Human papillomavirus (HPV)

Overview

Human papillomavirus (HPV) is the leading cause of cervical cancer, contributing to approximately 660,000 new cases and 350,000 cervical cancer deaths each year, with its highest rates of incidence and mortality in LMICs. Vaccination is an effective tool for preventing HPV, but accessibility issues in LMICs remain due to cost, the need to complete multiple dose regimens and cold-chain storage requirements. Low-tech diagnostic tools could improve early detection and treatment, and novel therapeutic antivirals and medicines are needed for individuals already exposed to HPV, since most sexually active men and women will acquire at least one genital HPV infection during their lives. Early diagnosis and treatment are crucial, as cervical cancer is highly treatable when detected in its early stages.

Unmet needs

Despite progress in rolling out preventive vaccines, challenges persist in developing affordable, effective solutions for global use across the prevention, diagnosis and treatment pathways. Key R&D needs include improving access to HPV preventive vaccines in LMICs through versions that are more cost-effective, single-dose, and, ideally, heat stable. Enhancing diagnostic tools for early detection of HPV infections and precancerous lesions that are low-tech and easy to use is also essential for preventing cancer progression. For those already exposed to HPV, there are also gaps in novel therapeutics, whether antivirals, other drug options or targeted biological therapies for HPV and HPV-related cancers, such as checkpoint inhibitors, cytokine immunotherapies, immunotherapy vaccines targeting oncoproteins like E6 and E7, and cell therapies.

Funding

Funding for human papillomavirus & HPV-related cervical cancer (collectively referred to here as ‘HPV’) partly rebounded in 2023 after a sharp drop in 2022, rising by $13m (11%) to $125m. This left it $17m below its 2021 peak but up $25m (25%) over the life of the survey.

The growth since 2018 mostly reflects contributions from the top two funders: the NIH and industry. NIH funding has grown by 37% ($13m) since 2018, to a total of $47m – or nearly 38% of overall funding. Funding from the NIH focused heavily on basic research, for which it has provided nearly 80% of the global total. Industry's funding was up $17m (65%) since 2018 and has become increasingly focused on vaccines. Industry has increased it spending on HPV vaccine R&D rise more than sixfold since 2018, to $39m, concentrating mostly on novel candidates rather than dose reduction studies for existing products, which had previously been the focus of HPV vaccine R&D. This growth has left industry responsible for substantially more than half of HPV vaccine R&D, though this may soon change following the mid-2024 abandonment of one major candidate following unimpressive trial results.

Funding from the Gates Foundation – the third largest funder of HPV – remained stable at around $25m in 2023, for the third year running. Unitaid – the fourth largest funder – decreased its funding to just $3m after peaking at $15m in 2021. In 2023, we also saw a record $2.4m in HPV funding from the Indian ICMR, exceeding its total funding over the previous five years put together.

Nearly 40% of HPV funding was for clinical development & post-registration studies, three-quarters of which were for vaccine trials. This funding is predominantly for post-registration, dose reduction studies of existing HPV vaccines over advanced clinical development of new vaccine candidates moving through the pipeline. There is still significant interest in dose reduction trials, with some recent successes in demonstrating their equal efficacy to multi-dose regimens and paving the way towards reducing barriers to uptake in LMICs where multiple doses can be challenging to administer.

Funding for HPV