GCSF Market: Competitive Landscape, Pipeline, and Market Analysis 2024

Granulocyte colony-stimulating factor (G-CSF or GCSF), also known as colony-stimulating factor 3 (CSF 3), is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. G-CSF  stimulates the survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils. Mechanism of action (MOA) of  GCSF analogs involves the Binding of G-CSF analogs to the G-CSFR initiates intracellular signaling cascades. The primary signaling pathway involves the activation of the JAK-STAT (Janus kinase-signal transducer and activator of transcription) pathway. This pathway leads to the phosphorylation and activation of specific transcription factors, primarily STAT3 and STAT5. Activated STAT proteins translocate to the cell nucleus and bind to specific DNA sequences, resulting in the transcription of genes involved in neutrophil production, maturation, and survival. These genes include those responsible for cell cycle progression, anti-apoptotic factors, and neutrophil-specific granule proteins. GCSF are used in the treatment of adenocarcinoma, digestive system diseases, neutropenia, lymphoma, multiple myeloma, leukemia, breast diseases, reperfusion injury, acute coronary syndrome, anemia, etc. Increased prevalence of digestive system disorders and various cancers are the key drivers for the GCSF market. For instance, according to the World Health Organization 2022, around 1.9 million new cancer cases were diagnosed in the US. breast and lung cancer are the most prevalent cancers in adults worldwide. The introduction of newer products by market players may look for opportunities that greatly impact comprehensive research and development in GCSF. For instance, Spectrum Pharmaceuticals launched the Rolvedon (Eflapegrastim-Xnst)  for the treatment of non-myeloid malignancies.  Moreover, to address the difficulties in therapy, numerous market participants are developing innovative compounds. For instance, Intas Neukine (Filgrastim Biosimilar) for the indication of neutropenia is under the various stages of clinical studies.

Key Market Developments:

• In November 2020, Y-mAbs Therapeutics received FDA approval for its Danyelza (Naxitamab-Gqgk) for the treatment of relapsed or refractory high-risk neuroblastoma in the bone or bone marrow.
• In September 2022, Spectrum Pharmaceuticals received FDA approval for its Rolvedon (Eflapegrastim-Xnst) Injection for the treatment of adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs.

 Approved Drug Molecules and Brand Names for GCSF:

    Rolvedon (Eflapegrastim-Xnst) Injection

    Danyelza (Naxitamab-Gqgk)

    Leukine (Sargramostim)

    Neulasta (Pegfilgrastim)

    Neutroval (Tbo-Filgrastim)

    Unituxin (Dinutuximab)

Drugs under the Pipeline for GCSF:

Neukine (Filgrastim Biosimilar)

Dulastin (Tripegfilgrastim)

Extimia (Empegfilgrastim Biosimilar)

Neupeg (Pegfilgrastim Biosimilar)

Nivestym (Filgrastim-Aafi)

Tevagrastim (Filgrastim Biosimilar)

Udenyca (Pegfilgrastim-Cbqv)

ANF-Rho (Pegfilgrastim Biosimilar)

Bria-IMT (SV-BR-1-GM)

GW003 (Balugrastim Biosimilar)

Jinyouli (Pegfilgrastim Biosimilar)

Neugranin (Balugrastim Biosimilar)

Neulapeg (Pegfilgrastim Biosimilar)

Neurapeg (Pegteograstim)

YPEG-Filgrastim (YPEG-Rhg-CSF)

BK0023 (Filgrastim Biosimilar)

Cavoley (Pegfilgrastim Biosimilar)

Fulphila (Pegfilgrastim-Jmdb)

Fylnetra (Pegfilgrastim-Pbbk)

Hygrastim (GX-G3)

Neumax (Filgrastim Biosimilar)

Peg-Grafeel (Pegfilgrastim Biosimilar)

Pegcyte (Pegfilgrastim Biosimilar)

Pelmeg (Pegfilgrastim Biosimilar)

RP2

Stimufend (Pegfilgrastim-Fpgk)

Ziextenzo (Pegfilgrastim-Bmez)

Pegfilgrastim Biosimilar

Pegfilgrastim Biosimilar

8MW0511

BP14 (Pegfilgrastim Biosimilar)

Emgrast (Filgrastim Biosimilar)

Filcad (Filgrastim Biosimilar)

Filgrastine (Filgrastim Biosimilar)

Fiprima (Filgrastim Biosimilar)

Jisaixin (Filgrastim Biosimilar)

MEDI5395

MK-4214 (Filgrastim Biosimilar)

Myograf (Filgrastim Biosimilar)

Nugraf (Filgrastim Biosimilar)

Peg-Neutropine (Pegfilgrastim Biosimilar)

Pegagen (Pegfilgrastim Biosimilar)

Religrast (Filgrastim Biosimilar)

SBC-014 (Filgrastim Biosimilar)

Clinical Activity and Developments of GCSF:

Up until June 2023, there will be about 20 companies with over 50 compounds that focus on various cancer diseases. For these molecules, more than 500 of  clinical trials are being conducted and majority are in phase-2, phase-3 clinical trials by the players across the globe. For instance,

• In January 2019, Intas has completed phase 4, comparison study of biosimilar G-CSF versus originator G-CSF for autologous peripheral blood stem cell mobilization.
• In December 2018, IIkogen has completed phase 2, a randomized, parallel group, multi-centre phase-2 study of GX-G3 compared with Pegfilgrastim as an adjunct to chemotherapy in patients with non-hodgkin's lymphoma.