Pharmaceutical Market New Rules for the Pharmaceutical Industry

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Personalized medicine, automation, sustainability: How the pharmaceutical industry is dealing with the upheaval and what it means for the supplier industry.

The cards are being reshuffled in the pharmaceutical industry. Individualized medicine, automation and digitalization are the aces up every company’s sleeve, and the trend towards sustainability could soon prove to be a real wildcard. The pharmaceutical market is growing uninterruptedly at rates of three to six percent annually and there is no end in sight. At least, that is what the experts from IMS Health say in their latest study.

Companies that are active in the generics market and the “pharmerging markets” also have good cards — for the latter, the experts predict growth of ten percent, in contrast to the established markets in Europe, North America and Japan. According to the analysts at IMS Health, 2021 also saw an impressive number of genuine innovations.

Novartis, Pfizer and others launched 84 new drugs onto the market, twice as many as five years ago. Of the 72 new pharmaceuticals launched in the US in 2021, 44 were classified as first-in-class by the FDA. More than half had orphan drug status at the time of approval.

All Organic or What?

Especially exciting is the field of biotherapeutics, which represents the next generation of pharmaceuticals. The approvals of the gene therapy Zolgensma from Novartis and the CAR-T cell therapies Kymriah (Novartis) and Yescarta (Kitepharma) are just the tip of the iceberg. Behind the scenes, companies are working feverishly. There are currently 800 therapies in the pipeline, compared to “only” 600 in 2019, with a focus on CAR-T and NK cell therapies, gene editing and RNA therapeutics.

Such therapies are interesting not just for their disruptive power. They are also arousing ambitions in companies that were previously active in other markets: Examples are Optima, Harro Höfliger and Bausch+Ströbel, all of which are developing new production methods for gene therapies.

All supplier companies are watching these developments very closely, because whoever bets on the wrong horse or arrives too late will be punished by the market. Expectations are high. Johannes Rauschnabel, Chief Pharma Expert at Syntegon, expects the demand for “ready-to-use” equipment and equipment that enables fast set-up times to increase.

Everyone only wants to spend money on equipment that is fit for the future, and for him that means digitalization above all. The industry also has some catching up to do in terms of automation, which means that investments are likely to increase in the future and automation companies should be pleased: “Everything that can be automated will be automated,” emphasizes Rauschnabel.

The New Annex 1 Relies Fully on Automation

In addition, the regulatory requirements are also pointing in the direction of automation, and especially robotics. The EU GMP Annex 1, something like the bible of aseptic production, is currently being revised and will leave no stone unturned after its finalization, which is expected at the end of the summer. The directive, which is supposed to finally harmonize the national tangle of regulations, applies in 15 countries, says Rauschnabel. Pharmaceutical experts expect a huge impact and expectations are correspondingly high. If the Annex takes effect after a transitional period, it will inevitably trigger a modernization push for existing sterile production facilities.

The core of the guideline is the strict separation by barrier systems of humans and active ingredients. “The human being should get out of the sterile zone,” emphasizes the Syntegon expert, and that can only be achieved through the consistent use of robotics and cobots. The long-term goal is gloveless sterile production — the pinnacle of automation.

So there is a lot in store for the machine-builders: multifunctional robots and electromagnetic transport systems are just some of the technologies that are currently still in the development stage.

Sustainability Becomes More Important

The industry is driven not only by the regulatory authorities, but also by politics and society. The pharma industry, too, is now expected to make its contribution to environmental protection and resource conservation, and companies are slowly starting to do their homework. There is hardly a pharmaceutical player whose website isn’t talking about sustainability.

GSK, for example, plans “to achieve a balanced climate footprint and a net positive impact on nature by 2030” and points to savings in carbon emissions of 34 per cent, landfill waste of 78 per cent and total water consumption of 31 per cent in 2019. This also puts pressure on supplier companies, which have to prove their carbon footprint to the companies according to Scope 2 of the Greenhouse Gas Protocol. Dr Harald Stahl, Head of Innovation & Strategy for Gea Pharma & Healthcare, recognizes the need to invest in energy-saving technologies. That’s why Gea has developed low-emissions alternatives for freeze-drying with refrigeration systems based on an air cycle and CO₂ for cooling.

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