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市場調查報告書

液態切片 (Liquid Biopsy) : 大幅改善癌症管理的新興市場

Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management

出版商 Insight Pharma Reports 商品編碼 324805
出版日期 內容資訊 英文
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液態切片 (Liquid Biopsy) : 大幅改善癌症管理的新興市場 Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management
出版日期: 2015年02月27日 內容資訊: 英文
簡介

近年來被稱為液態切片 (Liquid Biopsy) 透過分析體液中標記的低侵入性技術受到許多癌症生技標記研究者的矚目。過去數年間液態切片相關產品與服務邁向商業化、許多新興企業以及數間大型醫療皆開始著手計畫。

本報告針對液態切片 (Liquid Biopsy) 的進化與商業化動向進行調查、提供液態切片發展歷史、檢驗對象與相關技術、主要企業商業化計畫、企業間各種合約、合作動向、收益規模推算、預測、專家訪談等。

摘要整理

  • 背景、歷史
  • 基礎研究
  • 液態切片 (Liquid Biopsy) 商業面
  • 市場動力學
  • 動向

第1章 介紹

第2章 背景、經緯

  • CTC細胞種類
  • CTC檢測、計算
  • ctDNA
  • 細胞外囊泡

第3章 液態切片 (Liquid Biopsy) 研究

  • 循環腫瘤細胞 (CTC)
  • 技術
  • 微射流
  • 影像
  • 腫瘤細胞DNA (ctDNA)
  • 技術
  • 研究成果
  • 細胞外囊泡
  • 技術
  • 液態切片的引進

第4章 液態切片 (Liquid Biopsy) 商業面

  • 循環腫瘤細胞 (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
  • 腫瘤細胞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 市場動力學

  • 收益推算、預測
  • 競爭環境
  • 液態切片相關合約
    • 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、各種醫療藥品企業
    • Exosome Diagnostics、Eli Lilly、Qiagen
  • 合約分類
  • 市場調查

第6章 液態切片 (Liquid Biopsy) 動向

  • 法規制度動向與對液態切片的影響
  • CTC vs ctDNA vs 細胞外囊泡:競爭或互補
  • 抗藥性與轉移

第7章 專家訪談

  • 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 (Life Sciences Consultant)

關於Cambridge Healthtech Institute

目錄

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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