종양 침윤성 림프구(TIL) 치료법은 고형암에 대항하기 위해 환자 자신의 면역계를 활용하는 것을 목적으로 한 차세대 개별화 면역 치료법 접근법입니다. 이러한 치료법은 환자의 종양으로부터 TIL을 분리 및 확장하고, 생체외에서 재프로그래밍하고, 표적 면역 반응을 발생시키기 위해 재접종하는 것을 포함합니다. 수십년에 걸친 학술 개발 이후 TIL 치료 분야는 2024년 Iovance Biotherapeutics가 개발한 AMTAGVI가 진행성 흑색종 치료제로 FDA에 승인되어 큰 이정표를 달성했습니다. 최초로 승인된 TIL 기반 치료제로서 AMTAGVI는 고형암의 세포 치료에 패러다임 이동을 보였으며, 기존 체크포인트 억제제와 표적 약물이 지배적이었던 영역에서 발판을 구축했습니다.
AMTAGVI의 승인은 TIL의 상업적 및 임상적 잠재력을 검증하고 이 치료법에 대한 보다 광대한 투자에 대한 문을 열었습니다. Obsidian Therapeutics의 OBX-115는 흑색종과 비소세포 폐암(NSCLC)을 대상으로 현재 1/2단계 시험 중입니다. 기타, Biosyngen의 BST02(간암), KSQ Therapeutics의 KSQ-001 EX와 KSQ-004 EX등의 초기 단계의 에셋은 HNSCC, 췌관선암(PDAC), 대장암, NSCLC에의 광범위한 응용을 모색하고 있어 여러 종양의 유형에 걸칩니다.
본 보고서는 종양 침윤성 림프구(TIL) 치료법의 주요 7개 시장(미국, 독일, 프랑스, 이탈리아, 스페인, 영국, 일본)에 대해 조사 분석하여 각 지역 시장 규모와 예측, 현재의 치료법, 신약, 미충족 수요(Unmet Needs) 등의 정보를 제공합니다.
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.
Study Period: 2020-2034
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.
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.
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.
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.
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
The abstract list is not exhaustive and will be provided in the final report.