Antibiotics market ‘fragile and failing’, report says

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The global death toll from antibiotic-resistant infections is expected to accelerate through 2050.

The antibiotics pipeline has dried up and the companies that make the bulk of antibiotics face multiple challenges, a new report from Biotechnology Innovation Organization (BIO) says.

There is an ongoing struggle between antibiotic-resistant infections – superbugs such as Methicillin resistant Staphylococcus aureus— and the manufacturers of antibiotics. the world death toll is alarming, with more than 1.2 million people dying each year and estimated mortality expected to reach 10 million people per year by 2050.

There is an urgent need to increase the development of antibacterial drugs, says the BIO report. “Despite the availability of 106 unique direct-acting antibacterial therapeutic entities on the market in the United States and 28 unique antibacterials outside the United States, there remains a need for alternatives to currently available drugs that will circumvent bacterial drug resistance. More than 82% of all antibiotic approvals took place before the year 2000. The majority of drugs remaining on the market face an eventual loss of efficacy due to resistance developed by bacterial strains encountering these treatments in the population.

Small and young biotech companies dominate the development of new antibiotics, with 80% of potential new antibiotics in development coming from these companies, the BIO report says. Funding for antibiotic development is insufficient, according to the report.

“Funding has been scarce for these antibacterial developers, and the ecosystem is fragile and failing. Over the past decade, antibacterial start-ups have raised a total of just $2.3 billion in venture capital and [initial public offerings], well below other fields of medicine and not enough to compensate for the need for a large ecosystem and a diverse pool of candidates. In comparison, during that same decade, oncology companies raised $38 billion in venture capital and IPOs, more than 16 times the amount invested in antibacterials,” the report states.

A decline in the number of clinical trial launches shows that biotech companies large and small are pulling out of the antibiotics market, the report said. “Phase I trial initiations decreased by 46% compared to previous five-year periods (2011-2015 versus 2016-2020). Phase II and III trial initiations decreased by 33%. The same percentage decline was seen when segmenting by company size, suggesting that the decline in interest from large companies is shared by smaller companies and their investors.This is of particular concern as large companies have traditionally been an essential part of the antibiotic ecosystem, with their extensive manufacturing infrastructure and global distribution capability.

According to the report, three dynamics are driving investors away from the antibiotics market. “First, large companies have been leaving the space for some time, with very few of them listed as co-sponsors of small company pipeline applicants. mergers and acquisitions are drying up, -stage investors such as venture capitalists Second, the majority of recent examples of “successful” biotechs (those that have raised venture capital, secured funding through public offerings , … and obtained marketing approval from the FDA) have been business failures, with recent stories of antibacterial company bankruptcies and acquisitions during sellout valuations as evidence to avoid investing in this segment of the The third factor is the lack of effective policy and regulatory solutions to address the unique characteristics of the antimicrobial market.

According to the report, economic factors driving the use of new antibiotics are driving large biotech companies out of the antibacterial market and undermining smaller companies financially. “First, new antimicrobials will primarily be used as ‘last line’ therapies for use in hospitals when other options are ineffective. These products are short-acting therapies and will experience slow uptake as they are typically used sparingly to preserve their effectiveness New antimicrobials are also generally undervalued by reimbursement systems relative to the benefits they bring to society Finally, hospital-based pooled reimbursement mechanisms may discourage the use of new antibacterials, even when they constitute the most appropriate treatment for a patient, contributing not only to market challenges but also to patient access to new products. Taken together, these challenges create a market with little or no return on investment for antibacterial drugs. »

Christopher Cheney is the Clinical Care Editor at HealthLeaders.

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