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市场调查报告书

血液肿瘤:多发性骨髓瘤(MM) - 早期彻底的诊断和新的治疗选择带给疾病管理大幅影响的可能性

Hematological Malignancies: Multiple Myeloma (MM) - Early and Robust Diagnosis along with New Treatment Options can have Considerable Impact on Management of the Disease

出版商 MP Advisors 商品编码 323219
出版日期 内容信息 英文 82 Pages
商品交期: 最快1-2个工作天内
价格
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血液肿瘤:多发性骨髓瘤(MM) - 早期彻底的诊断和新的治疗选择带给疾病管理大幅影响的可能性 Hematological Malignancies: Multiple Myeloma (MM) - Early and Robust Diagnosis along with New Treatment Options can have Considerable Impact on Management of the Disease
出版日期: 2015年01月21日 内容信息: 英文 82 Pages
简介

对多发性骨髓瘤(MM)治疗的未满足需求扩大,以及发生机制和诊断、治疗方法相关研究也有所进展。现在诊断方法也多样化,随著临床实验的发展到认证、上市的努力达到目标的产品也出来了。对应复发、难治性多发性骨髓瘤(RRMM)的产品开发也有所进展。但,研究能推进到哪里,还有诊断标准是否变更等,留下各种课题。

本报告提供多发性骨髓瘤(MM)的诊断药、治疗药到目前为止的开发情形和今后市场趋势的分析、诊断与治疗关键的标的(单株抗体和小分子等等)、现在与临床实验中/已上市的产品概要与潜在市场、现在与未来的开发趋势、资本联盟等的动向、主要企业简介、研究体制的信息汇整,为您概述为以下内容。

第1章 摘要整理

第2章 疾病概要、诊断法、目前治疗方法

  • 多发性骨髓瘤的诊断工具概要
  • 骨髓瘤的诊断标准和近几年的修改
  • 对多发性骨髓瘤的诊断方法
  • 骨髓瘤的分子生物学的特徵
  • 未满足需求
  • 诊断上的新见解与技术
  • 「伴同性」诊断(CDx)
  • 基因整体排列
  • RNA为基础的技术
  • 下一代型定序(NGS)技术

第3章 多发性骨髓瘤诊断工具

  • Affymetrix GeneChip
  • SkylineDx MMprofiler
  • AgenaBio iPLEX Genotyping
  • Signal Genetics MyPRS
  • Cancer Genetics Genomic Products
  • Illumina NGS
  • NeoGenomics CLIA-certified Cancer Test
  • Exiqon microRNA PCR
  • Regulus Therapeutics microRNA Marker
  • Rosetta Genomics Cancer Origin Test
  • Sequenta LymphoSIGHT Platform

第4章 诊断药相关的企业合并、收购(M&A)交易与市场机会

第5章 目前治疗方法

  • NDMM(初发多发性骨髓瘤)
    • NDMM的竞争环境
  • RRMM(复发/难治性多发性骨髓瘤)
    • RRMM的竞争环境
  • 已认证治疗药
    • Revlimid
    • Velcade
    • Kyprolis
    • POMALYST
  • 数据比较
    • NDMM的情况
    • RRMM的情况

第6章 新标的

  • 单株抗体
    • Elotuzumab
    • Situximab
    • Daratumumab
    • MOR202
    • SAR650984
    • BI-505
    • BHQ880
    • CT-011
    • IPH2101/ Lirilumab
    • BMS-936564 (ulocuplumab)
  • 小分子
    • Panobinostat
    • Ixazomib (MLN9708)
    • Aplidin (plitidepsin)
    • ARRY-520 (filanesib)
    • Oprozomib
    • KPT-330 (selinexor)
    • SNS01-T
    • Ibrutinib
    • Ricolinostat
    • Afuresertib
    • KW-2478
    • BT-062

第7章 临床上的里程碑

第8章 临床实验的后期阶段产品开发中产品的上市时间表和商业机会

第9章 企业合并、收购(M&A)/授权合约,及未联盟的产品的市场机会

分析对象企业

  • Affymetrix
  • SkylineDx
  • AgenaBio
  • Signal Genetics
  • Cancer Genetics Inc
  • Illumina
  • NeoGenomics
  • Exiqon
  • Regulus Therapeutics
  • Rosetta Genomics
  • Sequenta
  • 武田药品工业
  • Celgene
  • Amgen
  • 小野药品工业
  • Abbott
  • BMS
  • Mundipharma
  • Novartis
  • MorphoSys
  • JNJ
  • Innate Pharma
  • Merck
  • Xencor
  • Array Biopharma
  • Altor Bioscience
  • Astex pharma(现在:大冢制药)
  • Biotest pharma
  • Immunogen
  • Exelixis
  • Oncopeptides
  • Karyopharm Therapeutics
  • CureTech
  • Curis
  • GSK
  • Innate Pharma
  • Lilly
  • Pharmacyclics
目录
Product Code: 4472

While targeting unmet needs in the treatment of hematological malignancies/ cancer through innovative drug development strategies have witnessed favorable outcomes, the specific choice of the therapies is dependent on the identification of important genomic alterations in cancerous cells that allow for the tumor's sub classification. Over the past decade, Proteasome inhibitor and the immunomodulatory drugs have become the cornerstone of treatment for pts with Multiple Myeloma (MM) resulting in improved survival. However, eventually all pts relapse and use of modern diagnosis will enable risk stratification to help distinguish pts along the spectrum of the condition. This can aid in the selection of new treatment options for Relapsed/ Refractory Multiple Myeloma (RRMM) to further improve survival and quality of life of each patient. Two new drugs have successfully fulfilled this need - POMALYST/ IMNOVID (pomalidomide - POM, Celgene, approved) and Kyprolis (carfilzomib-CFZ, Amgen/ Ono Pharma - JP, approved). While novel targets address unmet need, the pertinent Question remains - is there a need for further improvement? What should be the diagnosis criteria and/or novel imaging / diagnostic tools that can further stratify a pts' risk profile?

Precision medicine approaches in myeloma require fast, robust, and practicable molecular diagnostic tools, and the current diagnostic standard iFISH (interphase fluorescence in situ hybridization) is unable to fulfill any of these criteria. Integration of Diagnostics into therapeutic products/ industry has potential to improve trial design, enhance safety profile, enhance therapeutic efficacy, accelerate trial outcome, and increase commercial success. However, there are few hurdles which are also associated with new model, such as understanding the diagnostic industry, complex trial execution, seeking a 'right' diagnostic partner, managing the co-development process, regulatory uncertainty around companion diagnostics and intellectual property issues.

In this report, we highlight the emerging new treatments in RRMM /NDMM, which includes combination of small molecules and biologics, and novel approach of molecular analysis of MM. This report also provides M&A deals in the diagnostic, cancer area along with growing market opportunities. Furthermore, the competitive landscape of NDMM and RRMM is also highlighted. The rivalry prevalent in the global onco-diagnostic and therapeutic MM market is quite fierce with numerous local and global players contenting for the market share. On the global diagnostic front, the key players are Roche, Abbott Diagnostics, and Illumina; and in Tx area, the key players are Celgene, Takeda pharma, Amgen, Novartis, and JNJ.

Keywords: : Multiple Myeloma, Relapsed and/or Refractory Multiple Myeloma, RRMM, Newly Diagnosed Multiple Myeloma, NDMM, molecular diagnostics, FISH, next generation sequencing, Kyprolis, carfilzomib, POMALYST, pomalidomide, Velcade, bortezomib, Revlimid, lenalidomide, Panobinostat, Elotuzumab, Masivet, masitinib, Ixazomib, Aplidin, plitidepsin, Daratumumab, Imbruvica, ibrutinib, Imetelstat, Sylvant, siltuximab, ACE-011, sotatercept, Oprozomib, ARRY-520, filanesib, ALT-801, AT7519M, BT-062, Cabozantinib, Melflufen, KPT-330, selinexor, CT-011, pidilizumab, LymphoSIGHT, microRNAs, ExiLENTSYBR, CLIA-certified, Flow Cytometry, Immunohistochemistry, Illumina, DNA-based cancer diagnostics, Gene Expression Profiling, GEP, iPLEX Genotyping, MMprofiler, GeneChip

Table of Contents

1. Executive Summary

2. Disease Overview, Diagnosis, and Current Treatment

  • 2.1 Overview of Diagnostic tools for Multiple Myeloma
  • 2.2 Diagnostic Criteria of Myeloma and Recent Amendment
  • 2.3 Diagnostic Approaches for Multiple Myeloma
  • 2.4 Molecular pathogenesis of Myeloma
  • 2.5 Unmet Need
  • 2.6 New Diagnostics Perspective and Technologies
  • 2.7 'Companion' Diagnostics (CDx)
  • 2.8 Genome-wide array
  • 2.9 RNA based technologies
  • 2.10 Next-Generation Sequencing (NGS) technology

3. Diagnostic Tools for Multiple Myeloma

  • 3.1 Affymetrix GeneChip
  • 3.2 SkylineDx MMprofiler
  • 3.3 AgenaBio iPLEX Genotyping
  • 3.4 Signal Genetics MyPRS
  • 3.5 Cancer Genetics Genomic Products
  • 3.6 Illumina NGS
  • 3.7 NeoGenomics CLIA-certified Cancer Test
  • 3.8 Exiqon microRNA PCR
  • 3.9 Regulus Therapeutics microRNA Marker
  • 3.10 Rosetta Genomics Cancer Origin Test
  • 3.11 Sequenta LymphoSIGHT Platform

4. M&A Deals and Market Opportunity in Diagnostic Space

5. Current Therapies

  • 5.1 Newly Diagnosed Multiple Myeloma (NDMM)
    • a. Competitive Landscape for NDMM
  • 5.2 Relapsed and/or Refractory Multiple Myeloma (RRMM)
    • a. Competitive Landscape for RRMM
  • 5.3 Approved Therapies
    • a. Revlimid
    • b. Velcade
    • c. Kyprolis
    • d. POMALYST
  • 5.4 Data Comparison
    • a. Newly Diagnosed Multiple Myeloma (NDMM)
    • b. Relapsed and/or Refractory Multiple Myeloma (RRMM)

6. Novel Targets

  • 6.1 Monoclonal Antibodies
    • a. Elotuzumab
    • b. Situximab
    • c. Daratumumab
    • d. MOR202
    • e. SAR650984
    • f. BI-505
    • g. BHQ880
    • h. CT-011
    • i. IPH2101/ Lirilumab
    • j. BMS-936564 (ulocuplumab)
  • 6.2 Small Molecules
    • a. Panobinostat
    • b. Ixazomib (MLN9708)
    • c. Aplidin (plitidepsin)
    • d. ARRY-520 (filanesib)
    • e. Oprozomib
    • f. KPT-330 (selinexor)
    • g. SNS01-T
    • h. Ibrutinib
    • i. Ricolinostat
    • j. Afuresertib
    • k. KW-2478
    • l. BT-062

7. Clinical Milestones

8. Launch Timeline and Commercial Opportunity of Late-Stage Pipeline

9. M&A/ Licensing Deals and Unpartnered Product Opportunities

Companies mentioned:

  • Affymetrix
  • SkylineDx
  • AgenaBio
  • Signal Genetics
  • Cancer Genetics Inc
  • Illumina
  • NeoGenomics
  • Exiqon
  • Regulus Therapeutics
  • Rosetta Genomics
  • Sequenta
  • Takeda Pharma
  • Celgene
  • Amgen
  • Ono Pharma
  • Abbott
  • BMS
  • Mundipharma
  • Novartis
  • MorphoSys
  • JNJ
  • Innate Pharma
  • Merck
  • Xencor
  • Array Biopharma
  • Altor Bioscience
  • Astex pharma (now Otsuka pharma)
  • Biotest pharma
  • Immunogen
  • Exelixis
  • Oncopeptides
  • Karyopharm Therapeutics
  • CureTech
  • Curis
  • GSK
  • Innate Pharma
  • Lilly
  • Pharmacyclics
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