Granulocyte Colony-Stimulating Factor Stimulators Market: Competitive Landscape, Pipeline, and Market Analysis 2023

Granulocyte Colony-Stimulating Factor (G-CSF) Stimulators Market Size, Share, Growth, Trends, and Global Industry Analysis: Competitive Landscape, Pipeline, and Market Size, Share, Growth, Trends, and Global Industry Analysis: Analysis 2023

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.

Key Features of the Report

  • The report provides granular level information about the market size, regional market share, historic market (2019-2023), and forecast (2024-2030)
  • The report covers in-detail insights about the competitor’s overview, company share analysis, key market developments, and key strategies
  • The report outlines drivers, restraints, unmet needs, and trends that are currently affecting the market
  • The report tracks recent innovations, key developments, and start-up details that are actively working in the market
  • The report provides a plethora of information about market entry strategies, regulatory framework, and reimbursement scenario
  • The report analyses the impact of the socio-political environment through PESTLE Analysis and competition through Porter's Five Force Analysis in addition to recent technology advancements and innovations in the market

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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.

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Author

Muni Kumar Meravath

Muni Kumar Meravath is a seasoned Healthcare Market Research Analyst with over 6 years of experience in the healthc.....

Key Market Players

  • 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

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