CD4+ T Cells Market: Competitive Landscape, Pipeline, and Market Analysis 2023

CD4 cells or CD4⁺ T helper cells, which stands for Cluster of Differentiation 4, are glycoproteins present on the surface of immune cells such as T  helper cells, macrophages, monocytes, and dendritic cells. Our immune system is unique in the sense that it keeps a record of all the pathogens that it has encountered and develops antibodies against the pathogen. These cells are responsible for maintaining an effective response to the pathogens. These get activated after interaction with an anti-MHC complex which then differentiates into specific subtypes depending on the cytokine present in the environment. This post-activation secretes cytokines mediating the effect. These cells carry out many functions, including activation of B-lymphocytes, cytotoxic T cells, immune system, and nonimmune cells. These also play a role in the suppression of immune reactions. Average CD4⁺ count in an individual range from 500 – 1500 cells/mm³. However, this count decreases to a very low value when a person is infected with diseases like HIV/AIDS. Hence, the reduced cell count is a diagnostic indication for AIDS. Extensive research is being conducted globally to discover new and novel molecules to be used as immunomodulators that function to decrease the number of activated T cells. The development and launch of new products will thus increase the market’s revenue in the forecasted years. The count is aberrant in autoimmune diseases such as Rheumatoid Arthritis (RA), Systemic Lupus Erythromaticus (SLE), Inflammatory Bowel Disease (IBD), Plaque Psoriasis, and others. Arthritis Foundation estimates the global prevalence of RA to be 0.5% to 1% in developed countries. Females are affected more than males, with 75% being females.

A number of these inhibitors are in the market, while many are in ongoing clinical trials. Many companies have various products in their pipelines, with 48 products in different stages of clinical trials. 3 products in Phase 4, 2 in Phase 3, 11 in Phase 2, and 10 in Phase 1 of the clinical trials.

Key Developments of CD4⁺ T Cells

• In May 2023, FDA approved the 1^st topical novel chemical entity in the USA - Vtama (tapinarof) cream, 1% for treating Plaque Psoriasis in adults.
• In January 2022, Orencia (abatacept) became the 1^st drug to be approved by the FDA for the prophylaxis of acute graft vs. host disease, in combination with Methotrexate and a Calcineurin inhibitor, in adults and pediatric patients two years of age and older undergoing hematopoietic stem cell transplantation from a matched or one allele-mismatched unrelated donor.

Approved molecules of CD4⁺ T Cells

• Thymoglobulin (anti-thymocyte globulin (rabbit))
• Orencia (abatacept)
• Vtama (tapinarof)

Drugs in the Pipeline of CD4⁺ T Cells

• VRC01
• rhIL-15
• HuMax-CD4 (zanolimumab)
• Lupuzor (rigerimod)
• Resolaris (resokine)
• VRC01LS
• tregalizumab (BT-061)
• Tcelna (imilecleucel-T)
• VTP-300
• AGT103-T
• AMP-110
• BAT6026
• CN1
• HepTcell (FP-02.2)
• MTRX 1011A
• HFB200301
• IMA203CD8
• IMCY-0141
• JCXH-212
• MazF gene therapy
• NG-348
• RTL 1000
• combinectin (GSK3732394)

Clinical Activity and Developments of CD4⁺ T Cells

As of June 2023, various companies have approximately 48 products for 768 diseases. For these diseases, many trials are being conducted by players globally. For instance,

• In January 2023, the National Institute of Allergy and Infectious Diseases (NIAID) completed a Phase 4 clinical trial to evaluate SARS-CoV-2 immune responses after COVID-19 therapy and subsequent vaccine.
• In October 2022, St George's, University of London conducted a Phase 4 clinical trial to compare Abatacept with Tumor Necrosis Factor Inhibitors in treating Rheumatoid Arthritis pain.
• In March 2022, University Medical Center Groningen completed a Phase 4 clinical trial to study optimal repeated dose strategy for SARS-CoV-2 vaccination in kidney transplant patients.
• Dermavant Sciences, Inc. is conducting a Phase 4 clinical trial to investigate the efficacy and safety of VTAMA® (Tapinarof) cream 1% in the treatment of Plaque Psoriasis in intertriginous areas that were expected to complete by June 2023.