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TIL-based Therapies Market by Target Indications, Key Players and Key Geographies: Industry Trends and Global Forecasts, 2021-2030

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  • 260 Pages
  • April 2021
  • Region: Global
  • Roots Analysis
  • ID: 5359103

Lucrative Opportunities Await the Companies Having the Required Capabilities to Develop and Manufacture TIL-based Therapies

The inadequacy of legacy pharmacological interventions, such as chemotherapy, radiation therapy, and surgery, in addressing the complex treatment-related needs of cancer patients, have paved way for more effective and versatile alternatives. Amidst the current initiatives to develop targeted anti-cancer therapies, 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 efficacy and therapeutic superiority (over conventional treatment options) of TIL-based therapies. Their tumor-cell killing efficiencies are attributed to the fact that they are pre-sensitized to cancer specific antigens. The contemporary TIL-based therapies market is characterized by a healthy and growing pipeline of close to 60 product candidates; in fact, more than 28 of such therapies, including CCRT+TIL (Sun Yat-sen University), Lifileucel (Iovance Biotherapeutics), LTX-315 and TILs (Lytix Biopharma/Herlev Hospital), and IOV-2001 (Iovance Biotherapeutics), are in the advanced stages of development. The first TIL-based therapy, LN-145 being developed by Iovance Biotherapeutics, is expected to get approval in 2022. Given the therapeutic benefits that they have displayed thus far, it is likely that the lucrative opportunities await the companies having the required capabilities to develop and manufacture TIL-based therapies, in the foreseen future.

Over time, the clinical success of several TIL-based immunotherapy candidates, have inspired numerous research groups across the world, to focus their efforts on this relatively novel class of anti-cancer therapies. Post 2014, the interest in T-cell therapies, including those involving TILs, has grown exponentially. Moreover, a substantial body of evidence favoring the therapeutic benefits of TIL-based therapies, has prompted the establishment of numerous strategic partnerships (focused on therapy development and clinical research) and caused several public and private investors to put in significant capital into innovator companies involved in this domain. Promising clinical results, and ongoing technical developments, coupled to the growing interest of biopharmaceutical developers, are anticipated to enable the rapid progression of pipeline candidates into higher phases of development and eventually, into the market. We are led to believe that the global TIL-based therapies market is poised to witness significant growth in the foreseen future.

Scope of the Report

The report features an extensive study of the current market landscape and future potential of TIL-based therapies. The report highlights the efforts of both industry players and academic organizations in this rapidly evolving segment of the biopharmaceutical industry. 

Amongst other elements, the report features the following:

  • A detailed assessment of the current market landscape of TIL-based therapies with respect to type of developer (industry/non-industry), phase of development (preclinical, phase I, phase I/II and phase II), therapeutic area (hematological cancer, solid tumor and others), popular target indications (melanoma, ovarian cancer, pancreatic cancer, head and neck cancer, sarcoma, colon cancer, acute myeloid leukemia, stomach cancer, chronic lymphocytic leukemia, cervical cancer, breast cancer and others), source of T-cells (autologous and allogeneic), dose frequency (single dose, multiple dose and split dose), target patient segment (children, adults and elderly patients) and type of therapy (monotherapy and combination therapy). Further, the chapter provides detail on the most active players (in terms of number of pipeline candidates) engaged in this domain. 
  • An analysis highlighting the key opinion leaders (KOLs) in this domain. It features a 2×2 matrix assessing the relative experience of KOLs shortlisted based on their contributions (in terms of involvement in various clinical studies) in this field, and a schematic world map representation, indicating the geographical location of eminent scientists/researchers engaged in the development of TIL-based therapies.
  • Detailed profiles of therapies being evaluated in clinical stages (phase I/II or above); each profile features an overview of the therapy, its mechanism of action, current development status, key clinical trial results, dosage regimen and manufacturing information.
  • An overview of key therapeutic areas that are being targeted by TIL-based therapies. It also includes an assessment of the opportunity (in terms of revenue generation potential from therapy sales) across oncological disease indications.
  • An analysis of the partnerships that have been established in the recent past, covering R&D agreements, license agreements (specific to technology platforms and product candidates), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures and others.
  • An analysis of investments that have been made into companies which have proprietary TIL-based products/technologies. The various type of funding instances reported in this domain include seed financing, venture capital financing, capital raised from IPOs and subsequent public offerings, grants, and debt financing.
  • A case study on manufacturing of cell therapy products, highlighting the key challenges associated with the production of such therapies. In addition, it features a detailed list of contract service providers and in-house manufacturers engaged in this market.
  • 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 adopt, in order to decide the price of a TIL-based therapy.
  • A review of the key promotional strategies that have been adopted by developers of marketed T-cell therapies, namely KYMRIAH® and YESCARTA®.

One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities for 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 2021-2030. 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 [A] target indications (melanoma, head and neck cancer, breast cancer, hepatocellular cancer, sarcoma, chronic lymphocytic leukemia, acute lymphoblastic leukemia, and cervical cancer), [B] key players and [C] key geographies (North America, Europe, Asia Pacific). In order to account for future uncertainties and to 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.

Key Questions Answered

  • What are the prevalent R&D trends related to TIL-based therapies?
  • Which are the key therapeutic areas targeted by TIL-based therapies?
  • Who are the leading industry and non-industry players engaged in the development of TIL-based therapies?
  • What challenges are commonly faced by stakeholders engaged in this domain?
  • Who are the key investors in this domain? 
  • Who are the key opinion leaders/experts engaged in this upcoming field of therapeutics?
  • Which types of partnership models are commonly adopted by industry stakeholders? 
  • Which are the key regions where contract manufacturing support is available for TIL-based therapies?
  • What are the different types of promotional strategies that are likely to be adopted for approved/yet to be commercialized TIL-based therapies?
  • Which factors are likely to influence the evolution of this upcoming market?
  • How is the current and future market opportunity likely to be distributed across key market segments?

Table of Contents

1.1. Scope of the Report
1.2. Research Methodology
1.3. Key Questions Answered
1.4. Chapter Outlines

3.1. Chapter Overview
3.2. Pillars of Cancer Therapy
3.3. Overview of Immunotherapy
3.4. Fundamentals of Cancer Immunotherapy
3.5. Classification of Cancer Immunotherapies
3.5.1. By Mechanism of Action Active Immunotherapy Passive Immunotherapy
3.5.2. By Type of Target
3.5.3. By Approach Activation and Suppression Immunotherapy
3.5.4. By Product Class Monoclonal Antibodies Bispecific Antibodies Cytokines Oncolytic Virus Therapy Therapeutic Cancer Vaccines Cell-based Therapies
3.6. T-Cell Immunotherapies
3.6.1. Historical Evolution of T-Cell Immunotherapies
3.6.2. Key Considerations for Developing T-Cell Immunotherapies
3.6.3. Strategies Employed for the Redirection of T-Cells
3.6.4. Manufacturing Process of Engineered T-Cells
3.6.5. T-Cell Transduction and Transfection Methods Retroviral Vectors Lentiviral Vectors Non-viral Transfection Methods
3.7. Tumor Infiltrating Lymphocyte (TIL)-based Cell Therapies
3.7.1. Historical Evolution
3.7.2. Development of TIL-based Therapies
3.7.3. Key Challenges and Roadblocks Associated with the Development of TIL
3.8. Concluding Remarks

4.1. Chapter Overview
4.2. TIL-based Therapies: Overall Market Landscape
4.2.1. Analysis by Type of Developer
4.2.2. Analysis by Phase of Development
4.2.3. Analysis by Therapeutic Area
4.2.4. Analysis by Popular Target Indications
4.2.5. Analysis by Source of T-Cells
4.2.6. Analysis by Dose Frequency
4.2.7. Analysis by Target Patient Segment
4.2.8. Analysis by Type of Therapy
4.2.9. Key Industry Players: Analysis by Number of TIL-based Therapies
4.2.10. Key Non-Industry Players: Analysis by Number of TIL-based Therapies

5.1. Chapter Overview
5.2. TIL-based Therapies: Key Opinion Leaders
5.2.1. TIL-based Therapies: Most Prominent Key Opinion Leaders

6.1. Chapter Overview
6.2. Autologous TIL Therapies (Iovance Biotherapeutics)
6.2.1. Therapy Overview
6.2.2. Current Development Status LN-144 LN-145
6.2.3. Key Clinical Trial Results LN-144 LN-145
6.2.4. Dosage Regimen and Manufacturing
6.2.5. Patent Portfolio
6.3. TIL (Nantes University Hospital)
6.3.1. Therapy Overview
6.3.2. Current Development Status
6.3.3. Key Clinical Trial Results
6.3.4. Dosage Regimen and Manufacturing
6.4. TIL (Netherlands Cancer Institute)
6.4.1. Therapy Overview
6.4.2. Current Development Status
6.4.3. Key Clinical Trial Results
6.4.4. Dosage Regimen and Manufacturing

7.1. Chapter Overview
7.2. Hematological Malignancies
7.2.1. Leukemia and Lymphoma Leukemia: Introduction and Epidemiology Lymphoma: Introduction and Epidemiology Current Treatment Landscape Targeted Therapies TIL-based Therapies and Affiliated Research Landscape TIL-based Therapies and Leukemia
7.3. Solid Tumors
7.3.1. Metastatic Melanoma Introduction and Epidemiology Current Treatment Landscape TIL-based Therapies and Affiliated Research Landscape
7.3.2. Pancreatic Cancer Introduction and Epidemiology Current Treatment Landscape TIL-based Therapies and Affiliated Research Landscape
7.3.3. Liver Cancer Current Treatment Landscape TIL-based Therapies and Affiliated Research Landscape
7.3.4. Breast Cancer Introduction and Epidemiology Current Treatment Landscape TIL-based Therapies and Affiliated Research Landscape
7.3.5. Ovarian Cancer Introduction and Epidemiology Current Treatment Landscape TIL-based Therapies and Affiliated Research Landscape

8.1. Chapter Overview
8..2. Types of Partnership Models
8.3. TIL-based Therapies: Partnerships and Collaborations
8.3.1. Analysis by Year of Partnership
8.3.2. Analysis by Type of Partnership
8.3.3. Analysis by Type of Partner
8.3.4. Most Active Industry Players: Analysis by Number of Partnerships
8.3.5. Most Active Non-Industry Players: Analysis by Number of Partnerships
8.3.6. Most Active Contract Manufacturers: Analysis by Number of Manufacturing
8.3.7. Analysis by Geography Region-wise Distribution Country-wise Distribution

9.1. Chapter Overview
9.2. Types of Funding
9.3. TIL-based Therapies: Funding and Investment Analysis
9.3.1. Analysis by Year of Investment
9.3.2. Analysis by Amount Invested
9.3.3. Analysis by Type of Funding
9.3.4. Most Active Players: Analysis by Number of Funding Instances
9.3.5. Analysis by Type of Investor
9.3.6. Most Active Investors: Analysis by Number of Funding Instances
9.3.7. Regional Analysis by Amount Invested

10.1. Chapter Overview
10.2. Overview of Cell Therapy Manufacturing
10.3. Cell Therapy Manufacturing Models
10.3.1. Centralized Manufacturing Model
10.3.2. Decentralized Manufacturing Model
10.4. Scalability of Cell Therapy Manufacturing Processes
10.4.1. Scale-up
10.4.2. Scale-out
10.5. Types of Cell Therapy Manufacturers
10.6. Key Challenges associated with Manufacturing of Cell Therapies
10.7. Factors Affecting the Process of Cell Therapy Manufacturing
10.7.1. Characterization
10.7.2. Cost of Goods
10.8. Automation of Cell Therapy Manufacturing Processes
10.9. Cell Therapy Manufacturing Supply Chain
10.10. Companies with In-House Capabilities
10.11. Contract Manufacturers
10.12. Regulatory Landscape

11.1. Chapter Overview
11.2. Factors Contributing to the High Price of Cell/Gene Therapies
11.3. Pricing Models for T-Cell Therapies
11.3.1. Based on Associated Costs
11.3.2. Based on Availability of Competing Products
11.3.3. Based on Target Patient Segment
11.3.4. Based on the Opinions of Industry Experts
11.4. Reimbursement-related Considerations for T-Cell Therapies
11.4.1. Case Study: The National Institute for Health and Care Excellence (NICE) Appraisal of CAR-T Cell Therapies

12.1. Chapter Overview
12.2. Cellular Biomedicine Group
12.3. Iovance Biotherapeutics
12.4. Lytix Biopharma
12.5. Phio Pharmaceuticals

13.1. Chapter Overview
13.2. Scope and Limitations
13.3. Key Assumptions and Forecast Methodology
13.4. Overall TIL-based Therapies Market
13.4.1. TIL-based Therapies Market: Distribution by Target Indication
13.4.2. TIL-based Therapies Market:  Distribution by Key Players
13.4.3. TIL-based Therapies Market: Distribution by Geography TILs (Netherlands Cancer Institute) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis Lifileucel (LN-144) (Iovance Biotherapeutics) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis LN-145 (Iovance Biotherapeutics) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis IOV-2001 (Iovance Biotherapeutics) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis LTX-315 and TILs (Lytix Biopharma) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis Allogeneic donor lymphocyte infusions (DLI) (Amgen/University of Munich) Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis TILs (CAR-T (Shanghai) Cell Biotechnology) (CAR-T (Shanghai) Cell Target Patient Population Sales Forecast (USD Million) Net Present Value (USD Million) Value Creation Analysis

14.1. Chapter Overview
14.2. Channels Used for Promotional Campaigns
14.3. Summary of Product Website Analysis
14.4. Summary of Patient Support Services and Informative Downloads
14.5. KYMRIAH®: Promotional Analysis
14.5.1. Drug Overview
14.5.2. Product Website Analysis Messages for Healthcare Professionals Messages for Patients
14.5.3. Patient Support Services and Informative Downloads
14.5.4. Other Promotional Activities Presence in Conferences
14.6. YESCARTA®: Promotional Analysis
14.6.1. Drug Overview
14.6.2. Product Website Analysis Messages for Healthcare Professionals Messages for Patients
14.6.3. Patient Support Services and Informative Downloads
14.6.4. Other Promotional Activities Presence in Conferences

16.1. Chapter Overview
16.2. Iovance Biotherapeutics
16.2.1. Interview Transcript: Peter Ho, Director, Process Development17. APPENDIX 1: TABULATED DATA18. APPENDIX 2: LIST OF COMPANIES AND ORGANIZATIONS

Companies Mentioned

  • Alexandria Real Estate Equities
  • Amgen
  • Astero Bio
  • Autolus
  • Beijing Cancer Hospital
  • BioLife Solutions
  • Blood Centers of America 
  • Bristol-Myers Squibb
  • CAR-T (Shanghai) Cell Biotechnology
  • Casebia Therapeutics
  • Cell and Gene Therapy Catapult
  • Cellectis
  • Cellular Biomedicine Group 
  • Center for Cell and Gene Therapy
  • Cognate BioServices
  • CRISPR Therapeutics 
  • Cryoport
  • Dana-Farber Cancer Institute
  • Eastern Hepatobiliary Surgery Hospital
  • Fred Hutchinson Cancer Research Center
  • H. Lee Moffitt Cancer Center and Research Institute
  • Hadassah Medical Center
  • Herlev Hospital
  • Henan Cancer Hospital
  • Herlev Hospital
  • Immetacyte
  • Incyte
  • Intima Bioscience
  • Intrexon
  • Iovance Biotherapeutics
  • Johns Hopkins University
  • Karolinska Institutet
  • Karolinska University Hospital
  • Keio University
  • Key Biologics
  • KSQ Therapeutics
  • Lausanne University Hospital
  • Leukemia and Lymphoma Society
  • Lonza
  • Lyell Immunopharma
  • Lytix Biopharma
  • Marker Therapeutics
  • Masonic Cancer Center
  • Massachusetts General Hospital
  • MaSTherCell
  • MaxCyte
  • MD Anderson Cancer Center
  • MedImmune
  • Merck
  • Miltenyi Biotec
  • Nantes University Hospital
  • National Cancer Institute
  • National Institutes of Health
  • Oxford BioMedica
  • PACT Pharma
  • PharmaCell
  • Phio Pharmaceuticals
  • PolyBioCept
  • Precision BioSciences
  • Prometheus Laboratories
  • Roswell Park Cancer Institute
  • Sheba Medical Center
  • Stratophase 
  • Sun Yat-sen University
  • Synthace 
  • The Japanese Society for Regenerative Medicine
  • The Netherlands Cancer Institute
  • The Ohio State University 
  • TILT Biotherapeutics
  • Tongji Medical College of Huazhong University of Science and Technology
  • TrakCel
  • University of North Carolina (UNC) School of Medicine 
  • University Health Network, Toronto
  • University of California
  • University of Manchester
  • University of Minnesota
  • University of Munich
  • University of Pittsburgh
  • V Foundation for Cancer Research
  • Vineti
  • WindMIL Therapeutics
  • WuXi AppTec
  • Yale University