Granulocyte colony-stimulating factor (G-CSF or CSF 3) is a glycoprotein that stimulates the bone marrow to produce granulocytes and stem cells and release them into the bloodstream. It also stimulates the survival, proliferation, differentiation, and function of neutrophil precursors and mature neutrophils. G-CSF also induces some end-cell functional activation of neutrophils, including enhanced phagocytic ability, priming of the cellular metabolism associated with a respiratory burst, antibody-dependent killing, and increased expression of some cell surface antigens. G-CSF stimulators mimic the actions of endogenous G-CSF and facilitate the release of neutrophils from the bone marrow into the blood. Thus G-CSF stimulators are used to reduce the incidence, severity, and duration of neutropenia and febrile neutropenia in patients undergoing cytotoxic chemotherapy. Amgen, Roche, Teva Pharmaceuticals, Biocad, Novartis, Jiangsu Hengrui Pharma, Pfizer, and CSPC Pharma are some of the major players in the G-CSF stimulators market.
Key Market Developments:
- In Feb 2021, Teva Pharmaceuticals preregistered Lipegfilgrastim for neutropenia in the European Union, Ireland, Liechtenstein, and Norway.
- In Jan 2022, Amneal Pharmaceuticals launched Filgrastim biosimilar for neutropenia in the USA.
- In Feb 2023, The Centers for Medicare and Medicaid Services (CMS) issued a permanent reimbursement J-code for, JI449 for Hanmi Pharmaceutical’s Eflapegrastim.
Approved Drug Molecules with Brand Names:
- Neulasta (Pegfilgrastim)
- Granocyte (Lenograstim)
- Lonquex (Lipegfilgrastim biosimilar)
- Leucostim (rhG-CSF biosimilar)
- Rolvedon (Eflapegrastim-xnst)
- Zarxio (Filgrastim-sndz)
- Mecapegfilgrastim (Pegfilgrastim biosimilar)
- Neukine (Filgrastim biosimilar)
- Dulastin (Tripegfilgrastim)
- Extimia (Empegfilgrastim biosimilar)
- Neupeg (Pegfilgrastim biosimilar)
- Jinyouli (Pegfilgrastim biosimilar)
- Peg-Neutropine (Pegfilgrastim biosimilar)
- PegaGen (Pegfilgrastim biosimilar)
- ReliGrast (Filgrastim biosimilar)
- Topneuter (Filgrastim biosimilar)
- Filgrastim biosimilar
Drugs under the Pipeline for G-CSF Stimulators:
- Fezagepras (PBI-4050)
- Nyvepria (Pegfilgrastim-apgf)
- CD40L cell vaccine
- Nivestym (Filgrastim-aafi)
- TevaGrastim (Filgrastim biosimilar)
- Udenyca (Pegfilgrastim-cbqv)
- ANF-Rho (Pegfilgrastim biosimilar)
- Bria-IMT (SV-BR-1-GM)
- GW003 (Balugrastim 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)
- RP2
- Stimufend (Pegfilgrastim-fpgk)
- Ziextenzo (Pegfilgrastim-bmez)
- 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)
- SBC-014 (Filgrastim biosimilar)
Clinical Activity and Developments of G-CSF Stimulators:
Currently, there are more than 50 drug products in the G-CSF Stimulators, including 17 approved drug products and the rest of them are in the clinical development phases.
- In Apr 2022, Megalabs initiated enrolment in a phase-I pharmacokinetic trial in healthy volunteers in Brazil.
- In Aug 2022, Jiangsu HengRui Medicine initiated a phase-II trial for breast cancer in adults and elderly in China for Mecapegfilgrastim.
- In Oct 2022, Kyowa Kirin completed a phase-II trial in stem cell mobilization in Japan for Pegfilgrastim.
|
Molecular Name |
Number of Studies |
|
Fezagepras (PBI-4050) |
9 |
|
Nyvepria (Pegfilgrastim-apgf) |
6 |
|
GM.CD40L cell vaccine |
5 |
|
Nivestym (Filgrastim-aafi) |
4 |
|
TevaGrastim (Filgrastim biosimilar) |
4 |
|
Udenyca (Pegfilgrastim-cbqv) |
4 |
|
ANF-Rho (Pegfilgrastim biosimilar) |
3 |
|
Bria-IMT (SV-BR-1-GM) |
3 |
|
GW003 (Balugrastim biosimilar) |
3 |
|
Neugranin (Balugrastim biosimilar) |
3 |
|
Neulapeg (Pegfilgrastim biosimilar) |
3 |
|
Neurapeg (Pegteograstim) |
3 |
|
YPEG-Filgrastim (YPEG-rhG-CSF) |
3 |
|
BK0023 (Filgrastim biosimilar) |
2 |
|
Cavoley (Pegfilgrastim biosimilar) |
2 |
|
Fulphila (Pegfilgrastim-jmdb) |
2 |
|
Fylnetra (Pegfilgrastim-pbbk) |
2 |
|
HyGrastim (GX-G3) |
2 |
|
Neumax (Filgrastim biosimilar) |
2 |
|
Peg-grafeel (Pegfilgrastim biosimilar) |
2 |
|
Pegcyte (Pegfilgrastim biosimilar) |
2 |
|
RP2 |
2 |
|
Stimufend (Pegfilgrastim-fpgk) |
2 |
|
Ziextenzo (Pegfilgrastim-bmez) |
2 |
|
Pegfilgrastim biosimilar |
2 |
|
8MW0511 |
1 |
|
BP14 (Pegfilgrastim biosimilar) |
1 |
|
Emgrast (Filgrastim biosimilar) |
1 |
|
Filcad (Filgrastim biosimilar) |
1 |
|
Filgrastine (Filgrastim biosimilar) |
1 |
|
Fiprima (Filgrastim biosimilar) |
1 |
|
Jisaixin (Filgrastim biosimilar) |
1 |
|
MEDI5395 |
1 |
|
MK-4214 (Filgrastim biosimilar) |
1 |
|
Myograf (Filgrastim biosimilar) |
1 |
|
Nugraf (Filgrastim biosimilar) |
1 |
|
SBC-014 (Filgrastim Biosimilar) |
1 |
Target Indication Analysis of G-CSF Stimulators
G-CSF Stimulators such as Pegfilgrastim, Lenograstim, Lipegfilgrastim, Eflapegrastim, Filgrastim, and others are used to reduce the incidence, severity, and duration of neutropenia and febrile neutropenia in patients undergoing cytotoxic chemotherapy. These are also used to mobilize hematopoietic progenitor cells into the peripheral blood in order to reduce the risk of bleeding complications and the need for platelet transfusions. Some of the other drugs are in the clinical trial phases for conditions such as breast cancer, solid tumor, diabetic neuropathies, and others.
Regional Analysis of G-CSF Stimulators
G-CSF Stimulators Market
Amgen’s Neulasta (Pegfilgrastim) had a total sale of US$ 1,126 million in the year 2022, with USD 959 million sales in the USA alone. According to a report, the incidence of febrile neutropenia is estimated at 60,294 per year including 7.83 cases per 1000 cancer patients and 43.3 cases per 1000 in individuals that are suffering from hematological malignant tumors. With the growing burden of cancer cases and increasing research & development activities, the G-CSF stimulator market is also expected to grow.
Latin America
Europe
Asia Pacific
Middle East
North America
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Frequently Asked Questions
Neulasta (Pegfilgrastim), Granocyte (Lenograstim), Lonquex (Lipegfilgrastim biosimilar), Leucostim (rhG-CSF biosimilar), Rolvedon (Eflapegrastim-xnst), Zarxio (Filgrastim-sndz) are some of the approved G-CSF stimulators.
Amgen, Roche, Teva Pharmaceuticals, Biocad, Novartis, Jiangsu Hengrui Pharma, Pfizer, and CSPC Pharma are some of the major players in the G-CSF stimulators market.
Major indications for G-CSF stimulators are neutropenia and febrile neutropenia in patients undergoing cytotoxic chemotherapy.
There are more than 35 molecules in the clinical development phases for G-CSF Stimulators.
- Amgen
- Roche
- Teva Pharmaceuticals
- Biocad
- Liminal BioScience
- Spectrum Pharma
- Novartis
- Jiangsu Hengrui Pharma
- Pfizer
- CSPC Pharma
- GC Biopharma
- AMEGA Biotech
- CinnaGen
- Reliance Life Sciences
- AstraZeneca
- Sanofi