Page 193 - CW E-Magazine (14-11-2023)

Special Report

Table 1: control of Manufacturing capacity of these products in development is ex-
2023 rank 2027 rank company company Type pected to be less than 100-kg per pro-
1 1 F. Hoffmann-La Roche Product duct per year. Just 8% of the products
within our forecast are each projected
2 2 Samsung Biologics CMO to require over 750-kg per year. Typi-
3 6 Boehringer Ingelheim Hybrid cally, these projected high kilogram re-
4 5 Lonza Group CMO quirements can be attributed to sizable
5 7 Johnson & Johnson Product dosage requirements, high frequency of
dosing and indications with significant
6 4 WuXi Biologics CMO numbers of patients including Alzheimer’s
7 8 Amgen Product disease, Parkinson’s disease, diabetes,
8 10 Biogen Product and some cancer-related products.
9 – Novartis Hybrid A closer review of future projected
10 – Sanofi Product commercial manufacturing demands
– 3 FujiFilm Diosynth Bio CMO for products in Phase 2 and Phase 3
technologies clinical development reveals nearly
– 9 Celltrion Product 75% of the products in development
can likely be met with a single 2,000-L
or 5,000-L bioreactor assuming 18
batches per year per bioreactor and a
90% success rate for batch manufactur-
ing (Table 2). However, this does not
mean that large scale capacity is no lon-
ger needed. Our model predicts that the
remaining products will need bioreac-
tor capacity of 10,000-L and greater to
meet the forecasted demand. Increasing
the number of bioreactors able to service
a single product increases the manu-
facturing capacity and not surprisingly,
causes a shift in the percentage of
products whose projected demand can
Fig. 5: Geographic Distribution of capacity likely be met. As an example, a single
followed by Europe and Asia. In the the demand for the nearly 165 remain- 2,000-L bioreactor is capable of manu-
prior five years (2017-2022), there has ing marketed antibody products, com- facturing 60% of the products in Phase
been minimal capacity growth in North bined was approximately 28-tonnes (an 2 and Phase 3, while a trio of bioreac-
America and significant growth in both average of ~197-kg each, and a median tors at this scale would be capable of
Europe and Asia, which is projected of 34-kg). For antibody products still in manufacturing over 75% of the pro-
to continue into 2027. By 2027, with development, in a best-case commer- ducts in development.
growth rates projected in Asia of 10%, cial scenario where market success and
Europe of approximately 7% and North maximum market penetration are as- If we analyze the number and scale
America at 3%, Europe will surpass sumed, projected demand for over 65% of bioreactors online and projected to
North America in total liters of capa-
city. Table 2: Percentage of Product Demand Met by bioreactor scale
No. bioreactors 2,000 L 5,000 L 10,000 L > 10,000 L
As described earlier, different pro- bioreactor bioreactor bioreactor bioreactor
ducts require different capacity. For ex- 1 60% 13% 11% 16%
ample, the kilogram demand in 2022 for 2 68% 15% 8% 9%
the top four selling antibody products
totaled approximately 2.1-tonnes while 3 76% 11% 7% 6%

Chemical Weekly November 14, 2023 193

Contents Index to Advertisers Index to Products Advertised