Ready for change? Where is Big Pharma Headed After the Patent Cliff?

Author / Editor: Gert Moelgaard / Anke Geipel-Kern

The low hanging fruits have been picked - after the patent cliff pharmaceutical manufacturers have to face another challenge. Product portfolios have changed from large to small volumes. There is a need for more flexibility and the question is: Are pharmaceutical manufacturers ready for the requirements of the "Facilities of the Future"? Gert Moelgaard about the future of pharmaceutical production.

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Gert Moelgaard is Head of Strategic Development at NNE Pharmaplan.
Gert Moelgaard is Head of Strategic Development at NNE Pharmaplan.
(Picture: NNE Pharmaplan)

We can now see the end of the patent cliff and most of the big pharma companies are through the biggest challenges of the largest block of patent expiries in the history of pharmaceuticals.

Now, most companies are looking into their future products and we can start to see some of the common challenges and opportunities for manufacturing going forward. It seems clear that the manufacturing challenges are very different from what they were before the patent cliff and it will be necessary to revisit the manufacturing strategy for many companies.

If we compare the top 20 pharmaceutical products before the patent cliff with the biggest blockbusters today, we see a huge difference. Five years ago the top 10 were mainly OSD products in very large volumes that were produced in many millions in dedicated facilities. These facilities served well in the blockbuster era because of the huge volumes of the blockbuster products. But the big value products today are specialty drugs in much smaller volumes — and many of them are parenterals.

Changing Demands

The blockbuster era drove manufacturing towards large dedicated facilities that could supply products in the large quantities demanded. Not just manufacturing but the whole supply chain was designed to supply large quantities of uniform products to the market and one of the nice advantages of OSD products is that they can be manufactured, stored and managed without very special requirements on temperature, humidity etc.

From a manufacturing, distribution and consumer perspective the blockbuster facilities are effective and convenient to deal with. But as the products went out of patent, the demand has changed. Now, many of these facilities are too big, too specialised and too expensive to run cost-effective.

How to Get More Flexibility in the Pharmaceutical Industry

Therefore the “Facilities of the Future” require flexibility. The specialty products are typically very different. In fact, only few of the formerly successful blockbuster products will be followed by a product with a similar manufacturing setup. Therefore, the future after the patent cliff is starting to have significant impact on manufacturing and also on manufacturing technology.

From Large to Medium Volumes

We are again facing a steady, "normal" rate of patent expiries and the pharmaceutical industry is again becoming very predictable on patent expiries as well as on new products to come. It is not hard to predict that we are shifting from the big volume traditional pharmaceutical products to the medium or small volume specialty medicines.

Today the biggest products from a sales perspective are specialty drugs for e.g. arthritis, diabetes or cancer. Yet, these volumes are not nearly as big as those of the big products in the blockbuster era but at least as complicated.

Besides, they are not OSD but injectable products that require complex manufacturing and distribution processes in order to maintain the coolchain requirements of protein-based medicines. In other words: a new generation of medicines in small volumes but with a high complexity — and a quite high price tag.

It is the price rather than the volume that makes them to blockbuster products.

Typically, these new drugs are manufactured together with other drugs and require flexible facilities that can cope with changes between products. Most of these high value products are made by biopharmaceutical upstream processes and aseptic fill–finish downstream processing.

This is a sign of the future: there will be more products and they will be manufactured in smaller quantities. Many facilities are not well prepared for this. Most traditional facilities are still designed for high volume throughput and many of them have equipment optimised for large batches and high volumes. In these facilities, changeover takes a lot of time and makes manufacturing flexibility very expensive.

After the Blockbusters: Are we Ready for the Future?

There is still only limited equipment on the market that makes flexibility easy and cost–efficient. At the Interpack 2014 in Düsseldorf there were some new product announcements from some of the significant pharma equipment suppliers that point towards effective flexibility. But there are still only very limited equipment options that are truly designed with high up–time in a flexible environment in mind. This is probably about to change. One must expect the demand on flexibility will rise and thus also the awareness that flexible facilities will become mainstream. The big question is: are you prepared for that ….?

* Gert Moelgaard is Head of Strategic Development at NNE Pharmaplan.