Page 191 - CW E-Magazine (14-11-2023)

Special Report

for products in development, we
employ a phase-based commercialization
probability assumption when calculating
future demand.

Figure 2 depicts the projected kilo-
gram quantities of product needed to
meet annual commercial and clini-
cal demand for all product types pro-
duced using mammalian production
systems. In 2022, a total of just over
37-tonnes of product was required. As
more products enter the pipeline and
products in development receive com-
Fig. 1: Distribution of Mammalian Products by Product Type and Phase of Development mercial approval each year, the overall
kilogram requirements needed to meet
product demand increase from just over
37-tonnes in 2022 to nearly 85-tonnes
in 2027. During the pandemic, demand
for COVID-19 related products had a
unique demand algorithm and were not
included within the typical forecast,
which is shown below. However, given
that the pandemic has waned, products
related to COVID-19 will be included
in our standard analyses in the future
and will be grouped with other recom-
binant products for infectious diseases.

The projected volumetric capacity
needed to meet annual commercial and
Fig. 2: Estimated Quantity of bulk Kilograms Needed to Meet Product Demand clinical demand for all product types
duct’s reported annual sales data, verted to liters of manufacturing capa- using mammalian production systems
along with estimates of each product’s city for each product using cell line is depicted in Figure 3. In 2022, the
future growth rates. Our future product expression level and overall purifica- annual volumetric requirements were
growth estimates take into considera- tion yield estimates. These estimates just over 2,500-kL, while in 2027, the
tion a product’s age, as sales growth are based on product type, industry volumetric requirement is projected to
typically slows as a product matures, benchmarks at the time the product was be nearly 4,400-kL, a 5-year growth
while newly approved products often being developed and the maturity of rate of nearly 11.5%. Similar to the
do not reach full market penetration for the company developing the process. kilogram demand, volumetric demand
several years. For example, the commercial process for COVID-19 related products is not
for a product launched more than ten included within this forecast analysis.
With a projected treatment popula- years ago will likely have a lower
tion size estimate, based on price per expression level assigned in our forecast As with any forecasting model, our
mg and sales for 2022, we combine the algorithm than a product currently in assumptions for a typical year are based
estimated population with the yearly clinical development. For products in on the most probable scenarios and in-
per patient dosing, allowing us to fore- development, future commercial de- clude estimations for biopharmaceuti-
cast the kilogram quantities required mand is estimated based on the market cals which are being developed for cer-
to meet the projected demand of each penetration of currently approved pro- tain large patient population indications
product for the next five years. These ducts or, in some cases, proxy products such as Alzheimer’s disease or broad
kilogram quantity forecasts can be con- with similar indications. Additionally, cancer treatments like PDL/PDL-1

Chemical Weekly November 14, 2023 191

Contents Index to Advertisers Index to Products Advertised