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만성 골수성 백혈병(CML) : 세계 의약품 예측과 시장 분석(-2030년)

Chronic Myeloid Leukemia (CML) - Global Drug Forecast and Market Analysis to 2030

리서치사 GlobalData
발행일 2021년 12월 상품코드 1054012
페이지 정보 영문 141 Pages 배송안내
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만성 골수성 백혈병(CML) : 세계 의약품 예측과 시장 분석(-2030년) Chronic Myeloid Leukemia (CML) - Global Drug Forecast and Market Analysis to 2030
발행일 : 2021년 12월 페이지 정보 : 영문 141 Pages

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

주요 8개국에서는 BCR-ABL1 저해제 3종과 줄기세포 이식용 세포치료 1종의 총 4종이 예측기간 중에 출시되거나 확대될 것으로 예측됩니다. 이러한 제품 출시와 확대 및 환자 증가가 시장 성장의 원동력이 될 것으로 예상됩니다. 그러나, 이러한 성장은 현재 판매되고 있는 제2세대 및 제3세대 저해제를 대신하는 제네릭 의약품 도입에 의한 브랜드 판매에 큰 부정적인 영향을 상쇄하지는 못할 것으로 예상됩니다.

세계의 만성 골수성 백혈병(CML: Chronic Myeloid Leukemia) 시장에 대해 조사분석했으며, 병 개요, 역학, 미충족 요구와 기회 평가, 연구개발 전략 등의 정보를 전해드립니다.

목차

목차

제1장 CML : 개요

  • 2030년까지 42억 5,000만 달러에서 33억 5,000만 달러로 감소하는 CML 시장
  • 시장을 이끄는 지위가 될 것으로 예상되는 Novartis
  • CML 시장의 낮은 미충족 요구 수준
  • 안전하고 효과적인 BCR-ABL1TKI가 요구되고 있는 CML에 신규 기업이 시장에 진출할 수 있는 여지는 없다
  • 2030년까지 시장을 주도하는 브랜드가 될 것으로 예상되는 Scemblix
  • 의사의 견해

제2장 서론

  • 성장 촉진요인
  • 관련 보고서
  • 향후의 보고서

제3장 질병 개요

  • 병인과 병태생리학
    • 병인
    • 병태생리학
  • 분류/staging 시스템

제4장 역학

  • 질병의 배경
  • 위험 요인과 병존 질환
  • 세계 및 과거 동향
  • 예측 조사 방법
    • 출처
    • 예측의 전제조건과 방법
    • CML 진단 사례
    • CML 진단 사례 : 병기 분류별
    • CML 진단 사례 : 리스크 현황별
    • CML 진단 사례 : T315I 변이별
    • CML의 진단된 5년/10년/15년/20년 유병률
  • CML의 역학 예측(2020년-2030년)
    • CML 진단 사례
    • CML 진단 사례 : 연령별
    • CML 진단 사례 : 성별
    • CML 진단 사례 : 병기 분류별
    • CML 진단 사례 : 리스크 현황별
    • CML 진단 사례 : T315I 변이 별
    • CML 진단 된 20년 유병률
  • 토론
    • 역학 예측 인사이트
    • COVID-19의 영향
    • 분석의 한계
    • 분석의 강점

제5장 질병 관리

  • KOL(Key Opinion Leader) 인사이트를 포함한 진단 및 치료 개요
    • 미국
    • EU
    • 일본
    • 캐나다

제6장 경쟁 평가

  • 개요

제7장 미충족 요구와 기회 평가

  • 개요
  • 고혈압 환자를 위한 옵션 부족
  • TKI에 저항성 또는 불내성인 환자를 위한 보다 우수한 옵션의 필요성
  • 안전하게 치료를 중지하고, 치료를 받지 않고 있을 수 있는 환자를 늘릴 필요성
  • 컴플라이언스를 개선할 필요성

제8장 연구개발 전략

  • 개요
    • 기존 BCR-ABL1 저해제보다 강력한 버전 개발
    • 일반적인 내성 변이에 대한 BCR-ABL1 저해제 개발
    • 부작용 프로파일이 개선되어 독성 우려가 적은 BCR-ABL1 저해제 개발
  • 임상시험 설계
    • CP 질환에서의 양호한 엔드포인트
    • 첨단 질환 시험에서의 다른 설계가 필요

제9장 파이프라인 평가

  • 개요
  • 임상 개발에서의 유망 약제

제10장 파이프라인 평가 분석

  • 개요
  • 경쟁 평가

제11장 현재 및 향후 기업

  • 개요
  • 거래 결정 동향

제12장 시장 전망

제13장 부록

LSH 22.02.10

List of Tables

List of Tables

  • Table 1: CML: Key Metrics in the 8MM
  • Table 2: Staging of CML as Defined by Commonly Used Staging Systems
  • Table 3: Prognostic Scoring Systems for CML
  • Table 4: Risk Factors and Comorbid Conditions Associated with CML
  • Table 5: Treatment Guidelines for CML
  • Table 6: Top Deals by Value, 2016-2020
  • Table 7: CML Market - Global Drivers and Barriers, 2020-2030
  • Table 8: Key Events Impacting Sales for CML in the US, 2020-2030
  • Table 9: CML Market - Drivers and Barriers in the US, 2020-2030
  • Table 10: Key Events Impacting Sales for CML in the 5EU, 2020-2030
  • Table 11: CML Market - Drivers and Barriers in the 5EU, 2020-2030
  • Table 12: Key Events Impacting Sales for CML in Japan, 2020-2030
  • Table 13: CML Market - Drivers and Barriers in Japan, 2020-2030
  • Table 14: Key Events Impacting Sales for CML in Canada, 2020-2030
  • Table 15: CML Market - Drivers and Barriers in Canada, 2020-2030
  • Table 15: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

List of Figures

  • Figure 1: Global Sales Forecast by Country for CML in 2020 and 2030
  • Figure 2: Analysis of the Company Portfolio Gap in CML During the Forecast Period
  • Figure 3: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of CP CML Patients During the Forecast Period
  • Figure 4: Competitive Assessment of the Late-Stage Pipeline Agents that GlobalData Expects to Be Licensed for the Treatment of Advanced-Phase CML Patients During the Forecast Period
  • Figure 5: Diagram of the Translocation Event that Occurs Between Chromosomes Nine and 22 in CML
  • Figure 6: 8MM, Diagnosed Incidence of CML, Men, Cases Per 100,000 Population, All Ages, 2010-2030
  • Figure 7: 8MM, Diagnosed Incidence of CML, Women, Cases Per 100,000 Population, All Ages, 2010-2030
  • Figure 8: 8MM, Sources Used to Forecast Diagnosed Incident Cases of CML (ICD-10 = C92.1)
  • Figure 9: 8MM, Sources Used to Forecast the Five-, 10-, 15-, and 20-Year Diagnosed Prevalent Cases of CML (ICD-10 = C92.1)
  • Figure 10: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by Staging
  • Figure 11: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by Risk Status
  • Figure 12: 8MM, Sources Used to Forecast the Diagnosed Incident Cases of CML (ICD-10 = C92.1) by T315I Mutation
  • Figure 13: 8MM, Diagnosed Incident Cases of CML, N, Both Sexes, All Ages, 2020
  • Figure 14: 8MM, Diagnosed Incident Cases of CML by Age, N, All Ages, 2020
  • Figure 15: 8MM, Diagnosed Incident Cases of CML by Sex, N, All Ages, 2020
  • Figure 16: 8MM, Diagnosed Prevalent Cases of CML by Staging, N, All Ages, 2020
  • Figure 17: 8MM, Diagnosed Incident Cases of CML by Risk Status, N, All Ages, 2020
  • Figure 18: 8MM, Diagnosed Incident Cases of CML by T315I Mutation, N, Both Sexes, All Ages, 2020
  • Figure 19: 8MM, 20-Year Diagnosed Prevalent Cases of CML, N, Both Sexes, All Ages, 2020
  • Figure 20: Overview of the Treatment Algorithm in CML
  • Figure 21: Unmet Needs and Opportunities in CML
  • Figure 22: Overview of the Development Pipeline in CML
  • Figure 23: Key Late-Stage Trials for the Promising Pipeline Agents that GlobalData Expects to Be Licensed for CML in the 8MM During the Forecast Period
  • Figure 24: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against Sprycel in CP Disease
  • Figure 25: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against Iclusig in Advanced Disease
  • Figure 26: Analysis of the Company Portfolio Gap in CML During the Forecast Period
  • Figure 27: Global (8MM) Sales Forecast by Country for CML in 2020 and 2030
  • Figure 28: Sales Forecast by TKI for CML in the US in 2020 and 2030
  • Figure 29: Sales Forecast by TKI for CML in the 5EU in 2020 and 2030
  • Figure 30: Sales Forecast by TKI for CML in Japan in 2020 and 2030
  • Figure 31: Sales Forecast by TKI for CML in Canada in 2020 and 2030

Chronic myeloid leukemia (CML) is a myeloproliferative cancer resulting from the formation of an abnormal gene; BCR-ABL1. Although CML is now highly survivable due to the availability of multiple effective BCR-ABL1 inhibitors, the patient population is increasing as a result of longer life expectancies and an aging population. CML is almost exclusively treated with BCR-ABL1 inhibitors. Patients are likely to receive Novartis' first-generation inhibitor Gleevec (or a generic version of imatinib) in the first line. However, high-risk patients, and those progressing receive second- or third-generation inhibitors, including Novartis' Tasigna, BMS' Sprycel, Pfizer's Bosulif or Takeda/Incyte's Iclusig.

The global market is expected to experience negative growth during the forecast period. Just four agents are forecast to either launch or expand in the forecast period in the 8MM; three BCR-ABL1 inhibitors and one stem cell transplant cell therapy product. Growth will be driven by the launch and expansion of these products, along with an increase in prevalent cases. However, this growth will not offset the significant negative effect on branded sales the introduction of generic alternatives to the currently available second- and third-generation inhibitors is expected to have on the market.

Key Highlights

  • The main drivers of growth include the anticipated approval and launch of 3 pipeline therapies, and the label expansion of one currently marketed therapy across the 8MM during the forecast period, as well as an increase in prevalent cases.
  • The main barriers to growth in the 8MM are key patent expiries of all but one of the currently marketed BCR-ABL1 inhibitors
  • Among the late-stage pipeline products and marketed agents, BCR-ABL1 TKIs are expected to continue to dominate sales
  • The most important unmet needs in the CML market include: wider therapeutic options for patients who progress to advanced disease, a wider range of options for patients intolerant or resistant to currently available therapies, to increase the proportion of patients successfully discontinuing therapy in the long-term, and a need to improve compliance.

KEY QUESTIONS ANSWERED

  • 4 late-stage pipeline agents are expected to enter the CML market from 2021 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 CML, which pipeline agents are positioned to counter these unmet needs?
  • What are the opportunities for R&D?
  • What is the market outlook in the 8MM from 2020-2030? Considering major patent expiries, launch of new premium priced agents and expected label expansions.
  • What are the main corporate trends?
  • Who are the current and future players?

Scope

  • Overview of CML including epidemiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline CML 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 CML 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 CML 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 CML therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global CML 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 CML therapeutics market from 2019-2029.
  • 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 CML: Executive Summary

  • 1.1 The CML Market Will Decline from $4.25B to $3.35B by 2030
  • 1.2 Novartis Expected to Take Market-Leading Position
  • 1.3 The Level of Unmet Need in the CML Market Is Relatively Low
  • 1.4 The CML Space Is Crowded with Safe and Effective BCR-ABL1 TKIs, Leaving Little Room for New Market Entrants
  • 1.5 Scemblix Is Expected to Become the Market-Leading Brand by 2030
  • 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 Forecast Methodology
    • 4.4.1 Sources
    • 4.4.2 Forecast Assumptions and Methods
    • 4.4.3 Diagnosed Incident Cases of CML
    • 4.4.4 Diagnosed Incident Cases of CML by Staging
    • 4.4.5 Diagnosed Incident Cases of CML by Risk Status
    • 4.4.6 Diagnosed Incident Cases of CML by T315I Mutation
    • 4.4.7 Five-, 10-, 15-, 20-Year Diagnosed Prevalent Cases of CML
  • 4.5 Epidemiological Forecast for CML (2020-2030)
    • 4.5.1 Diagnosed Incident Cases of CML
    • 4.5.2 Age-Specific Diagnosed Incident Cases of CML
    • 4.5.3 Sex-Specific Diagnosed Incident Cases of CML
    • 4.5.4 Diagnosed Incident Cases of CML by Staging
    • 4.5.5 Diagnosed Incident Cases of CML by Risk Status
    • 4.5.6 Diagnosed Incident Cases of CML by T315I Mutation
    • 4.5.7 20-Year Diagnosed Prevalent Cases of CML
  • 4.6 Discussion
    • 4.6.1 Epidemiological Forecast Insight
    • 4.6.2 COVID-19 Impact
    • 4.6.3 Limitations of the Analysis
    • 4.6.4 Strengths of the Analysis

5 Disease Management

  • 5.1 Diagnosis and Treatment Overview Including KOL Insights
    • 5.1.1 US
    • 5.1.2 EU
    • 5.1.3 Japan
    • 5.1.4 Canada

6 Competitive Assessment

  • 6.1 Overview

7 Unmet Needs and Opportunity Assessment

  • 7.1 Overview
  • 7.2 Lack of Options for Patients with BP Disease
  • 7.3 Need for Greater Options for Patients Refractory or Intolerant to TKIs
  • 7.4 Need to Increase the Number of Patients Who Can Safely Discontinue Therapy and Remain Treatment-Free
  • 7.5 Need to Improve Compliance

8 R&D Strategies

  • 8.1 Overview
    • 8.1.1 Development of More Potent Versions of Existing BCR-ABL1 Inhibitors
    • 8.1.2 Development of BCR-ABL1 Inhibitors Against Common Resistance Mutations
    • 8.1.3 Development of BCR-ABL1 Inhibitors with Improved Side-Effect Profiles and Fewer Toxicity Concerns
  • 8.2 Clinical Trials Design
    • 8.2.1 Preferred Endpoints in CP Disease
    • 8.2.2 Advanced-Disease Trials May Require Different Design

9 Pipeline Assessment

  • 9.1 Overview
  • 9.2 Promising Drugs in Clinical Development

10 Pipeline Valuation Analysis

  • 10.1 Overview
  • 10.2 Competitive Assessment

11 Current and Future Players

  • 11.1 Overview
  • 11.2 Deal-Making Trends

12 Market Outlook

13 Appendix

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