$10 Billion Health Security Market

The Global Biodefense market was valued at $9.7 billion in 2015 and is expected to reach a value of $18 billion by 2025; between 2001 and 2014, the U.S. government spent nearly $79 billion on a broad array of civil biodefense initiatives.

As a leader in health security and recipient of government funding for more than a decade, SIGA has cultivated relationships with key health security constituencies in the U.S. government, including the Biodefense Advanced Research Development Authority (BARDA).

These relationships have generated consistent, long-term mutual benefits that have helped to advance the development of TPOXX® while enhancing U.S. national health security and preparedness against a potential smallpox threat.

What is Health Security?

Medical countermeasures (MCMs) including vaccines, therapeutics, diagnostics, and non-pharmaceutical countermeasures, to secure our nation from chemical, biological, radiological, and nuclear (CBRN) threats, as well as from pandemic influenza and emerging infectious diseases.

Smallpox

Smallpox is a highly contagious and lethal infectious disease and is considered a high-priority biological threat agent. Vaccines alone cannot address a smallpox outbreak and therefore investments in MCMs include vaccines and TPOXX® (tecovirimat), the only FDA approved drug for the treatment of smallpox.

Anthrax

Anthrax is an acute infectious disease caused by the spore-forming bacterium Bacillus anthracis, which can cause human disease via gastrointestinal, cutaneous, or pulmonary routes. Investments in anthrax MCMs include both vaccines and therapeutics.

Botulinum Toxin

Botulism is a serious paralytic illness caused by neurotoxins produced by several Clostridium botulinum strains. The U.S. Government stockpiles a Botulism Antitoxin which is effective against all seven known serotypes of botulinum toxin.

Chemical and Thermal Threats

Chemical threats include nerve agents, chemical burn agents, pulmonary agents including pulmonary edema and fibrosis, and blood /metabolic agents, as well as toxic industrial chemicals and toxic industrial materials. The thermal burn program aims to improve burn treatment across the burn care spectrum.

Radiological and Nuclear Threats

Medical consequences of a nuclear detonation result in radiation-induced illness, thermal and radiation burns, and trauma. The acquisition and ready availability of MCMs to address the multitude of injuries is essential to our Nation's preparedness and response capabilities.

Ebola / Filoviruses

Ebola reemerged as a health threat in 2018 in the Democratic Republic of the Congo (DRC). The second outbreak, in eastern DRC, has yet to be contained. The Ebola MCM strategy includes development, manufacturing and evaluation of vaccines, monoclonal antibodies and antiviral drug therapeutic candidates.

Emerging Infectious Diseases

Emerging infectious disease threats that may not have available treatments or vaccines can directly affect the security of the world's health since these diseases also know no boundaries and will easily cross borders. The nation is witnessing the impacts of naturally occurring outbreaks such as Influenza, Ebola, Zika, and SARS.

Broad Spectrum Antimicrobials

The Broad Spectrum Antimicrobials program was established in January 2010 and is focused on developing novel antibacterial and antiviral drugs for the treatment or prevention of disease caused by currently defined and future biological threats.

Partner with Us

We are seeking to expand our portfolio in health security through strategic partnerships and in-licensing opportunities. We would also like to hear from small businesses with capabilities across drug development, formulation, commercial manufacturing, clinical, and regulatory services.

Key Government Stakeholders

Public Health Emergency Medical Countermeasures Enterprise (PHEMCE)
PHEMCE is led by the HHS Office of the Assistant Secretary for Preparedness and Response (ASPR) and includes three primary HHS internal agency partners: the Centers for Disease Control and Prevention (CDC), the Food and Drug Administration (FDA) and the National Institutes of Health (NIH), as well as several interagency partners such as the Department of Defense (DoD).

Biodefense Advanced Research Development Authority (BARDA)
BARDA supports the transition of medical countermeasures such as vaccines, drugs, and diagnostics from research through advanced development towards consideration for approval by the FDA and inclusion into the Strategic National Stockpile. BARDA’s support includes funding, technical assistance and core services, ranging from a clinical research organization network to Centers for Innovation in Advanced Development and Manufacturing, and a fill-finish manufacturing network. To-date, BARDA has supported 42 FDA approvals for products addressing health security threats.

Stockpiling Lifesaving Medical Countermeasures
The Division of CBRN MCMs is responsible for developing and establishing stockpiles of lifesaving vaccines, drugs, and diagnostics against CBRN threats. The Project BioShield Act of 2004 established the Special Reserve Fund (SRF), a one-time appropriation of $5.6 billion (2004 – 2013) to accelerate the research, development and acquisition of MCMs against CBRN threat agents. Eight Project BioShield programs have led to the acquisition of MCMs for the Strategic National Stockpile (SNS). These include an anthrax vaccine for post-exposure prophylaxis, anthrax therapeutics, a novel smallpox vaccine, a smallpox antiviral drug, a botulinum antitoxin, and radiation countermeasures.

Department of Defense
The Defense Threat Reduction Agency (DTRA) is working hard to protect American warfighters and their allies from threats posed by chemical and biological weapons. They provide a wide spectrum of support to the military services, combatant commands and international partners, from innovating new technologies to detect chemical and biological threats, to developing new capabilities to protect them through programs such as the Transformational Medical Technologies Initiative.

Additional Resources

PHEMCE Multiyear Budget
The multiyear budget highlights spending plans for the various HHS agencies within the PHEMCE and provides Congress and external stakeholders with information on funds that have been invested in specific threat areas and future plans for investments in specific threat areas, based on availability of funds.
Learn more.

The Johns Hopkins Center for Health Security
Works to protect people’s health from the consequences of epidemics and disasters and to make communities more resilient to major challenges.
Learn more.

CIDRAP
Works to prevent illness and death from targeted infectious disease threats through research and the translation of scientific information into real-world, practical applications, policies, and solutions.
Learn more.

Citations: