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市場調查報告書

血液腫瘤:多發性骨髓瘤(MM) - 早期徹底的診斷和新的治療選擇帶給疾病管理大幅影響的可能性

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 商品編碼 323219
出版日期 內容資訊 英文 82 Pages
商品交期: 最快1-2個工作天內
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血液腫瘤:多發性骨髓瘤(MM) - 早期徹底的診斷和新的治療選擇帶給疾病管理大幅影響的可能性 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 內容資訊: 英文 82 Pages
簡介

對多發性骨髓瘤(MM)治療的未滿足需求擴大,以及發生機制和診斷、治療方法相關研究也有所進展。現在診斷方法也多樣化,隨著臨床實驗的發展到認證、上市的努力達到目標的產品也出來了。對應復發、難治性多發性骨髓瘤(RRMM)的產品開發也有所進展。但,研究能推進到哪裡,還有診斷標準是否變更等,留下各種課題。

本報告提供多發性骨髓瘤(MM)的診斷藥、治療藥到目前為止的開發情形和今後市場趨勢的分析、診斷與治療關鍵的標的(單株抗體和小分子等等)、現在與臨床實驗中/已上市的產品概要與潛在市場、現在與未來的開發趨勢、資本聯盟等的動向、主要企業簡介、研究體制的資訊彙整,為您概述為以下內容。

第1章 摘要整理

第2章 疾病概要、診斷法、目前治療方法

  • 多發性骨髓瘤的診斷工具概要
  • 骨髓瘤的診斷標準和近幾年的修改
  • 對多發性骨髓瘤的診斷方法
  • 骨髓瘤的分子生物學的特徵
  • 未滿足需求
  • 診斷上的新見解與技術
  • 「伴同性」診斷(CDx)
  • 基因整體排列
  • RNA為基礎的技術
  • 下一代型定序(NGS)技術

第3章 多發性骨髓瘤診斷工具

  • 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 診斷藥相關的企業合併、收購(M&A)交易與市場機會

第5章 目前治療方法

  • NDMM(初發多發性骨髓瘤)
    • NDMM的競爭環境
  • RRMM(復發/難治性多發性骨髓瘤)
    • RRMM的競爭環境
  • 已認證治療藥
    • Revlimid
    • Velcade
    • Kyprolis
    • POMALYST
  • 資料比較
    • NDMM的情況
    • RRMM的情況

第6章 新標的

  • 單株抗體
    • 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 臨床上的里程碑

第8章 臨床實驗的後期階段產品開發中產品的上市時間表和商業機會

第9章 企業合併、收購(M&A)/授權合約,及未聯盟的產品的市場機會

分析對象企業

  • Affymetrix
  • SkylineDx
  • AgenaBio
  • Signal Genetics
  • Cancer Genetics Inc
  • Illumina
  • NeoGenomics
  • Exiqon
  • Regulus Therapeutics
  • Rosetta Genomics
  • Sequenta
  • 武田藥品工業
  • Celgene
  • Amgen
  • 小野藥品工業
  • Abbott
  • BMS
  • Mundipharma
  • Novartis
  • MorphoSys
  • JNJ
  • Innate Pharma
  • Merck
  • Xencor
  • Array Biopharma
  • Altor Bioscience
  • Astex pharma(現在:大塚製藥)
  • Biotest pharma
  • Immunogen
  • Exelixis
  • Oncopeptides
  • Karyopharm Therapeutics
  • CureTech
  • Curis
  • GSK
  • Innate Pharma
  • Lilly
  • Pharmacyclics
目錄
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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