ARTICLE
27 August 2025

Next-Generation Antibodies: A New Era In Immuno-Oncology

As the immune checkpoint inhibitor (ICI) market nears a patent cliff, the $50B immuno-oncology (IO) field is now seeking to surpass the limitations of earlier ICIs by enhancing survival outcomes...
United States Food, Drugs, Healthcare, Life Sciences

As the immune checkpoint inhibitor (ICI) market nears a patent cliff, the $50B immuno-oncology (IO) field is now seeking to surpass the limitations of earlier ICIs by enhancing survival outcomes, broadening coverage, and overcoming resistance mechanisms.

Shifting Priorities in Immuno-Oncology

  • A series of high-profile Phase 3 trial failures dampened enthusiasm for novel IO targets, prompting a strategic pivot in the field.
  • Several IO therapies struggled to demonstrate overall survival (OS) advantages over standard of care therapies, highlighting the inherent challenges in this space.
  • As a result, both large-cap pharmaceutical firms (-49%) and private investors (-60%) significantly downgraded IO as a top-three technological priority in 2024, marking a sharp decline from 2023 levels1.

Bispecifics Take Center Stage

  • In the quest for innovation, next-generation antibodies are gaining traction, offering compelling efficacy, strong commercial promise, and lower development risk.
  • Bispecific anti-PD(L)1/VEGFantibodies (bsAbs), are attracting growing interest due to their synergistic potential in solid tumor treatment.
  • This trend is supported by Phase 3 data, where bsAbs demonstrate a 52% success rate, outperforming the broader oncology average of 44% PTRS 2.
  • The global bsAb market is also forecasted to grow from $8.65 billion in 2023 to an estimated $485 billion by 2034 3.

The Opportunity: A $25B Market in Transition

  • A&M projects that anti-PD(L)1/VEGFcould reach peak sales of up to $25 billion, largely by replacing legacy ICIs in treatment regimens.
  • However, the greatest value will likely go to early entrants and those deploying innovative combinations, such as ADCs, anti-TGFβ agents, or other orthogonal mechanisms of action (MoAs).

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Footnotes

1. Lazard Global Biopharmaceutical Leaders Study

2. Pharma Phorum

3. Precedence Research

Originally published on 25 August, 2025

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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