A newly released industry report from CPhI takes an in-depth look into what might lie ahead in the coming year, examining potential supply chain strategies, pharma manufacturing capacity, vaccine nationalism, growth in contract development and manufacturing organization (CDMO growth, and more.
The document shares expert analysis, divided into 12 key findings. It predicts a rosy outlook for the pharmaceutical manufacturing supply chain (thanks to demand for increased second-source contingencies), and likely expansion in contract services across all product classes and therapeutic areas.
Also, the report muses about a potential return of ‘forgotten priorities’ from recent years, such as continuous manufacturing, which could bring about novel manufacturing approaches.
Interestingly, the CPhI report highlights that ‘forgotten priorities’ of recent years like AMR (anti-microbial resistance), and continuous manufacturing will return – with the latter potentially simulating new manufacturing approaches for novel applications like RNA technologies.
“Continuous or intensified processes are in early feasibility stages currently, with investments in research being provided by CEPI and the Gates Foundation,” commented Bikash Chatterjee, CEO of Pharmatech Associates. “Most likely, with the continuation of the pandemic and the extremely high demand for vaccines, we could see a push to incorporate these processes post approval.”
One trend predicted to emerge early in the year, according to the report, is ‘vaccine nationalism’—i.e., a share of the early doses kept for home markets—prior to scale up and wider availability.
“Initial demand for COVID-19 vaccines is going to be global, simultaneous, and will vastly outstrip supply, requiring careful management of this scarce resource, but it’s understandable there will be some degree of nationalism as countries try to secure vaccines for their domestic population first,” commented Mike Whelan, project leader at Coalition for Epidemic Preparedness Innovations (CEPI).
The report also points toward likely growth in CDMO business, thanks to the surge in vaccine production, growth across therapeutic areas and evolution in supply-chain strategy. Peter Bigelow, president of xCell Strategic Consulting and chairman of the Pharma and Biopharma Outsourcing Association (PBOA), said, “CDMOs are likely to benefit from capacity reservation, with strategic customers and governments looking to maintain available capacity in case it is needed.”
Also, Gill Roth, PBOA president, said he envisions new payment models for therapies creating new contract structures for CDMOs.
“Innovations like cell and gene therapies, which accrue a front-loading of the patient population, with many patients treated upon launch, and diminishing volumes required over time as fewer patients remain to be treated will mean such a model for CDMO as well,” Roth commented. “Contracts will need to shift from ongoing volumes typically treated in contract relationships to much larger upfront payments.”
The report can be viewed at bit.ly/3mZHl6J.