T-cell engagers to drive immuno-oncology next growth wave: GlobalData

The global immuno-oncology (IO) market expanded at an impressive 24.3 per cent compound annual growth rate from $10.4 billion in 2014 to $74 billion in 2024. The success of immune checkpoint inhibitors (ICIs) and CAR-T cell therapies fueled this initial market growth. As many of the ICIs approach the patent cliff, the spotlight has shifted toward next-generation products. Among these, bispecific T-cell engagers (TCEs) have gained traction, with multiple recent approvals in both hematologic and solid tumor indications, says GlobalData.

GlobalData’s latest report, “Strategic Intelligence: Immuno-oncology (2025),” reveals that TCEs accounted for 10 per cent of the IO market in 2024; this share will rise to 35 per cent by 2031, while ICIs will decline from 77 per cent to 43 per cent of the projected $186 billion market over the same period.

In 2024, two landmark approvals underscored the continued evolution of the IO space. Adaptimmune’s Tecelra became the first FDA-approved T-cell receptor (TCR) therapy for synovial sarcoma, while Iovance Biotherapeutics’ Amtagvi became the first tumor-infiltrating lymphocyte (TIL) therapy approved for melanoma.

Israel Stern, MSc, Oncology & Hematology Analyst at GlobalData, comments, “These therapies offer new hope for patients, with the potential for long-term remissions and even curative outcomes. Continued investment in IO research and development—both in academia and the biopharmaceutical industry—will be key to further improving clinical outcomes for oncology patients.”

The current IO pipeline is extensive and diverse, with over 900 agents in clinical development across the eight major markets (8MM: The US; 5EU: Germany, France, Italy, Spain, the UK; Japan and China). Cell therapies represent the most advanced segment, with more than 300 agents in development, the majority of which are CAR-T cell therapies. Checkpoint modulators follow with around 160 agents currently in clinical development.

Stern adds, “The greatest investment is concentrated in therapeutic classes with proven efficacy, namely cell therapies and TCEs. The ICI landscape, while still growing, is becoming increasingly saturated. New entrants need to target novel immune checkpoints that either improve response rates or offer treatment options for patients previously exposed to checkpoint inhibitors.

“There is intense competition facing pipeline cell therapies entering the blood cancer space, especially in B-cell malignancies, with several CAR-T therapies on the market. To gain an edge, next-generation therapies such as CRISPR Therapeutics’ CTX-112, an allogeneic off-the-shelf CAR-T with shortened manufacturing time, may present a more scalable and accessible solution.”

Another IO class showing strong potential is multispecific antibodies, the majority of which are bispecific TCEs. Currently, eight out of ten globally approved bispecific TCEs  target hematologic cancers.

There is growing enthusiasm among physicians for wider adoption of TCEs.These off-the-shelf therapies link the patient’s T-cells to tumor-expressed antigens, promoting a direct and targeted immune response. Four TCEs are FDA-approved in relapsed/refractory multiple myeloma, three of which bind BCMA. Regeneron’s Lynzotyfic, the most recent entrant, offers a key advantage: monthly dosing after a partial response, compared to biweekly dosing required by competitors following a complete response.

Reimbursement challenges represent the most significant access barrier, particularly for cell therapies, and in some cases for checkpoint inhibitors and bispecific antibodies. The need for specialised centers and trained healthcare professionals creates additional limitations, particularly for advanced modalities like CAR-T and TIL therapies, which require complex administration protocols.

Stern concludes, “Other unmet clinical need experts highlight include predictive biomarkers to identify patients who are likely to respond, given the high cost and potential toxicities associated with these agents. Additionally, limited efficacy in so-called ‘cold’ tumors that are not immunogenic, as well as resistance to IO therapies in immunogenic tumors is common. Next-generation IO therapies with novel mechanisms of action may help address these persistent gaps.”