The new pharma manufacturing reality includes a challenge that nobody talks about – yet. But hopefully it will come soon, because it will be a huge challenge:

There are many, many small diseases in the world. Some of them are recognised as rare diseases and few of them does have a treatment – typically an “orphan drug”. Orphan drugs are manufactured in very small volumes. Very, very small, in fact. But since the orphan drug products generally are quite expensive, nobody really cared in the past how effective the drug manufacturing was.

In fact there has been several instances of orphan drugs manufacturing warning letters because the manufacturing of these small volumes are more like an art than like a craft. But of course the GMP requirements are the same for all commercial products, no matter what the production volume is. So some of the most important orphan drug companies have had significant warning letters or even concent decrees on their manufacturing, sometimes leading to scaring drug shortage situations for the very small patient populations.

But this is only a beginning. The number of orphan drugs is growing rapidly – actually exponentially. And some of the latest mergers and acquisitions are driven by the prospects of orphan drugs. Money are flowing into orphan drugs rapidly – so products will flow out. Some orphan drugs products are about to loose patent protection – and all products are under price pressure in all countries. So we need a cost-effective way to product orphan drugs, throughout the supply chain.

And this is only the beginning, in my opinion. You may have noticed that within almost every disease indication recent studies shows that there are several sub-types of the disease. And drugs does not work equally well for all disease subtypes. Some of them does not work at all for some of the subtypes, in fact. So we must expect that more and more diseases are split into subtypes as the scientific research progresses. It is good news for patients – and bad news for manufacturers. Because much more flexibility will be needed – and we don’t have it. Yet.

I am a big admirer of Wired Magazine. It rarely covers the pharmaceutical industry, but when it does, it is very inspiring. Anyway, many years ago the former editor in chief, Chris Andersson coined a term called “The Long Tail“. It has to do with media, not with pharmaceuticals. But I think it is a very visionary term that expresses our future manufacturing challenge: a long tail of smaller and smaller products that each address a very important, albeit small, disease indication. So visionary pharmaceutical manufacturers will have to start to think different and face the fact that their pipeline of new products looks like “The Long Tail”…!