Three Major Trends That Impact the Pharmaceutical Industry
The pharmaceutical industry is in a state of flux. Even if the Covid-19 pandemic is not the trigger, it has played its part in how the industry will evolve going forward. In this article, we highlight three trends that will impact the pharmaceutical industry in the future.
Growing demand for digital solutions
The pandemic has shown how we depend on digital solutions in all areas of our life. It is therefore not surprising that the importance of remote approaches and digital tools will continue to grow. To date, many pharmaceutical companies worldwide have already adopted remote assessment techniques into their everyday operations at an accelerated rate. Such techniques can assist with corporate overviews, internal audits, supply chain verification, or certification audits. However, not only pharmaceutical manufacturers are increasing their focus on remote solutions. More and more pharmaceutical regulators continue to leverage remote approaches as well. While regulatory agencies from countries like Canada, Australia or those across Europe use remote inspections, the FDA does not yet have certified remote assessments in place. For this reason, the FDA is facing growing criticism.
New framework conditions lead to changes in manufacturing processes
Currently, no medication exists for many rare diseases. In the future, this will most likely change, as experts predict that the industry will continue to shift towards niche medicines. The focus will be on Contract Development and Manufacturing Organizations (CDMOs), which will produce in smaller manufacturing scales, leading to new ways of working.
Another trend shows that research for personalized medicine will continue. Personalized medicines not only affect standardized production processes, but also harm sustainability by forcing smaller production runs. These are more wasteful because downtime affects energy and time between batches produced. It is therefore important that pharmaceutical manufacturers are equipped with machines in their production process that not only increase productivity, even with individual requirements, but also support the sustainability of the entire production process.
Building a stronger quality culture
The search for a Covid-19 vaccine has shown that the pharmaceutical industry in particular has had to react with flexibility to the new circumstances brought about by the pandemic. In the search for a vaccine, three challenges became apparent:
1. The rapidly increasing numbers of infections made it necessary to find a vaccination against the virus as quickly as possible in order to prevent further spread.
2. Restricted travel and working conditions had an impact on the productivity in pharmaceutical production plants.
3. Despite the difficult conditions, quality standards had to be maintained. For this reason, quality management programs have served their purpose and once again proven how indispensable they are.
The FDA has recently announced a Quality Management Maturity (QMM) pilot program to gain insights into the quality management of pharmaceutical manufacturers. The FDA says "Through this pilot program, a third-party contractor identified by the FDA will conduct an onsite assessment of a facility's quality management system, accompanied by FDA staff. The Agency will gain insight from the results of the QMM assessments to inform the development of a framework for conducting QMM assessments of manufacturers and a rating system that will incentivize industry investments in quality management maturity."
If you are interested in this topic and want to learn more about what the pharmaceutical industry can expect from 2021, you can find more information here.