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시장보고서
상품코드
2126035
종양 침윤 림프구(TIL) 요법 : 시장 규모, 대상 환자층, 경쟁 구도 및 시장 예측(2036년)Tumor-Infiltrating Lymphocyte (TIL) Therapies - Market Size, Target Population, Competitive Landscape & Market Forecast - 2036 |
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DelveInsight
본 TIL 치료법 시장 보고서에서는 현재의 치료 실태, 신흥 의약품, 개별 치료법의 시장 점유율, 그리고 2022-2036년까지의 TIL 치료법 시장 규모(주요 7개국)에 대한 현황과 전망을 다루고 있습니다. 또한 이 보고서에서는 현재의 TIL 요법, 치료 현황/알고리즘, 미충족 의료 수요에 대해서도 다루며, 최적의 비즈니스 기회를 엄선하고 시장의 잠재력을 평가하고 있습니다.
종양 침윤 림프구(TIL) 요법의 개요
종양 침윤 림프구(TIL)란 종양 내에 상주하는 T세포를 말합니다. TIL은 환자 특이적 네오항원을 포함하여 광범위한 암 관련 항원을 인식할 수 있는 이질적인 T세포의 집합체입니다. 절제된 종양 유래 TIL은 면역억제적인 종양 미세환경으로부터 격리하여 배양하고, 체외에서 증식시킬 수 있습니다. TIL을 이용한 입양 세포 치료(ACT)에서는 이를 대량으로 증식시킨, 변형되지 않은 자가 T세포를 맞춤형 면역요법으로 투여합니다. 최근 임상적 진보에 따라 TIL 요법의 적용 범위는 흑색종에 그치지 않고, 비소세포폐암(NSCLC), 두경부 편평상피암(HNSCC), 자궁경부암, 유방암, 대장암, 골육종 등 다른 고형암으로도 확대되고 있습니다.
TIL 요법의 작용 기전
TIL 요법은 환자 자신의 면역 세포를 이용하여 암을 표적으로 하는 입양 세포 요법입니다. TIL은 절제된 종양 조직에서 분리되어 인터루킨-2를 이용하여 체외에서 증식시킨 후, 림프구 제거 화학요법 시행 후에 환자에게 재투여됩니다. 이처럼 증식시킨 T세포에는 종양 특이적 항원을 인식하는 종양 반응성 클론이 풍부하게 포함되어 있으며, 이를 통해 암세포를 직접 세포 독성으로 사멸시키고, 종양 미세환경 내의 항종양 면역 반응을 회복시킬 수 있습니다.
이 보고서의 ‘TIL 요법의 역학’ 장에서는 주요 7개국에서 선정된 적응증별 총 사례 수에 따라 분류된 과거 및 미래의 역학 데이터를 제공합니다. 주요 7개국에서 적응증별 TIL 요법의 대상 환자 수와, 2022-2036년까지 미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국, 일본을 대상으로 한 주요 7개국내 적응증별 TIL 요법 치료 사례 수에 대한 과거 데이터 및 미래 예측을 수록하고 있습니다.
TIL 요법의 개발은 1980년대에 스티븐 로젠버그 씨가 LAK 세포와 TIL에 대해 보고한 데서 비롯되었으며, 1986년에는 IL-2로 증식시킨 TIL이 전임상 모델에서 뛰어난 종양 퇴축 효과를 보인 것이 확인되었습니다.
AMTAGVI(리필셀)는 고형암에 대해 FDA 승인을 받은 최초의 T세포 치료제로서, 종양학 분야에서 획기적인 성과로 평가받고 있습니다. 이 맞춤형 단일 투여 TIL 기반 면역요법은 절제 불가능하거나 전이성 흑색종을 가진 성인을 대상으로 승인되었으며, BRAF-V600 변이가 양성인 경우,표준 치료인 1차 선택 PD-1 요법 및 발암 유전자 BRAF 또는 BRAF/MEK 억제제를 이용한 표적 요법을 이미 받은 환자를 대상으로 하며, 치료 수요가 높으나 충족되지 않은 후기 치료 단계의 환자층을 대상으로 합니다.
2024년 2월 FDA의 신속 승인을 통해 AMTAGVI의 선점자 우위가 확립되었으며, 이는 시장내 조기 침투로 빠르게 이어져 2024년 이후의 매출 성장세를 지원하고 있습니다.
AMTAGVI의 흑색종 적응증 승인 이후, 경쟁 구도가 확대되고 있으며, 오브시디언 테라퓨틱스(OBX-115)와 KSQ 테라퓨틱스(KSQ-001EX, KSQ-004EX)가 차세대 TIL 요법 개발을 추진하고 있습니다.
DelveInsight's "Tumor-infiltrating Lymphocytes (TIL) Therapies - Target Population, Competitive Landscape, and Market Forecast - 2036" report delivers an in-depth understanding of TIL therapies, historical and forecasted epidemiology, as well as TIL therapies market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.
The TIL therapies market report provides current treatment practices, emerging drugs, market share of individual therapies, and current and forecasted 7MM TIL therapies market size from 2022 to 2036. The report also covers current TIL therapies, treatment practices/algorithms, and unmet medical needs to curate the best opportunities and assess the market's potential.
Tumor-infiltrating Lymphocytes (TIL) Therapies Overview
Tumor-infiltrating Lymphocytes (TILs) are T cells that are resident within tumors. TILs represent a heterogeneous collection of T cells that can recognize a broad range of cancer-associated antigens, including patient-specific neoantigens. TILs derived from resected tumors can be cultured away from the immunosuppressive tumor microenvironment and expanded ex vivo. Adoptive Cell Therapy (ACT) with TILs involves the infusion of these massively expanded, unmodified autologous T cells as a personalized immunotherapy. Recent clinical advances have extended the application of TIL therapy beyond melanoma to other solid tumors, including NSCLC, HNSCC, cervical carcinoma, breast cancer, colorectal cancer, and osteosarcoma.
Mechanism of TIL Therapies
TIL therapy is an adoptive cell therapy that harnesses a patient's own immune cells to target cancer. TILs are isolated from resected tumor tissue, expanded ex vivo with interleukin-2, and reinfused into the patient after lymphodepleting chemotherapy. These expanded T cells are enriched for tumor-reactive clones that recognize tumor-specific antigens, enabling direct cytotoxic killing of cancer cells and restoration of anti-tumor immune responses within the tumor microenvironment.
The TIL therapies epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by Total cases of selected indications in the 7MM, Indication wise target patient pool of TIL therapies in the 7MM, and Indication wise treated cases of TIL therapies in the 7MM covering the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2022 to 2036.
The drug chapter segment of the TIL therapies report encloses a detailed analysis of the marketed and mid and early-stage (Phase II and I/II) pipeline drugs. The marketed drugs segment encloses AMTAGVI (lifileucel) (Iovance Bioterapeutics) only. Furthermore, the current key players for the upcoming emerging drugs are LN-145 (Iovance Biotherapeutics), TIL therapy (REPROCELL), and others. The drug chapter also helps understand the TIL therapies clinical trial details, expressive pharmacological action, agreements and collaborations, approval and patent details, and the latest news and press releases.
Marketed Drugs
Lifileucel (AMTAGVI/LN-144): 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. This indication is approved under accelerated approval based on ORR. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s). At the end of 2024, more than 200 patients were treated with AMTAGVI during the first three quarters of launch.
In August 2026, as per the Q2 2026 report, Iovance Biotherapeutics resubmitted the MAA for AMTAGVI in the UK in early July. The application is currently undergoing an expedited review by the MHRA, with a potential approval expected later in 2026.
Emerging Drugs
LN-145: Iovance Biotherapeutics
LN-145 is called autologous TIL therapy. It activates WBCs to attack the tumor. LN-145 is made by collecting and growing specialized white blood cells (called T-cells) that are collected from the patient's tumor. LN-145-S1 is made using a modified process that chooses a specific portion of the T-cells. The T cells may specifically recognize, target, and kill the tumor cells. The US FDA granted Fast Track Designation (FTD) for lifileucel for the treatment of adults with metastatic nonsquamous NSCLC.
In August 2026, as per the Q2 2026 report, Iovance announced that the IOV-LUN-202 trial enrollment is nearly complete in the pivotal cohorts and program updates are expected in 4Q26 and support a supplemental BLA for lifileucel in nonsquamous NSCLC, with a potential launch in 2027.
In November 2025, Iovance Biotherapeutics announced interim data from its registrational Phase II IOV-LUN-202 trial of lifileucel monotherapy in patients with previously treated advanced nonsquamous NSCLC.
TIL therapy: REPROCELL
TIL therapy is a type of adoptive immunotherapy in which immune cells called TILs, contained in a patient's cancer tissue, are harvested and cultured in large numbers outside the body, and then the TILs are returned to the patient. In June 2023, REPROCELL entered into an agreement with the Department of Obstetrics and Gynecology of Keio University School of Medicine for the development of a new pipeline for TIL therapy in Advanced Medical Treatment B for advanced cervical cancer. Under this agreement, joint research and development has been conducted.
OBX-115: Obsidian Therapeutics
Obsidian's lead investigational cytoTIL15 program, OBX-115, is a novel engineered TIL cell therapy armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors. Obsidian is investigating OBX-115 in the Phase I/II Agni-01 multicenter trial in patients with advanced solid tumors
In August 2026, Obsidian Therapeutics announced the first patient has been enrolled in the registration-enabling cohort of the Phase I/II Agni-01 multicenter study of OBX-115 in patients with immune checkpoint inhibitor (ICI)-resistant advanced or metastatic melanoma. The company anticipated the topline data from the registration-enabling cohort by year-end 2027.
Drug Class Insights
TIL-based therapies under development encompass a range of adoptive cell therapy approaches, including conventional autologous TIL products (LN-145, CC-38), next-generation engineered or edited TILs (CISH-inactivated TILs, KSQ-001EX [SOCS1 single-edit eTIL], KSQ-004EX [SOCS1/Regnase-1 dual-edit eTIL], IOV-3001, and IOV-4001), cytokine-optimized platforms (OBX-115, an IL-2-sparing engineered TIL therapy), and highly selected tumor-reactive T-cell populations (AGX148, enriched for CD39?CD103?CD8? cells).
Recent Developments in the TIL Therapy Market
The development of TIL therapy began in the 1980s when Steven Rosenberg described LAK cells and TILs, with 1986 marking the first IL-2-expanded TILs showing superior tumor regression in preclinical models.
AMTAGVI (lifileucel) represents a landmark entry in oncology as the first FDA-approved T-cell therapy for a solid tumor. This personalized, one-time TIL-based immunotherapy is approved for adults with unresectable or metastatic melanoma who have previously received standard of care front-line PD-1 therapy and targeted therapy with a proto-oncogene BRAF or BRAF/MEK inhibitor, if BRAF-V600 mutation is positive, addressing a high-unmet, late-line population.
The accelerated FDA approval in February 2024 established AMTAGVI's first-mover advantage, translating quickly into early market uptake and encouraging revenue momentum in 2024 and beyond.
Post-approval of AMTAGVI in melanoma, the competitive landscape has broadened, with Obsidian Therapeutics (OBX-115) and KSQ Therapeutics (KSQ-001EX, KSQ-004EX) advancing next-generation TIL therapies.
This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2026-2036, which depends on the competitive landscape, safety, efficacy data, and 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.
AMTAGVI's uptake is highly dependent on expanding the authorized treatment centers network; insufficient center onboarding could slow adoption and revenue growth.
Tumor-infiltrating Lymphocytes (TIL) Therapies Activities
The report provides insights into different therapeutic candidates in the Phase III and Phase II stages. It also analyzes key players involved in developing targeted therapeutics.
Pipeline Development Activities
The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for intra-tumoral cancer therapies and emerging therapies.
KOL Views
To keep up with the real-world scenario in current and emerging market trends, we take opinions from key industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient therapy switching acceptability, and drug uptake, along with challenges related to accessibility, including Medical/Scientific writers, Professors, and others.
Delveinsight's analysts connected with 15+ KOLs to gather insights; however, interviews were conducted with 10+ KOLs in the 7MM. Centers such as the University of Pittsburgh Cancer Institute, MD Anderson Cancer Center, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or TIL market trends.
Qualitative Analysis
We perform qualitative and market intelligence analysis using various approaches, such as SWOT analysis and analyst views. 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
Market Access refers to the ability of all patients to have access to a given product quickly, conveniently, and affordably. Reimbursement is the negotiation of a price between the manufacturer and payer that allows the manufacturer access to that market. It is provided to reduce the high costs and make essential drugs affordable.
IovanceCares Patient Support Programs
IovanceCares provides comprehensive support to patients, caregivers, and healthcare providers throughout the Iovance treatment journey. IovanceCare includes the IovanceCares Portal, IovanceCares Reimbursement, and Patient Support.
Patient Assistance Program
Patients who are uninsured or underinsured may qualify for other financial assistance.
Co-pay Support Program
Through the Copay Program, IovanceCares will cover out-of-pocket costs up to a certain limit for Iovance products for Commercial patients. Covers expenses for approved Iovance products only.