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.