Global Neoantigen Cancer Vaccine Market Size Likely to Reach at a CAGR of 15.2% By 2034

Neoantigen Cancer Vaccine Market Size

As per the Neoantigen Cancer Vaccine Market size analysis conducted by the CMI Team, the global Neoantigen Cancer Vaccine Market is expected to record a CAGR of 15.2% from 2025 to 2034. In 2025, the market size is projected to reach a valuation of USD 0.55 Billion. By 2034, the valuation is anticipated to reach USD 1.98 Billion.

Neoantigen Cancer Vaccine Market Overview

As per the industry experts at CMI, the Neoantigen Cancer Vaccine Market is quickly growing as a result of the significance placed on personalized cancer therapies. The leading companies include OSE Immunotherapeutic SA, Gritstone Bio Inc., BioNTech SE, Hoffmann-La Roche Ltd and Pfizer Inc., all of whom are developing individualized cancer vaccines targeting patient-specific tumor neoantigens to enhance the immune response. Various malignancies are receiving these vaccines to enhance their outcomes.

Governments are supporting clinical trials and exploring fast-track CRA regulatory approvals to help accelerate the process and innovations. The pharma, biotechnology, and research community continue driving collaborations to advance cancer vaccines. Investment funding is increasing in the neoantigen cancer vaccine products globally—North America, Europe and Asia- pacific are the top three regions. This experience will add a new wave of molecularly-targeted and precisely effective cancer immunotherapies to the suite of effective pharmaceutical therapies worldwide.

Neoantigen Cancer Vaccine Market Growth Factors and Dynamics

• Increasing incidence of cancer: The increasing incidence of cancer worldwide is a driving force behind the growth of the neoantigen cancer vaccine market. The increasing incidence of cancer creates a large demand for innovative, personalized therapies. Neoantigen vaccines designed to target mutations unique to an individual’s tumor provide a breaking point in addressing multiple cancers effectively. The recent, notable positive Phase 2 results by BioNTech for its mRNA immunotherapy candidate BNT111 in patients with advanced melanoma in 2024 illustrate a greater focus on personalized cancer therapies. Furthermore, the increasing incidence of cancer diagnoses shown by the U.S. National Cancer Institute provides a pertinent need for advanced therapies like neoantigen vaccines.

• Advances in delivery systems: Advances in delivery systems for vaccines, such as lipid nanoparticles and viral vectors, have provided stability, targeting, and greater efficacy regarding neoantigen vaccines, in addition to improving clinical response and efficacy in personalized cancer therapies. Again, the international Phase 3 “Artemia” trial, which was launched by OSE Immunotherapeutics in 2024, is noteworthy. This Phase 3 trial is for Tedopi, an “off-the-shelf” neo-epitope-based cancer vaccine for HLA-A2-positive patients with metastatic non-small cell lung cancer (NSCLC) and lethargy who developed secondary resistance to immune checkpoint inhibitors. This pivotal trial aims to gain regulatory approval for Tedopi. This is a meaningful advancement in the neoantigen vaccine delivery system and cancer treatment.

• Increased cancer incidence: The incidence of cancer worldwide is one of the major factors propelling growth of the neoantigen cancer vaccine market. As pointed out by the World Health Organization (WHO), cancer is one of the leading causes of death worldwide, with approximately 20 million new cases and 10 million deaths every year. The increasing rates of cancer demand new, more effective, and targeted treatments other than the traditional ones of chemotherapy and radiation. Neoantigen cancer vaccines are unique and extremely specific personalized therapies that stimulate the immune system to identify and attack cancer cells ‘with laser precision’, without employing belated-acting toxic treatments like chemotherapy and radiation on healthy tissue. The increasing rates of difficult to treat cancers such as melanoma, non-small cell lung cancer, and particularly glioblastoma hold potential for these types of precision-based immunotherapy.

• Advancements in Immunotherapy: Recent breakthroughs in immunotherapy have significantly contributed to the emergence and expansion of the neoantigen cancer vaccine market. Immunotherapy has revolutionized oncology by offering treatments that harness the body’s immune system to target and eliminate cancer cells. Among these, neoantigen vaccines represent a cutting-edge class of therapies that are personalized based on tumor-specific mutations, making them uniquely suited for individualized treatment strategies. Innovations such as checkpoint inhibitors, CAR-T cells, and adoptive T-cell therapies have validated the immune system’s potential in combating cancer, laying the groundwork for further development of neoantigen approaches. Additionally, the integration of advanced computational biology and next-generation sequencing technologies enables rapid identification and synthesis of neoantigens, accelerating vaccine production timelines and improving therapeutic outcomes. These technological advancements are critical in transforming experimental treatments into viable commercial products.

Report Scope

Neoantigen Cancer Vaccine Market SWOT Analysis

• Strengths: Neoantigen cancer vaccines offer a significant degree of personalization in treatment as they target the specific mutations that can be found in each patient’s tumors, which promotes precision in treatment. They have demonstrated great potential in treating cancers not otherwise treatable with standard therapies. In addition, the advances of both genomic sequencing and mRNA and its abbreviated immunogenicity promise, neoantigen cancer vaccines have the potential to show equally enhanced immunogenicity. Growing investment from major biotech firms and government agencies supports rapid R&D. Regulatory agencies like the FDA and EMA are offering fast-track approvals. Early clinical trials, especially in melanoma and NSCLC, have demonstrated promising results.

• Weaknesses: High development costs and complex production processes limit scalability and accessibility. The need for advanced genomic sequencing and bioinformatics infrastructure creates technical bottlenecks. Turnaround time for creating personalized vaccines can be lengthy. Reimbursement challenges exist due to the novel nature of the therapy. Limited long-term efficacy data in many cancer types also restricts broader adoption. Workforce and supply chain challenges can delay progress, as seen in recent clinical trial halts.

• Opportunities: Some developing markets such as India, Brazil, and South Africa present new opportunities for clinical expansion. Off-the-shelf vaccine approaches may provide the opportunity for scalability and reduced cost. Improved AI and bioinformatics technology may increase neoantigen prediction accuracy and ease of vaccine design. Biotech and healthcare companies are entering into strategic collaborative agreements, which are improving access. Governments and organizations are interested in funding initiatives in personalized cancer care. Increasing global incidence of cancer is increasing demand for new therapies.

• Threats: As immunotherapies increase competition from other immunotherapies such as checkpoint inhibitors and CAR-T cells, this will cannibalize market share. Regulatory challenges and lack of standards in approvals may increase timeframes. Investor confidence may be challenged due to late-stage clinical trial failures potentially demonstrated by Gritstone Bio, which affect confidence in further investment into the new treatment that is a neoantigen cancer vaccine. The type of information shared digitally is related to genomic data and presents cybersecurity challenges. There may also be pricing barriers for access within the healthcare systems due to potential sensitivity towards the cost of the intervention. Similarly, I believe that we can expect frequent patent disputes and IP threats associated with the emergence of personalised cancer therapy.

List of the prominent players in the Neoantigen Cancer Vaccine Market:

• OSE Immunotherapeutics SA
• Gritstone bio Inc.
• BioNTech SE
• Hoffmann-La Roche Ltd.
• Pfizer Inc.
• Merck & Co. Inc.
• Moderna Inc.
• Avidea Technologies Inc.
• Eli Lilly and Company
• Vaccibody AS
• Agenus Inc.
• Novogene Co. Ltd.
• ZIOPHARM Oncology Inc.
• ISA Pharmaceuticals B.V.
• BrightPath Biotherapeutics Co. Ltd.
• Vaximm AG
• Medigene AG
• Genocea Biosciences Inc.
• Advaxis Inc.
• Others

The Neoantigen Cancer Vaccine Market is segmented as follows:

By Product

• Personalised neo-antigen vaccine
• Off-the-shelf neoantigen vaccine

By Neoantigen Type

• Synthetic Long Peptide
• Nucleic acid
• Dendritic cell
• Tumour cell

By Route of Administration

• Intravenous
• Intramuscular
• Transdermal

Regional Coverage:

North America

• U.S.
• Canada
• Mexico
• Rest of North America

Europe

• Germany
• France
• U.K.
• Russia
• Italy
• Spain
• Netherlands
• Rest of Europe

Asia Pacific

• China
• Japan
• India
• New Zealand
• Australia
• South Korea
• Taiwan
• Rest of Asia Pacific

The Middle East & Africa

• Saudi Arabia
• UAE
• Egypt
• Kuwait
• South Africa
• Rest of the Middle East & Africa

Latin America

• Brazil
• Argentina
• Rest of Latin America