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Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management

  • February 2015
  • -
  • Insight Pharma Reports
  • -
  • 106 pages

Overview

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

Liquid Biopsy: An Emerging Market for Radically Improved Cancer Management
Table of Contents
Executive Summary vi
Background and history vi
Basic research vii
Commercial aspects of liquid biopsy viii
Market dynamics ix
Trends x
CHAPTER 1
Introduction 12
Scope and contents of the report 13
CHAPTER 2
Background and History 14
CTC cell types 15
CTC detection and enumeration 16
ctDNA 17
Extracellular vesicles 17
CHAPTER 3
Liquid Biopsy Research 19
Circulating tumor cells (CTCs) 19
Technologies 19
Microfluidics 20
Imaging 23
Circulating tumor DNA (ctDNA) 24
Technologies 25
Research results 26
Extracellular vesicles 27
Technologies 27
Applications of liquid biopsy 29
CHAPTER 4
Commercial Aspects of Liquid Biopsy 31
Circulating tumor cells (CTCs) 31
AdnaGen 31
Angle plc 31
ApoCell 32
Biocept 32
BioFluidica 33
Clearbridge BioMedics 33
Cynvenio 33
Cytolumina Technologies Corp. 35
CytoTrack 35
Diagnologix LLC 36
Epic Sciences 36
Fluxion Biosciences 37
iCellate 37
Janssen Diagnostics 37
Rarecells SAS 39
Silicon Biosystems 39
SRI International 40
Circulating tumor DNA (ctDNA) 44
Agena Bioscience 44
Boreal Genomics 45
Chronix Biomedical 45
Genomic Health 46
Guardant Health 46Inivata 47
MolecularMD 47
Myriad Genetics 47
Natera 48
Personal Genome Diagnostics 48
Qiagen 49
Sysmex Inostics GmbH 49
Trovagene 49
Extracellular vesicles (EVs) 51
Exosome Diagnostics 51
Exosome Sciences Inc. 53
HansaBiomed OU 53
CHAPTER 5
Market Dynamics 55
Revenue estimates and projections 55
Competitive environment 56
Liquid Biopsy Deals 57
Agena Bioscience and Sequenom 59
Affymetrix and ScreenCell 59
Biocept and Rosetta Genomics 59
Biocept and Insight Genetics 60
Theradiag and IRCM 60
Cynvenio Biosystems and CollabRx, Inc. 60
Fluxion Biosciences and Stanford University School of Medicine 60
Janssen Diagnostics and Asuragen, Inc. 60
Janssen Diagnostics, Veridex, and Massachusetts General Hospital 60
Qiagen and AstraZeneca 60
Roche and iCellate 61
Sysmex Inostics GmbH and Merck KGaA 61Epic Sciences and various pharmaceutical companies 61
Exosome Diagnostics with Eli Lilly and Qiagen 61
Deal categories 61
Market Survey 62
CHAPTER 6
Liquid Biopsy Trends 68
Regulatory trends and their effects on liquid biopsy 68
CTCs vs ctDNA vs Exosomes, competitive or complementary 70
Drug resistance and metastasis 75
CHAPTER 7
Interview Transcripts 78
Nicholas Dracopoli, Ph.D., Vice President, Oncology Translational Research, Janssen Pharmaceuticals 78
Paul Dempsey, Ph.D., Chief Scientific Officer, Cynvenio Biosystems 82
Johan Skog, Ph.D., CSO and Founding Scientist, Exosome Diagnostics 86
Lidia Sambucetti, Ph.D., Sr. Director of Cancer Biology, and Ted Ira, Director of Sales, SRI Biosciences Div. 89
Harry Glorikian, Life Sciences Consultant 93
About Cambridge Healthtech Institute 98

Table and Figures

Exhibit 2.1 Examples of genes carrying mutations useful in companion diagnostics for targeted cancer drugs 18
Exhibit 3.1 Microfluidic Device from the Laboratory of Dr. Yong Chen 21
Exhibit 3.2 CTC Isolation Means from the Laboratory of Dr. Shana Kelley 22
Exhibit 3.3 The Peter Kuhn Lab's Approach to CTC Imaging and Analysis 23
Exhibit 4.1 CTC-based liquid biopsy companies 43
Exhibit 4.2 ctDNA-based liquid biopsy companies 50
Exhibit 4.3 Exosome-based liquid biopsy companies 54
Exhibit 5.1 Current estimates and revenues projections for liquid biopsy products and services, worldwide, 2014-2020 56
Exhibit 5.2 Liquid biopsy-related deals 58
Exhibit 5.3 Type of organization where respondents work 62
Exhibit 5.4 Respondents employed by 63
Exhibit 5.5 Respondents' positions within their organizations 63
Exhibit 5.6 Nature of respondents' liquid biopsy work 63
Exhibit 5.7 Sample category in respondents' liquid biopsy work 64
Exhibit 5.8 CTC capture or identification approaches 64
Exhibit 5.9 Respondents' use of downstream analytical technologies for CTC liquid biopsy 65
Exhibit 5.10 Technologies used by those who work with tumor nucleic acids in liquid biopsy 65
Exhibit 5.11 Types of extracellular vesicles addressed by respondents who work in that area 65
Exhibit 5.12 Contents of extracellular vesicles addressed by respondents who work in that area 65
Exhibit 5.13 Methods employed by respondents who work with extracellular vesicles 66
Exhibit 5.14 Numbers of respondents who agree with particular statements re liquid biopsy 66
Exhibit 5.15 Respondents' ratings on clinical value of liquid biopsy sample sources during the next five years 67
Exhibit 5.16 Respondents' ratings on likely adoption of various technologies to be used in liquid biopsy during the next five years 67

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