Biotech Spain  Article

Publication date: 11/07/2013

Last update: 11/07/2013

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The market for therapeutic antibodies

In a previous issue at BiotechSpain we presented the biology of therapeutic antibodies and the immense possibilities as new biological drugs. Indeed, their natural flexibility and specificity makes them ideal candidates for personalized medicine. This versatility has not gone unnoticed by the pharmaceutical industry.

 

The market fortherapeutic monoclonal has experimented a continuous rise in recent years. Already in 2011there were approximately 28 monoclonals in US and the EU. Today, about 10 monoclonals have already achieved category of "blockbuster", that is they are widely used medications that have been able to generate profits of more than one billion dollars (each) to companies that market them. And in 2012, global sales of antibody-based therapeutic products exceeded $50 billion; among the 15 top-selling drugs in that year, six are antibody-based molecules.

 

And of course, new therapeutic antibodies are on the way, given the increasing number of these drugs in various stages of clinical testing.

The molecular nature of therapeutic antibodies has also evolved as have developed different technologies for producing them. The first monoclonals were murine molecules as the classical technique of monoclonal antibody production (through the generation of hybridomas) was based on o mouse cell cultures. However, molecular biology and protein engineering have been making it possible to create monoclonals with increasing proportion of human sequences in their composition and this has also affected their marketing strategy.

In this sense, we have in the market chimeric antibodies in which the entire antibody is human except the variable regions of the molecule; humanized antibodies, in which the murine portion is confined only to the complementarity determining regions or CDRs; and finally completely human monoclonals with no trace of mouse sequences. At present, development of fully murine or chimeric antibodies is in decline in favor of fully human or humanized versions, since these versions offer advantages associated with decreased immunogenicity.

 

As amolecule, antibodies are very versatile and allow the addition of features to diversify its function. Thus, antibodies can be used as systems to target molecules (antibody-drug) to specific locations. Among the molecules already attached to antibodies are toxins and radioactive molecules. There is also work on the structure of the antibody itself, to create smaller or multivalent versions.

Regarding therapeutic indications, the therapeutic antibody market is primarily aimed at two groups of indications, oncology and immunology, being autoimmune disorders and inflammation the leading representatives of the second. In 2010, oncology indications made ​​up just over 50% of sales, while the immunological area accounted for almost 40%. This bias in favor of oncology and inflammation therapeutic area is expected to continue in the future, since among the antibodies in phase III development, there is a majority of oncology indications.

Among related industries that will be affected by this hegemony of antibodies in the market for biotech drugs,  all those related to the production, purification and modification of antibodies will be crucial. In this sense, all the new technologies that improve these processes are continually under study, as their potential impact on the biologics market is huge. Regarding production of therapeutic antibodies, high performance production techniques, analysis methods, improvements in stability and ways to reduce or prevent aggregation during production will be more than important.

 

The 15 best-selling drugs of 2012 Source: FierceBiotech

Major indications for therapeutic antibodies Source: Therapeutic antibodies: Market considerations, disease targets and bioprocessing

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