New technologies to capture over 10% of the antibody therapeutics market by 2023

Friday 29 March 2013, Amsterdam

A new report shows that next-generation technologies will become a major driver for the antibody therapeutics market. Worth just under $170m in 2012, the new wave of products will represent over 10% of all antibody therapeutics revenues by the end of 2023. Antibody-drug conjugates (ADCs) are leading the way, but Fc-engineered, bispecific, and biosimilar antibodies, as well as next-generation fragments and antibody-like proteins will also show high revenue growth to 2023, the study predicts. That revenue forecast and others appear in Next-Generation Antibody Therapeutics Market 2013-2023, published in February 2013.

Signs that next-generation antibody development is coming to fruition include the 2011 FDA approval of Seattle Genetics’ Adcetris (brentuximab vedotin) and the 2012 approval in Japan of Kyowa Hakko Kirin’s Poteligeo (mogamulizumab). Poteligeo is the first approved mAb with glycosylation patterns engineered for improved efficacy. Biosimilar antibodies came a step closer in 2012 too, with the South Korean approval of CellTrion’s Remsima. The potential of next-generation technologies was underlined when Amgen acquired Micromet and its bispecific T-cell engager (BiTE) platform, also in 2012.

James Evans, a pharmaceutical industry analyst, said: “Antibody therapeutics will be the first, second and third-highest selling pharma products in 2013. But the massive achievements of the antibodies sector need to be renewed by next-generation products. We’re approaching a situation where every druggable target has been tried, the market is getting saturated, the low-hanging fruit has gone. The market needs new kinds of products to keep it moving.

“With the EMA guidance in place, biosimilar antibodies will soon light a fire under the sector, increasing competition and forcing innovator companies to start differentiating their antibody products. The next-generation platforms offer a kind of toolkit for doing differentiation and lifecycle management. You can see Roche getting in on the ground floor there with what they’re doing with obinituzumab and T-DM1, using engineering and ADC technologies to extend their rituximab and trastuzumab franchises. T-DM1 is potentially a major watershed for the next-generation field, because it’s the first ADC against a solid tumour target. Adcetris has had a pretty ordinary start in commercial terms, but in any case it’s a lymphoma treatment. The real question is whether ADC approaches can give mAbs the potency to start hitting solid tumours.

“Bispecifics aren’t as far along as ADCs or glycoengineered mAbs yet, but blinatumomab is looking good, and Amgen clearly thinks so too. Also at the heavily re-engineered end of the technology spectrum, a few of the small proteins, both Ig-based and alternative scaffolds, have got into phase 2 testing. The Allergan DARPin has got people’s attention in the AMD field, for example. None of those platforms have made it all the way yet, but the R&D is continuing, and big pharma is watching closely there too.”

Our forecasts a CAGR of over 50% for the next-generation market through 2023, as the novel technologies advance across a broad front and new antibody modalities gain validation and acceptance by the industry.

The analyses include revenue forecasts to 2023 for two overall world markets:

• Therapeutic antibodies (overall sales)
• Next-generation therapeutic antibodies.

They also include submarket forecasts to 2023 for five next-generation technologies:

• Engineered antibodies
• Antibody-drug conjugates (ADCs)
• Bispecific antibodies (bisAbs)
• Antibody fragments and antibody-like proteins
• Biosimilar antibody products.