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Global Regulatory T-Cell  (Tregs) Therapies Market

Regulatory T-Cell (Tregs) Therapies Market Size, Share & Trends Analysis Report Therapeutic Area (Autoimmune Disorders, Oncological Disorders, Post-Transplant Infection, Neurological Disorders, Metabolic Disorders, Dermatological Disorders), by Products (Tregs, Interleukin 2, Monoclonal Antibodies, Small Molecules, CAR-Treg, Other Products), by Source of T-Cells (Autologous, Allogeneic), By Region, And By Segment Forecasts, 2026-2035

Report ID : 1200 | Published : 2024-08-12 | Pages: 160 | Format:

Regulatory T cells (Tregs) are T cells that function to regulate other cells in the immune system through various contact-dependent and independent mechanisms. They are vital in preventing and controlling excessive immune responses and autoimmunity. As of now, there is no approved marketed product available in the global market for Regulatory T-Cell Therapies. Based on our estimates, Regulatory T-Cell (Tregs) Therapies Market is estimated to grow at a 40.0% CAGR during the forecast period for 2026-2035.

tregs

The multiple factors driving the growth of the Regulatory T-Cell Therapies (Tregs) Market include the rising chronic conditions such as autoimmune diseases, allergies, & organ transplantation, increasing technological advances in therapy techniques, surging demand for cost-efficient immunotherapies, growing awareness among people regarding the advantages of T-cell therapeutics, and increasing government support for the R&D of innovative regulatory T-cell therapies. The companies operating in this market are collaborating with technologies companies to develop & commercialize Treg therapies. For instance, in June 9, 2023 AstraZeneca collaborated with Quell to develop regulatory T cell therapies for Type 1 diabetes and inflammatory bowel disease. Similarly, in September 2021, Adaptimmune Therapeutics plc, a leader in cell therapy to treat cancer, collaborated with Genentech to develop and commercialize allogeneic T cell therapies and to treat multiple oncology indications. Therefore, increasing collaborations are projected to accelerate market expansion in the future. However, the cost of regulatory T-cell therapies, poor reimbursement policies for cell therapies, side effects associated with these therapies, and the complicated production and supply chain methods may impede the market growth in the upcoming years.  

Market Segmentation

The Regulatory T-Cell Therapies (Tregs) Market is classified based on therapeutic area, products, source of T-cells and region. Based on therapeutic area the market is segmented into autoimmune disorders, oncological disorders, post-transplant infection, neurological disorders, metabolic disorders, dermatological disorders. By-products, the market is segmented into Tregs, interleukin 2, monoclonal antibodies, small molecules, CAR-Treg and other products. The Tregs segment is expected to dominate this market during the forecast years due to its increasing therapeutic applications. The Source of T-Cells segment comprises autologous and allogeneic. Regionally, the market is studied across North America, Europe, Asia-Pacific, Latin America, the Middle East and Africa. The North America regional segment is anticipated to dominate the regulatory T-cell therapies (Tregs) Market over the forecast period (2026-2035), owing to the increasing pharmaceutical R&D expenditure and the rising number of clinical trials for T-cell therapies in this region.

Competitive Landscape

Some major key players in the Regulatory T-Cell (Tregs) Therapies Market:

  • Abata Therapeutics (US),
  • Cellenkos Inc (US),
  • Coya Therapeutics (US),
  • Roche (Switzerland),
  • Lisata Therapeutics
  • Sonoma Biotherapeutics (US),
  • Nektar Therapeutics (US),
  • Eli Lilly and Company (US),
  • Baudax Bio
  • TRACT Therapeutics (US),
  • VT Bio (South Korea),
  • Sangamo Therapeutics (TxCell) (US),
  • TRexBio
  • Mozart Therapeutics
  • Pfizer Inc. (US), PolTREG S.A.. (Poland),
  • Parvus Therapeutics (Canada)
  • ILTOO Pharma (France),
  • GentiBio
  • Tr1X
  • Quell Therapeutics
  • AstraZeneca 
  • Kyverna Therapeutics, Inc.
  • Others

The Regulatory T-Cell (Tregs) Therapies Market Report Scope

Report Attribute

Specifications

Growth Rate CAGR

CAGR of 40.0% from 2026 to 2035

Quantitative Units

Representation of revenue in US$ Billion and CAGR from 2026 to 2030

Historic Year

2025-2035

Forecast Year

2026-2035

Report Coverage

The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends

Segments Covered

By Therapeutic Area, Product, Source of T-Cells

Regional Scope

North America; Europe; Asia Pacific; Latin America; Middle East & Africa

Country Scope

U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico ; France; Italy; Spain; South Korea; South East Asia

Competitive Landscape

Abata Therapeutics (US), Cellenkos Inc (US), Coya Therapeutics (US), Roche (Switzerland), Lisata Therapeutics, Sonoma Biotherapeutics (US), Nektar Therapeutics (US), Eli Lilly and Company (US), Baudax Bio, TRACT Therapeutics (US), VT Bio (South Korea), Sangamo Therapeutics (TxCell) (US), TRexBio, Mozart Therapeutics, Pfizer Inc. (US), PolTREG S.A. (Poland), Parvus Therapeutics (Canada), ILTOO Pharma (France), GentiBio, Tr1X, Quell Therapeutics, AstraZeneca, Kyverna Therapeutics, Inc., Others 

Customization Scope

Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape.

Pricing And Available Payment Methods

Explore pricing alternatives that are customized to your particular study requirements.

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Chapter 1. Methodology and Scope

1.1. Research Methodology

1.2. Research Scope & Assumptions

Chapter 2. Executive Summary

Chapter 3. Global Regulatory T-Cell (Tregs) Therapies Market Snapshot

Chapter 4. Global Regulatory T-Cell (Tregs) Therapies Market Variables, Trends & Scope

4.1. Market Segmentation & Scope

4.2. Drivers

4.3. Challenges

4.4. Trends

4.5. Investment and Funding Analysis

4.6. Industry Analysis – Porter’s Five Forces Analysis

4.7. Clinical Trial/Pipeline Analysis

4.8. Impact of Covid-19 Analysis

Chapter 5. Market Segmentation 1: By Therapeutic Area Estimates & Trend Analysis

5.1. By Therapeutic Area & Market Share, 2025 & 2035

5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2025 to 2035 for the following By Therapeutic Area:

5.2.1. Autoimmune Disorders

5.2.2. Oncological Disorders

5.2.3. Post-Transplant Infection

5.2.4. Neurological Disorders

5.2.5. Metabolic Disorders

5.2.6. Dermatological Disorders

Chapter 6. Market Segmentation 2: By Products Estimates & Trend Analysis

6.1. By Products & Market Share, 2025 & 2035

6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2025 to 2035 for the following By Products:

6.2.1. Tregs

6.2.2. Interleukin 2

6.2.3. Monoclonal Antibodies

6.2.4. Small Molecules

6.2.5. CAR-Treg

6.2.6. Other Products

Chapter 7. Market Segmentation 3: By Source of T-Cells Estimates & Trend Analysis

7.1. By Source of T-Cells & Market Share, 2025 & 2035

7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2025 to 2035 for the following By Source of T-Cells:

7.2.1. Autologous

7.2.2. Allogeneic

Chapter 8. Regulatory T-Cell (Tregs) Therapies Market Segmentation 5: Regional Estimates & Trend Analysis

8.1. North America

8.1.1. North America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts By Therapeutic Area, 2026-2035

8.1.2. North America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts By Types, 2026-2035

8.1.3. North America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Products, 2026-2035

8.1.3. North America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Source of T-Cells, 2026-2035

8.1.4. North America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by country, 2026-2035

8.2. Europe

8.2.1. Europe Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Therapeutic Area, 2026-2035

8.2.2. Europe Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Types, 2026-2035

8.2.3. Europe Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Products, 2026-2035

8.2.3. Europe Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Source of T-Cells, 2026-2035

8.2.4. Europe Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) by country, 2026-2035

8.3. Asia Pacific

8.3.1. Asia Pacific Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Therapeutic Area, 2026-2035

8.3.2. Asia Pacific Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Types, 2026-2035

8.3.3. Asia Pacific Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Products, 2026-2035

8.3.3. Asia Pacific Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Source of T-Cells, 2026-2035

8.3.4. Asia Pacific Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) by country, 2026-2035

8.4. Latin America

8.4.1. Latin America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Therapeutic Area, 2026-2035

8.4.2. Latin America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Types, 2026-2035

8.4.3. Latin America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Products, 2026-2035

8.4.3. Latin America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Source of T-Cells, 2026-2035

8.4.4. Latin America Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) by country, 2026-2035

8.5. Middle East & Africa

8.5.1. Middle East & Africa Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Therapeutic Area, 2026-2035

8.5.2. Middle East & Africa Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) By Types, 2026-2035

8.5.3. Middle East & Africa Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Products, 2026-2035

8.5.3. Middle East & Africa Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) estimates and forecasts by Source of T-Cells, 2026-2035

8.5.4. Middle East & Africa Regulatory T-Cell (Tregs) Therapies Market revenue (US$ Million) by country, 2026-2035

Chapter 9. Competitive Landscape

9.1. Major Mergers and Acquisitions/Strategic Alliances

9.2. Company Profiles 

  • Abata Therapeutics (US),
  • Cellenkos Inc (US),
  • Coya Therapeutics (US),
  • Roche (Switzerland),
  • Lisata Therapeutics
  • Sonoma Biotherapeutics (US),
  • Nektar Therapeutics (US),
  • Eli Lilly and Company (US),
  • Baudax Bio
  • TRACT Therapeutics (US),
  • VT Bio (South Korea),
  • Sangamo Therapeutics (TxCell) (US),
  • TRexBio
  • Mozart Therapeutics
  • Pfizer Inc. (US), PolTREG S.A.. (Poland),
  • Parvus Therapeutics (Canada)
  • ILTOO Pharma (France),
  • GentiBio
  • Tr1X
  • Quell Therapeutics
  • AstraZeneca
  • Kyverna Therapeutics, Inc.
  • Others

Segmentation of Global Regulatory T-Cell Therapies (Tregs) Market

Global Regulatory T-Cell Therapies (Tregs) Market, by Therapeutic Area, 

  • Autoimmune Disorders
  • Oncological Disorders
  • Post-Transplant Infection
  • Neurological Disorders
  • Metabolic Disorders
  • Dermatological Disorders

 

tregsGlobal Regulatory T-Cell Therapies (Tregs) Market, by Products

  • Tregs
  • Interleukin 2
  • Monoclonal Antibodies
  • Small Molecules
  • CAR-Treg
  • Other Products

Global Regulatory T-Cell Therapies (Tregs) Market, by Source of T-Cells

  • Autologous
  • Allogeneic

Global Regulatory T-Cell Therapies (Tregs) Market, by Region,

  • North America
  • Europe
  • Asia Pacific
  • Latin America
  • Middle East & Africa

North America Regulatory T-Cell Therapies (Tregs) Market, by Country, 2025-2030 (Value US$ Mn)

  • U.S.
  • Canada

Europe Regulatory T-Cell Therapies (Tregs) Market, by Country, 2025-2030 (Value US$ Mn)

  • Germany
  • France
  • Italy
  • Spain
  • Russia
  • Rest of Europe

Asia Pacific Regulatory T-Cell Therapies (Tregs) Market, by Country, 2025-2030 (Value US$ Mn)

  • India
  • China
  • Japan
  • South Korea
  • Australia & New Zealand

Latin America Regulatory T-Cell Therapies (Tregs) Market, by Country, 2025-2030 (Value US$ Mn)

  • Brazil
  • Mexico
  • Rest of Latin America

Middle East & Africa Regulatory T-Cell Therapies (Tregs) Market, by Country, 2025-2030 (Value US$ Mn)

  • GCC Countries
  • South Africa
  • Rest of Middle East & Africa

Competitive Profiles

  • Abata Therapeutics
  • Cellenkos Inc
  • Coya Therapeutics
  • Roche
  • Caladrius Biosciences
  • Sonoma Biotherapeutics
  • Nektar Therapeutics
  • Eli Lilly and Company
  • REGiMMUNE
  • Miltenyi Biotec
  • TeraImmune
  • TRACT Therapeutics
  • VT Bio
  • Amgen
  • Sangamo Therapeutics (TxCell)
  • Pfizer Inc.
  • PolTREG S.A..
  • Parvus Therapeutics
  • ILTOO Pharma
  • Philogen S.p.A.
  • Celgene
  • AHEAD THERAPEUTICS S.L.
  • Egle Therapeutics
  • TRex Bio
  • Mozart Therapeutics, Inc.
  • Alcea Therapeutics
  • Alderaan Biotechnology
  • Other Prominent Players

InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.

Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.

Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.

Secondary research

The secondary research sources that are typically mentioned to include, but are not limited to:

  • Company websites, financial reports, annual reports, investor presentations, broker reports, and SEC filings.
  • External and internal proprietary databases, regulatory databases, and relevant patent analysis
  • Statistical databases, National government documents, and market reports
  • Press releases, news articles, and webcasts specific to the companies operating in the market

The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista

Primary Research:

Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies

The contributors who typically take part in such a course include, but are not limited to: 

  • Industry participants: CEOs, CBO, CMO, VPs, marketing/ type managers, corporate strategy managers, and national sales managers, technical personnel, purchasing managers, resellers, and distributors.
  • Outside experts: Valuation experts, Investment bankers, research analysts specializing in specific markets
  • Key opinion leaders (KOLs) specializing in unique areas corresponding to various industry verticals
  • End-users: Vary mainly depending upon the market

Data Modeling and Analysis:

In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.

The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.

 

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Frequently Asked Questions

Who are the Key Players in the Global Regulatory T-cells (Tregs) therapies Market?

The Regulatory T-Cell (Tregs) Therapies Market is estimated to grow at a 40.0% CAGR during the forecast period for 2026-2035.

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