The Antibody–Drug Conjugate (ADC) Landscape 2024–2026: Global Development, Regulation, Commercial Momentum and Next-Generation Technologies

From 2024 to 2026, antibody–drug conjugates (ADCs) have shifted from niche, late-line options into a central pillar of solid-tumour oncology. Clinical practice, regulation, and investment have all pivoted around a handful of highly visible programmes, Enhertu (trastuzumab deruxtecan), datopotamab deruxtecan, Trodelvy, disitamab vedotin, and a growing ecosystem of HER3, FRα, Nectin-4 and B7-H3/B7-H4 ADCs, while a second wave of technology companies pushes the field towards more precise, safer, and more versatile conjugates. Recent reviews characterise this era as a transition from second- to third-generation ADCs, with improved linker design, diversified payloads and “engineered safety” approaches widening the therapeutic window.[1–3]

This article synthesises recent peer-reviewed analyses, regulatory documents, company reports, and market insights to provide a 2024–2026 state-of-the-art view of the ADC landscape, spanning clinical development, safety, regulation, commercial dynamics and next-generation technologies.[1–7

Enhertu (trastuzumab deruxtecan, T-DXd) is the single most transformative ADC in this period. In April 2024, the US FDA granted a tumour-agnostic accelerated approval for unresectable or metastatic HER2-positive solid tumours based on pooled DESTINY pan-tumour data demonstrating durable responses across multiple malignancies.[4,5] Subsequent label evolution has entrenched Enhertu across HER2-positive and HER2-low breast cancer, HER2-positive gastric/gastro-oesophageal junction cancer and HER2-mutant NSCLC in the US, EU and Japan, with the EMA EPAR detailing multiple indications and ongoing post-authorisation safety studies.[5,8]

In January 2025, the FDA further expanded Enhertu into the HER2-ultralow segment, hormone receptor-positive metastatic breast cancer with IHC 0 but faint membrane staining, prior to chemotherapy, effectively redrawing the HER2 landscape and pushing ADCs into earlier treatment lines.[6,7,9] These approvals rest on DESTINY-Breast04 and DESTINY-Breast06 datasets and pan-tumour evidence showing clinically meaningful improvements in progression-free survival (PFS) and objective response rates (ORR) versus physician’s choice.[4–6]

Datopotamab deruxtecan (Dato-DXd) has emerged as the second major DXd-based pillar, targeting Trop-2 in HR+/HER2-negative breast cancer and lung cancer. Japan’s PMDA approved Datroway for unresectable or metastatic HR+/HER2-negative breast cancer at 6 mg/kg in December 2024, followed in January 2025 by US FDA approval of datopotamab deruxtecan-dlnk based on TROPION-Breast01.[10–12] CHMP has issued a positive opinion recommending EU approval for the same setting.[13]

TROPION-Breast01 showed significant improvement in PFS versus chemotherapy, higher ORR and better patient-reported outcomes; final overall survival did not reach statistical significance (HR ~0.84), but trends favoured Dato-DXd and regulators judged the benefit–risk profile acceptable.[23–29] Dato-DXd’s toxicity profile is dominated by stomatitis, nausea, alopecia and manageable interstitial lung disease (ILD), with ILD incidence numerically lower than Enhertu but still requiring dedicated monitoring.[23–26] In NSCLC, TROPION-Lung studies have supported priority regulatory pathways; an initial EU NSCLC filing was withdrawn after CHMP feedback, but the FDA has granted accelerated approval in EGFR-mutant disease with confirmatory trials mandated.[8,10,29]

Trodelvy (sacituzumab govitecan) remains an important Trop-2 ADC with established roles in metastatic triple-negative breast cancer (TNBC) and HR+/HER2-negative breast cancer across the US, EU and other major markets.[14–16] Ongoing clinical data continue to show durable benefit in heavily pre-treated breast-cancer populations, with predictable neutropenia and diarrhoea reflecting the SN-38 payload.[15,24]

However, TROPiCS-04 failed to demonstrate overall-survival benefit versus chemotherapy in urothelial carcinoma, leading Gilead and the FDA to withdraw this indication in late 2024.[14,17,18] Safety concerns did not fundamentally change, myelosuppression and gastrointestinal toxicity remain class-consistent, but the withdrawal highlights regulators’ increasing insistence on confirmatory survival data for accelerated ADC approvals.[19–21] In parallel, the FDA granted Breakthrough Therapy Designation for Trodelvy in extensive-stage small-cell lung cancer after progression, underscoring its broader potential in lung cancer if future data are positive.[19]

China has become a major ADC originator and market, with disitamab vedotin (RC48) and MRG002 leading regional HER2 targeting.[20–22,35] Disitamab vedotin is approved by the NMPA for HER2-positive gastric and urothelial cancers and is being evaluated in HER2-positive and HER2-low breast cancer, including in real-world cohorts treated between 2021 and 2024.[20–22] These cohorts report ORR around 26% overall and higher responses in HER2-positive versus HER2-low disease, with toxicity aligned to MMAE, peripheral neuropathy, neutropenia and fatigue, without unexpected safety signals.[20–22,31,32]

Trastuzumab duocarmazine (SYD985) provides an instructive contrast: in the phase 3 TULIP trial in heavily pre-treated HER2-positive metastatic breast cancer, SYD985 improved PFS versus physician’s choice (HR ~0.64) but with modest absolute PFS gain and high rates of ocular toxicity, including keratopathy and dry eye.[26,27,33,34] These toxicities led to more dose reductions and discontinuations and have constrained regulatory acceptance despite efficacy, cementing ocular safety as a central concern for duocarmycin payloads.[26,27,33,34]

MRG002 (an MMAE-based HER2 ADC) and ARX788 (a site-specific Amberstatin-based HER2 ADC) are advancing rapidly, with early-phase data demonstrating activity in HER2-positive and HER2-low breast cancer and gastric cancer and toxicity profiles consistent with their payload classes.[35–37] These agents, alongside disitamab vedotin and SYD985, signal a crowded next-generation HER2 ADC field competing with Enhertu.

Enhertu’s success in HER2-low and HER2-ultralow metastatic breast cancer has re-shaped histopathological practice, driving reclassification of HER2 expression and a wave of trials examining HER2-low and ultralow populations across multiple ADC platforms (ARX788, MRG002, disitamab vedotin, SYD985).[2,6,22,24,28]

HER3-directed ADCs, led by patritumab deruxtecan, are advancing in EGFR-mutant NSCLC and other indications, with late-stage programmes expected to support filings after 2026; Daiichi Sankyo lists HER3-DXd among its core deruxtecan portfolio.[1–3,13] Trop-2 remains one of the most competitive targets with Trodelvy, Dato-DXd and a range of regional entrants, including Chinese agents such as SKB264, aiming to optimise tolerability and tissue penetration.[2,3]

Nectin-4 targeting is dominated by enfortumab vedotin (Padcev), already established in urothelial cancer with combinations and earlier-line use in development; Nectin-4 remains a meaningful revenue contributor within the Seagen/Pfizer portfolio despite ongoing safety scrutiny for severe skin reactions and hyperglycaemia.[1,3,5] B7-H3/B7-H4 ADCs, including ifinatamab deruxtecan, represent an emerging checkpoint-linked class being explored in lung and other solid tumours.[1–3,13]

FRα-directed ADCs, particularly mirvetuximab soravtansine (Elahere), have re-shaped the management of FRα-positive platinum-resistant ovarian cancer and contribute critical learning on ocular toxicity, dose modification and prophylactic eye-care regimens that now inform development of other ocular-risk ADCs.[2,3,5]

Recent safety reviews and regulatory analyses highlight convergent toxicity themes across platforms.[1–3,13]

DXd-based ADCs (Enhertu, Dato-DXd, HER3-DXd) are primarily associated with ILD/pneumonitis, with pooled any-grade ILD rates around 10–15% and a small but persistent risk of fatal events.[1,5,6,23,29] Risk factors appear to include pre-existing lung disease, prior thoracic radiotherapy and Asian ethnicity, leading regulators to require baseline assessment, regular symptom review and immediate interruption at any sign of new pulmonary symptoms.[11–13,29,30]

SN-38-based ADCs such as Trodelvy exhibit significant myelosuppression and diarrhoea; diarrhoea requires proactive loperamide, hydration and sometimes hospitalisation, while neutropenia mandates growth-factor use and dose modifications.[15,17,24]

Vedotin (MMAE/MMAF) ADCs including Tivdak, Padcev, disitamab vedotin and MRG002 frequently cause peripheral neuropathy and neutropenia.[18,20–22,35] Enfortumab vedotin carries additional risk of severe dermatological reactions and hyperglycaemia, particularly when combined with immunotherapy.[3,5]

Duocarmycin ADCs (trastuzumab duocarmazine) and some FRα ADCs display a high incidence of ocular surface disease, including keratopathy, conjunctivitis and blurred vision.[26,27,33,34] Mitigation strategies include prophylactic steroid and lubricating eye drops, cooling eye masks and close collaboration with ophthalmology.

Across ADCs, the bystander effect, where membrane-permeable payloads diffuse into neighbouring cells, improves efficacy in heterogeneous tumours but can amplify off-tumour toxicity when target antigens are expressed at low levels in normal tissues. Regulators increasingly scrutinise antigen expression profiles in normal tissues and require robust PK/PD modelling and non-clinical safety data.[1–3]

Regulators have combined accelerated access with heightened safety oversight and more rigorous post-marketing expectations.[1–3]

For Dato-DXd, FDA and PMDA approvals include prominent warnings on ILD/pneumonitis, stomatitis and ocular adverse events, along with detailed dose-modification algorithms.[6–9,29] The multidiscipline reviews outline post-marketing requirements to characterise ILD, including prospective safety studies, pooled analyses across tumour types and continued central adjudication.[1,29]

Enhertu’s tumour-agnostic approval and HER2-ultralow expansion maintain a boxed warning for ILD, with prespecified stopping rules and registries embedded in US and EU risk-management plans.[4,5,11–14,30]

Tivdak’s conversion from accelerated to full FDA approval in 2024 left its boxed warning for ocular toxicity intact, embedding quasi-REMS elements directly in the label: mandatory ophthalmic exams, steroid and lubricating eye drops, vasoconstrictor use and strict dose-modification guidance.[15–18,31]

Trodelvy’s urothelial withdrawal illustrates regulators’ willingness to remove indications when confirmatory survival benefits fail to materialise, even for approved ADCs with established safety profiles.[17–21] At the same time, agencies continue to support indication expansions in settings where robust PFS and OS data exist.

Across ADCs, regulators now routinely require: detailed characterisation of off-tumour antigen expression; prospective ILD and ocular-toxicity monitoring with predefined adjudication; robust post-authorisation safety studies; and randomised confirmatory trials for accelerated approvals.[1–3,11,12,14,29,32]

Commercially, 2024–2026 marks a consolidation and scale-up phase in which large pharmaceutical companies lock up core ADC platforms through megadeals and long-term alliances.[2–7]

Pfizer’s USD 43 billion acquisition of Seagen, completed in 2023 and integrated through 2024, has doubled Pfizer’s oncology pipeline and placed Adcetris (CD30), Padcev (Nectin-4), Tivdak (tissue factor) and a suite of investigational ADCs at the centre of its growth strategy. Pfizer projects more than USD 10 billion in annual revenue from Seagen-sourced products by 2030.[5,8–10,31]

AstraZeneca and Daiichi Sankyo’s deruxtecan alliance remains one of the industry’s largest ADC franchises. Investor materials highlight Enhertu’s global sales surpassing USD 3.7 billion in 2024 and position Dato-DXd, HER3-DXd and B7-H3-DXd as additional multi-billion-dollar assets.[11–13,25] Daiichi Sankyo explicitly describes itself as an “ADC-first” oncology company, with ADCs as its primary growth engine.[3,12]

Gilead’s acquisition of ImmunoGen integrated mirvetuximab soravtansine and FRα technology into its existing Trodelvy-anchored portfolio, consolidating its position in women’s cancers.[6,11,14,22] Mersana’s trajectory, once a high-valuation ADC platform company, later acquired by Day One Biopharmaceuticals in a back-loaded deal, illustrates both the volatility and enduring strategic value of novel ADC chemistry. Despite clinical setbacks, its Immunosynthen (iADC) and Dolaflexin platforms remain partnered with GSK and Merck KGaA for up to USD 2.2 billion in potential milestones.[7,15–18,22]

Analysts estimate the global ADC market at roughly USD 12–16 billion in 2024–2025, with forecasts of USD 28–57 billion by 2030 and beyond, implying mid-teens to low-20s compound annual growth.[2–4,19,32] HER2 ADCs are expected to dominate near-term revenues; Trop-2 and FRα ADCs add substantial incremental value, while HER3, Nectin-4, B7-H3/B7-H4 and BCMA ADCs represent the next wave.[2–4,6,19–21] Breast cancer remains the largest indication segment, with lung, urothelial and gynaecologic cancers growing fastest.[4,19,21]

Payers and HTA agencies have generally accepted premium pricing for ADCs that deliver clear survival and quality-of-life benefits (e.g., Enhertu in breast and lung cancer) but show more caution in indications where OS gains are marginal or toxicity burdens are high.[6,20,21] ILD, ocular toxicity and neutropenia are increasingly prominent in reimbursement assessments and managed-entry discussions.[3,6,20]

Technologically, 2024–2026 is defined by attempts to broaden the therapeutic window through more precise conjugation, diversified payloads and sophisticated activation mechanisms.[1–3,38]

Site-specific conjugation platforms use engineered cysteines, enzymatic tags (e.g. sortase A motifs), glycan remodelling or Fc-selective chemistry to generate homogeneous ADCs with controlled drug–antibody ratios (DAR) and improved pharmacokinetics.[10,11,38,39] These approaches, deployed by companies such as Sutro, Tubulis and Duality, have been associated with improved stability and reduced off-target toxicity in preclinical models.[10,13–16,18,38–40]

Tumour-sensitive linkers, including β-glucuronide and pH-triggered designs, aim to maximise stability in circulation while enabling efficient payload release in the tumour microenvironment or endosomal compartments.[8,11,12,39,40] Hydrophilic spacers and linker architectures help reduce aggregation, increase solubility and allow higher DAR without compromising safety.[11,39,40]

Payload innovation now extends beyond microtubule inhibitors to topoisomerase-I inhibitors (DXd and exatecan), duocarmycins, PBD dimers, and immune-stimulating warheads such as STING and TLR agonists.[5,6,17,20–23] Sutro and Mersana, among others, are exploring dual-payload and immune-stimulatory ADCs (iADCs) that combine direct cytotoxicity with local immune activation, with preclinical data suggesting more durable responses than either cytotoxic or immune-stimulating conjugates alone.[18,19,22,23]

Tubulis’ Tubutecan topo-I payloads and P5 site-specific conjugation have shown encouraging early clinical activity (e.g. TUB-040 with ORR ~59%) with favourable safety, supporting a €308 million Series C financing in 2025 and strategic deals with large pharma.[3,15,16,37] Duality’s DITAC platform, licensed to Adcendo, emphasises sustained payload delivery and bystander effect with an improved safety profile.[13,14,29]

Safety-engineering across new platforms explicitly targets ILD, neuropathy and ocular toxicity. Strategies include optimising payload hydrophobicity and tissue distribution, lowering DAR while preserving potency, adopting more stable linkers, and integrating masking or tumour-restricted activation to reduce on-target off-tumour exposure.[7,9,10,15,20,21,30,31,38–40] Clinical experience with Enhertu, Dato-DXd, Tivdak, mirvetuximab and SYD985 now feeds directly into risk-management plans and engineering choices for the next wave of ADCs.[1–3,26,27,33,34]

Between 2024 and 2026, ADCs have become one of oncology’s most strategically important modalities. Clinically, they underpin treatment algorithms in HER2-positive, HER2-low and HR+/HER2-negative breast cancer and are rapidly expanding in lung, urothelial and gynaecologic malignancies. Regulators are balancing rapid access, including pan-tumour indications, with more assertive safety and confirmatory-trial requirements. Commercially, ADCs sit at the centre of multi-billion-dollar strategies at Pfizer, AstraZeneca, Daiichi Sankyo, Gilead and their peers. Technologically, advances in linkers, payloads, conjugation and tumour-specific activation are pushing the field into a third generation focused on improved tolerability and deeper efficacy.

If current trajectories hold, ADCs will not only remain a cornerstone of cancer therapy but will increasingly be deployed earlier in treatment lines, in combination with immunotherapy and targeted agents, and potentially in curative-intent regimens. The challenge, and opportunity, over the coming decade will be to sustain innovation while addressing the hard-learned safety lessons of ILD, neuropathy and ocular toxicity that define the first and second waves of ADCs.

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26. Turner NC, et al. Trastuzumab duocarmazine in pretreated HER2-positive advanced breast cancer. [Internet]. Available from: https://pure.rug.nl/ws/files/1286315803/turner-et-al-2024-trastuzumab-duocarmazine-in-pretreated-human-epidermal-growth-factor-receptor-2-positive-advanced-or.pdf

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31. Pfizer. Pfizer completes acquisition of Seagen, doubling its oncology pipeline [Internet]. Available from: https://www.pfizer.com/news/press-release/press-release-detail/pfizer-completes-acquisition-seagen

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35. Tubulis. Tubulis raises €308 million Series C to accelerate clinical development of TUB-040 and expand ADC pipeline [Internet]. Available from: https://tubulis.com/news/tubulis-raises-e308-million-series-c-to-accelerate-clinical-development-of-lead-adc-candidate-tub-040-and-expand-pipeline/

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39. Schneider H, et al. Broadening the therapeutic window of ADCs using hydrophilic linkers. ChemBioChem [Internet]. Available from: https://chemistry-europe.onlinelibrary.wiley.com/doi/10.1002/cbic.202500305

40. Deonarain MP, et al. Broadening the therapeutic window of ADCs using target- and linker-engineering. Mol Cancer Ther [Internet]. Available from: https://aacrjournals.org/mct/article/24/6/803/762661/Broadening-the-Therapeutic-Window-of-ADCs-Using