Trends in Antimicrobial Drug Development: Implications for the Future

TLDR

The growing threat of multidrug‑resistant pathogens, emerging infections, and bioweapon potential heightens the need for new antimicrobials, yet many pharmaceutical companies are reducing anti‑infective research programs. This study evaluates FDA approval data and the R&D portfolios of major pharma and biotech firms to document declining antimicrobial development and to propose strategies to stimulate new agent discovery. The authors analyzed FDA databases of approved drugs and the developmental pipelines of the largest companies, projecting that only six of 506 disclosed drugs are antibacterial agents. FDA approvals of new antibacterial agents fell 56% from 1998‑2002 to 1983‑1987, and overall development of these agents is declining despite the critical need.

Abstract

The need for new antimicrobial agents is greater than ever because of the emergence of multidrug resistance in common pathogens, the rapid emergence of new infections, and the potential for use of multidrug-resistant agents in bioweapons. Paradoxically, some pharmaceutical companies have indicated that they are curtailing anti-infective research programs. We evaluated the United States Food and Drug Administration (FDA) databases of approved drugs and the research and development programs of the world's largest pharmaceutical and biotechnology companies to document trends in the development of new antimicrobial agents. FDA approval of new antibacterial agents decreased by 56% over the past 20 years (1998-2002 vs. 1983-1987). Projecting future development, new antibacterial agents constitute 6 of 506 drugs disclosed in the developmental programs of the largest pharmaceutical and biotechnology companies. Despite the critical need for new antimicrobial agents, the development of these agents is declining. Solutions encouraging and facilitating the development of new antimicrobial agents are needed.