FYLNETRA Sales Forecast, and Market Size Analysis - 2034
상품코드:1909218
리서치사:DelveInsight
발행일:On Demand Report
페이지 정보:영문 30 Pages
라이선스 & 가격 (부가세 별도)
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한글목차
FYLNETRA 성장 촉진요인
1. 시장 점유율 확대와 신규 환자 증가
FYLNETRA는 종양학 지원 치료에서의 채택 증가에 힘입어 미국 페그필그라스팀 바이오시밀러 시장에서 꾸준히 입지를 확대하고 있습니다.
신규 환자 처방 증가는 종양학 환경에서의 보험사 주도 바이오시밀러 전환, 처방 목록 포함, 비용 절감 전략에 의해 주도되고 있습니다.
Coherus의 집중적인 상업 전략, 특히 종양 부문의 고객 참여 및 계약 전략은 병원 및 드립 센터의 채택을 뒷받침하고 있습니다.
2. 주요 적응증의 확대
항암제 유발성 중성구감소증(CIN) : FYLNETRA는 골수억제성 항암제를 투여받는 환자의 열성 중성구감소증 예방을 위해 점점 더 많이 사용되고 있습니다.
고형암 : 페그필글라스팀에 의한 예방이 표준적으로 권장되는 유방암, 폐암, 소화기암에서 사용이 증가하고 있습니다.
혈액암 : 호중구 지원이 필요한 림프종 및 백혈병 치료 요법에서 지속적인 채택이 이루어지고 있습니다.
수명 주기 관리 노력은 질병 특이적인 확장이 아니라 여러 화학요법 프로토콜에서 FYLNETRA의 역할을 강화하는 것을 목표로 합니다.
3. 지리적 확대
현재 상업적 공급은 미국에 집중되어 있으며, 지불자 및 공급자 인센티브로 인해 바이오시밀러 채택이 가속화되고 있습니다.
규제 당국의 승인과 파트너십 전략에 따라 다른 세계 시장에도 확대 기회가 존재합니다.
미국 내 종양학 네트워크, 단체 구매 조직(GPOs), 통합 의료 네트워크(IDNs)와의 관계 강화는 접근성 및 활용도 확대의 핵심입니다.
4. 신규 적응증 승인
FYLNETRA는 참조 제품 페그필그라스팀과 동일한 모든 적응증에 대해 바이오시밀러로 승인되었습니다.
적응증을 배제하지 않고 광범위한 적응증을 다루는 라벨은 다양한 암종 및 화학요법 요법의 사용을 지원합니다.
규제 당국의 승인은 레퍼런스 제품 및 기타 페그필글라스팀 바이오시밀러에 대한 경쟁 우위를 강화하여 가격 및 접근성의 유연성에 기여합니다.
5. 강력한 종양 지지 요법 수요 증가
암 지지 요법은 주요 촉진요인이며, 바이오시밀러의 침투율 향상에 의해 브랜드 페그필글라스팀의 사용이 대체되고 있습니다.
사용량 증가는 바이오시밀러를 선호하는 의료 기관의 프로토콜, 의료 시스템의 비용 절감, 일관된 임상 성능에 의해 지원됩니다.
실제 임상의 이용 동향은 특히 비용이 많이 드는 고용량 종양 센터에서 참조 생물학적 제형으로부터의 꾸준한 전환을 보여줍니다.
6. 경쟁적 차별화와 시장 동향
주기당 1회 투여는 확립된 페그필그라스팀 치료 워크플로우와 일치하여 임상 실무에 최소한의 방해를 보장합니다.
입증된 임상적 동등성, 안전성 및 면역원성 비교 가능성은 의사의 신뢰를 뒷받침합니다.
FYLNETRA는 가치에 기초한 종양학 케어와 지불자 주도의 처방약 리스트 관리 등 바이오시밀러 도입을 뒷받침하는 광범위한 시장 동향의 혜택을 받고 있습니다.
실제 임상 증거(RWE) 및 시판 후 경험은 종양학자, 약사 및 지불자 사이의 신뢰를 강화하고 있습니다.
본 보고서는 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국)에서 알츠하이머병과 같은 승인된 적응증에 대한 FYLNETRA의 종합적인 인사이트를 제공합니다. 본 보고서는 2020년부터 2034년 사이의 주요 7개국에서 FYLNETRA의 사용 상황, 진입 전망, 승인된 적응증의 실적에 대한 상세한 분석, 승인된 적응증에서 FYLNETRA의 상세한 설명을 제시합니다. 또한 이 제품의 매출 예측, 작용기전(MoA), 투여량 및 투여 방법, 규제상의 이정표를 포함한 연구개발 및 기타 개발 활동에 대한 통찰을 제공합니다. 또한 과거 및 현재 FYLNETRA의 실적, 미래 시장 평가, 주요 7개국 시장 예측 분석, SWOT 분석, 분석가의 견해, 경쟁업체의 종합적인 개요, 각 적응증에 대한 기타 신흥 치료법의 개요, FYLNETRA의 매출 예측 분석, 시장 주도 요인 등도 정리했습니다.
목차
제1장 보고서 개요
제2장 알츠하이머병 등의 승인된 적응증에 대한 FYLNETRA의 개요
제품 상세
임상 개발
임상 연구
임상시험 정보
안전성과 유효성
기타 개발 활동
제품 프로파일
제3장 FYLNETRA : 경쟁 구도(시판 중인 치료제)
제4장 FYLNETRA : 경쟁 구도(개발 후기 치료제)
제5장 FYLNETRA : 시장 평가
승인된 적응증에 대한 시장 전망
주요 7개국 분석
승인된 적응증에 대한 주요 7개국 시장 규모
국가별 시장 분석
미국
독일
영국
제6장 FYLNETRA : SWOT 분석
제7장 애널리스트의 견해
제8장 부록
제9장 DelveInsight의 서비스 내용
제10장 면책사항
제11장 DelveInsight 정보
제12장 보고서 구매 옵션
HBR
영문 목차
영문목차
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
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?
Table of Contents
1. Report Introduction
2. FYLNETRA Overview in approved indications like Alzheimer's disease
