at Purdue University
Trends & Drivers
Trends and Drivers examines key factors shaping pharmaceutical manufacturing in the U.S. , including demographic shifts, pricing pressures, stability of new drug modalities, geopolitical influences, environmental concerns, and AI integration. These trends and drivers impact industry practices, drive innovation, and influence strategic decisions.
Demographics
Lower birth rates, increased life span, and an aging population continue to drive demand for preventative health care and treatment of chronic disease states. Along with this comes the need for trustworthy new technology to enable greater flexibility in dosing, more convenient administration, and better patient compliance. Social media use is increasing in all age groups, and is a new means of monitoring safety and efficacy, as well as acting as a safeguard against the spread of misinformation.Generational shifts in workplace culture increase competition for new talent and require innovative career education and reskilling.
Public perception that the high cost of Research & Development (R&D) does not justify the public health burden has motivate new laws which decrease patent protection for new drugs. The Inflation Reduction Act of 2022 introduced mechanisms to shorten patent protection and may impact R&D and investment decisions by the pharmaceutical industry. Income and wealth inequality, at a global scale, threaten to render advanced medicines inaccessible to many populations driving societal actions.
Pricing Pressure
New Modalities
The COVID-19 pandemic led to groundbreaking advancements in new drug modalities, manufacturing methods, logistical strategies, and regulatory approval cycles. Significant areas of interest within the freeze-drying community include mRNA-LNP vaccines and therapeutics, cell and gene-based therapies, gene editing, and other personalized medicines. These products will likely drive demand for smaller batch sizes and faster turnaround times, leading to innovative bulk drying systems, continuous manufacturing methods, and alternative product dosage forms. However, steep investment costs and deeply embedded risk aversion in the pharmaceutical manufacturing domain are expected to limit immediate traction.
Global conflicts and the recent COVID-19 pandemic have driven the need for strengthening of domestic manufacturing and supply chains and has increased demand for shelf stable medicines and vaccines. The CHIPS and Science Actcommitted large investments into advanced manufacturing in the United States. Global IP theft drives tighter security protocols and trade barriers. Emerging markets often lack the regulatory infrastructure, laws, and trained regulators, slowing U.S. industry entrance into new markets.
Geopolitics
Environment & Climate
Environmental initiatives and tighter governmental regulations have placed increased pressures on pharmaceutical manufacturers to aggressively reduce their water and energy use, and eliminate toxic waste. Freeze-drying is a viable alternative to cold-chain storage but requires upfront CO2 production. These pressures have stimulated implementation of “green” refrigerants, innovative dosage forms, continuous manufacturing, improved system efficiency, adoption of closed loop or optimized open loop drying, novel packaging with reduced waste. New investments are being made into renewable energy with leading companies pledging carbon neutrality in the near term.
New digital technologies such as artificial intelligence, digital twins, automation, and big data have become prolific across most of the major manufacturing sectors. However, adoption by the pharmaceutical freeze-drying community has been relatively slow and primarily confined to research and development environments. Likely causes for the lack of traction include internal misalignment between research and manufacturing, heightened cybersecurity threats, regulatory stigmas, unwanted operational risks, and low financial incentives. The active areas of interest in this area include closed-loop control of the freeze-drying process, automated handling and inspection, reliable secondary drying models, and process data management.
