TIL Therapies

Global TIL Therapy Market (2nd Edition), 2023-2035: Distribution by Target Indication, Key Players and Key Geographical Regions (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2023-2035

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TIL Therapy Overview

The global TIL therapy market is estimated to be worth $0.09 billion in 2023 and is expected to grow at compounded annual growth rate (CAGR) of 40% during the forecast period. The global TIL therapy market is a growing market within the cell therapy market and is estimated to grow at a CAGR of 40% during the forecast period. Over the years, various studies have validated the successful use of tumor infiltrating lymphocytes (TILs) in treating patients diagnosed with refractory diseases. TILs are a heterogeneous population of mononuclear lymphocytes that comprise of T-cells, B-cells, NK cells and macrophages isolated from the tumor. These lymphocytes selectively mediate the elimination of tumor cells. Ongoing and planned clinical research initiatives in this direction are driven by encouraging results achieved in past trials, which were mostly focused on various solid tumors. Driven by the ongoing pace of innovation in this field, sufficient financial support from investors and encouraging clinical trial results, the TIL therapy market is likely to witness significant growth during the forecast period.

Key Market Insights

The Global TIL Therapy Market (2nd Edition), 2023-2035: Distribution by Target Indication (Melanoma, Head and Neck Carcinoma, Chronic Lymphocytic Leukemia, Sarcoma, Hepatocellular Carcinoma, Breast Cancer, Acute Myeloid Leukemia and Cervical Carcinoma), Key Players and Key Geographical Regions (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World):  Industry Trends and Global Forecasts, 2023-2035 report features an extensive study of the current market landscape, market size and future opportunity for the companies focused on the development of TIL cell therapy. The market report answers many key questions related to this industry.

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Need for TIL Cell Therapy for the Treatment of Various Types of Cancer

Modified tumor infiltrating lymphocytes (TIL)-based interventions have emerged as a viable and potent option to selectively eradicate the tumor population, with minimal side effects. Till date, several clinical trials have demonstrated the efficacy and therapeutic superiority (over conventional treatment options) of TIL therapies. Their tumor-cell killing efficiency is attributed to the fact that they are pre-sensitized to cancer specific antigens. Additionally, this emerging class of biologics is believed to possess the potential to cater to the unmet pharmacological needs, across both oncological and non-oncological disorders, even those where small molecule drugs have proven to be inadequate.

Current Tumor Infiltrating Lymphocytes Market Landscape 

Over 75 TIL cell therapy are being evaluated across different stages of preclinical / clinical development, either as monotherapies or in combination with other drugs. Both industry and non-industry players have demonstrated keen interest in the development of novel tumor infiltrating lymphocytes as therapeutics. Further, melanoma emerged as the most popular target indication in TIL therapy market. More than 95% of the TIL therapy candidates that are being developed to target a wide range of disease indications are autologous in nature.

Indication Analysis: Melanoma to Drive TIL Therapy Market Size in the Short-Term

With a growing focus on the development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate (CAGR) of 40% in the next decade. Specifically, in terms of target indication, the market is anticipated to be driven by TIL therapy targeting melanoma and head and neck carcinoma. Iovance Biotherapeutics’ drug lifileucel is expected to be the first TIL therapy to receive FDA approval in 2023. Iovance Biotherapeutics first submitted a rolling BLA for lifileucel in the treatment of patients with metastatic melanoma to the FDA in August 2022 and received FDA feedback for additional information in November 2022. The company expects to complete the rolling BLA submission for lifileucel in Q1 2023. TIL cell therapy for treatment of solid tumors has also reached phase II clinical trials and will drive the market growth in the long-term, owing to the presence of a number of drug developers evaluating this indication.

Regional Analysis: North America Holds the Largest TIL Therapy Market Share

Additionally, close to 90% of the market is anticipated to be captured by players based in North America and Europe, in 2035. Within North America, the US is expected to see the first TIL therapy approval in 2023. Once approved, lifileucel will continue to drive the market growth in the short term. According to the National Cancer Institute statistic, there were an estimated 1,413,976 people living with melanoma of the skin in the US in 2020. Although melanoma only accounts for 1% of all the skin cancers in the US, it still accounts for a high mortality amongst all skin cancer. There have been novel, effective treatment options available for melanoma approved by the FDA that have changed the treatment paradigm for melanoma; however, there is need for more effective therapeutics. Overall, we are led to believe that the global TIL therapy market is poised to witness significant growth in the foreseen future.   

Technology Analysis: Development of Genetically-Engineered TIL Therapy

A number of TIL therapy developers have also started evaluating genetically engineered tumor infiltrating lymphocytes. The companies have developed proprietary technology platforms for engineering TILs. In December 2022, US based Instil Bio discontinued its TIL therapy ITIL-168, in phase 2 clinical trials for metastatic melanoma, stating its intent to focus on genetically-engineered TIL therapy instead of unmodified tumor infiltrating lymphocytes. As such, the company’s lead molecule now is ITIL-306, an autologous TIL cell therapy engineered using their CoStAR platform. The TIL therapy is in phase I clinical trial for solid tumors. Another US based company, Obsidian Therapeutics has a proprietary cytoDRIVE® platform for development of engineered TIL therapy. Their lead candidate, OBX-115, is an engineered TIL being tested in phase I clinical trials in patients with metastatic melanoma. Such technological developments is likely to contribute to the improvement in the safety and efficacy of TIL therapies, driving the TIL therapy market growth.

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Trends Analysis: TIL Therapy to Introduce the “Academic Pharma” Model

TIL therapy market has a number of academic / non-industry players actively conducting and sponsoring clinical trials. The lead TIL cell therapy against melanoma is in phase III clinical trials at the Netherlands Cancer Institute. The team of researchers presented positive results from phase 3 trial at ESMO Congress in September 2022, in which the TIL therapy was evaluated in patients with melanoma with Ipilimumab used as a comparator drug. The Netherlands Cancer Institute plans to gain EMA approval for its TIL therapy and ensure its access to melanoma patients at affordable prices, without the involvement of pharmaceutical industry. In line with its plans, the institute has also set up a manufacturing unit within its premises. The approval can introduce a new business model of Academic Pharma, motivating the other institutes to also take the lead in ensuring market access to tumor infiltrating lymphocytes.

Increase in Funding and TIL Therapy Clinical Trials Reflect the Rising Interest in Tumor Infiltrating Lymphocytes Market

A growing interest in TIL cell therapy is reflected from the increase in the partnerships focused on R&D of such therapies. Several investors, having realized the opportunity within this upcoming segment of T-cell immunotherapy, have invested USD 2.7 billion, across 30 instances, since 2013. Further, in the last 10 years, close to 95 TIL therapy clinical trials have been registered across different geographies. Mostly driven by the need for effective treatment options for cancer, the TIL therapy pipeline is expected to steadily grow over the forecast period. Moreover, clinical success is likely to draw in investments that are likely to support the ongoing and anticipated therapy development initiatives. The market includes a number of start-ups and the funding will provide them necessary support to move their drug candidates towards commercialization. These developments will support the market growth of TIL therapy during the forecast period.

Key Companies in TIL Therapy Market

Examples of key players engaged in this domain (which have also been captured in this report) include Bristol-Myers Squibb, CAR-T (Shanghai) Cell Biotechnology, Cellectis, Incyte Corporation, Instil Bio, Iovance Biotherapeutics, Lytix Biopharma, Phio Pharmaceuticals and Prometheus Laboratories. This market report includes an easily searchable excel database with all TIL therapy / tumor infiltrating lymphocyte developers, both industry and academic institutes, worldwide.

Recent Developments in TIL Therapy Market

Several recent developments have taken place in the field of TIL therapies. We have outlined some of these recent initiatives below. These developments, even if they took place post the release of our market report, substantiate the overall market trends that have been outlined in our analysis.

  • In August 2023, Phio Pharmaceuticals in collaboration with AgonOx and Providence Cancer Institute  announced the dosing of first patient suffering from melanoma and other advanced solid tumors with AGX148 'double positive' (DP) CD8 tumor-infiltrating lymphocytes (TIL) alone and in combination with Phio's PD-1 silencing PH-762. 
  • In July 2023,  Iovance Biotherapeutics received positive regulatory and clinical updates for IOV-LUN-202 with an aim to accelerated approval of TIL therapy in Post-Anti-PD-1 Advanced Non-Small Cell Lung Cancer (NSCLC). 
  • In May 2023, Iovance Biotherapeutics announced the FDA acceptance of its biologics license application (BLA) for lifileucel.  Additionally, lifileucel received priority review status.

Scope of the Report

The study presents an in-depth analysis of the various firms / organizations that are engaged in this domain, across different attrributes / segments as defined in the below table:

Key Report Attributes Details

Forecast Period

2023 – 2035

Base Year 2022
CAGR 40%

Target Indication

Melanoma, Head and Neck Carcinoma, Chronic Lymphocytic Leukemia, Sarcoma, Hepatocellular Carcinoma, Breast Cancer, Acute Myeloid Leukemia, Cervical Carcinoma

Key Players

Iovance Biotherapeutics, Bristol-Myers Squibb, Instil Bio, Lytix Biopharma, CAR-T (Shanghai) Cell Biotechnology, Incyte Corporation, Prometheus Laboratories

Key Geographical Regions

North America, Europe, Asia-Pacific, Latin America, Middle East and North Africa, Rest of the World

Key Companies Profiled

Cellectis, Cellular Biomedicine Group, Iovance Biotherapeutics, Lytix Biopharma, Phio Pharmaceuticals

Customization Scope

15% Free Customization Option (equivalent to 5 analyst working days)

PowerPoint Presentation (Complimentary)

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Excel Data Packs (Complimentary)

Market Landscape AnalysisClinical Trial Analysis, KOL Analysis, Partnership and Collaboration Analysis, Funding and Investment Analysis, Patent Analysis, Market Forecast and Opportunity Analysis

The research report presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this market, across different geographies. Amongst other elements, the report includes:

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  • An executive summary of the insights captured during our research. It offers a high-level view on the current state of global TIL therapy market and its likely evolution in the mid-long term.
  • A general overview of TIL  therapies in comparison to conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes historical evolution of cancer immunotherapy, general manufacturing procedure of T-cell immunotherapies, and key attributes in the development of TIL cell therapies.
  • A detailed assessment of the overall market landscape of TIL therapy, based on several relevant parameters, such as type of developer (industry and non-industry), phase of development (preclinical, phase I, phase I/II, phase II, phase III and approved), therapeutic area (hematological cancer, solid tumor and others), key target indications (melanoma, ovarian cancer, cervical cancer, lung cancer, pancreatic cancer, sarcoma, breast cancer, squamous cell carcinoma, fallopian tube cancer, gastric cancer, head and neck squamous cell carcinoma and others), source of T-cells (autologous and allogeneic), route of administration (intravenous and hepatic arterial infusion), dosing frequency (single dose and multiple dose), target patient segment (children, adults and seniors), and type of therapy (monotherapy and combination therapy). Further, the chapter also provides developer landscape of industry and non-industry players engaged in this market. 
  • An analysis of completed, ongoing, and planned TIL therapy clinical trials , based on several relevant parameters, such as trial registration year, enrolled patient population, trial status, trial phase, target patient segment, type of sponsor / collaborator, study design, most active players (in terms of number of registered trials), key focus areas and geography.
  • An insightful analysis highlighting the key opinion leaders (KOLs) in tumor infiltrating lymphocytes market, featuring an analysis of the various principal investigators of clinical trials related to TIL therapies, considering them to be KOLs, who are actively involved in R&D of TIL therapies. In addition, it compares the relative expertise of KOLs based on a proprietary scoring criterion with that of a third party.
  • Elaborate profiles of mid- to late-stage clinical products (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, dosage information, details on the cost and sales information (wherever available), a clinical development plan, and clinical trial results.
  • A detailed analysis of recent partnerships inked between several stakeholders engaged in TIL therapy market, covering R&D agreements, license agreements (specific to technology platforms and product candidates), manufacturing agreements, clinical trial collaborations and others.
  • An analysis of the funding and investments that have been made into companies having proprietary TIL therapies / technologies, including venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing.
  • An in-depth analysis of patents related to tumor infiltrating lymphocytes, filed / granted till 2022, based on several relevant parameters, such as type of patent (granted and patent applications), patent publication year, geographical distribution, type of player, Cooperative Patent Classification (CPC) symbols, emerging focus areas, leading players (in terms of number of patents), and patent benchmarking. In addition, it features a patent valuation analysis, which evaluates the qualitative and quantitative aspects of the patents. 
  • A case study on manufacturing cell therapy products, highlighting the key challenges, and a detailed list of contract service providers and in-house manufacturers involved in this space.
  • An elaborate discussion on various factors that form the basis for the pricing of cell-based therapies. It features different models / approaches that a pharmaceutical company may choose to adopt to decide the price of a TIL- therapy that is likely to be marketed in the coming years.
  • Elaborate profiles of the leading players in the TIL therapy market. Each company profile includes an overview of the developer and a brief description of the product portfolio specific to TIL therapies, the technology portfolio (if available), recent developments related to TIL therapies, and the manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

One of the key objectives of the research report was to estimate the current market size and the future growth potential of tumor infiltrating lymphocytes over the forecast period. Based on several parameters, such as target consumer segments, region-specific adoption rates, and expected prices of such products, we have developed informed estimates of the likely evolution of the market over the period 2022-2035. The report also includes likely sales forecasts of TIL therapies that are in the mid- to late stages of development. Additionally, it features market size projections for the overall TIL therapy market, wherein both the current and upcoming opportunity is segmented across target indication (melanoma, head and neck carcinoma, chronic lymphocytic leukemia, sarcoma, hepatocellular carcinoma, breast cancer, acute myeloid leukemia and cervical carcinoma), key players and key geographical regions (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World). In order to account for future uncertainties and add robustness to our model, we have provided three market forecast scenarios, namely the conservative, base, and optimistic scenarios, which represent different tracks of the industry’s evolution.

All actual figures have been sourced and analyzed from publicly available information forums and primary research discussions. Financial figures mentioned in this report are in USD, unless otherwise specified.

The opinions and insights presented in the report were also influenced by discussions held with senior stakeholders in the industry.

Frequently Asked Questions

Question 1: What are tumor infiltrating lymphocytes (TIL Therapy)?

Answer: TILs are a heterogeneous population of mononuclear lymphocytes that comprise of T-cells, B-cells, NK cells and macrophages isolated from the tumor.

Question 2: Are there any approved TIL therapies?

Answer: As of date, there is no approved TIL therapy. The first TIL therapy is expected to receive FDA approval in 2023.

Question 3: What are the side effects of TIL cell therapy?

Answer: Some of the side effects noted in TIL therapy clinical trials are fever, chills and shortness of breath. Few other adverse events mainly associated with chemotherapy or IL-2 treatment given before and with TIL cell therapy are neutropenia, lymphopenia and coagulopathy.

Question 4: What is the growth rate of TIL therapy market?

Answer: The global TIL therapy market is expected to grow at a compound annual growth rate (CAGR) of 40% during the forecast period 2023-2035.

Question 5: Which region has the highest growth rate in the TIL therapy market?

Answer: Europe is growing at the highest CAGR, over the forecast period 2023-2035.

Question 6: How many players are developing tumor infiltrating lymphocytes?

Answer: Close to 30 industry and non-industry players are currently evaluating the potential of over 75 TIL- therapies for the treatment of various oncological and non-oncological disorders.

Question 7: Which target indication is likely to cover the largest TIL therapy market share in 2035?

Answer: Melanoma is likely to capture the maximum share (51%) of the TIL therapy market in 2035.

Question 8: What is the partnership and collaboration trend in the TIL therapy market?

Answer: Currently, R&D agreements, licensing agreements, and manufacturing agreements are the common types of partnerships inked by developers involved in the tumor infiltrating lymphocytes market.

Question 9: What is the current IP landscape of tumor infiltrating lymphocytes market?

Answer: More than 70% of the filed patents were patent applications, while around 28% were granted patents. Of the total granted applications, more than 95% were filed in the US.

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