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BIOPHARM PROCESSING


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Global Biomanufacturing Trends, Capacity, and Technology Drivers: Industry Biomanufacturing Capacity Overview


Patti Seymour Senior Consultant


Dawn M. Ecker Consultant


BioProcess Technology Consultants, Inc. Abstract


Biologic-based drugs are an increasingly important part of the product growth strategies for pharmaceutical and biopharmaceutical companies. As the number of commercial products and pipeline candidates grows, a crucial issue facing the industry is the current and future state of biomanufacturing capacity, the availability of that capacity, and the technologies impacting upstream and downstream bioprocessing. Pharmaceutical and biopharmaceutical companies and contract manufacturing organizations (CMOs) are aligning their strategies to not only address capacity but to address greater complexity in supplier risk and the adoption of advanced biomanufacturing technologies.


Biopharmaceutical products have rapidly become a larger percentage of overall pharmaceutical company revenue with sales of the top six selling antibody products, Humira, Remicade, Enbrel, Rituxan, Avastin, Herceptin, at just over $51B in 2015. The compound annual revenue growth rate for antibody products, which includes antibody conjugates, naked antibodies, and antibody fusion proteins, from 2003 to 2014 was 21%; however, this growth is expected to slow to the high teens in the coming years due to the maturation of many products, and emerging alternative technologies. Also, it is more difficult to sustain such growth rates the larger the market becomes.


To provide context about this growing segment of the market, BPTC estimates that there are over 900 biopharmaceutical products in some


22 | | May/June 2016


stage of clinical development in the United States or Europe, and the large majority of these products, 77%, are produced in mammalian cell culture systems. To further refine the biopharmaceutical man- ufacturing market, we evaluated the distribution of mammalian products by product type and phase of development. Figure 1 shows the distribution of the following product types, antibody products (which include naked monoclonal antibodies, Fc-fusion proteins, antibody fragments, bispecifics, antibody conjugates, and other antibody-related products), blood proteins, cytokines, enzymes, fusion proteins, hormones and other recombinant proteins, by phase of development. Antibody products are the dominant product type for all phases of development, but this product type is even more dominant for early phase products. Antibody products comprise nearly half, 48%, of currently marketed products. Recall that many of the early commercial biopharmaceutical products, such as growth hormones, insulins and interferons, are produced in microbial systems, but the use of microbial production systems is much less common now. The percentage of antibody products currently in the BLA, or equivalent, stage of regulatory submission is 67% (BLA/MAA stage in Figure 1). Antibody products make up 82% of products in Phase 3 development and 90% of products in Phase 1 and 2 development.


Whether approved or in development, all of these products need access to mammalian production capacity. To better understand the production requirements needed to meet the demand for all of these products, we created a demand forecast. The future demand for current commercially approved biopharmaceutical products is estimated from each product’s reported annual sales data, along with


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