TGF-beta Inhibitor Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Transforming growth factor beta (TGF-β) is a multifunctional cytokine belonging to the transforming growth factor superfamily that includes three different mammalian isoforms (TGF-β 1 to 3, HGNC symbols TGFB1, TGFB2, TGFB3) and many other signaling proteins. TGFB proteins are produced by all white blood cells. TGF-beta inhibits proliferation and induces apoptosis in various cell types, and accumulation of loss-of-function mutations in the TGF-beta receptor. The mechanism of action (MOA) of TGF-β Inhibitor is that work by the suppression of the production of TGF-β leads to the inhibition of TGF-β activity.

Moreover, the blockage of the interaction of TGF-β with its receptors and the inhibition of the kinase activity of the TGF-β receptor. TGF-β Inhibitor is used in the treatment of Blood coagulation disorders, carcinoma, urologic diseases, endocrine system diseases, diabetes mellitus, genetic diseases, kidney diseases, skin diseases, pulmonary fibrosis, albinism, angina pectoris, etc. Increased prevalence of blood disorders and cardiovascular disorders are the key drivers for the TGF-β Inhibitor market. For instance, according to the Centers for Disease Control And Prevention 2021, there were 1,85,318 people worldwide who had hemophilia A and around 17,951 people with other platelet disorders. The launch of newer products by the market players could seek opportunities that influence extensive research and development in TGF-β Inhibitor. For instance, Bristol Myers Squibb Reblozyl (Luspatercept-Aamt) is used to treat anemia. Moreover, the development of novel molecules by many market players is coming up to overcome challenges in therapy. For instance, Biocon’s BCA101 for the treatment to suppress tumor growth under the various stages of clinical studies.

TGF-beta Inhibitor Market Key Developments:

• In November 2019, Bristol Myers Squibb in collaboration with Acceleron Pharma received FDA approval for a Reblozyl (Luspatercept-Aamt) for the treatment of anemia in adults with beta thalassemia requiring regular RBC transfusion.
• In April 2020, Bristol Myers Squibb has received FDA approval for a Reblozyl (Luspatercept-Aamt) for additional indication for the treatment of anemia failing an erythropoiesis stimulating agent and requiring 2 or more red blood cell units over 8 weeks in adult patients with very low- to intermediate-risk myelodysplastic syndromes with ring sideroblasts or with myelodysplastic or myeloproliferative neoplasm.
• In october 2021, Merck completed an acquisition of Acceleron Pharma for US$11.5 billion to strengthens cardiovascular portfolio.

Approved Drug Molecules and Brand Names for TGF-β Inhibitor:

• Reblozyl (Luspatercept-Aamt)
• Artiveda (Artemisinin)

Drugs under the Pipeline for TGF-β Inhibitor:

• Bintrafusp Alfa (M7824)
• Retlirafusp Alfa (SHR-1701)
• Sotatercept (MK-7962)
• Fresolimumab (GC 1008)
• Ascrinvacumab (GT90001)
• TQB2858
• Yifenidone (HEC585)
• BMS-986416
• KER-050
• SAR439459
• Diacerein Controlled Release (AC 201)
• Efmitermant Alfa (ACE-083)
• Isomyosamine (MYMD-1)
• Aerodone (Aerosol Pirfenidone)
• Lucanix (Belagenpumatucel-L)
• Deuterium Pirfenidone (LYT-100)
• AAV1-Follistatin
• ES014
• FT011
• JS201
• KER-012
• Dalutrafusp Alfa (AGEN1423)
• Recombinant Human Follistatin-288 (PB01)
• 6MW3511
• ACE-2494
• AK130
• BCA101
• BPB-101
• IDL-2965
• ISTH-0036
• JYB1907
• LB-P8
• PM8001
• QLS31901
• TQB2868
• Y101D
• ZGGS18
• Dimethyl Fumarate (CU01)
• Losartan
• Pirfenidone Sustained Release (EXCL-100)

Clinical Activity and Developments of TGF-β Inhibitor:

Till June 2023, more than 46 companies have approximately 43 molecules targeting 173 blood and endocrine diseases. For these molecules, more than 162 clinical trials are being conducted and the majority are in phase-2, and phase-3 clinical trials by players across the globe. For instance,

• In June 2023, Bristol Myers Squibb’s Luspatercept (ACE-536) completed phase 2, a multicenter, single-arm study for evaluating the safety and efficacy of the treatment of anemia due to the risk of myelodysplastic syndromes in Japanese subjects who are not requiring red blood cell transfusion, funded by Celgene Corporation.
• In August 2021, Oncotelic Therapeutics Artiveda (Artemisinin) completed phase 3, a randomized, multi-center, open-label, interventional study to evaluate the Safety and Efficacy of Artemisinin 500 mg capsule in the treatment of Adult Subjects and proven active against mild to moderate COVID-19.