The Future of the Biodefense Industry: Regulation, funding opportunities company profiles

Date: September 22, 2009
Pages: 183
Price:
US$ 3,835.00
Publisher: Business Insights
Report type: Strategic Report
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The Future of the Biodefense Industry: Regulation, funding opportunities  company profiles
Introduction

The major contemporary bioterrorist event which has opened up programs of research and development (R&D) in pharmaceutical countermeasures and treatments was the anthrax mail attacks which occurred only weeks after the 9/11 atrocities, in October 2001. The mailings killed five people and exposed hundreds more – with thousands of US citizens seeking prophylactic antibiotics. Since then the biodefense industry has grown massively, with the US releasing around $50bn in biodefence funding in 2001-2009. Other international bodies, such as the EU, have also increased their vigilance and research efforts.

This report sets out to describe and analyze the work of the biodefense industry in terms of past, present and future pharmaceutical research, development and production to counter or treat diseases caused by biological attack. It also will describe government policies and initiatives in several countries which have spurred research and production in pharmaceutical countermeasures and treatments for such diseases and will examine the various factors which influence those policies and the market, including current and future threats and how the industry is responding to new discoveries.


Scope of this report

  • Analysis of government funding levels in the US and Europe and information on current grants available for biodefense research.
  • Estimation of biodefense in the US for 2010 and forecast figures to 2012.
  • In-depth analysis of the major biodefense firms operating in the US, Europe, Australia and Canada as well as well as those operating in emerging markets such as China, India and Israel.
  • Analysis of the major threat areas in the biodefense market including - anthrax, plague, tularemia, small pox viral hemorrhagic fevers, botulism, ricin, staphylococcal enterotoxins, brucella, glanders, melioidosis and Q fever.


  • Key findings from this report

  • The US is driving the industry and total biodefense funding between 2001-2009 reached $49.6bn. However, growth is set to slow significantly in the coming years as all Project BioShield funding has now released.
  • However, a single serious bioterrorist incident in the US could spur another round of government spending as happened after the 2001 anthrax attacks. Recent threats such as pandemic swine flu are also forcing governments to consider the creation of large stockpiles of medical countermeasure.
  • The current economic crisis could be especially serious for the biodefense industry. As many of the active participants are small-scale and reliant on outside funding to maintain operations, reduced credit options could force them out of business


  • Key issues

  • Since 2001 US funding for Biodefense has reached $49.6bn. The peak year for spending was 2005, due to a large dissemination of funds from Project BioShield, however 2009 was also witnessed strong investment.
  • In 2010, Business Insights estimates that total biodefense funding in the US will reach $5,932mn. If you were to take BioShield funding out of the figures for 2009, then 2010 represented growth of 1.4% (year-on-year), a reversal of the trend seen between 2006-2008.
  • There have only been a small number of bioterrorist incidents in the past thirty years, with the number of fatalities remaining limited. But due in part to the psychological fear created by these weapons, the US military, in particular, has invested heavily in preparing vaccines and therapeutics.
  • The rarity of bioterrorist attacks, due to the extreme difficulty in weaponizing and delivering biological agents, has caused numerous scientific groups to criticize the current high spending levels on research into medical counter measures.


  • Use this report to:

  • What are the major trends driving the biodefense market?
  • What is the current state of R&D in the biodefense market?
  • How has the regulatory pathway changed in recent years, and how is this effecting industry development?
  • What are the current funding levels for biodefense and what is the forecast 2010-2012?
  • Which product areas provide the greatest opportunity for future development?

  • The Future of the Biodefense Industry
    Executive summary 12
    Setting the scene 12
    Regulatory environment 13
    Major pathogens for BW 14
    Biodefense funding 15
    Company profiles 16
    Future perspectives 17

    CHAPTER 1 SETTING THE SCENE

    Summary 20
    Introduction 21
    The use of biological agents in warfare and terrorism 22
    Warfare 22
    Offensive BW programs 23
    Bioterrorism: Extent and nature of the threat 24
    Creation 26
    Bulk manufacture 27
    Weaponization 27
    Delivery 27
    Future threats 29
    Pre-2001 bioterrorism 29
    2001 - September 11 and the anthrax attacks 30

    CHAPTER 2 REGULATORY ENVIRONMENT

    Summary 34
    Introduction 35
    US bodies 36
    FDA 38
    Center for Biologics Evaluation and Research (CBER) 38
    Center for Drug Evaluation and Research (CDER) 40
    Office of Counterterrorism and Emerging Threats 41
    National Institutes of Health (NIH) 41
    The National Institute of Allergy and Infectious Diseases (NIAID) 42
    Biomedical Advanced Research and Development Authority (BARDA) 43
    Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) 44
    Project Bioshield 45
    Centers for Disease Control and Prevention (CDC) 48
    US Army Medical Materiel Development Activity (USAMMDA) 49
    European bodies 49
    European Commission 50
    European Council Health Security Committee 51
    European Centre for Disease Prevention and Control (ECDC) 54
    The European Medicines Agency (EMEA) 55
    Economic Commission for Europe 57
    Joint Commission/Pharmaceutical Industry Task Force 57
    2009-2011 Indicative Program for the Instrument for Stability 58
    International Agencies 58
    World Health Organisation (WHO) 58
    United Nations 59
    Global Health Security Initiative (GHSI) 59

    CHAPTER 3 MAJOR PATHOGENS FOR BW

    Summary 62
    Introduction 63
    Anthrax 64
    Developmental therapeutics and vaccines 65
    Plague 68
    Developmental therapeutics and vaccines 69
    Tularemia 70
    Developmental therapeutics and vaccines 70
    Smallpox 71
    Developmental therapeutics and vaccines 72
    Viral Hemorrhagic Fevers - Ebola, Marburg, Crimean-Congo, Hantavirus, Lassa 74
    Developmental therapeutics and vaccines 75
    Botulism 77
    Developmental therapeutics and vaccines 77
    Ricin 79
    Developmental therapeutics and vaccines 80
    Staphylococcal enterotoxins 81
    Developmental therapeutics and vaccines 81
    Brucella group 82
    Developmental therapeutics and vaccines 82
    Glanders 83
    Developmental therapeutics and vaccines 83
    Melioidosis (Whitmore’s disease) 84
    Developmental therapeutics and vaccines 84
    Q fever 85
    Developmental therapeutics and vaccines 86
    Conclusion 87

    CHAPTER 4 BIODEFENSE FUNDING

    Summary 90
    US funding 91
    Department of Health and Human Services (HHS) 93
    Biomedical Research and Development Authority (BARDA) 94
    Department of Homeland Security (DHS) 96
    Other departments 97
    Grants available for biodefense R&D in the US 97
    NIH Challenge grants in health & science research 98
    NIH Cooperative Research & Development Agreement (CRADA) 98
    Small business awards 99
    NIH small business biodefense program awards 100
    Project BioShield awards 101
    Regional Centers of Excellence for Biodefense and Emerging
    Infectious Diseases (RCE) 102
    Defense Threat Reduction Agency (DTRA) 103
    US Army Medical Research Institute of Infectious Diseases (USAMRIID) 103
    Technology transfer 103
    Defense Advanced Research Projects Agency (DARPA) 104
    European funding 104
    United Kingdom 105
    France 106
    Germany 106
    EU biodefense programs 107
    European Defense Agency (EDA) 107
    EDA’s Joint R&D Investment Program 107
    Bio-Edep 108
    Bioterrorism Research Resilience Reaction (BIO3R) 108
    Biodefense industry 108
    New and Emerging Science and Technology (NEST) 109
    Health Protection Agency (HPA) 110
    Defense Science and Technology Laboratory (Dstl) 110
    Japan 111

    CHAPTER 5 COMPANY PROFILES

    Summary 114
    Introduction 115
    US 117
    Achaogen 117
    Contracts 118
    Advanced Life Sciences 118
    Contracts 119
    Alnylam Pharmaceuticals 119
    Contracts 119
    Cleveland BioLabs 120
    Contracts 120
    Dynavax Technologies Inc. 121
    Contracts 121
    Dynport Vaccine Company Llc (DVC) 122
    Contracts 122
    Elusys Therapeutics 122
    Contracts 123
    Emergent BioSolutions 123
    Contracts 125
    Ichor Medical Systems 126
    Contracts 126
    Nanotherapeutics 127
    Contracts 127
    Peregrine Pharmaceuticals, Inc. 127
    Contracts 128
    PharmAthene 128
    Contracts 129
    SIGA Technologies 130
    Contracts 131
    VaxGen 132
    Contracts 132
    XOMA 132
    Contracts 132
    Canada 133
    Affinium Pharmaceuticals 133
    Contracts 133
    Cangene 133
    Contracts 135
    ID Biomedical Corporation 135
    Contracts 136
    UK 136
    Acambis 136
    Contracts 137
    Cambridge Biostability (CBL) 137
    Contracts 138
    MNLpharma 138
    Contracts 138
    Denmark 139
    Bavarian Nordic 139
    Contracts 140
    Australia 141
    Vaxine Pty 141
    Contracts 141
    India 141
    Panacea Biotec Ltd. 142
    Contracts 142
    China 143
    Sinovac Biotech Ltd. 144
    Israel 144
    Medison Pharma 145
    Conclusion 145
    Biodefense products: the risks 147

    CHAPTER 6 FUTURE PERSPECTIVES

    Summary 152
    Introduction 153
    Assessing future threats 153
    GM technology 154
    Synthetic biology 156
    US funding – the reality 157
    Has the US got value for its £50 billion-worth of funding since 2001? 159
    Potential biodefense business 159
    Getting a grant in the US 160
    Project Bioshield 161
    Is Europe doing enough? 162
    Lack of coordination 164
    US 164
    EU 165
    Biodefense – at the expense of other research? 166
    Mismanagement of the stockpile 167
    Case study: VaxGen 167
    Problems of biosecurity 169
    US 169
    Russia and the FSU 171
    Fulfilling unmet needs 172
    Conclusion 173

    CHAPTER 7 APPENDIX

    CDC characterization of biological threats 176
    Glossary 177
    Index 181

    LIST OF FIGURES

    Figure 1.1: Bioterrorism incidents 1970-2008 26
    Figure 2.1: US biodefense funding by department 2001-09 37
    Figure 3.1: R&D funding pathway for biodefense medical countermeasures 43
    Figure 4.1: Project BioShield procurement process 46
    Figure 4.5: US biodefense funding ($m), 2001-12 93
    Figure 4.6: BARDA funding forecasts ($m), 2009-14 96
    Figure 5.7: Cleveland BioLabs research spending on Protectan CBL502 for biodefense applications ($m), 2008-09 121
    Figure 5.8: Emergent BioSolutions operating results ($m), 2008-09 125
    Figure 5.9: PharmAthene financial results ($m), 2008-09 130
    Figure 5.10: Cangene financial results ($m), 2004-08 134
    Figure 5.11: Bavarian Nordic financials (DKKm), 2004-08 140
    Figure 6.12: US biodefense funding ($m), 2001-09 158
    Figure 6.13: VaxGen financials ($m), 2005-08 168
    Figure 6.14: NIH funded biocontainment laboratories 170
    Figure 7.15: CDC characterization of biological threats 176

    LIST OF TABLES

    Table 2.1: US biodefense presidential acts 40
    Table 2.2: US biodefense acts post-2001 48
    Table 2.3: European Biodefense Legislation 54
    Table 3.4: Developmental therapeutics and vaccines for anthrax 66
    Table 3.5: Developmental therapeutics and vaccines for plague 69
    Table 3.6: Developmental therapeutics and vaccines for tularemia 71
    Table 3.7: Developmental therapeutics and vaccines for smallpox 73
    Table 3.8: Developmental therapeutics and vaccines for VHF 76
    Table 3.9: Developmental therapeutics and vaccines for botulism 78
    Table 3.10: Developmental therapeutics and vaccines for ricin 80
    Table 3.11: Developmental therapeutics and vaccines for staphylococcal enterotoxins 81
    Table 3.12: Developmental therapeutics and vaccines for brucella 82
    Table 3.13: Developmental therapeutics and vaccines for glanders 84
    Table 3.14: Developmental therapeutics and vaccines for melioidosis 85
    Table 3.15: Developmental therapeutics and vaccines for Q fever 86
    Table 4.16: US biodefense funding by department ($m), 2001-10 92

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