Analytical Framework for Examining the Value of Antibacterial Products. 4.2.5 Costs of Supply Chain Activities

04/15/2014

Vaccine developers, like drug sponsors, need to undertake a variety of additional activities concurrently with clinical development, including sample preparation, process research, process development, process design, and plant design and construction.  These activities are discussed in greater detail in Section 4.2.5, and Table 9 in Section 4.2.5 presents the cost estimates for each of these supply chain activities as available from Blau et al. (2004).  We use the same figures for vaccines as were used for new drugs, with the exception of plant build costs.  For this parameter, we used a vaccine-specific cost estimate found in Murphy (2002) and inflated to 2012 dollars to arrive at a total of approximately $500 million.  This is substantially higher than the plant build cost used for development of a new antibacterial drug and reflects the unique challenges of vaccine manufacturing.  As vaccines are complex products that are created from living organisms and are mainly given to healthy people (making any side effects highly undesirable), vaccine development involves processes and regulatory requirements that are different from those for drugs intended for use by sick people; therefore, construction of special facilities is a necessity in most cases (Murphy, 2002).

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