In the ever-evolving landscape of oncology, small-molecule drugs are carving a significant niche in lung cancer treatment. In 2015, AstraZeneca’s Tagrisso achieved landmark approval from the FDA following the results of the Phase III AURA trial. This approval marked a significant advancement in the treatment of metastatic EGFR T790M mutation-positive non-small cell lung cancer (NSCLC). Tagrisso is projected to be a pivotal contributor to AstraZeneca’s portfolio, with anticipated sales surpassing $7 billion and a 48 per cent market share of small molecules in lung cancer treatment by 2029, according to GlobalData.
GlobalData’s patient-based forecasts indicate a robust demand for small molecules in the treatment of NSCLC in the eight major markets (US, France, Germany, Italy, Spain, UK, Japan, and China), projecting the market to reach over $15 billion by 2029, representing approximately 40 per cent of the total NSCLC market.
Dr Biswajit Podder, Oncology and Hematology Analyst at GlobalData, comments, “Tagrisso’s approval marked a paradigm shift in the treatment of lung cancer, especially in the early stages where tumor resection is possible but recurrence is common (Phase III ADAURA trial). In addition, the groundbreaking results of the Phase III FLAURA trial added a new standard to the first-line treatment of EGFR-mutated NSCLC. This ensures that a wider spectrum of patients can reap the benefits of targeted small-molecule medicines like Tagrisso.”
Roche is expected to secure the second position with projected sales of over $2.5 billion and a market share of 17 per cent, while Amgen is anticipated to follow closely, holding the third position with projected sales of over $1 billion and a market share of 7.3 per cent.
GlobalData reveals that a total of 39 small molecules have been commercialised for the treatment of lung cancer, with a total of 4,951 ongoing Phase III trials employing 34 distinct small molecules globally. In addition, 14 new small molecules for the treatment of lung cancer are currently undergoing Phase III clinical trials, indicating a robust and dynamic clinical trial landscape.
Podder concludes, “In addition to the success of Tagrisso, the other promising pipeline drugs of AstraZeneca, particularly Orpathys, are contributing to the company’s small-molecule lung cancer treatment portfolio. It is anticipated to generate $361 million in sales for lung cancer treatment by 2029. Furthermore, Lynparza, another small molecule from AstraZeneca, is undergoing clinical trials for the treatment of lung cancer. However, Eisai and Merck’s new asset, Kisplyx/Lenvima, is another major small molecule in Phase III development for the treatment of NSCLC, with projected sales of $176 million by 2029.’’