CPhI Worldwide, the world’s largest pharma event – taking place in Madrid (9-11, October 2018) and organized by UBM (part of Informa plc) – releases its annual report analysis of opioid contract services and continuous manufacturing. Ahead of the event’s opening next week, the findings highlight major treats and opportunities for CDMOs and pharma companies over the next 1-5 years.
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 five 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 CM 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 six 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.
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.
“However,pportunities 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.
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.”
