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

Published by: Business Insights

Published: Sep. 1, 2009 - 183 Pages

Table of Contents

Project Bioshield

Is Europe doing enough?

Lack of coordination

US

EU

Biodefense - at the expense of other research?

Mismanagement of the stockpile

Case study: VaxGen

Problems of biosecurity

US

Russia and the FSU

Fulfilling unmet needs

Conclusion

Chapter 7 Appendix

CDC characterization of biological threats

Glossary

Index

List of Figures

Figure 1.1: Bioterrorism incidents 1970-2008

Figure 2.1: US biodefense funding by department 2001-09

Figure 3.1: R&D funding pathway for biodefense medical countermeasures

Figure 4.1: Project BioShield procurement process

Figure 4.5: US biodefense funding ($m), 2001-12

Figure 4.6: BARDA funding forecasts ($m), 2009-14

Figure 5.7: Cleveland BioLabs research spending on Protectan CBL502 for biodefense applications ($m), 2008-09

Figure 5.8: Emergent BioSolutions operating results ($m), 2008-09

Figure 5.9: PharmAthene financial results ($m), 2008-09

Figure 5.10: Cangene financial results ($m), 2004-08

Figure 5.11: Bavarian Nordic financials (DKKm), 2004-08

Figure 6.12: US biodefense funding ($m), 2001-09

Figure 6.13: VaxGen financials ($m), 2005-08

Figure 6.14: NIH funded biocontainment laboratories

Figure 7.15: CDC characterization of biological threats

List of Tables

Table 2.1: US biodefense presidential acts

Table 2.2: US biodefense acts post-2001

Table 2.3: European Biodefense Legislation

Table 3.4: Developmental therapeutics and vaccines for anthrax

Table 3.5: Developmental therapeutics and vaccines for plague

Table 3.6: Developmental therapeutics and vaccines for tularemia

Table 3.7: Developmental therapeutics and vaccines for smallpox

Table 3.8: Developmental therapeutics and vaccines for VHF

Table 3.9: Developmental therapeutics and vaccines for botulism

Table 3.10: Developmental therapeutics and vaccines for ricin

Table 3.11: Developmental therapeutics and vaccines for staphylococcal enterotoxins

Table 3.12: Developmental therapeutics and vaccines for brucella

Table 3.13: Developmental therapeutics and vaccines for glanders

Table 3.14: Developmental therapeutics and vaccines for melioidosis

Table 3.15: Developmental therapeutics and vaccines for Q fever

Table 4.16: US biodefense funding by department ($m), 2001-10

Abstract

• 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.

• 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

• 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.

• 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?

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