Regulatory T-Cell Therapies Market by Target Indications, Key Players and Key Geographies : Industry Trends and Global Forecast, 2021-2035

INTRODUCTION Given the various benefits offered, including high target specificity, customization potential and ability to generate immunological memory, regulatory T-cell (Treg) therapies have garnered significant attention among key industry stakeholders for the treatment of various oncological and non-oncological disease indications.


New York, Dec. 10, 2021 (GLOBE NEWSWIRE) -- Reportlinker.com announces the release of the report "Regulatory T-Cell Therapies Market by Target Indications, Key Players and Key Geographies : Industry Trends and Global Forecast, 2021-2035" - https://www.reportlinker.com/p06189682/?utm_source=GNW
The National Cancer Institute (NCI) has estimated that, by 2030, over 22 million individuals are likely to be diagnosed with some form of cancer in the US alone. , As a result of the growing patient population affected by this disease, there is a rise in the demand for effective treatment modalities. The conventional approaches, such as chemotherapy, surgery and radiation therapy, employed for the treatment of oncological indication(s) are considered to be inadequate, specifically for late-stage cancers. Therefore, in recent years, the focus of the research community has shifted towards the development of novel treatment modalities, such as Treg cell therapies, that exhibit high efficacy. The Tregs are a mature subpopulation of T-cells that play a critical role in mediating immunological tolerance to self-antigens and suppress immune responses that are harmful to the host, thereby, enabling a balance to homeostasis. In recent years, Treg based therapies have become a research hotspot in the field of immunotherapy due to their ability to prevent / delay graft rejection and control autoimmune responses generated post adoptive transfer in vivo.

Over time, more than 90 pharmaceutical companies and academic / research institutes have undertaken various initiatives to develop effective Treg cell therapies against multiple target indications. At present, the pipeline features close to 95 product candidates, and this number is anticipated to grow further in the foreseen future. Of the total candidates, more than 15 Treg therapies, including ALS001 (Coya Therapeutics), CLBS03 (Caladrius Biosciences), ILT-101 (ILTOO Pharma), NKTR-358 (Eli Lilly) and RGI-2001 (REGiMMUNE), are currently being evaluated in advanced stages of development. The growing interest of pharmaceutical stakeholders in this field is also reflected from the recent rise in clinical trials being registered for such candidates. Moreover, multiple collaborations have been inked between both industry and non-industry players in order to advance the development of various pipeline candidates, over the past decade. It is also worth highlighting that, in the last five years, capital investments worth around USD 3 billion have been made by strategic investors in this domain. We believe that this niche, but upcoming market, is poised to grow at a healthy pace over the next decade, with pioneers in the field likely to benefit from the first-to-market advantage.

SCOPE OF THE REPORT
The “Regulatory T-Cell Therapies Market by Target Indications (Crohn Disease, Bipolar Disorder, Allergic Rhinoconjunctivitis, COVID 19, Diabetes Mellitus, Systemic Lupus Erythematosus, Alzheimer Disease and Graft Vs Host Disease), Key Players and Key Geographies (North America, Europe and Asia Pacific): Industry Trends and Global Forecast, 2021-2035” report features an extensive study of the current market landscape and the associated future potential. The report highlights efforts of both industry players and academic organizations. Amongst other elements, the report features the following:
A detailed overview of the current market landscape of Treg cell therapies, along with information on several relevant parameters, such as type of product (Tregs, interleukin 2, monoclonal antibodies, small molecules and others), phase of development (preclinical / discovery, phase I, phase I/II, phase II, phase II / III and phase III), therapeutic area (autoimmune disorders, oncological disorders, post-transplant infection, neurological disorders, metabolic disorders, dermatological disorders, infectious diseases, and others), target indication (diabetes mellitus, graft vs host diseases, post liver transplant infection, post kidney transplant infection, amyotrophic lateral sclerosis, multiple sclerosis, myelodysplastic syndromes, atopic dermatitis and acute myeloid leukemia), source of T-cells (autologous and allogeneic), route of administration (intravenous, subcutaneous and intramuscular), dose frequency (multiple dose and single dose), target patient segment (children, adults and elderly patients), type of therapy (monotherapy and combination therapy) and type of developer (industry and non-industry). In addition, it presents details of the companies developing Treg cell therapies, highlighting their year of establishment, company size, location of headquarters and most active players (in terms of number of pipeline candidates).
An in-depth analysis of completed, ongoing and planned clinical studies of various Treg cell therapies, based on various relevant parameters, such as trial registration year, enrolled patient population, trial phase, trial recruitment status, study design, average time taken, target patient segment, gender of enrolled patients, type of sponsor / collaborator, leading industry players (in terms of number of trials conducted) and regional distribution of trials.
An analysis of the recent partnerships inked between various players engaged in this domain, during the period 2015-2021 (till August). Additionally, it includes a brief description of various types of partnership models (such as R&D agreements, product development and commercialization agreements, licensing agreements, acquisitions, clinical trial agreements, and manufacturing agreements) that have been adopted by stakeholders, during the given period.
A detailed analysis of various investments, such as seed financing, venture capital financing, capital raised from IPOs and subsequent public offerings, grants and debt financing that were undertaken by companies engaged in this domain, during the period 2014-2021 (till August).
Detailed profiles of clinical stage Treg cell therapies (phase I/II or above); each profile features an overview of the therapy, along with information on clinical trials and its endpoints, dosage regimen, key insights and estimated sales revenues (if available).
A qualitative analysis, highlighting the five competitive forces prevalent in this domain, including threats for new entrants, bargaining power of suppliers, bargaining power of buyers, threats of substitute products and rivalry among existing competitors.
Elaborate profiles of prominent players engaged in the development of Treg cell therapies. Each profile features a brief overview of the company, details related to its financials (if available), product portfolio and recent developments.

One of the key objectives of the report was to estimate the existing market size and identify potential growth opportunities associated with Treg cell therapies, over the coming decade. The report also includes likely sales forecasts of Treg cell therapies that are in the mid to late stages of development. Additionally, it features market size projections for the overall Treg cell therapies market, wherein both the current and upcoming opportunity is segmented across [A] target indication (Crohn Disease, Bipolar Disorder, Allergic Rhinoconjunctivitis, COVID 19, Diabetes Mellitus, Systemic Lupus Erythematosus, Alzheimer Disease and Graft Vs Host Disease), [B] key players and [C] key geographies (North America, Europe and 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.

The opinions and insights presented in this study were influenced by discussions conducted with stakeholders in this domain.

KEY QUESTIONS ANSWERED
• What are the prevalent R&D trends related to Treg cell therapies?
• What are the key therapeutic areas for which Treg cell therapies are being / have been developed?
• What are the key challenges faced by stakeholders engaged in this domain?
• Who are the leading industry and non-industry players engaged in the development of Treg cell therapies?
• What are the key geographies where research focused on Treg cell therapies is being conducted?
• What are the key value drivers that 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?

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

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.

CHAPTER OUTLINES
Chapter 2 provides an executive summary of the insights captured during our research. It offers a high-level view on the likely evolution of the Treg cell therapies market in the short to mid-term and long term.

Chapter 3 provides a general overview of Treg cell therapies. In addition, it includes information on the key characteristics and function of Treg cell therapies, along with information on their mechanism of action and the challenges and future perspectives associated with Treg cell therapies.

Chapter 4 includes detailed assessment on close to 95 Treg cell therapy candidates that are currently approved or are in different stages of development along with information on several relevant parameters, such as type of product (Tregs, interleukin 2, monoclonal antibodies, small molecules and others), phase of development (preclinical / discovery, phase I, phase I/II, phase II, phase II / III and phase III), therapeutic area (autoimmune disorders, oncological disorders, post-transplant infection, neurological disorders, metabolic disorders, dermatological disorders, infectious diseases, and others), target indication (diabetes mellitus, graft vs host diseases, post liver transplant infection, post kidney transplant infection, amyotrophic lateral sclerosis, multiple sclerosis, myelodysplastic syndromes, atopic dermatitis and acute myeloid leukemia), source of T-cells (autologous and allogeneic), route of administration (intravenous, subcutaneous and intramuscular), dose frequency (multiple dose and single dose), target patient segment (children, adults and elderly patients), type of therapy (monotherapy and combination therapy) and type of developer (industry and non-industry). In addition, it presents details of the companies developing Treg cell therapies, highlighting their year of establishment, company size, location of headquarters and most active players (in terms of number of pipeline candidates).

Chapter 5 provides detailed profiles of clinical stage Treg cell therapies (phase I/II or above); each profile features an overview of the therapy, clinical trial information, clinical trial endpoints, dosage regimen, key insights and estimated sales revenues (if available).

Chapter 6 An in-depth analysis of completed, ongoing and planned clinical studies of various Treg cell therapies, based on various relevant parameters, such as trial registration year, enrolled patient population, trial phase, trial recruitment status, study design, average time taken, target patient segment, gender of enrolled patients, type of sponsor / collaborator, leading industry players (in terms of number of registered trials conducted) and key geographical regions.

Chapter 7 features an elaborate discussion and analysis of the recent collaborations and partnerships inked between various players engaged in this domain, during the period 2015-2021 (till August). Further, the partnership activity in this domain has been analyzed based on various parameters, such as year of partnership, type of partnership model (R&D agreements, product development and commercialization agreements, licensing agreements, acquisitions, clinical trial agreements, manufacturing agreements and others), type of product, target therapeutic area, type of partner, key players and regional distribution of the collaborations.

Chapter 8 provides details on the various investments and grants that have been awarded to players focused on the development of Treg cell therapies. It includes a detailed analysis of the funding instances that have taken place during the period 2014 to 2021 (till August), highlighting the growing interest of venture capital (VC) community and other strategic investors in this domain.

Chapter 9 provides insights on a qualitative analysis highlighting five competitive forces in this domain, including threats for new entrants, bargaining power of suppliers, bargaining power of buyers, threats of substitute products and rivalry among existing competitors.

Chapter 10 includes brief profiles of prominent players engaged in the development of Treg cell therapies. Each profile features a brief overview of the company, details related to its financials (if available), product portfolio and recent developments.

Chapter 11 features an elaborate discussion on the future commercial opportunity offered by Treg cell therapies. It provides a comprehensive market forecast analysis for molecules that are approved or are in phase I/II and above development stages 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 on the basis of [A] target indication (Crohn Disease, Bipolar Disorder, Allergic Rhinoconjunctivitis, COVID 19, Diabetes Mellitus, Systemic Lupus Erythematosus, Alzheimer Disease and Graft Vs Host Disease), [B] key players and [C] key geographies (North America, Europe and Asia Pacific)

Chapter 12 summarizes 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 13 provides the transcripts of interviews conducted with key stakeholders of this market. In this chapter, we have presented the details of our conversation with Pascal Merchiers (Chief Scientific Officer, Oncurious).

Chapter 14 is an appendix, which provides miscellaneous charts and figures, list of figures, list of tables and list of companies and organizations.
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