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The second part of the CPhI Annual Report has predicted an accelerated rate of change in pharma manufacturing and supply over the coming five years.
The second part of the CPhI Annual Report, released on Oct. 25, 2021, has predicted an accelerated rate of change in pharma manufacturing and supply over the coming five years, with adoption of automated cobots, artificial intelligence (AI), real-time-release, and rapid growth in areas such as messenger RNA vaccines.
Released ahead of the 2021 event, which is being held as a hybrid event with the in-person show taking place in Milan, Italy between Nov. 9–11, 2021, the report predicts that China and the United States will lead innovation by 2030, followed by European nations and Japan. Emerging economies are expected to be nurturing new R&D centers in the near future.
“Our experts suggest that the rate of change in pharma manufacturing and supply is likely to accelerate over the next five-years and we will see adoption that might have otherwise taken 10-years to achieve [pre-pandemic],” said Orhan Caglayan, brand director at CPhI Worldwide, in a press release. “Pharma is seeking new partners, ingredients providers, and contracts services organizations—with the supply chain competing to align not only with the new therapies coming through discovery, but also with next-generation technologies that will enable better and potentially cheaper medicines.”
One of the experts who provided insights for the report, Bikash Chatterjee, CEO at Pharmatech Associates (a USP Company), suggests that manufacturing is now producing better-quality products at potentially lower costs thanks to the combined adoption of continuous processing, process analytical technology (PAT), and process analytical chemistry (PAC). Chatterjee also emphasizes in the report that the adoption of newer manufacturing approaches has been sped up by the macro changes that have happened over the past year along with efforts from governments to reshore manufacturing and secure supply chain resiliency for essential medicines.
“The integrity of the strategic national stockpile (SNS) will be a springboard for the development and refinement of advanced manufacturing technologies. For industry, the chief benefit from broader adoption of such approaches is to take advantage of lower cost of goods by reducing waste and the cost of poor quality (COPQ), and that in itself may increase the industry’s comfort with principles such as real time release (RTR),” said Chatterjee in the press release. “In a market likely to continue to encounter consistent downward pricing pressures, the adoption of these elements will allow manufacturers to lower their costs and still manage a profit as they provide improved, higher quality drug therapies to patients—this is a win-win in anyone’s book.”
Furthermore, Chatterjee anticipates that the industry is on the cusp of a standards revolution, with COPQ factoring in development and methodology, AI used in process selection, and new PAT and PAC standards likely being defined by regulatory bodies or the International Council for Harmonisation.
Aurelio Arias, engagement manager, Thought Leadership, IQVIA, who also provided expert insight for the CPhI report, reveals that therapeutic indications in the pipeline will also change by 2030, in addition to the adjustments expected in manufacturing processes. “By 2030 we expect the leading therapeutic indications accompanying oncology will be in crossover areas like inflammation and cancer vaccines. Growth potential will also be sourced from rare diseases and niche immunology areas. Some therapies will experience a revival, like cardiovascular, liver disease, and central nervous system—with or without Alzheimer’s—already showing huge potential to be treated using digital therapeutics,” Arias said in the press release. “Significantly, the modalities in which we can tackle these disease areas will increase with the development of platform technologies, more specifically in RNA, Cell and Gene, Digital and Microbiome.”
Both experts highlighted increased digital innovation in the supply chain, which can transform manufacturing efficiencies and improve patient adherence. However, a challenge in the form of regulations may be witnessed, as regulators may not be able to keep pace with the speed of change, which could hinder innovation.
Moreover, the innovative manufacturing approaches are enabling more personalization of medicine at scale, which the experts specify will mean that pharma companies need to rebalance book and divert costs from traditional engagements to leaner, smarter ways of operating. “The top pharma companies in 2030 will be those that can navigate this sea change by ruthlessly creating a path of prioritizing investments in promising countries and disease areas,” added Arias in the press release.
The full report is available to those attending CPhI Worldwide.