How will liquid biopsy change cancer care?
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3. 3
Biographies & contacts
ABOUT THE AUTHORS
Dr. MarjorieVillien
Sébastien Clerc
• Sébastien Clerc is a Medical Technologies Analyst at Yole Développement, the "More than Moore" market research and strategy consulting company.
After graduating from Grenoble Institute of Technology with a Master’s degree in Biomedical Technologies, he completed his training with a Master’s
of Innovation and Technology Management, during which he oversaw strategy and marketing.
• Email: clerc@yole.fr
• As a Technology & Market Analyst, Dr. Marjorie Villien works in the Microfluidic & Medical Technologies (MedTech) business unit at Yole
Développement, the "More than Moore" market research and strategy consulting company. She is a daily contributor to the development of
MedTech activities, with a dedicated collection of market & technology reports as well as custom consulting projects. After spending two years at
Harvard, Dr. Villien served as a research scientist at INSERM in the field of MRI & PET imaging. She has spoken at numerous international
conferences and has authored or co-authored 11 papers and one patent. Dr. Villien graduated from Grenoble INP and holds a PhD in Physics &
Medical Imaging.
• Email: villien@yole.fr
Asma Siari
• As a Technology & Market Analyst in the Medical Technologies (MedTech) business unit at Yole Développement (Yole), Asma Siari is involved in the
development of technology & market reports as well as the production of custom consulting projects. After a Master’s degree in Biotechnologies,
Diagnostic Therapeutics & Management, Asma serves as Research Assistant at the Moores Cancer Center (San Diego, CA). She is a coauthor in two
scientific publications published in the Molecular Cancer Research Journal. In addition to her mission at Yole, Asma is graduated with an Advanced
Master’s degree in International Strategy & Marketing BtoB (EM Lyon Business School, France).
• Email: siari@yole.fr
4. 4
REPORT CONTENT
• Explain what liquid biopsy is, why it is used, and the characteristics of each biomarker (ctDNA,
CTC, exosomes)
• Market analysis of M&A, collaborations, fundraisings, and business models
• Technical and biological requirements, product examples, key players, market share, and technology
trends
• Market overview and forecasts at service and device levels, for ctDNA and CTC applications
• Overview of the market’s main players and the technologies involved, including company profiles
• Focus on downstream analysis and identification of the main technologies used for liquid biopsy
• Supply chain analysis
5. 5
WHO SHOULD BE INTERESTED BY THIS REPORT?
o Biotechnology & Pharmaceutical Companies:
• To understand what is the state of the art of liquid
biopsy technologies
• To identify the different players across the supply chain
• To understand behavior evolution and identify new
business models
• To identify competitors and targets for collaborations
or M&A
o Equipment & Material suppliers:
• To understand the technical evolution of ctDNA, CTC
and exosome solutions involved in the detection and
isolation process
• To identify business opportunities and prospects
o R&D players:
• To understand challenges linked to the use of liquid
biopsy systems
• Address the right market with the right technology
o Industrial & service companies:
• Grasp which solutions could bring operational benefits
o Medical devices outsourcing companies:
• To have a broad overview of all applications & markets
• To identify new Liquid biopsy markets
• To monitor and benchmark potential competitors
• To understand behaviors evolution
o Microfluidic foundries and device makers:
• Grasp technical requirements, depending on the
application
• Target business opportunities and prospects
o Financial & Strategic investors:
• To understand the potential of liquid biopsy in the
consumer and healthcare industries
• To know the latest moves within the industry
• To get a list of players and their activities in the field of
diagnostic using liquid biopsy
o Healthcare & governmental organizations:
• Evaluate the benefits of using non invasive testing
• Pinpoint relevant companies
6. 6
TABLE OF CONTENTS
• Executive Summary 9
• Introduction 50
• What is liquid biopsy?
• What can we learn from Liquid Biopsy?
• Circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA)
• Report scope
• Liquid Biopsy Market Analysis 64
• Applications and drivers
• Cancer prevalence
• Liquid biopsy ecosystem
• Mergers and acquisitions/collaborations
• Fundraising analysis
• Market data and forecasts 2017 - 2023
• Business models
• Regulations status
• Roadmaps
• Circulating Tumor DNA and Exosomes 89
• Introduction to ctDNA and exosome technologies in liquid biopsy
• Workflow for detection of ctDNA and exosomes in cancer patients
• Main players and market share
• Market data and forecasts 2017 – 2023
• Supply chain analysis
• Company profiles
• Circulating Tumor Cells 132
• Introduction to CTCs
• CTCs - analysis workflows in liquid biopsy
• CTCs - enrichments and isolation methods
• Workflow coverage for the main CTC players
• Main players and players map
• Market data and forecasts 2017 – 2023
• Supply chain analysis
• Company profiles
• Downstream Analysis 184
• Overview of analytical approaches for liquid biopsy
• Main technologies and requirements
• Focus on next-generation sequencing: main players and applications
• Focus on polymerase chain reaction and beaming technology - main players
and applications
• Company profiles
• General Conclusions 208
7. 7
LIQUID BIOPSY
Definition
The
advantages of
liquid biopsy
• Liquid biopsy hold the hopes of answering the needs for a
less invasive procedure that could give a better picture of
the cancer diagnosis, treatment or recurrence.
• Tissue biopsy are more invasive hence only provide a
snapshot of the disease as it can’t be easily repeated.
• But maybe the greatest limitation to tissue based biopsy
techniques is that sampling of a single tumor may not
capture all of the mutations present.
• Liquid biopsy allows for real-time, serial and longitudinal
monitoring during cancer therapy.
• It also provides a more comprehensive view of the tumor’s
biomarkers. http://liquid-biopsy.gene-quantification.info/
8. 8
LIQUID BIOPSY
What is analyzed?
Analyses of
circulating tumor
cells (CTC),
circulating tumor
DNA (ctDNA),
and tumor-
derived
extracellular
vesicles can
enable tumor
characterization
by minimally
invasive means
Liquid biopsy
Circulating tumor cells (CTCs) Circulating tumor DNA (ctDNA)
Extracellular vesicles (EVs)
9. 9
LIQUID BIOPSY
Liquid biopsy in the care pathway of cancer patients
• According to the National Institutes of Health’s clinical trials database, clinicaltrials.gov, over 250 trials are currently studying the
use of liquid biopsies in cancer detection, identification, or treatment in the USA only.
• Liquid biopsy can be used at various stage in the care pathway of cancer patients from screening, to monitoring of treatments
and understanding drug resistance mechanisms.
• What’s needed to make a difference in patients’ lives is clinical evidence of sensitivity, selectivity, and efficacy.
Screening for
Early Detection
Profiling
Cancer
Developing
Personalized
Treatment
Monitoring
Treatment
Assessing
Possible
Recurrence
Detect cancer earlier to
start treatment earlier
Identify people at risk for
developing cancer
Understand molecular
mechanisms associated
with this patient
Choose and develop a
tailored treatment
Monitor treatment’s
efficiency along with
drug resistance
Screening for disease
recurrence
10. 10
LIQUID BIOPSY
Scope of the report
• We decided to focus our report on cancer liquid biopsy as the other applications are quite different in term of
market dynamics and players.
• We focused our reports on ctDNA, CTCs and exosomes analysis as protein analysis for liquid biopsy are more
in a research stage today.
• In our market analysis we focused on companies developing liquid biopsy kits, instruments and service.
In the report Not in the report
Applications Cancer
Others (noninvasive prenatal testing,
etc.)
Biomarkers ctDNA, CTCs, exosomes Proteins
Market analysis
Companies developing liquid biopsy kits,
instruments and services
17. Cancer is a rising concern in modern society.
Numerous drivers contribute to the increase of
cancer cases, such as ageing of the population,
lifestyle, and environment. According to the World
Health Organization, cancer is responsible for one
in six deaths worldwide, and one in two people are
likely to develop cancer in their lifetime. Cancer
cells are cells whose genes have mutated; in order
to understand each cancer’s mechanisms and
determine the appropriate treatment, these tumors
require analysis. Traditional biopsy methods involve
obtaining a piece of the tumor through invasive
surgery. However, these procedures are expensive
and exhausting for the patient, and cannot be
reproduced regularly in order to monitor a cancer’s
evolution and treatment efficiency over time.
However, it is now possible to avoid such invasive
procedures thanks to a “liquid biopsy”. Indeed, it
is possible to collect a simple blood draw in which
relevant biomarkers can provide useful information
about the patient’s cancer. In particular, a number
of companies are developing technologies to
collect, isolate, and analyze circulating tumor
DNA (ctDNA: DNA molecules shed by cancerous
cells) and circulating tumor cells (CTCs: tumor
cells shed from the original tumor) that spread
into the bloodstream. Thanks to these tools, it is
possible to not only diagnose cancer uninvasively,
but also to understand the molecular mechanisms
associated with each patient, choose and develop
a tailored treatment, monitor the treatment’s
efficiency (along with drug resistance), and screen
for disease recurrence. Some companies are even
working on screening for early detection, although
this is a more long-term application.
Liquid biopsy thus has the potential to assist
at every stage of cancer care, saving lives and
cutting healthcare costs. The opportunity is huge,
and the associated market is already large and
growing extremely fast. According to this Yole
Développement report, the liquid biopsy market
will grow from $1.7B in 2017 at a CAGR2017-2023
of 29%, reaching $7.8B by 2023. This includes
hardware (systems and devices) and reagent kit
sales, along with service revenue, for CTC and
ctDNA applications.
LIQUID BIOPSY: FROM ISOLATION TO DOWNSTREAM
APPLICATIONS 2018
Market & Technology report - June 2018
LIQUID BIOPSY: A POWERFUL EMERGING TOOL FOR CANCER CARE, AND
A HUGE BUSINESS OPPORTUNITY
How will liquid biopsy change cancer care?
KEY FEATURES
• Introduction to liquid biopsy
testing, definitions, and why it is
used
• Market analysis of mergers and
acquisitions, collaborations,
fundraisings and business models
• Technical and biological
requirements, product examples,
key players, market share, and
technology trends
• Market overview and forecasts at
both service and device levels, for
circulating tumor DNA (ctDNA:
DNA molecules shed by cancerous
cells) and for circulating tumor cells
(CTCs: tumor cells shed from the
original tumor) applications
• Overview of the market’s main
players and the technologies
involved, including company
profiles
• Focus on downstream analysis
and identification of the main
technologies used for liquid biopsy
• Supply chain analysis
(Yole Développement, June 2018)
Liquid biopsy: a game-changer in cancer care
WHY LIQUID BIOPSY?
WHAT IS ANALYZED IN LIQUID
BIOPSY?
WHAT QUESTIONS COULD
LIQUID BIOPSY ANSWER?
vs
Circulating Tumor
Cells (CTCs)
Exosomes
Circulating Tumor
DNA(ctDNA)
Early detection
and diagnosis
Personalized
treatment
Monitoring
treatment
Assessing
recurrence
Standard
Biopsy
Liquid Biopsy
Invasive Minimally invasive
Localized sampling
of tissue
Comprehensive
tissue profile
Time intensive Quick
Some associated
pain and risk
for the patient
Minimal pain
and risk for
the patient
AN IMPRESSIVE RANGE OF COMPANIES AND BUSINESS MODELS
Studying mutations in cancer cells’ DNA is not
an easy task, and requires many different tools
and skills. From the enrichment and analysis
of biomarkers to the bioinformatics analysis of
mutation profiles, the path is long and many players
are involved. This report confirms the role of each
player at each level of the supply chain, explains
who is specialized in which step, and details where
the value lies and how the development of liquid
biopsy is boosting downstream analysis equipment
markets like sequencing and digital PCR. The
difference and complementarity of ctDNA and
CTCs is also described, and Yole Développement’s
analysts explain why CTC has yet to attract
significant funding, and how the situation may now
change thanks to recent findings.
Indeed, ctDNA companies have raised more than
$3.7B since 2010, while CTC companies have only
raised around $280M. In terms of revenue, the split
18. LIQUID BIOPSY: FROM ISOLATION TO DOWNSTREAM APPLICATIONS 2018
TECHNOLOGICAL BREAKTHROUGHS ARE DRIVEN BY MICROFLUIDIC TECHNOLOGY
Many steps in the liquid biopsy workflow have been
made possible thanks to microfluidic technologies.
From isolation to downstream analysis, microfluidic
devices are involved everywhere. A major part of CTC
enrichment and isolation systems relies on microfluidic
devices that enable separation of CTCs from other
blood cells, using their physical properties such as
size, shape, deformability, and dielectric properties.
Important companies such as Angle plc, Celsee,
Clearbridge Biomedics, and Vortex Biosciences rely
on microfluidics. These microfluidic methods work
for a wide range of cells and enable high throughput
capture at a low cost. Moreover, downstream analysis
solutions also rely on microfluidic technologies in
numerous cases: DNA sequencers from Illumina, Ion
Torrent, and others use microfluidic flow cells, and
other technologies like droplet digital PCR from Bio-
Rad, Stilla Technologies, and RainDance (acquired by
Bio-Rad) are also microfluidic technologies.
All of these state-of-the-art technologies are enabled
by innovative microfluidic hardware and allow more
complex analyses to be performed, thus contributing to
concrete improvements in cancer care. In this report,
Yole Développement focuses on these microfluidic
technologiesateveryleveloftheliquidbiopsy workflow.
is also unbalanced in favor of ctDNA companies. This
is primarily due to business models: most ctDNA
companies offer testing services in their Clinical
Laboratory Improvement Amendments (CLIA)
labs, performing tests developed in-house which do
not require Food and Drug Administration (FDA)
clearance. Moreover, DNA is easier to transport and
store than live cells, which is another advantage for
ctDNA. On the contrary, most CTC companies are
developing instruments that are directly sold to end-
users, along with the associated consumables.
However, most of these instruments for CTC
isolation are still for research use only because the
FDA requires more evidence of the benefits derived
from analyzing CTCs in patients’ survival rate, before
approving them for clinical use. This explains, at least
partially, why CTC companies are lagging behind in
terms of revenue. Thankfully, this situation may soon
change thanks to advances in technology and to the
increasing number of published works proving the
clinical value of CTC analysis: in fact, a complete live cell
can carry much more information than a DNA strand.
Immuno-enrichment
methods (antibody labeling)
Physical properties
Positive and/or negative
immuno-enrichment
Size, shape, deformability
(filtration, inertial focusing…)
Dielectric properties
Enrichment-free
Direct
imaging
Immunomagnetic separation,
fluorescence detection
Usually microfluidic chip /
microstructures / microfilters
Dielectrophoresis
(DEP) based CTC
enrichment
Fluorescence staining of glass
slides
Centrifugation + fluorescence
staining of glass slides
Enrichment-free / density-
based separation
Non-exhaustive list of companies, * CTC: circulating tumor cell
Density-based enrichment
Density gradient
centrifugation + fluorescence
staining of glass slides
Liquid biopsy market ecosystem for 2017
(Yole Développement, June 2018)
Indirect liquid
biopsy market:
downstream
analysis companies
ctDNA**
andexosomes
companies
CTC* companies
Liquid
biopsy
market
* CTC: circulating tumor cell
** ctDNA: circulating tumor DNA
Non-exhaustive list of companies
Liquid biopsy market: technologies for CTC* workflows
(Yole Développement, June 2018)
19. MARKET TECHNOLOGY REPORT
COMPANIES CITED IN THE REPORT (non exhaustive list)
Abbott, AdnaGen, Agilent Technologies, Amazon, Amgen, Angle, ApoCell, Assurex Health,
AstraZeneca, Axon Dx, BD, Beckman Coulter, BGI, Biocartis, Biocept, Biodesix, BioFluidica, Bio-Rad,
Bioview, Bristol Myers Squibb, Cambridge Consultants, CellMax Life, CellSearch, Celsee, Circulogix,
Cirina, Clearbridge BioMedics, Clinical Genomics, Cogent, Creativ MicroTech, Cynvenio, CytoLumina,
CytoTrack, DiaDx, Diagnologix, Epic Sciences, Epigenomics, Exact Sciences, ExosomeDx, FivePrime,
Fluxion, Foundation Medicine, Freenome, GE Healthcare, Genapsys, Gendia, Genomic Health, Gilupi,
GnuBio, Grail, Greiner Bio-One, Guardant Health, HP, IBM Watson, iCellate, IKOTECH, Illumina,
IncellDx, Inivata, Janssen Pharmaceuticals, Johnson Johnson, Life Technologies, LifeArc, Livzon,
Menarini Silicon Biosystems, Merck, Microsoft, Mikro Biyosistemler, Miltenyi Biotec, Myriad, Nabsys,
Nanostring, Natera, Noblegen, Novartis, Oncocyte, Oxford Nanopore, Pacific Biosciences, Pathway
Genomics, Personal Genome Diagnostics, Pfizer, Predicine, Qiagen, RareCells, Roche, SBI, ScreenCell,
Sigma Aldrich, Simfo, Sividon Diagnostics, SRI Biosciences, StemCell Technologies, Stratec, Streck,
Sysmex, TeloVision, Thermo Fisher, Thermo Fisher Scientific, ThinXXS, Trovagene, Veracyte, Vitatex,
Vortex Biosciences, Zomedica,… and many more
Executive summary 9
Introduction 50
What is liquid biopsy?
What can we learn from liquid biopsy?
Circulating Tumor Cells (CTCs) and circulating
tumor DNA (ctDNA)
Scope of the report
Liquid biopsy market analysis 64
Applications and drivers
Cancer prevalence
Liquid biopsy ecosystem
Mergers and acquisitions/Collaborations
Fundraising analysis
Market data and forecasts 2017-2023
Business models
Regulations status
Roadmaps
Circulating tumor DNA and exosomes 89
Introduction to ctDNA and exosomes
technologies in liquid biopsy
Workflow for detection of ctDNA and
exosomes in cancer patients
Main players and market share
Market data and forecasts 2017–2023
Supply chain analysis
Company profiles
Circulating tumor cell 132
Overview of analytical approaches for liquid
biopsy
Main technologies and requirements
Focus on next generation sequencing : main
players and applications
Focus on polymerase chain reaction and
beaming technology: main players and
applications
Company profiles
Downstream analysis 184
Introduction to CTCs
CTCs analysis workflows in liquid biopsy
CTCs enrichments and isolation methods
Workflow coverage for the main CTCs players
Main players and players map
Market data and forecasts 2017–2023
Supply chain analysis
Company profiles
General conclusions 208
TABLE OF CONTENTS (complete content on i-Micronews.com)
OBJECTIVES OF THE REPORT
• Explain what liquid biopsy is, why it is used, and the characteristics of each biomarker (ctDNA,
CTC, exosomes)
• Show what constitutes “state-of-the-art” is today and what is expected for tomorrow, and
understand the positive and negative impacts on the adoption of liquid biopsy for clinical use
• Provide a players overview at each supply chain level, from enrichment and isolation to
downstream analysis, for CTC and ctDNA applications
• Provide a list and analysis of fundraisings and MA
• Provide an analysis of the business models used in the liquid biopsy field
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AUTHORS
Sébastien Clerc worksasaTechnologies
Market Analyst, Microfluidics Medical
Technologies. Sébastien authored a
collection of market and technology reports
dedicated to topics such as microfluidics,
point-of-care and more. In parallel, he is
daily involved in custom projects. Thanks
to its technology market expertise,
Sébastien has spoken in more than 10
industry conferences worldwide over the
last 2 years. Sébastien Clerc is graduated
from Grenoble Institute of Technology
(Grenoble INP - Grenoble, France) with a
Master degree in Biomedical Technologies.
Then he completed his cursus with a Master
degree in Innovation and Technology
Management in the same institute.
As a Technology Market Analyst,
Biotechnologies Molecular Innovations,
Asma Siari is involved in the development
of technology market reports as well as
custom consulting projects. After a Master’s
degree in Biotechnologies, Diagnostic
Therapeutics Management, Asma served
as Research Assistant at the Moores Cancer
Center (San Diego, CA). She is a coauthor
in two scientific publications. Asma Siari
is graduated with an Advanced Master’s
degree in International Strategy Marketing
BtoB from EM Lyon Business School (Lyon,
France).
As a Technology Market Analyst,
Medical Imaging Biophotonics, Dr.
Marjorie Villien is a daily contributor
to the development of medical technologies
activities with a dedicated collection of
market technology reports as well as
custom consulting projects. After spending
two years at Harvard, Marjorie served
as a research scientist at INSERM in the
field of medical imaging. She has spoken
in numerous international conferences and
has authored or co-authored 11 papers and
1 patent. Marjorie Villien is graduated from
Grenoble INP (Grenoble, France) and holds
a PhD in physics medical imaging.
Dr. Marjorie Villien, Asma Siari and Sébastien Clerc,
all part of the Life Sciences Healthcare division at
Yole Développement co-authored the Liquid Biopsy:
From Isolation To Downstream Applications report:
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details about
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