The FDA approved the first antibody-drug conjugate (ADC), Pfizer’s Mylotarg (gemtuzumab ozogamicin), in 2000. However, it wasn’t until 2022 that an ADC was approved specifically for non-small-cell lung cancer (NSCLC). This milestone went to AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), developed for patients with HER2-mutated NSCLC.
Following this milestone, the market for ADCs in NSCLC is expected to grow steadily. According to a GlobalData report, the ADC market in NSCLC is projected to grow at a compound annual growth rate (CAGR) of 6.8 per cent across seven major markets (7MM) and reach over $3.9 billion by 2032.
The forecast shows that two key drugs will lead the market: AstraZeneca/Daiichi Sankyo’s Datroway (datopotamab deruxtecan) and Pfizer’s sigvotatug vedotin. Datroway is currently being tested in five Phase III clinical trials as a first-line treatment, often in combination with other therapies like immune checkpoint inhibitors, bispecific antibodies, and EGFR inhibitors.
AstraZeneca is also testing Datroway in early-stage disease settings, alongside its own immune therapy, rilvegostomig, in trials such as TROPION-Lung12. According to GlobalData’s analysis, Datroway is expected to lead the NSCLC ADC market by 2032, making up more than 32.6 per cent of sales (over $1.2 billion), followed by Pfizer’s sigvotatug vedotin with 27.3 per cent market share (over $1 billion).
Other promising ADCs in development include Merck’s and Gilead’s Trodelvy (sacituzumab govitecan), which targets TROP2, Enhertu which targets HER2, and Datroway, which targets HER3. These drugs are being tested across a wide range of lung cancer patients. While Enhertu and AbbVie’s Emrelis (telisotuzumab vedotin) are already approved, Datroway is in the pre-registration stage for second-line use. Companies are also beginning to focus on using ADCs earlier in the treatment journey, similar to what happened with other targeted therapies like Tagrisso (osimertinib) and immunotherapies like Keytruda (pembrolizumab).
The ADC development pipeline is currently very active. There are 29 ongoing Phase III trials in NSCLC sponsored by major pharmaceutical companies like Merck & Co., AbbVie, AstraZeneca, and Daiichi Sankyo. AstraZeneca and Daiichi Sankyo are running six trials, and Merck is involved in four, including trials for its own ADC, Giatelai (sacituzumab tirumotecan), in early-stage settings.
To support this growing demand, companies like Lonza and AstraZeneca are investing in expanding their manufacturing capacity, with new facilities expected in Switzerland and the US by 2028 and 2029.
Despite their promise, ADCs still face challenges such as treatment resistance, side effects like lung disease and low platelet counts, and variations in how tumors respond. However, by discovering new targets, using better drug linkers, combining ADCs with other treatments, and identifying the right patients through biomarkers, experts believe ADCs could eventually replace chemotherapy and become a safer, more effective cancer treatment option.
