Pharmaceutical manufacturing operations must prepare for faster drug approvals and increased time-to-market pressure. Pharmaceutical companies, which aimed to be Best-in-Class, will need to explore new ways to make the “facilities of the future". Gerd Moelgaard about the future of pharmaceutical production...
Pharmaceutical manufacturing operations must prepare for faster drug approvals and increased time-to-market pressure. Not all pharmaceutical companies are well prepared for that, but the most innovative companies will need to explore new ways to make the “facilities of the future”.
After many years of declining numbers of approved new drugs in USA and Europe the trend is shifting. The so-called “pharma innovation gap” is now behind us and there are again many new, promising drug candidates in the pipeline. Although 2013 did not set a new record in the number of new drug approvals, it marked a trend that can have a significant impact on the future of pharmaceutical manufacturing: Fast approval of new drugs. FDA's breakthrough approval path is an important part of this, but there are more. What could it mean for the future of pharmaceutical facility investments?
As we are passing the patent cliff in the pharmaceutical industry, it is time to look back — and also look forward. Before we entered the periods of the biggest and most significant patent expires in the more than 100-years history of the pharmaceutical industry, observers were concerned about the “end of the blockbuster era”. One of the root causes behind was identified as the so-called “pharma innovation gap” and it was one of the big concerns for investors as the future outlook of the industry was uncertain and the inherent risk, that is a fundamental condition of our industry, was very certain.
The Pharmaceutical Industry was in Crisis
Measured by the number of new drugs, or rather new molecular entities (NMEs), approved per year, the pharmaceutical industry was clearly in a crisis. Partly due to decreasing R&D productivity it was estimated that the price of a new drug development was 2.5 times as high in 2005 as in 1995. Even worse, the overall number of new drugs approved was not moving despite of the investments, so the drug development model seemed to be broken.
Drug Approval Number Rising
Almost ten years after, we fortunately see signs that this is no longer the case. For the last few years the number of new drugs approved has been increasing again and now we not only need to count it by NMEs. Now it can be counted again by an even more important measure, namely by diseases for which there are significantly better treatments available — including several for which there were no effective treatment or cure in the past. 2013 was perhaps a landmark for what may follow over the next 10 years. FDA started evaluating new drugs with the new breakthrough therapy program and although the jury is still out on the overall effectiveness of the program, it could very well be a sign of faster approvals as we go forward. This is good news for millions of patients around the world, but it will be a challenge for all of us working in or around pharmaceutical operations.
Gert Moelgaard is Head of Strategic Development in NNE Pharmaplan.
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