GlobalData forecasts ADC NSCLC market to reach $3.9 bn in 2032

Despite the FDA first approving Pfizer’s antibody-drug conjugate (ADCs) Mylotarg (gemtuzumab ozogamicin) in 2000, it was not until 2022 for non-small-cell lung cancer (NSCLC) to see its first ADC approval, AstraZeneca’s and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan), for human epidermal growth factor receptor (HER) 2-mutated patients. Following this approval, the ADC market in NSCLC is projected to grow at a CAGR of 6.8 per cent across the seven major markets (7MM*) and exceed $3.9 billion in 2032, forecasts GlobalData.

GlobalData’s patient-based forecast highlights that ADCs will see significant sales in the NSCLC space by 2032, led by AstraZeneca/Daiichi Sankyo’s Datroway (datopotamab deruxtecan) and Pfizer’s sigvotatug vedotin. Datroway is currently being evaluated in five Phase III clinical trials as a first-line therapy in combination with immune checkpoint inhibitors (ICIs), bispecific antibodies, and epidermal growth factor receptor inhibitors.

AstraZeneca is also assessing Datroway’s potential in adjuvant settings in combination with its own ICI rilvegostomig (TROPION-Lung12). Datroway is expected to lead the NSCLC ADCs market, accounting for over 32.6 per cent of sales and generating more than $1.2 billion by 2032 across the 7MM, closely followed by Pfizer’s sigvotatug vedotin with 27.3 per cent market share and over $1 billion in projected sales.

Biswajit Podder, PhD, Oncology and Haematology Analyst, GlobalData, notes, “Trophoblast cell surface antigen 2-directed ADCs like Merck’s and Gilead’s Trodelvy (sacituzumab govitecan), HER2-targeting ADC Enhertu, and HER3-directed ADCs such as Datroway are being explored across broad NSCLC populations. Although Enhertu and AbbVie’s Emrelis (telisotuzumab vedotin) have received approval, and Datroway is in the pre-registration stage for second-line treatment, companies are increasingly focusing on first-line and even early disease settings, similar to the trajectory of targeted therapies like AstraZeneca’s Tagrisso (osimertinib) and immunotherapies like Merck’s Keytruda (pembrolizumab) in recent years.”

The ADC late development pipeline in NSCLC is active, with 29 Phase III ongoing global clinical trials sponsored by big pharmaceutical companies, including Merck & Co., AbbVie, AstraZeneca, and Daiichi Sankyo.

AstraZeneca and Daiichi Sankyo, along with Merck, are leading the efforts to advance ADCs into earlier lines of therapy in NSCLC, with six and four Phase III trials, respectively. In addition, Merck is evaluating its ADC Giatelai (sacituzumab tirumotecan) in adjuvant and maintenance settings. To meet the rising ADC demand, Lonza and AstraZeneca are expanding their manufacturing capacities in Switzerland and the US, respectively, with facilities expected to be operational by 2028 and 2029.

Podder concludes, “ADCs face several challenges, including resistance to the payload, narrow therapeutic window, molecular heterogeneity, and toxicity, such as interstitial lung disease and thrombocytopenia. However, by identifying novel targets, developing bispecific antibodies, engineering better linkers, using multiple different payloads on one ADC, and identifying suitable patient populations using biomarkers, ADCs have the potential to replace chemotherapy, improve safety and efficacy, and prevent resistance mechanisms by combining ADCs with other treatment modalities such as immunotherapy.”

*7MM: The US, France, Germany, Italy, Spain, the UK, and Japan.