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Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....
GCSF Market: Competitive Landscape, Pipeline, and Market Analysis 2024
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:
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,
|
Molecule Name |
Number of Studies |
|
Neukine (Filgrastim Biosimilar) |
5 |
|
Dulastin (Tripegfilgrastim) |
4 |
|
Extimia (Empegfilgrastim Biosimilar) |
4 |
|
Neupeg (Pegfilgrastim Biosimilar) |
4 |
|
Nivestym (Filgrastim-Aafi) |
4 |
The molecules such as Rolvedon (Eflapegrastim-Xnst) Injection developed by Spectrum Pharmaceuticals for the line of treatment to decrease the incidence of infection, as manifested by febrile neutropenia, in adult patients with non-myeloid malignancies receiving myelosuppressive anti-cancer drugs associated with a clinically significant incidence of febrile neutropenia. Moreover, Y-mAbs Therapeutics Danyelza (Naxitamab-Gqgk) is used in combination with granulocyte-macrophage colony-stimulating factor (GM-CSF), for the treatment of pediatric patients 1 year of age and older and adult patients with relapsed or refractory high-risk neuroblastoma in the bone or bone marrow who have demonstrated a partial response, minor response, or stable disease to prior therapy.
Total sales of spectrum in collaboration with Hanmi Pharmaceutical’s Rolvedon (Eflapegrastim-Xnst) for the full year FY2022 were US$10.114 million in the US. during the fourth quarter of last year, 70 vendors purchased Rolvedon and the top three community oncology networks began utilizing Rolvedon. The top three account for 22 percent of the total clinic market. In December of last year, the National Comprehensive Cancer Network (NCCN) of the United States included Rolvedon in guidelines for febrile neutropenia prevention and treatment presented by the National Comprehensive Cancer Network (NCCN) of the United States. Moreover, the Centers for Medicare and Medicaid Services (CMS) of the United States recently decided to apply J-code J1449 for permanent reimbursement to Rolvedon from April 2023. This is because it is on the list of drugs subject to reimbursement by public insurance in the United States, reducing the burden of medical expenses for patients using the CMS and simplifying the refunding process. Additionally, the Increase incidence of cancer populations ranging from adenocarcinoma to leukemia and autoimmune disorders in the US also contributes to growth in oncology; Seems to create an opportunity for the future and burgeon the growth of the GCSF market. For instance, according to the Centers for Disease Control and Prevention 2020, about 1.6 million new cancer cases in the US were reported, and is expected to create a lucrative opportunity for the GCSF market.
Latin America
Europe
Asia Pacific
Middle East
North America
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Rolvedon (Eflapegrastim-Xnst) Injection, Danyelza (Naxitamab-Gqgk) are the few FDA approved GM-CSF.
Total sales of spectrum in collaboration with Hanmi Pharmaceutical’s Rolvedon (Eflapegrastim-Xnst) for the full year FY2022 were US$10.114 million in the US.
Amgen, Spectrum Pharmaceuticals, Roche, Y-mAbs Therapeutics, Teva, etc are few leading market players in GM-CSF.
Major Indications for GCSF are used to treat adenocarcinoma, digestive system diseases, neutropenia, lymphoma, multiple myeloma, leukemia, breast diseases, reperfusion injury, etc.
There are more than 30 molecules that are in Phase-1, Phase-2, and Phase-3 clinical development.
Key Market Players
Author
Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthcare domain, encompassing pharmaceuticals, medical devices, and diagnostics. A graduate in Pharmacy, he possesses a strong foundation in the intricacies of the healthcare sector. He further enhanced his expertise by pursuing an MBA in Pharmaceuticals, equipping him with valuable business acumen. His analytical skills and market insights have contributed to strategic decision-making and enhanced market positioning for various healthcare organizations. Committed to driving innovation and excellence, Muni continues to seek opportunities to improve healthcare delivery through data-driven insights.