Antibacterial drug resistance: market landscape, challenges and upcoming

Since the discovery of penicillin in 1948, antibiotics have emerged as a crucial class of pharmacological interventions responsible for treating several infectious conditions. In addition, antibiotics are also used for prophylactic purposes in patients who have undergone surgery, or immunocompromised patients (cancer patients undergoing chemotherapy), a market researcher ReportBuyer said in a report.

The researcher noted that the inappropriate use of antibiotics, both in healthcare and food production, has rapidly accelerated an evolutionary response of antibiotic drug resistance in bacteria, rendering most existing antibiotics ineffective. In addition to high mortality rates, antibiotic drug resistance adds considerable costs to the healthcare system, thereby, significantly increasing the economic burden. In the US, antibiotic resistance leads to a loss of $20 billion in direct healthcare costs, with additional costs, as high as $35 billion per year, to society in terms of lost productivity.

Several companies have made an attempt to develop new generation antibiotics that can combat the widespread antibiotic drug resistance, the researcher notes. These antibiotics are either the improved derivatives of existing antibiotics or combination products of antibiotics and ?-lactamase inhibitors. In addition, several players are actively involved in the development of alternative therapies, such as phage based therapies, vaccines and monoclonal antibodies, which can potentially be utilized to target drug-resistant bacteria.

To safeguard the use of antibiotics and support the development of new generation molecules, a myriad of initiatives have been taken by government bodies across the globe. Examples include the Biopharmaceutical companies from Europe innovating in Anti-Microbial resistance (BEAM) Alliance, Driving Reinvestment in Research and Development and Responsible Antibiotic Use (DRIVE-AB), Global Antibiotic Research and Development (GARD, partnership between DNDi and WHO), Global Action Plan on Antimicrobial Resistance (GAP-AMR), National Action Plan for Combating Antibiotic Resistance Bacteria (NAP-CARB), and Biomedical Advanced Research and Development Authority (BARDA). In September 2016, leaders from across the globe decided to meet at the United Nations General Assembly to discuss health concerns related to anti-microbial resistance (AMR).

Various initiatives to classify drug resistant bacteria have been undertaken to assess the varying levels of threats posed by such pathogens and establish appropriate treatment regimens for infections caused by them. For this purpose, ReportBuyer says, the IDSA has identified a set of bacterial pathogens, dubbed ESKAPE (Enterococcus faecium, Staphylococcus aureus, Klebsiella pneumoniae, Acinetobacter baumannii, Pseudomonas aeruginosa and Enterobacter spp.) pathogens, which are known to be responsible for high risk and other life threatening conditions. Similarly, the CDC has come up with its own system of categorizing high risk bacterial pathogens; in this system, bacteria are classified as urgent, concerning and serious threats depending upon the severity of infections that they are known to cause. With a considerable number of candidate drugs in the late stages of clinical development and given the existing government support, the new generation antibiotics market is expected to witness significant growth with the launch of multiple drugs over the next decade.

As the researcher has indicated earlier, owing to the over-prescription of antibiotics due to improper diagnosis, lack of adherence to proper dosage regimens, their widespread availability as over-the-counter (OTC) drugs, and overuse in agriculture and poultry farming, most antibiotics have been rendered ineffective. Moreover, there currently exists an expanding lag between the pace at which drug resistant bacteria evolve and the time taken for new drugs to reach the market. As a result, ReportBuyer says, antibiotic drug resistance has escalated into a global threat. There are concerns that the lack of effective drugs in this domain may soon trigger the relapse of the pre-antibiotic era, in which individuals died due to day-to-day bacterial infections. According to certain studies, currently, an estimated 700,000 deaths annually are known to occur due to anti-microbial resistance worldwide. In future, the growing threat of antibiotic resistance is anticipated to prove to be more fatal than cancer.

The current scenario depicts an urgent need for new antibiotics with novel mechanisms of action, having the ability to combat antibiotic resistance. The US and EU governments have amended their action plans and conducted many conferences to raise awareness about the situation among both experts in the domain and the general public. Such initiatives are addressed to support R&D strategies of companies engaged in the development of drugs to combat antibiotic resistance. Efforts are underway to assist drug developers in their clinical trial design issues, and even the simplification of regulatory pathways to expedite the time to market for such drugs. In addition, such initiatives endorse public-private partnerships in advancing scientific and clinical efforts in this domain, aid the setting up of surveillance programs to track the widespread use of antibiotics and the development of resistance, and track the growing economic burden due to this phenomenon as well.

The new generation antibiotics pipeline comprises of several molecules that target infections caused by deadly pathogens classified under ESKAPE or as urgent threats by the CDC. Several start-ups have entered the market and undertaken various initiatives to develop novel antibiotics with unique mechanisms of action, the researcher said.