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Treg Therapy 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

October 2021 | 145 pages | ID: T2CD5EE31A19EN
Roots Analysis

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The Treg therapy market is expected to reach USD 5 million in 2023 and anticipated to grow at a CAGR of 44% during the forecast period 2023-2035.

The application of regulatory T cell (Treg) therapies has garnered significant attention among key industry stakeholders due to their notable advantages, including high target specificity, customizable potential, and the ability to trigger immunological memory. The National Cancer Institute (NCI) predicts that by 2030, more than 22 million individuals in the US might receive a cancer diagnosis. Consequently, there's a rising demand for effective treatment methods, especially given the limitations of traditional approaches like chemotherapy, surgery, and radiation therapy, particularly for advanced cancers. This has led the research community to focus on developing innovative treatment modalities such as Treg cell therapies, which show promising efficacy. Tregs, a specialized subset of regulatory T cells, play a crucial role in maintaining immune tolerance to self-antigens and suppressing harmful immune responses, contributing to overall host homeostasis.

The realm of Treg-based therapies has become a central point in immunotherapy research due to their ability to prevent or delay graft rejection and manage autoimmune reactions post adoptive transfer in vivo. Over 90 pharmaceutical companies, academic institutions, and research centers have initiated various efforts to develop effective Treg cell therapies targeting multiple indications. Currently, there are nearly 95 product candidates in the pipeline, with expectations for further expansion. Among these candidates, over 15 Treg therapies—such as ALS001 (Coya Therapeutics), CLBS03 (Caladrius Biosciences), ILT-101 (ILTOO Pharma), NKTR-358 (Eli Lilly), and RGI-2001 (REGiMMUNE)—are undergoing advanced-stage evaluations. The increased interest of pharmaceutical stakeholders in the Treg therapy market is evident from the surge in registered clinical trials for these candidates. Furthermore, numerous collaborations between industry and non-industry entities have been established in the last decade to advance the development of various pipeline candidates.

It's notable that in the past five years, strategic investors have infused approximately USD 3 billion in capital investments into the Treg therapy market. This niche yet burgeoning market is poised for robust growth in the forecast period, with pioneering entities expected to leverage the first-to-market advantage.

Report Coverage
  • The report conducts an in-depth analysis of the Treg therapy market, focusing on target indications, key players, and significant geographical regions.
  • It examines factors influencing market growth, such as drivers, restraints, opportunities, and challenges.
  • Evaluation of potential advantages and obstacles within the market landscape is provided, along with insights into the competitive environment for leading market players.
  • Revenue forecasts for market segments are outlined concerning three major regions.
  • A comprehensive assessment of the current Treg cell therapy market scenario includes various aspects: product types, developmental phases, therapeutic areas, target indications, T-cell sources, administration routes, dosing schedules, target patient demographics, therapy types, and developer categories.
  • The report thoroughly analyzes completed, ongoing, and planned clinical studies of diverse Treg cell therapies, considering parameters like trial registration years, enrolled patient demographics, trial phases, recruitment statuses, study designs, duration, targeted patient segments, gender representation, sponsors/collaborators, key industry players involved, and geographic distribution of trials.
  • Examination of recent partnerships within the Treg therapy market, spanning 2015 to August 2021, along with an overview of partnership models adopted during this period.
  • Detailed scrutiny of investments made by Treg therapy companies between 2014 and August 2021, including seed financing, venture capital, IPOs, subsequent public offerings, grants, and debt financing.
  • Elaborate profiles of clinical-stage Treg cell therapies in phase I/II or beyond, encompassing therapy overviews, clinical trial specifics, key insights, and potential estimations of sales revenues.
  • Qualitative analysis highlighting the competitive forces within the Treg therapy market, including threats of new entrants, supplier bargaining power, buyer bargaining power, substitute product threats, and existing competitor rivalry.
  • Detailed profiles of significant entities involved in Treg cell therapy development, comprising company overviews, financial details (if available), product portfolios, and recent advancements.
Key Market Companies
  • Abata Therapeutics
  • Cellenkos
  • Coya Therapeutics
  • ILTOO Pharma
  • NEKTAR
  • Roche
  • Sonoma Biotherapeutics
  • TeraImmune
  • TRACT Therapeutics
1. PREFACE

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

2. EXECUTIVE SUMMARY

3. INTRODUCTION

3.1. Overview of Regulatory T-Cell Therapies
3.2. Characteristics of Treg Cell Therapies
3.3. Function of Treg Cell Therapies
3.4 Mechanism of Action of Treg Cell Therapies
3.5 Advantages of Treg Cell Therapies
3.6 Challenges and Future Perspectives Associated with Treg Cell Therapies

4. MARKET LANDSCAPE

4.1. Treg Cell Therapies: Overall Market Landscape
  4.1.1. Analysis by Type of Product
  4.1.2. Analysis by Phase of Development
  4.1.3. Analysis by Therapeutic Area
  4.1.4. Analysis by Phase of Development and Therapeutic Area
  4.1.5. Analysis by Target Indication
  4.1.6. Analysis by Source of T-Cells
  4.1.7. Analysis by Route of Administration
  4.1.8. Analysis by Dose Frequency
  4.1.9. Analysis by Target Patient Segment
  4.1.10. Analysis by Type of Therapy
  4.1.11. Analysis by Type of Developer
  4.1.12. Leading Industry Players: Analysis by Number of Treg Cell Therapies
  4.1.13. Leading Non-Industry Players: Analysis by Number of Treg Cell Therapies
4.2. Treg Cell Therapies: List of Developers
  4.2.1. Analysis by Year of Establishment
  4.2.2. Analysis by Company Size
  4.2.3. Analysis by Location of Headquarters
  4.2.4. Regional Landscape of Developers

5. THERAPY PROFILES

5.1. arTreg-CSB (National Institute of Allergy and Infectious Diseases / Immune Tolerance Network)
  5.1.1. Company Overview
  5.1.2. Therapy Overview
  5.1.3. Clinical Trial Information
  5.1.4. Clinical Trial Endpoints
  5.1.5. Dosage Regimen
5.2. CLBS03 (Caladrius Biosciences)
  5.2.1. Company Overview
  5.2.2. Therapy Overview
  5.2.3. Clinical Trial Information
  5.2.4. Clinical Trial Endpoints
  5.2.5. Dosage Regimen
  5.2.6. Key Insights
  5.2.7. Estimated Sales Revenue
5.3. ILT-101 (Iltoo Pharma / Assistance Publique - Hфpitaux de Paris)
  5.3.1. Company Overview
  5.3.2. Therapy Overview
  5.3.3. Clinical Trial Information
  5.3.4. Clinical Trial Endpoints
  5.3.5. Dosage Regimen
  5.3.6. Estimated Sales Revenue
5.4. Low Dose IL-2 (Iltoo Pharma / Assistance Publique - Hфpitaux de Paris)
  5.4.1. Company Overview
  5.4.2. Therapy Overview
  5.4.3. Clinical Trial Information
  5.4.4. Clinical Trial Endpoints
  5.4.5. Dosage Regimen
  5.4.6. Key Insights
5.5. NKTR-358 / LY3471851(Nektar Therapeutics / Eli Lilly)
  5.5.1. Company Overview
  5.5.2. Therapy Overview
  5.5.3. Clinical Trial Information
  5.5.4. Clinical Trial Endpoints
  5.5.5. Dosage Regimen
  5.5.6 Key Insights
  5.5.7. Estimated Sales Revenue
5.6. RGI-2001 (REGiMMUNE)
  5.6.1. Company Overview
  5.6.2. Therapy Overview
  5.6.3. Clinical Trial Information
  5.6.4. Clinical Trial Endpoints
  5.6.5. Dosage Regimen
  5.6.6. Key Insights
  5.6.7. Estimated Sales Revenue
5.7. rhIL-2 (Iltoo Pharma / Assistance Publique - Hфpitaux de Paris)
  5.7.1. Company Overview
  5.7.2. Therapy Overview
  5.7.3. Clinical Trial Information
  5.7.4. Clinical Trial Endpoints
  5.7.5. Dosage Regimen
  5.7.6. Estimated Sales Revenue
5.8. TR004 (Miltenyi Biotec)
  5.8.1. Company Overview
  5.8.2. Therapy Overview
  5.8.3. Clinical Trial Information
  5.8.4. Clinical Trial Endpoints
  5.8.5. Dosage Regimen
  5.8.6. Estimated Sales Revenue
5.9. TX200 (Sangamo Therapeutics)
  5.9.1 Company Overview
  5.9.2. Therapy Overview
  5.9.3. Clinical Trial Information
  5.9.4. Clinical Trial Endpoints
  5.9.5. Dosage Regimen
  5.9.6. Key Insights
5.10. VT301 / GB301 (VT Bio / BHT Lifescience Austrailia)
  5.10.1. Company Overview
  5.10.2. Therapy Overview
  5.10.3. Clinical Trial Information
  5.10.4. Clinical Trial Endpoints
  5.10.5. Dosage Regimen

6. CLINICAL TRIAL ANALYSIS

6.1. Methodology and Parameters
6.2. Treg Cell Therapies: Snapshot of Clinical Trials (till July 2021)
  6.2.1. Analysis by Trial Registration Year and Enrolled Patient Population
  6.2.2. Analysis by Trial Phase
  6.2.3. Analysis by Trial Phase and Enrolled Patient Population
  6.2.4. Analysis by Trial Recruitment Status
  6.2.5. Analysis by Year and Trial Recruitment Status
  6.2.6. Analysis by Type of Allocation
  6.2.7. Analysis by Purpose of Study
  6.2.8. Analysis by Type of Masking
  6.2.9 Analysis by Intervention Model
  6.2.10. Analysis by Year and Trial Phase
  6.2.11. Analysis by Year, Average Time Taken and Trial Phase
  6.2.12. Analysis by Target Patient Segment
  6.2.13. Analysis by Gender of Enrolled Patients
  6.2.14. Analysis by Type of Sponsor(s)
  6.2.15. Leading Non-Industry Players: Analysis by Number of Trials Registered
  6.2.16. Leading Industry Players: Analysis by Number of Trials Registered
  6.2.17. Analysis by Location of Trial
  6.2.18. Analysis by Trial Status and Geography

7. PARTNERSHIPS AND COLLABORATIONS

7.1. Chapter Overview
7.2. Treg Cell Therapies: Partnerships and Collaborations
  7.2.1 Analysis by Year of Partnership
  7.2.2. Analysis by Type of Partnership
  7.2.3. Analysis by Year and Type of Partnership
  7.2.4. Analysis by Type of Product
  7.2.5. Analysis by Year and Type of Product
  7.2.6. Analysis by Therapeutic Area
  7.2.7. Analysis by Type of Partner
  7.2.8. Analysis by Type of Partner and Type of Partnership
  7.2.9. Leading Industry Players: Analysis by Number of Partnerships
  7.2.10. Region-wise Distribution
  7.2.11. Country-wise Distribution

8. FUNDING AND INVESTMENT ANALYSIS

8.1. Chapter Overview
8.2. Treg Cell Therapies: Funding and Investment
  8.2.1. Analysis by Year of Investment and Amount Invested
  8.2.2. Analysis by Type of Funding
  8.2.3. Analysis by Year of Investment and Type of Funding
  8.2.4. Analysis by Type of Product
  8.2.5. Analysis by Year of Investment and Type of Product
  8.2.6. Analysis by Type of Investor
  8.2.7. Leading Investors: Analysis by Number of Funding Instances
  8.2.8. Leading Players: Analysis by Number of Funding Instances
  8.2.9. Analysis by Geography

9. PORTER’S FIVE FORCES ANALYSIS

9.1. Chapter Overview
9.2. Methodology and Key Parameters
9.3 Porter’s Five Forces
  9.3.1. Threat of New Entrants
  9.3.2. Bargaining Power of Developers
  9.3.3. Bargaining Power of Customers
  9.3.4. Threat of Available Substitute Therapies
  9.3.5. Rivalry Among Existing Competitors

10. COMPANY PROFILES

10.1. Abata Therapeutics
  10.1.1. Company Overview
  10.1.2. Key Insights
  10.1.3. Product Portfolio
  10.1.4 Recent Developments and Future Outlook
10.2. Cellenkos
  10.2.1. Company Overview
  10.2.2. Key Insights
  10.2.3. Product Portfolio
  10.2.4 Recent Developments and Future Outlook
10.3. Coya Therapeutics
  10.3.1. Company Overview
  10.3.2. Key Insights
  10.3.3. Product Portfolio
  10.3.4 Recent Developments and Future Outlook
10.4. ILTOO Pharma
  10.4.1. Company Overview
  10.4.2. Key Insights
  10.4.3. Product Portfolio
  10.4.4 Recent Developments and Future Outlook
10.5. NEKTAR
  10.5.1. Company Overview
  10.5.2. Key Insights
  10.5.3. Product Portfolio
  10.5.4 Recent Developments and Future Outlook
10.6. Roche
  10.6.1. Company Overview
  10.6.2. Key Insights
  10.6.3. Financial Information
  10.6.4 Product Portfolio
  10.6.5 Recent Developments and Future Outlook
10.7. Sonoma Biotherapeutics
  10.7.1. Company Overview
  10.7.2. Key Insights
  10.7.3. Product Portfolio
  10.7.4 Recent Developments and Future Outlook
10.8. TeraImmune
  10.8.1. Company Overview
  10.8.2. Key Insights
  10.8.3. Product Portfolio
  10.8.4 Recent Developments and Future Outlook
10.9. TRACT Therapeutics
  10.9.1. Company Overview
  10.9.2. Key Insights
  10.9.3. Product Portfolio
  10.9.4 Recent Developments and Future Outlook

11. MARKET SIZING AND OPPORTUNITY ANALYSIS

11.1. Forecast Methodology and Key Assumptions
11.2. Global Treg Cell Therapies Market, 2021-2030
  11.2.1. Treg Cell Therapies Market: Analysis by Type of Product
  11.2.2. Treg Cell Therapies Market: Analysis by Target Indication
  11.2.3. Treg Cell Therapies Market: Analysis by Key Players
  11.2.4. Treg Cell Therapies Market: Analysis by Geography
  11.2.5. Treg Cell Therapies: Forecast of Individual Product Sales
    11.2.5.1. CLBS03 (Caladrius Biosciences): Estimated Sales Revenues
    11.2.5.2. ILT-101 (Iltoo Pharma / Assistance Publique - Hфpitaux de Paris): Estimated Sales Revenues
    11.2.5.3. NKTR-358 / LY3471851(Nektar Therapeutics / Eli Lilly): Estimated Sales Revenues
    11.2.5.4. RGI-2001 (REGiMMUNE): Estimated Sales Revenues
    11.2.5.5. rhIL-2 (Iltoo Pharma / Assistance Publique - Hфpitaux de Paris): Estimated Sales Revenues
    11.2.5.6. TR004 (Miltenyi Biotec): Estimated Sales Revenues
    11.2.5.7. VT301 / GB301 (VT Bio / BHT Lifescience Austrailia): Estimated Sales Revenues

12. CONCLUSION

13. EXECUTIVE INSIGHTS

13.1. Chapter Overview
13.2. Oncurious
  13.2.1. Company Snapshot
  13.2.2. Interview Transcript: Pascal Merchiers, Chief Scientific Officer

14. APPENDICES

14.1 Miscellaneous Charts and Figures
14.2 List of Figures
14.3 List of Tables
14.4 List of Companies and Organizations


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