Alexander Fleming’s discovery of penicillin, more than eight decades ago paved the way for many more discoveries of antibiotics. The wave of revolution that Fleming started continued for a few more decades with new antibiotics adding to the global medicine market. However, the enthusiasm surrounding new antibiotics started to wane as market conditions changed over the years. The antibiotic business was not adding too much to the balance sheets of antibiotic producers and so, antibiotics further climbed down the priority lists of pharma companies. Though pharma companies have shown depleting interest in the business of antibiotics, on the other hand, need of antibiotics for consumer remained the same.
Market slump
Many pharma companies have decided to do away with the antibiotic business and they have their own justification to support their action. Though for around eight decades antibiotics helped mankind keep diseases at bay, overuse or wrong administration of antibiotics has also made different bacteria resistant to many antibiotics. Currently, multi-drug resistant superbugs are giving a hard time to scientists.
 “Since last few decades, the well known American and European pharma companies have been ignoring their antibiotic portfolios.”Sharad Dahatonde General Manager – Biotechnology, Elder Pharmaceuticals |
“Since the last few decades, well known American and European pharma companies have been seen ignoring their antibiotic portfolios. Moreover, many of them have closed their antibacterial departments. The situation is worsened by recent merger and acquisition activity,whereby one new pharma company can come to represent the cumulative assets of up to six formerly independent firms. These mergers tend to be accompanied by stagnation or disappearance of the merged companies’ antibiotic portfolios, reflecting the new corporate entity’s lack of interest in antibacterials,” says, Sharad Dahatonde, General Manager, Biotechnology, Elder Pharmaceuticals.
Though generic competition is also widely blamed as the reason behind antibiotic crisis, according to Dahatonde, poor returns on the investment has also turned out to be the biggest culprit. For many companies reinvestment into antibiotics research programmes might have proved a wrong move due to lower sales and eroding profits.
 “New approaches are required to be developed to further exploit microbial resources and their biosynthetic potential as an untapped source of novel metabolites.”Dr Girish Mahajan Sr Group Leader, Anti-infective Discovery-Natural Products, Piramal Life Sciences |
Dr Girish Mahajan, Senior Group Leader, Anti-infective Discovery-Natural Products, Piramal Life Sciences, says, “The discovery of antibiotics like penicillin in 1928 and that of streptomycin in 1943, has been pivotal to the exploration of nature as a source of new lead molecules. Globally, the microbiologist today is recognised as a key player in the drug discovery programme. The microbial products have been a phenomenal success for the past seven decades. Disease management has undergone a sea change since the discovery of antibiotics.”
He adds, “29 antibacterial medication were licensed between 1980 and 1989. The number fell to nine between 2000 and 2009. Over the past 30 years, only two truly novel classes of antibiotics have entered the market: the oxazolidinones (linezolid) and cyclic lipopeptides (daptomycin), and resistance has been documented for both of these compounds.”
According to Mahajan, besides multi-drug resistant bacteria, economic and regulatory factors are also responsible for the shrinking antibiotic pipeline.
Is the crisis reversible?
Though, arguably, pharma industry is the origin of the antibiotic crisis, according to industry experts, the industry itself is capable of coming out of this uncomfortable situation. However, as problem is critical, the solution is also bound to be very demanding.
Mahajan suggests, “The first thing required is that the big pharma companies should believe firmly that there is need for new antibiotic discovery and it is profitable. Since the safety requirements today are more stringent than perhaps few decades ago, there should be enough leads available to to clinical phases through IND. Microbiologically in order to counter to the current challenge of discovering novel antibiotics, new approaches are required to be developed to further exploit microbial resources and their biosynthetic potential as an untapped source of novel metabolites.”
He informs, “Among the latest efforts to remedy the antibiotic problem is the Food and Drug Administration’s Antibacterial Drug Development Task Force. On September 24, the FDA announced the creation of the panel, which will consist of 19 clinicians and scientists who are part of the FDA Center for Drug Evaluation and Research.
According to Dahatonde, big pharma’s participation will be necessary to resuscitate antibiotic drug discovery. He insists, “There is an urgent need to provide incentives for drugmakers to induce them to develop new antibiotics to treat antibiotic-resistant bacteria. These incentives should include a priority review of new antibiotics by the FDA and an obligation by the agency to act on applications for approval no later than six months after submission. Also, allow new antibiotics to be eligible for the FDA fast-track approval programme, and companies would be granted five additional years of market exclusivity for newly approved drugs.”
According to Dahatonde, a major focus should be towards the formation of non-profit, public-private partnerships (PPPs) between government agencies and private entities with the primary goal of quickly advancing promising new antibiotics to approved products. “PPP advocates contend that by removing the profit motive from the equation, novel new antibiotics can be developed regardless of market size and commercialisation potential. PPPs would be funded by both public money and private capital,” Dahatonde explains.
A consultant biologist with Mumbai-based Kohinoor Hospital says, “The R&D crisis can be slowed down by putting obligations on pharma companies to have actual R&D rather than having these only on paper. The companies should be given some benefits like terms of taxation if they show obvious results.”
Government should step in
According to pharma players, developing new antibiotics is costly procedure and also less profitable. However, looking at the importance of antibiotics for public health, should Government offer some help to pharma companies? Survival of any industry is largely determined by the Government, which monitors that particular region and pharma industry is also not an exception.
“Of course, developing new antibiotics is very costly process. Strong industry-academia collaborations with brain storming strategies, technical meetings are to be worked out to set new antibiotics discovery ways and set antibiotic policies in the country. This matter should be taken very seriously, the way the pulse polio campaign is being followed. It will not only generate huge revenue but also ensure win against resistant bugs,” says Mahajan.
Even if any pharma company decides to develop new antibiotic, the time required to launch new molecule will be lengthy. So, no sudden positive development is expected as far as launch of new antibiotics is concerned. There is also a general belief among pharma experts that policy makers and Government haven’t yet understood the antibiotic crisis fully. Such an approach would perhaps make the situation even tougher to handle. Though the Government’s approval for higher prices of new antibiotics would make pharma companies feel more secure, the Government is unlikely to entertain such requests.
Market forecast
Though there is a need for antibiotics, financial insecurity is making pharma companies’ attitude hostile towards antibiotics. With even big players showing a thumbs down to the antibiotics business, the future of domestic and global antibiotic market appears uncertain. Efforts should also be directed towards finding out cost effective alternatives to modern day antibiotics.
Dahatonde explains overall market scenario for antibiotics by providing figures published by Global Research and Data Services, which is a leading international publisher of market research reports “Global demand for antibiotics is forecast to reach 34.1 billion euros in 2016. The market has been expanding with an average annual growth of 6.6 per cent between 2005 and 2011. The market expansion is expected to slow to 4.6 per cent in the coming years. Currently, the industry is dominated by product group other antibiotics (includes e.g. aminoglycoside antibiotics) which covers 79 per cent of the demand while penicillins has 8 per cent, erythromycin 7 per cent, tetracyclines 4 per cent, chloramphenicol 1 per cent and streptomycins 1 per cent share of the market.”
Mahajan feels that, though the growth conditions are not 100 per cent favourable, but nevertheless it is very obvious that there is heavy demand for new scaffolds. Mahajan acknowledges the fact that it is becoming difficult to get new leads satisfying the desired criteria. “The return of trust in natural products, especially microbial should again bring back the era of antibiotics to reduce burden of diseases due to resistance bugs. The task force created at US FDA is indicative that there will be huge market for new antibiotics in future. If natural products are considered as a parallel way to synthetic chemistry to get new leads I think India will be a hub for new antibiotics as it harbours huge biodiversity. The biodiversity will be assets for giving novel antibiotics for future,” signs off, Mahajan.
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