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血液腫瘍:多発性骨髄腫(MM) - 早期の徹底的な診断と新たな治療オプションが疾患管理に多大な影響を与える可能性

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

発行 MP Advisors 商品コード 323219
出版日 ページ情報 英文 82 Pages
納期: 即日から翌営業日
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血液腫瘍:多発性骨髄腫(MM) - 早期の徹底的な診断と新たな治療オプションが疾患管理に多大な影響を与える可能性 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: 2015年01月21日 ページ情報: 英文 82 Pages
概要

多発性骨髄腫(MM)の治療に対するアンメットニーズが拡大するとともに、その発生メカニズムや診断・治療法に関する研究も進んできました。現在では診断方法も多様化し、治験の進展に伴って認証・上市にまでこぎつけた製品も出てきました。再発・難治性多発性骨髄腫(RRMM)に対応する製品の開発も進んできました。ただし、研究をどこまで進めるのか、また診断基準に変更があるのか、などさまざまな課題が残されています。

当レポートでは、多発性骨髄腫(MM)の診断薬・治療薬の現在までの開発状況と今後の市場動向について分析し、診断・治療の鍵となる標的(モノクローナル抗体や小分子など)や、現在治験中/上市済みの製品の概要と潜在的市場、現在・将来の開発動向、資本提携などの動き、主要企業のプロファイルと研究体制といった情報を取りまとめてお届けいたします。

第1章 エグゼクティブ・サマリー

第2章 疾患の概要・診断法・現在の治療法

  • 多発性骨髄腫の診断ツールの概要
  • 骨髄腫の診断基準と近年の改定
  • 多発性骨髄腫への診断的アプローチ
  • 骨髄腫の分子生物学的特徴
  • アンメットニーズ
  • 診断上の新たな見解と技術
  • 「コンパニオン」診断(CDx)
  • ゲノム全体の配列
  • RNAベースの技術
  • 次世代型シーケンシング(NGS)技術

第3章 多発性骨髄腫向け診断ツール

  • 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 診断薬関連の企業合併・買収(M&A)取引と市場機会

第5章 現在の治療法

  • NDMM(初発多発性骨髄腫)
    • NDMMの競争環境
  • RRMM(再発/難治性多発性骨髄腫)
    • RRMMの競争環境
  • 認証済み治療薬
    • Revlimid
    • Velcade
    • Kyprolis
    • POMALYST
  • データの比較
    • NDMMの場合
    • RRMMの場合

第6章 新たな標的

  • モノクローナル抗体
    • エロツズマブ
    • シルツキシマブ
    • ダラツムマブ
    • MOR202
    • SAR650984
    • BI-505
    • BHQ880
    • CT-011
    • IPH2101/ Lirilumab
    • BMS-936564 (ulocuplumab)
  • 小分子
    • パノビノスタット
    • Ixazomib (MLN9708)
    • Aplidin (plitidepsin)
    • ARRY-520 (filanesib)
    • Oprozomib
    • KPT-330 (selinexor)
    • SNS01-T
    • Ibrutinib
    • Ricolinostat
    • Afuresertib
    • KW-2478
    • BT-062

第7章 臨床上のマイルストーン

第8章 治験の後期段階にあるパイプライン製品の上市タイムラインと商業的機会

第9章 企業合併・買収(M&A)/ライセンス契約、および未提携の製品の市場機会

分析対象企業

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