Neoantigen-based Personalized Cancer Therapeutic Vaccines Market

Key Highlights

• Bacillus Calmette-Guérin (BCG) was the first immunotherapy of any type to be approved by the FDA and is still used for the treatment of early-stage bladder cancer. In 2010, PROVENGE (sipuleucel-T) was approved by the US Food and Drug Administration (FDA) for the treatment of advanced prostate cancer followed by the approval of IMLYGIC (talimogene laherparepvec) in 2015 for the treatment of melanoma.
• The cancer vaccines market is characterized by a healthy and growing pipeline including IO102-IO103 (IO Biotech), CAN-2409 (Candel Therapeutics), mRNA-4157 (V940) + KEYTRUDA (Merck and Moderna), and others which are designed to target a wide range of cancers including NSCLC, colorectal cancer, glioblastoma, melanoma, and breast cancer.
• It is estimated that the cancer vaccine landscape will experience significant changes during the forecast period of 2024–2034.
• IO Biotech’s presented trial design of Phase I of IO102-IO103 vaccine + pembrolizumab in patients with BCG-intolerant or unresponsive non-muscle invasive bladder cancer in ASCO Genitourinary Cancers 2024.
• As per the April 2024 presentation, IO Biotech’s IO102-IO103 Phase III pivotal trial was fully enrolled, with progression-free survival (PFS) as the primary endpoint. An interim analysis is expected in Q3 2024, followed by potential accelerated approval in 2025 if supported by interim analysis.
• In April 2024, Geneos Therapeutics announced the positive Phase I/II data for GT-30 trial of GNOS-PV02 in advanced hepatocellular carcinoma and selected clinical trial data also presented at the 2024 AACR Annual Meeting.
• During the Society for Neuro-Oncology 2023 Annual Meeting, investigators presented updated results from ROSALIE demonstrating that patients who received EO2401 with nivolumab and bevacizumab achieved an 18-month overall survival rate of 43.1%.

DelveInsight’s “Neoantigen-based Personalized Cancer Therapeutic Vaccines – Target Population, Competitive Landscape, and Market Forecast – 2034” report delivers an in-depth understanding of the neoantigen-based personalized cancer therapeutic vaccines, historical and Competitive Landscape as well as the neoantigen-based personalized cancer therapeutic vaccines market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The neoantigen Personalized Cancer Therapeutic Vaccines market report provides current treatment practices, emerging drugs, market share of individual therapies, and the current and forecasted 7MM neoantigen-based personalized cancer therapeutic vaccines market size from 2020 to 2034. The report also covers current neoantigen-based personalized cancer therapeutic vaccine treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market’s potential.

Geography Covered

• The United States
• EU4 (Germany, France, Italy, and Spain) and the United Kingdom
• Japan

Study Period: 2020–2034

Neoantigen-based Personalized Cancer Therapeutic Vaccines Understanding 

Neoantigen-based personalized cancer therapeutic vaccines Overview

Broadly, there are two types of tumor antigens: Tumor Associated Antigens (TAAs) and Tumor-Specific Antigens (TSAs). Neoantigens, a subclass of TSAs, differ from TAAs in that they are unique to tumor cells, while TAAs are derived from over-expressed proteins that may also be present in normal cells. Cancer vaccines can be classified into three main types: preventive, therapeutic, and personalized neoantigen vaccines. Preventive cancer vaccines target viral infections responsible for certain cancers, such as the HPV vaccine for cervical cancer and the HBV vaccine for liver cancer. Therapeutic cancer vaccines, like the Sipuleucel-T vaccine, stimulate the immune system to attack cancer cells by targeting abnormal proteins overexpressed by these cells, such as prostatic acid phosphatase in prostate cancer. Additionally, Bacillus Calmette-Guérin (BCG) is a therapeutic vaccine used for early-stage bladder cancer. Personalized neoantigen vaccines target unique mutations (neoantigens) in tumor cells, offering a highly specific approach to cancer treatment while sparing healthy cells. The main focus of therapeutic vaccines is to enhance the body's immune response to recognize and combat cancer cells effectively. Personalized therapeutic cancer vaccines predicated on Neoantigen are feasible, safe, and immunogenic in patients with melanoma and glioblastoma. Different vaccine formats and delivery strategies are currently being tested in clinical studies involving patients with various tumor types. 

Further details related to country-based variations are provided in the report…

Neoantigen-based Personalized Cancer Therapeutic Vaccines Epidemiology

The neoantigen-based personalized cancer therapeutic vaccines epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total incident cases of selected indications for neoantigen based personalized cancer therapeutic vaccines, total eligible patient pool for neoantigen-based personalized cancer therapeutic vaccines in selected indications, total treated cases in selected indications for neoantigen-based personalized cancer therapeutic vaccines in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034. 

Neoantigen-based Personalized Cancer Therapeutic Vaccines Drug Chapters

The drug chapter segment of the neoantigen-based personalized cancer therapeutic vaccines reports encloses a detailed analysis of neoantigen-based personalized cancer therapeutic vaccines late-stage (Phase III and Phase II) pipeline drugs. It also helps understand the neoantigen-based personalized cancer therapeutic vaccines’ clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, advantages and disadvantages of each included drug and the latest news and press releases.

Marketed Drugs

IMLYGIC (talimogene laherparepvec): Amgen

IMLYGIC is a genetically modified oncolytic viral therapy indicated for the local treatment of unresectable cutaneous, subcutaneous, and nodal lesions in patients with recurrent melanoma after the initial surgery. IMLYGIC has been genetically modified to replicate within tumors and to produce the immune stimulatory protein GM-CSF. IMLYGIC causes lysis of tumors, followed by the release of tumor-derived antigens, which, together with virally derived GM-CSF, may promote an antitumor immune response. However, the exact mechanism of action is unknown. The US Food and Drug Administration approved IMLYGIC in October of 2015.

In August 2023, 5-year follow-up data were published. According to the data, primary analysis of the safety and efficacy of neoadjuvant IMLYGIC (NCT02211131) demonstrated a 2-year recurrence-free survival (RFS) of 29.5% for IMLYGIC + surgery and 16.5% for surgery alone in patients with advanced, resectable melanoma, persisting at 3 years. 

PROVENGE (sipuleucel-T): Dendreon Pharmaceuticals

PROVENGE (Sipuleucel-T), developed by Dendreon Pharmaceuticals, is an autologous cellular immunotherapy available as a suspension for intravenous infusion. PROVENGE consists of autologous peripheral blood mononuclear cells, including antigen-presenting cells (APCs) that have been activated during a defined culture period with a recombinant human protein, PAP-GM-CSF, consisting of prostatic acid phosphatase (PAP), an antigen expressed in prostate cancer tissue, linked to granulocyte-macrophage colony-stimulating factor (GM-CSF), an immune cell activator. It was approved by the US FDA in 2010 for the treatment of asymptomatic or minimally symptomatic metastatic castrate-resistant (hormone-refractory) prostate cancer. Still, it was hindered by its hefty price tag and uncertainty over insurance coverage and the company went bankrupt in 2014.

Emerging Drugs

IO102-IO103: IO Biotech

IO102-IO103 is an investigational therapeutic cancer vaccine designed to kill both tumor cells and immune-suppressive cells in the tumor microenvironment (TME) by stimulating activation and expansion of T cells against indoleamine 2,3-dioxygenase (IDO) and/or programmed death-ligand 1 (PD-L1) cells. The company is currently conducting a pivotal Phase III trial (IOB-013/KN-D18; NCT05155254) investigating IO102-IO103 in combination with pembrolizumab versus pembrolizumab alone in patients with advanced melanoma, for which data is anticipated in Q3 2024 and potential BLA submission by the end of 2024. The company is developing a cancer vaccine aiming to improve patient outcomes without adding systemic toxicity, focusing on efficacy, durability, safety, and tolerability. 

CAN-2409: Candel Therapeutics

CAN-2409, Candel’s most advanced multimodal biological immunotherapy candidate, is an investigational off-the-shelf replication-defective adenovirus designed to deliver the herpes simplex virus thymidine kinase gene to a patient’s tumor and induce an individualized, systemic anti-tumor immune response. Currently, Candel is evaluating the effects of treatment with CAN-2409 in non-small cell lung cancer, borderline resectable PDAC, and localized, non-metastatic prostate cancer. CAN-2409 has been granted fast-track designation by the FDA for the treatment of PDAC, stage III/IV NSCLC. Candel’s pivotal Phase III clinical trial in prostate cancer is being conducted under a Special Protocol Assessment by FDA for which data is anticipated in Q4 2024.

Note: Detailed emerging therapies assessment will be provided in the final report.

Neoantigen-based Personalized Cancer Therapeutic Vaccines Market Outlook 

The market for neoantigen-based personalized cancer therapeutic vaccines is expected to grow significantly in the coming years. This is due to the increasing number of patients being diagnosed with cancer, the growing awareness of neoantigen-based personalized cancer therapeutic vaccines, and the increasing number of neoantigen-based personalized cancer therapeutic vaccines under clinical trials by various companies. 

Cancer vaccines, evolving over decades, differ significantly from typical vaccines targeting infectious diseases. Unlike preventive vaccines administered to healthy individuals, therapeutic cancer vaccines aim to boost the patient's immune responses to eradicate cancer cells. For instance, IMLYGIC by Amgen gained FDA approval in 2015, following PROVENGE from Dendreon Pharmaceuticals in 2010. However, PROVENGE struggled in the market due to its high cost and reimbursement issues. Similarly, despite being newer, IMLYGIC faced challenges because of its intratumoral administration method and competition from immune checkpoint inhibitors (CPIs), which are more effective with fewer side effects. These factors contributed to the limited revenue of both therapies. Although cancer vaccines have not yet demonstrated a significant clinical impact, they possess enormous potential for therapeutic purposes. Currently being tested as monotherapies and in combination with immuno-oncology agents, these vaccines can confer long-lasting immunity against cancer recurrence and hold promise as a crucial component of future cancer treatment strategies.

Several key players, including IO Biotech, Candel Therapeutics, Merck/Moderna, Geneos Therapeutics, Enterome, Johnson & Johnson Innovative Medicine, and others, are involved in developing drugs for neoantigen-based personalized cancer therapeutic vaccines for acute myeloid leukemia. Overall, this is an exciting new class of agents with great potential for development. The maturation of current studies over the next few years will lead to a better understanding of neoantigen-based personalized cancer therapeutic vaccines and define their role in the therapy of cancer.

Neoantigen-based Personalized Cancer Therapeutic Vaccines Drugs Uptake

This section focuses on the uptake rate of potential approved and emerging neoantigen-based personalized cancer therapeutic vaccines expected to be launched in the market during 2024–2034.

Neoantigen-based Personalized Cancer Therapeutic Vaccines Pipeline Development Activities

The report provides insights into different therapeutic candidates in Phase III, Phase II, and Phase I. It also analyzes key players involved in developing targeted therapeutics. 

The presence of numerous drugs under different stages is expected to generate immense opportunity for neoantigen-based personalized cancer therapeutic vaccines market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for neoantigen-based personalized cancer therapeutic vaccines. 

KOL Views

To keep up with current and future market trends, we take Industry Experts’ opinions working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts were contacted for insights on neoantigen-based personalized cancer therapeutic vaccines' evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, drug uptake, along challenges related to accessibility.

DelveInsight’s analysts connected with 20+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM, including centers such as Roswell Park Comprehensive Cancer Center, Johns Hopkins Sidney Kimmel Cancer Center, UCSF Health, Memorial Sloan Kettering Cancer Center, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or neoantigen-based personalized cancer therapeutic vaccines market trends. This will support the clients in potential upcoming novel treatments by identifying the overall market scenario and unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of disease diagnosis, patient awareness, patient burden, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided. These pointers are based on the analyst’s discretion and assessment of the patient burden, cost analysis, and existing and evolving treatment landscape.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and payer that allows the manufacturer access to the market. It is provided to reduce the high costs and make the essential drugs affordable. Health technology assessment (HTA) plays an important role in reimbursement decision-making and recommending the use of a drug. These recommendations vary widely throughout the seven major markets, even for the same drug. 

In the US healthcare system, both Public and Private health insurance coverage are included. Also, Medicare and Medicaid are the largest government-funded programs in the US. The major healthcare programs including Medicare, Medicaid, the Children's Health Insurance Program (CHIP), and the state and federal health insurance marketplaces are overseen by the Centers for Medicare & Medicaid Services (CMS). Other than these, Pharmacy Benefit Managers (PBMs), and third-party organizations that provide services, and educational programs to aid patients are also present.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

American Association for Cancer Research (AACR) 2024 Updates 

The abstract list is not exhaustive, will be provided in the final report

Scope of the Report

• The report covers a segment of key events, an executive summary, and a descriptive overview of the neoantigen-based personalized cancer therapeutic vaccines, explaining their mechanism and therapies (emerging).
• Comprehensive insight into the Competitive Landscape, and forecasts, the future growth potential of treatment rate, drug uptake, and drug information have been provided.
• Additionally, an all-inclusive account of emerging therapies and the elaborative profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the neoantigen-based personalized cancer therapeutic vaccines market, historical and forecasted market size, market share by therapies, detailed assumptions, and rationale behind our approach is included in the report, covering the 7MM drug outreach.
• The report provides an edge while developing business strategies, by understanding trends, through SWOT analysis, expert insights/KOL views, and treatment preferences that help shape and drive the 7MM neoantigen-based personalized cancer therapeutic vaccines market.

Neoantigen-based Personalized Cancer Therapeutic Vaccines Report Insights

• Neoantigen-based personalized cancer therapeutic vaccines Targeted Patient Pool
• Therapeutic Approaches
• Neoantigen-based personalized cancer therapeutic vaccines Pipeline Analysis
• Neoantigen-based personalized cancer therapeutic vaccines Market Size and Trends
• Existing and future Market Opportunity

Neoantigen based personalized cancer therapeutic vaccines Report Key Strengths

• Eleven years Forecast
• The 7MM Coverage 
• Key Cross Competition 
• Drugs Uptake and Key Market Forecast Assumptions

Neoantigen based personalized cancer therapeutic vaccines Report Assessment

• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Qualitative Analysis (SWOT)

Key Questions

• What was the Neoantigen-based Personalized Cancer Therapeutic Vaccines' total market size, the market size by therapies, market share (%) distribution, and what would it look like in 2034? What are the contributing factors for this growth?
• Which drug is going to be the largest contributor in 2034?
• Which is the most lucrative market for Neoantigen-based Personalized Cancer Therapeutic Vaccines?
• What are the risks, burdens, and unmet needs of treatment with Neoantigen-based Personalized Cancer Therapeutic Vaccines? What will be the growth opportunities across the 7MM for the patient population of Neoantigen-based Personalized Cancer Therapeutic Vaccines?
• What are the key factors hampering the growth of the N Neoantigen-based Personalized Cancer Therapeutic Vaccines market?
• What are the indications for which recent novel therapies and technologies have been developed to overcome the limitations of existing treatments?
• What key designations have been granted to the therapies for Neoantigen-based Personalized Cancer Therapeutic Vaccines?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?

Reasons to buy

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the Neoantigen-based Personalized Cancer Therapeutic Vaccines Market.
• Understand the existing market opportunities in varying geographies and the growth potential over the coming years.
• Distribution of historical and current patient share based on real-world prescription data along with reported sales of approved products in the US, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
• Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
• Detailed analysis and ranking of indication-wise emerging therapies under the conjoint analysis section to provide visibility around leading indications.
• Highlights of Access and Reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and patient assistance programs.
• To understand Key Opinion Leaders’ perspectives around the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
• Detailed insights on the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.