Breast Cancer - Recent approvals increase pressure on pipeline candidates

Incidence of breast cancer in the seven major markets will total 455,000 in 2008, while 115,000 women will die from the disease. Despite advances in treatment over the past decade, significant unmet needs remain. This level of demand and the large patient potential make breast cancer a relatively attractive indication for drug developers.

There are 121 drugs in clinical development for breast cancer. Molecular targeted therapies are the predominant therapy class in the breast cancer pipeline, accounting for 50% of the pipeline. Cytotoxic therapies account for 25% of the pipeline, while therapeutic vaccines account for 13%, and endocrine therapies account for just 6% of the pipeline.

Seven drugs are in late-phase development for breast cancer, of which four are molecular targeted therapies. Collectively, the late-phase pipeline candidates are forecast to achieve $2,230m in sales in 2017 in the seven major pharmaceutical markets. The late-phase molecular targeted therapies account for the majority of this with sales of $2,142m.

The majority (82%) of clinical trials of drugs in late-phase development for breast cancer are in the metastatic setting. This reflects the higher level of unmet need, lower bar to market entry and shorter trial completion time as compared with the adjuvant or neoadjuvant treatment setting.

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