The Biopharmaceutical Manufacturing Survey - Pharmaceutical Technology

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The Biopharmaceutical Manufacturing Survey
A Pharmaceutical Technology report looks at trends in biopharmaceutical manufacturing. This article contains bonus online-exclusive material.


Pharmaceutical Technology
Volume 33, Issue 7

While on the ferry between Manhattan and New Jersey, I struck up a conversation with a fellow traveler, an investment banker who follows the pharmaceutical and healthcare industries, as it turns out. The first thing he told me was that the economy would turn around in September 2009—not too long to wait. The second thing he told me was that the rally would be led by the healthcare and pharmaceutical industries, due specifically to all the new biopharmaceutical products that would be released on the market. The timetable seems a little tight, but the expectation for new biopharmaceutical products to reignite a stalled economy is hardly news to anyone who works in—or really follows—the healthcare and pharmaceutical industries.

Surveys conducted in this magazine and by countless accounting firms, investment houses, and marketing outfits have for some time been predicting an economic boost from the development and sale of biopharmaceuticals. And even the most cursory walk around the exhibit hall of the Biotechnology International Organization's annual conference will reveal that a great many geographic regions—from US cities, counties, and states, to entire nations—are banking on biotechnology and its drug products to lift their economies out of the doldrums.

Over the past few years, other large industry trade shows traditionally devoted to the science of small-molecule drug manufacturing have increasingly added tracks addressing the needs of biopharmaceutical manufacturers. Equipment manufacturers are increasingly expanding their productive offerings to include equipment and consumables geared toward biopharmaceutical manufacturing. Clearly, it's not just investment bankers that expect growth in this sector of the pharmaceutical industry.

Given all of the gathering interest in large-molecule drug manufacturing, we at Pharmaceutical Technology thought it high time to survey our readers involved in some aspect of biopharmaceutical manufacturing to learn more about the products they produce, the equipment they use, and the challenges they encounter. The following is a summary of the results to our survey questions from respondents, representing the roughly 41% of our readers engaged in the manufacture of biopharmaceuticals. The values given are 95% accurate to within 6.3 percentage points plus or minus.

Products and processes


Figure 1: Companies producing small-molecule versus large-molecule drugs.
Thirty-three percent of respondents work for companies that produce biopharmaceuticals only; 46% produce both biopharmaceutical and small-molecule drugs; and the rest produce equipment and/or services for the biopharmaceutical manufacturing market (see Figure 1).


Figure 2: Reasons for adding biocapacity. Total exceeds 100% because multiple responses were allowed.
More than 50% of respondents work for companies that have been producing biopharmaceuticals for more than five years; 2008 was the year in which the greatest amount of biopharmaceutical manufacturing capacity was added, with 8.1% of respondents reporting the addition. Five-and-a-half percent respondents report their company added biopharmaceutical manufacturing capacity in 2007, and 5.1% said their companies added capacity this year. Fifty-nine percent of respondents reported the additional capacity was added to accommodate internally developed products; almost 29% of respondents say that biopharmaceutical capacity and products came into their companies through mergers or acquisition; and 24% reported that biopharmaceutical drugs were in-licensed (see Figure 2, multiple answers were allowed).


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Survey
FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
Reducing drug shortages
Breakthrough designations
Protecting the supply chain
Expedited reviews of drug submissions
More stakeholder involvement
Reducing drug shortages
70%
Breakthrough designations
4%
Protecting the supply chain
17%
Expedited reviews of drug submissions
2%
More stakeholder involvement
7%
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Source: Pharmaceutical Technology,
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