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"May you live in interesting times," goes the allegedly ancient Chinese curse. Well, these have been "interesting times" indeed for those working in the pharmaceutical industry.
"May you live in interesting times," goes the allegedly ancient Chinese curse. Well, these have been "interesting times" indeed for those working in the pharmaceutical industry. Long thought of as the most stable industry, the pharmaceutical industry has in the past few years found itself in the midst of upheavals of all sorts: technological, geographical, strategic, regulatory, and economic. We at Pharmaceutical Technology often hear from readers that globalization has had a profound influence on the industry. The locus of manufacturing, R&D, and sales is slowly shifting from its traditional bases in the US and Western Europe to emerging markets in Asia and Latin America. Technologically, there can be no doubt that the pace of biopharmaceutical development and manufacturing stands to outstrip that of small-molecule development. And many analysts predict the demise of the "blockbuster" one-size-fits-all approach to drug making in favor of more targeted drug development. Of course the largest growth area appears to be in generics, and once regulatory issues are worked out, biosimilars after that.
(IMAGE: PHOTOS.COM/MELISSA MCEVOY)
Regulatory sands are shifting in uncertain ways both here and abroad. FDA is changing both philosophically and operationally, with initiatives such as Quality by Design, Process Analytical Technology, and the Critical Path. Of course, as the industry abroad matures, so do overseas regulations. And that necessitates efforts to standardize regulations so firms can operate smoothly and efficiently, and so drugs are of uniform quality, in multiple markets. Taken together, the current picture is one of an industry in flux. So, we couldn't resist asking industry experts how they think it will all shake out. What, we asked, will the pharmaceutical industry look like in 2037 when Pharmaceutical Technology celebrates its 60th anniversary? The following is an edited version of their replies. Jim Miller, Pharmaceutical Technology's columnist on outsourcing and president of PharmSource Information Services, may have summed it all up best when he said, "New players, new technologies, new geographies—in 30 years, it won't be your parents'... industry."
Michelle Hoffman, editor-in-chief,