Mabs Continue to Drive Growth of Biopharmaceutical Market
With the approval of Humulin, the modern biotechnology era began in 1982 and now celebrating its 35th year, the biopharma industry has grown tremendously, launching nearly 225 recombinant biopharmaceuticals. As indicated in Figure 1, the 221 currently marketed products have generated an unprecedented $169B in global sales in 2016.
Figure 1: Biopharmaceutical Market Comparison 2006/2016
Figure 1 also shows that within a decade, mammalian antibody products (which include Fc-fusion proteins, antibody fragments, antibody-drug conjugates as well as standard monoclonal antibodies (MAbs)) sales have nearly quadrupled. In 2006, the sales of antibody products increased from $23B to nearly $100B and contributing to this growth is the antibody Humira. For a fifth consecutive year, Humira is the world’s best-selling biologic and for the last four years, sales of Humira have exceeded $10B. Humira, the first biologic to break the $10B barrier in 2013, sold $16.1B in 2016, recording the highest sales for a recombinant product since the beginning of the modern biotechnology era. Table 1 displays the remaining top ten biopharmaceuticals of 2016, which include a cytokine conjugate, two insulins, two antibody fusion proteins and four MAbs. These 10 products represent nearly $75B and nearly 45% of all biopharma sales.
Table 1: 2006/2016 Comparison of Top 10 Selling Biopharmaceuticals
Looking back a decade to 2006, when biopharma was celebrating its Silver Jubilee – total sales for the then 105 approved products totaled nearly $67B. The top ten selling biopharmaceuticals in 2006 were slightly more diverse, a cytokine conjugate, an insulin, an antibody fusion protein, four monoclonal antibodies and three hormones. Interestingly, in both 2006 and 2016, the top ten selling products comprised nearly half of all biopharmaceutical sales and six of the top ten products in 2006 have remained on the top ten list for 2016: Enbrel, Remicade, Rituxan/Mabthera, Herceptin, Avastin and Neulasta/Neupogen. Gone from the 2006 top ten list are the three epoetin-based hormones and the human insulin, replaced with two insulin analogs, an antibody fusion protein and a MAb.
Antibody products first entered the biopharmaceutical market in 1986 with the approval of Orthoclone OKT3, and ten years ago, for the first time, antibody products outsold all other mammalian recombinant products. Since then, antibody products are a formidable portion of today’s biopharma landscape. Surveying the overall recombinant biopharmaceutical pipeline, it is clear from our bioTRAK® database, that antibody products dominate the development pipeline. Of the nearly 450 products in late stage development (Phase 2 through BLA/MAA/NDA application), approximately 70% are antibody related products. Looking closer at the antibody products and fragments in development, nearly 8% of these antibody products are produced in microbial systems. With several companies developing single chain, domain fragments and some full-length antibodies in non-mammalian systems, potential exists in the next decade for the additional commercialization of these microbial-based antibody products.
Interestingly, if we review the 33 products pending US/EU marketing approval (as of June 1, 2017), there are 11 microbial products pending approval, only one of which is an antibody fragment. In contrast, of the 22 mammalian based products awaiting approval, 20 are antibody products (7 MAbs, 11 biosimilar MAbs, and 2 MAb conjugates), the remaining two products are recombinant blood proteins.
As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, we can be assured antibody products will remain the cornerstone of the biopharmaceutical market for the foreseeable future. When looking forward to 2026, does the past decade suggest that the top 10 will be all antibody products? Will microbial manufactured antibodies and fragments be more prevalent, becoming “the next big thing” and begin to erode the mammalian domination of biopharmaceutical sales? Only time will tell, but we can’t wait to see the discoveries and technological advances in the biopharmaceutical sciences, which will propel product revenues for the biopharmaceutical industry in the next decade.
If you wish to stay current on worldwide biomanufacturing capacity, demand for manufacturing capacity for individual biopharmaceutical products, and industry trends that may impact overall capacity utilization, BPTC’s new bioTRAK® report subscriptions can help. Based on the most frequently asked questions around the supply and demand for biomanufacturing capacity, the biannual reports released in April and October, focus on mammalian and/or microbial expression technologies providing extensive information on manufacturing capacity and/or product demand. To learn more about our bioTRAK® report subscriptions, please visit us at BIO2017 in San Diego, June 20-22 at booth #1124 or simply contact us.
Blog article by: Dawn Ecker