Tumor-Infiltrating Lymphocyte (TIL) Therapies - Target Population, Competitive Landscape, and Market Forecast - 2034

Key Highlights:

• Over the last ten years, cell-based immunotherapy has emerged as a promising approach for treating solid tumors. Tumor-infiltrating lymphocytes, which are lymphocytes found within tumor tissues, have gained attention. Advances in technology have enhanced the methods for isolating and expanding TILs from tumors, and their clinical application in solid tumor treatment has demonstrated encouraging effectiveness.
• TIL therapy has shown success in treating patients with metastatic melanoma and other solid tumors. Unlike other adoptive cell therapies (ACTs) like CAR-T and TCR-T, TIL therapy offers distinct advantages. TILs consist of diverse T-cell receptor (TCR) clones, enabling them to target both shared self-antigens and tumor-specific neoantigens. This broad reactivity allows TILs to better address tumor heterogeneity and potentially improve treatment outcomes.
• TIL therapies are active in multiple indications, including melanoma, cervical cancer, non-small cell lung cancer (NSCLC), endometrial cancer, head and neck squamous cell carcinoma (HNSCC), colorectal cancer, and other solid tumors.
• Iovance's AMTAGVI (lifileucel) is the first and only approved TIL therapy approved by US Food and Drug Administration (FDA) in February 2024 for the treatment of unresectable or metastatic melanoma.
• TIL therapies have a pipeline, with candidates such as OBX-115, BST02, KSQ-001 EX, KSQ-004 EX in early Phase (I/II) trials targeting diverse indications like advanced gastric, gastroesophageal junction and other solid tumors.
• In June 2025, Iovance Biotherapeutics, announced that the Journal of Clinical Oncology has published the final analysis from the Phase II C-144-01 clinical trial evaluating the individualized T cell therapy AMTAGVI in patients with advanced melanoma. These five-year follow-up results are being simultaneously presented during an oral session today at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
• Several companies including Iovance Biotherapeutics, Obsidian Therapeutics, Biosyngen, KSQ Therapeutics, and others are currently engaged in the development and production of TIL therapies, which have the potential to significantly impact and enhance the TIL therapies market.

DelveInsight's "Tumor-Infiltrating Lymphocyte (TIL) Therapies- Target Population, Competitive Landscape, and Market Forecast - 2034" report delivers an in-depth understanding of the Tumor-Infiltrating Lymphocyte, historical and Competitive Landscape as well as the Tumor-Infiltrating Lymphocyte therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

The Tumor-Infiltrating Lymphocyte therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM Tumor-Infiltrating Lymphocyte therapies market size from 2020 to 2034. The report also covers current Tumor-Infiltrating Lymphocyte therapies 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

Tumor-Infiltrating Lymphocyte Therapies Disease Understanding and Treatment Algorithm

TIL Therapies Overview

TIL therapy represents an advanced form of adoptive cell therapy (ACT) wherein naturally occurring, polyclonal T cells extracted from a patient's tumor microenvironment are expanded ex vivo and re-infused following non-myeloablative lymphodepletion. Unlike genetically engineered modalities such as CAR-T or TCR therapies, TIL therapy exploits the intrinsic tumor specificity of endogenous lymphocyte populations, which are already primed to recognize a diverse array of neoantigens unique to the patient's tumor.

The therapeutic rationale hinges on the ability of these tumor-resident T cells to mount a more comprehensive and physiologically relevant anti-tumor response. Upon re-infusion, the expanded TILs can persist and traffic to tumor sites, where they mediate cytotoxic activity against malignant cells. This approach has demonstrated durable responses, particularly in immunologically "hot" tumors such as metastatic melanoma, cervical cancer, and NSCLC, even in patient's refractory to immune checkpoint blockade.

The landmark FDA approval of AMTAGVI in 2024 for unresectable or metastatic melanoma marked a pivotal regulatory milestone, establishing TILs as the first approved autologous cell therapy for solid tumors. Despite manufacturing and logistical challenges, particularly around tumor tissue acquisition, scalability, and turnaround times, the clinical potential of TILs in solid tumor indications where other ACT modalities have largely underperformed positions them as a transformative modality in the evolving immuno-oncology landscape.

Tumor-Infiltrating Lymphocyte Therapies Epidemiology

The TIL therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented as total cases of selected indication for TIL therapies, total eligible patients of selected indication, total treated cases in selected indication for TIL therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain), and the United Kingdom, and Japan from 2020 to 2034.

Tumor-Infiltrating Lymphocyte Therapies Drug Chapters

The drug chapter segment of the TIL therapies reports encloses a detailed analysis of marketed drugs and early-stage (Phase II and Phase I) pipeline drugs. It also helps to understand the TIL 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.

Marketed Drugs

AMTAGVI (lifileucel): Iovance Biotherapeutics

AMTAGVI is a tumor-derived autologous T cell immunotherapy indicated for the treatment of adult patients with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody, and if BRAF V600 mutation positive, a BRAF inhibitor with or without a MEK inhibitor. The specific mechanism of action of AMTAGVI is unknown.

The proposed mechanism for AMTAGVI offers a new cell therapy approach that deploys patient-specific T cells called TIL cells. When cancer is detected, the immune system creates TIL cells to locate, attack, and destroy cancer. TIL cells recognize distinctive tumor markers on the cell surface of each person's cancer. When cancer develops and prevails, the body's natural TIL cells can no longer perform their intended function to fight cancer.

In February 2024, Iovance Biotherapeutics announced that the FDA has approved AMTAGVI suspension for intravenous infusion. AMTAGVI is approved under an accelerated approval based on overall response rate (ORR) and duration of response. Iovance is also conducting TILVANCE-301, a Phase III trial to confirm clinical benefit.

Currently, AMTAGVI is also being developed as both monotherapy and combination therapy with pembro for multiple indications like NSCLC, cervical cancer etc. which are in late Phases (III/II) of clinical trials.

Emerging Drugs

OBX-115: Obsidian Therapeutics

OBX-115 is a next-generation, TIL therapy designed using Obsidian's proprietary cytoDRIVE platform. The TILs are genetically engineered to express membrane-bound interleukin-15 (mbIL-15), which supports T cell proliferation, persistence, and antitumor activity without the need for high-dose IL-2, a major driver of toxicity in conventional TIL therapy

OBX-115 TIL are engineered to express mbIL15 fused to a drug-responsive domain, which allows for a dose-dependent increase in functional mbIL15 levels in the presence of an FDA-approved stabilizing drug (acetazolamide [ACZ]), avoiding the need for IL2.

In September 2024, Obsidian Therapeutics announced that the FDA has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor (ICI) therapy.

Tumor-Infiltrating Lymphocyte Therapies Market Outlook

TIL therapies represent a next-generation, personalized immunotherapy approach aimed at harnessing a patient's own immune system to fight solid tumors. These therapies involve isolating and expanding TILs from a patient's tumor, reprogramming them ex vivo, and reinfusing them to generate a targeted immune response. After decades of academic development, the TIL therapy field achieved a major milestone in 2024 with the FDA approval of AMTAGVI, developed by Iovance Biotherapeutics, for the treatment of advanced melanoma. As the first approved TIL-based therapy, AMTAGVI marks a paradigm shift in cell therapy for solid tumors, establishing a foothold in a space traditionally dominated by checkpoint inhibitors and targeted drugs.

AMTAGVI's approval has validated the commercial and clinical potential of TILs and has opened the door for broader investment in the modality. Several companies are now actively developing next-generation TIL products, including OBX-115 from Obsidian Therapeutics, currently in Phase I/II trials for melanoma and non-small cell lung cancer (NSCLC). Other early-stage assets such as BST02 from Biosyngen (in liver cancer), and KSQ-001 EX and KSQ-004 EX from KSQ Therapeutics, are exploring broader applications in HNSCC, pancreatic ductal adenocarcinoma (PDAC), colorectal cancer, and NSCLC, reflecting a growing belief in the platform's adaptability across multiple tumor types.

However, while the clinical promise is evident, the TIL therapy landscape faces notable challenges. Manufacturing complexities, long lead times, the need for specialized infrastructure, and high production costs limit scalability and accessibility. Unlike off-the-shelf immunotherapies, TIL products are autologous and highly personalized, requiring robust logistical coordination. Moreover, competition from more mature immunotherapy modalities like CAR-T and immune checkpoint inhibitors adds pressure for TILs to demonstrate not only efficacy but also operational and cost efficiency.

Despite these hurdles, the pipeline, though still early-stage, continues to evolve, with companies focusing on engineering improvements, automation of TIL expansion, and combination strategies with checkpoint blockade to enhance durability and response rates. The scarcity of approved products, juxtaposed with broadening clinical exploration of AMTAGVI and others, underscores both the nascent stage of the field and its significant potential.

Tumor-Infiltrating Lymphocyte Therapies Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, and efficacy data, along with the order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

Tumor-Infiltrating Lymphocyte Therapies Pipeline Development Activities

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

The presence of numerous drugs at different stages is expected to generate immense opportunities for the TIL therapies market growth over the forecasted period.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for TIL therapies.

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 TIL therapies' 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. Centers such as the Anderson Cancer Center, Massachusetts General Hospital Cancer Center, National Cancer Center Hospital East, Memorial Sloan Kettering Cancer Center, Sorbonne University, University Medical Center Mainz, University of Cambridge, and others.

Their opinion helps understand and validate current and emerging therapy treatment patterns or TIL therapies market trends. This will support the clients in potential upcoming novel treatments by identifying the overall scenario of the market and the unmet needs.

Qualitative Analysis

We perform Qualitative and market Intelligence analysis using various approaches, such as SWOT analysis and Conjoint Analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Conjoint Analysis analyzes multiple approved and emerging therapies based on relevant attributes such as safety, efficacy, frequency of administration, route of administration, and order of entry. Scoring is given based on these parameters to analyze the effectiveness of therapy. In efficacy, the trial's primary and secondary outcome measures are evaluated; for instance, in event-free survival, one of the most important primary outcome measures is event-free survival and overall survival.

Further, the therapies' safety is evaluated, wherein the acceptability, tolerability, and adverse events are majorly observed, and it sets a clear understanding of the side effects posed by the drug in the trials. In addition, the scoring is also based on the probability of success and the addressable patient pool for each therapy. According to these parameters, the final weightage score and the ranking of the emerging therapies are decided.

Market Access and Reimbursement

Reimbursement may be referred to as the negotiation of a price between a manufacturer and a 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.

Key Updates on Tumor-Infiltrating Lymphocyte Therapies

• In June 2025, Obsidian Therapeutics announced initial Phase I safety and efficacy data from the Phase I/II Agni-01 multicenter study of OBX-115, a summarized data, will be presented by Director and Chief Administrative Officer of UofL Health - Brown Cancer Center/Oncology Service Line at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting.
• In April 2025, KSQ Therapeutics announced the first patient dosed in the Phase I/II clinical study of KSQ-004EX, a novel CRISPR-engineered Tumor Infiltrating Lymphocyte (eTIL) therapy. KSQ-004EX consists of eTIL in which the SOCS1 and Regnase-1 genes are inactivated by CRISPR/Cas9 gene editing, giving it the potential to be a best-in-class treatment for a variety of solid tumor indications. KSQ's CRISPRomics platform identified SOCS1 and Regnase-1 as key genes inhibiting the ability of TIL to eradicate solid tumors in preclinical models.
• In July 2024, Obsidian Therapeutics announced that the FDA has granted Fast Track Designation (FTD) to OBX-115 for the treatment of patients with metastatic or locally advanced melanoma that is refractory to or has relapsed after PD-1/PD-L1-based immune checkpoint inhibitors (ICI).
• In June 2024, Iovance Biotherapeutics submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for AMTAGVI. If approved, this will be the first and only approved therapy in this treatment setting in all European Union (EU) member states.
• In January 2024, Biosyngen's TIL therapy BST02 was granted FTD by the FDA for liver cancer. BST02, a breakthrough product in the field of cell and gene therapy, represents the world's first TIL therapy designed for the treatment of all types of liver cancer to progress into the clinical stage.

The abstract list is not exhaustive and 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 Tumor-Infiltrating Lymphocyte, explaining its mechanism and therapies (current and 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 the current and emerging therapies and the elaborate profiles of late-stage and prominent therapies will impact the current landscape.
• A detailed review of the Tumor-Infiltrating Lymphocyte therapies 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 Tumor-Infiltrating Lymphocyte therapies market.

Tumor-Infiltrating Lymphocyte Therapies Report Insights

• TIL Targeted Patient Pool
• Therapeutic Approaches
• TIL therapies Pipeline Analysis
• TIL therapies Market Size and Trends
• Existing and future Market Opportunity

Tumor-Infiltrating Lymphocyte Therapies Report Key Strengths

• Ten-Year Forecast
• The 7MM Coverage
• Key Cross Competition
• Drug Uptake and Key Market Forecast Assumptions

Tumor-Infiltrating Lymphocyte Therapies Report Assessment

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

Key Questions:

• What was the Tumor-Infiltrating Lymphocyte therapies 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?
• What are the pricing variations among different geographies for approved therapies?
• How the reimbursement landscape has for Tumor-Infiltrating Lymphocyte therapies evolved since the first one was approved? Do patients have any access issues that are driven by reimbursement decisions?
• What are the risks, burdens, and unmet needs of treatment with Tumor-Infiltrating Lymphocyte therapies? What will be the growth opportunities across the 7MM for the patient population of Tumor-Infiltrating Lymphocyte therapies?
• What are the key factors hampering the growth of the Tumor-Infiltrating Lymphocyte therapies 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 Tumor-Infiltrating Lymphocyte?
• What is the cost burden of approved therapies on the patient?
• Patient acceptability in terms of preferred therapy options as per real-world scenarios?
• What are the country-specific accessibility issues of expensive, recently approved therapies?

Reasons to buy:

• The report will help develop business strategies by understanding the latest trends and changing dynamics driving the Tumor-Infiltrating Lymphocyte therapies 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), 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 current and 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.