A Product and Pipeline Analysis of the Antibacterial Drugs Market
Executive Summary—Key Findings
2014 has turned out to be a flagship year in the history of antibacterial drugs development.
Three new systemic antibacterial drugs gained Food and Drugs Administration (FDA) approval for acute bacterial skin and skin structure infection in 2014, including Dalvance (Durata Therapeutics), Orbactive (The Medicines Company), and Sivextro (Cubist Pharmaceuticals).
New Drug Applications (NDA) were submitted for two combination bacterial therapies for complicated Urinary Tract Infection (UTI) and complicated intra-abdominal infection indications in 2014.
Only two new systemic antibacterial agents were approved for use in humans by the US FDA from 2008–2012, while sixteen of them were approved from 1983–1987, including Ceftolozane/Tazobactam (Cubist Pharmaceuticals) and Ceftazidime/Avibactam (AstraZeneca/Forest Laboratories).
It is alarming to note that no new classes of antibacterial drugs have been approved for the treatment of Gram-negative Bacilli (GNB) in the last 40 years, leaving fluoroquinolones as the last new class of antibacterial drugs to treat GNB.
Drug-resistant bacteria, or superbugs, pose a serious threat to human health.
According to the Centre for Disease Control and Prevention (CDC), million Americans acquire serious infections caused by antibiotic-resistant bacteria every year, of which die.
Developing new antibacterial drugs requires a great deal of time, effort, expenditure, and scientific research, making it a less attractive segment for investment by pharmaceutical companies.
Several new initiatives and measures have been adopted by agencies such as the FDA and the Infectious Diseases Society of America (IDSA) to spur the development of novel antibacterial drugs and help lure companies back into antibacterial research and development (R&D)
Electronic Access - Site License Fulfilled By Publisher
Electronic Access - Global site License Fulfilled By Publisher