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BIOPHARM PROCESSING


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estimates of each product’s future growth rates. A product’s growth in sales is calculated from actual sales data for the current and previous year. Where available, analysts’ forecasts may also be used to estimate year-to-year sales growth for commercial products. Our calculated future product growth estimations also take into consideration a product’s age; sales growth typically slows as a product matures, while newly approved products often do not reach full market penetration for several years.


Using the sales growth data along with the number of patients treated in the current year (based on price per mg and sales), an estimated treatment population for future years can be calculated for each year during the forecast period. This forecasted treatment population, combined with the yearly per patient dosing calculates the kilogram quantities of each product that will be required in future years. These forecasted product quantities along with an estimated expression level and overall yield estimates for each product can then be used to


calculate the estimated amount of cell culture capacity (L/yr) that will be required for each product in future years.


Figure 2 shows the forecasted kilogram quantities of product needed to meet annual commercial demand for all products types produced using mammalian production systems. In 2014, approximately 13 metric tons of product are needed, and the large majority of the demand is for currently commercial products (teal band). The orange band labeled Clinical on each bar represents an estimate of clinical trial material manufactured to support the clinical development of all pipeline product candidates in a given year. The green band, present but not visible in the 2016 bar, represents products that have submitted a BLA, or equivalent, and are estimated to receive regulatory approval and enter the commercial market in 2016. The cycle time of 1 to 1.5 years from submission of BLA to approval is based on industry standard product development success rates. Similarly, the grey band fi rst appearing in the 2017 bar represents products in Phase 3 clinical development in 2014 that are projected to receive regulatory approval and begin entering the commercial market in 2017. This grey band increases each year as the commercial demand for the products grows. The purple band and the light blue band represent the products in Phase 2 and Phase 1 development, respectively, that are forecasted to begin entering the commercial market in 2018 and 2019, respectively. As more products receive commercial approval each year, the overall kilogram requirements needed to meet commercial product demand increase from just over 13 metric tons in 2014 to nearly 40 metric tons in 2020.


Figure 1. Distribution of Mammalian Products by Product Type and Phase of Development


Another way to view the total production capacity needed to meet product demand between 2014 and 2020 is to think of the demand in terms of total installed volume of mammalian cell culture capacity. Figure 3 shows the volumetric capacity required to support the clinical development and eventual commercial sales of all current pipeline product candidates in the year shown. An estimation of yield is


Figure 2. Forecast of Bulk Kilograms Needed to Meet Product Demand


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| May/June 2016


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