Human papilloma viruses (HPV) members of the papillomaviridae family are extremely common with an estimated worldwide prevalence of ~11-12%. Although nearly all sexually-active men and women acquire the virus at some point in their lives, most infections are asymptomatic and self-limiting; with 90% clearing within two years. High risk forms of HPV (16/18) can cause changes in the cells lining the mouth, throat or anogenital tract (including the cervix); called dysplasia and can lead to cancer. All (100%) of cervical cancers are thought to be caused by HPV which is thought to be responsible for 610,000 cancers worldwide.
Two prophylatic vaccines against HPV are currently licensed (Gardasil/Merck & Co & Cervarix/GSK Biologicals). Despite their deployment, it is estimated it would take approximately 20 years from the implementation of mass vaccination for preventative vaccines to impact cervical cancer rates. In addition, in most HPV associated malignancies genomic integration of the virus has already occurred necessitating a different mechanism of action for an HPV therapeutic vaccine.
Currently, there are several HPV therapeutic vaccines in clinical development targeting established cancers and neoplasias such as CIN2/3. Key programs showing positive efficacy signals are Axalimogene Filolisbac, AXAL (Advaxis, Phase III) in Cervical cancer and VGX-3100 (Inovio Pharmaceuticals) in CIN2/3. Axalimogene Filolisbac has recently undergone a conditional filing in the EU.
This MarketVIEW product is a comprehensive commercial opportunity assessment detailing the potential market for HPV therapeutic vaccine(s) using a patient based value/volume forecast for major Western markets to 2030. Two target product profiles (TPP) are forecasted targeting neoplasias: HPV16/18+ CIN, AIN, PIN, VIN & VAIN and HPV16/18+ established cancers - recurrent/persistent cervical cancer, oropharyngeal and anal cancer. The analysis also includes an up-to-date review of epidemiology/guidelines/classifications, discussion of pricing considerations/cost effectiveness and an overview of current research and development in the field.
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