The global liquid biopsy market should reach $6.1 billion by 2023 from $2.4 billion in 2018 at a compound annual growth rate (CAGR) of 20.8% for the period 2018 to 2023.
Report Scope:
The scope of the report includes liquid biopsy technologies, applications, industry subsegments, biomarker technologies, major funding initiatives, patents and companies.The market sizes for liquid biopsy diagnostics are given for the years 2015, 2016, 2017 (estimated) and 2022 (forecasted).
This report reviews liquid biopsy biomarkers and technologies and provides background on why liquid biopsy is increasingly viewed as a replacement for, or a companion to, tissue biopsy.It then discusses several of the significant large-scale research initiatives that are contributing to liquid biopsy development.Market driving forces are also discussed.
The structure of several important industry subsectors is reviewed, as well as major industry acquisitions and strategic alliances from January 2016 through July 2017.Industry subsectors analyzed includenext-generation sequencing(NGS) instruments, droplet digital PCR, target enrichment and amplification, single-cell DNA polymerase, prenatal screening, liquid biopsy, direct to consumer, and clinical laboratory.
The market for liquid biopsy diagnostics is analyzed in depth.The market is analyzed by application (cancer, reproductive health, transplant), biomarker type (nucleic acids, cells, extracellular vesicles, proteins), analysis platform (microarray, NGS, PCR, proteomics and other), analysis purpose (screening/early detection, diagnosis, therapy guidance, monitoring) and geography (North America, Europe, Asia-Pacific, Rest of World).
Market data cover the years 2015, 2016, 2017 (estimated) and 2022 (forecasted).
More than 165 companies in the liquid biopsy industry are profiled in this report.
BCC Research provides a summary of the main industry acquisitions and strategic alliances from January 2016 through July 2017, including key alliance trends.
Report Includes:
- An overview of the global markets for liquid biopsy research tools, services, and diagnostics
- Analyses of global market trends, with data from 2015 and 2016, estimates for 2017, and projections of compound annual growth rates (CAGRs) through 2022
- Coverage of how these technologies can reduce invasive tumor biopsies, drive early cancer detection, and support precise drug administration
- Detailed analysis of liquid biopsy workflow technologies, biomarker classes, sample types, and research tools reagents
- Breakdowns of the market by product, product type, application, end use industry, technology, and indication
- Evaluation of the market's dynamics, specifically growth drivers, restraints, and opportunities
- Profiles of major players in the industry
Summary
Liquid biopsy is rapidly gaining traction as a supplement or alternative to doing a tissue biopsy for applications in reproductive health, cancer and transplant medicine. The liquid biopsy captures and analyzes biomarkers, mostly cell-free DNA, found in body fluids, most often in blood. In the noninvasive prenatal testing market, liquid biopsy has achieved significant penetration in the high-risk pregnancy segment and is moving into the low-risk sector.
In cancer, liquid biopsy is gaining significant market traction. Two trends stand out: Payors are being influenced by mounting clinical data supporting the use of liquid biopsy, and an emerging tissueagnostic labeling strategy for cancer drugs is driving the use of liquid biopsy companion diagnostics. An example of the former trend is the agreement in June 2017 by the U.S. Department of Veterans Affairs to provide a liquid biopsy test, PlasmaSelect 64, to advanced cancer patients being treated at its facilities.
An example of the latter trend is the expanded approval in May 2017 by the U.S. Food and Drug Administration (FDA) of the checkpoint inhibitor drug Keytruda (Merck, pembrolizumab) for advanced cancer patients with microsatellite instability or mismatch repair deficiency. This approval highlighted a new paradigm in cancer care, where the patient is treated based on specific genomic defects rather than on the organ of origin. This will boost the market for molecular diagnostics that can detect these genomic markers and be used to guide treatment decisions associated with these drugs.
Table of Contents
Chapter 1: Introduction ......................................................................................... 2
Study Goals and Objectives........................................................................................................................... 2
Reasons for Doing This Study ........................................................................................................................ 2
Scope of Report ............................................................................................................................................. 3
Information Sources ...................................................................................................................................... 3
Methodology ................................................................................................................................................. 3
Geographic Breakdown ................................................................................................................................. 4
Analyst's Credentials ................................................................................................................................... 10
Related BCC Research Reports.................................................................................................................... 10
Chapter 2: Summary and Highlights ..................................................................... 12
Chapter 3: Overview ............................................................................................ 16
Introduction ................................................................................................................................................ 16
Report Scope ............................................................................................................................................... 17
Liquid Biopsy versus Traditional Biopsy ...................................................................................................... 17
Markets ....................................................................................................................................................... 18
Growth Driving Forces ................................................................................................................................ 19
Key Trends ................................................................................................................................................... 20
Industry ....................................................................................................................................................... 22
Chapter 4: Technology Background .................................................................... 24
Liquid Biopsy Biomarkers ............................................................................................................................ 24
Cancer Genomics ........................................................................................................................................ 25
Noninvasive Prenatal Testing ...................................................................................................................... 29
Circulating Tumor Cell Technologies ........................................................................................................... 30
CTC Workflow ............................................................................................................................................. 31
Cell Isolation Technologies.......................................................................................................................... 31
CTC Sample Preparation Technologies ....................................................................................................... 34
CTC Downstream Analysis Technologies .................................................................................................... 35
Comparison of Liquid Biopsy with Conventional Biopsy ............................................................................ 36
Cancer Testing ......................................................................................................................................... 36
Prenatal Testing ....................................................................................................................................... 39
Chapter 5: Liquid Biopsy Initiatives ...................................................................... 43
Blood Profiling Atlas .................................................................................................................................... 44
Cambridge Single Cell Analysis Core Facility ............................................................................................... 44
Cancer-ID ..................................................................................................................................................... 44
CTCTrap Consortium ................................................................................................................................... 44
Early Cancer Detection Consortium ............................................................................................................ 45
Hematologic Oncology Consortium ............................................................................................................ 45
National Center for Single-Cell Biology ....................................................................................................... 45
Precancer Genome Atlas ............................................................................................................................. 45
Precision Medicine Initiative ....................................................................................................................... 46
Single Cell Analysis Program ....................................................................................................................... 46
TopMed ....................................................................................................................................................... 47
Worldwide Innovative Networking (WIN) Consortium ............................................................................... 47
Chapter 6: Liquid Biopsy Applications .................................................................. 49
Introduction ................................................................................................................................................ 49
Cancer Applications .................................................................................................................................... 49
Precision Medicine .................................................................................................................................. 49
Cancer Biomarker Status ......................................................................................................................... 51
Cancer Market Segments ........................................................................................................................ 52
Reproductive Health Applications .............................................................................................................. 54
Transplant Diagnostics Applications ........................................................................................................... 56
Chapter 7: Liquid Biopsy Industry ........................................................................ 58
Introduction ................................................................................................................................................ 58
NGS Instrument Industry ............................................................................................................................ 59
Third-Generation Sequencing Industry ....................................................................................................... 63
Droplet Digital PCR Industry ....................................................................................................................... 66
Target Enrichment and Amplification Industry ........................................................................................... 68
Single-Cell DNA Polymerase Industry ......................................................................................................... 69
NGS Clinical Informatics Industry ................................................................................................................ 71
Testing Services Industry ............................................................................................................................ 73
Noninvasive Prenatal Testing Industry ....................................................................................................... 78
Fetal Cell NIPT Industry ............................................................................................................................... 84
CTC Capture and Detection Industry .......................................................................................................... 85
Liquid Biopsy Industry ................................................................................................................................. 88
Direct-to-Consumer Genetic Testing Industry ............................................................................................ 98
Chapter 8: Acquisitions and Strategic Alliances ................................................. 102
Acquisitions ............................................................................................................................................... 102
Strategic Alliances ..................................................................................................................................... 106
Trends .................................................................................................................................................... 111
2016 Alliances ........................................................................................................................................ 112
2017 Alliances ........................................................................................................................................ 117
Chapter 9: Liquid Biopsy Markets ...................................................................... 123
Growth Driving Forces .............................................................................................................................. 123
Liquid Biopsy Market by Indication........................................................................................................... 125
Liquid Biopsy Market by Biomarker Type ................................................................................................. 127
Liquid Biopsy Market by Analysis Platform ............................................................................................... 128
Liquid Biopsy Market by Analysis Purpose ............................................................................................... 128
Noninvasive Prenatal Testing Market ....................................................................................................... 130
Cancer Markets ......................................................................................................................................... 135
Cancer Market by Indication ................................................................................................................. 135
Cancer Market by Analysis Purpose ...................................................................................................... 145
Cancer Market by Biomarker Class ....................................................................................................... 153
Cancer Market by Analysis Method ...................................................................................................... 155
Breast Cancer Market ............................................................................................................................ 158
Colorectal Cancer Market...................................................................................................................... 159
Hematological Cancer Market ............................................................................................................... 160
Lung Cancer Market .............................................................................................................................. 161
Pan-Cancer Market ................................................................................................................................ 162
Transplant Markets ................................................................................................................................... 163
Geographical Market ................................................................................................................................ 167
Chapter 10: Patent Review ................................................................................ 175
Circulating Tumor Cell Patents.................................................................................................................. 175
Cell-Free DNA Patents ........................................................................................................................... 176
Liquid Biopsy- and Sequencing-Related Patent Issues ............................................................................. 176
Chapter 11: Company Profiles ........................................................................... 181
About BCC Research ......................................................................................... 292
About BCC Research.................................................................................................................................. 293
BCC Membership ...................................................................................................................................... 293
BCC Custom Research ............................................................................................................................... 293
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