CPHI Online 2024 Pharma Trends Outlook “Three Pharmatech Associates experts have contributed their insight on trends in pharma for the year, in a new report published in January: CPHI Online 2024 Pharma Trends Outlook “Collaboration, Market Maturity, and Digital Futures – What 2024 holds for Pharma.”

Here are the Highlights:

p. 7 – Generative AI is now a must. “Applying machine learning and artificial intelligence can optimize and accelerate all aspects of bioprocessing, from cell culture and upstream processing to downstream processing with chromatography and filtration. PAT sensor technology and sophisticated chemometric modelling all continue to improve in terms of accuracy, thanks to the maturation of support vector machine quantum computing software and analytical tools.” – Bikash Chatterjee, president and chief scientific officer, Pharmatech Associates

p. 19 – Mature quality management and control – prevention is better than a cure. “Over the last few years, there has been significant focus on regulatory oversight and regulatory actions. Issues such as product recalls and drug shortages all continue to point to the importance of focusing on quality…now, we cannot just address quality at the backend by checking whether somebody is complying – we need to start at the front end and ask what can be proactively put in place to ensure quality. QMM is a great initiative that looks at culture approaches, fostering a mindset of continual improvement that we hope will result in fewer backend issues that require correction actions, at a huge cost for all involved.” – Sireesha Yadlapalli, CEO, Pharmatech Associates

p. 35 – Patient-centricity is now less of a trend and more a necessity for the pharmaceutical industry. “The off-label use of GLP-1 for weight loss has driven worldwide drug shortages and left patients scrambling to find alternative supplies,” Chatterjee explains. “Big Pharma companies are committing funds to build capacity for both API and drug products while contract manufacturers struggle to keep pace with demand. Realistically, intermittent shortages of GLP-1 receptor agonists will be the norm through 2024, and potentially 2025 for some programs, as Big Pharma looks to bring new capacity online.”” – Bikash Chatterjee, president and chief scientific officer, Pharmatech Associates

p. 36 – Despite increased manufacturing for generics, pricing challenges are putting pressure on drug manufacturers. “The US domestic market is in untested waters regarding generic drug pricing,” Chatterjee states. “Between 2022 and 2023, more than 46% of drugs on the market saw prices increases above the inflation rate. The passage of the Inflation Reduction Act would penalise drug manufacturers for price increases above the inflation rate for any drugs sold to Medicare, and since Medicare makes up approximately 18.7% of the US population today, its impact on bottom line profitability is tangible. As inflation cools, so will the ability to raise prices significantly.” – Bikash Chatterjee, president and chief scientific officer, Pharmatech Associates