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PUBLISHER: DelveInsight | PRODUCT CODE: 1909218

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PUBLISHER: DelveInsight | PRODUCT CODE: 1909218

FYLNETRA Sales Forecast, and Market Size Analysis - 2034

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Key Factors Driving FYLNETRA Growth

1. Market Share Gains and New Patient Starts

  • FYLNETRA is steadily gaining traction in the U.S. pegfilgrastim biosimilar market, supported by increasing adoption in oncology supportive care.
  • Growth in new patient starts is being driven by payer-driven biosimilar switching, formulary inclusions, and cost-containment strategies in oncology settings.
  • Coherus' focused commercial execution, including oncology account engagement and contracting strategies, is supporting uptake across hospitals and infusion centers.

2. Expansion Across Key Indications

  • Chemotherapy-Induced Neutropenia (CIN): FYLNETRA is increasingly used for prophylaxis against febrile neutropenia in patients receiving myelosuppressive chemotherapy.
  • Solid Tumors: Growing utilization in breast, lung, and gastrointestinal cancers where pegfilgrastim prophylaxis is routinely recommended.
  • Hematologic Malignancies: Continued uptake in lymphoma and leukemia treatment regimens requiring neutrophil support.
  • Lifecycle management efforts aim to reinforce FYLNETRA's role across multiple chemotherapy protocols rather than disease-specific expansion.

3. Geographic Expansion

  • Commercial availability is currently focused on the United States, where biosimilar adoption is accelerating due to payer and provider incentives.
  • Expansion opportunities exist in additional global markets, subject to regulatory approvals and partnership strategies.
  • Strengthening relationships with U.S. oncology networks, group purchasing organizations (GPOs), and integrated delivery networks (IDNs) is central to expanding reach and utilization.

4. New Indication Approvals

  • FYLNETRA is approved as a biosimilar to reference pegfilgrastim for all eligible indications, consistent with the originator label.
  • Broad label coverage without indication carve-outs supports its use across diverse cancer types and chemotherapy regimens.
  • Regulatory approval enhances competitive positioning against both the reference product and other pegfilgrastim biosimilars, contributing to pricing and access flexibility.

5. Strong Oncology Supportive Care Volume Momentum

  • Oncology supportive care remains the primary growth driver, with increasing biosimilar penetration replacing branded pegfilgrastim usage.
  • Volume growth is supported by institutional protocols favoring biosimilars, cost savings for healthcare systems, and consistent clinical performance.
  • Real-world utilization trends indicate steady conversion from reference biologics, particularly in cost-sensitive and high-volume oncology centers.

6. Competitive Differentiation and Market Trends

  • Once-per-cycle dosing aligns with established pegfilgrastim treatment workflows, ensuring minimal disruption to clinical practice.
  • Demonstrated clinical equivalence, safety, and immunogenicity comparability support physician confidence.
  • FYLNETRA benefits from broader market trends favoring biosimilar adoption, including value-based oncology care and payer-led formulary management.
  • Real-World Evidence (RWE) and post-marketing experience are reinforcing confidence among oncologists, pharmacists, and payers.

FYLNETRA Recent Developments

FYLNETRA have centered on commercial execution and market access expansion within the US oncology biosimilars landscape. Coherus has highlighted progress in payer coverage wins, formulary placements, and increased penetration within oncology clinics and hospital systems. Strategic updates have emphasized FYLNETRA's role in supporting healthcare cost reduction while maintaining clinical consistency with reference pegfilgrastim. Ongoing focus remains on strengthening provider education, expanding contracting strategies, and sustaining momentum amid intensifying competition in the pegfilgrastim biosimilar market.

"FYLNETRA Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of FYLNETRA for approved indication like Alzheimer's disease in the 7MM. A detailed picture of FYLNETRA's existing usage in anticipated entry and performance in approved indications in the 7MM, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan for the study period 2020 -2034 is provided in this report along with a detailed description of the FYLNETRA for approved indications. The FYLNETRA market report provides insights about FYLNETRA's sales forecast, mechanism of action (MoA), dosage and administration, as well as research and development including regulatory milestones, along with other developmental activities. Further, it also consists of historical and current FYLNETRA performance, future market assessments inclusive of the FYLNETRA market forecast analysis for approved indications in the 7MM, SWOT, analysts' views, comprehensive overview of market competitors, and brief about other emerging therapies in respective indications. It also provides analysis of FYLNETRA sales forecasts, along with factors driving its market.

FYLNETRA Drug Summary

FYLNETRA is a biosimilar to Neulasta, developed by Amneal Pharmaceuticals and FDA-approved in 2023 as a leukocyte growth factor. It consists of pegfilgrastim, a polyethylene glycol-conjugated form of granulocyte colony-stimulating factor (G-CSF), which binds to specific cell surface receptors on hematopoietic cells to stimulate neutrophil proliferation, differentiation, and maturation. Indicated to decrease the incidence of febrile neutropenia in patients with non-myeloid malignancies receiving myelosuppressive chemotherapy and to increase survival in those exposed to myelosuppressive radiation doses, it is administered as a single 6 mg subcutaneous injection (weight-based for pediatrics <45 kg) at least 24 hours post-chemotherapy and no sooner than 14 days before. The report provides FYLNETRA's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the FYLNETRA Market Report

The report provides insights into:

  • A comprehensive product overview including the FYLNETRA MoA, description, dosage and administration, research and development activities in approved indication like Alzheimer's disease.
  • Elaborated details on FYLNETRA regulatory milestones and other development activities have been provided in FYLNETRA market report.
  • The report also highlights FYLNETRA's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved indications across the United States, Europe, and Japan.
  • The FYLNETRA market report also covers the patents information, generic entry and impact on cost cut.
  • The FYLNETRA market report contains current and forecasted FYLNETRA sales for approved indications till 2034.
  • Comprehensive coverage of the late-stage emerging therapies for respective indications.
  • The FYLNETRA market report also features the SWOT analysis with analyst views for FYLNETRA in approved indications.

Methodology:

The FYLNETRA market report is built using data and information sourced primarily from internal databases, primary and secondary research and in-house analysis by DelveInsight's team of industry experts. Information and data from the secondary sources have been obtained from various printable and nonprintable sources like search engines, news websites, global regulatory authorities websites, trade journals, white papers, magazines, books, trade associations, industry associations, industry portals and access to available databases.

FYLNETRA Analytical Perspective by DelveInsight

  • In-depth FYLNETRA Market Assessment

This FYLNETRA sales market forecast report provides a detailed market assessment of FYLNETRA for approved indication like Alzheimer's disease in the seven major markets, i.e., the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan. This segment of the report provides current and forecasted FYLNETRA sales data uptil 2034.

  • FYLNETRA Clinical Assessment

The FYLNETRA market report provides the clinical trials information of FYLNETRA for approved indications covering trial interventions, trial conditions, trial status, start and completion dates.

FYLNETRA Competitive Landscape

The report provides Insights on competitors and marketed products within the domain, along with a summary of emerging products and their respective launch dates, posing significant competition in the market.

FYLNETRA Market Potential & Revenue Forecast

  • Projected market size for the FYLNETRA and its key indications
  • Estimated FYLNETRA sales potential (FYLNETRA peak sales forecasts)
  • FYLNETRA Pricing strategies and reimbursement landscape

FYLNETRA Competitive Intelligence

  • Number of competing drugs in development (pipeline analysis)
  • FYLNETRA Market positioning compared to existing treatments
  • FYLNETRA Strengths & weaknesses relative to competitors

FYLNETRA Regulatory & Commercial Milestones

  • FYLNETRA Key regulatory approvals & expected launch timelines
  • Commercial partnerships, licensing deals, and M&A activity

FYLNETRA Clinical Differentiation

  • FYLNETRA Efficacy & safety advantages over existing drugs
  • FYLNETRA Unique selling points

FYLNETRA Market Report Highlights

  • In the coming years, the FYLNETRA market scenario is set to change due to strong adoption, increased prescriptions and broader uptake in multiple immunological indications; which would expand the size of the market.
  • The FYLNETRA companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence FYLNETRA's dominance.
  • Other emerging products for Alzheimer's disease are expected to give tough market competition to FYLNETRA and launch of late-stage emerging therapies in the near future will significantly impact the market.
  • A detailed description of regulatory milestones, and developmental activities, provide the current development scenario of FYLNETRA in approved indications.
  • Analyse FYLNETRA cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
  • Our in-depth analysis of the forecasted FYLNETRA sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of FYLNETRA in approved indications.

Key Questions:

  • What is the class of therapy, route of administration and mechanism of action of FYLNETRA? How strong is FYLNETRA's clinical and commercial performance?
  • What is FYLNETRA's clinical trial status in each individual indications such as Alzheimer's disease and study completion date?
  • What are the key collaborations, mergers and acquisitions, licensing and other activities related to the FYLNETRA Manufacturers?
  • What are the key designations that have been granted to FYLNETRA for approved indications? How are they going to impact FYLNETRA's penetration in various geographies?
  • What is the current and forecasted FYLNETRA market scenario for approved indications? What are the key assumptions behind the forecast?
  • What are the current and forecasted sales of FYLNETRA in the seven major countries, including the United States, Europe (Germany, France, Italy, Spain) and the United Kingdom, and Japan?
  • What are the other emerging products available and how are these giving competition to FYLNETRA for approved indications?
  • Which are the late-stage emerging therapies under development for the treatment of approved indications?
  • How cost-effective is FYLNETRA? What is the duration of therapy and what are the geographical variations in cost per patient?
Product Code: DIDM1529

Table of Contents

1. Report Introduction

2. FYLNETRA Overview in approved indications like Alzheimer's disease

  • 2.1. Product Detail
  • 2.2. FYLNETRA Clinical Development
    • 2.2.1. FYLNETRA Clinical studies
    • 2.2.2. FYLNETRA Clinical trials information
    • 2.2.3. Safety and efficacy
  • 2.3. Other Developmental Activities
  • 2.4. Product Profile

3. FYLNETRA Competitive Landscape (Marketed Therapies)

4. Competitive Landscape (Late-stage Emerging FYLNETRA Therapies)

5. FYLNETRA Market Assessment

  • 5.1. FYLNETRA Market Outlook in approved indications
  • 5.2. 7MM Analysis
    • 5.2.1. FYLNETRA Market Size in the 7MM for approved indications
  • 5.3. Country-wise Market Analysis
    • 5.3.1. FYLNETRA Market Size in the United States for approved indications
    • 5.3.2. FYLNETRA Market Size in Germany for approved indications
    • 5.3.3. FYLNETRA Market Size in France for approved indications
    • 5.3.4. FYLNETRA Market Size in Italy for approved indications
    • 5.3.5. FYLNETRA Market Size in Spain for approved indications
    • 5.3.6. FYLNETRA Market Size in the United Kingdom for approved indications
    • 5.3.7. FYLNETRA Market Size in Japan for approved indications

6. FYLNETRA SWOT Analysis

7. Analysts' Views

8. Appendix

  • 8.1. Bibliography
  • 8.2. Report Methodology

9. DelveInsight Capabilities

10. Disclaimer

11. About DelveInsight

12. Report Purchase Options

Product Code: DIDM1529

List of Tables

  • Table 1: FYLNETRA, Clinical Trial Description, 2023
  • Table 2: FYLNETRA, General Description
  • Table 3: Competitive Landscape (Marketed Therapies)
  • Table 4: Competitive Landscape (Emerging Therapies)
  • Table 5: FYLNETRA's pricing and cost Assumptions
  • Table 6: FYLNETRA's Sales Analysis in the 7MM, in USD million (2020-2034)
  • Table 7: FYLNETRA Market Size in the US, in USD million (2020-2034)
  • Table 8: FYLNETRA Market Size in Germany, in USD million (2020-2034)
  • Table 9: FYLNETRA Market Size in France, in USD million (2020-2034)
  • Table 10: FYLNETRA Market Size in Italy, in USD million (2020-2034)
  • Table 11: FYLNETRA Market Size in Spain, in USD million (2020-2034)
  • Table 12: FYLNETRA Market Size in the UK, in USD million (2020-2034)
  • Table 13: FYLNETRA Market Size in Japan, in USD million (2020-2034)

List of Figures

  • Figure 1: FYLNETRA's Sales Analysis in the 7MM, USD million (2020-2034)
  • Figure 2: FYLNETRA Market Size in the United States, USD million (2020-2034)
  • Figure 3: FYLNETRA Market Size in Germany, USD million (2020-2034)
  • Figure 4: FYLNETRA Market Size in France, USD million (2020-2034)
  • Figure 5: FYLNETRA Market Size in Italy, USD million (2020-2034)
  • Figure 6: FYLNETRA Market Size in Spain, USD million (2020-2034)
  • Figure 7: FYLNETRA Market Size in the United Kingdom, USD million (2020-2034)
  • Figure 8: FYLNETRA Market Size in Japan, USD million (2020-2034)
Have a question?
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Jeroen Van Heghe

Manager - EMEA

+32-2-535-7543

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Christine Sirois

Manager - Americas

+1-860-674-8796

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