In recent years the reputation of therapeutic vaccines has been blackened by developmental glitches and setbacks, with many failing to make it to market and those few that have pulling in just mediocre sales. Consequently, investors have generally glanced away from the whole area, especially after a spate of high-profile pipeline failures and a lack of approvals in the USA.

But, according to a new report from market analyst Datamonitor, the industry may be on the brink of a turnaround, similar to the long-awaited success of monoclonal antibodies.

The development of therapeutic vaccines is still largely focused on cancer vaccines, which represent 60.6% of the current 208 active pipeline projects, notes Datamonitor pharmaceutical markets senior analyst Joanna Chertkow.

“HIV and infectious disease projects are also relatively well-represented. In the early-stage pipeline greater interest is also starting to be shown in additional therapeutic areas, including nicotine addiction, and allergic, CNS and cardiovascular diseases.”

But, as yet, no therapeutic vaccine has managed to get a foot in the door to the all-important US market, with many being turned away at the gate, such CancerVax’s Canvaxin and Biomira’s Theratope to name but a few. “With 12 therapeutic vaccines currently in Phase III or Phase II/III trials, the Industry is reaching a critical point where regulatory success stories are desperately needed,” remarks Chertkow.

And yet, even those that have come through the regulatory approval process in other regions are finding it difficult to make their mark in the sector. The first three therapeutic to reach the market - Avax Technologies’ M-Vax, Intracel’s OncoVax and Corixa’s Melacine - are not selling well, with each being introduced in just a handful of countries, Datamonitor notes.

Lack of commercial success has dented investor confidence, leading to a situation where a lack of funding and partnerships with big pharma has led to sub-standard product development, resulting in poor clinical results which have further damaged the industry’s reputation, the group says.

But, according to Datamonitor, a new spurt of generalised, ‘off-the-shelf’ vaccines could rectify the commercial disadvantages associated with the early personalized vaccines, such as their very high cost and low scalability of manufacture, logistical complications, sterility issues and more the complex regulatory approval process. And, as clinical experience is growing and new delivery technologies are developed, an era of novel, non-toxic therapies for big killers such as cancer and HIV is drawing closer, the report suggests.

“Although the near-term prospects for therapeutic vaccines remain doubtful, with total sales not expected to surpass $500m in 2010, Datamonitor believes that technological evolution will ultimately enable therapeutic vaccines to make similar commercial breakthroughs after their initial disappointments,” concludes Chertkow.