Tumor-infiltrating Lymphocytes (TIL) Therapies Market Forecast to 2036: Target Population, Competitive Landscape, and Growth Opportunities

Dublin, Oct. 09, 2026 (GLOBE NEWSWIRE) -- "Tumor-Infiltrating Lymphocyte (TIL) Therapies - Market Size, Target Population, Competitive Landscape & Market Forecast - 2036" has been added to ResearchAndMarkets.com's offering.

The report provides a comprehensive assessment of the TIL therapies market across the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. It examines historical and forecasted epidemiology, current treatment practices, marketed and emerging therapies, competitive positioning, drug uptake, market access, and commercial opportunities from 2022 to 2036.

Key Market Highlights

• TIL therapy is reshaping solid-tumour immunotherapy by addressing cancers in which CAR-T approaches have faced limitations. Clinical development extends beyond metastatic melanoma into NSCLC, HNSCC, colorectal, pancreatic, prostate, cervical, endometrial, and other solid tumors.
• Prostate cancer represents a substantial Target opportunity because of its high incidence, low immunogenicity, limited response to checkpoint inhibitors, and shortage of effective options following standard treatment.
• AMTAGVI (lifileucel) has secured first-mover leadership as the first FDA-approved individualized TIL therapy and the first approved T-cell therapy for a solid tumor. Its one-time price of USD 515,000 may increase payer scrutiny and reimbursement sensitivity.
• The United States remains the primary commercial focus for TIL therapy developers. Activity in Japan is more limited, although REPROCELL's Phase II program could support local market development and potentially Benefit from lower manufacturing costs.
• OBX-115 has received FDA Fast Track Designation and uses outpatient core needle biopsy-based TIL collection, positioning it as a potentially streamlined competitor in PD-1/PD-L1-refractory melanoma.
• Iovance Biotherapeutics, Obsidian Therapeutics, KSQ Therapeutics, Intima Bioscience, CuraCell, and REPROCELL are advancing conventional, engineered, edited, and cytokine-optimized TIL platforms across multiple solid-tumor indications.

TIL Therapies Epidemiology and Target Population

The report analyzes Total Fina Elf cases, indication-specific Target populations, and treated cases across the 7MM. DelveInsight's analysis estimated approximately 55,000 melanoma cases in the United States in 2025. Spain recorded an estimated 27,000 incident NSCLC cases, while the United Kingdom had nearly 50,000 incident colorectal cancer cases. Japan reported approximately 12,000 incident cervical cancer cases during the same year.

These patient populations support significant long-term demand for personalized cell therapies, particularly among patients whose disease progresses after checkpoint inhibition, targeted therapy, chemotherapy, or other standard-of-care regimens. Among selected indications, melanoma is expected to generate the largest TIL therapy market size in the 7MM by 2036.

Marketed TIL Therapy

AMTAGVI (lifileucel/LN-144): Iovance Biotherapeutics

AMTAGVI is approved for adults with unresectable or metastatic melanoma previously treated with a PD-1 blocking antibody and, for patients with a BRAF V600 mutation, a BRAF inhibitor with or without a MEK inhibitor. The FDA granted accelerated approval based on overall response rate, with continued authorization potentially dependent on confirmatory evidence of clinical Benefit .

More than 200 patients received AMTAGVI during the first three quarters following launch. In 2025, the therapy generated USD 232 million in revenue and dominated the TIL therapy market as the only approved product in this category. Commercial uptake remains closely linked to the expansion of authorized treatment centers, manufacturing capacity, reimbursement coverage, and patient access.

In July 2026, Iovance resubmitted the AMTAGVI marketing authorization application in the United Kingdom. The application is undergoing expedited review by the MHRA, with potential approval expected later in 2026.

Emerging TIL Therapy Pipeline

LN-145: Iovance Biotherapeutics

LN-145 is an autologous TIL therapy being evaluated across solid tumors. The FDA granted Fast Track Designation for lifileucel in adults with metastatic nonsquamous NSCLC. Enrollment in the pivotal cohorts of the Phase II IOV-LUN-202 trial was nearly complete as of the second quarter of 2026. Program updates expected in the fourth quarter of 2026 could support a supplemental BLA and a potential NSCLC launch in 2027.

OBX-115: Obsidian Therapeutics

OBX-115 is an engineered TIL therapy incorporating pharmacologically regulatable membrane-bound IL15. It is being evaluated in the Phase I/II Agni-01 multicenter study for advanced solid tumors. In August 2026, the first patient entered the registration-enabling cohort for immune checkpoint inhibitor-resistant advanced or metastatic melanoma. Topline results are anticipated by year-end 2027.

TIL Therapy: REPROCELL

REPROCELL is developing a TIL therapy for advanced cervical cancer in collaboration with the Department of Obstetrics and Gynecology at Keio University School of Medicine. The partnership, established in June 2023, supports joint research and development under Japan's Advanced Medical Treatment B framework.

Next -generation Programs

The development pipeline includes conventional autologous products such as LN-145 and CC-38, engineered or edited candidates including CISH-inactivated TILs, KSQ-001EX, KSQ-004EX, IOV-3001, and IOV-4001, and cytokine-optimized therapies such as OBX-115. Iovance is also advancing IOV-5001, an interleukin-12 tethered TIL therapy intended for administration without IL-2. In June 2026, the FDA allowed its Phase I/II basket trial to proceed, with enrollment scheduled to begin during the second half of 2026.

CuraCell enrolled the first patient in its Phase I/IIa study of CC-38 for metastatic colorectal and metastatic prostate cancer in 2026. These programs demonstrate the industry's focus on improving efficacy, safety, manufacturing efficiency, tumor coverage, and treatment convenience.

TIL Therapies Market Outlook

Market growth is expected to accelerate from 2027 as potential approvals in additional indications and label expansions increase the eligible patient population. TIL therapies could gain a larger role in earlier treatment settings, intensifying competition with checkpoint inhibitors, targeted therapies, chemotherapy, and other cell therapy platforms.

AMTAGVI's leadership is supported by its regulatory advantage, established manufacturing infrastructure, and early commercial adoption. However, its PREMIUM price and complex treatment pathway create access challenges. Competitors may differentiate through outpatient collection, reduced cytokine requirements, enhanced tumor persistence, edited immune-cell functionality, or more efficient production.

By 2036, LN-145 in relapsed/refractory NSCLC is projected to capture a substantial market share. The broader commercial trajectory will depend on clinical outcomes, durability of response, safety, treatment-center availability, payer policies, manufacturing scalability, regulatory timing, and physician acceptance.

Market Access and Patient Support

The report evaluates reimbursement policies, affordability barriers, geographic accessibility, and patient assistance initiatives. IovanceCares supports patients, caregivers, and healthcare providers through reimbursement assistance, treatment coordination, and digital resources. Eligible uninsured or underinsured patients may qualify for financial assistance, while commercially insured patients may receive support for qualifying out-of-pocket costs related to approved Iovance products.

Report Scope and Strategic Value

• Historical and forecasted TIL therapy epidemiology from 2022 to 2036
• Market size, therapy-level revenue, market share, and drug uptake analysis
• Profiles of marketed, Phase III, Phase II, and Phase I/II candidates
• Clinical trial, regulatory, patent, licensing, collaboration, acquisition, and merger activity
• Current treatment algorithms, patient journeys, unmet needs, and therapy preferences
• Country-specific pricing, reimbursement, and accessibility considerations
• SWOT analysis, competitive intelligence, market attractiveness, and forecast assumptions
• Insights from more than 10 key opinion leader interviews across the 7MM, including engagement with major cancer research and treatment centers

The report supports pharmaceutical companies, biotechnology developers, investors, healthcare providers, and market access teams seeking to understand the evolving TIL therapies competitive landscape. Its 11-year forecast identifies high-potential indications, emerging competitors, commercial barriers, patient access requirements, and strategic opportunities across the global solid-tumor cell therapy market.

Key Topics Covered

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 Fina Elf 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
9.10. 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 Fina Elf Market Size of TIL Therapies by Country in the 7MM
10.6. Total Fina Elf Market Size of TIL Therapies by Indications in the 7MM
10.7. The United States
10.7.1. Total Fina Elf Market Size of TIL Therapies by Indications in the United States
10.7.2. Total Fina Elf Market Size by Therapies in the US
10.8. EU4 and the UK
10.8.1. Total Fina Elf Market Size of TIL Therapies by Indications in EU4 and the UK
10.8.2. Total Fina Elf Market Size by Therapies in EU4 and the UK
10.9. Japan
10.9.1. Total Fina Elf Market Size of TIL Therapies by Indications in Japan
10.9.2. Total Fina Elf 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
14.3. Japan
14.3.1. MHLW
14.4. TIL Market Access and Reimbursement

15. APPENDIX
15.1. Bibliography
15.2. Report Methodology

List of Tables [28]

List of Figures [20]

For more information about this report visit https://www.researchandmarkets.com/r/qi6zof

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