Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market Size, Product Pipelines, Clinical Trials, Latest Developments, Demand and Growth Forecast 

What is Driving the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

The biosimilars of G-CSF for chemotherapy-induced neutropenia market is defined by the increasing global focus on affordable oncology care. Biosimilars of granulocyte colony-stimulating factor (G-CSF) are biologic agents developed to replicate the efficacy and safety of reference G-CSF drugs, primarily used to treat neutropenia, a common and severe side effect of chemotherapy. These biosimilars stimulate neutrophil production, enabling faster immune recovery in cancer patients undergoing cytotoxic treatment. 

Recent trends indicate accelerated adoption of biosimilars due to mounting healthcare cost pressures and expanded regulatory approvals. Multiple biosimilars for filgrastim and pegfilgrastim have been introduced globally in the past few years, marking a pivotal transition from brand-dependence to biosimilar integration. In mature markets, biosimilars of G-CSF account for over half of treatment volumes, while their usage in emerging economies continues to rise steadily. These developments signal strong momentum in the biosimilars of G-CSF for chemotherapy-induced neutropenia market across all regions. 

 

What is Fueling Demand in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

The demand in the biosimilars of G-CSF for chemotherapy-induced neutropenia market is strongly driven by the rising global burden of cancer and the growing need for supportive oncology care. With global cancer incidence surpassing 19 million annually, and more than 70 percent of patients undergoing chemotherapy at some stage of treatment, the need for G-CSF products remains high. Chemotherapy-induced neutropenia affects approximately 50 percent of patients receiving cytotoxic drugs, creating a continuous clinical need for neutrophil-boosting therapies. 

Biosimilars present a cost-effective alternative, offering an average price reduction of 30 to 50 percent compared to branded G-CSF drugs. For instance, in healthcare systems where patient access is constrained by reimbursement limitations, biosimilars have led to a measurable increase in treatment volumes. The penetration rate of biosimilars of G-CSF in hospital settings has surged from below 15 percent to over 40 percent in several countries within a five-year span. These shifts underscore the expanding demand for biosimilars, particularly among healthcare providers managing budget constraints. 

 

What are the Latest Trends in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Emerging trends in the biosimilars of G-CSF for chemotherapy-induced neutropenia market point toward innovation in delivery formats, regulatory acceleration, and growing physician acceptance. A key trend is the preference for long-acting pegfilgrastim biosimilars over short-acting alternatives due to reduced dosing frequency and improved patient convenience. These long-acting variants have seen year-over-year growth rates of over 15 percent, outperforming short-acting biosimilars in outpatient oncology clinics. 

Additionally, the development of self-administered delivery systems has helped biosimilars move closer to patient-centric models of care. Autoinjectors and on-body delivery devices have seen a marked increase in adoption, especially in settings where reducing hospital visits is a priority. As healthcare systems adopt remote monitoring solutions, these device-enabled biosimilars are anticipated to gain broader acceptance. 

There is also a rise in biosimilar adoption in national formularies and public health procurement systems. In several middle-income countries, government-led tenders for biosimilars have increased procurement volumes by up to 60 percent in just two years, highlighting the impact of favorable pricing on market growth. 

 

What Market Forces are Shaping the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Several powerful forces are shaping the biosimilars of G-CSF for chemotherapy-induced neutropenia market. Chief among them is the expiration of patents for key originator products. The loss of exclusivity for drugs such as filgrastim and pegfilgrastim has paved the way for competition, resulting in a more dynamic and price-sensitive market. The result has been a sharp reduction in treatment costs and a notable redistribution of market share in favor of biosimilars. 

Another major influence is healthcare system reform across both developed and developing nations. Policies aimed at promoting biosimilar usage, such as automatic substitution and prescriber incentives, have contributed to higher prescription rates. These reforms have been especially effective in regions where healthcare budgets are under pressure and biosimilars present a scalable solution for cost management. 

Additionally, market consolidation is driving expansion as larger pharmaceutical companies partner with regional manufacturers to extend reach. These collaborations have led to improved distribution networks and more consistent supply chains, ensuring that biosimilars of G-CSF are available across urban and rural healthcare settings alike. 

 

What is the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market Size and Growth Outlook? 

The biosimilars of G-CSF for chemotherapy-induced neutropenia market size stood at an estimated 5.2 billion dollars in 2024. It is projected to grow at a compound annual growth rate of 10.5 percent through 2029, reaching approximately 8.7 billion dollars by the end of the forecast period. This growth is underpinned by the rising incidence of cancer, increased chemotherapy usage, and broader accessibility of biosimilar options. 

One of the strongest growth indicators is the shift from hospital-based to home-based administration. Biosimilars suitable for outpatient use are increasingly preferred, especially in community oncology centers where treatment volume is high. It is projected that by 2027, more than 50 percent of all G-CSF biosimilar administrations will take place outside of hospital settings. 

 

What Role Does Regional Expansion Play in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Regional dynamics are critical to understanding the long-term trajectory of the biosimilars of G-CSF for chemotherapy-induced neutropenia market. While North America and Europe collectively account for over 70 percent of the global market share, high-growth opportunities are rapidly emerging in Asia-Pacific, Latin America, and parts of the Middle East and Africa. 

In Asia-Pacific, the market is expanding at over 13 percent annually due to high cancer burden, growing healthcare infrastructure, and local manufacturing capabilities. Countries such as China and India are advancing biosimilar development with supportive regulatory frameworks, leading to faster product approvals and broader usage in government programs. 

In Latin America, local production incentives and cross-border licensing agreements have enabled biosimilars to gain significant traction, particularly in public hospitals. Markets that once relied heavily on imported reference products are now transitioning to domestically available biosimilars, reflecting a shift in purchasing preferences. 

 

What are the Innovation Trends in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Innovation within the biosimilars of G-CSF for chemotherapy-induced neutropenia market is evolving from traditional replication to therapeutic enhancement. New formulations focus on extended shelf life, higher stability at room temperature, and better patient tolerability. These developments are especially relevant in regions with limited cold-chain logistics, where maintaining product quality has historically been a challenge. 

The use of artificial intelligence in clinical development is also gaining ground. Trial designs are becoming more efficient through predictive analytics, reducing both development time and cost. This has enabled biosimilar developers to bring products to market within five years, compared to earlier timelines of seven to eight years. 

Additionally, digital integration is transforming physician education and patient outreach. Online platforms, digital prescribing tools, and remote monitoring technologies are helping accelerate biosimilar adoption by creating awareness and providing real-time data on treatment outcomes. This, in turn, is contributing to more consistent usage and greater market penetration across healthcare ecosystems. 

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How is Regional Expansion Influencing the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Regional growth dynamics are playing a transformative role in the biosimilars of G-CSF for chemotherapy-induced neutropenia market. While North America and Western Europe represent high-value, mature markets, the fastest acceleration in volume and revenue is currently observed across Asia-Pacific, Latin America, and parts of the Middle East. 

In Asia-Pacific, cancer prevalence has reached over nine million cases annually, with chemotherapy being a cornerstone in over 70 percent of treatment regimens. This has directly contributed to a surge in biosimilars of G-CSF for chemotherapy-induced neutropenia demand. In India, for instance, annual growth in G-CSF biosimilar sales is exceeding 17 percent, supported by local manufacturing capabilities and national health coverage expansions. China has rapidly approved several new G-CSF biosimilars, contributing to a doubling of public hospital biosimilar usage within a two-year period. 

Latin America has adopted regional procurement frameworks, enabling cost optimization and improved drug access. In Brazil and Argentina, centralized tenders have resulted in price reductions of over 40 percent for biosimilars of G-CSF, facilitating broader adoption across oncology centers. In the Middle East and Africa, demand is expanding in line with increasing cancer screening initiatives and international collaboration with biosimilar developers. 

 

How is Market Segmentation Defining the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Segmentation is a defining feature of the biosimilars of G-CSF for chemotherapy-induced neutropenia market, structured across multiple variables such as product type, dosage format, cancer indication, distribution model, and end-user base. 

By product, the market is segmented into filgrastim and pegfilgrastim biosimilars. Pegfilgrastim variants now contribute nearly 60 percent of total biosimilar G-CSF revenues due to longer half-life, single-dose per cycle administration, and improved patient convenience. Filgrastim biosimilars, while more commonly used in certain regions, are seeing lower growth compared to their pegylated counterparts. 

By dosage format, prefilled syringes dominate with over 70 percent share, but advanced options like on-body injectors and autoinjectors are gaining traction. These delivery formats support home administration and are driving increased usage in decentralized care models. Growth in autoinjector-based G-CSF biosimilars has exceeded 20 percent year over year in urban outpatient centers. 

When viewed by cancer indication, breast cancer leads the biosimilars of G-CSF for chemotherapy-induced neutropenia demand, accounting for almost 30 percent of overall use. Other significant segments include lung, gastrointestinal, and hematological malignancies. Each indication’s reliance on multi-cycle chemotherapy sustains recurring G-CSF biosimilar utilization, particularly in high-dose regimens. 

 

How Are Product Pipelines Accelerating the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

The pipeline for biosimilars of G-CSF for chemotherapy-induced neutropenia is expanding in both scale and complexity. More than 20 candidates are in active development stages globally, with several currently in Phase III trials. These products target therapeutic equivalence to leading G-CSF brands, with added focus on formulation enhancements and delivery technologies. 

Next-generation G-CSF biosimilars are being engineered to offer better storage conditions, with thermostable formulations allowing for transport without cold-chain logistics. This directly addresses a significant access barrier in regions lacking temperature-controlled supply chains. Several pipeline products also incorporate dual-delivery packaging—both syringe and injector—tailored for institutional and at-home use. 

Small and mid-tier companies are entering the pipeline through licensing and contract development routes. Their entry is expanding the biosimilars of G-CSF for chemotherapy-induced neutropenia market by creating greater supply diversity, regional specialization, and competitive pricing. The growing number of approvals is projected to exert downward pricing pressure while improving patient access across all economic tiers. 

 

How Are Clinical Trials Building Confidence in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Clinical trials are central to establishing biosimilarity and driving confidence in the biosimilars of G-CSF for chemotherapy-induced neutropenia market. Trials conducted over the past three years have focused on pharmacokinetic equivalence, safety profiles, and immunogenicity response. As of 2025, over 30 large-scale trials have either been completed or are actively recruiting across North America, Europe, and Asia. 

A significant portion of these trials has focused on patients undergoing adjuvant chemotherapy for breast and lung cancers. Findings consistently demonstrate non-inferiority to reference G-CSF biologics, resulting in broader physician adoption and payer acceptance. In addition to standard metrics, recent trials have included real-world endpoints such as hospitalization rates due to neutropenic fever and antibiotic usage, offering deeper clinical value insights. 

Recent studies have expanded their demographic reach to include pediatric, elderly, and immunocompromised populations. This has opened the door to extended applications and improved biosimilars of G-CSF for chemotherapy-induced neutropenia demand in treatment-resistant cancer types and high-risk cohorts. 

 

What Investments Are Fueling Innovation in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Strategic investments are playing a vital role in shaping the future of the biosimilars of G-CSF for chemotherapy-induced neutropenia market. Over the last three years, more than six billion dollars have been allocated globally to biosimilar development and biologics manufacturing infrastructure, with a sizeable portion focused on supportive oncology therapies. 

Biotech hubs in South Korea, Eastern Europe, and Southeast Asia have witnessed the launch of multiple biosimilar manufacturing facilities equipped with modular and flexible production systems. These facilities are designed to reduce cycle times and manufacturing costs by over 30 percent, supporting aggressive market entry timelines and scale-up capabilities. 

Additionally, investments in clinical data platforms and artificial intelligence are helping streamline biosimilar development. Predictive modeling tools are now being used to select trial participants and optimize formulation stability, cutting trial durations by up to 20 percent. This innovation cycle has enabled smaller players to compete more effectively, increasing both diversity and competition in the biosimilars of G-CSF for chemotherapy-induced neutropenia market. 

 

How is Distribution Strategy Driving Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Demand? 

Distribution strategy is emerging as a key driver of biosimilars of G-CSF for chemotherapy-induced neutropenia demand. Hospital pharmacies remain the dominant channel, especially in countries with government-funded oncology care. However, new trends indicate a significant shift toward retail pharmacies and specialty clinics, where patients seek more accessible and faster options. 

Growth in the retail channel is evident in urban centers where patients prefer convenience over hospital-based services. Sales volumes for pegfilgrastim biosimilars in retail outlets have increased by over 25 percent annually. Specialty distributors have also become integral to supply chains, especially for biosimilars requiring cold storage and same-day delivery for oncology infusion centers. 

Home delivery of G-CSF biosimilars is another growing segment. Driven by rising outpatient care and telehealth follow-ups, biosimilars are increasingly being integrated into pharmacy-at-home programs. This has reduced hospitalization risk and improved treatment adherence, adding a new layer of demand in the biosimilars of G-CSF for chemotherapy-induced neutropenia market. 

 

How is the Competitive Landscape Evolving in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

Competition in the biosimilars of G-CSF for chemotherapy-induced neutropenia market is intensifying as both established pharmaceutical companies and emerging biotech firms expand their portfolios. The top five global players currently hold over 65 percent of market share, but this concentration is expected to decline as regional entrants gain approval and market access. 

Several new players are leveraging regional partnerships, co-marketing agreements, and differential pricing strategies to penetrate local markets. For instance, in Southeast Asia, local biosimilar manufacturers have seen their sales double in two years due to government preference programs favoring domestic producers. 

Product differentiation is also beginning to emerge. While all biosimilars must meet equivalency standards, companies are investing in value-added services such as digital adherence tools, patient education platforms, and clinician dashboards. These services are becoming decisive factors in procurement decisions, especially in institutional settings where long-term outcome tracking is critical. 

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Who Are the Leading Players in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

The biosimilars of G-CSF for chemotherapy-induced neutropenia market is characterized by a mix of established pharmaceutical giants and emerging biotech firms. These companies are actively engaged in developing, manufacturing, and marketing biosimilar versions of granulocyte colony-stimulating factors (G-CSFs) to address the growing demand for cost-effective treatments in oncology supportive care. 

Amgen Inc. remains a dominant force in this market, primarily through its originator products, Neupogen (filgrastim) and Neulasta (pegfilgrastim). Despite facing competition from biosimilars, Amgen’s early entry and established brand recognition have allowed it to maintain a significant market share. 

Sandoz, a division of Novartis, has been instrumental in pioneering biosimilar development. Its product Zarzio (filgrastim-sndz) was among the first biosimilars approved in Europe and has since gained substantial market traction. Sandoz also offers Ziextenzo (pegfilgrastim-bmez), expanding its footprint in the long-acting G-CSF segment. 

Coherus BioSciences has made notable strides with its pegfilgrastim biosimilar, Udenyca (pegfilgrastim-cbqv). Since its approval, Udenyca has captured a significant portion of the U.S. market, offering a cost-effective alternative to Neulasta. 

Teva Pharmaceutical Industries Ltd. markets Granix (tbo-filgrastim), a short-acting G-CSF biosimilar. Teva’s global distribution network and competitive pricing strategies have enabled Granix to secure a stable position in various markets. 

Pfizer Inc. entered the biosimilar arena with Nivestym (filgrastim-aafi), providing another alternative in the short-acting G-CSF category. Pfizer’s extensive reach and reputation have facilitated Nivestym’s adoption among healthcare providers. 

Biocon Biologics Ltd., in collaboration with Mylan (now part of Viatris), offers Fulphila (pegfilgrastim-jmdb), a biosimilar that has gained approval in multiple regions. Their partnership has focused on increasing accessibility to biosimilars in emerging markets. 

Spectrum Pharmaceuticals introduced Rolvedon (eflapegrastim-xnst), a novel long-acting G-CSF, adding diversity to the available treatment options. Rolvedon’s unique formulation aims to provide prolonged neutrophil support with potentially fewer injections. 

Evive Biotech has developed Ryzneuta (efbemalenograstim alfa), which has received approvals in several countries. Ryzneuta represents a new class of long-acting G-CSFs, offering an alternative mechanism of action and dosing regimen. 

Intas Pharmaceuticals and its subsidiary Accord Healthcare have been active in the European market with products like Accofil (filgrastim) and Pelgraz (pegfilgrastim), contributing to the competitive landscape. 

Apotex Inc. markets Grastofil (filgrastim) and Lapelga (pegfilgrastim) in Canada and other regions, focusing on providing affordable biosimilar options to healthcare systems. 

 

What Are the Recent Developments in the Biosimilars of G-CSF for Chemotherapy-Induced Neutropenia Market? 

The biosimilars of G-CSF for chemotherapy-induced neutropenia market has witnessed several significant developments in recent years, reflecting the dynamic nature of this sector. 

In March 2023, Coherus BioSciences received FDA approval for Udenyca Onbody, a novel delivery system for its pegfilgrastim biosimilar. This on-body injector allows for automatic administration of the drug the day after chemotherapy, enhancing patient convenience and adherence. 

Amneal Pharmaceuticals launched Fylnetra (pegfilgrastim-pbbk) in the U.S. market in 2023, marking its third biosimilar introduction within a year. Fylnetra offers a cost-effective alternative to existing pegfilgrastim products, aiming to increase patient access to essential supportive care. 

Biocon Biologics expanded its global footprint by securing regulatory approvals for its G-CSF biosimilars in multiple emerging markets throughout 2024. These approvals are part of Biocon’s strategy to address the unmet needs in oncology supportive care across diverse geographies. 

In the realm of clinical trials, BeyondSpring Pharmaceuticals announced positive topline results from its Phase 3 PROTECTIVE-2 study in 2023. The trial evaluated the combination of plinabulin and pegfilgrastim, demonstrating superior efficacy in preventing chemotherapy-induced neutropenia compared to pegfilgrastim alone. 

Cinfa Biotech reported favorable data from its clinical trials for B12019, a biosimilar candidate to Neulasta. The studies confirmed the biosimilar’s comparability in pharmacodynamics and immunogenicity, supporting its potential as a viable alternative in the market. 

These developments underscore the ongoing efforts by pharmaceutical companies to innovate and expand the biosimilars of G-CSF for chemotherapy-induced neutropenia market, aiming to improve patient outcomes and reduce healthcare costs.