The hidden costs of antibiotic development

In an age when antibiotic resistance poses a severe threat to global health, a new study sheds light on the often-overlooked hurdles of drug commercialization.

Soaring costs associated with bringing new antimicrobials to market are stifling innovation, according to research published in the journal Academy of Management Proceedings.

The study’s author, Sina Khoshsokhan, assistant professor of strategy and entrepreneurship in the Leeds School of Business, said that while the scientific community has made strides in understanding drug research and development, the transition from laboratory breakthroughs to market-ready products is riddled with obstacles.

“As researchers in innovation, we tend to have a deeper understanding of the research side of drug development, while the complexities of the commercialization process are often overlooked,” Khoshsokhan said. “We have a wealth of new discoveries, but without effective pathways to market, many promising innovations never see the light of day.”

As part of the study, Khoshsokhan analyzed data from Clarivate, which tracks drug discovery, development, regulatory affairs and market access in pharmaceutical and biotechnology companies. He compared the drug development trajectories of antimicrobial candidates with those targeting immune-related diseases to identify key trends and challenges that hinder the commercialization of antibiotics.

While all drugs must meet safety and efficacy standards, antimicrobials face particularly stringent FDA regulations and must undergo extensive clinical trials to demonstrate safety and efficacy, resulting in significant financial burdens.

Khoshsokhan pointed out that large corporations often shy away from antibiotic development in favor of more lucrative long-term medications, such as those for diabetes or cardiovascular diseases. “This misalignment of incentives has resulted in a troubling gap in the market,” he said. “Startups are often the source of innovative ideas, but without partnerships with larger firms, many promising inventions never reach patients.”

Antimicrobial resistance claims some 700,000 lives annually worldwide. If left unaddressed, that number could soar to 10 million by 2050, surpassing deaths from cancer, according to a 2019 report from the UN Interagency Coordination Group. Khoshsokhan argues for an approach that encourages startups while also incentivizing large corporations to invest in antibiotic development.

The paper won the Academy of Management Strategic Management Division’s Distinguished Paper Award in the area of knowledge, learning, and innovation strategy, highlighting its contribution to understanding the commercialization challenges in the pharmaceutical industry.

Khoshsokhan believes that interdisciplinary collaboration is essential. “Antimicrobial resistance is a grand challenge that warrants attention from both natural and social sciences,” he said. “We need more research to effectively combat this issue.”

Khoshsokhan remains optimistic that stakeholders throughout the pharmaceutical industry will work together to foster innovation and ensure the availability of life-saving antibiotics. “It’s crucial that we encourage not just startups but also larger firms to invest in the health of our society,” he stated. “We can’t afford to neglect the development of antibiotics in the face of rising resistance.”