It’s common knowledge that the pharmaceutical industry is in the throes of change. The blockbuster model it has relied upon for decades is no longer viable, but what will take its place? Finding a niche area, perhaps, or going after orphan drugs, or moving into emerging markets.

It’s common knowledge that the pharmaceutical industry is in the throes of change. The blockbuster model it has relied upon for decades is no longer viable, but what will take its place? Finding a niche area, perhaps, or going after orphan drugs, or moving into emerging markets.

Or taking the plunge into the rapidly developing field of pharmacogenomics – so-called personalized medicine. Since the Human Genome Project was completed in 2000, excitement has been growing around the idea that someday we will be able to design individual treatments based on a specific patient’s genetic make-up.

No more adverse, toxic or even fatal reactions resulting from the lack of – or too much of – a particular enzyme in the patient’s body. Dosing will be exact, and efficacy will spectacularly improved.

The key word in this description, of course, is ‘someday’. The completion of the Human Genome Project was only the beginning. It will take scientists years to decode every genetic variation and then work out how this will effect reactions to a particular medicine. Only a handful of tests are currently available.

There are signs, though, that pharmacogenomics is already being taken seriously within the industry, by big pharma companies and by regulators such as the FDA and the EMEA. According to a recent report by PricewaterhouseCoopers, ‘Diagnostics 2009: Moving towards personalised medicine,’ a number of pharmaceutical companies have indicated that they plan to incorporate it as part of, if not the core of, their corporate strategies.

The regulators have begun to require biomarker testing to guide how drugs are prescribed. Two examples of this are testing for infection by a specific HIV subtype that is required prior to the use of Selzentry, and testing for epidermal growth factor receptor expression prior to the use of Erbitux. As biomarker testing often increases efficacy in addition to reducing adverse events, this practice is likely to become more common.

Even if it can’t solve all of our problems now, science will continue to move forward no matter what the pharmaceutical industry does. Personalization is a mega trend in many sectors, including healthcare, automotive, transportation, environment and building technologies, and there is no sign that this is about to change. Smart pharma companies will harness this trend, and use it to fashion their own, custom-fitted future.