Pharma manufacturers warned to invest in continuous manufacturing

CMOs hit by reduced volumes of opioid manufacturing from DEA quota changes, but cannabis sales to ignite.

Emil W. Ciurczak, of Doramaxx Consulting, and Fiona Barry, editor at PharmSource, a GlobalData product, respectively analysed ‘the effects of continuous manufacturing’ and ‘contract manufacturing in light of recent DEA quota changes for controlled substances’.

Over the next 5 years, Emil Ciurczak predicts exponential growth of continuous manufacturing driven by competitive and financial pressures, better equipment and a larger pool of trained scientists. He boldly predicts that all generic manufacturers and CMOs will need to convert to continuous manufacturing facilities in the next 10 years.

“The companies who have begun using continuous manufacturing have enjoyed (overall) success, making products faster and with virtually no rejects. The movement from development to full-scale production, skipping the scale-up step (as much as 6 months) brings the products to market faster. The question is no longer, “Will continuous manufacturing work?”, but “When will everyone be doing it?” added Ciurczak.

He suggests that many pharmaceutical companies may not yet feel the need to convert to continuous manufacturing, as there is less financial incentive to streamline the manufacturing process for innovative medicines, which can yield thousands of dollars of profits. However, he explains that industry-wide changes are putting production costs under new scrutiny. Competition between countries, the imposition of pricing restrictions and the constant cost of R&D means that simply raising prices to consumers may no longer be a viable option so ultimately, he forecasts that Big Pharma that declines to invest will be left behind — and this change will take place within the next 5-10 years.

Fiona Barry identified opportunities and threats created by recent changes in US regulations. In particular, she predicted many CMOs will be hit hard by the proposed production cut of opioid compounds by the DEA to combat the opioid addiction crisis. Conversely, she also predicted that the development of non-opioid painkillers could be a possible replacement revenue stream and will become a profitable opportunity for CMOs and drug companies in the near future.

“Out of the 30 CMOs involved in commercial drug manufacture using controlled substances, 18 (60%) produce opioids. While contractors involved in controlled substance production constitute a minority of US CMO facilities, it is clear that they will be hit particularly hard by the reduced volumes of opioid manufacturing. The ever-growing number of opioid lawsuits —such as the US state lawsuits against Purdue Pharma — is likely to deter pharma companies from producing and outsourcing these products in the future.

“However, opportunities for CMOs and drug companies relating to non-opioid painkiller manufacture are likely to become more lucrative in the future, as alternatives to addictive opioids are sought,” concluded Barry.

In addition to these opportunities, Barry went on to predict that there may also be many new approvals for cannabis-derived drugs in the pipeline. She pointed to shifting regulatory attitudes — following the first FDA approval of a plant-derived cannabinoid drug, Epidiolex — as well as the recent DEA quota changes, which will increase maximum marijuana volumes by 250% in 2019 as evidence of these emerging trends.

CPHI Brand Director Europe, Orhan Caglayan added: “These findings are particularly relevant to many of the CDMO exhibitors at ICSE who are already exploring and invested in continuous manufacturing approaches. Our experts suggest the industry may now be undergoing a fundamental long-term shift in manufacturing and many of the sessions at CPHI Worldwide will explore these implications. Similarly, there are clearly both opportunities and challenges ahead in the short and long term in relation to opioid and alternatives manufactured for the US market. This is an evolving space and I would encourage both branded pharma and CDMOs to study how they adjust their business, with CBD compounds widely seen to represent a quickly growing sector.