The therapeutic vaccines segment of the immunotherapy market is primed for growth, with a new report pegging their major-market sales at $1.2 billion in 2022. But vaccine makers will have their fair share of challenges navigating that market--not to mention the hurdles they'll have to clear to make it there in the first place.
According to new research by Decision Resources Group, 5 new approvals will join the sole cancer vaccine on the market, Dendreon's ($DNDN) Provenge, and the group will see 13.6% annual sales growth over the next 8 or so years. DRG analysts expect the antigen- and peptide-based vaccines among them--Celldex Therapeutics' ($CLDX) brain cancer treatment rindopepimut and tecemotide, the lung cancer candidate from Merck Serono and Oncothyreon ($ONTY)--to churn out 44% of the segment's major-market sales.
DRG expects Bavarian Nordic's Prostvac-VF-TRICOM, Amgen's ($AMGN) T-Vec and Northwest Biotherapeutis' ($NWBO) DCVax-L to round out the list, company analyst Khurram Nawaz told FierceVaccines, with the 5-pack of newcomers generating sales growth that will counterbalance declines for Provenge.
But that may be easier said than done. Northwest Bio, for one, said its Phase I/II study for DCVax-L was too small and "informal" to deliver decisive data, and its current pivotal trial has produced anecdotal results. Some industry-watchers have gone as far as to deem the therapy little more than a placebo--a tag the company has repeatedly rejected.
Tecemotide, too, has seen dark days, with Merck finally initiating a new Phase III study this April after a 2012 failure in the clinic sunk partner Oncothyreon's shares by 50% in just one day. Even the highly anticipated T-Vec hit a snag a couple months back, missing on its Phase III trial's secondary endpoint of overall survival.
And the hardships don't end at regulatory approval--just ask Dendreon, whose manufacturing woes and subsequent sales disappointment for Provenge cast a dark cloud over the cancer vaccine field. Indeed, experts interviewed by DRG said they were "uncertain about the logistics and processes involved in the manufacture of personalized therapeutic vaccines … and are concerned about potential impact on patient management in routine practice."
These factors will weigh down cancer vaccines even while other immunotherapy drugs--including Bristol-Myers Squibb's ($BMY) nivolumab--explode onto the scene, scoring $7.9 billion in 2022, the group predicts. But that's not to say the vaccines don't have their place in cancer treatment. Some of the experts DRG interviewed said vaccines could play a greater role in earlier disease settings--as an adjuvant treatment, for example--rather than later in the disease course.
- read DRG's release