Global lung cancer ADCs have moved from niche to scale: the new Kuick Research analysis pegs 2024 revenue at more than US$4 billion, with over US$2.5 billion booked in the first half of 2025, five agents approved for lung cancer as of October 2025, and a clinical pipeline exceeding 120 conjugates. Targets now span HER2, TROP2, c-Met, B7-H3, AXL, and DLL3, with multiple Phase 3 programs queued up behind early launches.
The core development is the publication of Kuick Research’s 2030 outlook on lung cancer antibody-drug conjugates, which consolidates approvals, pricing, pipelines, and regional dynamics. Enhertu’s 2022 approval in HER2-mutant NSCLC is positioned as the inflection point, followed by TROP2- and c-Met–directed entries and additional HER2 assets in 2025. The report highlights rapid uptake in the US and China, expanding expedited pathways in major agencies, and an accelerating late-stage slate that includes ifinatamab deruxtecan (B7-H3), sigvotatug vedotin (AXL), and telisotuzumab adizutecan (c-Met). It also flags emergent formats like bispecific ADCs and broadened collaboration models, such as DLL3 programs for SCLC.
Strategically, the surge reflects a land grab around validated targets and payload-linker IP, plus a recalibration away from IO/TKI combinations toward potent, pathology-driven cytotoxics. Sponsors are pursuing parallel tracks: deepening penetration in large biomarker-defined NSCLC subsegments (TROP2, HER2-low/mutant, c-Met) while seeding next targets to hedge against cross-resistance and class toxicities. The tension is operational and regulatory as much as scientific: accelerating approvals increases pressure for clean confirmatory designs and commercially viable safety profiles amid known ADC risks like ILD, stomatitis, and myelosuppression. Manufacturing is a gating factor; high-potency payload supply, conjugation capacity, and in-process controls are now competitive differentiators, not back-office concerns.
For sites, the pivot intensifies demands on genomic and IHC screening, pathology turnaround, and pulmonary monitoring, while shifting infusion chair allocation toward serial ADC administration and AE surveillance. Sites with integrated molecular diagnostics and strong supportive care protocols will capture more volume; those without will face referral leakage. CROs will see more MRCTs that straddle US-China-EU with companion diagnostics embedded, tighter safety monitoring windows, and adaptive designs to answer confirmatory endpoints under accelerated timelines. Central labs, CDx developers, and bioanalytical vendors sit at the critical path, as do CDMOs with linker-payload and conjugation expertise. Regulators are supportive but will likely tighten expectations on OS and durable benefit, especially where ORR-based accelerations become crowded within the same target class.
Near term, watch three pivots: pivotal readouts for B7-H3, AXL, and c-Met programs that could expand the treatable lung cancer addressable market; DLL3 assets in SCLC, where unmet need is high but toxicity management and patient selection will be decisive; and the emergence of bispecific ADCs that promise better tumor selectivity but add CMC and safety complexity. Reimbursement friction is the sleeper risk—overlapping indications within targets, site-of-care economics under buy-and-bill, and companion diagnostic coverage could slow uptake even as approvals multiply. Manufacturing resilience will also be tested as more players scale commercial supply simultaneously. The signal to track is whether confirmatory trials can convert early response gains into survival and QoL advantages with manageable toxicity; if not, regulators may recalibrate the class’s runway just as pipelines peak.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
