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Big, bigger, but will they be the biggest? The past, present and future of MAbs in the market place

The modern biotechnology era began in 1982 with the approval of Humulin in 1982[a], the first recombinant product. Throughout its 32 years of existence, the biopharma industry has grown tremendously, launching over 200 biopharmaceuticals. As indicated in Figure 1, the 182 currently marketed products have generated an unprecedented $152B in global sales[b] in 2014. When the current number of pipeline products in development are coupled with discoveries and technological advances in the biopharmaceutical sciences, product revenues for the biopharmaceutical industry can only continue to grow.

For a third consecutive year, Humira is the world’s best-selling biologic and for the last two years, sales of Humira have exceeded $10B. The first biologic to break the $10B barrier in 2013, Humira sold $12.5B in 2014, 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 2014, which include a cytokine, two insulins and seven antibody-based products. The antibody product Lucentis, which has made its initial debut in the top ten in 2014, has the distinction of being the first commercialized antibody fragment product produced using a microbial system.

Looking back a decade to 2004, when biopharma was in its twenties – total sales for the then 88 approved products didn’t quite reach $50B. The top ten selling biopharmaceuticals back then were slightly more diverse, with four hormones, three antibody products, two cytokines and an insulin. Interestingly, in both 2004 and 2014, the top ten selling products comprised nearly half of all biopharmaceutical sales and four of the top ten products in 2004 have remained on the top ten list for 2014: Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen. Gone from the 2004 top ten list are the four epoetin-based hormones, the human insulin and the cytokine, replaced with insulin analogs, and more antibody products.

Ten years ago, monoclonal antibodies were beginning to make their presence known, and now, MAbs 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 400 products in late stage development (Phase 2 through BLA/MAA/NDA application), over 80% are antibody related products. Looking closer at the antibody products and fragments in development, nearly 10% 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.

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Slide2As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, we can be assured antibodies will remain the cornerstone of the biopharmaceutical market for the foreseeable future. When looking forward to 2025, does the past decade suggest that Enbrel, Remicade, Rituxan/Mabthera, and Neulasta/Neupogen will continue to be amongst the top 10? Will microbial manufactured antibodies and fragments be “the next big thing”? Only time will tell, but we can’t wait to see.

 

Blog article by: Dawn M. Ecker

 


[a]http://www.fda.gov/AboutFDA/WhatWeDo/History/ProductRegulation/SelectionsFromFDLIUpdateSeriesonFDAHistory/ucm081964.htm#ftn10back

[b] http://www.bptc.com/pipeline-databases.php