The hope of vaccinating against cancer is not new: in 1990, the first vaccine––Bacillus Calmette–Guérin (BCG)––was approved by the Food & Drug Administration (FDA) to treat bladder cancer.¹ This advance was followed by Gardasil, the first preventative vaccine approved by the FDA and the European Medicine Agency (EMA) in 2006,² and then Provenge (sipuleucel-T), a cell-based vaccine approved by the FDA in 2010 and considered the first therapeutic cancer vaccine.³

The COVID-19 pandemic dramatically accelerated cancer-vaccine science by validating the mRNA technology at global scale and expanding the manufacturing platforms and funding required to successfully develop these vaccines. While publicly available data are limited, recent reviews estimate that over 60 to over 120 mRNA-based oncology vaccines are currently in development.^4,5

In this article, we examine recent developments in cancer vaccines and outline a pricing & access framework for manufacturers to successfully commercialise these vaccines.

Cancer Vaccines: Presentation and Promise

Cancer vaccines can be defined as a form of immunotherapy that trains the immune system to recognize and fight cancer cells. While vaccines in general have been developed with preventative primary purposes, current developments in oncology vaccination focus on preventing and treating cancers.

Cancer vaccines are commonly classified in four main categories (see figure 1)⁶:

1. Whole-Cell Vaccines | Collect entire tumour cells from the patient (autologous) or a donor (allogenic) to expose the immune system to a broad set of cancer antigens.
2. Antigen-Specific Vaccines | Deliver a defined tumour antigen, either directly as a protein or a peptide, or indirectly via genetic instructions to make it (e.g. DNA or mRNA) to train a patient’s immune system to recognize and attack cancer cells expressing that antigen.
3. Antigen-Presenting Cell (APC) Vaccines | Use dendritic cells collected from the patient and then loaded with tumour antigens ex vivo before being returned to the patient to stimulate a targeted anti-tumour immune response.
4. Non-Specific / Immune-Modulating Vaccines | Involve the administration of immune signalling molecules (usually proteins) to boost the general immune activity to help the body fight cancer, but are not targeted to a specific antigen / cancer.

In 2025, the cancer vaccine market was estimated to be approximately of $10 billion.ix Conservative estimates suggest this market will more than double by 2033, growing at a projected compound annual growth (CAGR) of ~11% (see figure 2).ix While commercial growth appears relatively uniform between preventative and therapeutic cancer vaccines, innovation is increasingly concentrated in a new and rapidly evolving category: personalized therapeutic cancer vaccines.

These vaccines, mostly investigated in the adjuvant and minimal residual disease settings, suggest the potential for durable immune activation and longer-term reductions in recurrence risk: by targeting tumour-specific antigens, including patient-specific neoantigens, they aim to more precisely address residual disease, support long-term disease control, and, in selected contexts, contribute to curative-intent strategies. Prominent examples include personalized neoantigen vaccines, such as Moderna / Merck’s mRNA-4157 (V940)⁷ and BioNTech’s individualized programs,⁸ which are being studied in late-stage clinical development in combination with checkpoint inhibitors. Although these vaccines have not yet been commercially launched, they demonstrate how technology scaled during the COVID-19 pandemic are accelerating the feasibility and scalability of personalized therapeutic cancer vaccine development.

Reframing Value Demonstration, Pricing, and Access for Cancer Vaccines

Not all cancer vaccines will have similar value demonstration expectations and reimbursement approaches, and payer willingness-to-pay is likely to be highly variable depending on the type of vaccine. We hereby propose a pricing & access framework summarizing key considerations that manufacturers must consider when planning for the launch of their cancer vaccines (see figure 3).

Consideration #1 – Vaccine Primary Purpose: Therapeutic vs. Preventative | The most fundamental distinction among cancer vaccines lies in whether they are preventive or therapeutic. This distinction determines not only the clinical evidence strategy but also how payers conceptualize value and willingness-to-pay, as well as which decision-making bodies are involved in evaluation and funding.

Preventive (cancer) vaccines, such as those targeting HPV or hepatitis B, are evaluated within immunization policy frameworks.In many countries, recommendations are first assessed by National Immunization Technical Advisory Groups (NITAGs) before being reviewed for pricing & reimbursement. Evidence requirements focus on long-term infection prevention, cancer incidence reduction, safety across large populations, and demonstration of favourable population-level cost-effectiveness to support NITAG recommendation and budget allocation. Price, on the other hand, is largely influenced by population-level affordability and budget impact, given their potential for widespread use across healthy populations.For example, HPV vaccines such as Gardasil are priced at approximately $600-$1,000 for a full series in the U.S., around £300-450 in the UK private market, and at lower net prices through centralized public procurement across EU countries, where vaccination is largely publicly funded. In such settings, procurement processes, public funding structures, and comparisons to traditional vaccines will likely constrain price ceilings for preventative cancer vaccines.

In contrast, therapeutic cancer vaccines operate within a fundamentally different paradigm as these are administered to patients with established diseases. As such, evidence expectations, pricing & reimbursement evaluation processes align with cancer drugs standards. Akey challenge for therapeutic cancer vaccines manufacturers will be to demonstrate that the immune response correlates with durable and clinically meaningful efficacy outcomes, independent of any background / combination therapies and over a sufficiently long-time horizon. As such, while traditional efficacy outcomes such as survival and recurrence rates will remain central, endpoints such as antigen-specific T-cell responses may increasingly be included in clinical trials as surrogate evidence of durability, and in the future, contribute to the development of validated surrogate endpoints in earlier vs. later oncology settings (see our previous publication on the growing role of non-OS endpoints in oncology¹³).

Additionally, while therapeutic cancer vaccines are designed to deliver long-term clinical benefit, demonstrating durable benefits will require long follow-ups. For example, BioNTech reported multi-year persistence of immune responses in follow-up for its individualised mRNA vaccine candidate (BNT122, RO7198457)¹⁴ which is currently being evaluated in Phase 2 studies with planned long-term follow-up for OS (up to ~5 years).¹⁵ Additionally, Moderna / Merck reported improved recurrence-free outcomes in high-risk melanoma with their personalised neoantigen vaccine (mRNA-4157 (V940)) in combination with pembrolizumab, supporting the durability narrative in the adjuvant setting.¹⁶

Consideration #2 – Curative Intent | Demonstrating a curative intent in oncology has been an aspiration for manufacturers of oncology assets – whether drugs of vaccines. However, establishing a curative potential requires extensive evidence showing sustained low-to-non-existent remission rates and immune memory, and is likely to introduce uncertainty at the point of reimbursement.

The immunogenic nature and objective of cancer vaccines, aimed at inducing durable immune responses, positions them as potential curative treatment options. However, as soon as a curative intent is claimed or even demonstrated, payers are likely to scrutinise the evidence provided, particularly where clinical trials are perceived to be of short durations. This not only increase pressure for evidence demonstration, but is also likely to trigger significant pricing resistance, reflecting uncertainty around the true durability of benefit, the need for re-dosing, and the long-term effectiveness of a limited or finite treatment course. In this context, a more conservative approach for manufacturers can be to emphasize a durable benefit rather than curative intent.

Consideration #3 – Dosing Paradigm | Dosing structure is a critical determinant of both clinical evidence requirements and economic evaluation. While vaccines are often perceived as limited-series interventions, therapeutic cancer vaccines frequently require multi-dose induction regimens and, in some cases, booster schedules to achieve adequate immune priming in patients with established malignancy. For example, sipuleucel-T (Provenge) is administered as three infusions at approximately two-week intervals in metastatic castration-resistant prostate cancer.¹⁷ In contrast, the personalized neoantigen mRNA vaccine mRNA-4157 (V940) has been administered for up to nine doses in combination with pembrolizumab in the KEYNOTE-942 study.²⁸ Similarly, PROSTVAC, a viral vector–based therapeutic vaccine targeting prostate-specific antigen (PSA) in prostate cancer, follows a multi-dose “prime–boost” schedule, beginning with an initial vaccination and followed by several booster doses to reinforce the immune response over time.¹⁹

From a pricing and reimbursement perspective, dosing structure influences budget impact dynamics. A finite, time-limited course concentrates costs upfront while benefits are realized over years. This resembles the economic profile of cell and gene therapies, where single-administration pricing generates payer concerns about fiscal-year budget exposure and durability uncertainty. In such scenarios, outcome-based agreements or staged payments may be necessary to mitigate payer risk.

Conversely, regimens involving multiple or extended dosing may distribute costs over time, potentially easing annual budget impact. However, prolonged dosing may also shift payer comparisons toward cancer drugs, thereby anchoring price expectations differently.

Consideration #4 – Personalized vs. Off-the-Shelf | Personalized cancer vaccines represent a new paradigm. Unlike standardized therapies, they lack an established evidence base, access pathway, or pricing framework to guide commercialization. Value demonstration may be more complex, as individualized products challenge traditional approaches to scalability, comparability, and population-level extrapolation of clinical outcomes. Manufacturing logistics, timelines, and per-patient cost structures further complicate assessment within existing HTA and reimbursement models. Sipuleucel-T (Provenge) illustrates the commercialization challenges of personalized cancer vaccines.²⁰ As an autologous therapy manufactured individually for each patient, it launched in the U.S. at approximately $93,000 per course, reflecting complex production and logistics. Although it demonstrated an overall survival benefit, uptake was limited. In the U.S., coverage timing created meaningful barriers, as providers often faced significant upfront financial exposure before receiving payment. Uptake was further constrained by the emergence of oral therapies such as Zytiga (abiraterone) and Xtandi (enzalutamide), which offered more convenient administration and were easier to integrate into routine clinical practice. Outside the U.S., reimbursement and HTA hurdles were even more challenging with markets either delayed coverage decisions or applied stringent cost-effectiveness thresholds that personalized therapies struggled to meet given their high per-patient cost and unconventional evidence base. As a result, broader international commercialization was ultimately discontinued.

Even off-the-shelf therapeutic vaccines, while more standardized than personalized vaccines, are likely to face similar evidence and access considerations as other oncology therapeutics (captured by Consideration #1 about therapeutic cancer vaccines). And the fundamental question of who will pay for these vaccines will directly impact the way these are reimbursed and funded.

Funding for Cancer Vaccines – Who Will Pay?

Beyond these considerations remains the question of who is paying for cancer vaccines, particularly those that are personalized: traditionally, oncology therapies are funded by (public) national health services of (public or private) insurances. However, public and private healthcare systems have been under increasing pressure to reduce expenditure (which has notably been amplified by recent measures such as the Most Favored Nations, see our previous publication²¹) so that the willingness-to-pay of these “traditional” payers will only decrease over time.

This contrasts with the complexity and high associated costs of developing and commercializing cancer vaccines: from a development standpoint, cancer vaccines will require long trials, are frequently use in combination with high-cost immunotherapies, and – when personalised – complex and costly patient identification, driven by tumour antigen heterogeneity. From a manufacturing standpoint, these vaccines often involve small-batch or patient-specific production when personalised, resulting in structurally higher production complexity and cost.

Considering this, the extent to which traditional funding pathways will apply to cancer vaccines remains uncertain. And while alternative funding pathways, such as dedicated government-based funds, could be considered, there exists a possibility that patient self-pay emerges as a complementary funding pathway for certain cancer vaccines, particularly in in contexts where these vaccines offer personalised benefits, face initial reimbursement uncertainty, and/or are used as add-ons to established treatment pathways.

Conclusion

Developments in cancer vaccines create immense opportunities and hope for patients. However, the successful commercialisation of these vaccines requires re-thinking their development and evidence generation plans, access and funding pathways. And while oncology is traditionally publicly and/or privately funding, the possibility of increased patient self-pay exists, particularly for those vaccines that will deliver personalized benefits.

Sources

1. Although BCG is not a “cancer vaccine” in the modern biologic-engineering sense as it was originally developed in the early 1920 as a tuberculosis vaccine and not engineered to target specific tumour antigens, it stimulates immune activation in the bladder to reduce recurrence and progression of non–muscle-invasive bladder cancer, and remains the first (live attenuated) vaccine used therapeutically
2. Gardasil aims to prevents human papillomavirus (HPV), which can lead to cervical, anal, and other cancers
3. Provenge was only approved by the FDA. Its application to the EMA was withdrawn by the manufacturer
4. https://www.globenewswire.com/news-release/2025/07/07/3110926/28124/en/mRNA-Cancer-Vaccines-Clinical-Trials-Future-Market-Outlook-2025-Personalized-mRNA-Cancer-Vaccines-Revolutionize-Oncology-with-Neoantigen-Driven-Immunotherapy.html
5. https://pubmed.ncbi.nlm.nih.gov/39798545/
6. https://cancerquest.org/patients/treatments/vaccines-treat-cancer
7. https://www.merck.com/news/merck-and-moderna-initiate-phase-3-trial-evaluating-adjuvant-v940-mrna-4157-in-combination-with-keytruda-pembrolizumab-after-neoadjuvant-keytruda-and-chemotherapy-in-patients-with-certain-ty/
8. https://www.nasdaq.com/press-release/biontech-expands-late-stage-clinical-oncology-portfolio-with-initiation-of-further
9. https://www.grandviewresearch.com/industry-analysis/cancer-vaccine-market-report
10. https://www.verifiedmarketreports.com/product/therapeutic-cancer-vaccines-market/
11. https://www.grandviewresearch.com/industry-analysis/personalized-cancer-vaccine-market-report
12. https://www.fortunebusinessinsights.com/cancer-vaccines-market-106958
13. https://www.pharmexec.com/view/rethinking-oncology-htas-growing-role-endpoints
14. https://investors.biontech.de/news-releases/news-release-details/three-year-phase-1-follow-data-mrna-based-individualized
15. https://clinicaltrials.gov/study/NCT05968326
16. https://www.thelancet.com/journals/lancet/article/PIIS0140-6736(23)02268-7/abstract
17. https://www.fda.gov/vaccines-blood-biologics/cellular-gene-therapy-products/provenge-sipuleucel-t
18. https://clinicaltrials.gov/study/NCT03897881
19. https://ascopubs.org/doi/pdfdirect/10.1200/JCO.18.02031
20. https://biologyinsights.com/why-provenge-failed-despite-its-scientific-breakthrough/
21. https://www.pharmexec.com/view/most-favored-nation-policy-outlook-implications-beyond