Neoantigen Targeted Therapies Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Target Disease Indication (Bone Cancer, Colorectal Cancer, Gynecological Cancer, Non-Small Cell Lung Cancer, Renal Cell Carcinoma), By Neoantigens Type (Off-the-Shelf Neoantigens, Personalized Neoantigens), By Immunotherapy Type (Dendritic Cell Vaccines, DNA / RNA-Based Vaccines, Protein / Peptide-based Vaccines, TIL-Based Therapies), By Route of Administration (Intradermal, Intravenous, Subcutaneous), By Region & Competition, 2021-2031F

Forecast Period	2027-2031
Market Size (2025)	USD 1.99 Billion
CAGR (2026-2031)	8.41%
Fastest Growing Segment	Off-the-Shelf Neoantigens
Largest Market	North America
Market Size (2031)	USD 3.23 Billion

Market Overview

The Global Neoantigen Targeted Therapies Market will grow from USD 1.99 Billion in 2025 to USD 3.23 Billion by 2031 at a 8.41% CAGR. Neoantigen targeted therapies are immunotherapeutic agents engineered to identify and eliminate tumor-specific antigens arising from DNA mutations, thereby directing the immune system solely against cancer cells. The market is primarily propelled by the rising global prevalence of malignancies and the urgent clinical requirement for regimens that minimize off-target toxicity. These foundational drivers are distinct from temporary technological trends, as they stem directly from the fundamental need to improve long-term survival rates through heightened specificity in oncology treatment.

However, the widespread adoption of these therapies is challenged by the intricate and capital-intensive manufacturing processes required for individual patient formulations. This logistical barrier complicates the industry's ability to meet the substantial demand indicated by recent health statistics. According to the American Cancer Society, in 2025, an estimated 2,041,910 new cancer cases were projected to occur in the United States. Consequently, establishing scalable and cost-efficient production models remains the significant obstacle impeding the broader commercial expansion of this sector.

Key Market Drivers

The integration of bioinformatics and artificial intelligence constitutes a primary catalyst for the market, enabling the precise identification of tumor-specific mutations from vast next-generation sequencing datasets. This technological convergence allows developers to select neoantigens with the highest immunogenicity, significantly enhancing the clinical efficacy of personalized vaccines compared to non-specific immunotherapies. The clinical viability of this approach was substantiated recently by positive trial outcomes. According to Moderna, June 2024, in the 'Press Release detailing mRNA-4157 Phase 2b results', the investigational neoantigen therapy combined with pembrolizumab reduced the risk of recurrence or death by 49% in high-risk melanoma patients compared to monotherapy. Such data confirms that computational prediction algorithms are maturing into viable therapeutic tools.

Simultaneously, the expansion of strategic partnerships and research investments is accelerating the transition of these therapies from experimental stages to commercial pipelines. Pharmaceutical entities are heavily funding mRNA and vector-based delivery platforms to overcome manufacturing bottlenecks and support late-stage trials. According to BioNTech, March 2024, in the 'Full Year 2023 Financial Results', the company projected a research and development spend of up to €2.6 billion for the 2024 financial year to advance its oncology portfolio. This influx of capital is critical given the broader context of the disease burden. According to the International Agency for Research on Cancer, in 2024, projections indicated that the cancer burden is expected to rise to 35 million new cases by 2050, underscoring the immense addressable market for scalable neoantigen solutions.

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Key Market Challenges

The challenging factor identified in the overview is the intricate and capital-intensive manufacturing process required for individual patient formulations. This logistical barrier directly hampers the growth of the Global Neoantigen Targeted Therapies Market by preventing the scalability necessary to meet global demand. Unlike "off-the-shelf" pharmaceuticals, these personalized immunotherapies require a unique production cycle for every patient, which eliminates standard economies of scale and results in prohibitively high costs of goods sold. Consequently, manufacturers face severe constraints in expanding production capacity to match the rising prevalence of malignancies, limiting market penetration and patient access.

The impact of these manufacturing hurdles is evident in the difficulty companies face in transitioning from clinical development to broad commercial success. The high complexity of producing personalized treatments creates a bottleneck where only a few therapies manage to reach a substantial volume of patients. This struggle for scalability is reflected in recent industry data. According to the Alliance for Regenerative Medicine, in 2025, approximately 75 percent of the global revenue in the advanced therapy sector was generated by fewer than 10 products. This statistic underscores the significant friction that manufacturing limitations impose on the broader commercial expansion of personalized oncology regimens.

Key Market Trends

The emergence of off-the-shelf shared neoantigen therapies addresses the critical scalability limits inherent in personalized manufacturing. By targeting common driver mutations like KRAS that appear across specific patient populations, these ready-to-use formulations eliminate the lengthy production cycles required for bespoke vaccines, thereby enabling immediate patient access. This streamlined model is beginning to generate substantial clinical evidence, proving that standardizing target selection can yield therapeutic benefits comparable to fully individualized regimens. According to Elicio Therapeutics, December 2024, in the 'Press Release regarding updated results from the Phase 1 AMPLIFY-201 study', the off-the-shelf candidate ELI-002 achieved a median recurrence-free survival of 16.3 months in patients with resected KRAS-mutant solid tumors, validating the efficacy of this shared-antigen approach.

Concurrently, clinical development is pivoting toward adjuvant and early-stage settings, moving beyond the historical reliance on metastatic salvage lines. This strategy aims to eradicate minimal residual disease by deploying neoantigen vaccines when the patient's immune system is most robust and the tumor burden is minimal, significantly increasing the likelihood of preventing relapse. This shift is yielding durable remission data in aggressive indications where standard treatments often fail. According to BioNTech, April 2024, in the 'Press Release detailing 3-year follow-up data at AACR 2024', adjuvant autogene cevumeran in resected pancreatic cancer resulted in a median recurrence-free survival that was not reached in immune responders, significantly outperforming the 13.4 months observed in non-responders.

Segmental Insights

The Off-the-Shelf Neoantigens segment is positioning itself as the fastest growing category in the Global Neoantigen Targeted Therapies Market. This expansion is primarily driven by the operational efficiency of targeting shared mutations found across multiple patients rather than manufacturing unique treatments for each individual. Such an approach significantly eliminates the extensive lead times and high costs associated with fully personalized therapies. Furthermore, the potential for scalable production has attracted substantial industry investment. Regulatory support from the US FDA for treatments addressing high unmet needs continues to bolster the development of these readily available therapeutic options.

Regional Insights

North America currently dominates the Global Neoantigen Targeted Therapies Market, driven by its extensive network of biotechnology firms and advanced research institutions. This leadership is sustained by significant investments in genomic sequencing technologies and a high volume of oncology clinical trials. The region benefits from a supportive regulatory environment, where the U.S. Food and Drug Administration (FDA) actively facilitates the development of personalized cancer vaccines through expedited review pathways. Additionally, the rising prevalence of cancer across the United States drives urgent demand for these precision therapies, ensuring North America remains the central hub for industry innovation and commercialization.

Recent Developments

• In October 2024, Merck and Moderna initiated a pivotal Phase 3 randomized clinical trial, INTerpath-007, to assess the efficacy of their individualized neoantigen therapy, mRNA-4157 (V940), in combination with pembrolizumab. The study was designed to evaluate the investigative treatment as both a neoadjuvant and adjuvant therapy for patients with resectable locally advanced cutaneous squamous cell carcinoma. This launch marked a strategic expansion of the collaboration's clinical development program, which already included ongoing Phase 3 trials in melanoma and non-small cell lung cancer, aiming to establish the therapeutic potential of mRNA-based personalized cancer vaccines across multiple solid tumor indications.
• In June 2024, Moderna and Merck reported long-term findings from the Phase 2b KEYNOTE-942 study evaluating their investigational individualized neoantigen therapy, mRNA-4157 (V940), combined with pembrolizumab. Presented at the American Society of Clinical Oncology (ASCO) Annual Meeting, the three-year data revealed that the combination therapy reduced the risk of recurrence or death by 49% in patients with high-risk stage III/IV melanoma following complete resection, compared to pembrolizumab monotherapy. Executives from both companies noted that the sustained improvement in distant metastasis-free survival further validated the durability of the immune response generated by the personalized regimen.
• In April 2024, Geneos Therapeutics announced the publication of positive results from its Phase 1/2 GT-30 clinical trial in the journal Nature Medicine. The study evaluated the company's personalized therapeutic cancer vaccine, GNOS-PV02, administered in combination with a PD-1 inhibitor to patients with advanced hepatocellular carcinoma. The data indicated that the treatment met its primary endpoints for safety and immunogenicity, while achieving a statistically significant objective response rate compared to historical controls. The Chief Medical Officer of Geneos stated that the trial provided definitive evidence that the vaccine could induce new, neoantigen-specific T cells capable of trafficking to the tumor site.
• In April 2024, BioNTech and Genentech presented three-year follow-up data from a Phase 1 trial of their investigational individualized neoantigen-specific immunotherapy, autogene cevumeran, at the American Association for Cancer Research (AACR) Annual Meeting. The research demonstrated that the mRNA-based vaccine candidate stimulated the persistence of neoantigen-specific T cells in patients with resected pancreatic ductal adenocarcinoma for up to three years. The study highlighted that patients who maintained this immune response experienced significantly longer median recurrence-free survival compared to non-responders, underscoring the potential of personalized vaccines in treating cancers with high recurrence rates.

Key Market Players

• BioNtech SE
• Gritstone Bio, Inc.
• Genocea Biosciences Inc.
• Moderna Inc.
• Agenus Inc.
• Immatics NV
• Advaxis Inc
• Precision Biologics
• Gilead Sciences, Inc.
• Cellular Biomedicine Group Inc.
• Achillies Therapeutics Plc.
• Merck & Co Inc.

By Target Disease Indication	By Neoantigens Type	By Immunotherapy Type	By Route of Administration	By Region
Bone Cancer Colorectal Cancer Gynecological Cancer Non-Small Cell Lung Cancer Renal Cell Carcinoma	Off-the-Shelf Neoantigens Personalized Neoantigens	Dendritic Cell Vaccines DNA / RNA-Based Vaccines Protein / Peptide-based Vaccines TIL-Based Therapies	Intradermal Intravenous Subcutaneous	North America Europe Asia Pacific South America Middle East & Africa

Report Scope:

In this report, the Global Neoantigen Targeted Therapies Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:

• Neoantigen Targeted Therapies Market, By Target Disease Indication:

• Bone Cancer
• Colorectal Cancer
• Gynecological Cancer
• Non-Small Cell Lung Cancer
• Renal Cell Carcinoma

• Neoantigen Targeted Therapies Market, By Neoantigens Type:

• Off-the-Shelf Neoantigens
• Personalized Neoantigens

• Neoantigen Targeted Therapies Market, By Immunotherapy Type:

• Dendritic Cell Vaccines
• DNA / RNA-Based Vaccines
• Protein / Peptide-based Vaccines
• TIL-Based Therapies

• Neoantigen Targeted Therapies Market, By Route of Administration:

• Intradermal
• Intravenous
• Subcutaneous

• Neoantigen Targeted Therapies Market, By Region:

• North America
• United States
• Canada
• Mexico
• Europe
• France
• United Kingdom
• Italy
• Germany
• Spain
• Asia Pacific
• China
• India
• Japan
• Australia
• South Korea
• South America
• Brazil
• Argentina
• Colombia
• Middle East & Africa
• South Africa
• Saudi Arabia
• UAE