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When comparing clinical versus commercial capacity, it is evident that the total volume of capacity devoted to commercial manufacturing far exceeds that devoted to clinical production. In 2016, nearly 390 KL (11%) of capacity are designated for clinical manufacturing compared to nearly 3,250 KL (89%) for commercial products. In 2021, percentages do not change, with approximately 600 KL of clinical capacity and just over 5,000 KL for commercial capacity. This is not surprising because of the relatively small demand for clinical supply in comparison to the larger demand for commercial sale.


Figure 3. Forecast of Volumetric Capacity Needed to Meet Product Demand


required to go from kilogram demand to liter demand and introduces some uncertainty in the forecast due to the fact that most companies do not publish their production yields. For this reason, our analysis uses industry average estimates. As described for annual kilogram demand in Figure 2, each bar represents the volume required for those products in the indicated phase of development in 2014 that successfully reach the commercial market. In 2014, the annual volumetric requirements were just over 1,600 KL, while in 2020, the volumetric requirements will be just over 3,400 KL.


Given this increase in volumetric demand over the next 5 years, the industry is concerned about the availability of production capacity. There is always some degree of uncertainty in balancing the demand and supply equation due to production problems, market demand over time and competitive factors. As shown in Figure 4, in 2016, the available mammalian cell culture supply is currently approximately 3,600 KL and is projected to grow to approximately 5,600 KL by 2021. However, not all capacity is equally available throughout the industry. In 2016, Product companies (companies focused on product development) hold approximately 73% of the installed mammalian cell culture capacity, while Excess companies (companies that are developing products, but also sell or make available any excess manufacturing capacity) and CMOs control signifi cantly less capacity, 13% and 14%, respectively. The forecasted distribution of capacity changes only slightly in 2021, with Product companies holding 68% of the installed capacity, while CMO companies increase to 15% and Excess companies increase to 17% of the capacity.


While Product companies control the majority of cell culture capacity, capacity is highly concentrated among ten companies. Table 1 shows the distribution of capacity among the top ten capacity holders in a given year. Capacity for companies not ranked in the top 10 are included in the “All Others” category. In 2016, the “All Others” category includes 120 companies, and in 2021 “All Others” include 128 companies. In 2016, 67% of the mammalian cell culture capacity is controlled by ten companies; in 2021, this changes to 61%. Based on substantial capacity investments, Samsung, Bristol-Myers Squibb and Novartis will displace Pfi zer, Celltrion and Lilly from the top ten capacity holders by 2021.


Geographic distribution of capacity may also skew the accessibility to capacity. Figure 5 shows in 2016, North America holds the greatest percentage of capacity (52%), followed by Europe (32%) and Asia (16%). In 2021, the order remains the same but the percentages change slightly – North America (42%), Europe (34%) and Asia (24%). There has been signifi cant growth of capacity in Asia, particularly in Korea and Singapore, due to government incentives and tax advantages. Asian locations for manufacturing also tend to be more attractive to companies with mature pipelines and the ability to manage complex global supply chains.


Irrespective of ownership or geographic location, there is a surplus of capacity as shown in the balance between a demand for mammalian cell culture and total available capacity in Figure 6. The light grey band in each bar represents the remaining available capacity. This analysis assumes an average capacity utilization of 18 batches per bioreactor per year. The demand for manufacturing capacity has been adjusted forward one year to account for the fact that bulk product is typically made well ahead of actual sales, on which demand calculations are based. For the majority of products sold in 2014, for example, bulk drug substance was manufactured in 2013.


Figure 4. Current Mammalian Manufacturing Capacity


Figure 5. Geographic Distribution of Capacity


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| May/June 2016


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