The global G-CSF and G-CSF biosimilars market size is estimated to grow at a CAGR of 6.22% during the forecast period (2025–2033). The increasing prevalence of neutropenia in the past few years due to chemotherapy in cancer patients is driving demand for G-CSF and G-CSF biosimilars. The growing cancer burden worldwide further boosts adoption, enhancing treatment outcomes and reducing infection-related complications.
Granulocyte Colony-Stimulating Factor is a glycoprotein that stimulates the production of neutrophils, a white blood cell essential for fighting infections. It is widely used in cancer patients undergoing chemotherapy to prevent neutropenia. G-CSF Biosimilars are biologic drugs highly similar to the original G-CSF reference product, offering comparable efficacy and safety at a lower cost. These biosimilars help improve patient access to neutropenia treatment and are used in oncology and hematology. Common G-CSF biosimilars include filgrastim and pegfilgrastim biosimilars, which enhance immune recovery post-chemotherapy.
The rising acceptance of biosimilars is a significant driver for the G-CSF market, as these cost-effective alternatives provide similar therapeutic benefits to biologics. Healthcare systems worldwide are actively promoting biosimilars to reduce treatment costs and improve patient access. Regulatory bodies, including the FDA and EMA, have established clear pathways for biosimilar approvals, ensuring their safety and efficacy.
Thus, the increasing availability of such biosimilars enhances competition, leading to price reductions and greater affordability, further driving market expansion and adoption across various healthcare settings.
The expiration of key patents for G-CSF and G-CSF biosimilars has intensified market competition, leading to significant price erosion. As biosimilar manufacturers introduce cost-effective alternatives, originator companies face declining revenues and reduced market share. While this benefits patients through lower costs, it pressures companies to differentiate their products through enhanced formulations or extended indications.
Additionally, the influx of multiple biosimilars in key markets creates pricing challenges, limiting profitability. This competitive landscape forces companies to adopt aggressive pricing strategies, impacting research investments. As a result, sustained innovation and long-term market sustainability become critical concerns for stakeholders in the G-CSF sector.
The increasing approval of G-CSF and biosimilars is driving market growth by enhancing accessibility and affordability for neutropenia treatment. Regulatory bodies like the FDA and EMA are fast-tracking biosimilar approvals to reduce healthcare costs and improve patient outcomes. This trend is fostering market expansion and intensifying competition among pharmaceutical companies.
With increasing regulatory support and streamlined approval processes, the G-CSF biosimilars market is poised for sustained growth, offering lucrative opportunities for manufacturers to expand their global footprint.
| ATTRIBUTES | DETAILS |
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| Study Period | 2021-2033 |
| Historical Year | 2021-2024 |
| Forecast Period | 2025-2033 |
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The Filgrastim segment holds a significant market share in the G-CSF and G-CSF biosimilars market, driven by its widespread use in neutropenia treatment. As a short-acting G-CSF, Filgrastim is extensively prescribed for chemotherapy-induced neutropenia and bone marrow transplantation. The growing availability of biosimilar versions has enhanced accessibility and affordability. Moreover, increasing clinical research on Filgrastim's potential applications in stem cell mobilization is further fueling market growth.
The neutropenia treatment segment dominates the market due to the rising prevalence of chemotherapy-induced neutropenia. G-CSF drugs, including biosimilars, are widely used to stimulate white blood cell production and reduce infection risks in cancer patients undergoing chemotherapy. The segment's growth is propelled by increasing cancer cases, improved reimbursement policies, and the launch of cost-effective biosimilars, which enhance treatment accessibility across developed and emerging healthcare markets.
The hospitals & clinics segment accounts for a major share of the global G-CSF and G-CSF biosimilars market due to the high patient footfall for neutropenia treatment and cancer therapies. Hospitals serve as primary centers for chemotherapy and stem cell transplants, necessitating G-CSF administration. Increasing investments in hospital infrastructure and the adoption of biosimilars in clinical settings are enhancing segment growth. Additionally, favorable reimbursement policies for hospital-based treatments contribute to market expansion.
The online pharmacies segment is witnessing rapid growth due to the increasing digitalization of healthcare and patient preference for home delivery services. The availability of G-CSF biosimilars through e-commerce platforms enhances convenience and affordability, particularly in remote areas. Competitive pricing, easy prescription uploads, and growing telemedicine adoption further support market expansion. Additionally, regulatory initiatives promoting digital healthcare services are fostering the growth of online pharmacy sales worldwide.
North America plays a crucial role in the global G-CSF and G-CSF biosimilars market, which is driven by advanced healthcare infrastructure, strong regulatory frameworks, and increasing adoption of biosimilars. The United States, in particular, leads this market due to the presence of key industry players, high cancer incidence rates, and favorable reimbursement policies.
A prime example of North America's influence is the U.S. FDA's approval of multiple pegfilgrastim biosimilars, such as UDENYCA® (Coherus BioSciences), Fulphila® (Mylan/Biocon), and Ziextenzo® (Sandoz). These biosimilars provide cost-effective alternatives to Neulasta® (Amgen), significantly reducing the financial burden on patients undergoing chemotherapy. The increased competition has driven down prices, making G-CSF treatment more accessible.
Moreover, collaborations between North American pharmaceutical firms and biosimilar developers have accelerated market growth. For instance, Pfizer's NIVESTYM®, a filgrastim biosimilar, gained traction due to strategic partnerships and robust distribution channels. Similarly, Mylan and Biocon's joint venture has strengthened biosimilar penetration across the U.S. and Canada.
The impact of biosimilars is further evident in healthcare cost savings. A 2023 report from the Association for Accessible Medicines (AAM) highlighted that biosimilars saved patients and the U.S. healthcare system over USD 2.9 trillion in the last 10 years, with a significant portion attributed to G-CSF biosimilars.
Thus, with ongoing regulatory support, increasing provider acceptance, and continued investments in biosimilar innovation, North America is poised to remain a dominant force in the G-CSF and G-CSF biosimilars market.
February 2025- Kashiv BioSciences, a biopharmaceutical company based in the United States, stated that Health Canada has awarded marketing authorization for its Pegfilgrastim Injection, marketed as Pexegra. The permit permits the commercial introduction of Pegfilgrastim in Canada.
