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New edition updates regulatory developments, economics of transportation modes and trends in international product movement
Despite a disastrous 2009 for global logistics firms overall, cold chain services and technologies for temperature-controlled shipping of pharma products held steady for most, and even grew for some, according to the 2nd edition of Pharmaceutical Commerce’s Bio/Pharma Cold Chain Sourcebook. During 2010 and into this year, business has recovered for most logistics providers. Going forward, the market for cold chain packaging and transportation services is projected to grow to $6.9 billion in 2012, and $8.7 billion by 2015.
“Cold chain services are driven first of all by growth of biotech and conventional drug products requiring temperature control,” says Nick Basta, editor of Pharmaceutical Commerce and co-editor of the Sourcebook. “In 2009, five of the top-selling drugs in dollar value were cold-chain products; in 2016, 8 of the top ten, and 27 of the top 50, will be.” At the same time, he says, the regulatory environment under which cold chain services are provided continues to get tighter globally. Canada, Saudi Arabia, Singapore, Malaysia and Argentina are among the countries that have made documentation of individual shipments of cold chain pharmaceuticals an entry requirement. Europe has updated its Good Distribution Practices guidance, and US organizations like US Pharmacopeia and the Parenteral Drug Assn. are updating and expanding their guidance. “Pharma companies are making their internal processes more rigorous, and demanding more quality assurance measures from their logistics providers,” he says.
Shipments of vaccines and blood products will add to the volume of regulated shipping in coming years at rates higher than the average for the pharma industry overall, according to the Sourcebook. However, one additional area of activity—clinical trials logistics—is projected to grow only slightly, from $2.6 billion in 2009 to $2.8 billion by 2015. “Industry surveys show a peaking of the launch of new clinical trials, which will hold growth down in this area,” says Basta. On the flip side, while biosimilars (aka “follow on biologics”) will not be much of a factor in 2012 or 2013, they could be a significant part of cold chain logistics thereafter.
2011 Bio/Pharma Cold Chain Sourcebook is available for purchase from Pharmaceutical Commerce. Call 203 831 0711, or e-mail at firstname.lastname@example.org for details.