Results of KNect365’s Antibodies Emerging Tech Survey shows biopharma remains focused on monoclonal antibodies but acknowledges challenges persist, particularly in the discovery stage.

There were over 200 respondents to the survey, with 81% of the organizations focusing on developing monoclonal antibody (MAb) therapeutics. This comes as no surprise, as the first Mab entered the market over 30 years ago in the form of Janssen-Cilag’s Orthoclone OKT3 (muromonab) and the modality has been deemed well-characterized by the US Food and Drug Administration (FDA) since 2003.

So, while much attention is on emerging modalities – 51% of respondents said they are developing bispecifics, 33% antibody-drug conjugates, and 21% cellular therapies – the MAb market is far from being in decline.

Image: iStock/anusorn nakdee

In fact, over 100 MAbs have been approved by the FDA and, while not all encompassing, clinicaltrials.gov lists over 4,500 monoclonal antibodies in clinical trials.

But while these molecules are well-characterized and abundant, there remain gaps in all aspects of their discovery and development that emerging technologies are looking to plug.

For example, the discovery stage needs better and more accurate technology. “Currently, our understanding of targets and their biology is still very poor,” a survey respondent said. “As a result biotherapeutics are still designed and developed in a surprisingly naive way. We could and can do better.”

Nearly half of the respondents use display libraries to generate their monoclonal antibody leads, but many responses mentioned the limitations of these. One claims there are issues with the “deep sequencing of an entire synthetic or human IgG repertoire library,” saying “it’s still not possible to sequence every member of a 1e12 library.”

As such, it is no surprise that when asked at what stage is it most critical to think about investing in technology, 63% stated ‘Discovery/target identification.’ A fifth said preclinical is where they would put their money, while only 3% believe there is a need to invest in new technologies once a molecule is in the clinic. Manufacturing and commercialization were only cited by 6% of the respondents.

Download the full report here.