비소세포폐암 시장 - 시장 인사이트, 역학, 시장 예측(-2034년)
Non-Small Cell Lung Cancer - Market Insight, Epidemiology, and Market Forecast -2034
상품코드 : 1652667
리서치사 : DelveInsight
발행일 : On Demand Report
페이지 정보 : 영문 880 Pages
 라이선스 & 가격 (부가세 별도)
US $ 7,950 ₩ 11,486,000
PDF (Single User License) help
PDF 보고서를 1명만 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 11,925 ₩ 17,229,000
PDF (2-3 User License) help
PDF 보고서를 동일 사업장에서 3명까지 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 15,900 ₩ 22,972,000
PDF (Site License) help
PDF 보고서를 동일 사업장의 모든 분이 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.
US $ 23,850 ₩ 34,458,000
PDF (Global License) help
PDF 보고서를 동일 기업의 모든 분이 이용할 수 있는 라이선스입니다. 인쇄 가능하며 인쇄물의 이용 범위는 PDF 이용 범위와 동일합니다.


ㅁ Add-on 가능: 고객의 요청에 따라 일정한 범위 내에서 Customization이 가능합니다. 자세한 사항은 문의해 주시기 바랍니다.
ㅁ 보고서에 따라 최신 정보로 업데이트하여 보내드립니다. 배송기일은 문의해 주시기 바랍니다.

한글목차

비소세포폐암(NSCLC) 시장 규모는 환자 수 증가, 면역관문억제제를 중심으로 한 승인된 치료제의 지속적인 보급, 잠재적인 고가 신약의 진입, KRAS, BRAF, c-Met 등의 돌연변이에 대한 인식이 높아짐에 따라 지난 10년간 혁명적인 변화를 겪어왔습니다. 비소세포폐암의 총 시장 규모는 2024년 주요 7개국에서 300억 달러에 달할 것으로 예상됩니다.

실제 치료 트렌드는 표적치료제와 면역치료제로의 극적인 전환을 보여주고 있으며, 이는 현재 가장 큰 기여를 할 것으로 예상됩니다." 비소세포폐암은 점점 더 바이오마커 중심 시장이 되고 있으며, EGFR은 수익성이 높은 바이오마커 분야 중 하나이며, 타그리소와 같은 블록버스터 치료제가 있습니다. EGFR은 현재 연간 60억 달러에 가까운 매출을 기록하는 EGFR 억제제인 타그리소와 같은 블록버스터 치료제가 있으며, 타그리소가 1차 치료제로 승인된 이후 EGFR 내성 돌연변이 환자의 유병률이 증가하고 있습니다. 타그리소 후 설정은 미충족 수요가 가장 높은 분야 중 하나입니다.

현재 ALK TKI의 1차 선택 약물은 ALECENSA와 ALUNBRIG이며, ALECENSA는 ALUNBRIG에 비해 훨씬 더 널리 사용되어 ALK 시장을 독점하고 있으며, ALECENSA와 ALUNBRIG가 진입하기 전에는 XALKORI가 ALK 환자의 1차 선택 약물이었습니다. 약물이었습니다.

비소세포폐암(NSCLC)은 폐암 중 가장 흔한 유형으로 전체 폐암 진단의 81%를 차지하며, 조기 진단이 가장 좋은 예후를 보이는 암입니다. 그러나 비소세포폐암을 비롯한 폐암은 일반적인 질병이나 장기간 흡연의 영향으로 오인할 수 있는 증상이 많기 때문에 진단이 어려울 수 있습니다. 이 때문에 비소세포폐암 진단을 받은 사람의 80%는 이미 병이 진행되어 치료가 어려운 상태입니다. 폐암이 의심되는 경우, 의사는 폐와 그 주변의 이상을 확인하기 위해 영상검사(CT, PET, MRI 검사)를 권유합니다. 또한, 점액 샘플을 현미경으로 검사할 수도 있습니다.

이러한 초기 검사에서 암이 확인되면 폐 생검을 시행할 수도 있습니다. 기관지 내시경 검사도 권장될 수 있으며, 이를 통해 의사는 조직을 시각화하여 절제할 수 있습니다. 폐암이 확인되면 폐 조직에 대한 유전자 검사를 실시하여 치료에 도움이 되는 암의 세부 사항을 파악할 수 있습니다.

본 보고서는 주요 7개국의 비소세포폐암 시장을 조사했으며, 시장 개요와 함께 역학, 환자 동향, 새로운 치료법, 2034년까지 시장 규모 예측, 의료 미충족 수요 등을 조사하여 정리하였습니다.

목차

제1장 주요 인사이트

제2장 보고서 서론

제3장 주요 하이라이트

제4장 주요 요약

제5장 전이성 비소세포폐암 시장 개요

제6장 주요 이벤트

제7장 역학과 시장 예측 조사 방법

제8장 질환 배경과 개요

제9장 비소세포폐암 진단

제10장 현재 치료법 : 비소세포폐암

제11장 비소세포폐암(NSCLC) 치료 가이드라인과 추천 사항

제12장 역학과 환자 인구

제13장 환자 동향

제14장 비소세포폐암의 중요 엔드포인트

제15장 출시 약제

제16장 신흥 약제

제17장 비소세포폐암 : 주요 7개국 시장 분석

제18장 미충족 요구

제19장 SWOT 분석

제20장 KOL(Key Opinion Leader)의 견해

제21장 시장 접근과 상환

제22장 부록

제23장 DELVEINSIGHT 기능

제24장 면책사항

제25장 DELVEINSIGHT에 대해

LSH
영문 목차

영문목차

Key Highlights:

DelveInsight's "Non-small Cell Lung Cancer (NSCLC) - Market Insights, Epidemiology, and Market Forecast - 2034" report delivers an in-depth understanding of top oncogenic drivers/biomarkers in NSCLC (such as EGFR, c-MET, ROS1, KRAS, ALK, HER2, BRAF, RET fusion, NRG1 fusion, NTRK1/2/3 gene fusion, PD-L1, etc.), historical and forecasted epidemiology as well as the NSCLC market trends in the United States, EU4 (Germany, France, Italy, and Spain) and the United Kingdom, and Japan.

NSCLC market report provides real-world prescription pattern analysis, emerging drugs, market share of individual therapies, and historical and forecasted 7MM NSCLC market size from 2020 to 2034. The report also covers current NSCLC treatment practices/algorithms and unmet medical needs to curate the best opportunities and assess the market's potential.

Geography Covered:

Study Period: 2020-2034

NSCLC Understanding and Treatment Algorithm

NSCLC Overview and Diagnosis

NSCLC is the most common type of lung cancer, accounting for 81% of all lung cancer diagnoses. Early diagnosis offers the best prognosis for NSCLC. However, NSCLC and other lung cancers can be difficult to diagnose because these cancers often have symptoms mistaken for common illnesses or the effects of long-term smoking. Because of this, 80% of people diagnosed with NSCLC have already progressed to advanced stages, making it more difficult to treat. If lung cancer is suspected, the physician will recommend imaging tests (CT, PET, or MRI scans) to identify abnormalities in and around the lungs. The physician may also examine a sample of mucus under the microscope.

If these initial tests identify cancer, a lung biopsy can be conducted. A bronchoscopy can also be recommended, allowing the physician to visualize and remove tissue. If lung cancer is confirmed, genetic testing can be done on the lung tissue to identify details about the cancer that can help inform treatment.

NSCLC Treatment

Treatment options and recommendations depend on several factors, including the type and stage of cancer, possible side effects, and the patient's preferences and overall health. The most common treatments for NSCLC are:

NSCLC Epidemiology

The NSCLC epidemiology chapter in the report provides historical as well as forecasted epidemiology segmented by total incident cases of NSCLC, gender-specific cases of NSCLC, age-specific cases of NSCLC, total incident cases of NSCLC by histology, total cases of NSCLC by stages, total incident cases of NSCLC by genetic mutation/biomarkers, Line wise Treated Cases of Metastatic NSCLC in the 7MM covering the United States, EU4 countries (Germany, France, Italy, and Spain) and the United Kingdom, and Japan from 2020 to 2034.

NSCLC Drug Chapters

The drug chapter segment of the NSCLC report encloses a detailed analysis of NSCLC marketed drugs and late-stage (Phase III and Phase II) pipeline drugs. It also deep dives into the NSCLC pivotal clinical trial details, recent and expected market approvals, patent details, the latest news, and recent deals and collaborations.

Marketed Drugs

KEYTRUDA (pembrolizumab): Merck

KEYTRUDA is a PD-1-blocking antibody. It is mainly used for advanced cancers that have spread to other body parts or are not responding to other treatments. In some cancers, it is only given to patients whose tumors produce high protein levels known as PD-L1. KEYTRUDA was first approved in October 2015 by the US FDA as a monotherapy for metastatic NSCLC. Later, the labels were expanded in 2016, 2017, 2018, and in 2023. In October 2023, the FDA approved KEYTRUDA platinum-containing chemotherapy as neoadjuvant treatment, and with continuation of single-agent KEYTRUDA as post-surgical adjuvant treatment for resectable (tumors =4 cm or node positive) NSCLC. The drug has also received approvals in EU4 and the UK (August 2016) and Japan (December 2016), where the labels were expanded as well. Recently in September 2024, Merck announced that the MHLW has approved new indications for KEYTRUDA in combination with chemotherapy as a neoadjuvant treatment. Earlier in March 2024, Merck announced that the EC has approved KEYTRUDA in combination with platinum-containing chemotherapy as neoadjuvant treatment

In December 2024, Merck announced that it is discontinuing the Phase III KeyVibe-003 and KeyVibe-007 trials, which are evaluating the fixed-dose combination of vibostolimab and pembrolizumab in certain patients with NSCLC, based on the recommendation of an independent Data Monitoring Committee (DMC).

TECENTRIQ (atezolizumab): Genentech/Roche

TECENTRIQ is a PD-L1-blocking antibody. It is an Fc-engineered, humanized, non-glycosylated IgG1 kappa immunoglobulin with a calculated molecular mass of 145 kDa. According to Roche's recent product development portfolio published in October 2024, the company anticipates submitting a filing for TECENTRIQ in the periadjuvant treatment of NSCLC in 2025.

TECENTRIQ was initially approved by the US FDA for the treatment of people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy and have progressed on an appropriate FDA-approved targeted therapy if their tumor has EGFR or ALK gene abnormalities in October 2016. Later, the company expanded the label in 2018, 2019, 2020, 2021, and 2024. The drug was also approved in the EU (September 2017) and in Japan (April 2018) for the treatment of NSCLC. Recently, in September 2024, the US FDA approved TECENTRIQ and HYBREZA (hyaluronidase-tqjs), the first and only PD-(L)1 inhibitor for SC, under the skin injection for patients in the US.

Emerging Drugs

Telisotuzumab vedotin: AbbVie

Teliso-V is an investigational antibody-drug conjugate targeting c-Met, a receptor tyrosine kinase overexpressed in tumors, including Non-small Cell Lung Cancer. Teliso-V has the potential to become an important new treatment option in non-small cell lung cancer, with an anticipated approval in 2L+ NSCLC in 2024. In January 2022, AbbVie announced that the FDA granted Breakthrough Therapy Designation to investigational telisotuzumab vedotin for the treatment of patients with advanced/metastatic epidermal growth factor receptor wild type, nonsquamous non-small cell lung cancer with high levels of c-Met overexpression whose disease has progressed on or after platinum-based therapy. In May 2022, AbbVie initiated a Phase III clinical trial to evaluate Teliso-V versus docetaxel for the treatment of patients with previously treated c-Met overexpressing, epidermal growth factor receptor wild type, and advanced/metastatic non-squamous NSCLC.

Datopotamab deruxtecan (Dato-DXd): AstraZeneca and Daiichi Sankyo

Datopotamab deruxtecan (Dato-DXd) is an investigational TROP2-directed ADC. Designed using Daiichi Sankyo's proprietary DXd ADC technology, datopotamab deruxtecan is one of the most advanced programs in AstraZeneca's ADC scientific platform and one of the three leading ADCs in the oncology pipeline of Daiichi Sankyo. In January 2023, a Phase III clinical trial, combined with immune checkpoint inhibitors for the first-line treatment for Non-Small Cell Lung Cancer without actionable genomic alterations, PD-L1 <50% (trial name: TROPION-Lung07), was initiated. No TROP2-directed therapies are currently approved for treating Non-Small Cell Lung Cancer patients. AstraZeneca and Daiichi Sankyo are interrogating Dato-DXd in 1L non-driver mutation patients with TROPION-Lung08 (trying to knock off the Keynote-024 regimen) and with TROPION-Lung07 (trying to dethrone Keynote-189 regimen, the most important indication for Merck's KEYRTUDA), as well as covering 2L and 3L patients with TROPION-Lung01. In December 2024, Daiichi Sankyo announced Dato-DXd has been granted BTD in the US for the treatment of adult patients with locally advanced or metastatic EGFR-mutated NSCLC with disease progression on or after treatment with an EGFR tyrosine kinase inhibitor (TKI) and platinum-based chemotherapy.

Drug Class Insights

The existing NSCLC treatment is mainly dominated by targeted therapies for mutations such as EGFR-sensitizing mutations, EGFR exon 20 insertions, ALK fusions, ROS1 fusions, BRAFV600E mutation, MET exon 14 skipping mutations, RET fusions, and KRASG12C mutation.

EGFR mutations and ALK rearrangements are well-known genetic abnormalities that drive the development of NSCLC. The use of TKIs as a treatment approach has shown better results in terms of patient outcomes when compared to chemotherapy.

EGFR mutations are frequently observed, EGFR exon 19 deletions and EGFR exon 21 L858R mutations. The FDA has approved various TKIs to treat these mutations, with TAGRISSO considered the standard treatment. GILOTRIF is approved for patients with other EGFR sensitivity mutations like S768I, L861Q, and G719X. However, approximately 8-10% of EGFR mutations involve exon 20 insertions, which do not respond to treatments targeting exon 19 or 21 alterations, including osimertinib. Currently, three targeted therapies, RYBREVANT, TAGRISSO and EXKIVITY, are approved for EGFR. Later EXKIVITY were withdrawn from the market. These mutations represent an area of unmet medical need in NSCLC. While treatment with EGFR TKIs effectively eliminates most cancer cells, a small population of drug-tolerant cells may persist. These cells can remain inactive and undetectable for extended periods but eventually resume growth and spread to other body parts.

NSCLC Market Outlook

As more targetable mutations are discovered, and new targeted drugs are developed, patients and oncologists will have an expanding array of treatment options. Given the rapid pace of drug approvals, it is important to pause and ensure sufficient data supports the use of specific agents in the appropriate treatment settings, including adjuvant, consolidation, first-line, or subsequent therapy.

Previously, molecular-based treatments were limited to advanced-stage Non-small Cell Lung Cancer. However, recent findings have demonstrated their efficacy in early-stage and locally advanced disease. New studies have explored therapies targeting a wider range of oncogenes, aiming to overcome drug resistance and provide treatment options for patients previously excluded from clinical trials for advanced-stage lung cancer. The emerging data from these ongoing trials are expected to influence future treatment guidelines and foster the adoption of personalized medicine. As a result, a continuous evolution of the treatment landscape is anticipated, ultimately leading to improved survival rates and enhanced quality of life for lung cancer patients.

PD-L1 Expression

With more than 500,000 cases in the 7MM region, lung cancer is one of the leading causes of death worldwide. This condition is often diagnosed when the patient reaches the advanced, inoperable, or metastatic stage, adversely affecting their quality of life.

Till the last decade, chemotherapy was used as the standard of care in the advanced and metastatic stages until the first ICI 'KEYTRUDA (pembrolizumab)' got approved in 2015 as a second-line treatment option for such advanced patients; a similar path was followed by TECENTRIQ (atezolizumab) who entered the market in 2016. These therapies entered the first-line domain after 2016 and expanded their labels by expanding the targetable pool. Recently, in 2020, OPDIVO (nivolumab) + ipilimumab was approved as a 1L treatment for patients with metastatic NSCLC.

EGFR Mutation

The treatment of EGFR-mutant NSCLC has been transformed by the development of targeted therapies in the last two decades; however, choosing the best therapy after EGFR TKIs fail is still a challenge. There are five EGFR tyrosine kinase inhibitors (TKIs) approved for first-line treatment of advanced NSCLC with common EGFR-sensitizing mutations (e.g., EGFR exon 19 deletions or exon 21 mutations [L858R]): erlotinib, gefitinib, afatinib, dacomitinib, and osimertinib. These drugs have different efficacy and safety profiles and are classified as first- (e.g., erlotinib, gefitinib), second- (e.g., afatinib, dacomitinib), or third-generation (e.g., osimertinib) TKIs. Afatinib and osimertinib, which are second- and third-generation TKIs, respectively, have shown prolonged activity against some rare EGFR mutations (e.g., T790M [osimertinib], G719X, L861Q, or S768I [afatinib and osimertinib]).

Key players, such as AstraZeneca, Bristol Myers Squibb, AbbVie, Roche, Merck, Novartis, Pfizer, Takeda, Eli Lilly, Immutep, Sanofi, GlaxoSmithKline, and others, are evaluating their lead candidates in different stages of clinical development, respectively. They aim to investigate their products to treat Non-Small Cell Lung Cancer.

NSCLC Drugs Uptake

This section focuses on the uptake rate of potential drugs expected to be launched in the market during 2025-2034, which depends on the competitive landscape, safety, efficacy data, and order of entry. It is important to understand that the key players evaluating their novel therapies in the pivotal and confirmatory trials should remain vigilant when selecting appropriate comparators to stand the greatest chance of a positive opinion from regulatory bodies, leading to approval, smooth launch, and rapid uptake.

By overcoming the resistance from first and second-generation EGFR inhibitors and better efficacy in terms of overall response and progression-free survival, TAGRISSO become the market leader in the EGFR NSCLC market with fast uptake.

Lorlatinib is a third-generation ALK inhibitor. It showed higher potency and selectivity for ALK mutation, better penetration into the brain, and broader activity against different resistance mutations compared to the previous generation ALK inhibitor. Its uptake is fast compared to alectinib. However, by 2034, the highest market size will be captured by alectinib.

NSCLC Activities

The report provides insights into therapeutic candidates in Phase III and II. It also analyzes key players involved in developing targeted therapeutics.

Pipeline Development Activities

The report covers information on collaborations, acquisitions and mergers, licensing, and patent details for NSCLC emerging therapies.

KOL Views

To keep up with the real-world scenario in current and emerging market trends, we take opinions from Key Industry leaders working in the domain through primary research to fill the data gaps and validate our secondary research. Industry Experts contacted for insights on the evolving treatment landscape, patient reliance on conventional therapies, patient's therapy switching acceptability, and drug uptake along with challenges related to accessibility, including Medical/scientific writers, Medical Oncologists, Pulmonologists and Professors, Chief of the Thoracic Service at the Memorial Sloan Kettering Cancer Center, and Others.

DelveInsight's analysts connected with 40+ KOLs to gather insights; however, interviews were conducted with 18+ KOLs in the 7MM. Centers such as MD Anderson Cancer Center, Texas, UT Southwestern Medical Center in Dallas, Cancer Research UK Barts Centre in London, LUNGevity Foundation, etc., were contacted. Their opinion helps understand and validate current and emerging therapy treatment patterns or Non-Small Cell Lung Cancer market trends.

We perform qualitative and market Intelligence analysis using various approaches, such as SWOT analysis. In the SWOT analysis, strengths, weaknesses, opportunities, and threats in terms of gaps in disease diagnosis, patient awareness, physician acceptability, competitive landscape, cost-effectiveness, and geographical accessibility of therapies are provided.

Market Access and Reimbursement

The cost of treating NSCLC has shown significant increases over time, irrespective of the stage of the disease. According to real-world findings, this is particularly true for younger patients treated in the outpatient setting. Although first-generation epidermal growth factor receptor tyrosine kinase inhibitors were reimbursed and available in all countries for other registered therapies-even for ALK inhibitors and checkpoint inhibitors in first-line-there were apparent gaps in availability and/or reimbursement.

The report further provides detailed insights on the country-wise accessibility and reimbursement scenarios, cost-effectiveness scenario of approved therapies, programs making accessibility easier and out-of-pocket costs more affordable, insights on patients insured under federal or state government prescription drug programs, etc.

Scope of the Report:

NSCLC Report Insights

NSCLC Report Key Strengths

NSCLC Report Assessment

FAQs:

Reasons to buy:

Table of Contents

1. KEY INSIGHTS

2. REPORT INTRODUCTION

3. KEY HIGHLIGHTS

4. EXECUTIVE SUMMARY

5. METASTATIC NSCLC MARKET OVERVIEW AT A GLANCE

6. KEY EVENTS

7. EPIDEMIOLOGY AND MARKET FORECAST METHODOLOGY

8. DISEASE BACKGROUND AND OVERVIEW

9. DIAGNOSIS OF NSCLC

10. CURRENT TREATMENT PRACTICES: NSCLC

11. TREATMENT GUIDELINES AND RECOMMENDATIONS FOR NON-SMALL CELL LUNG CANCER (NSCLC)

12. EPIDEMIOLOGY AND PATIENT POPULATION

13. PATIENT JOURNEY

14. KEY ENDPOINTS IN NSCLC

15. MARKETED DRUGS

16. EMERGING DRUGS

17. NSCLC: 7MM MARKET ANALYSIS

18. UNMET NEEDS

19. SWOT ANALYSIS

20. KOL VIEWS

21. MARKET ACCESS AND REIMBURSEMENT

22. APPENDIX

23. DELVEINSIGHT CAPABILITIES

24. DISCLAIMER

25. ABOUT DELVEINSIGHT

(주)글로벌인포메이션 02-2025-2992 kr-info@giikorea.co.kr
ⓒ Copyright Global Information, Inc. All rights reserved.
PC버전 보기