The Future of the Biodefense Industry: Regulation, funding opportunities & company profiles - 2009/09/01 - Business Insights

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

from Business Insights
183 page report published Sep 01, 2009

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IntroductionThe 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
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-Analysis of government funding levels in the US and Europe and information on current grants available for biodefense research.
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-Estimation of biodefense in the US for 2010 and forecast figures to 2012.
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-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.
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- 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
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-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.
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-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.
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-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 businessKey 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 th

Source:

Business Insights

Document ID:

rbhc0243

Industry:

Biotechnology

Industry:

Pharmaceutical

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Title	Starting Page	Number of Pages
Sections
Table of Contents 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 20 Summary 20	0	1
Table of Contents	0	1
The Future of the Biodefense Industry	0	1
Executive summary 12	0	1
Setting the scene 12	0	1
Regulatory environment 13	0	1
Major pathogens for BW 14	0	1
Biodefense funding 15	0	1
Company profiles 16	0	1
Future perspectives 17	0	1
Chapter 1 Setting the scene 20	0	1
Summary 20	0	1
Introduction 21	0	1
The use of biological agents in warfare and terrorism 22	0	1
Warfare 22	0	1
Offensive BW programs 23	0	1
Bioterrorism: Extent and nature of the threat 24	0	1
Creation 26	0	1
Bulk manufacture 27	0	1
Weaponization 27	0	1
Delivery 27	0	1
Future threats 29	0	1
Pre-2001 bioterrorism 29	0	1
2001 - September 11 and the anthrax attacks 30	0	1
Chapter 2 Regulatory environment 34	0	1
Summary 34	0	1
Introduction 35	0	1
US bodies 36	0	1
FDA 38	0	1
Center for Biologics Evaluation and Research (CBER) 38	0	1
Center for Drug Evaluation and Research (CDER) 40	0	1
Office of Counterterrorism and Emerging Threats 41	0	1
National Institutes of Health (NIH) 41	0	1
The National Institute of Allergy and Infectious Diseases (NIAID) 42	0	1
Biomedical Advanced Research and Development Authority	0	1
(BARDA) 43	0	1
Public Health Emergency Medical Countermeasures Enterprise	0	1
(PHEMCE) 44	0	1
Project Bioshield 45	0	1
Centers for Disease Control and Prevention (CDC) 48	0	1
US Army Medical Materiel Development Activity (USAMMDA) 49	0	1
European bodies 49	0	1
European Commission 50	0	1
European Council Health Security Committee 51	0	1
European Centre for Disease Prevention and Control (ECDC) 54	0	1
The European Medicines Agency (EMEA) 55	0	1
Economic Commission for Europe 57	0	1
Joint Commission/Pharmaceutical Industry Task Force 57	0	1
2009-2011 Indicative Program for the Instrument for Stability 58	0	1
International Agencies 58	0	1
World Health Organisation (WHO) 58	0	1
United Nations 59	0	1
Global Health Security Initiative (GHSI) 59	0	1
Chapter 3 Major pathogens for BW 62	0	1
Summary 62	0	1
Introduction 63	0	1
Anthrax 64	0	1
Developmental therapeutics and vaccines 65	0	1
Plague 68	0	1
Developmental therapeutics and vaccines 69	0	1
Tularemia 70	0	1
Developmental therapeutics and vaccines 70	0	1
Smallpox 71	0	1
Developmental therapeutics and vaccines 72	0	1
Viral Hemorrhagic Fevers - Ebola, Marburg, Crimean-Congo, Hantavirus, Lassa 74	0	1
Developmental therapeutics and vaccines 75	0	1
Botulism 77	0	1
Developmental therapeutics and vaccines 77	0	1
Ricin 79	0	1
Developmental therapeutics and vaccines 80	0	1
Staphylococcal enterotoxins 81	0	1
Developmental therapeutics and vaccines 81	0	1
Brucella group 82	0	1
Developmental therapeutics and vaccines 82	0	1
Glanders 83	0	1
Developmental therapeutics and vaccines 83	0	1
Melioidosis (Whitmoreâ€™s disease) 84	0	1
Developmental therapeutics and vaccines 84	0	1
Q fever 85	0	1
Developmental therapeutics and vaccines 86	0	1
Conclusion 87	0	1
Chapter 4 Biodefense funding 90	0	1
Summary 90	0	1
US funding 91	0	1
Department of Health and Human Services (HHS) 93	0	1
Biomedical Research and Development Authority (BARDA) 94	0	1
Department of Homeland Security (DHS) 96	0	1
Other departments 97	0	1
Grants available for biodefense R&D in the US 97	0	1
NIH Challenge grants in health & science research 98	0	1
NIH Cooperative Research & Development Agreement (CRADA) 98	0	1
Small business awards 99	0	1
NIH small business biodefense program awards 100	0	1
Project BioShield awards 101	0	1
Regional Centers of Excellence for Biodefense and Emerging	0	1
Infectious Diseases (RCE) 102	0	1
Defense Threat Reduction Agency (DTRA) 103	0	1
US Army Medical Research Institute of Infectious Diseases (USAMRIID) 103	0	1
Technology transfer 103	0	1
Defense Advanced Research Projects Agency (DARPA) 104	0	1
European funding 104	0	1
United Kingdom 105	0	1
France 106	0	1
Germany 106	0	1
EU biodefense programs 107	0	1
European Defense Agency (EDA) 107	0	1
EDAâ€™s Joint R&D Investment Program 107	0	1
Bio-Edep 108	0	1
Bioterrorism Research Resilience Reaction (BIO3R) 108	0	1
Biodefense industry 108	0	1
New and Emerging Science and Technology (NEST) 109	0	1
Health Protection Agency (HPA) 110	0	1
Defense Science and Technology Laboratory (Dstl) 110	0	1
Japan 111	0	1
Chapter 5 Company profiles 114	0	1
Summary 114	0	1
Introduction 115	0	1
US 117	0	1
Achaogen 117	0	1
Contracts 118	0	1
Advanced Life Sciences 118	0	1
Contracts 119	0	1
Alnylam Pharmaceuticals 119	0	1
Contracts 119	0	1
Cleveland BioLabs 120	0	1
Contracts 120	0	1
Dynavax Technologies Inc. 121	0	1
Contracts 121	0	1
Dynport Vaccine Company Llc (DVC) 122	0	1
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 Tech	0	1

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