Global TCR-based Therapy Market (2nd Edition), 2022-2035

Global TCR-based Therapy Market (2nd Edition), 2022-2035

Modified T-cell receptor (TCR)-based therapy is an emerging class of adoptive therapy that employs genetically modified lymphocytes to target specific tumor markers. Their tumor-cell killing efficacy may be primarily attributed to the fact that they are pre-sensitized to cancer specific antigens; this enables such interventions to selectively target and eliminate tumor cells from the body of a host with negligible treatment-related side effects. Ongoing and planned clinical research initiatives in this direction are driven by encouraging results achieved in past trials, which were mostly focused on various hematological cancers and solid tumors. Driven by the ongoing pace of innovation in this field, sufficient financial support from investors and encouraging clinical trial results, the TCR-based therapy market is likely to witness significant growth in the foreseen future.

KEY MARKET INSIGHTS

The “Global TCR-based Therapy Market (2nd Edition), 2022-2035: Distribution by Target Indication (Nasopharyngeal Carcinoma, Multiple Myeloma, Head and Neck Carcinoma, Sarcoma, Melanoma, Acute Myeloid Leukemia, Lung Cancer, Ovarian Cancer, and Merkel Cell Cancer), Target Antigen (NY-ESO-1, EBV, gp100, and others), Key Players and Key Geographies (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World): Industry Trends and Global Forecasts, 2022-2035” report features an extensive study of the current market landscape and future potential of TCR-based therapies. The report highlights the efforts of several stakeholders engaged in this rapidly evolving segment of the biopharmaceutical industry. The report answers many key questions related to this domain:

Need for TCR-based Therapies for the Treatment of Various Types of Cancer

Modified T-cell receptor (TCR)-based therapies, an upcoming class of cell-based interventions, is a promising therapeutic modality. Similar to other T-cell based interventions (such as CAR-T cells and TILs), TCR-based therapies are designed to target the underlying causes (or primary mediators) of a clinical condition. Additionally, this emerging class of biologics is believed to possess the potential to cater to unmet pharmacological needs across both oncological and non-oncological disorders, even those where small molecule drugs have proven to be inadequate. , Although TCR-based immunotherapies are still considered an experimental approach, several clinical studies demonstrate the efficacy and therapeutic superiority of TCR cell products.

Current Market Landscape of TCR-based Therapies

Presently, more than 100 industry and non-industry players across the globe are evaluating the potential of over 190 TCR-based immunotherapies for the treatment of various oncological and non-oncological disorders. It is worth highlighting that, in January 2022, the FDA approved the first TCR-based therapy, Kimmtrak® (Immunocore), for the treatment of adult patients with unresectable or metastatic uveal melanoma. More than 90% of the therapy candidates that are being developed to target a wide range of disease indications are autologous in nature. Further, NY-ESO-1 and MAGE emerged as the most popular target antigens in this domain.

Rising Interest in TCR-based Therapies

The growing interest in this field is reflected in the notable increase in partnerships inked (close to 140 deals inked in the past decade; CAGR 23%) by several industry players and academic / research institutes. Additionally, various investors, having realized the opportunity within this upcoming segment of T-cell immunotherapy, have invested USD 11 billion across 140 instances, since 2007. Further, in the last 10 years, close to 110 clinical trials have been registered across different geographies for the evaluation of TCR-based therapies. Mostly driven by the need for effective treatment options for cancer, the TCR-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 TCR-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 51% in the next decade. Specifically, in terms of target indication, the market is anticipated to be driven by nasopharyngeal carcinoma, multiple myeloma, and head and neck carcinoma. Additionally, more than 80% of the market is anticipated to be captured by players based in Europe and Asia-Pacific in 2035. Overall, we are led to believe that the global TCR-based therapy market is poised to witness significant growth in the foreseen future.

Who are the Key Players in the TCR-based Therapy Market

Examples of key players engaged in this domain (which have also been captured in this report) include Adaptimmune Therapeutics, Alaunos Therapeutics, blubird bio, Bristol Myers Squibb, Cellular Biomedicine Group, China Immunotech, Gilead Sciences, GlaxoSmithKline, Immatics

Immunocore, Intellia Therapeutics, Lion TCR, Takara Bio, TCRCure Biopharma, and Zelluna Immunotherapy.

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:

TCR-based Therapies Market: Report Attribute / Market Segmentations

Report Attribute Details

Forecast Period 2022 – 2035

Target Indications Nasopharyngeal Carcinoma

Multiple Myeloma

Head and Neck Carcinoma

Sarcoma

Melanoma

Acute Myeloid Leukemia

Lung Cancer

Ovarian Cancer

Merkel Cell Cancer

Target Antigens NY-ESO-1

EBV

gp100

Others

Key Players GlaxoSmithKline

China Immunotech

Xinqiao Hospital of Chongqing

TCRCure Biopharma

Adaptimmune Therapeutics

Immunocore

Intellia Therapeutics

Takara Bio

bluebird bio

Key Geographical Regions North America

Europe

Asia-Pacific

Latin America

Middle East and North Africa

Rest of the World

Key Companies Profiled Adaptimmune Therapeutics

Alaunos Therapeutics

Bristol Myers Squibb

Cellular Biomedicine Group

Gilead Sciences

GlaxoSmithKline

Immatics

Immunocore

Lion TCR

Takara Bio

Zelluna Immunotherapy

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 TCR-based therapies market and its likely evolution in the mid-long term.

A general overview of TCR-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 development of TCR-based therapies

A detailed assessment of the overall market landscape of TCR-based therapies, based on several relevant parameters, such as type of developer (industry and non-industry), phase of development (approved, phase II, phase I / II, phase I, and preclinical), therapeutic area (hematological cancer, solid tumor, and undisclosed), key target indication (lung cancer, melanoma, hepatocellular carcinoma, cervical cancer, ovarian cancer, sarcoma, breast cancer, gastric cancer, multiple myeloma, pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, nasopharyngeal carcinoma, and others), key target antigen (NY-ESO-1, MAGE, HBV, PRAME, KRAS, EBV, HPV, Neoantigen, LAGE-1a, Meso, HLA, and others), source of T-cells (autologous / allogeneic), route of administration (intravenous and intratumoral), dosing frequency (single dose, multiple dose, and split dose), target patient segment (children, adults, and elderly patients), type of therapy (monotherapy and combination therapy) and most active players (in terms of number of TCR-based therapies). Further, the chapter also provides developer landscape of industry and non-industry players engaged in this domain.

A detailed analysis of popular target antigens, based on the number of TCR-based therapies that are being developed for a particular type of antigen by various industry stakeholders to identify potential targets.

An analysis of completed, ongoing, and planned clinical studies related to TCR-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, 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 TCR-based therapies, considering them to be KOLs, who are actively involved in R&D of TCR-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 marketed and 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), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures, and others.

An analysis of the funding and investments that have been made into companies having proprietary TCR-based products / technologies, including seed financing, venture capital financing, capital raised from IPOs and subsequent offerings, grants, and debt financing.

An in-depth analysis of patents related to TCR-based therapies, filed / granted till 2022, based on several relevant parameters, such as type of patent (granted, patent applications, and search reports), patent publication year, geographical distribution, Cooperative Patent Classification (CPC) symbols, emerging focus area, type of player, leading player (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.

A n 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 TCR-based therapy that is likely to be marketed in the coming years.

A review of the key promotional strategies that are being implemented by the developers of the approved TCR-based therapy (Kimmtrak®).

Elaborate profiles of the leading players in the domain of TCR-based therapies. Each company profile includes an overview of the developer and a brief description of the product portfolio specific to TCR-based therapies, the technology portfolio (if available), recent developments related to TCR-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 TCR-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 TCR-based therapies that are in the mid- to late stages of development. Additionally, it features market size projections for the overall TCR-based therapies market, wherein both the current and upcoming opportunity is segmented across target indication (nasopharyngeal carcinoma, multiple myeloma, head and neck carcinoma, sarcoma, melanoma, acute myeloid leukemia, lung cancer, ovarian cancer and merkel cell cancer), target antigen (NY-ESO-1, EBV, gp100 and others), 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.

The opinions and insights presented in this study were influenced by discussions conducted with several stakeholders in this domain. The report features detailed transcripts of interviews held with the following individuals:

Vincent Brichard (Vice President, Immuno-Oncology, Celyad)

Adrian Bot (Vice President, Scientific Affairs, Kite Pharma)

Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR)

Miguel Forte (Former Chief Operating Officer, TxCell)

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.

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, 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 segments. Where 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 TCR-based therapy market?

Answer: The global TCR-based therapies market is expected to grow at a compound annual growth rate of 51% from 2022-2035.

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

Answer: Asia Pacific is growing at the highest CAGR, over the period 2022- 2035.

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

Answer: More than 100 industry and non-industry players are currently evaluating the potential of over 190 TCR-based immunotherapies for the treatment of various oncological and non-oncological disorders.

Question 4: Which target indication covers the largest TCR-based therapy market share?

Answer: Multiple myeloma, presently, captures the maximum share (43%) of TCR-based therapy market in 2022. This share is likely to decrease in the foreseen future as several promising leads are anticipated to be commercially launched over the coming decade.

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

Answer: Currently, R&D agreements, licensing agreements, and product development and commercialization agreements are the common type of partnerships inked by developers involved in the TCR-based therapy domain.

Question 6: What is the current IP landscape of TCR-based therapies market?

Answer: Close to 76% of the filed patents were patent applications, while around 24% were granted patents and search reports. Of the total granted applications, close to 78% were filed in the US.

CHAPTER OUTLINES

Chapter 1 is a preface providing an introduction to the full report, TCR-based therapy market (2nd Edition), 2022-2035.

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 TCR-based therapy market in the short to mid-term and long term.

Chapter 3 provides a general overview of TCR-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 development of TCR-based therapies.

Chapter 4 includes detailed assessment of the current market landscape of more than 190 TCR-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 / non-industry), phase of development (approved, phase II, phase I / II, phase I, and preclinical), therapeutic area (hematological cancer, solid tumor, and undisclosed), key target indication (lung cancer, melanoma, hepatocellular carcinoma, cervical cancer, ovarian cancer, sarcoma, breast cancer, gastric cancer, multiple myeloma, pancreatic cancer, acute myeloid leukemia, myelodysplastic syndrome, nasopharyngeal carcinoma, and others), key target antigen (NY-ESO-1, MAGE, HBV, PRAME, KRAS, EBV, HPV, Neoantigen, LAGE-1a, Meso, HLA, and others), source of T-cells (autologous / allogeneic), route of administration (intravenous and intratumoral), dose frequency (single dose, multiple dose, and split dose), target patient segment (children, adults and elderly patients), type of therapy (monotherapy and combination therapy). Additionally, it highlights the most active industry and non-industry players (in terms of number of pipeline candidates) engaged in development of TCR-based therapies. 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 comprehensive target antigen analysis, highlighting the most popular target antigens related to hematological malignancies and solid tumors, based on the number of TCR-based therapies that are being developed for a particular type of antigen by various industry stakeholders to identify potential targets.

Chapter 6 presents a detailed analysis of completed, ongoing, and planned clinical studies related to TCR-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, most active players (in terms of number of registered trials), and geography.

Chapter 7 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 TCR-based therapies, considering them to be KOLs, who are actively involved in R&D of TCR-based therapies. In addition, it compares the relative expertise of KOLs based on a proprietary scoring criterion with that of a third party.

Chapter 8 provides detailed profiles of marketed and mid to late stage TCR-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 9 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), product development and commercialization agreements, manufacturing agreements, clinical trial collaborations, product supply management agreements, joint ventures, and others, companies involved, type of therapy, prominent product candidates involved and regional distribution of the collaborations.

Chapter 10 provides details on the various funding and investments that have been made into companies having proprietary TCR-based products / technologies, including seed financing, 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 2005 to 2022, highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 11 provides an in-depth analysis of patents related to TCR-based therapies, filed / granted till 2022, based on several relevant parameters, such as type of patent (granted, patent applications, and search reports), patent publication year, geographical distribution, Cooperative Patent Classification (CPC) symbols, emerging focus area, type of player, leading player (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 12 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 13 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 TCR-based therapy product can be marketed. Additionally, we have provided a brief overview of the reimbursement consideration for TCR-based therapies.

Chapter 14 features an elaborate discussion on the future commercial opportunity offered by TCR-based therapies. It provides a comprehensive market forecast analysis for TCR-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 (nasopharyngeal carcinoma, multiple myeloma, head and neck carcinoma, sarcoma, melanoma, acute myeloid leukemia, lung cancer, ovarian cancer and merkel cell cancer), target antigen (NY-ESO-1, EBV, gp100 and others), key players, and key geographical regions (North America, Europe, Asia Pacific, Latin America, Middle East and North Africa, and Rest of the World).

Chapter 15 highlights the key promotional strategies that are being implemented by the developers of the approved TCR-based therapy (Kimmtrak®). The promotional aspects covered in the chapter include details that are provided on the product website (covering key messages for patients and healthcare professionals), patient support offerings, and informative downloadable content.

Chapter 16 includes brief company profiles of the leading players in the domain of TCR-based therapies. Each company profile includes an overview of the developer and brief description of the product portfolio specific to TCR-based therapies, technology portfolio (if available), recent developments related to TCR-based therapies and manufacturing capabilities of the companies. Additionally, we have provided details of the strategic / venture capital investments made in these companies.

Chapter 17 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 18 is a collection of transcripts of interviews conducted with key stakeholders in the market. In this chapter, we have presented the details of our conversations with Vincent Brichard (Vice President, Immuno-Oncology, Celyad), Adrian Bot (Vice President, Scientific Affairs, Kite Pharma), Victor Lietao Li (Co-Founder and Chief Executive Officer, Lion TCR), and Miguel Forte (Former Chief Operating Officer, TxCell).

Chapter 19 is an appendix, which provides tabulated data and numbers for all the figures included in the report.

Chapter 20 is an appendix, which contains a list of companies and organizations mentioned in the report.