No therapeutic cancer vaccine has received approval in any of the seven major pharmaceutical markets, despite extensive research efforts. However, with one product in pre-registration in the US, the prospect of the first marketed therapeutic cancer vaccine in the seven major markets is now closer to reality.
The theoretical market potential for therapeutic cancer vaccines in the seven major markets totals over $4.7 billion. Due to the limitations associated with the first generation of cancer vaccines, Datamonitor forecasts the current late-phase therapeutic cancer vaccines to achieve lower sales of $1.3 billion by 2018.
High risk and uncertain rewards have limited larger companies' involvement in the therapeutic cancer vaccines. Of the larger companies, GlaxoSmithKline and Merck KGaA have made the greatest commitment. The prospect of the first therapeutic vaccine approval in the US could stimulate renewed interest in this therapy class from further key players.
Of the 13 vaccines in late-phase development, Provenge (Dendreon), Stimuvax (Merck KGaA/Oncothyreon) and MAGE-A3 ASCI (GlaxoSmithKline) have the highest clinical and commercial potential. Provenge is likely to be the first therapeutic cancer vaccine to market, having shown a statistically significant overall survival advantage in prostate cancer.