Antibodies: $75B in sales and no slow-down in sight
Antibody related products[i] have been a staple in the biopharmaceutical landscape for over 10 years. In preparing a recently published article on antibody related products, it became apparent that antibody related products are much more than a staple – but in fact are a cornerstone of the biopharmaceutical market. Representing nearly a third (1/3) of all approved and currently marketed recombinant therapeutics (51 of 178), antibody products generated nearly $75B of the $140B in sales of biopharmaceuticals for 2013.[ii]
Since recombinant products entered the market in 1982, 61 antibody related products have been approved over the last 30 years.[iii] If we take a closer look at the number of antibody related products approved every year, since the approval the first therapeutic monoclonal antibody Orthoclone OKT3 in 1986, 2014 saw a record number of nine antibody products approved (see Figure 1 below), which exceeded both 1998 and 2006’s six antibody approvals. Of the 2014 approved products, six are full length monoclonal antibodies: Cyramza, Sylvant, Entyvio, Keytruda, Blincyto and Opdivo while the remaining three products are Fc-fusion proteins: AlprolIX, Eloctate, and Trulicity.
Surveying the overall recombinant biopharmaceutical pipeline, it is clear from our bioTRAK® database that antibody products dominate the development pipeline. Of the nearly 375 products in late stage development (Phase 2 through BLA/MAA/NDA application), 70% are antibody related products. Over 90% of these antibody products are produced in mammalian systems.
Barely one month into 2015, the first antibody of the year, secukinumab, has been approved in both the EU and the US and the market is preparing for another influx of approvals, with six products under FDA or EMA review. Four of these candidates are full length antibodies (mepolizumab, necitumumab, evolocumab, and dinutuximab) and the remaining two are Fc-Fusion proteins (asfotase alfa) and the first etanercept biosimilar for the European market. If we look even further back into the pipeline, there are over sixty antibody related products in development. Although many of these products are still in active clinical trials, we expect that some of these products may possibly file for review and be approved before the end of 2015.
As the development and commercialization of antibody products continue to forge ahead with no slowdown in sight, antibodies will remain the cornerstone of the biopharmaceutical market for the foreseeable future.
Figure 1. Annual approvals of monoclonal antibody products from 1982-2014
Blog article by: Dawn M. Ecker
[i] We consider antibody products to include full length monoclonal antibodies, antibody fragments (Fab fragments), Fc-fusion proteins, antibody-drug conjugates, and other conjugated antibody products for therapeutic use in humans.
[ii] Sales data for biopharmaceuticals sold in 2014 have not yet been released. Please check back for a new blog revealing 2014 sales.
[iii] Eleven of antibody products have been since withdrawn from the market.