Regulatory T-Cell (Tregs) Therapies Market Size to Reach USD 320.4 million in 2032

The Regulatory T-Cell (Tregs) Therapies market, valued at USD 16.7 million in 2024, is expected to register robust revenue CAGR of 44.6%.

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October 09, 2025- The growing incidence of autoimmune disorders and transplant rejections is a major factor driving revenue growth in the Regulatory T-Cell (Treg) therapies market. Data from the Lupus Foundation of America indicates that lupus affects about 1.5 million people in the U.S. and at least five million worldwide, with 90% of cases occurring in women. Most patients are diagnosed between ages 15 and 44, and systemic lupus represents more than 70% of all cases.

In March 2023, Sonoma Biotherapeutics, Inc., and Regeneron Pharmaceuticals, Inc. announced a collaboration to leverage their combined scientific expertise and technology platforms to develop novel Treg therapies for autoimmune diseases. This partnership integrates Regeneron's VelociSuite technologies for discovering and characterizing fully human antibodies and T cell receptors (TCRs) with Sonoma's capabilities in Treg development.

Treg therapies hold significant promise for treating autoimmune diseases, preventing transplant rejection, and managing inflammatory conditions by harnessing the body's natural immune regulators. However, they present greater challenges than other adoptive cell therapies like CAR-T. The limited availability of Tregs and the critical need for highly pure cell populations make their development and manufacturing particularly complex.

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Segments market overview and growth Insights
Based on source, the Regulatory T-Cell (Tregs) therapies market is segmented into Autologous Tregs and Allogeneic Tregs. The Autologous Tregs segment accounted for the largest market share in 2024. In September 2024, PolTREG S.A., a clinical-stage biotechnology company focused on cellular therapies for autoimmune diseases, announced the launch of a study evaluating CAR-Treg cells in a humanized mouse model of neuroinflammatory disease. These CAR-Treg cells are derived from PolTREG's PTG-007 Treg cells, an autologous polyclonal candidate showing promise for the treatment of type 1 diabetes.

Regional market overview and growth insights
North America held the largest market share in the Regulatory T-Cell (Tregs) Therapies market in 2024. The market is being driven by the growing prevalence of autoimmune disorders and transplant rejections, along with advancements in cell therapy and immunomodulation. Data from the Autoimmune Association indicate that autoimmune diseases impact over 50 million Americans, representing 8% of the U.S. population, and prevalence continues to rise. Epidemiological studies further reveal that the global incidence of autoimmune diseases has been increasing by 19.1% annually, with rheumatological conditions such as Sjögren's syndrome and lupus rising by 7.1% each year.

Competitive Landscape and Key Competitors
The Regulatory T-Cell (Tregs) Therapies market is characterized by a fragmented structure, with many competitors holding a significant share of the market. list of major players included in the Regulatory T-Cell (Tregs) Therapies market report are:

o Abata Therapeutics
o PolTREG S.A.
o Kyverna Therapeutics
o Sonoma Biotherapeutics
o Quell Therapeutics
o Sangamo Therapeutics
o GentiBio
o Parvus Therapeutics Inc.
o Mozart Therapeutics
o Egle Therapeutics
o Nektar Therapeutics
o Coya Therapeutics, Inc
o TR1X, Inc.
o Egle Therapeutics
o Cugene, Inc.

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Major strategic developments by leading competitors
Abata Therapeutics: In August 2024, Abata Therapeutics, a company focused on advancing Treg therapies for severe autoimmune and inflammatory diseases, announced an equity investment from Bristol Myers Squibb to support the development of its Treg cell therapy programs. The funding will enable Abata to advance its pipeline, with clinical trials of ABA-101 in progressive multiple sclerosis expected to start soon.

Kyverna Therapeutics: In August 2023, Kyverna Therapeutics, a clinical-stage cell therapy company focused on developing a new generation of treatments for autoimmune diseases, announced the successful completion of an oversubscribed USD 60 million Series B extension, raising the total Series B funding to USD 145 million. The proceeds will support Kyverna's clinical trials in the U.S. and Europe, accelerating progress toward delivering transformative and life-saving therapies to patients.

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Navistrat Analytics has segmented the Regulatory T-Cell (Tregs) therapies market based on source, therapeutic type, indication, and end-use, and region:
• Source Outlook (Revenue, USD Million; 2022-2032)
o Autologous Tregs
o Allogeneic Tregs

• Therapeutic Type Outlook (Revenue, USD Million; 2022-2032)
o Polyclonal Tregs
o Antigen-Specific Tregs
o CAR-Tregs (Chimeric Antigen Receptor Tregs)
o Engineered Tregs

• Indication Outlook (Revenue, USD Million; 2022-2032)
o Autoimmune Diseases
o Transplantation
o Graft-Versus-Host Disease (GvHD)
o Inflammatory and Allergic Disorders
o Oncology
o Others

• End-Use Outlook (Revenue, USD Million; 2022-2032)
o Hospitals and Clinics
o Pharmaceutical and Biotechnology Companies
o Research Institutes and Academic Centers
o Contract Research Organizations (CROs)

• Regional Outlook (Revenue, USD Million; 2022-2032)
o North America
a. U.S.
b. Canada
c. Mexico

o Europe
a. Germany
b. France
c. U.K.
d. Italy
e. Spain
f. Benelux
g. Nordic Countries
h. Rest of Europe

o Asia Pacific
a. China
b. India
c. Japan
d. South Korea
e. Oceania
f. ASEAN Countries
g. Rest of APAC

o Latin America
a. Brazil
b. Rest of LATAM

o Middle East & Africa
a. GCC Countries
b. South Africa
c. Israel
d. Turkey
e. Rest of MEA

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