New study has suggested that therapeutics based on monoclonal antibodies (mAbs) are fare more likely to be commercially successful than their small molecule predecessors. According to a study completed by // consultancy Propagate Pharma, about half the mAbs launched so fare appear to be profitable. That means mAbs are recouping more in revenues than their estimated $1 billion to $1.8 billion cost of development and marketing. By comparison, the study estimates that only 30% of conventional small molecule drug launches ever recover their costs. Drug is likely to be profitable if peak revenues pass the $300 million mark. So far, of the 17 mAbs launched in the US, eight have achieved this benchmark. And of these, four have become blockbusters earning over a billion dollars a year.

Of 57 mAbs launched so far, 16 have become blockbusters, 14 have at least recouped their costs, and the other 27 are either question marks or failures. The high success rate of biotherapeutics is due to low levels of competition in the markets they address, says Jo Collett, author of the Propagate study. There are signs that the tail end of a biotherapeutics products life cycle might be more profitable than that of a small molecule drug. However, this high level of success may be difficult to sustain as competition increases, especially in the cancer market, says Propagate’s Collett. “It’s not going to be quite as easy as it was for the pioneers,” she prophesies.

There are more than 150 mAbs in development worldwide, over 100 of which are in phase 2 or phase 3 trials. Nearly 40% of these are in the oncology field; 18 are in development for breast cancer alone. Collett predicts that companies launching the next generation of mAb therapeutics will have to be more commercially acute with a better understanding of their products positioning that the pioneers of the field were. Although there is respectable data showing that obtaining regulatory approval tends to be easier
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