Intratumoral Cancer Therapies Market Insight

DelveInsight’s ‘Intratumoral Cancer Therapies - Market Insights, Epidemiology and Market Forecast—2030’ report delivers an in-depth understanding of the Intratumoral Cancer Therapies, historical and forecasted epidemiology as well as the Intratumoral Cancer Therapies market trends in the United States, EU5 (Germany, France, Italy, Spain, and United Kingdom), and Japan.

The Intratumoral Cancer Therapies market report provides emerging drugs, Intratumoral Cancer Therapies market share of the individual cancer types, current and forecasted Intratumoral Cancer Therapies market size from 2018 to 2030 segmented by seven major markets. The Report also covers current Intratumoral Cancer Therapies market drivers, market barriers and unmet medical needs to curate best of the opportunities and assesses underlying potential of the market.

Geography Covered

• The United States
• EU5 (Germany, France, Italy, Spain and the United Kingdom)
• Japan

Study Period: 2018–2030

Intratumoral Cancer Therapies Understanding and Treatment Algorithm

Intratumoral Cancer Therapies Overview

Over the years, the research and development in cancer have drastically increased, and patients now have several treatment options, which mainly includes chemotherapy, hormone therapy, immunotherapy, gene therapy, radiotherapy, stem cell transplant, surgery, and targeted therapy. However, there is still a segment of the cancer patient population who cannot achieve any benefit or improvement from these therapeutic options. These patients face several challenges, including the development of resistance against these therapies. While the research and development for developing treatment options to mitigate prevailing limitations are still undergoing, researchers and industries have developed a keen interest in Intratumoral therapies. Intratumoral (intralesional) administration of immunotherapeutics is a promising way to target local tumor immunity barriers directly. Even though intratumoral therapy most often refers to direct injection into the tumors, it can also refer to any therapy provided in close anatomical proximity to a tumor with the goal of direct uptake by tumors. There are different categories of intratumoral therapies: cytokines, pathogen-associated molecular patterns (PAMPs), oncolytic viruses, cancer gene therapy, monoclonal antibodies, and small molecules.

Currently, only three intratumoral therapies are approved; Imlygic (Talimogene laherparepvec/T-VEC; Amgen), the first oncolytic virus that was approved by the US FDA for the local treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery in 2015. Later, in April 2020, the EU granted approval (CE mark) to Hensify (NBTXR3; Nanobiotix) for the treatment of locally advanced soft tissue sarcoma (STS), however it is not launched yet. Recently, in June 2021, Delytact (teserpaturev/G47∆; Daiichi Sankyo) received conditional and time-limited approval from the Japan Ministry of Health, Labour and Welfare (MHLW) for the treatment of patients with malignant glioma. The emerging pipeline is majorly focused on the treatment of melanoma, head and neck cancer, Nonmelanoma skin cancer, along with some other cancers and expectations are high from Intratumoral Cancer Therapies.

Intratumoral Cancer Therapies Epidemiology

The Intratumoral Cancer Therapies epidemiology division provides the insights about historical and current Intratumoral Cancer Therapies patient pool and forecasted trend for each seven major countries. It helps to recognize the causes of current and forecasted trends by exploring numerous studies and views of key opinion leaders. This part of the DelveInsight report also provides the diagnosed patient pool and their trends along with assumptions undertaken.

Key Findings

The disease epidemiology covered in the report provides historical as well as forecasted Intratumoral Cancer Therapies epidemiology [segmented as Total Incident cases of selected cancer types (Melanoma, Nonmelanoma skin cancer, Head and Neck Cancer, Pancreatic Cancer, Renal Cell Carcinoma, Colorectal Cancer, Breast Cancer, Brain Cancer, and Soft Tissue Sarcoma), Target patient Pool of Intratumoral therapies by Cancer Types and Treated cases by Cancer Types] scenario of Intratumoral Cancer Therapies in the 7MM covering United States, EU5 countries (Germany, France, Italy, Spain, and United Kingdom), and Japan from 2021 to 2030.

Country Wise- Intratumoral Cancer Therapies Epidemiology

• Among selected nine major indications for the Intratumoral therapies, Nonmelanoma skin cancer (NMSC) contributed to the highest number of cases in the 7MM. The total number of NMSC in the 7MM was 774,926 in 2020. The United States, with 524,737 NMSC incident cases, had the highest number of NMSC incident cases among the seven major markets.
• In 2020, the total Indication-wise eligible cases were 736,184 cases in the 7MM, whereas, Japan accounted for 126,718 Indication-wise eligible cases in the same year which are projected to increase during the forecast period, i.e., 2021–2030.
• In the 7MM, the total treated cases of all selected cancer types in neoadjuvant/adjuvant setting and first-line were 1,065,771, and 736,184 in 2020, which are expected to grow during the forecast period, i.e., 2021–2030

Intratumoral Cancer Therapies Drug Chapters

Drug chapter segment of the Intratumoral Cancer Therapies report encloses the detailed analysis of Intratumoral Cancer Therapies marketed drugs and late stage (Phase-III and Phase-II) pipeline drugs. It also helps to understand the Intratumoral Cancer Therapies 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.

Intratumoral Cancer Therapies Approved Drugs

Delytact (teserpaturev/G47∆/ DS-1647): Daiichi Sankyo

Recently, approved in June 2021, Delytact (teserpaturev) is a genetically engineered oncolytic herpes simplex virus type 1 (HSV-1). It has triple mutation within the viral genome that cause augmented and selective replication in cancer cells and enhanced induction of antitumor immune response while retaining high safety features. Delytact has received conditional and time-limited approval in Japan for the treatment of patients with malignant gliomas based on the Phase II study results. Delytact is not approved for any use outside of Japan. Beyond glioblastoma, the product has also been evaluated in patients with castration-resistant prostate cancer, as part of a single-arm, phase I trial (UMIN000010463).

Imlygic (Talimogene laherparepvec; T-VEC): Amgen

Imlygic is a genetically modified herpes simplex virus type 1 designed to replicate within tumors and produce an immunostimulatory protein called granulocyte-macrophage colony-stimulating factor (GM-CSF). Imlygic causes cell lysis, or death, which ruptures tumors, releasing tumor-derived antigens, which along with GM-CSF, may promote an anti-tumor immune response. However, the exact mechanism of action is unknown. In 2015, the drug was approved both in the US as well as in Europe for the treatment of unresectable cutaneous, subcutaneous and nodal lesions in patients with melanoma recurrent after initial surgery.

Hensify (NBTXR3/ PEP503): Nanobiotix

Hensify, the commercial name of NBTXR3, is an aqueous suspension of crystalline hafnium oxide (HfO2) nanoparticles designed for injection directly into a tumor prior to a patient’s first standard radiotherapy treatment. After getting exposed to ionizing radiation, the drug intensifies the localized, intratumor killing effect of that radiation. In April 2020, the drug obtained a European market approval (CE mark) enabling commercialization for the treatment of locally advanced soft tissue sarcoma (STS), however this drug has not been launched yet. The company have started with post registrational study of Hensify (Study 401). The trial involves 100 participants and the company aims to launch Hensify in the second half of 2021.

Note: Detailed Current therapies assessment will be provided in the full report of Intratumoral Cancer Therapies

Intratumoral Cancer Therapies Emerging Drugs

Vidutolimod (CMP-001): Checkmate Pharmaceuticals

Vidutolimod (CMP-001) comprises a virus-like particle utilizing a CpG-A oligonucleotide. The company designed it to trigger the body’s innate immune system via TLR9 and infiltrate the tumor microenvironment by the subsequent induction of both innate and adaptive antitumor immune responses. Currently, the company is conducting multiple trials for this drug in indications like neoadjuvant melanoma, CMP-001 as first-line for melanoma, head and neck cancer, and nonmelanoma skin cancers.

Tavokinogene telseplasmid (Tavo): OncoSec Medical Incorporated

Tavo (tavokinogene telseplasmid) is a DNA-based interleukin-12 (IL-12), a naturally occurring protein body with immune-stimulating functions. TAVO is administered directly into the tumor using the company’s proprietary electroporation (EP) gene delivery system, which employs a series of momentary energy pulses. Those pulses are designed to increase the permeability of the cell membrane and facilitate the uptake of IL-12 coded DNA into cells. The drug is being studied in multiple clinical trials, including a registration-directed pivotal Phase II trial (NCT03132675) in metastatic melanoma and other Phase II trials in triple-negative breast cancer, regionally advanced melanoma, and head and neck cancer.

RP1 (Vusolimogene Oderparepvec): Replimune

RP1 is a next-generation oncolytic immunotherapy being developed for indications such as melanoma, cutaneous squamous cell carcinoma, NMSC, and MSI-H. RP1 is a genetically modified HSV-1 designed to destroy tumors directly and generate an antitumor immune response. It is based on a proprietary new strain of the HSV engineered to maximize tumor-killing potency, the immunogenicity of tumor cell death, and the activation of a systemic antitumor immune response. CERPASS (Registration-directed clinical trial) and IGNYTE are Phase II trials and ARTACUS is an ongoing Phase I trial.

INT230-6 (Cisplatin/vinblastine): Intensity Therapeutics

INT230-6 is a formulation consisting of the company’s proprietary amphiphilic cell penetration enhancer molecule, 8-([2-hydroxybenzoyl] amino) octanoate, also referred to as SHAO, combined with cisplatin and vinblastine. The penetration enhancer facilitates dispersion of the two drugs throughout injected tumors and enables increased diffusion into cancer cells. Currently, this drug is undergoing a Phase I/II (NCT03058289) clinical trial for soft-tissue sarcoma. In April 2020, the US FDA granted Fast Track designation to INT230-6 for the treatment of patients with relapsed or metastatic triple negative breast cancer who have failed at least two prior lines of therapy.

NanoPac (LSAM Paclitaxel): NanOlogy

NanoPac is made up of tiny particles of another drug called paclitaxel, a chemotherapy drug approved by the US FDA for other types of cancer. NanoPac microparticles are designed for local administration and become entrapped in the tumor, allowing for sustained therapeutic drug release. Currently, NanoPac is being studied in an ongoing Phase II (NCT03077685) trial for locally advanced pancreatic adenocarcinoma. In November 2020, NanOlogy enrolled the first patient in a Phase II (NCT04221828) trial of NanoPac for local prostate cancer but due to lack of enrollment, this trial has been terminated.

LOAd703 (delolimogene mupadenorepvec): Lokon Pharma AB

LOAd703 is an immunostimulatory oncolytic virus, based on company’s proprietary LOAd technology, used in a family of armed oncolytic viruses that can activate the body’s immune system to identify, seek out, and destroy cancer cells. LOAd703 is in the initial phase of clinical development and being evaluated in multiple Phase I/II trials. In 2015, the US FDA and EMA granted Lokon Pharma an Orphan Drug designation for LOAd703 immunotherapy to treat pancreatic cancer, and the ongoing trial (NCT02705196) assessing the drug to treat this cancer is expected to get completed by December 2021.

Intuvax (Ilixadencel): Immunicum AB

Intuvax uses dendritic cells sourced from healthy human donors that are specifically activated to produce significant amounts of vigorous immune stimulatory factors. By intratumoral administration, these cells induce a local inflammatory reaction, leading to the destruction of tumor cells and recruitment and activation of the patient’s dendritic cells into the tumor environment. It is currently being evaluated in the Phase Ib/II (NCT03735290) study in combination with checkpoint inhibitors in patients with advanced cancer who are candidates for CPI Therapy.

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

Intratumoral Cancer Therapies Market Outlook

Key Findings

The Intratumoral Cancer Therapies market size in the 7MM is expected to change during the forecast period 2021–2030. According to the estimates, the highest market size of Intratumoral Cancer Therapies is found in the United States.

The United States Market Outlook

In United States, the total market size of Intratumoral Cancer Therapies is expected to increase at a CAGR of 42.0% during the study period (2018–2030).

EU-5 Countries: Market Outlook

In the EU-5 countries, the total market size of Intratumoral Cancer Therapies is expected to increase at a CAGR of 44.4% during the study period (2018–2030).

Intratumoral Cancer Therapies Pipeline Development Activities

The drugs which are in pipeline include:

• Vidutolimod (CMP-001): Checkmate Pharmaceuticals
• Tavo (tavokinogene telseplasmid): OncoSec Medical Incorporated
• CAVATAK (V937; CVA21): Merck & Co (Viralytics)
• PVSRIPO (PVS-RIPO): Istari Oncology
• RP1 (vusolimogene oderparepvec): Replimune/ Regeneron
• Daromun (Nidlegy): Philogen
• Cavrotolimod (AST-008): Exicure
• Cotsiranib (STP705): Sirnaomics
• Hensify (NBTXR3/ PEP503): Nanobiotix
• INT230-6 (Cisplatin/vinblastine): Intensity Therapeutics
• NanoPac (LSAM paclitaxel): NanOlogy
• Delolimogene mupadenorepvec (LOAd703): Lokon Pharma
• Intuvax (Ilixadencel): Immunicum
• Tasadenoturev (DNX-2401): DNAtrix
• G207: Treovir
• Tilsotolimod (IMO-2125): Idera Pharmaceuticals
• AlloStim: Immunovative Therapies

And others…..

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

Intratumoral Cancer Therapies Drugs Uptake

Analysts Insight

Imlygic from Amgen, is the first and only the FDA approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intratumoral mode of cancer gene therapy, Imlygic’s debut did not translate into much commercial success in the melanoma market. Limitations of the intratumoral administration, no statistically significant benefit in overall survival and the intense competition from immune checkpoint inhibitors due to their efficacy and manageable side effects are some of the main factors for insignificant revenues of this novel therapy. Currently, the pipeline for Intratumoral Cancer Therapies is very rich with potential candidates of various drug classes. Most of the emerging therapies are working on the principle of turning ""cold"" tumors to ""hot"" and then simultaneously targeting the tumor with immune checkpoint inhibitors. DelveInsight’s analysts have also accessed that Melanoma will dominate the Intratumoral therapeutic landscape when it comes to the nine cancer indications that are chosen for market assessment of Intratumoral therapies.

Access and Reimbursement Scenario in Intratumoral Cancer Therapies

• NICE intended to appraise the clinical and cost-effectiveness of NBTXR-3 within its CE marked indication for neoadjuvant treatment of soft-tissue sarcoma. The company has informed NICE that it wishes to wait until its evidence is more mature before making a submission. Therefore, NICE decided to suspend this appraisal on its work program.
• Germany’s Federal Joint Committee (G-BA) published an unfavorable final decision on the early benefit assessment of Imlygic, reaching the same verdict as the Institute for Quality and Efficiency in Healthcare (IQWiG) in its earlier dossier evaluation, namely that there was no added benefit with treatment. The price in Germany was subsequently slashed in half. However, the HTA outcome in the UK was far more favorable, with NICE recommending the treatment and estimating that the incremental cost-effectiveness ratio (ICER) of Imlygic versus best supportive care in patients for whom systemic immunotherapy is unsuitable was GBP 24,000 per quality-adjusted life-year (QALY) gained.

KOL-Views

To keep up with current market trends, we take KOLs and SME’s opinion working in Intratumoral Cancer Therapies domain through primary research to fill the data gaps and validate our secondary research. Their opinion helps to understand and validate current and emerging therapies treatment patterns or Intratumoral Cancer Therapies market trend. This will support the clients in potential upcoming novel treatment by identifying the overall scenario of the market and the unmet needs.

Competitive Intelligence Analysis

We perform Competitive and Market Intelligence analysis of the Intratumoral Cancer Therapies Market by using various Competitive Intelligence tools that includes – SWOT analysis, PESTLE analysis, Porter’s five forces, BCG Matrix, Market entry strategies etc. The inclusion of the analysis entirely depends upon the data availability.

Scope of the Report

• The report covers a detailed overview of the development of Intratumoral Cancer Therapies across the several selected indications, explaining its various classes, benefits, and challenges for future
• Comprehensive insight has been provided into the Intratumoral Cancer Therapies epidemiology and treatment in the 7MM.
• Additionally, an all-inclusive account of both the current and emerging therapies for Intratumoral Cancer Therapies is provided, along with the assessment of new therapies, which will have an impact on the current treatment landscape.
• A detailed review of Intratumoral Cancer Therapies market; historical and forecasted is included in the report, covering drug outreach in the 7MM.
• The report provides an edge while developing business strategies, by understanding trends shaping and driving the global Intratumoral Cancer Therapies market.

Report Highlights

• In the coming years, Intratumoral Cancer Therapies market is set to change due to improved patient outcomes, treatment of cold tumors, rich emerging pipeline and convenient production and administration; which would expand the size of the market to enable the drug manufacturers to penetrate more into the market.
• The companies and academics are working to assess challenges and seek opportunities that could influence Intratumoral Cancer Therapies R&D. The therapies under development are focused on novel approaches to treat/improve the disease condition.
• Major players are involved in developing therapies for Intratumoral Cancer Therapies. Launch of emerging therapies, will significantly impact the Intratumoral Cancer Therapies market.
• Our in-depth analysis of the pipeline assets across different stages of development (Phase III and Phase II), different emerging trends and comparative analysis of pipeline products with detailed clinical profiles, key cross-competition, launch date along with product development activities will support the clients in the decision-making process regarding their therapeutic portfolio by identifying the overall scenario of the research and development activities.

Intratumoral Cancer Therapies Report Insights

• Patient Population
• Therapeutic Approaches
• Intratumoral Cancer Therapies Pipeline Analysis
• Intratumoral Cancer Therapies Market Size and Trends
• Market Opportunities
• Impact of upcoming Therapies

Intratumoral Cancer Therapies Report Key Strengths

• 10 Years Forecast
• 7MM Coverage
• Intratumoral Cancer Therapies Epidemiology Segmentation
• Key Cross Competition
• Highly Analyzed Market
• Drugs Uptake

Intratumoral Cancer Therapies Report Assessment

• SWOT Analysis
• Current Treatment Practices
• Unmet Needs
• Pipeline Product Profiles
• Market Attractiveness
• Market Drivers and Barriers

Key Questions

Market Insights:

• What was the Intratumoral Cancer Therapies Market share (%) distribution in 2018 and how it would look like in 2030?
• What would be the Intratumoral Cancer Therapies total market size as well as market size by therapies across the 7MM during the study period (2018–2030)?
• What are the key findings pertaining to the market across the 7MM and which country will have the largest Intratumoral Cancer Therapies market size during the study period (2018–2030)?
• At what CAGR, the Intratumoral Cancer Therapies market is expected to grow in the 7MM during the study period (2018–2030)?
• What would be the Intratumoral Cancer Therapies market outlook across the 7MM during the study period (2018–2030)?
• What would be the Intratumoral Cancer Therapies market growth till 2030 and what will be the resultant market size in the year 2030?
• How would the market drivers, barriers and future opportunities affect the market dynamics and a subsequent analysis of the associated trends?
• Intratumoral Cancer Therapies patient types/pool where unmet need is more and whether emerging therapies will be able to address the residual unmet need?
• How emerging therapies are performing on the parameters like efficacy, safety, route of administration (RoA), treatment duration and frequencies on the basis of their clinical trial results?
• Among the emerging therapies, what are the potential therapies which are expected to disrupt the Intratumoral Cancer Therapies market?

Epidemiology Insights:

• What is the challenges and unmet needs of the Intratumoral Cancer Therapies?
• What is the historical Intratumoral Cancer Therapies patient pool in the seven major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What would be the forecasted patient pool of Intratumoral Cancer Therapies in the 7 major markets covering the United States, EU5 (Germany, France, Italy, Spain, and the United Kingdom) and Japan?
• What will be the growth opportunities in the 7MM with respect to the patient population pertaining to Intratumoral Cancer Therapies?
• Out of all the 7MM countries, which country would have the highest incident population of Intratumoral Cancer Therapies during the study period (2018–2030)?
• At what CAGR the population is expected to grow in the 7MM during the study period (2018–2030)?
• What are the various recent and upcoming events which are expected to improve the uptake of Intratumoral Cancer Therapies?

Current Treatment Scenario and Emerging Therapies:

• What are the current treatment guidelines for the treatment of selected diseases with the help of Intratumoral Cancer Therapies in the US, Europe and Japan?
• How many companies are developing Intratumoral Cancer Therapies?
• How many Intratumoral Cancer Therapies are developed by each company?
• How many emerging therapies are in mid stage, and late stage of development?
• What are the key collaborations (Industry–Industry, Industry–Academia), Mergers and acquisitions, licensing activities related to the Intratumoral Cancer Therapies?
• What are the recent novel therapies, targets, mechanisms of action and technologies developed to overcome the limitation of existing therapies?
• What are the clinical studies going on for Intratumoral Cancer Therapies and their status?
• What are the key designations that have been granted for the emerging therapies for Intratumoral Cancer Therapies?
• What is the global historical and forecasted market of Intratumoral Cancer Therapies?

Reasons to buy

• The report will help in developing business strategies by understanding trends shaping and driving the Intratumoral Cancer Therapies market.
• To understand the future market competition in the Intratumoral Cancer Therapies market and Insightful review of the key market drivers and barriers.
• Organize sales and marketing efforts by identifying the best opportunities for Intratumoral Cancer Therapies in the US, Europe (Germany, France, Italy, Spain, and the United Kingdom) and Japan.
• Identification of strong upcoming players in market will help in devising strategies that will help in getting ahead of competitors.
• Organize sales and marketing efforts by identifying the best opportunities for Intratumoral Cancer Therapies market.
• To understand the future market competition in the Intratumoral Cancer Therapies market.