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Therapeutic monoclonal antibodies
The biopharmaceutical market, like the global pharmaceutical market, has been expanding every year and is expected to reach approximately 230billion dollars in 2018, twice the sum in 2010 (1). It is forecasted to be >380billion dollars in 2024 (1). Recombinant proteins, followed by therapeutic antibodies, have been the main contributors to the biopharmaceutical market in the past. However, in 2017 (2) the sales of antibody-based medicines took on the leading position, with expected sales of 172.8billion dollars in 2022, about 20% of the global pharmaceutical market (2).
It is noteworthy that the range of therapeutic monoclonal antibodies has been remarkably increasing since the late 1990s, the total number approved by the US FDA reaching 64 in 2018 (2,3) (see Table 1 list for those from 2015 to 2017). In 2017, a total of 11 therapeutic monoclonal antibodies were approved. There are interesting changes in the characteristics of the antibodies attracting attention. As shown in Figure 1, the percentage of human and humanized antibodies in the total has dramatically increased. The reasons for continuous expansion of the market for therapeutic antibodies include an increase in the number of approvals, efforts to explore other target diseases for the already approved therapeutic antibodies, as well as improvements in formulations and dosage forms. Finding new target antigens will be of critical importance for further development of antibody-based medicines in the future.
Table 1. The US FDA-approved therapeutic monoclonal antibodies from 2015 to 2017.27 therapeutic monoclonal antibodies were approved by the US FDA from 2015 to 2017. The number has been increasing year by year.| Name of antibody | Brand name | Approved year | Target antigen | Target disease |
|---|---|---|---|---|
| Dinutuximab | Unituxin® | 2015 | GD2 | Pediatric high-risk neuroblastoma |
| Idarucizumab | Praxbind® | 2015 | Dabigatran | Emergency reversal of anticoagulant dabigatran |
| Mepolizumab | Nucala® | 2015 | IL-5 | Severe asthma |
| Elotuzumab | Empliciti® | 2015 | SLAMF7 | Multiple myeloma |
| Nivolumab | Opdivo® | 2015 | PD-1 | Metastatic melanoma |
| Secukinumab | Cosentyx® | 2015 | IL-17A | Plaque psoriasis |
| Evolocumab | Repatha® | 2015 | PCSK9 | Heterozygous familial hypercholesterolemia, Refractory hypercholesterolemia |
| Alirocumab | Praluent® | 2015 | PCSK9 | Heterozygous familial hypercholesterolemia, Refractory hypercholesterolemia |
| Necitumumab | Portrazza® | 2015 | EGFR | Metastatic squamous non-small-cell lung carcinoma |
| Daratumumab | Darzalex® | 2015 | CD38 | Multiple myeloma |
| Obiltoxaximab | Anthim® | 2016 | Bacillus anthracis toxin | Inhalational anthrax |
| Ixekizumab | Taltz® | 2016 | IL-17A | Plaque psoriasis |
| Reslizumab | Cinqair® | 2016 | IL-5 | Severe asthma |
| Atezolizumab | Tecentriq® | 2016 | PD-L1 | Urothelial carcinoma |
| Olaratumab | Lartruvo® |