The face of pharmaceuticals is ever-evolving, but with the technological advantages given to the field, changes have happened quite rapidly. FDA regulations, as well as a growing demand worldwide, have resulted in several trends for 2019.
Generic Drug Shortage
Greater demand for generic versions of popular prescription drugs worldwide has resulted in a shortage of generic alternatives for over a year now. Since 2017, the FDA has attempted to address the shortfall, but many people, especially those on fixed incomes, are having to go without. Supply chain disruptions are partly the reason, as damage from Hurricane Maria interrupted production in Puerto Rico.
The FDA has encouraged competition among leading pharmaceutical companies, resulting in more effective medications and a revolution in the field. Addressing the generic drug shortage is part of the reason, allowing different companies to create generic versions of similar brand-name medications. The increased competition has led to reinvestment in U.S. facilities, as recent tax reforms have made creating research facilities and production plants more enticing.
Pfizer, Amgen, and Eli Lilly have all announced plans to build multi-million dollar research and development facilities in the U.S. These facilities each promise leading-edge equipment, especially automated systems. Additional automation in the research and development sector led to a streamlining of production. These advances in technology, robotics, and information sharing are designed to help combat the growing demand.
IoT and Digitization
Expect to see increases in 3D printing in the pharmaceutical production process. The FDA approved the first 3D printed drug in 2015, leading to an increase in utilizing this technology in the Emerging Technologies divisions of many of the larger pharmaceutical companies.
In addition to 3D technology, and the trend for production is the integration of “Internet of Technology” into overall production. IoT includes devices with a remote and a sensor, allowing real-time data to be captured at every stage of the research and manufacturing process. These IoT devices are being integrated into the plant schematics for several new facilities in the U.S.
Digitization of this data and its ability to be shared quickly in cloud-based systems allow developers and researchers access to data at critical points. Shred information encourages collaboration at all stages of development.
Properly managing the supply chain for pharmaceuticals is nothing new. Improvements in technology have allowed companies to be more responsive to demands for certain medications, as well as address the generic drug shortage. Introducing predictive analysis into the pharmaceutical supply planning is based on collecting data from users, including lifestyle patterns. This, in turn, allows development and production to respond to anticipated demand in a more timely fashion. The goal is to reduce drug shortages.
Except to see technology play a much larger role in all aspects of the pharmaceutical industry in 2019. Trends in production technology have been eagerly embraced by many of the larger companies, with regulations from the FDA designed to encourage companies to innovate. Streamlining the supply chain process is easier with the newer facilities that have been built, and global competition is causing greater advances. Expect to see the FDA take a more active role in their own research, parallel to that being done in private labs. As a result, regulations and approval from the FDA may take place in a shorter window of time, allowing new drugs, 3D manufactured medications, and a broader selection of generics to be approved quicker.
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