TGF-Beta 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 cell lineages. The mechanism of action (MOA) of the TGF-Beta inhibitors works by binding of TGF-β receptor, the type 2 receptor kinase phosphorylates and activates the type 1 receptor kinase that activates a signaling cascade. This leads to the activation of different downstream substrates and regulatory proteins, inducing transcription of different target genes that function in differentiation, chemotaxis, proliferation, and activation of many immune cells. The TGF-β superfamily includes endogenous growth-inhibiting proteins; an increase in expression of TGF-β often correlates with the malignancy of many cancers and a defect in the cellular growth inhibition response to TGF-β. Its immunosuppressive functions then come to dominate, contributing to oncogenesis. TGF-Beta inhibitors are used in the treatment of autoimmune diseases, bronchial neoplasms, carcinoma, endocrine gland neoplasm, digestive system diseases, respiratory tract neoplasm, skin diseases, kidney diseases, urologic diseases, hematologic diseases, and CNS neoplasms, etc. Increased prevalence of autoimmune disorders, life-threatening cancers, tobacco use, high body mass index, alcohol consumption, low fruit, and vegetable intake, and lack of physical activity, etc. are the key drivers for the TGF-Beta inhibitors market. For instance, according to the World Health Organization 2020, there were 2.26 million new cases of breast cancer and 1.41 million cases of prostate cancer worldwide. The introduction of newer products by market players may look for opportunities that greatly impact comprehensive research and development in TGF-Beta inhibitors. For instance, BMS launched Reblozyl (Luspatercept-Aamt) for the treatment of anemia. Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, EMD Serono’s Bintrafusp Alfa (M7824) for the indication of various cancers is under the various stages of clinical studies.

Key Market Developments:

• In November 2019, Bristol Myers Squibb in global collaboration with Acceleron received FDA approval for Reblozyl (Luspatercept-Aamt) for the treatment of anemia in adults with beta-thalassemia requiring regular RBC transfusion.
• In April 2020, Bristol Myers Squibb in global collaboration with Acceleron received FDA approval for the expanded indication of Reblozyl (Luspatercept-Aamt) for the treatment of anemia failing an erythropoiesis-stimulating agents and requiring 2 or more red blood cell units over 8 weeks in adult patients with ring sideroblasts.

Approved Drug Molecules and Brand Names for TGF-Beta:

 Reblozyl (Luspatercept-Aamt)

Drugs under the Pipeline for TGF-Beta:

Bintrafusp Alfa (M7824)

Retlirafusp Alfa (SHR-1701)

Galunisertib (LY2157299)

Sotatercept (MK-7962)

Vactosertib (TEW-7197)

Rizaben (Tranilast)

Simtuzumab (GS 6624)

Vigil (Gemogenovatucel-T)

Fresolimumab (GC 1008)

Nisevokitug (NIS793)

Cutasil (Cotsiranib)

Ascrinvacumab (GT90001)

TQB2858

Yifenidone (HEC585)

CBP501

DW 1029M

Trabedersen (OT-101)

Zinpentraxin Alfa (RG6354)

BMS-986416

KER-050

LY3200882

SAR439459

Apitegromab (SRK-015)

Diacerein Controlled Release (AC 201)

Efmitermant Alfa (ACE-083)

 Isomyosamine (MYMD-1)

Aerodone (Aerosol Pirfenidone)

GFH018

Lucanix (Belagenpumatucel-L)

Remedisc (SB-01)

YL-13027

Deuterium Pirfenidone (LYT-100)

Disitertide (P144)

AAV1-Follistatin

AGMB-129

Artiveda (Artemisinin)

CART-PSMA- TGFβRDN Cells

ES014

FT011

HB-002

HCW9218

JS201

KER-012

NCE 401

STP707

ZSP1603

Allogeneic Umbilical Cord-Derived Mesenchymal Stem Cells (EN001)

Dalutrafusp Alfa (AGEN1423)

 Itacnosertib (TP-0184)

Lenvatinib Gel Suspension (AIV007)

Livmoniplimab (ABBV-151)

Recombinant Human Follistatin-288 (PB01)

6MW3511

ACE-2494

AK130

ATB-301

BCA101

BJ-005

BNT151

BPB-101

Charis1000

FMPV-1

HB002.1M

IDL-2965

IMC-TR1

INCA33890

ISTH-0036

JYB1907

LB-P8

LBL-015

LY2382770

MK-2225

NP-011

PF-06952229

PM8001

Pleneva (BGC 200134)

QLS31901

RG6440

SH3051

SRK-181

TD-1058

TQB2868

TRK-250

TST005

Y101D

ZGGS18

Dimethyl Fumarate (CU01)

Pirfenidone Sustained Release (EXCL-100)

Clinical Activity and Developments of TGF-Beta:

Up until July 2023, there were more than 25 companies with over 190 compounds that focused on various forms of autoimmune disorders and cancers. For these molecules, more than 563 clinical trials are being conducted and the majority are in phase-2, and phase-3 clinical trials by the players across the globe. For instance,

• In June 2023, Eli Lilly is conducting phase 1, a dose-escalation study of Galunisertib (LY2157299) monotherapy in combination with Lomustine in patients with recurrent malignant glioma.
• In February 2023, EMD Serono is conducting a phase 3, open-label, multicenter follow-up study to collect long-term data on participants from multiple Bintrafusp Alfa (M7824) Clinical Studies.