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市場調查報告書

骨髓發育不良症候群(MDS):市場機會分析及2028年前的預測

Myelodysplastic Syndromes: Opportunity Analysis and Forecasts to 2028

出版商 GlobalData 商品編碼 940438
出版日期 內容資訊 英文 193 Pages
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骨髓發育不良症候群(MDS):市場機會分析及2028年前的預測 Myelodysplastic Syndromes: Opportunity Analysis and Forecasts to 2028
出版日期: 2020年05月30日內容資訊: 英文 193 Pages
簡介

本報告提供世界主要7個國家(美國、歐盟五國、日本的骨髓發育不良症候群(MDS)市場的相關調查,提供MDS概要及流行病學,市場需求,機會和預測等資訊。

第1章 目錄

  • 表格的清單
  • 圖的清單

第2章 骨髓發育不良症候群:概要

第3章 簡介

第4章 疾病概要

  • 病因與病理學
    • 病因
    • 病理生理學
  • 與臨床簡報診斷
  • 分類
    • MDS的WHO分類標準
    • IPSS-R分類

第5章 流行病學

  • 病的背景
  • 風險要素與並存症
  • 世界及過去趨勢
  • 預測的調查手法
  • MDS的流行病學預測(2018年∼2028年)
  • 討論

第6章 目前治療選擇

第7章 潛在的需求和機會的評估

第8章 R&D的作戰

第9章 管線評估

第10章 開發平台評估分析

第11章 附錄

目錄
Product Code: GDHC110POA

Myelodysplastic syndromes (MDS) are a relatively rare group of acquired clonal hematopoietic stem cell disorders characterized by dysfunctional hematopoiesis leading to cytopenias, with the potential to transform into acute myeloid leukemia (AML). DNA damage and mutations are the predominant factors contributing to MDS development and progression. As such, aging and the associated accumulation of mutations over time appear to be the most important risk factors for the disease. Clonal shifts in hematopoietic stem and progenitor cells due to mutations, cytogenetic alterations, and modified epigenetic marks can promote the expansion of abnormal, dysfunctional cells. In symptomatic MDS, these cellular changes manifest in pathophysiological changes including fatigue, bleeding and bruising, and increased risk of infection.

The greatest drivers of growth in the global MDS market include the launch of 10 new pipeline therapies during the forecast period and a growing number of incident cases in many 7MM countries due to an aging population.

The main barriers to growth in the MDS market include the launch of generics and biosimilars of major brands, including Vidaza (azacitidine), Revlimid (lenalidomide), and Aranesp (darbepoetin alfa), and the dominance of safe and effective generic and biosimilar products in the first-line setting for both LR-MDS and HR-MDS.

Among the late-stage pipeline products, KOLs were particularly enthusiastic about BMS's recently approved anti-anemia agent, Reblozyl (luspatercept) for the treatment of LR-MDS and Aprea Therapeutics' eprenetapopt plus azacitidine combination therapy for the treatment of TP53 mutant HR-MDS.

The most important unmet needs in the MDS disease space are the needs for novel therapeutics targeting difficult-to-treat patient groups including patients with HR-MDS and LR-MDS who fail the standard of care; LR-MDS patients with symptomatic neutropenia and thrombocytopenia; and more generally, HR-MDS patients, the majority of which are ineligible to safely receive HSCT, which is the only currently available curative therapy option.

KEY QUESTIONS ANSWERED

  • Therapeutic goals for patients with MDS differ depending on whether patients have lower or higher risk disease.
  • How do the treatment goals for patients with HR-MDS and LR-MDS differ?
  • How well are currently marketed therapies addressing the different needs of patients with higher and lower risk MDS?

With the launch of ten new pipeline agents expected between 2018 and 2028, GlobalData expects the MDS competitive landscape to undergo a significant transformation during the next decade

  • What are the main R&D trends in the MDS market and which companies are leading the way?
  • In what ways is clinical trial design for LR-MDS and HR-MDS changing and what aspects do KOLs believe should be addressed in the future?
  • Are there major differences in the mechanisms of action used by therapies in late-stage versus early-stage clinical development?
  • Despite the recent burst in pipeline development for MDS, KOLs interviewed by GlobalData still noted a continued high level of unmet need for therapies targeting difficult-to-treat populations of patients.
  • Which MDS patient populations have the greatest unmet need and why?
  • How can the pharmaceutical industry address these needs?
  • To what degree will the therapies under development fulfill these unmet needs?

Scope

  • Overview of MDS including epidemiology, etiology, pathophysiology, symptoms, diagnosis, and treatment guidelines.
  • Topline MDS 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 MDS therapeutics sales in the 7MM.
  • Pipeline analysis: Comprehensive data split across different phases, emerging novel trends under development, and detailed analysis of late-stage pipeline drugs.
  • Analysis of the current and future market competition in the global MDS therapeutics market. Insightful review of the key industry drivers, restraints 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 MDS therapeutics market.
  • Drive revenues by understanding the key trends, innovative products and technologies, market segments, and companies likely to impact the global MDS 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 MDS therapeutics market from 2018-2028.
  • Organize your sales and marketing efforts by identifying the market categories and segments that present maximum opportunities for consolidations, investments and strategic partnerships.

1 Table of Contents

  • 1.1 List of Tables
  • 1.2 List of Figures

2 Myelodysplastic Syndromes: Executive Summary

  • 2.1 Moderate Growth Expected in MDS Market Between 2018 and 2028
  • 2.2 Drug Developers Position Agents to Fill Key Vacancies in the Treatment Paradigms for Higher- and Lower-Risk MDS
  • 2.3 Unmet Needs Persist in Difficult-to-Treat MDS Subgroups, Leaving Substantial Opportunity for Future Players
  • 2.4 Current Late-Stage MDS Pipeline Offers a Range of New Options for Patients in the Front-Line and Later Treatment Settings
  • 2.5 What Do Physicians Think?

3 Introduction

  • 3.1 Catalyst
  • 3.2 Related Reports
  • 3.3 Upcoming Related Reports

4 Disease Overview

  • 4.1 Etiology and Pathophysiology
    • 4.1.1 Etiology
    • 4.1.2 Pathophysiology
  • 4.2 Clinical Presentation and Diagnosis
  • 4.3 Classification
    • 4.3.1 WHO Classification Criteria for MDS
    • 4.3.2 IPSS-R Classification

5 Epidemiology

  • 5.1 Disease Background
  • 5.2 Risk Factors and Comorbidities
  • 5.3 Global and Historical Trends
  • 5.4 Forecast Methodology
    • 5.4.1 Sources
    • 5.4.2 Forecast Assumptions and Methods
  • 5.5 Epidemiological Forecast for MDS (2018-2028)
    • 5.5.1 Diagnosed Incident Cases of MDS
    • 5.5.2 Age-Specific Diagnosed Incident Cases of MDS
    • 5.5.3 Sex Specific Diagnosed Incident Cases of MDS
    • 5.5.4 Diagnosed Incident Cases of MDS/MPN
    • 5.5.5 Diagnosed Incident Cases of MDS by Subtype
    • 5.5.6 Diagnosed Incident Cases of Primary/Secondary MDS
    • 5.5.7 Diagnosed Incident Cases of MDS by Risk Group
    • 5.5.8 Diagnosed Incident Cases of MDS by Mutations
    • 5.5.9 Five-Year Diagnosed Prevalent Cases of MDS
  • 5.6 Discussion
    • 5.6.1 Epidemiological Forecast Insight
    • 5.6.2 Limitations of the Analysis
    • 5.6.3 Strengths of the Analysis

6 Current Treatment Options

7 Unmet Needs and Opportunity Assessment

8 R&D Strategies

9 Pipeline Assessment

10 Pipeline Valuation Analysis

11 Appendix

List of Tables

  • Table 1: Myelodysplastic Syndromes: Key Metrics in the 7MM
  • Table 2: Common cytogenetic abnormalities in MDS
  • Table 3: Frequent mutations in MDS
  • Table 4: Tests used in the Diagnosis of MDS
  • Table 5: 2016 WHO Classification Criteria for MDS
  • Table 6: Cytopenia-defining values for MDS
  • Table 7: IPSS-R Prognostic Risk Categories/Scores and Clinical Outcomes
  • Table 8: IPSS-R Prognostic Score Values
  • Table 9: MDS Cytogenetic Scoring System
  • Table 10: Risk Factors and Comorbidities for MDS
  • Table 11: Leading Treatments for MDS and Country-Specific Launch Dates, 2020
  • Table 12: Treatment Guidelines for MDS
  • Table 13: IWG 2006 Proposed Modified Response Criteria for Altering the Natural History of MDS
  • Table 14: IWG 2006 Proposed Modified Response Criteria for Hematologic Improvement
  • Table 15: IWG 2018 Suggested Modified HI-E Criteria for Response Evaluation
  • Table 16: IWG 2018 Suggested Modified HI-P and HI-N Criteria for Response Evaluation
  • Table 17: Comparison of Therapies in Development for HR-MDS and LR-MDS, 2018-2028
  • Table 18: Innovative Early Stage Approaches for MDS, 2020
  • Table 19: Clinical Benchmark of Key Pipeline Drugs - HR-MDS
  • Table 20: Clinical Benchmark of Key Pipeline Drugs - HR-MDS
  • Table 21: Clinical Benchmark of Key Pipeline Drugs - HR-MDS - Allogeneic HSCT
  • Table 22: Clinical Benchmark of Key Pipeline Drugs - LR-MDS
  • Table 23: Clinical Benchmark of Key Pipeline Drugs - LR-MDS
  • Table 24: Commercial Benchmark of Key Pipeline Drugs - HR-MDS
  • Table 25: Commercial Benchmark of Key Pipeline Drugs - HR-MDS
  • Table 26: Commercial Benchmark of Key Pipeline Drugs - HR-MDS -HSCT
  • Table 27: Commercial Benchmark of Key Pipeline Drugs - LR-MDS
  • Table 28: Commercial Benchmark of Key Pipeline Drugs - LR-MDS
  • Table 29: MDS Market - Global Drivers and Barriers, 2018-2028
  • Table 30: Key Events Impacting Sales for MDS in the US, 2018-2028
  • Table 31: Key Events Impacting Sales for MDS in the 5EU, 2018-2028
  • Table 32: Key Events Impacting Sales for MDS in Japan, 2018-2028
  • Table 33: Key Historical and Projected Launch Dates for MDS
  • Table 34: Key Historical and Projected Patent/Exclusivity Expiry Dates for MDS
  • Table 35: High-Prescribing Physicians (non-KOLs) Surveyed, By Country

List of Figures

  • Figure 1: Global Sales Forecast by Country for MDS in 2018 and 2028
  • Figure 2: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, HR-MDS
  • Figure 3: Competitive Assessment of Omidubicel Against the Standard of Care, HR-MDS
  • Figure 4: Competitive Assessment of the Marketed and Pipeline Drugs Benchmarked Against the Standard of Care, LR-MDS
  • Figure 5: Key Therapeutic Mechanisms in MDS
  • Figure 6: 8MM, Diagnosed Incidence Rates of MDS, Men and Women, Ages ≥18 Years, Cases per 100,000 Population, 2008-2028
  • Figure 7: Sources Used for Diagnosed Incident Cases of MDS
  • Figure 8: Sources Used for Diagnosed Incident Cases of MDS/MPN
  • Figure 9: Sources Used for Diagnosed Incident Cases of MDS Subtypes
  • Figure 10: Sources Used for Diagnosed Incident Cases of Primary/Secondary MDS
  • Figure 11: Sources Used for Five-Year Diagnosed Prevalent Cases of MDS
  • Figure 12: 8MM, Diagnosed Incident Cases of MDS, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 13: 8MM, Age-Specific Diagnosed Incident Cases of MDS, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 14: 8MM, Sex-Specific Diagnosed Incident Cases of MDS, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 15: 8MM, Diagnosed Incident Cases MDS/MPN, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 16: 8MM, Proportion of Diagnosed Incident Cases of MDS by Subtype, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 17: 8MM, Proportion of Diagnosed Incident Cases of Primary/Secondary MDS, Men and Women, Ages ≥18 Years, 2018
  • Figure 18: 8MM, Diagnosed Incident Cases of MDS by Risk Group, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 19: 8MM, Diagnosed Incident Cases of MDS by Mutation, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 20: 8MM, Five-Year Diagnosed Prevalent Cases of MDS, Men and Women, Ages ≥18 Years, N, 2018
  • Figure 21: NCCN Treatment Flow for HR-MDS
  • Figure 22: NCCN Treatment Flow for LR-MDS
  • Figure 23: Unmet Needs and Opportunities in MDS
  • Figure 24: Overview of the Development Pipeline in MDS
  • Figure 25: Key Phase II/III Trials for Promising Pipeline Agents that GlobalData Expects be Licensed for MDS in the 7MM During the Forecast Period
  • Figure 26:Competitive Assessment of Marketed and Pipeline Drugs Benchmarked Against the SOC, HR-MDS
  • Figure 27:Competitive Assessment of Omidubicel Against the SOC, HR-MDS
  • Figure 28:Competitive Assessment of Marketed and Pipeline Drugs Benchmarked Against the SOC, LR-MDS
  • Figure 29: Global Sales Forecast by Country for MDS in 2018 and 2028
  • Figure 30: Global MDS Sales Forecast by Class, 2018 and 2028
  • Figure 31: US MDS Sales Forecast by Class, 2018 and 2028
  • Figure 32: 5EU MDS Sales Forecast by Class, 2018 and 2028
  • Figure 33: Japan MDS Sales Forecast by Class, 2018 and 2028