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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

발행일: | 리서치사: 구분자 DelveInsight | 페이지 정보: 영문 120 Pages | 배송안내 : 2-10일 (영업일 기준)

    
    
    




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한글목차
영문목차

주요 하이라이트 :

  • TIL 요법은 고형암 면역요법에 패러다임 전환을 초래하는 것으로, CAR-T 요법으로는 효과가 미흡했던 영역을 효과적으로 표적화할 수 있게 되었으며, 전이성 흑색종에서 PD-1 및 BRAF/MEK 억제제 이외의 치료 선택지를 확대함과 동시에, 비소세포폐암(NSCLC), 두경부암(HNSCC), 대장암(CRC), 췌장암, 전립선암, 자궁경부암 및 기타 암에 이르는 광범위한 임상 연구를 지원하고 있습니다.
  • 전립선암은 TIL 요법의 최대 표적이며, 그 다음으로 비소세포폐암(NSCLC)이 뒤를 잇습니다. 이는 높은 발병률뿐만 아니라, 극히 낮은 면역원성, 체크포인트 억제제에 대한 반응이 낮다는 점, 그리고 표준 치료 후 효과적인 선택지가 제한적이라는 점에 기인하며, 이는 충족되지 않은 막대한 임상적 요구를 여실히 드러내고 있습니다.
  • AMTAGVI(리필셀)는 최초로 승인된 맞춤형 TIL 요법으로서 선구자적 지위를 확립했으며, PD-1 치료 후 진행된 악성 흑색종에 대해 FDA의 신속 승인을 획득했습니다. 그러나 51만 5,000달러라는 고가의 1회 투여 가격은 세포 치료 비용 범위의 상한선에 위치하여, 보험 적용에 대한 우려를 높일 가능성이 있습니다.
  • TIL 요법 개발 기업은 세계 최대 상업 시장인 미국에서 Iovance사의 ‘퍼스트-인-클래스(First-in-Class)’ 승인을 계기로 주로 미국 시장을 목표로 하고 있습니다. 반면, 아시아, 특히 일본에서의 개발은 여전히 제한적입니다. ReproCELL사의 2상 임상시험 프로그램은 일본에서의 초기 시도이며, 성공할 경우 낮은 제조 비용을 활용하여 일본 환자들의 치료 선택지를 확대할 가능성이 있습니다.
  • OBX-115는 FDA의 FTD(First-in-Traffic) 승인 및 외래 환자 대상 코어 바늘 생검을 통한 TIL 채취를 바탕으로, PD-1/PD-L1 내성 흑색종 분야에서 리파일셀을 대체할 수 있는 효율적이고 잠재적으로 경쟁 가능한 대안으로서의 입지를 확립하고 있습니다.
  • Iovance, Obsidian, KSQ, Intima, CuraCell, REPROCELL을 비롯한 주요 TIL 치료제 개발 기업은 주로 흑색종을 표적으로 삼으면서도 더 광범위한 고형암으로의 적용을 모색하며, 다양한 차세대 플랫폼 개발을 추진하고 있습니다. Iovance가 TIL 요법을 조기 치료 단계로 자리매김하려는 움직임은 치료 전망과 경쟁 구도 모두를 크게 바꿀 가능성이 있습니다.

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.

대상 지역 :

  • 미국
  • EU4(독일, 프랑스, 이탈리아, 스페인) 및 영국
  • 일본

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.

종양 침윤 림프구(TIL) 요법의 역학

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.

  • DelveInsight의 분석에 따르면 2025년 미국의 악성 흑색종 사례 수는 약 5만 5,000건이었습니다.
  • DelveInsight의 추정에 따르면 2025년 스페인의 비소세포폐암(NSCLC) 신규 환자 수는 2만 7,000건이었습니다.
  • DelveInsight의 추정에 따르면 2025년 영국의 대장암 신규 환자 수는 5만 건에 육박했습니다.
  • DelveInsight의 추정에 따르면 2025년 일본의 자궁경부암 신규 환자 수는 약 1만 2,000건이었습니다.

시장 전망

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.

  • 선정된 적응증(비소세포폐암, 두경부암, 대장암, 자궁내막암 및 흑색종) 중 2036년까지 주요 7개국에서 가장 큰 시장 규모를 창출할 것으로 예상되는 것은 흑색종입니다.
  • 2027년 이후 추가 적응증에 대한 승인이 예상됨에 따라 시장 성장은 가속화될 것으로 전망됩니다. 이에 따른 적응증 확대로 TIL 요법은 더 큰 시장 점유율을 확보하고 상승세를 유지할 수 있을 것으로 보입니다. 예측 기간(2025-2036년) 동안 현저한 성장이 예상됩니다.
  • TIL 요법은 PD-1 및 BRAF/MEK 치료 후 전이성 흑색종에 대한 치료 선택지를 확대하고 있으며, FDA가 승인한 최초의 고형암용 T세포 요법으로서 혈액암의 범위를 넘어 세포 요법의 혁신적인 영향을 확대하고 있습니다.
  • Iovance사의 차세대 TIL 프로그램인 IOV-4001(PD-1 비활성화, 제I/II상) 및 IOV-5001(유도형 IL-12, 2026년 초 IND 신청 예정)은 여전히 초기 단계에 있으며,1/2상 임상시험 결과가 공개된 오브시디언의 OBX-115에는 뒤처져 있지만, 유효성 및 안전성 향상과 대상 종양 범위의 확대를 목표로 한 설계 덕분에 이오반스사는 급속히 진화하는 TIL 치료 분야에서 리더십을 유지할 수 있는 입장에 있습니다.
  • 주요 7개국에서 AMTAGVI는 2025년, 흑색종에 대한 유일한 승인 치료제로서 TIL 치료 시장을 휩쓸었습니다. 추가 적응증에 대한 승인이 예상됨에 따라 시장 성장은 가속화될 것으로 전망됩니다. 또한 적응증 확대를 통해 환자의 접근성이 높아져 2036년까지 지속적인 성장이 지원될 것으로 보입니다.
  • 2025년, AMTAGVI는 2억 3,200만 달러의 매출을 기록했으나, 2036년까지 재발성·난치성 비소세포폐암(NSCLC)을 대상으로 한 LN-145가 상당한 시장 점유율을 확보할 것으로 예측됩니다.

자주 묻는 질문

  • TIL 요법의 주요 대상 암은 무엇인가요?
  • AMTAGVI(리필셀)의 주요 특징은 무엇인가요?
  • TIL 요법의 시장 규모는 어떻게 예측되나요?
  • TIL 요법의 작용 기전은 무엇인가요?
  • TIL 요법의 시장 전망은 어떻게 되나요?
  • TIL 요법 개발 기업은 어떤 방향으로 나아가고 있나요?

목차

제1장 서론

제2장 개요

제3장 주요 이벤트

제4장 예측 조사 방법

제5장 시장 개요

제6장 질환의 개요

제7장 역학 및 환자 인구

제8장 시판되고 있는 치료법

제9장 신규 치료법

제10장 주요 시장의 분석

제11장 미충족 수요

제12장 SWOT 분석

제13장 KOL의 견해

제14장 시장 참여 및 보험 상환

제15장 부록

제16장 DelveInsight의 서비스 내용

제17장 면책사항

KSA 26.09.10

Key Highlights:

  • TIL therapy represents a paradigm shift in solid-tumour immunotherapy, enabling effective targeting where CAR-T approaches have fallen short, expanding treatment options beyond PD-1 and BRAF/MEK inhibitors in metastatic melanoma, and supporting broad clinical exploration across NSCLC, HNSCC, CRC, pancreatic, prostate, cervical, and other cancers.
  • Prostate cancer represents the largest TIL therapy target, followed by NSCLC, driven not only by high incidence but also by extremely low immunogenicity, low response to checkpoint inhibitors, and limited effective post-standard-of-care options, highlighting a significant unmet clinical opportunity.
  • AMTAGVI (lifileucel) has established first-mover leadership as the first approved individualized TIL therapy, securing accelerated FDA approval in post-PD-1 advanced melanoma, though its premium one-time price of USD 515,000 positions it at the upper end of the cell therapy cost spectrum and may raise reimbursement sensitivity.
  • TIL therapy developers are primarily targeting the US market, driven by Iovance's first-in-class approval in the world's largest commercial market, while development in Asia, particularly Japan, remains limited; ReproCELL's Phase II program represents an early local effort that, if successful, could leverage lower manufacturing costs and expand treatment options for Japanese patients.
  • OBX-115's FDA FTD and outpatient core needle biopsy-based TIL collection position it as a streamlined, potentially competitive alternative to lifileucel in PD-1/PD-L1-refractory melanoma.
  • Key TIL therapy developers, including Iovance, Obsidian, KSQ, Intima, CuraCell, and REPROCELL, are advancing diverse, next-generation platforms, largely targeting melanoma while exploring broader solid tumors; Iovance's push to position TIL therapy in earlier-line settings could significantly reshape both the treatment landscape and competitive dynamics.

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.

Geography Covered:

  • The United States
  • EU4 (Germany, France, Italy, and Spain) and the United Kingdom
  • Japan

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.

Tumor-infiltrating Lymphocytes (TIL) Therapies Epidemiology

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.

  • As per DelveInsight analysis, the US had around 55,000 cases of melanoma in 2025.
  • As per DelveInsight estimates, there were 27,000 incident cases of NSCLC in Spain in 2025.
  • DelveInsight estimates that in 2025, there were nearly 50,000 incident cases of colorectal cancer in the UK.
  • As per DelveInsight estimates, there were nearly 12,000 incident cases of cervical cancer in Japan in 2025.

Drug Chapters

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

  • 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.
  • In June 2026, Iovance Biotherapeutics announced an allowance to proceed from the US Food and Drug Administration (FDA) for the investigational new drug (IND) application for a Phase I/II basket trial of IOV-5001, a next-generation interleukin-12 (IL-12) tethered TIL therapy. The Phase I/II trial will begin enrolling in the second half of 2026 to investigate the safety and efficacy of a one-time IOV-5001 treatment regimen without the use of IL-2.
  • In April 2026, CuraCell TX AB (CuraCell) announced that the first patient has been successfully included into its ongoing Phase I/IIa clinical trial evaluating the company's novel autologous TIL therapy, CC-38, for patients with metastatic colorectal and metastatic prostate cancer.
  • In March 2026, CuraCell TX AB (CuraCell) announced that the first patient has been successfully included into its ongoing Phase I/IIa clinical trial evaluating the company's novel autologous TIL therapy, CC-38, for patients with metastatic colorectal and metastatic prostate cancer.

Market Outlook

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.

  • Among the selected indications (NSCLC, SCCHN, colorectal, endometrial cancer, and melanoma), melanoma is expected to generate the largest market size in the 7MM by 2036.
  • Market growth is expected to accelerate from 2027 onward, driven by anticipated approvals across additional indications, with subsequent label expansions enabling TIL therapies to capture a larger market share and sustain an upward growth trajectory. Significant rise in growth is expected to be observed over the forecast period (2025-2036).
  • TIL therapy has expanded treatment options for metastatic melanoma post-PD-1 and BRAF/MEK progression, marking the first FDA-approved solid tumor T-cell therapy and extending the transformative impact of cell therapy beyond blood cancers.
  • Iovance's next-generation TIL programs, IOV-4001 (PD-1 inactivation, Phase I/II) and IOV-5001 (inducible IL-12, IND planned early 2026), remain early-stage and behind Obsidian's OBX-115 with Phase I/II result available, but their design for improved efficacy, safety, and broader tumor coverage positions Iovance to maintain leadership in a rapidly evolving TIL therapy landscape.
  • In the 7MM, AMTAGVI dominated the TIL therapy market in 2025 as the only approved treatment for melanoma. Market growth is expected to accelerate with anticipated approvals in additional indications, while label expansions are likely to broaden patient access and support sustained growth through 2036.
  • In 2025, AMTAGVI generated USD 232 million in revenue, while by 2036, LN-145 in relapsed/refractory NSCLC is projected to capture a substantial market share.

Drugs Uptake

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.

Scope of the Report:

  • The report covers a segment of key events, an executive summary, and a descriptive overview of TIL therapies, explaining their causes, signs and symptoms, pathogenesis, and currently available therapies.
  • Comprehensive insight has been provided into the epidemiology segments and forecasts, the future growth potential of the diagnosis rate, disease progression, and treatment guidelines.
  • 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 treatment landscape.
  • A detailed review of the TIL 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 and expert insights/KOL views, patient journey, and treatment preferences that help in shaping and driving the 7MM TIL therapies market.

Tumor-infiltrating Lymphocytes (TIL) Therapies Report Insights

  • Patient population
  • Therapeutic approaches
  • TIL Therapies pipeline analysis
  • TIL Therapies market size and trends
  • Existing and future market opportunity

Tumor-infiltrating Lymphocytes (TIL) Therapies Report Key Strengths

  • 11-year forecast
  • The 7MM coverage
  • TIL Therapies epidemiology segmentation
  • Key cross competition
  • Drug uptake and key market forecast assumptions

Tumor-Infiltrating Lymphocytes (TIL) Therapies Report Assessment

  • Current treatment practices
  • Unmet needs
  • Conjoint Analysis
  • Pipeline product profiles
  • Market attractiveness
  • Qualitative analysis (SWOT)

FAQs:

  • What is the historical and forecasted TIL Therapies patient pool in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan?
  • What was the TIL Therapies total market size, the market size by therapies, market share (%), distribution in 2025, and what would it look like by 2036? What are the contributing factors for this growth?
  • Which therapy is going to be the largest contributor by 2036?
  • What are the pricing variations among different geographies for approved and off-label therapies?
  • What are the recent novel therapies, targets, mechanisms of action, and technologies developed to overcome the limitations of existing therapies?
  • Patient acceptability in terms of preferred treatment 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 in developing business strategies by understanding the latest trends and changing treatment dynamics driving the TIL Therapies market.
  • Insights on patient burden/disease cases, evolution in diagnosis, and factors contributing to the change in the epidemiology of the disease during the forecast years.
  • 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) and the United Kingdom, and Japan.
  • Identifying strong upcoming players in the market will help devise strategies to help get ahead of competitors.
  • Highlights of access and reimbursement policies of approved therapies, barriers to accessibility of expensive off-label therapies, and PAPs.
  • To understand key opinion leaders' perspectives on the accessibility, acceptability, and compliance-related challenges of existing treatment to overcome barriers in the future.
  • Detailed insights into the unmet needs of the existing market so that the upcoming players can strengthen their development and launch strategy.

Table of Contents

1. INTRODUCTION

2. EXECUTIVE SUMMARY

  • 2.1. Key Takeaways
  • 2.2. Market Insights
  • 2.3. Epidemiology Insights
  • 2.4. Summary of Market and Epidemiology Insights

3. KEY EVENTS

  • 3.1. Upcoming Key Catalysts
  • 3.2. Key Transactions and Collaborations
  • 3.3. Conference Highlights
  • 3.4. News Flow

4. FORECAST METHODOLOGY

5. MARKET OVERVIEW

  • 5.1. Clinical Landscape - Analysis by Phase, Companies, and Mechanism of Action [MoA]
  • 5.2. Market Share of TIL Therapies by Indication (%) in 2028
  • 5.3. Market Share of TIL Therapies by Indication (%) in 2036
  • 5.4. Market Share of TIL Therapies by Therapies (%) in 2028
  • 5.5. Market Share of TIL Therapies by Therapies (%) in 2036

6. DISEASE OVERVIEW

  • 6.1. Overview
    • 6.1.1. Administration of TIL Therapy
    • 6.1.2. Side Effects of TIL Therapy
    • 6.1.3. TIL Therapy in Other Solid Cancers
  • 6.2. Emerging Directions and Future Perspectives
    • 6.2.1. Genetically engineered TILs
    • 6.2.2. Cytokine Enhancement and On-demand Support
    • 6.2.3. Optimizing Lymphodepletion Regimens
    • 6.2.4. Quality Attributes for TIL Products
  • 6.3. Guidelines
    • 6.3.1. Clinical Management of Patients Receiving TIL Cell Therapy: Guidelines and Best Practices
    • 6.3.2. NCCN Guidelines for Melanoma

7. EPIDEMIOLOGY AND PATIENT POPULATION

  • 7.1. Key Findings
  • 7.2. Assumptions and Rationale
    • 7.2.1. Prevalence of Prostate Cancer
  • 7.3. Epidemiology Scenario in the 7MM
    • 7.3.1. Total Cases of Selected Indications in the 7MM
    • 7.3.2. Indication-wise Eligible Cases in the 7MM
    • 7.3.3. Indication-wise Treated Cases in the 7MM

8. Marketed Therapy

  • 8.1. Details of Marketed Therapy
  • 8.2. Lifileucel (AMTAGVI/LN-144): Iovance Biotherapeutics
    • 8.2.1. Product Description
    • 8.2.2. Regulatory Milestones
    • 8.2.3. Other Developmental Activities
    • 8.2.4. Summary of Pivotal Trial
    • 8.2.5. Clinical Development Activity
    • 8.2.6. Safety and Efficacy
    • 8.2.7. Analyst Views

9. EMERGING THERAPIES

  • 9.1. Key Competitors
  • 9.2. LN-145: Iovance Biotherapeutics
    • 9.2.1. Product Description
    • 9.2.2. Other Developmental Activities
    • 9.2.3. Clinical Development Timeline
    • 9.2.4. Clinical Development
    • 9.2.5. Safety and Efficacy
    • 9.2.6. Analyst Views
  • 9.3. TIL Therapy: REPROCELL
    • 9.3.1. Product Description
    • 9.3.2. Other Developmental Activities
    • 9.3.3. Clinical Development
    • 9.3.4. Analyst Views
  • 9.4. IOV-3001: Iovance Biotherapeutics
    • 9.4.1. Product Description
    • 9.4.2. Other Developmental Activities
    • 9.4.3. Clinical Development
    • 9.4.4. Safety and Efficacy
    • 9.4.5. Analyst Views
  • 9.5. IOV-4001: Iovance Biotherapeutics
    • 9.5.1. Product Description
    • 9.5.2. Other Developmental Activities
    • 9.5.3. Clinical Development
    • 9.5.4. Analyst Views
  • 9.6. CC-38: Curacell Holding
    • 9.6.1. Product Description
    • 9.6.2. Other Developmental Activities
    • 9.6.3. Clinical Development
    • 9.6.4. Analyst Views
  • 9.7. CISH inactivated TIL: Intima Bioscience
    • 9.7.1. Product Description
    • 9.7.2. Other Developmental Activities
    • 9.7.3. Clinical Development
    • 9.7.4. Safety and Efficacy
    • 9.7.5. Analyst Views
  • 9.8. KSQ-001EX: KSQ Therapeutics
    • 9.8.1. Product Description
    • 9.8.2. Other Developmental Activities
    • 9.8.3. Clinical Development
    • 9.8.4. Analyst Views
  • 9.9. KSQ-004EX: KSQ Therapeutics
    • 9.9.1. Product Description
    • 9.9.2. Other Developmental Activities
    • 9.9.3. Clinical Development
    • 9.9.4. Analyst Views
  • 9.1. OBX-115: Obsidian Therapeutics
    • 9.10.1. Product Description
    • 9.10.2. Other Developmental Activities
    • 9.10.3. Clinical Development
    • 9.10.4. Safety and Efficacy
    • 9.10.5. Analyst Views

10. LEADING MARKETS ANALYSIS

  • 10.1. Key Findings
  • 10.2. Market Outlook
  • 10.3. Conjoint Analysis
  • 10.4. Key Market Forecast Assumptions
    • 10.4.1. Cost Assumptions
  • 10.5. Total Market Size of TIL Therapies by Country in the 7MM
  • 10.6. Total Market Size of TIL Therapies by Indications in the 7MM
  • 10.7. The United States
    • 10.7.1. Total Market Size of TIL Therapies by Indications in the United States
    • 10.7.2. Total Market Size by Therapies in the US
  • 10.8. EU4 and the UK
    • 10.8.1. Total Market Size of TIL Therapies by Indications in EU4 and the UK
    • 10.8.2. Total Market Size by Therapies in EU4 and the UK
  • 10.9. Japan
    • 10.9.1. Total Market Size of TIL Therapies by Indications in Japan
    • 10.9.2. Total Market Size by Therapies in Japan

11. UNMET NEEDS

12. SWOT Analysis

13. KOL VIEWS

  • 13.1. Key Questions Addressed

14. MARKET ACCESS AND REIMBURSEMENT

  • 14.1. United States
    • 14.1.1. Centre for Medicare & Medicaid Services (CMS)
  • 14.2. EU4 and the UK
    • 14.2.1. Germany
    • 14.2.2. France
    • 14.2.3. Italy
    • 14.2.4. Spain
    • 14.2.5. The United Kingdom
    • 14.2.6. Japan
    • 14.2.7. MHLW
  • 14.3. TIL Market Access and Reimbursement

15. APPENDIX

  • 15.1. Bibliography
  • 15.2. Report Methodology

16. DELVEINSIGHT CAPABILITIES

17. DISCLAIMER

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