Biodefense Market Overview
The worldwide biodefense market can generally be divided into three segments: U.S. civilian, U.S. military, and non-U.S. markets. U.S. government funding represents the vast majority of the worldwide market for biodefense countermeasures. According to the University of Pittsburgh Medical Center, Center for Biosecurity, U.S. government biodefense military and civilian spending has averaged around $5.4 billion since 2007.
The U.S. civilian market includes funds to protect the U.S. population from biowarfare agents and is largely funded by the Project BioShield Act of 2004. Project BioShield, established under the Project BioShield Act of 2004 and the U.S. government’s largest biodefense initiative, is focused on acquiring medical countermeasures with low technology risk that will be available for purchase in the near term. The U.S. government has identified the following threats as priorities: anthrax, smallpox, botulinum toxin, radiation, and nerve agent exposure. To qualify for Project BioShield funding, products must demonstrate product efficacy in an animal model and complete advanced development activities, and companies must show that they can provide sufficient manufacturing capability. Of the $5.6 billion allocated to Project BioShield for medical countermeasures development and procurement, $3.4 billion was made available through fiscal year 2008, and the remaining $2.2 billion became available in fiscal year 2009. At the end of calendar year 2009 approximately $2 billion in procurement contracts had been awarded and approximately $1 billion had been transferred out of the Project BioShield Special Reserve fund for non-procurement related activities. Remaining funds in the SRF are now approximately $2.4 billion. As of December 31, 2010, 11 awards have been made under Project BioShield, including those for anthrax, smallpox, radiation and botulinum toxin.
The United States Department of Defense is responsible for the development and procurement of countermeasures for the U.S. military, which focuses on providing biowarfare protection for military personnel and civilians who are on active duty. The DoD biodefense budget for fiscal year 2011 was approximately $680 million, similar to amounts for 2010 and 2009. It is anticipated that annual funding for these programs in the near-term will increase slightly as the Department of Defense rolls out its advanced development and manufacturing initiative in 2012.
Non-U.S. markets address protection against biowarfare agents for both civilians and military personnel in foreign countries. It is widely expected that foreign countries will want to procure biodefense countermeasures as they are developed and validated by procurement by the U.S. government.