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市場調査レポート

リキッドバイオプシー (液体生検) : 癌管理を大幅に改善する新興市場

Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management

発行 Insight Pharma Reports 商品コード 324805
出版日 ページ情報 英文
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リキッドバイオプシー (液体生検) : 癌管理を大幅に改善する新興市場 Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management
出版日: 2015年02月27日 ページ情報: 英文
概要

近年、リキッドバイオプシー (液体生検) と呼ばれる体液中のマーカーを分析する低侵襲的手法に実に多くの癌バイオマーカー研究者が注目を寄せています。過去数年にあいだに、リキッドバイオプシー関連の製品およびサービスの商業化に向け、多くの新興企業や医療大手数社が取り組みを開始しています。

当レポートでは、リキッドバイオプシー (液体生検) の進化と商業化の動向について調査し、リキッドバイオプシーの発展の経緯、検出対象と関連技術、主要企業による商業化に向けた取り組み、企業間の各種契約・提携の動向、収益規模の推計・予測、専門家へのインタビューなどをまとめています。

エグゼクティブサマリー

  • 背景・経緯
  • 基礎研究
  • リキッドバイオプシー (液体生検) の商業的側面
  • 市場力学
  • 動向

第1章 イントロダクション

第2章 背景・経緯

  • CTC細胞のタイプ
  • CTCの検出・計数
  • ctDNA
  • 細胞外小胞

第3章 リキッドバイオプシー (液体生検) の研究

  • 血中循環腫瘍細胞 (CTC)
  • 技術
  • マイクロ流体
  • 画像
  • 血中循環腫瘍DNA (ctDNA)
  • 技術
  • 研究成果
  • 細胞外小胞
  • 技術
  • リキッドバイオプシーの導入

第4章 リキッドバイオプシー (液体生検) の商業的側面

  • 血中循環腫瘍細胞 (CTC)
    • AdnaGen
    • Angle plc
    • ApoCell
    • Biocept
    • BioFluidica
    • Clearbridge BioMedics
    • Cynvenio
    • Cytolumina Technologies Corp.
    • CytoTrack
    • Diagnologix LLC
    • Epic Sciences
    • Fluxion Biosciences
    • iCellate
    • Janssen Diagnostics
    • Rarecells SAS
    • Silicon Biosystems
    • SRI International
  • 血中循環腫瘍DNA (ctDNA)
    • Agena Bioscience
    • Boreal Genomics
    • Chronix Biomedical
    • Genomic Health
    • Guardant Health 46Inivata
    • MolecularMD
    • Myriad Genetics
    • Natera
    • Personal Genome Diagnostics
    • Qiagen
    • Sysmex Inostics GmbH
    • Trovagene
    • Extracellular vesicles (EVs)
    • Exosome Diagnostics
    • Exosome Sciences Inc.
    • HansaBiomed OU

第5章 市場力学

  • 収益推計・予測
  • 競合環境
  • リキッドバイオプシー関連の契約
    • Agena Bioscience・Sequenom
    • Affymetrix・ScreenCell
    • Biocept・Rosetta Genomics
    • Biocept・Insight Genetics
    • Theradiag・IRCM
    • Cynvenio Biosystems・CollabRx, Inc.
    • Fluxion Biosciences・Stanford University School of Medicine
    • Janssen Diagnostics・Asuragen, Inc.
    • Janssen Diagnostics・Veridex・Massachusetts General Hospital
    • Qiagen・AstraZeneca
    • Roche・iCellate
    • Sysmex Inostics GmbH・Merck KGaA 61Epic Sciences・各種医薬品企業
    • Exosome Diagnostics・Eli Lilly・Qiagen
  • 契約カテゴリー
  • 市場調査

第6章 リキッドバイオプシー (液体生検) の動向

  • 法規制の動向とリキッドバイオプシーへの影響
  • CTC vs ctDNA vs 細胞外小胞:競合か補完か
  • 薬剤耐性と転移

第7章 専門家へのインタビュー

  • Nicholas Dracopoli博士 (Ph.D., Vice President, Oncology Translational Research, Janssen Pharmaceuticals)
  • Paul Dempsey博士 (Ph.D., Chief Scientific Officer, Cynvenio Biosystems)
  • Johan Skog博士 (Ph.D., CSO and Founding Scientist, Exosome Diagnostics)
  • Lidia Sambucetti博士 (Ph.D., Sr. Director of Cancer Biology, and Ted Ira, Director of Sales, SRI Biosciences Div.)
  • Harry Glorikian氏 (Life Sciences Consultant)

Cambridge Healthtech Instituteについて

目次

Cancer diagnostics based on measuring biomarkers in tissue samples has already in the past decade provided revolutionary advances in diagnosis, prognosis, and therapy selection. A major drawback of the tissue-based approach centers on the need for invasive surgical procedures in sample collection, which in a great many instances preclude following the progression or regression of disease during therapy.

In recent years, an impressive number of cancer biomarker researchers have turned their attention to the analysis of markers present in biological fluids, which can be collected with minimal invasiveness and permit following the disease over time. This highly dynamic field has come to be called liquid biopsy. In the past few years a significant and growing number of startups and several major companies have taken up the challenge of commercializing and offering liquid biopsy products and services to the market

These procedures, for the most part, query blood samples for information to be gleaned from circulating tumor cells (CTCs), circulating tumor DNA (ctDNA) fragments, and extracellular vesicles (EVs). CTCs have the longest history as subjects for liquid biopsy. Indeed, one decade-old commercial product has already garnered FDA approval for in vitro diagnostic use. Circulating tumor DNA, a more recent entry on the liquid biopsy scene, is fast becoming an alternative or adjunct to CTC assays. EVs are the newest and least developed of the three liquid biopsy sample sources, and while highly promising, their ultimate value has yet to be fully established.

The report delves deeply into recent progress and emerging trends in this highly dynamic area of research and commerce. Following an introductory chapter that sets the stage for what is to follow, Chapter 2 provides a survey of historical and evolutionary aspects of liquid biopsy, and provides required background and definitions helpful in understanding subsequent material. Chapter 3 covers basic research activities arranged according to the three aforementioned analyte classes (CTCs, ctDNA, and EVs).

CTCs, the first such entities on the liquid biopsy scene, have accounted for much of what's been learned to date. However, the relative ease of isolating cell-free DNA has quickened research activity in this field, and ready access to ctDNA has provided important insights that enhance and complement those derived from CTCs. EVs, though a recent arrival on the liquid biopsy scene, are rising rapidly in importance based on their perceived ability to add yet another important perspective to cancer diagnostics.

Chapter 4 examines commercial activity in the field, including brief profiles of relevant companies and status of current and forthcoming product offerings. Companies active in CTCs include AdnaGen, Angle, ApoCell, Biocept, Biofluidica, Clearbridge Biomedics, Cynvenio, Cytolumina, CytoTrack, Diagnologix, Epic Sciences, Fluxion Biosciences, iCellate, Janssen Diagnostics, Qiagen, Rarecells SAS, Silicon Biosystems, and SRI International. Biocept and Cynvenio exemplify companies that augment their CTC assays with ctDNA analysis.

Companies focused on ctDNA include Agena Bioscience, Boreal Genomics, Chronix Biomedical, Genomic Health, Guardant Health, Inivata, Molecular MD, Myriad Genetics, Natera, Personal Genome Diagnostics, Sysmex Inostics, and Trovagene. Those active in the EV segment include Exosome Diagnostics, Exosome Sciences, and HansaBiomed OU.

Chapter 5, which deals with market dynamics in the liquid biopsy space, includes commentary on the competitive environment, market size estimates and five-year revenue projections, tabulation and discussion of deal activity, and results from a market survey of more than 100 individuals active in the field.

Chapter 6 of the report examines some emerging trends that may affect the future development, acceptance, and market growth of liquid biopsy. Of particular interest are trends in government regulation that could possibly limit growth of the field, and even in the overall molecular diagnostics market. The report also discusses issues surrounding the relative merits of the three categories of liquid biopsy samples, and ways in which they may be competitive or complementary. Finally, the chapter examines important trends relevant to cancer drug resistance and metastasis.

The final chapter contains transcripts from extended interviews with six individuals who are highly knowledgeable in the liquid biopsy field.

These are:

  • Nicholas Dracopoli, Ph.D., Vice President Oncology Translational Research, Janssen Pharmaceuticals
  • Paul Dempsey, Ph.D., Chief Scientific Officer, Cynvenio Biosystems
  • Johan Skog, Ph.D., CSO and Founding Scientist, Exosome Diagnostics
  • Lidia Sambucetti, PhD, Sr. Director of Cancer Biology, and Ted Ira, Director of Sales, SRI Biosciences Div.
  • Harry Glorikian, Life Sciences Consultant

Table of Contents

EXECUTIVE SUMMARY

  • Background and history
  • Basic research
  • Commercial aspects of liquid biopsy
  • Market dynamics
  • Trends

CHAPTER - 1

  • Introduction
  • Scope and contents of the report

CHAPTER - 2

  • Background and History
  • CTC cell types
  • CTC detection and enumeration
  • ctDNA
  • Extracellular vesicles

CHAPTER - 3

  • Liquid Biopsy Research
  • Circulating tumor cells (CTCs)
  • Technologies
  • Microfluidics
  • Imaging
  • Circulating tumor DNA (ctDNA)
  • Technologies
  • Research results
  • Extracellular vesicles
  • Technologies
  • Applications of liquid biopsy

CHAPTER - 4

  • Commercial Aspects of Liquid Biopsy
  • Circulating tumor cells (CTCs)
    • AdnaGen
    • Angle plc
    • ApoCell
    • Biocept
    • BioFluidica
    • Clearbridge BioMedics
    • Cynvenio
    • Cytolumina Technologies Corp.
    • CytoTrack
    • Diagnologix LLC
    • Epic Sciences
    • Fluxion Biosciences
    • iCellate
    • Janssen Diagnostics
    • Rarecells SAS
    • Silicon Biosystems
    • SRI International
  • Circulating tumor DNA (ctDNA)
    • Agena Bioscience
    • Boreal Genomics
    • Chronix Biomedical
    • Genomic Health
    • Guardant Health 46Inivata
    • MolecularMD
    • Myriad Genetics
    • Natera
    • Personal Genome Diagnostics
    • Qiagen
    • Sysmex Inostics GmbH
    • Trovagene
    • Extracellular vesicles (EVs)
    • Exosome Diagnostics
    • Exosome Sciences Inc.
    • HansaBiomed OU

CHAPTER - 5

  • Market Dynamics
  • Revenue estimates and projections
  • Competitive environment
  • Liquid Biopsy Deals
    • Agena Bioscience and Sequenom
    • Affymetrix and ScreenCell
    • Biocept and Rosetta Genomics
    • Biocept and Insight Genetics
    • Theradiag and IRCM
    • Cynvenio Biosystems and CollabRx, Inc.
    • Fluxion Biosciences and Stanford University School of Medicine
    • Janssen Diagnostics and Asuragen, Inc.
    • Janssen Diagnostics, Veridex, and Massachusetts General Hospital
    • Qiagen and AstraZeneca
    • Roche and iCellate
    • Sysmex Inostics GmbH and Merck KGaA 61Epic Sciences and various pharmaceutical companies
    • Exosome Diagnostics with Eli Lilly and Qiagen
  • Deal categories
  • Market Survey

CHAPTER - 6

  • Liquid Biopsy Trends
  • Regulatory trends and their effects on liquid biopsy
  • CTCs vs ctDNA vs Exosomes, competitive or complementary
  • Drug resistance and metastasis

CHAPTER - 7

  • Interview Transcripts
  • Nicholas Dracopoli, Ph.D., Vice President, Oncology Translational Research, Janssen Pharmaceuticals
  • Paul Dempsey, Ph.D., Chief Scientific Officer, Cynvenio Biosystems
  • Johan Skog, Ph.D., CSO and Founding Scientist, Exosome Diagnostics
  • Lidia Sambucetti, Ph.D., Sr. Director of Cancer Biology, and Ted Ira, Director of Sales, SRI Biosciences Div.
  • Harry Glorikian, Life Sciences Consultant
  • About Cambridge Healthtech Institute
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