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2016 Rank


1 2 3 4 5


6 7 8 9


10 - -


-


2021 Rank


1 5 8 6 3


9 4 - - -


2 7


10


Table 1. Capacity Control Company


Roche Lonza


673 261


Johnson & Johnson 230 Sanofi


Boehringer Ingelheim


Amgen Biogen Pfi zer


Celltrion Lilly


Samsung


Bristol-Myers Squibb


Novartis


All Others (120/128)


223 205


204 196 149 140 137 - -


- 1,214 (33%)


2016 Volume (1,000s L)


2021 Volume (1,000s L)


909 281 230 243 338


225 316 - - -


362 237


205 2,106 (39%)


often consider “full utilization” in the range of 70-80% (or in some cases even lower) rather than 100% to account for change-overs, preventative maintenance, and facility upgrades. Product company manufacturers often take a proactive approach in protecting unused capacity to be able to respond to product demand surges and additional product indication approvals.


As with any forecasting model, our assumptions are based on the mostly probable scenarios. However, if biopharmaceuticals being developed for certain large patient population indications such as Alzheimer’s disease or those targeting the PDL/PDL-1 checkpoint in cancer are approved and covered by Pharmacy Benefi t Managers, a signifi cant increase in demand for manufacturing capacity will occur potentially leading to a serious capacity shortage.


Conversely, there are other manufacturing trends that will result in a lesser demand for some biopharmaceuticals, such as the increased focus on orphan drugs and a shift from full length naked antibodies to alternative antibody formats and more potent products, i.e., Antibody Drug Conjugates (ADCs), which would require lower doses, that in turn, would reduce the demand for manufacturing capacity.


Our analysis shows there is currently suffi cient mammalian cell culture capacity world-wide to meet the total industry demand and that in 2014, only 50% of industry-wide cell culture capacity was utilized. This analysis of capacity utilization also indicates that while manufacturing capacity in general is projected to grow in the coming years, the demand for capacity will grow at a slightly greater rate so that by 2020 industry-wide capacity utilization will increase to 73%. At this anticipated level of utilization in 2020, some companies are likely to be challenged meeting the demand for specifi c products or gaining access to capacity at CMOs.


A utilization rate of 50% may give the appearance that the industry is not currently operating at “full utilization”. However, manufacturers


As the biopharmaceutical industry has grown, the industry has built a certain type of capacity to meet the demands for the top six selling antibody products. The 2014 kilogram demand for each of the top six selling antibody products was >0.75 metric tons for a total 8.5 metric tons. The demand for all other antibody products combined was approximately 4 metric tons. The forecasted demand for approximately 70% of new products approved between 2016 and 2020 is expected to be less than 100 kg per year per product with the exception of Alzheimer’s, PD-1/PDL-1, asthma, and possibly some PCSK-9 products. Future commercial manufacturing demands for 50% of products in Phase 2 and Phase 3 clinical development today can likely be met with a 5,000L bioreactor or smaller per product (See Table 2). This does not mean that large scale capacity is no longer needed. Our forecasts predict that the remaining 50% of products will need bioreactor capacity of 10,000L and greater to meet the predicted demand.


Figure 6. Overall Industry Supply and Demand Balance


Overall, the biopharmaceutical industry is expected to continue to have strong growth for the foreseeable future, and antibody products will be the dominant driver of this growth. Installed capacity is currently able to meet the manufacturing demand for these products, but control and location of capacity can aff ect how accessible certain capacity is. The majority of capacity is product based, as opposed to CMO based, making it diffi cult for companies without capacity to access it at the right time and under the right conditions. North America has the greatest percentage of installed capacity, but Asia has seen a surge in new capacity installation. To meet increased product demand, installed capacity is forecasted to increase from approximately 3.6 KL in 2016 to approximately 5.6 KL in 2021. While capacity will increase, demand for capacity will increase at an even


Table 2. Number of Product Demand Met by Bioreactor Scale


# Products in Phase 2 and 3 Trials # of Bioreactors < 2,000L Bioreactor 5,000L Bioreactor 10,000L Bioreactor > 10,000L Bioreactor 285


1 2


118 (41%) 139 (49%)


25 (9%) 36 (13%)


32 (11%) 23 (8%)


110 (39%) 87 (31%)


28 |


| May/June 2016


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