According to the first ever study conducted by Pharmaceutical Commerce, the size of temperature sensitive global biopharmaceutical market space is around $5.1 billion and is expected to grow to $6.6 billion in 2011. While the North American market will grow by 15% over the 2008-2011 period (or roughly 5% annually, in line with the overall pharma market), the global market will show a growth rate of double that. The report entitled, "Cold Chain Biopharma Logistics Sourcebook 2010" surveys growth rates for pharma, biotech, vaccines, blood products and clinical materials, US and international regulatory bodies such as FDA, USP, PDA, IATA, MHRA and others, and air, ground and ocean carrier modes. It also includes packaging materials and technologies, refrigeration systems and instrumentation. The report suggests that seven of the top 10 global pharma products in 2014 will require cold-chain handling. According to industry estimates, vaccines will grow on average 8% per year through the next five years.
Global biopharma cold chain market
The clinical trials industry, which has been expanding globally in recent years, will add more volume during the coming decade. Biosimilars (biotech products made by other than the original inventor) are expected to hit the market by 2015. Further, new technologies to turn refrigerated biotech products into room-temperature-storage products will also kick in, affecting some product temperature and storage requirements. The challenges for biopharma manufacturers will not be in terms of developing new technologies to handle shipments, but in process changes to manage the regulatory and reporting demands cost-effectively.