Opportunity in antibiotics
Rising demand for antibiotics to counter increasing cases of drug-resistant infections, combined with decreasing research and development costs, is presenting an ideal opportunity for pharmaceutical manufacturers to launch novel products into the marketplace, according to a new report from the research and consulting company GlobalData.
The company’s latest report, “PharmaFocus: Market Access Strategies for Antibiotics Targeting Multidrug-Resistant Gram-Negative Bacteria,” concludes that over the coming years, the growing level of threat posed by multidrug-resistant bacteria, particularly Gram-negative organisms, will be a key driver behind the growth of the antibiotics market in the United States, France, Italy, Germany, Spain, and the UK.
A stagnant antibiotic pipeline has escalated medical concerns caused by MDR bacteria in these countries, and a significant unmet need exists for novel antibiotics to counter the problem.
However, low returns on investment, primarily caused by expensive R&D processes and convoluted regulatory requirements, have been deterring drug manufacturers from developing new products, according to the report.
“Many large pharmaceutical companies have previously abandoned antibiotics due to the drugs’ risky and prolonged R&D processes,” says Christopher Pace, Ph.D., GlobalData’s analyst covering infectious disease. “However, we can now expect to see upcoming regulatory reform on clinical trial design, led by guidance from the Food and Drug Administration and the European Medicines Agency, which will facilitate more efficient clinical development programs and reduce a number of barriers to market entry.”
As a result, regulators, pharmaceutical companies and physicians are now working more closely than ever to remove a number of obstacles for keen developers.
“Future financial backing from governments will also play a key role in all stages of the R&D process, helping to decrease the cost of antibiotic development and therefore better enabling more companies to
launch new products that address the current unmet clinical need,” says Brad Tebbets, Ph.D., GlobalData’s infectious disease analyst. “More specifically, public-private partnerships, represent an alternative business model that effectively aligns clinical and commercial needs.”
Posted: October 2013