Personalized Cancer Vaccine Market Size & Share 2026-2035

Personalized Cancer Vaccine Market Size

The global personalized cancer vaccine market was valued at USD 404 million in 2025, according to the latest report published by Global Market Insights Inc. The growth of the market can be attributed to the increasing cases of cancer and rising R&D in precision oncology research.

According to the World Health Organization (WHO), cancer is a leading cause of death worldwide, accounting for nearly 10 million deaths in 2020, or nearly one in six deaths. In addition, the International Agency for Research on Cancer (IARC) estimates that the global number of cancer cases could reach over 28 million annually by 2040, reflecting a substantial rise in the disease burden and the need for advanced therapies such as personalized immunotherapies.
 

Personalized cancer vaccines are therapeutic vaccines designed to trigger an immune response against tumor-specific antigens or neoantigens that are unique to an individual patient’s cancer. These vaccines are developed using genomic sequencing of the patient’s tumor to identify mutations and generate customized antigens capable of activating T-cells that recognize and destroy cancer cells. The market currently includes only one approved personalized therapeutic cancer vaccine, sipuleucel-T (Provenge), which was approved by the U.S. FDA for the treatment of asymptomatic or minimally symptomatic metastatic castration-resistant prostate cancer (mCRPC).
 

Sipuleucel-T is an autologous cellular immunotherapy in which a patient’s immune cells are collected through leukapheresis, activated with a prostate cancer antigen (PAP-GM-CSF), and reinfused to stimulate a targeted immune response. Clinical trials supporting its approval demonstrated that the therapy improved median overall survival by approximately 4.1 months compared with placebo, with a 22% reduction in the risk of death. However, this product has faced several challenges, including high treatment costs, complex manufacturing processes, and modest clinical benefits, which limited widespread adoption.
 

Personalized Cancer Vaccine Market Trends

• One of the most notable trends in the personalized cancer vaccine market is the rapid development of the mRNA-based vaccine platform. Several vaccine candidates based on the mRNA platform are in the clinical pipeline. for the treatment of melanoma, pancreatic cancer, and colorectal cancer.
   
• The development of mRNA vaccines has been a major breakthrough in the field of cancer therapy, with over 120 clinical trials conducted to date, demonstrating the potential of this technology in the treatment of various types of cancer, ranging from lung, breast, prostate, and melanoma cancers to other difficult-to-treat cancers like pancreatic and brain cancer.
   
• The pipeline for personalized cancer vaccines is rapidly expanding, particularly with the emergence of mRNA-based neoantigen vaccines. Several candidates are currently in late-stage clinical trials.
   
• One prominent example is mRNA-4157 (V940), developed by Moderna and Merck, which is a personalized mRNA vaccine designed to encode patient-specific neoantigens. In earlier clinical studies for melanoma, the vaccine in combination with  KEYTRUDA (pembrolizumab) demonstrated a 44–49% reduction in the risk of recurrence or death compared with pembrolizumab alone, and the therapy has progressed to Phase III clinical trials.
   
• Another advanced candidate is Autogene cevumeran (BNT122), a personalized mRNA neoantigen vaccine being developed by BioNTech in collaboration with Genentech/Roche. It is designed to target specific tumor neoantigens and is currently being evaluated in Phase 2 trials for various solid tumors, including pancreatic, colorectal, and melanoma.
   
• These programs highlight the strong clinical interest in individualized immunotherapies and are expected to significantly expand the personalized cancer vaccine market once they are approved.
   
• Another key trend in the personalized cancer vaccine market is the growing funding and strategic investments aimed at accelerating research and clinical development. Pharmaceutical companies and governments are increasingly investing substantial capital to expand mRNA vaccine platforms, build manufacturing facilities, and support large-scale clinical trials.
   
• For instance, in May 2025, BioNTech announced its plans to invest up to USD 1.33 billion in the UK over the next ten years to broaden its research and development activities. Under the deal, BioNTech will enroll up to 10,000 patients in clinical trials by the end of 2030 for personalized cancer therapies and make investments to expand the company's footprint in the country.
   
• These growing investments are expected to accelerate technological innovation, expand clinical pipelines, and support the commercialization of next-generation personalized cancer vaccines in the coming years, thereby driving the market growth.
   

Personalized Cancer Vaccine Market Companies

Below is the list of prominent players in the personalized cancer vaccine market, including both approved/commercialized companies and emerging or pipeline-stage developers:
 

• Approved/commercialized players
  • Dendreon Pharmaceuticals
• Emerging/ pipeline players
  • Immatics
  • Candel Therapeutics
  • Evaxion Biotech
  • Immunomic Therapeutics
  • Imugene
  • Elicio Therapeutics
  • Infinitopes
  • Takis Biotech
  • VacV Biotherapeutics
  • BioNTech
  • Moderna
  • OSE Immunotherapeutics
  • ImmunityBio
  • Agenus

• Dendreon Pharmaceuticals

Dendreon Pharmaceuticals is a key player in the personalized cancer vaccine market owing to its product sipuleucel-T (Provenge), the first therapeutic cancer vaccine approved by the U.S. Food and Drug Administration (FDA). Provenge, approved in 2010, is an autologous active cellular immunotherapy and has shown evidence of efficacy in reducing the risk of death among men with metastatic castration-resistant prostate cancer.

Phase III trials (IMPACT) showed that Provenge reduces the risk of death by 22%, increasing median overall survival by 4.1 months compared to placebo, establishing it as the first personalized immunotherapy to show a survival benefit in advanced prostate cancer. Since its FDA-approval in 2010, nearly 40,000 men have been prescribed Provenge.
 

• Moderna

Moderna is a prominent player in the personalized cancer vaccine market, leveraging its messenger RNA (mRNA) technology platform to develop individualized immunotherapies targeting tumor-specific mutations. The company is actively advancing mRNA-4157 (also known as V940), a personalized neoantigen mRNA cancer vaccine designed to encode multiple patient-specific tumor antigens that are identified through genomic sequencing. This vaccine is developed in collaboration with Merck & Co., Inc. and is being evaluated in combination with pembrolizumab for several cancers, including melanoma and non-small cell lung cancer. Clinical trial results have demonstrated promising efficacy, with studies showing that the combination therapy has reduced the risk of recurrence or death in high-risk melanoma patients by approximately 49% compared with pembrolizumab alone.
 

Personalized Cancer Vaccine Industry News

• In January 2026, Moderna, Inc. and Merck & Co., Inc. reported long-term data indicating that their personalized cancer vaccine mRNA-4157 (V940) combined with pembrolizumab reduced the risk of recurrence or death in melanoma patients by approximately 49%. Positive long-term efficacy results enhance the companies’ credibility in immuno-oncology and support the potential commercialization of personalized cancer vaccines.
   
• In November 2024, Transgene S.A. and NEC Corporation presented clinical data demonstrating that their personalized neoantigen cancer vaccine TG4050 generated strong immune responses in patients with head and neck cancer. This advancement helps strengthen the companies’ clinical development pipeline and highlights the potential of their AI-driven neoantigen identification platform.
   
• In October 2024, Moderna, Inc. and Merck & Co., Inc. announced the initiation of INTerpath-009, a pivotal Phase 3 randomized clinical trial evaluating V940 (mRNA-4157) in combination with KEYTRUDA (pembrolizumab) for patients with resectable non-small cell lung cancer and melanoma. This development strengthens the companies’ oncology pipelines and positions them as leading players in the emerging personalized cancer vaccine market.
   
• In May 2024, BioNTech SE announced positive Phase 2 clinical data for its mRNA cancer vaccine candidate BNT111, developed for advanced melanoma, in combination with cemiplimab. The study demonstrated promising anti-tumor activity and durable immune responses in patients with anti-PD-1-refractory melanoma. These findings support the continued advancement of BioNTech’s FixVac vaccine platform and strengthen the company’s oncology vaccine pipeline.
   
• In April 2024, Gritstone bio, Inc. announced positive preliminary data from the ongoing, signal-seeking Phase 2 portion of the Phase 2/3 study evaluating GRANITE, its personalized neoantigen cancer vaccine, in front-line metastatic microsatellite-stable colorectal cancer. This advancement supports the company’s strategy to develop next-generation individualized cancer vaccines and expand its presence in precision immunotherapy.
   

The personalized cancer vaccine market research report includes in-depth coverage of the industry with estimates and forecast in terms of revenue in USD Million from 2022 - 2035 for the following segments:

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Market sizing analysis

• Approved product market assessment – U.S.
• Future market potential analysis (Pipeline-driven projection) - Global
• Total addressable market (TAM) - Global