Turning the tide — will R&D efficiency improve in the current pharma landscape?

27 July 2017 14:56

Research and development efficiency has been in decline for many years, but now with bodies, like the FDA, aiming to accelerate approval times and a critical need for new therapies to combat antibiotic resistant strains of bacteria will we see the tide turn?

With demand for drug delivery technologies rising on a global scale^1,2 and emerging markets offering increased opportunities to pharmaceutical companies in several areas is it any wonder research and development (R&D) has taken a back seat?

The decline in R&D efficiency has been a continuing trend since the 50’s, as noted in the article by Scannell et al. in Nature Reviews Drug Discovery³ and, is also one of the sections highlighted as ‘in crisis’ within PricewaterhouseCoopers’ (PwC) ‘From vision to decision Pharma 2020’ report.⁴ Although these reports were published a few years ago, there hasn’t been a significant upturn in R&D efficiency of late either, which can be partially equated to the low proportion of drugs being approved by regulatory bodies.

However, in the current pharma landscape, more heavily focused on personalised medicines along with the rise (and rise!) of antibiotic resistance, plus a renewed stance from regulatory bodies, such as the FDA, to streamline and accelerate approval processes this may change.

Rising resistance

Recently, we have been inundated with headlines about increased incidences of antibiotic-resistant gonorrhoea, including a plea from the World Health Organisation (WHO) that ‘new drugs are needed’.⁵

“The bacteria that cause gonorrhoea are particularly smart,” explained Dr Teodora Wi, medical officer, human reproduction at WHO. “Every time we use a new class of antibiotics to treat the infection, the bacteria evolve to resist them.”

The R&D pipeline for this specific disease is very sparse with only three new candidate drugs in development. According to WHO,⁵ development of new antibiotics is not a particularly attractive prospect for pharma companies as treatments are short-term and have a limited efficacy lifetime due to the bacteria developing resistance. This means that more money will be required at regular intervals to develop newer antibiotic therapies that can combat the evolved disease.

Obviously, there are more cases coming to the fore in this potentially devastating problem with the current state of affairs being only the tip of the iceberg. This was emphasized by the BEAM Alliance, which has requested urgent action on the issue be taken by political leaders at the G20 summit.

“If nothing is done to thwart the progression of anti-microbial resistance, it will equate to a potential global economic burden of up to $100 trillion by 2050,” Florence Séjourné, president of the BEAM Alliance stated, citing estimates from the 2016 O'Neill-report.⁶

In a report from business intelligence provider GBI Research, covered by EPM earlier this year,⁷ it was revealed that the antibacterial drugs market is expected to reach $35.6 billion by the year 2022. It is anticipated that this growth will be a result of new companies emerging in the market as well as the approval of new products.

So, what is on the cards for the future? There is a definitive need to nurture R&D, improve pipelines and see development but maybe we will see these changes within new, smaller companies rather than the more traditional big pharma. Regulatory bodies need to address factors that may cause delays to approvals, for which we have seen promising inroads being made by the FDA. The public and health sector need to be better educated about the consequences of overuse of antibiotics. Finally, funding for small to medium-sized companies is crucial as these may prove to be the vanguard in our battle against antibiotic resistance.

Felicity Thomas

References

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