다형성교모세포종 : 세계 의약품 예측과 시장 분석(-2030년)

※ 본 상품은 영문 자료로 한글과 영문 목차에 불일치하는 내용이 있을 경우 영문을 우선합니다. 정확한 검토를 위해 영문목차를 참고해주시기 바랍니다.

세계의 다형성교모세포종(GBM) 시장은 주로 테모졸로마이드(temozolomide)와 베바시주맙(bevacizumab)에 의존하고 있으며, 2020년 총매출 5억 4,910만 달러 가운데 각각 46%와 51%를 차지하고 있습니다. 이 시장이 진정한 성장을 이루기 위해서는 테모졸로마이드 제네릭 의약품의 존재와 베바시주맙 바이오시밀러의 도입에 의해, 현재 판매되고 있는 제품이 거의 모두 새로운 파이프라인 제품으로 대체될 필요가 있습니다. 그러나 후기 단계 GBM 시험에 대해서는 역사적으로 높은 실패율이 관찰되고 있으며, 파이프라인 예측에 영향을 미쳐 시장 성장을 저해할 가능성이 있습니다. 그럼에도 불구하고 8개의 파이프라인 약제가 8MM에 참여하고, 2030년까지 4.7%의 CAGR로 GBM의 성장을 8억 6,850만 달러로 지지할 것으로 예상됩니다.

세계의 다형성교모세포종(GBM : Glioblastoma Multiforme) 시장을 조사했으며, 시장 개요, 질병 개요, 미충족 수요와 기회, 연구개발 전략, 파이프라인 평가와 분석, 경쟁 상황 등 체계적인 정보를 제공합니다.

목차

목차

제1장 다형성교모세포종 : 주요 요약

• 시장은 2030년까지 8MM에서 8억 6,850만 달러에 달할 것으로 예측
• Merck & Co.가 초기 단계 포트폴리오를 확대하고, Roche가 침식되는 한편, GBM-AGILE Candidates가 시장에 침투
• 특히 MGMT 프로모터의 메틸화되지 않은 환자와 절제 불가능한 환자에서 높은 미충족 수요의 존재
• 더 나은 예후 마커와 Drug Discovery 타겟을 갖춘 신규 참여자의 기회
• 예측기간 중 발매가 전망되는 신규 GBM-AGILE 약제 후보 및 면역요법
• 의사의 생각

제2장 서론

• 촉매
• 관련 보고서
• 향후 보고서

제3장 질병 개요

• 병인과 병태생리학
  • 병인
  • 병태생리학
• 분류 또는 병기결정 체계

제4장 역학

• 질병 배경
• 위험인자와 병존질환
• 세계적 및 역사적 동향
• 8MM 예측 조사 방법
  • 소스
  • 예측 가정과 방법
  • 뇌종양 진단된 인시던트 케이스
  • 종류별, 뇌종양 진단된 인시던트 케이스
  • 그레이드별, 교모세포종 진단된 인시던트 케이스
  • 기원별, 교모세포종 진단된 인시던트 케이스
  • 바이오마커별, 교모세포종 진단된 인시던트 케이스
  • 돌연변이별, 교모세포종 진단된 인시던트 케이스
  • 뇌종양의 5년간 진단된 일반적 증례
• 논의
  • 역학 예측 인사이트
  • COVID-19의 영향
• 뇌종양 역학 예측(2020-2030년)
  • 뇌종양 진단된 인시던트 케이스
  • 뇌종양 연령별, 진단된 인시던트 케이스
  • 뇌종양 성별, 진단된 인시던트 케이스
  • 종류별, 뇌종양 진단된 인시던트 케이스
  • 그레이드별, 교모세포종 진단된 인시던트 케이스
  • 기원별, 교모세포종 진단된 인시던트 케이스
  • 바이오마커별, 교모세포종 진단된 인시던트 케이스
  • 돌연변이별, 교모세포종 진단된 인시던트 케이스
  • 뇌종양의 5년간 진단된 일반적 증례
  • 분석의 한계
  • 분석의 강점

제5장 질병 관리

• 진단과 치료 개요
• 질병 관리에 관한 KOL 인사이트

제6장 현재 치료 옵션

• 개요

제7장 미충족 수요와 기회 평가

• 개요
• 바이오마커와 Drug Discovery 타겟 특정과 검증
• 혈액뇌장벽을 극복해 치료 유효성을 개선
• MGMT의 메틸화되지 않은 절제 불가능한 환자를 위한 더 나은 치료 선택사항
• 가진행과 진정한 진행의 구별

제9장 연구개발 전략

• 개요
  • GBM의 면역요법 유효성
  • 예측 바이오마커와 표적요법
  • 치료 관리 루트 개선
• 임상시험 설계
  • 임상 평가 항목
  • 기타 우산형 또는 플랫폼 시험 설계
  • Comparator Arms

제10장 파이프라인 평가

• 개요
• 임상 개발의 유망한 약제

제11장 파이프라인 평가 분석

• 개요
• 경쟁력 있는 평가

제12장 현재 및 향후 기업

• 개요
• 거래 동향

제13장 시장 전망

제14장 부록

List of Tables

List of Tables

• Table 1: Glioblastoma Multiforme: Key Metrics in the 8MM
• Table 2: Classification of Key Gliomas and Corresponding Diagnostic Genes
• Table 3: Risk Factors and Comorbid Conditions Associated with Brain Cancer
• Table 4: Treatment Guidelines for GBM
• Table 5: Top 10 Deals by Value, 2019-2021
• Table 6: GBM Market - Global Drivers and Barriers, 2020-2030
• Table 7: Key Events Impacting Sales for GBM in the US, 2020-2030
• Table 8: GBM Market - Drivers and Barriers in the US, 2020-2030
• Table 9: Key Events Impacting Sales for GBM in the 5EU, 2020-2030
• Table 10: GBM Market - Drivers and Barriers in the 5EU, 2020-2030
• Table 11: Key Events Impacting Sales for GBM in Japan, 2020-2030
• Table 12: GBM Market - Drivers and Barriers in Japan, 2020-2030
• Table 13: Key Events Impacting Sales for GBM in China, 2020-2030
• Table 14: GBM Market - Drivers and Barriers in China, 2020-2030
• Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

• Figure 1: Global (8MM) Sales Forecast by Country for GBM in 2020 and 2030
• Figure 2: Analysis of the Company Portfolio Gap in GBM During the Forecast Period, 2020-2030
• Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to be Licensed for the Treatment of Recurrent GBM During the Forecast Period
• Figure 4: Genetic and Molecular Pathogenesis of GBM
• Figure 5: 8MM, Diagnosed Incidence of Brain Cancer, Men, Cases Per 100,000 Population All Ages, 2010-2030
• Figure 6: 8MM, Diagnosed Incidence of Brain Cancer, Women, Cases Per 100,000 Population All Ages, 2010-2030
• Figure 7: 8MM, Sources Used to Forecast Diagnosed Incident Cases Brain Cancer (ICD-10 = C70, C71, C72)
• Figure 8: 8MM, Sources Used to Forecast the Five-Year Diagnosed Prevalent Cases of Brain Cancer (ICD-10 = C70, C71, C72)
• Figure 9: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Brain Cancer (ICD-10 = C70, C71, C72) by Type
• Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Glioblastoma by Grade (WHO Grading System)
• Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Glioblastoma by Origin
• Figure 12: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of Glioblastoma by Biomarkers and Mutations
• Figure 13: 8MM, Diagnosed Incident Cases of Brain Cancer, N, Both Sexes, All Ages, 2020
• Figure 14: 8MM, Diagnosed Incident Cases of Brain Cancer by Age, N, Both Sexes, 2020
• Figure 15: 8MM, Diagnosed Incident Cases of Brain Cancer by Sex, N, All Ages, 2020
• Figure 16: 8MM, Diagnosed Prevalent Cases of Brain Cancer by Type, N, Both Sexes, All Ages, 2020
• Figure 17: 8MM, Diagnosed Incident Cases of Glioblastoma by Grade, N, Both Sexes, All Ages, 2020
• Figure 18: 8MM, Diagnosed Incident Cases of Glioblastoma by Origin, N, Both Sexes, All Ages, 2020
• Figure 19: 8MM, Diagnosed Prevalent Cases of Glioblastoma by Biomarkers, N, Both Sexes, All Ages, 2020
• Figure 20: 8MM, Diagnosed Prevalent Cases of Glioblastoma by Mutations, N, Both Sexes, All Ages, 2020
• Figure 21: 8MM, Five-Year Diagnosed Prevalent Cases of Brain Cancer, N, Both Sexes, All Ages, 2020
• Figure 22: Overview of the Treatment Algorithm in GBM
• Figure 23: Unmet Needs and Opportunities in GBM
• Figure 24: Overview of the Development Pipeline in GBM
• Figure 25: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for GBM in the 8MM During the Forecast Period
• Figure 26: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Temodar, in Newly Diagnosed GBM
• Figure 27: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the SOC, Gleostine, in Recurrent GBM
• Figure 28: Analysis of the Company Portfolio Gap in GBM During the Forecast Period
• Figure 29: Global (8MM) Sales Forecast by Country for GBM in 2020 and 2030
• Figure 30: Sales Forecast by Class for GBM in the US in 2020 and 2030
• Figure 31: Sales Forecast by Class for GBM in the 5EU in 2020 and 2030
• Figure 32: Sales Forecast by Class for GBM in Japan in 2020 and 2030
• Figure 33: Sales Forecast by Class for GBM in China in 2020 and 2030

Glioblastoma multiforme (GBM) is now defined by the WHO 2021 as a diffuse astrocytic glioma with no mutations in IDH genes or histone H3 genes. It is the most common primary brain tumor in humans. Like other astrocytomas, GBM originates from astrocytes, a type of glial cells that are non-neuronal and function to provide structural and biochemical support to the brain's neuronal network. GBM continues to be a disease with some of the highest unmet needs in oncology, with patients having a median overall survival (OS) of between one and two years. The lack of therapies is primarily due to the inability of drugs to penetrate the blood-brain barrier (BBB).

The market of GBM relies predominantly on temozolomide and bevacizumab, which accounted for 46% and 51%, respectively, of the total $549.1M sales in 2020. For this market to witness true growth, the currently marketed products would need to be almost entirely replaced by new pipeline products, owing to the significant presence of generic temozolomide and the introduction of bevacizumab biosimilars. However, a high failure rate has been historically observed for late-stage GBM trials and may impact the pipeline forecast and impede the market growth. Nevertheless, eight pipeline agents are expected to enter the 8MM and drive the GBM growth to $868.5M by 2030 at a Compound Annual Growth Rate (CAGR) of 4.7%.

Key Highlights

• The main drivers of growth include the anticipated approval and launch of eight pipeline agents during the forecast period, of which cancer vaccines and protein kinase inhibitors are the dominating classes.
• The primary barrier to growth in the forecast period will be the high failure rates historically observed for Phase III GBM trials, impacting the pipeline forecast. The high genericization of temozolomide and recent patent expiration of Avastin, leading to biosimilar entry, also reduces the Glioblastoma Multiforme (GBM) market potential.
• DCVax-L, regorafenib, and paxalisib are the three pipeline agents expected to generate the highest sales for GBM from 2020-2030.
• Aside from improving OS, other key unmet needs in the GBM market include; Predictive biomarkers to guide personalized therapy and the need to find more efficacious treatment in O6-methylguanine-DNA methyltransferase (MGMT) unmethylated patients who typically have a poor response to temozolomide.

KEY QUESTIONS ANSWERED

• Eight Phase II-III pipeline agents are expected to enter the Glioblastoma market from 2024 onwards. What impact will these agents have on the market?
• Which of these drugs will have the highest peak sales, and why?
• What are the current unmet needs in GBM, which pipeline agents are positioned to counter these unmet needs?
• What are the opportunities for R&D?
• What are the current research and development (R&D) strategies being explored and how can developers incorporate these methods into their business strategy?
• What is the expected future uptake of protein kinase inhibitors across the 8MM?

Scope

• Overview of Glioblastoma Multiforme including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
• Topline Glioblastoma Multiforme market revenue, annual cost of therapy, and major pipeline product sales in the forecast period.
• Key topics covered include current treatment and pipeline therapies, unmet needs and opportunities, and the drivers and barriers affecting Glioblastoma Multiforme therapeutics sales in the 8MM.
• Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs (Phase II - III).
• Analysis of the current and future market competition in the global Glioblastoma Multiforme therapeutics market. Insightful review of the key industry drivers and challenges. Each trend is independently researched to provide qualitative analysis of its implications.

Reasons to Buy

The report will enable you to -

• Develop and design your in-licensing and out-licensing strategies, using a detailed overview of current pipeline products and technologies to identify companies with the most robust pipelines.
• Develop business strategies by understanding the trends shaping and driving the global Glioblastoma Multiforme therapeutics market.
• Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global Glioblastoma Multiforme market in the future.
• Formulate effective sales and marketing strategies by understanding the competitive landscape and by analyzing the performance of various competitors.
• Identify emerging players with potentially strong product portfolios and create effective counter-strategies to gain a competitive advantage.
• Track drug sales in the global Glioblastoma Multiforme therapeutics market from 2020-2030.
• Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

Table of Contents

Table of Contents

1 Glioblastoma Multiforme: Executive Summary

• 1.1 The Glioblastoma Multiforme Market is Forecast to Reach $868.5M by 2030 Across the 8MM
• 1.2 GBM-AGILE Candidates Set to Penetrate the Market While Merck & Co. Expands its Early-Stage Portfolio and Roche Experiences Erosion
• 1.3 High Unmet Needs Exist in the GBM Market, Especially in MGMT-Promoter Unmethylated Patients and Unresectable Patients
• 1.4 Opportunities for New Entrants with Better Markers of Prognosis and Drug Targets
• 1.5 Novel GBM-AGILE Drug Candidates and Immunotherapies Expected to Launch During the Forecast Period
• 1.6 What Do Physicians Think?

2 Introduction

• 2.1 Catalyst
• 2.2 Related Reports
• 2.3 Upcoming Reports

3 Disease Overview

• 3.1 Etiology and Pathophysiology
  • 3.1.1 Etiology
  • 3.1.2 Pathophysiology
• 3.2 Classification or Staging Systems

4 Epidemiology

• 4.1 Disease Background
• 4.2 Risk Factors and Comorbidities
• 4.3 Global and Historical Trends
• 4.4 8MM Forecast Methodology
  • 4.4.1 Sources
  • 4.4.2 Forecast Assumptions and Methods
  • 4.4.3 Diagnosed Incident Cases of Brain Cancer
  • 4.4.4 Diagnosed Incident Cases of Brain Cancer by Type
  • 4.4.5 Diagnosed Incident Cases of Glioblastoma by Grade
  • 4.4.6 Diagnosed Incident Cases of Glioblastoma by Origin
  • 4.4.7 Diagnosed Incident Cases of Glioblastoma by Biomarkers
  • 4.4.8 Diagnosed Incident Cases of Glioblastoma by Mutations
  • 4.4.9 Five-Year Diagnosed Prevalent Cases of Brain Cancer
• 4.5 Discussion
  • 4.5.1 Epidemiological Forecast Insight
  • 4.5.2 COVID-19 Impact
• 4.6 Epidemiological Forecast for Brain Cancer (2020-2030)
  • 4.6.1 Diagnosed Incident Cases of Brain Cancer
  • 4.6.2 Age-Specific Diagnosed Incident Cases of Brain Cancer
  • 4.6.3 Sex-Specific Diagnosed Incident Cases of Brain Cancer
  • 4.6.4 Diagnosed Incident Cases of Brain Cancer by Type
  • 4.6.5 Diagnosed Incident Cases of Glioblastoma by Grade
  • 4.6.6 Diagnosed Incident Cases of Glioblastoma by Origin
  • 4.6.7 Diagnosed Incident Cases of Glioblastoma by Biomarkers
  • 4.6.8 Diagnosed Incident Cases of Glioblastoma by Mutations
  • 4.6.9 Five-Year Diagnosed Prevalent Cases of Brain Cancer
  • 4.6.10 Limitations of the Analysis
  • 4.6.11 Strengths of the Analysis

5 Disease Management

• 5.1 Diagnosis and Treatment Overview
• 5.2 KOL Insights on Disease Management

6 Current Treatment Options

• 6.1 Overview

7 Unmet Needs and Opportunity Assessment

• 7.1 Overview
• 7.2 Identification and Validation of Biomarkers and Drug Targets
• 7.3 Overcoming the Blood-Brain Barrier to Improve the Efficacy of Treatments
• 7.4 Better Treatment Options for MGMT Unmethylated and Unresectable Patients
• 7.5 Differentiating Pseudoprogression and True Progression

9 R&D Strategies

• 9.1 Overview
  • 9.1.1 The Efficacy of Immunotherapy in GBM
  • 9.1.2 Predictive Biomarkers and Targeted Therapy
  • 9.1.3 Improving Therapy Administration Routes
• 9.2 Clinical Trials Design
  • 9.2.1 Clinical Endpoints
  • 9.2.2 More Umbrella or Platform Trial Designs
  • 9.2.3 Comparator Arms

10 Pipeline Assessment

• 10.1 Overview
• 10.2 Promising Drugs in Clinical Development

11 Pipeline Valuation Analysis

• 11.1 Overview
• 11.2 Competitive Assessment

12 Current and Future Players

• 12.1 Overview
• 12.2 Deal-Making Trends

13 Market Outlook

14 Appendix