From Technologies to Market

Liquid Biopsy: From Isolation to Downstream

Applications 2018

Sample

2018

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LIST OF COMPANIES MENTIONED IN THIS REPORT

©2018 | www.yole.fr | Liquid Biopsy: From Isolation to Downstream Applications 2018 | Sample

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, StemCellTechnologies, Stratec, Streck, Sysmex, TeloVision, Thermo Fisher, Thermo Fisher Scientific, ThinXXS, Trovagene, Veracyte, Vitatex, Vortex Biosciences, Zomedica,

and many more!

210+ slides of market and technology analysis

Information gathered through direct discussions with players all along the supply chain

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Biographies & contacts

ABOUT THE AUTHORS

Dr. Marjorie Villien

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’sof Innovation and Technology Management, during which he oversaw strategy and marketing.

• As a Technology & Market Analyst, Dr. Marjorie Villien works in the Microfluidic & Medical Technologies (MedTech) business unit at YoleDéveloppement, the "More than Moore" market research and strategy consulting company. She is a daily contributor to the development ofMedTech activities, with a dedicated collection of market & technology reports as well as custom consulting projects. After spending two years atHarvard, Dr. Villien served as a research scientist at INSERM in the field of MRI & PET imaging. She has spoken at numerous internationalconferences 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.

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).

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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

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WHO SHOULD BE INTERESTED BY THIS REPORT?

o Biotechnology & Pharmaceutical Companies:

• To understand what is the state of the art of liquidbiopsy technologies

• To identify the different players across the supply chain

• To understand behavior evolution and identify newbusiness models

• To identify competitors and targets for collaborationsor M&A

o Equipment & Material suppliers:

• To understand the technical evolution of ctDNA, CTCand exosome solutions involved in the detection andisolation process

• To identify business opportunities and prospects

o R&D players:

• To understand challenges linked to the use of liquidbiopsy 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 theapplication

• Target business opportunities and prospects

o Financial & Strategic investors:

• To understand the potential of liquid biopsy in theconsumer and healthcare industries

• To know the latest moves within the industry

• To get a list of players and their activities in the field ofdiagnostic using liquid biopsy

o Healthcare & governmental organizations:

• Evaluate the benefits of using non invasive testing

• Pinpoint relevant companies

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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 MarketAnalysis 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

• CirculatingTumor 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

• CirculatingTumor 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

• DownstreamAnalysis 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 playersand applications

• Company profiles

• General Conclusions 208

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LIQUID BIOPSY

Definition

The advantages of liquid biopsy

• Liquid biopsy hold the hopes of answering the needs for aless invasive procedure that could give a better picture ofthe cancer diagnosis, treatment or recurrence.

• Tissue biopsy are more invasive hence only provide asnapshot of the disease as it can’t be easily repeated.

• But maybe the greatest limitation to tissue based biopsytechniques is that sampling of a single tumor may notcapture all of the mutations present.

• Liquid biopsy allows for real-time, serial and longitudinalmonitoring during cancer therapy.

• It also provides a more comprehensive view of the tumor’sbiomarkers. http://liquid-biopsy.gene-quantification.info/

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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)

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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 theuse 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 treatmentsand 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

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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 ofmarket dynamics and players.

• We focused our reports on ctDNA, CTCs and exosomes analysis as protein analysis for liquid biopsy are morein 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 CancerOthers (noninvasive prenatal testing,

etc.)

Biomarkers ctDNA, CTCs, exosomes Proteins

Market analysisCompanies developing liquid biopsy kits,

instruments and services

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INTRODUCTION TO LIQUID BIOPSY

• What is liquid biopsy?

• What can we learn from Liquid Biopsy?

• Circulating tumor cells (CTCs) and circulating tumor DNA (ctDNA)

• Report scope

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LIQUID BIOPSY MARKET ANALYSIS

• Cancer prevalence

• Liquid biopsy ecosystem

• Mergers and acquisitions/collaborations/Fundraising analysis

• Market data and forecasts 2017 - 2023

• Business models, Regulations status

• Applications, drivers and roadmaps

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CIRCULATING TUMOR DNA AND EXOSOMES

• 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

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CIRCULATING TUMOR CELL

• 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

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DOWNSTREAM ANALYSIS

• 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