Chemical Information Services, April 2014
At a time of year when flu season is usually winding down, news of a new form of bird flu has emanated from China. The strain was identified as H7N9, which had not been found in humans before. However, it took the lives of two Shanghai residents in late March.
Initially, H7N9 was thought to be a low pathogenic strain that was not easily transmitted between humans. But an expert from the World Health Organization (WHO) has now expressed concern that the strain does show signs of mammalian adaptation. This news reminds us all too painfully of the recent swine flu pandemic, which killed 284,500 people in 2009 according to the Centers for Disease Control, and that the possibility of a global pandemic is real.
This news came after a particularly rough flu season, where increased demand for the flu vaccine created spot shortages across the United States. According to industry research released by Kalorama Information, the vaccine market has grown from $5.7 billion ten years ago to exceed $27 billion currently. Increased global demand for the influenza vaccine has contributed significantly to this growth because the vaccine does not offer long-term immunity and must therefore be administered annually.
Each year, infectious disease monitoring organizations worldwide coordinate with vaccine manufacturers, fill/finish suppliers, distributors and healthcare practitioners to try to ensure the parameters are in place to meet demand. The large market for the influenza vaccine brings two key vaccine production issues to the forefront – time-to-market and cost.
Improving time-to-market and reducing costs consistently rank among the top three reasons behind decisions to outsource work to a CMO (alongside improved quality). While vaccine production has historically been retained in-house for quality control and regulatory reasons, the evolving nature of outsourcing – from an ad hoc basis to more long-term partnerships — means it is highly likely we will see growth in outsourced vaccine manufacturing. Current predictions estimate the vaccine contract manufacturing market will reach $620 million by 2015.
In reviewing the data from Nice Insight’s pharmaceutical and biotechnology outsourcing survey, we looked at how CMOs offering vaccine manufacturing scored on productivity as it relates to improved time-to-market — and affordability, since decreasing manufacturing costs can positively impact product price. Two companies scored in the top five for both productivity and affordability — GlaxoSmithKline Biopharmaceuticals (76% and 71%) and OSO BioPharmaceuticals (75% and 71%).
The remaining CMOs to rank in the top five for productivity were Fujifilm Diosynth Biotechnologies (80%) – the only company to receive an “excellent” score in productivity — Althea (78%), and BioReliance (75%). For affordability, Cytovance (73%), Cook Pharmica (71%) and IDT Biologika (71%) joined GSK BioPharma and OSO Bio in the top five providers. It is important to note that GSK Biopharmaceuticals was the only company to rank in the top five for quality in addition to productivity and affordability. However, the companies that ranked highest in productivity and affordability tended to score above the benchmark in quality, meaning these businesses still performed above average among their competitors.
This news came after a particularly rough flu season, where increased demand for the flu vaccine created spot shortages across the United States.
Interestingly, there were no strong patterns across the twenty CMOs included in this analysis. Twelve different companies comprise the Top 5 lists for each of the six outsourcing drivers, with only one company scoring among the top five across all six categories — GlaxoSmithKline Biopharmaceuticals. As such, finding the right CMO for a specific project will vary depending on factors specific to the vaccine.
In the case of the influenza vaccine, improved time-to-market and affordability are key to reaching a large population on an annual basis. Another benefit of CMOs adding vaccine production is increased capacity, which will reduce the potential for vaccine shortages, including those caused by the need to shift production of seasonal flu vaccines to the manufacture of vaccines for new threats like the H7N9 bird flu.