Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market Size, Clinical Trials, Product Pipelines and Investment Trends, till 2032

Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market Size is estimated to be $562 million in 2024 and is expected to grow at an average yearly rate of around 8% during the timeframe (2025-2032).

What is Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia and what are the growth drivers of Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market?

Biosimilars of Granulocyte Colony-Stimulating Factor (G-CSF) are biologic medical products that are highly similar to an already approved reference G-CSF product. They are used to stimulate the bone marrow to produce more white blood cells, especially neutrophils, which are often depleted due to chemotherapy. Chemotherapy-induced neutropenia is a common and potentially serious side effect of cancer treatment, leading to increased risk of infections, hospitalization, and treatment delays. G-CSF biosimilars are designed to reduce the duration and severity of neutropenia, improve patient outcomes, and provide a cost-effective alternative to branded biologics.

Function and Benefits of G-CSF Biosimilars

G-CSF biosimilars function by binding to specific receptors on hematopoietic cells, stimulating the production, maturation, and activation of neutrophils. Their use in oncology is critical, as they enable patients to maintain chemotherapy schedules without the interruptions that can occur due to neutropenia. The availability of biosimilars also helps reduce healthcare costs, improves accessibility, and supports broader patient reach, particularly in regions where access to biologics is limited. Additionally, these biosimilars undergo rigorous regulatory review to ensure they match the reference product in safety, efficacy, and quality.

Growth Drivers of the G-CSF Biosimilars Market

The market for G-CSF biosimilars used in chemotherapy-induced neutropenia is growing steadily due to several key drivers:

Increasing Cancer Prevalence
The rising global incidence of cancer has directly contributed to a higher demand for chemotherapy treatments, which in turn has increased the prevalence of chemotherapy-induced neutropenia. This has led to an expanded need for supportive care agents like G-CSF biosimilars, making them a critical component of oncology treatment protocols.

Cost-Effectiveness and Healthcare Savings
Biosimilars are significantly more affordable than original biologic drugs. As healthcare systems globally aim to control spending while expanding access to high-quality care, biosimilars offer an attractive solution. This cost benefit has driven greater adoption of G-CSF biosimilars across public and private healthcare sectors.

Patent Expirations of Originator Biologics
As patents and market exclusivities for originator G-CSF products expire, biosimilar manufacturers gain opportunities to enter the market. This increases competition, lowers costs, and expands availability, thereby driving market growth. The entry of biosimilars has also encouraged innovation and investments in the biologics manufacturing sector.

Regulatory Support and Approvals
Favorable regulatory pathways in regions such as Europe, the United States, and Asia have accelerated the development and approval of biosimilars. Clear guidelines and supportive regulatory frameworks help ensure that biosimilars are safe, effective, and readily accepted by healthcare providers and patients.

Growing Acceptance Among Physicians and Patients
Over time, confidence in biosimilars has grown due to increased clinical evidence, successful real-world use, and educational initiatives. Physicians are more willing to prescribe biosimilars, and patients are becoming more accepting of them, especially given their affordability and comparable efficacy.



The research and analytics firm Datavagyanik released the updated version of its report on "Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market - Detailed Analysis, Business Opportunities and Forecasts".

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Clinical Trials in Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market and New Product Pipelines

Clinical trials play a critical role in establishing the safety, efficacy, and comparability of biosimilars of G-CSF used for treating chemotherapy-induced neutropenia. These trials are designed to demonstrate that biosimilars produce the same therapeutic effects as the original biologic drugs they replicate. For G-CSF biosimilars, clinical development usually follows a stepwise approach including analytical characterization, non-clinical studies, and clinical trials involving pharmacokinetics, pharmacodynamics, efficacy, safety, and immunogenicity.

Phase I trials typically focus on pharmacokinetic and pharmacodynamic comparisons between the biosimilar and the reference product in healthy volunteers. These trials assess how the drug is absorbed, distributed, metabolized, and excreted in the body, as well as its biological effects. Following successful Phase I results, Phase III trials are conducted in cancer patients undergoing chemotherapy to evaluate clinical efficacy and safety. Endpoints commonly include the duration of severe neutropenia, incidence of febrile neutropenia, time to absolute neutrophil count recovery, and occurrence of adverse events.

Multiple G-CSF biosimilars such as filgrastim and pegfilgrastim have undergone extensive clinical testing and are now widely used. These include biosimilars developed by companies such as Sandoz, Teva, Pfizer, and Amgen. The outcomes of these trials have consistently shown that G-CSF biosimilars are equivalent to their originator products in managing neutropenia, supporting their use as safe and effective alternatives in clinical practice.

New Product Pipelines in G-CSF Biosimilars Market

The biosimilars pipeline for G-CSF continues to evolve with a strong focus on innovation, extended formulations, and increased global access. Several new biosimilar candidates are in various stages of clinical development, with a mix of short-acting (filgrastim) and long-acting (pegfilgrastim) versions being pursued. Long-acting biosimilars, in particular, offer improved convenience by reducing the frequency of injections, enhancing patient compliance.

Emerging products in the pipeline are being developed by both established pharmaceutical companies and new entrants in the biosimilars market. These new candidates are undergoing comparative studies to meet regulatory requirements for market approval. The goal is to show no clinically meaningful differences in terms of efficacy, safety, and immunogenicity when compared with the reference biologic.

Many of these new pipeline products are also exploring novel delivery systems, such as on-body injectors, which enable patients to self-administer their medication without the need for clinic visits. Additionally, biosimilar manufacturers are working on expanding indications beyond chemotherapy-induced neutropenia, such as stem cell mobilization in bone marrow transplant settings.

The introduction of these new biosimilars is expected to further increase competition, reduce treatment costs, and improve accessibility, particularly in low- and middle-income countries. Regulatory authorities in regions like the United States, Europe, and Asia are actively supporting these developments through streamlined approval pathways and clear biosimilar guidelines.



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Important target segments driving the demand for Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market

The market for biosimilars of G-CSF used in managing chemotherapy-induced neutropenia is influenced by a range of target segments that drive demand. These segments are defined by clinical needs, demographic trends, healthcare infrastructure, and evolving treatment protocols. Understanding these core segments helps identify where the market is expanding and which populations are most benefiting from biosimilar G-CSF products.

Cancer Patients Undergoing Chemotherapy

The most critical target segment is cancer patients receiving myelosuppressive chemotherapy. Chemotherapy often leads to a significant reduction in white blood cells, particularly neutrophils, increasing the risk of infections and delaying treatment schedules. G-CSF biosimilars are used as prophylaxis to mitigate these risks. This group includes patients with solid tumors such as breast, lung, and colorectal cancers, as well as hematologic malignancies like lymphoma and leukemia. With the global rise in cancer cases and the continued use of aggressive chemotherapy regimens, this segment remains the largest and most consistent driver of demand.

Hospitals and Oncology Clinics

Healthcare institutions such as hospitals, cancer centers, and oncology clinics represent another vital segment. These facilities are the primary prescribers and administrators of G-CSF biosimilars. Due to budget constraints and the growing focus on cost-effective care, hospitals increasingly prefer biosimilars over branded biologics. They benefit from comparable efficacy and safety at reduced prices, allowing wider patient access without compromising clinical outcomes. The institutional demand is further supported by government tenders and bulk purchasing programs.

Health Insurance Providers and Payers

Payers, including public health agencies, private insurers, and managed care organizations, are instrumental in driving the adoption of G-CSF biosimilars. Cost containment is a major objective for these entities, especially in regions where oncology treatments contribute heavily to healthcare expenditure. Biosimilars offer a solution that aligns with payer priorities by providing similar clinical benefits at lower costs. Consequently, insurers often favor reimbursement policies that support biosimilar use, leading to increased market penetration.

Geriatric Population

The aging population is another important segment, as older adults are more prone to cancer and are frequent recipients of chemotherapy. Age-related decline in immunity makes elderly patients especially vulnerable to chemotherapy-induced neutropenia. G-CSF biosimilars help minimize complications and hospitalizations, making them highly relevant to this demographic. As the global population continues to age, this group is expected to contribute significantly to market growth.

Emerging Markets

Developing regions such as Asia-Pacific, Latin America, and parts of Eastern Europe represent high-growth potential segments. In these markets, the cost of originator biologics is often a barrier to access. Biosimilars, with their lower price point, allow healthcare systems to offer supportive cancer care to broader segments of the population. Increased government investment in healthcare infrastructure and biosimilar manufacturing further supports demand in these areas.



Key Players in Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia, Market Share

The biosimilars market for Granulocyte Colony-Stimulating Factor (G-CSF), particularly for chemotherapy-induced neutropenia, is shaped by several global and regional pharmaceutical companies. These key players have contributed to market expansion through innovation, cost-effective production, strategic partnerships, and regulatory approvals. Each player holds varying degrees of market share, depending on geographic presence, product portfolio, and competitive pricing strategies.

Sandoz (a Novartis division)

Sandoz is one of the leading players in the G-CSF biosimilars market. It was among the first companies to launch a G-CSF biosimilar in Europe with its product Zarzio, a biosimilar version of filgrastim. Zarzio has achieved widespread adoption in several markets and significantly contributed to the acceptance of biosimilars in oncology care. Sandoz also markets Ziextenzo, a biosimilar of pegfilgrastim, further strengthening its position in both short-acting and long-acting G-CSF segments.

Pfizer

Pfizer has established itself as a major competitor with its biosimilar filgrastim, marketed under the name Nivestym. Approved in multiple regions, including the United States and Europe, Nivestym has captured a significant portion of the biosimilars market due to Pfizer's strong distribution network and reputation. The company's active participation in the oncology biosimilar segment has made it a trusted name among healthcare providers.

Amgen

Although primarily the originator of G-CSF biologics such as Neupogen and Neulasta, Amgen also plays a role in the biosimilars space through its production of biosimilar versions in collaboration with partners. While it focuses more on originator products, its strategic response to biosimilar competition and adaptation to market trends help maintain its influence in the sector.

Coherus BioSciences

Coherus has become a notable player in the G-CSF biosimilars space with its product Udenyca, a biosimilar to pegfilgrastim. Since its entry into the market, Udenyca has rapidly gained market share in the United States by offering competitive pricing and reimbursement support. The company's aggressive market strategies have allowed it to challenge larger pharmaceutical firms effectively.

Biocon Biologics and Mylan (now part of Viatris)

The partnership between Biocon and Mylan has resulted in the development and marketing of several biosimilars, including pegfilgrastim under different brand names. Their products are available in both developed and emerging markets, offering a wide reach and improving access to affordable cancer supportive care. Their combined capabilities in manufacturing and global distribution enhance their competitiveness.

Teva Pharmaceuticals

Teva markets biosimilar filgrastim under the brand name Tevagrastim. The company has a strong footprint in Europe and selected other international markets. Its cost-driven approach and strategic alliances have helped it maintain a relevant share of the G-CSF biosimilars market.

Market Share Dynamics

The G-CSF biosimilars market is highly competitive, with no single player dominating all regions. In Europe, Sandoz holds a leading position due to early market entry and established trust. In the United States, market share is more fragmented among Coherus, Pfizer, and Sandoz. Emerging markets are witnessing a growing presence of local manufacturers, such as Dr. Reddy's and Intas, which cater to price-sensitive segments with regionally approved biosimilars.



Key Questions Answered in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia market report:

What is the total global Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Sales, and how has it changed over the past five years?

What is Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia investment trend?

Which countries have the highest Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia, and what factors contribute to their dominance in the market?

How does Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Sales vary across key manufacturers, and what expansions have been observed recently?

What is the current global revenue generated from Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Sales, and how does it compare to previous years?

Which industries drive the highest demand for Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia, and how is this demand expected to evolve in the next five years?

What are the major challenges impacting Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia industry and supply chain operations across key markets?

How do government policies, environmental regulations, and trade restrictions affect Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia and market dynamics?

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