한글목차

엔트렉티닙의 성장을 이끄는 주요 요인들

1. 시장 점유율 확대 및 신규 환자 수 증가

• 엔트렉티닙은 이중 표적 프로파일과 광범위한 종양 커버리지로 NTRK 융합 양성 및 ROS1 양성 종양 시장에서 점유율을 확대하고 있습니다.
• 종합유전체검사(NGS 패널)의 도입 확대로 적격 환자 발굴이 확대되면서 다양한 종양에 대한 새로운 치료법 개발이 가속화되고 있습니다.
• Roche/Genentech의 세계 의료 교육 및 바이오마커 인식 제고 프로그램을 통해 의사들의 확신이 깊어지고 사용이 확대되고 있습니다.

2. 주요 적응증 확대

• NTRK 융합 양성 고형암(조직 비의존성) : 종양 발생 부위에 관계없이 성인 및 소아 환자군에서 승인되었습니다.
• ROS1 양성 비소세포폐암(NSCLC) : 지속적인 뇌 및 전신 반응이 지원되며, 1차 치료 및 재발 치료에서 높은 채택률을 보이고 있습니다.
• 중추신경계(CNS) 전이: 엔트렉티닙의 뇌투과성 설계로 뇌 전이가 있는 환자에게도 사용할 수 있습니다.
• 수명주기 및 내성 전략: 내성 기전에 대한 지속적인 연구와 차세대 TRK/ROS1 억제제 개발로 장기적인 시장에서의 입지를 확보할 수 있을 것으로 기대됩니다.

3. 지역적 확장

• 엔트렉티닙은 미국, EU, 일본 및 기타 여러 시장에서 승인되었습니다.
• 아시아태평양은 각국의 정밀 암 치료 프로그램과 NGS 인프라 확충으로 주요 성장 지역으로 부상하고 있습니다.
• Roche는 세계 접근성 확대를 가속화하기 위해 진단 파트너십과 상환 경로를 지속적으로 강화해 나가고 있습니다.

4. 신규 적응증 승인

• 규제 당국은 NTRK 융합 양성 종양에 대해 조직 비의존적 승인을 승인했습니다. 이는 정밀의료의 중요한 이정표입니다.
• 지역 및 소아 환자군에서의 적응증 확대로 치료 대상 환자군이 확대되었습니다.
• 현재 진행 중인 규제 당국 신청과 실제 데이터는 초기 단계의 사용 가능성을 지원하고 있습니다.

5. 정밀 종양 분야에서의 탄탄한 치료 실적 확대

• 정밀 종양 분야는 여전히 주요 촉진요인으로, 폐암의 ROS1 검사와 희귀종양의 NTRK 검사가 더욱 일상화되고 있습니다.
• 높은 반응률, 지속적인 질병 조절, 두개내 효과로 처방량을 지원하고 있습니다.
• 리얼월드 증거는 다양한 종양 조직형에 대한 임상시험 결과의 유효성을 지속적으로 입증하고 있습니다.

6. 경쟁 차별화 및 시장 동향

• 엔트렉티닙은 이중 TRK 및 ROS1 억제 작용을 통해 단일 표적 치료제와의 차별화를 꾀하고 있습니다.
• 경구용 표적치료는 화학요법에 비해 편리함과 삶의 질 향상을 가져다 줍니다.
• 바이오마커 주도 치료, 조직 비의존적 승인, 중추신경계 활성 약물의 동향은 엔트렉티닙에 매우 유리하게 작용하고 있습니다.
• 리얼월드 증거에 대한 의존도가 높아짐에 따라 지불자와 처방자의 신뢰가 더욱 견고해지고 있습니다.

이 보고서는 비소세포폐암, 고형암 등 승인된 적응증과 뇌전이, 악성 흑색종, 포도막 흑색종 등 잠재적 적응증에 대한 주요 7개국(미국, EU4(독일, 프랑스, 이탈리아, 스페인), 영국)의 엔트렉티닙에 대한 종합적인 인사이트을 제공합니다. 2020-2034년까지 주요 7개국에서 엔트렉티닙의 승인된 적응증 및 잠재적 적응증에 대한 사용 현황, 진입 전망, 실적 전망, 승인된 적응증 및 잠재적 적응증에 대한 엔트렉티닙의 상세한 설명과 함께 2020-2034년까지 주요 7개국에서 엔트렉티닙의 승인된 적응증 및 잠재적 적응증에 대한 상세한 설명을 제공합니다. 또한 이 약물의 매출 예측, 작용기전(MoA), 용량 및 투여방법, 규제 마일스톤을 포함한 연구개발 및 기타 활동에 대한 정보를 제공합니다. 또한 엔트렉티닙의 과거 및 현재 실적, 미래 시장 평가, SWOT 분석, 애널리스트의 견해, 경쟁사 개요, 각 적응증별 다른 신흥 치료제의 개요, 매출 예측 분석, 시장 견인 요인 등을 정리했습니다.

목차

제1장 리포트 개요

제2장 엔트렉티닙 개요 : 비소세포폐암 및 고형 종양 등의 승인 적응증·뇌전이, 악성 흑색종, 포도막 흑색종 등의 잠재 적응증

제3장 엔트렉티닙 : 경쟁 구도(출시 치료제)

제4장 엔트렉티닙 : 경쟁 구도(개발 후기 치료제)

제5장 엔트렉티닙 : 시장 평가

제6장 엔트렉티닙 : SWOT 분석

제7장 애널리스트의 견해

제8장 부록

제9장 DelveInsight의 서비스 내용

제10장 면책사항

제11장 DelveInsight 소개

제12장 리포트 구입 옵션

영문목차

Key Factors Driving Entrectinib Growth

1. Market Share Gains and New Patient Starts

• Entrectinib is gaining share in the NTRK fusion-positive and ROS1-positive oncology markets, supported by its dual-target profile and broad tumor coverage.
• Rising uptake of comprehensive genomic testing (NGS panels) is driving identification of eligible patients and accelerating new starts across tumor types.
• Roche/Genentech's global medical education and biomarker awareness programs are strengthening physician confidence and expanding use.

2. Expansion Across Key Indications

• NTRK Fusion-Positive Solid Tumors (Tissue-Agnostic): Approved across adult and pediatric populations, regardless of tumor origin.
• ROS1-Positive Non-Small Cell Lung Cancer (NSCLC): Strong adoption in first-line and relapsed settings, supported by durable intracranial and systemic responses.
• Central Nervous System (CNS) Metastases: Entrectinib's brain-penetrant design supports use in patients with baseline brain metastases.
• Lifecycle and Resistance Strategy: Ongoing research into resistance mechanisms and next-generation TRK/ROS1 inhibitors supports long-term market presence.

3. Geographic Expansion

• Entrectinib is approved in the US, EU, Japan, and several other markets.
• Asia-Pacific is emerging as a major growth region, driven by national precision oncology programs and expanding NGS infrastructure.
• Roche continues to strengthen diagnostic partnerships and reimbursement pathways to accelerate global access.

4. New Indication Approvals

• Regulatory agencies granted tissue-agnostic approval for NTRK fusion-positive tumors, a major milestone in precision medicine.
• Expanded labeling across regions and pediatric populations has broadened the treatable patient base.
• Ongoing regulatory submissions and real-world datasets support potential earlier-line use.

5. Strong Precision Oncology Volume Momentum

• Precision oncology remains the primary growth driver, with ROS1 testing in lung cancer and NTRK testing in rare tumors becoming more routine.
• Prescription volumes are supported by high response rates, durable disease control, and intracranial efficacy.
• Real-world evidence continues to validate clinical trial outcomes across diverse tumor histologies.

6. Competitive Differentiation and Market Trends

• Dual TRK and ROS1 inhibition differentiates Entrectinib from single-target therapies.
• Oral targeted therapy offers convenience and improved quality of life versus chemotherapy.
• Broader trends toward biomarker-driven treatment, tissue-agnostic approvals, and CNS-active agents strongly favor Entrectinib.
• Increasing reliance on real-world evidence (RWE) is reinforcing payer and prescriber confidence.

Entrectinib Recent Developments

Roche have highlighted expanded global reimbursement, broader pediatric access, and long-term follow-up data confirming durable systemic and intracranial responses. New real-world and registry data presented at major oncology congresses have reinforced Entrectinib's role as a preferred TRK/ROS1 inhibitor, particularly in patients with brain metastases, supporting its continued growth in the precision oncology market.

"Entrectinib Sales Forecast, and Market Size Analysis - 2034" report provides comprehensive insights of Entrectinib for approved indication like Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma in the 7MM. A detailed picture of Entrectinib's existing usage in approved and anticipated entry and performance in potential 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 Entrectinib for approved and potential indications. The Entrectinib market report provides insights about Entrectinib'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 Entrectinib performance, future market assessments inclusive of the Entrectinib market forecast analysis for approved and potential 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 Entrectinib sales forecasts, along with factors driving its market.

Entrectinib Drug Summary

Entrectinib (Rozlytrek) is a potent, CNS-penetrant small-molecule tyrosine kinase inhibitor targeting TRKA, TRKB, TRKC (encoded by NTRK1/2/3 genes), ROS1, and ALK, indicated for adults with ROS1-positive metastatic non-small cell lung cancer (NSCLC) and for adult and pediatric patients 1 month and older with solid tumors harboring NTRK gene fusions (without acquired resistance mutations in TRK proteins) that are unresectable or metastatic, have progressed following prior systemic therapy, or for whom no acceptable alternative treatments exist. It competitively binds the ATP-binding sites of these kinases, blocking constitutive phosphorylation and downstream signaling via MAPK/ERK, PI3K/AKT, and PLCY pathways in fusion-driven oncogenesis (e.g., CD74-ROS1 in NSCLC, ETV6-NTRK3 in secretory carcinomas), yielding high objective response rates (~78% in ROS1+ NSCLC, ~57% in NTRK+ tumors) with intracranial activity. Administered orally once daily at 600 mg (capsules or oral solution) continuously until disease progression or intolerance, with dose reductions for toxicities like elevated ALT/AST, anemia, edema, dizziness, and QT prolongation, entrectinib requires molecular confirmation of ROS1/NTRK alterations via NGS/FISH/IHC prior to initiation. The report provides Entrectinib's sales, growth barriers and drivers, post usage and approvals in multiple indications.

Scope of the Entrectinib Market Report

The report provides insights into:

• A comprehensive product overview including the Entrectinib MoA, description, dosage and administration, research and development activities in approved indications like Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma.
• Elaborated details on Entrectinib regulatory milestones and other development activities have been provided in Entrectinib market report.
• The report also highlights Entrectinib's cost estimates and regional variations, reported and estimated sales performance, research and development activities in approved and potential indications across the United States, Europe, and Japan.
• The Entrectinib market report also covers the patents information, generic entry and impact on cost cut.
• The Entrectinib market report contains current and forecasted Entrectinib sales for approved and potential indications till 2034.
• Comprehensive coverage of the late-stage emerging therapies for respective indications.
• The Entrectinib market report also features the SWOT analysis with analyst views for Entrectinib in approved and potential indications.

Methodology:

The Entrectinib 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.

Entrectinib Analytical Perspective by DelveInsight

• In-depth Entrectinib Market Assessment

This Entrectinib sales market forecast report provides a detailed market assessment of Entrectinib for approved indication like Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma 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 Entrectinib sales data uptil 2034.

• Entrectinib Clinical Assessment

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

Entrectinib 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.

Entrectinib Market Potential & Revenue Forecast

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

Entrectinib Competitive Intelligence

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

Entrectinib Regulatory & Commercial Milestones

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

Entrectinib Clinical Differentiation

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

Entrectinib Market Report Highlights

• In the coming years, the Entrectinib 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 Entrectinib companies are developing therapies that focus on novel approaches to treat/improve the disease condition, assess challenges, and seek opportunities that could influence Entrectinib's dominance.
• Other emerging products for Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma are expected to give tough market competition to Entrectinib 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 Entrectinib in approved and potential indications.
• Analyse Entrectinib cost, pricing trends and market positioning to support strategic decision-making in the immunology landscape.
• Our in-depth analysis of the forecasted Entrectinib sales data uptil 2034 will support the clients in decision-making process regarding their therapeutic portfolio by identifying the overall scenario of Entrectinib in approved and potential indications.

Key Questions:

• What is the class of therapy, route of administration and mechanism of action of Entrectinib? How strong is Entrectinib's clinical and commercial performance?
• What is Entrectinib's clinical trial status in each individual indications such as Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma and study completion date?
• What are the key collaborations, mergers and acquisitions, licensing and other activities related to the Entrectinib Manufacturers?
• What are the key designations that have been granted to Entrectinib for approved and potential indications? How are they going to impact Entrectinib's penetration in various geographies?
• What is the current and forecasted Entrectinib market scenario for approved and potential indications? What are the key assumptions behind the forecast?
• What are the current and forecasted sales of Entrectinib 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 Entrectinib for approved and potential indications?
• Which are the late-stage emerging therapies under development for the treatment of approved and potential indications?
• How cost-effective is Entrectinib? What is the duration of therapy and what are the geographical variations in cost per patient?

Table of Contents

1. Report Introduction

2. Entrectinib Overview in approved indications like Non-small cell lung cancer and Solid tumours; as well as potential indications like Brain metastases, Malignant melanoma, and Uveal melanoma

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

3. Entrectinib Competitive Landscape (Marketed Therapies)

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

5. Entrectinib Market Assessment

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

6. Entrectinib 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