In 2025, the intratumoral cancer therapies market across the 7MM was valued at USD 115 million and is expected to grow at CAGR of 49% by 2034. Intratumoral therapies administered directly into tumors offer localized cancer control with minimal damage to surrounding tissues. Non-melanoma cancers represent the largest patient pool in the 7MM, while in the US, breast cancer accounts for about 30% of all cancer cases, with intratumoral therapy utilization steadily rising.
Currently, IMLYGIC is the only FDA-approved intratumoral therapy for melanoma and holds over 90% market share. Numerous modalities, including cytokine therapies, TLR/STING agonists, checkpoint inhibitors, suppressive cytokine traps, oncolytic viruses, and plasmid DNA products, are in development. Among emerging candidates, OncoSec’s TAVO is expected to generate the highest future revenue. Growing R&D activity from companies such as Nanobiotix, Replimune, and Sirnaomics, along with multiple FDA Fast Track designations, underscores strong innovation and a promising market outlook. The United States remains the largest market globally.
DelveInsight has published its latest report, “Intratumoral Cancer Therapies Market Insights, Epidemiology, and Market Forecast – 2034,” delivering a comprehensive evaluation of the global landscape for Intratumoral Cancer Therapies. The study encompasses both historical data and future epidemiology projections, as well as market dynamics across the United States, EU4 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. The analysis offers insights into present-day treatment strategies, newly emerging therapies, market share by product, and market size forecasts from 2020 through 2034 across the seven key regions. Additionally, it examines treatment algorithms, driving factors, restraints, unmet medical needs, and opportunities shaping the future of the intratumoral therapy market.
For detailed insights into the market outlook, therapy adoption, treatment landscape, and epidemiology trends, visit: Intratumoral Cancer Therapies Market Forecast
Key Highlights of the Intratumoral Cancer Therapies Market Report
- The Intratumoral Cancer Therapies market is projected to expand at a strong CAGR of 49% throughout 2020–2034.
- In January 2025, Intensity Therapeutics, Inc. (NASDAQ: INTS) provided a corporate update highlighting substantial progress for its lead immuno-oncology asset INT230-6.
- In January 2025, Lokon Pharma AB announced that the US FDA granted Fast Track status to its candidate LOAd703 for pancreatic cancer.
- In March 2024, ImmVira revealed that its oncolytic virus MVR-T3011 IT was awarded FDA Fast Track Designation for recurrent/metastatic head and neck squamous cell carcinoma resistant to platinum chemotherapy and anti-PD1/PD-L1 therapies.
- Various investigational strategies—cytokine-based immune enhancers, TLR/STING agonists, checkpoint inhibitors, inhibitory cytokine traps, plasmid DNA approaches, and oncolytic viruses (OVs)—are advancing in trials for melanoma.
- IMLYGIC remains the only FDA-approved intratumoral therapy for melanoma, representing 90%+ of market share.
- Among upcoming drugs, OncoSec Medical’s TAVO (plasmid IL-12) is predicted to capture the highest commercial revenue.
- The United States contributes nearly 80% of the total market value.
- Survival in cutaneous melanoma improves dramatically with early detection—81.6% localized diagnosis (99.5% 5-year survival), 9% regional, and 4% distant-stage cases.
- Between 2021–2022, the US recorded 98,046 melanoma cases, a figure projected to climb by 2032. In Germany, 2021 data showed 31,636 melanoma cases and 91,650 non-melanoma skin cancer (NMSC) cases.
- NMSC accounts for the largest share among nine main indications, with 793,007 cases across the 7MM in 2021.
Access detailed insight into drugs, clinical trials and recent developments here: Intratumoral Cancer Therapies Competitive Landscape
Intratumoral Cancer Competitive Landscape
Notable Companies Active in the Intratumoral Cancer Space
Amgen, Daiichi Sankyo, AiViva BioPharma, Lytix Biopharma, Regeneron Pharmaceuticals, Checkmate Pharmaceuticals, OncoSec Medical Incorporated, Merck, Istari Oncology, Replimune, Philogen, Sirnaomics, Exicure, Intensity Therapeutics, NanOlogy, Nanobiotix, Immunovative Therapies, DNAtrix, Idera Pharmaceuticals, Lokon Pharma, Treovir, Immunicum, and more.
Prominent Therapies in Development & Use
- IMLYGIC (talimogene laherparepvec): Amgen
- DELYTACT (G47Δ): Daiichi Sankyo
- AIV001: AiViva BioPharma
- LTX-315: Lytix Biopharma
- Vidutolimod + nivolumab: Regeneron Pharmaceuticals
- Vidutolimod (CMP-001): Checkmate Pharmaceuticals
- TAVO (tavokinogene telseplasmid): OncoSec Medical Incorporated
- CAVATAK (V937; CVA21): Merck
- PVSRIPO (PVS-RIPO): Istari Oncology
- RP1 (vusolimogene oderparepvec): Replimune / Regeneron
- Daromun (Nidlegy): Philogen
- Cotsiranib (STP705): Sirnaomics
- Cavrotolimod (AST-008): Exicure
- INT230-6 (cisplatin/vinblastine): Intensity Therapeutics
- NanoPac (LSAM paclitaxel): NanOlogy
- Hensify (NBTXR3/PEP503): Nanobiotix
- AlloStim: Immunovative Therapies
- Tasadenoturev (DNX-2401): DNAtrix
- Tilsotolimod (IMO-2125): Idera Pharmaceuticals
- Delolimogene mupadenorepvec (LOAd703): Lokon Pharma
- G207: Treovir
- Intuvax (Ilixadencel): Immunicum
Learn more about therapies expected to dominate the market: Intratumoral Cancer Treatment Market
Intratumoral Cancer Therapies – Market & Clinical Insights
The intratumoral cancer therapies market is projected for strong growth, driven by rising cancer diagnoses, increasing awareness, and a robust pipeline of investigational therapies. Currently, IMLYGIC (US, EU) and DELYTACT (Japan) are the only approved therapies, with IMLYGIC dominating the market. Emerging candidates like vidutolimod and RP1 are expected to reshape the landscape in the next decade.
Key developers include Nanobiotix, Sirnaomics, and Replimune. While melanoma leads in revenue generation, non-melanoma skin cancers are poised to become major future targets. Geographically, the US holds about 80% of market share, while within Europe, Germany leads, followed by France, with Spain holding the lowest share.
Intratumoral therapies involve direct delivery of agents into the tumor microenvironment, allowing for high local efficacy with minimal systemic toxicity. This method enhances immune activation, can induce systemic responses (abscopal effect), and is increasingly being investigated across cancers like melanoma, HNSCC, and triple-negative breast cancer.
Challenges include standardizing administration protocols, ensuring tumor accessibility, and optimizing delivery platforms. However, ongoing innovations are expected to reshape this therapeutic domain.
Download a complimentary sample of the Intratumoral Cancer Therapies Market Report: Intratumoral Cancer Therapies Clinical trials Market
Intratumoral Cancer Therapies Epidemiology Insights
The epidemiology section provides historic, current, and forecasted trends across the 7MM between 2020 and 2034, exploring prevalence, diagnosis rates, gender distribution, and disease severity.
Segmentation covers:
- Total prevalence
- Severity-specific prevalence
- Gender-specific prevalence
- Chronic vs. episodic diagnosed cases
Intratumoral Cancer Drug Uptake & Pipeline Activities
HENSIFY (NBTXR3) – Nanobiotix HENSIFY, developed by Nanobiotix, is a first-in-class intratumoral therapy that physically destroys tumors and stimulates the immune system when combined with radiation. It consists of hafnium oxide nanoparticles injected into tumors prior to radiotherapy, amplifying the tumor-killing effect of X-rays without increasing damage to healthy tissue. Currently in Phase III trials for head and neck squamous cell carcinoma, NBTXR3 is also being explored in lung, liver, prostate, and other cancers. In February 2020, the FDA granted Fast Track Designation for its use with or without cetuximab in locally advanced head and neck cancers unsuitable for platinum-based chemotherapy.
STP705 (cotsiranib) – Sirnaomics STP705 is Sirnaomics’ lead siRNA therapy that simultaneously inhibits TGF-β1 and COX-2 using nanoparticle-enhanced delivery. It is in late-stage trials for squamous cell carcinoma in situ, Phase II for basal cell carcinoma, and Phase I for fat remodeling. Additionally, it holds Orphan Drug Designation for cholangiocarcinoma (CCA) and primary sclerosing cholangitis (PSC).
Access detailed insight into market dynamics here: Intratumoral Cancer Therapies Market Drivers and Barriers
Scope of the Intratumoral Cancer therapies Market Report
- Study Timeline: 2020–2034
- Geographies Covered: US, EU5 (Germany, France, Italy, Spain, UK), and Japan
- Therapies: IMLYGIC, DELYTACT, AIV001, LTX-315, Vidutolimod, TAVO, CAVATAK, RP1, PVSRIPO, Daromun, and others
- Key companies: Amgen, Daiichi Sankyo, AiViva BioPharma, Lytix Biopharma, Regeneron Pharmaceuticals, Checkmate Pharmaceuticals, OncoSec Medical Incorporated, Merck, Istari Oncology, Replimune, Philogen, Sirnaomics, Exicure, Intensity Therapeutics, NanOlogy, Nanobiotix, Immunovative Therapies, DNAtrix, Idera Pharmaceuticals, Lokon Pharma, Treovir, Immunicum, among others.
- Assessments: Current vs. pipeline therapies, unmet needs, SWOT, PESTLE, Porter’s Five Forces, BCG Matrix, reimbursement, and KOL perspectives
About DelveInsight
DelveInsight is a leading life sciences market research and business consulting company recognized for its syndicated market research reports and customized solutions. With expertise spanning drug development, market forecasting, epidemiology, and competitive intelligence, DelveInsight empowers healthcare organizations to make informed strategic decisions.
Media Contact
Company Name: DelveInsight Business Research LLP
Contact Person: Ankit Nigam
Email: Send Email
Phone: +14699457679
Address:304 S. Jones Blvd #2432
City: Albany
State: New York
Country: United States
Website: https://www.delveinsight.com/consulting/competitive-intelligence-services