Global TIL-based Therapy Market (2nd Edition), 2023-2035

Global TIL-based Therapy Market (2nd Edition), 2023-2035

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-based therapy market is likely to witness significant growth in the foreseen future.

KEY MARKET INSIGHTS

The Global TIL-based 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 and future opportunity for the players focused on the development of TIL-based therapies. The report answers many key questions related to this domain.

Need for TIL-based Therapies 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-based 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 Market Landscape of TIL-based Therapies

Over 75 TIL immunotherapies 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 TIL-based cell therapies. Further, melanoma emerged as the most popular target indication in this domain. More than 95% of the therapy candidates that are being developed to target a wide range of disease indications are autologous in nature.

Rising Interest in TIL-based Therapies

A growing interest in TIL-based therapies 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 clinical trials evaluating TIL-based therapies have been registered across different geographies. Mostly driven by the need for effective treatment options for cancer, the TIL-based therapy pipeline is expected to steadily grow over the coming years. Moreover, clinical success is likely to draw in investments that are likely to support the ongoing and anticipated therapy development initiatives.

Market Size of the TIL-based Therapy Market

With a growing focus on the development pipeline and encouraging clinical results, the market is anticipated to witness an annualized growth rate of 40% in the next decade. Specifically, in terms of target indication, the market is anticipated to be driven by therapies being developed to target melanoma and head and neck carcinoma. Additionally, close to 90% of the market is anticipated to be captured by players based in North America and Europe, in 2035. Overall, we are led to believe that the global TIL-based therapy market is poised to witness significant growth in the foreseen future.

Who are the Key Players in the TIL-based 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.

SCOPE OF THE REPORT

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

TIL-based Therapies Market: Report Attribute / Market Segmentations

Key Report Attributes

Details

Forecast Period

2023– 2035

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)

Available

Excel Data Packs (Complimentary)

Market Landscape Analysis

Clinical Trial Analysis

KOL Analysis

Partnership and Collaboration Analysis

Funding and Investment Analysis

Patent Analysis

Market Forecast and Opportunity Analysis

Source: Roots Analysis

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

An executive summary of the insights captured during our research. It offers a high-level view on the current state of global TIL-based therapies market and its likely evolution in the mid-long term.

A general overview of TIL-based 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-based therapies.

A detailed assessment of the overall market landscape of TIL-based therapies, 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 domain.

An analysis of completed, ongoing, and planned clinical studies related to TIL-based therapies, 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 this domain, featuring an analysis of the various principal investigators of clinical trials related to TIL-based therapies, considering them to be KOLs, who are actively involved in R&D of TIL-based 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 this domain, 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-based products / technologies, including venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing.

An in-depth analysis of patents related to TIL-based therapies, 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-based therapy that is likely to be marketed in the coming years.

Elaborate profiles of the leading players in the domain of TIL-based therapies. Each company profile includes an overview of the developer and a brief description of the product portfolio specific to TIL-based therapies, the technology portfolio (if available), recent developments related to TIL-based 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 report was to estimate the current opportunity and the future growth potential of TIL-based therapies over the coming decade. 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-based therapies that are in the mid- to late stages of development. Additionally, it features market size projections for the overall TIL-based therapies 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.

RESEARCH METHODOLOGY

The data presented in this report has been gathered via secondary and primary research. For all our projects, we conduct interviews / surveys with experts in the area (academia, industry, medical practice and other associations) to solicit their opinions on emerging trends in the market. This is primarily useful for us to draw out our own opinion on how the market will evolve across different regions and technology segments. Wherever possible, the available data has been checked for accuracy from multiple sources of information.

The secondary sources of information include:

Annual reports

Investor presentations

SEC filings

Industry databases

News releases from company websites

Government policy documents

Industry analysts’ views

While the focus has been on forecasting the market till 2035, the report also provides our independent view on various technological and non-commercial trends emerging in the industry. This opinion is solely based on our knowledge, research and understanding of the relevant market gathered from various secondary and primary sources of information.

FREQUENTLY ASKED QUESTIONS

Question 1: What is the growth rate of TIL-based therapy market?

Answer: The global TIL-based therapies market is expected to grow at a compound annual growth rate (CAGR) of 40% from 2023-2035.

Question 2: Which region has the highest growth rate in the TIL-based Therapies market?

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

Question 3: How many players are developing TIL-based Therapies?

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

Question 4: Which target indication is likely to cover the largest TIL-based therapy market share in 2035?

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

Question 5: What is the partnership and collaboration trend in the TIL-based therapy domain?

Answer: Currently, R&D agreements, licensing agreements, and manufacturing agreements are the common types of partnerships inked by developers involved in the TIL-based therapy domain.

Question 6: What is the current IP landscape of TIL-based therapies 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.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, TIL-based therapy market (2nd Edition), 2023-2035.

Chapter 2 provides an executive summary of the insights captured in our research. It offers a high-level view on the likely evolution of the TIL-based therapy market in the short to mid-term and long term.

Chapter 3 provides a general overview of TIL-based therapies. In this section, we have briefly discussed the conventional forms of therapy that are being used for the treatment of various oncological indications. Further, it includes a discussion on the advent and historical evolution of cancer immunotherapy, general manufacturing procedure of T-cell immunotherapies, and key attributes in the development of TIL-based therapies.

Chapter 4 includes detailed assessment of the current market landscape of more than 75 TIL-based therapies that are currently approved or are in different stages of the development. It features a comprehensive analysis of pipeline molecules with respect to the 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, chapter also includes developer landscape analysis based on some relevant parameters, including year of establishment, company size (small, mid-sized, and large) and location of headquarters (North America, Europe, and Asia Pacific).

Chapter 5 presents a detailed analysis of completed, ongoing, and planned clinical studies related to TIL-based therapies, based on several relevant parameters, such as trial registration year, enrolled patient population, trial recruitment status, trial phase, target patient segment, type of sponsor / collaborator, study design, most active players (in terms of number of registered trials), and geography.

Chapter 6 presents an analysis highlighting the key opinion leaders (KOLs) in this domain, featuring an analysis of the various principal investigators of clinical trials related to TIL-based therapies, considering them to be KOLs, who are actively involved in R&D of TIL-based therapies. In addition, it compares the relative expertise of KOLs based on a proprietary scoring criterion with that of a third party.

Chapter 7 provides detailed profiles of mid to late-stage TIL-based therapies (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), clinical development plan, and key clinical trial results.

Chapter 8 features an analysis of the recent partnerships inked between several stakeholders engaged in this domain, covering R&D agreements, license agreements (specific to technology platforms and product candidates), manufacturing agreements, clinical trial collaborations and others, companies involved, type of therapy, prominent product candidates involved and regional distribution of the collaborations.

Chapter 9 provides details on the various funding and investments that have been made into companies having proprietary TIL-based products / technologies, including venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing. It includes a detailed analysis of the funding instances that have taken place in the period between 2013 to 2022, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 10 provides an in-depth analysis of patents related to TIL-based therapies, 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.

Chapter 11 provides case study on cell therapy manufacturing, highlighting the current challenges that exist in this domain, and the pre-requisites for owning and maintaining cell therapy manufacturing sites. Additionally, it includes a detailed list of various cell therapy manufacturers, covering both contract manufacturing organizations and companies with in-house manufacturing capabilities. For the players mentioned in the chapter, we have included details on location of various manufacturing facilities, the products being manufactured, scale of operation and compliance to cGMP standards.

Chapter 12 highlights our views on the various factors that must be taken into consideration while deciding the prices of cell-based therapies. It features discussions on different models / approaches that a pharmaceutical company may choose to follow to decide the price at which their TIL-based therapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for TIL-based therapies.

Chapter 13 features an elaborate discussion on the future commercial opportunity offered by TIL-based therapies. It provides a comprehensive market forecast analysis for TIL-based products that are approved or are in phase I/II and phase II of development, taking into consideration the target patient population, existing / future competition, likely adoption rates and the likely price of different therapies. The chapter also presents a detailed market segmentation, based on 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).

Chapter 14 includes brief company profiles of the leading players in the domain of TIL-based therapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to TIL-based therapies, technology portfolio (if available), recent developments related to TIL-based therapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

Chapter 15 is a summary of the overall report. In this chapter, we have provided a list of key takeaways from the report, and expressed our independent opinion related to the research and analysis described in the previous chapters.

Chapter 16 is a collection of transcripts of interviews conducted with key stakeholders in the market.

Chapter 17 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 18 is an appendix, which contains a list of companies and organizations mentioned in the report.