAL
PRODUCTS BY REGION, THROUGH 2017 ($ MILLIONS) 113
TABLE 60 PROJECTED AMERICAS MARKET FOR TB DIAGNOSTIC PRODUCTS
THROUGH 2017 ($ MILLIONS) 114
TABLE 61 PROJECTED AMERICAS MARKET FOR TB PHARMACEUTICAL
PRODUCTS, THROUGH 2017 ($ MILLIONS) 114
TABLE 62 PROJECTED EMRA MARKET FOR TB DIAGNOSTIC PRODUCTS,
THROUGH 2017 ($ MILLIONS) 115
TABLE 63 PROJECTED EMRA MARKET FOR TB PHARMACEUTICAL PRODUCTS,
THROUGH 2017 ($ MILLIONS) 115
TABLE 64 PROJECTED ASIAN MARKET FOR TB DIAGNOSTIC PRODUCTS,
THROUGH 2017 ($ MILLIONS) 116
TABLE 65 PROJECTED ASIAN MARKET FOR TB PHARMACEUTICAL PRODUCTS,
THROUGH 2017 ($ MILLIONS) 116
TABLE 66 CURRENT TB VACCINES IN DEVELOPMENT 117
TABLE 67 PHARMACEUTICALS IN DEVELOPMENT FOR THE TREATMENT OF
TB, 2012 118
TABLE 68 ESTIMATED 2010 GLOBAL MALARIA CASES AND DEATHS, WITH
RATE OF DECREASE OF MALARIA DEATHS BY REGION* SINCE 2000 120
TABLE 69 PROJECTED GLOBAL MARKET FOR MALARIA PREVENTION,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($
MILLIONS) 121
TABLE 70 PROJECTED GLOBAL MARKET FOR INSECTICIDE-TREATED NETS,
THROUGH 2017 ($ MILLIONS) 122
TABLE 71 PROJECTED GLOBAL MARKET FOR MALARIAL DIAGNOSTIC
PRODUCTS, THROUGH 2017 ($ MILLIONS) 123
TABLE 72 PROJECTED GLOBAL MARKET FOR MALARIA DRUG TREATMENTS,
THROUGH 2017 ($ MILLIONS) 123
TABLE 73 PROJECTED GLOBAL MARKET FOR MALARIAL PANDEMIC
PREVENTION, DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS BY REGION,
THROUGH 2017 ($ MILLIONS) 124
TABLE 74 PROJECTED AMERICAS MARKET FOR MALARIA PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS THROUGH 2017 ($
MILLIONS) 124
TABLE 75 MALARIAL PREVENTION PRODUCT MARKET IN THE AMERICAS BY
REGION, THROUGH 2017 ($ MILLIONS) 125
TABLE 76 MALARIAL DIAGNOSTIC PRODUCT MARKET IN THE AMERICAS BY
REGION, THROUGH 2017 ($ MILLIONS) 125
TABLE 77 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN THE
AMERICAS BY REGION, THROUGH 2017 ($ MILLIONS) 126
TABLE 78 PROJECTED EMRA MARKET FOR MALARIAL PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL PRODUCTS THROUGH 2017 ($
MILLIONS) 126
TABLE 79 MALARIAL PREVENTATIVE PRODUCT MARKET IN THE EMRA BY
REGION, THROUGH 2017 ($ MILLIONS) 127
TABLE 80 MALARIAL DIAGNOSTIC PRODUCT MARKET IN THE EMRA BY
REGION, THROUGH 2017 ($ MILLIONS) 127
TABLE 81 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN THE EMRA BY
REGION, THROUGH 2017 ($ MILLIONS) 128
TABLE 82 PROJECTED ASIA MARKET FOR MALARIA PREVENTATIVE,
DIAGNOSTIC AND PHARMACEUTICAL TREATMENTS, THROUGH 2017 ($
MILLIONS) 128
TABLE 83 MALARIAL PREVENTION PRODUCT MARKET IN ASIA BY REGION,
THROUGH 2017 ($ MILLIONS) 129
TABLE 84 MALARIAL DIAGNOSTIC PRODUCT MARKET IN ASIA BY REGION,
THROUGH 2017 ($ MILLIONS) 129
TABLE 85 MALARIAL PHARMACEUTICAL PRODUCT MARKET IN ASIA BY
REGION, THROUGH 2017 ($ MILLIONS) 130
TABLE 86 PROCESS OF CREATING DRUG TREATMENTS IN THE U.S. 132
TABLE 87 PANDEMIC DISEASE PHARMACEUTICAL PRODUCT PIPELINE, 2012 141
TABLE 88 PANDEMIC PHARMACEUTICAL AND VACCINE PATENTS (FEBRUARY
2006-DECEMBER 2012) 150
TABLE 89 PANDEMIC DIAGNOSTIC PATENTS (MARCH 2005 THROUGH
DECEMBER 2012) 154
TABLE 90 PANDEMIC PHARMACEUTICAL AND VACCINE PRODUCT PATENTS
(JANUARY 2005 THROUGH DECEMBER 2012) 155
TABLE 91 PANDEMIC DIAGNOSTIC PRODUCT PATENTS (JANUARY 2005
THROUGH DECEMBER 2012) 156
TABLE 92 PANDEMIC PRODUCT DIAGNOSIS AND TREATMENT PATENTS, BY
COUNTRY (JANUARY 2005 THROUGH DECEMBER 2012) 157
TABLE 93 PATENTS ISSUED FOR DIAGNOSIS AND TREATMENT OF PANDEMIC
DISEASES (MARCH 2005 THROUGH OCTOBER 2012) 158
TABLE 94 ABBOTT PHARMACEUTICAL PRODUCTS 161
TABLE 95 ABBOTT DIAGNOSTIC PRODUCTS 161
TABLE 96 ALERE DIAGNOSTIC PRODUCTS 162
TABLE 97 ALFA SCIENTIFIC DESIGNS DIAGNOSTIC PRODUCTS 163
TABLE 98 ATLAS LINK BIOTECH DIAGNOSTIC PRODUCTS 163
TABLE 99 BAXTER PHARMACEUTICAL PRODUCTS 164
TABLE 100 BAYER PHARMACEUTICAL PRODUCTS 164
TABLE 101 BIO-RAD DIAGNOSTIC PRODUCTS 165
TABLE 102 BOEHRINGER INGELHEIM PHARMACEUTICAL PRODUCTS 165
TABLE 103 BRISTOL-MYERS SQUIBB PHARMACEUTICAL PRODUCTS 166
TABLE 104 CREATIVE DIAGNOSTICS DIAGNOSTIC PRODUCTS 167
TABLE 105 DIAGNOSTIC AUTOMATION/CORTEZ DIAGNOSTICS DIAGNOSTIC
PRODUCTS 167
TABLE 106 DIAGNOSTIC PRODUCTS 168
TABLE 107 PHARMACEUTICAL PRODUCTS 169
TABLE 108 ENZO BIOCHEM DIAGNOSTIC PRODUCTS 169
TABLE 109 DIAGNOSTIC PRODUCT 170
TABLE 110 GILEAD SCIENCES PHARMACEUTICAL PRODUCTS 171
TABLE 111 GSK PHARMACEUTICAL PRODUCTS 171
TABLE 112 HOME ACCESS HEALTH DIAGNOSTIC PRODUCTS 172
TABLE 113 IMMUNOSTICS DIAGNOSTIC PRODUCTS 173
TABLE 114 IND DIAGNOSTIC PRODUCTS 173
TABLE 115 JANSSEN THERAPEUTICS PHARMACEUTICAL PRODUCTS 174
TABLE 116 MERCK PHARMACEUTICAL PRODUCTS 175
TABLE 117 NOVARTIS DIAGNOSTIC PRODUCTS 176
TABLE 118 ORASURE DIAGNOSTIC PRODUCTS 176
TABLE 119 ORTHO DIAGNOSTIC PRODUCTS 177
TABLE 120 PFIZER PHARMACEUTICAL PRODUCTS 177
TABLE 121 PRINCETON BIOMEDITECH DIAGNOSTIC PRODUCTS 178
TABLE 122 ROCHE PHARMACEUTICAL PRODUCTS 179
TABLE 123 SANOFI PASTEUR PHARMACEUTICAL PRODUCTS 180
TABLE 124 SCICLONE PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 181
TABLE 125 SHANGHAI KEHUA BIO-ENGINEERING DIAGNOSTIC PRODUCTS 181
TABLE 126 STANDARD DIAGNOSTICS DIAGNOSTIC PRODUCTS 182
TABLE 127 TRINITY BIOTECH DIAGNOSTIC PRODUCTS 183
TABLE 128 VERTEX PHARMACEUTICALS PHARMACEUTICAL PRODUCTS 183
TABLE 129 VIIV HEALTHCARE PHARMACEUTICAL PRODUCTS 184



LIST OF FIGURES

SUMMARY FIGURE PROJECTED MARKET FOR PANDEMIC INFECTIOUS
DISEASE PRODUCTS, BY REGION, 2012 AND 2017 (%) 7
FIGURE 1 TOP PHARMACEUTICAL MANUFACTURERS IN THE HEPATITIS
MARKET AND THEIR MARKET SHARE, 2011 (%) 36
FIGURE 2 MARKET SHARE FOR BRANDED HIV DRUGS BY MANUFACTURER,
2011 (%) 44
FIGURE 3 PROJECTED GLOBAL MARKET FOR DIAGNOSTIC PRODUCTS USED
TO DETECT HIV AND HEPATITIS PANDEMIC DISEASES, 2012 AND 2017 (%) 81
FIGURE 4 GLOBAL MARKET FOR VIRAL PANDEMIC PHARMACEUTICAL
PRODUCTS, 2012 AND 2017 (%) 83
FIGURE 5 MARKET SHARES FOR HEPATITIS C TREATMENTS, 2010 (%) 88
FIGURE 6 GLOBAL PANDEMIC VIRAL INFECTIOUS DISEASE DIAGNOSTIC
MARKET, 2012 AND 2017 (%) 89
FIGURE 7 GLOBAL PANDEMIC PHARMACEUTICAL MARKET, 2012 AND 2017 (%) 91
FIGURE 8 MARKET FOR PANDEMIC DIAGNOSTIC PRODUCTS IN ASIA 2012
AND 2017 (%) 96
FIGURE 9 DIAGNOSTIC AND PHARMACEUTICAL PATENTS ISSUED (BETWEEN
MARCH 2005 AND DECEMBER 2012) (%) 158

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