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Report Scope:
The scope of the report includes liquid biopsy technologies, applications, industry subsegments, biomarker technologies, major funding initiatives, NIPT methods, patents for both liquid biopsy and NIPT, and company profiles. The market sizes for liquid biopsy diagnostics with emphasis on NIPT are given for the years 2017, 2018 (estimated) and 2023 (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.
In addition to this, the report examines the markets by NIPT methods, high-risk and low-risk pregnancies and geography. The end-user segment of this market is based on disease area and healthcare setting. Disease areas include trisomy 21, 18 and 13 and Turner syndrome (a sex chromosome aneuploidy). Healthcare settings include diagnostic laboratories and hospitals. Market dynamics such as drivers and restraints for the NIPT market are also discussed.
The structure of several important industry subsectors was reviewed. The industry subsectors that are analyzed include next-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 by application (cancer, reproductive health, transplant), biomarker type (nucleic acids, cells, extracellular vesicles, proteins), analysis platform (microarray, NGS, PCR, proteomics and others), analysis purpose (screening/early detection, diagnosis, therapy guidance, monitoring) and geography (North America, Europe, Asia-Pacific, Rest of World). Similarly, the market size of non-cancer applications of liquid biopsy, NIPT, is analyzed based on risk-type, analysis purpose, biomarker class, analysis method, NIPT methods, high- and low-risk pregnancies, and geography.
Market data cover the years 2017, 2018 (estimated) and 2023 (forecasted).
More than 165 companies in the liquid biopsy industry are profiled in this report. Nearly 18 companies in the NIPT market have been profiled in detail.
BCC Research provides a summary of the main industry acquisitions and strategic alliances from January 2016 until December 2018, including key alliance trends.
Report Includes:
- 45 data tables and 94 additional tables
- An overview of liquid biopsy and non-invasive prenatal tests (NIPT) market
- Analyses of global market trends with data from 2017, 2018 and projections of compound annual growth rates (CAGRs) through 2023
- Country specific data and analysis for China, Japan, India, South Korea, UK, Germany, France, Italy, Spain and USA
- Comparative study of liquid biopsy with conventional biopsy and coverage of their respective biomarkers
- Snapshot of key liquid biopsy research and development programs
- Information on NIPT available in market such as NIFTY, Verifi prenatal test, Harmony prenatal test, Panorama, MaterniT21 and IONA test
- Description of chromosomal diseases where NIPT plays a vital role in detection and screening i.e. Down's Syndrome, Edwards Syndrome (Trisomy 18), Patau syndrome (Trisomy 13) and Turner syndrome
- Comprehensive company profiles of major players, including Agilent Technologies, Illumina, Natera, Oxford Nanopore, QIAGEN, and Thermo Fisher
Summary
Liquid biopsy is an attractive option as a supplement or alternative to doing a tissue biopsy for applications in reproductive health, cancer and transplant medicine.
Ongoing advances in sensitive molecular technologies such as next-generation DNA sequencing (NGS) and digital polymerase chain reaction (dPCR) enable the detection of biomarkers that are present in fluids at very low concentrations.
The biomarker types garnering the most interest include cell-free DNA (cfDNA), circulating tumor cells (CTCs) and exosomes.
When compared with conventional tissue biopsy, liquid biopsy tests address a significant medical need for a biopsy that is noninvasive and has little or no risk of medical complications. The validation of this testing platform and the demonstration of clinical utility first occurred in the high-risk pregnancy segment of the NIPT industry, resulting in high market penetration. Substantial progress is being made in the average-risk pregnancy NIPT market segment and in some applications in cancer and transplant medicine.
Reasons for Doing This Study
Traditional biopsy methods are often invasive, uncomfortable and carry risks of side effects. Liquid biopsy addresses these issues because it is noninvasive and carries little, if any, risks of side effects. Noninvasive prenatal testing (NIPT) is a liquid biopsy approach that has revolutionized medical genetics. NIPT is a blood test that detects with remarkable accuracy the risk of a fetus developing chromosomal abnormalities like Down syndrome, Edwards syndrome or Patau syndrome, as well as abnormalities with the X and Y sex chromosomes. NIPT involves a simple blood draw, unlike invasive methods such as chorionic villus sampling (CVS) or amniocentesis, each of which also has a small chance of miscarriage. NIPT comes with no risk of miscarriage.
In the age of genomics and personalized medicine, it is critical for clinicians to have diagnostic tools that can be used on a regular basis to screen, monitor, conduct surveillance, guide treatment or otherwise give valuable genomic information about a disease. Liquid biopsy provides this capability and thus is of high interest to the medical community. NIPT is used as a first screen for identifying high-risk pregnancies and will, in the future, be used for low-risk pregnancies as well.
Liquid-biopsy-enabling technologies are coming to the forefront and provide significant market growth momentum to the industry. Downstream analysis technologies like next-generation sequencing (NGS) and digital polymerase chain reaction (PCR) are progressing in terms of their capabilities, efficiency and costs. Upstream technologies like microfluidics, cell-free deoxyribonucleic acid (DNA) capture and isolation, cell capture, and DNA amplification are also making significant progress. The use of nextgeneration sequencing technologies in NIPT opened exciting new market applications. By 2017, the costs of sequencing rapidly reduced to the point where it is now feasible for complex NGS tests to be
priced in the range of other multiplex genetic tests. More than 85 clinical laboratories are now offering NGS-based testing services. For many applications, the clinical benefits have been proven.
Liquid biopsy is also gaining significant traction with key opinion leaders, medical societies and insurance payers. As a result, liquid biopsy is penetrating into attractive clinical applications, including average-risk noninvasive prenatal testing and cancer therapy guidance and monitoring.
Based on these trends, liquid biopsy markets are rapidly emerging and the need for industry and market characterization is great.
The outstanding growth potential for liquid biopsy diagnostics and the future growth potential for NIPTNGS diagnostics make the preparation of this updated report particularly timely.