Introduction

The overuse of antibiotics has resulted in antibiotic resistance, and as a result, there is a surging need for new antibiotics in the market. There has been no progress in antibiotic development since the 1980s, and any new antibiotic is just a modification of a prior drug.

Clinical trials of antibiotic development face unique challenges like selecting appropriate patient populations, endpoints, and trial designs. The multi-drug resistance complicates the clinical trial assessment.

Hence innovative strategies are required to develop novel antibiotics in real world settings. It is further a tedious and time-consuming process requiring financial and manual assistance.

Barriers To Antibiotic Development

There are various scientific, regulatory, economic, and societal barriers that one has to encounter before developing a new antibiotic.

Scientific Barrier

The first scientific barrier is a lack of expertise in dealing with gram-negative bacteria. These bacteria have double membranes and have efflux pumps that expel the drugs out of them, thus challenging the development of new antibiotics for them.

Another scientific concern is researching molecules that can work as effective antibiotics.

Regulatory Barrier

The regulatory barrier involves passing the test of the regulatory bodies to be able to enter the market. Any new development brings with it safety concerns and the question of merit.

Efforts to develop new antibiotics against gram-negative bacteria have been widely unsuccessful. Scientists require a deeper understanding of the pathophysiology of gram-negative bacteria to create a successful antibiotic.

The guidelines and criteria for antibiotics against gram-negative bacteria are strictly updated and maintained by regulatory bodies

The regulatory bodies are faced with two options either lowering the standards for antibiotic development or letting antibiotic resistance increase in the community.

Economic Barrier

The economic challenge further worsens the development of novel antibiotics. The development process can cost as much as $1 billion. Furthermore, it is difficult for the manufacturers to persuade the healthcare system to purchase the new antibiotics due to their limited life span, short course treatment, and low selling price.

Antibiotics are the only drugs where sales are kept as low as possible, further straining the pockets of manufacturers.

Societal Barrier

The societal challenges are no less. Antibiotics have long been effective against bacterial infections. People now expect a cure for the disease at a small cost with a handful of pills.

This creates a false sense of security and encourages the overuse of antibiotics.

Conclusion

The slow rate of antibiotic development and increasing antibiotic resistance calls for an intensive effort in this area. A combined effort by the health care center, government, and philanthropic organizations can help overcome the challenges in antibiotic development.

We have seen how COVID-19 vaccines have been successful when controlling the infection became a global priority. Similarly, despite all the scientific, regulatory, and economic barriers to antibiotic development, a successful antibiotic can surely be developed.