The future of pharmaceutical manufacturing

Pharmaceutical operations are constantly progressing, driven by factors such as product innovation, increasing focus on sustainability and the impact of technology

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To maintain competitiveness on the market, it is essential to interpret and exploit key trends to anticipate the significant evolutions that are revolutionizing the pharmaceutical sector. Luigi Braga, expert from Boston Consulting Group, highlighted various trends, often related among themselves, analyzing the consequences during the seminar “Innovation in Italian pharmaceutical manufacturing”, an event organized by Afi (Pharmaceutical Industry Association) and Ispe (International Society for Pharmaceutical Engineering.

Product innovation

The biopharmaceutical industry is undergoing a revolution in oncology and other complex diseases, thanks to a wave of innovation that continually leads to new pharmacological modalities. Thenew modalitieswill create unprecedented opportunities for biopharmaceutical companies that actively pursue them, but they also present unprecedented risks.
Therapies based on plasma, DNA and RNA derivatives are well-known technologies from a research and development point of view and are now starting to have a truly interesting backline. cell engines, which have already existed for a few years, and the most recent mRNA technologies offer new application possibilities. All this makes it necessary to manage much more complexity at the production level.

A characteristic of many new drugs is that they impact smaller patient populations than in the past, because they respond to increasingly personalized and, in some ways, niche health needs: this obviously generates an impact directly on the volumes. Manufacturers must be able to manage the production of more complex and expensive drugs, quickly adapting to new regulatory requirements and patient demands.

Being regulated, the innovation cycle in the production of new drugs takes a long time compared to other products, which however have many opportunities to shorten, requiring a quicker reaction capacity from operations managers. But this generates further benefits: once a company has developed the capabilities for one modality, it can apply them to other related ones through a platform approach that creates synergies.

Sustainability

An emerging theme, which no one can help but consider, is that of ESG (Environmental, social and governance): a set of factors that measure the impact of a company on the environment , society and governance.
Companies that work to improve their ESG profile are increasingly appreciated by consumers, investors and employees.
In particular, consumers are increasingly sensitive to the issues of environmental and social sustainability and are therefore more likely to choose products and services from brands that are committed to reducing their environmental and social impact. Investors, for their part, are more attentive to environmental risks and more inclined to invest in companies that have a good ESG profile, as they are less exposed to the risks associated with a lack of attention to these issues.

Geopolitical factors

Then there are some trends that reflect the strong geopolitical changes of recent years. In the past, pharmaceutical companiesrelied on a global supply chain model, which allowed them to source raw materials and components from anywhere in the world. This model was based on the perception that the world was a stable and safe place, where geopolitical crises were a rare event.
However, events in recent years, such as the wars in Ukraine and the Middle East, have shown that this model is no longer sustainable. Geopolitical crises can have a significant impact on the supply chain, causing shortages of materials and components which have also been evident to everyone in recent months.
As a result, pharmaceutical companies are starting to reconsider their supply chain model by adopting strategies that aim to reduce their dependence on a single source of supply and improve their resilience to crises.
Supply continuity and geopolitical uncertainty are leading to two main trends in the pharmaceutical sector: the increase in costs due to difficulties in supplying raw materials and the shifting locations, in which geopolitical, social and environmental risk factors weigh.

New technologies

And then there is clearly a technological paradigm: the pharmaceutical sector is undergoing a digital transformation, driven by artificial intelligence. It is the most talked about emerging technology in 2023 and is rapidly gaining importance also in the pharmaceutical sector, being able to be used to improve the efficiency, quality and safety of operations..

In reality, the adoption of artificial intelligence in the sector is still at an early stage, but its potential to help pharmaceutical companies overcome a series of challenges is increasingly evident. First of all, given an increase in product complexity, it can be used to automate repetitive activities and improve data quality; furthermore, given the need to reduce time to market, it can help accelerate the development and approval of new products. Furthermore, in a situation of great complexity of the supply chain, it can improve its visibility and reduce the risk of interruptions.

Some large clusters of artificial intelligence use cases are:

  • the digitalisation of processes
  • the creation of a solid database for training algorithms,
  • prediction of problems,
  • improving efficiency
  • the automation of repetitive activities, reducing the need for human resources.
  • Alongside more established systems, generative artificial intelligence (Gni) is a new technology that is rapidly gaining importance in the industrial sector and can be used to generate new ideas, products and processes.

The actual success of implementing AI in the pharmaceutical industry will depend on a number of factors. Coherent integration with existing processes is fundamental, an essential condition for it to be truly effective. Another point is data science capabilities: pharmaceutical companies must be able to analyze data to extract value from artificial intelligence. In short, success is only possible in the presence of a clear roadmap for the implementation of this emerging technology.
Under these conditions, artificial intelligence has the potential to transform the industrial sector in many ways: for example, it can be used to provide companies with information and suggestions on negotiating prices, helping them get better deals; it can automate reporting and meetings, freeing human resources to focus on more strategic activities; can create a digital copy of the supply chain, which would be easily accessible and true to reality.