A Product and Pipeline Analysis of the Antibacterial Drugs Market

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)

  • Executive Summary
    • Executive Summary-Key Findings
    • Antibacterial Drugs Market-Game-changing Strategies
    • Key Merger, Acquisition, and Partnership Assessment
    • Methodology and Scope
  • Introduction
    • Market Overview-Segmentation
  • Classification of Antibacterial Drugs by Mechanism of Action
    • Antibacterial Drugs-Approved and Novel Product Classes Synopsis
    • Dosing Regimen of Commonly Prescribed Antigens
      • Table Antibacterial Drugs Market: Dosing Regimen of Commonly Prescribed Antigens, Global, 2014
  • Antibacterial Drugs Market-Pipeline Analysis
    • Antibacterial Drugs-Competitive Landscape of Products in Development
    • Antibacterial Drugs-Pipeline Analysis
    • Antibacterial Drugs-Pipeline Synopsis
  • Antibacterial Drugs Market-Major Clinical Milestones
    • Antibacterial Drugs Market-Major Ongoing/Recently Completed Clinical Trials
  • Antibacterial Drugs Market-Product Dashboard of Recently Approved and Late-stage Pipeline Drug Candidates
    • Tedizolid Phosphate-Cubist Pharmaceuticals
    • Dalbavancin (Dalvance™)-Durata Therapeutics
    • Ceftolozane + Tazobactam-Cubist Pharmaceuticals
    • Oritavancin (Orbactiv™)-The Medicines Company
    • Ceftazidime + Avibactam (CAZ-AVI)-AstraZeneca
    • Cadazolid-Actelion Pharmaceuticals
    • Carbavance-Rempex Pharmaceuticals (The Medicines Company)
    • Delafloxacin-Melinta Therapeutics
    • Eravacycline-Tetraphase Pharmaceuticals
    • Plazomicin-Achaogen
    • Solithromycin-Cempra Pharmaceuticals
    • Surotomycin-Cubist Pharmaceuticals
  • Antibiotic Resistance-A Critical Unmet Need that Poses Challenges to Antibiotic R&D
    • Common Mechanisms of Antibiotic Resistance
    • Key Challenges to Antibiotic Research & Development
    • Hard-to-treat Pathogens/Superbugs That Pose a Serious Threat to Drug Makers
    • New Antibiotics in the Pipeline That Help Overcome Drug Resistance
  • Antibacterial Drugs Market-Timeline of Key Events
    • Antibacterial Drug Classes-FDA Approval Timeline
    • Antibacterial Drugs-FDA Approval Timeline
    • Antibacterial Drugs Market-Timeline of Key Events
  • Regulatory Approaches to Stimulate Antibiotics R&D
    • Regulatory Policies to Stimulate Antibiotics R&D
    • Generating Antibiotics Incentives Now (GAIN) Act
    • Implementation of the (GAIN) Act
    • Antibiotic Development to Advance Patient Treatment Act (ADAPT): H.R. 3742
    • IDSA's 10 x `20 Initiative
    • Additional Economic Incentives-Tax Credits
    • Additional Economic Incentives-Federal Research Funding
    • PPPs-The European Effort
    • PPPs-BARDA
  • Antibacterial Drugs Market-Key Companies to Watch
    • Key Companies to Watch
  • Conclusions
    • Conclusions and Recommendations
  • Appendix
    • List of Abbreviations

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