Cell-Free DNA (cfDNA) Testing Market Report – Research, Industry Analysis Reports and Market Demands

Cell-Free DNA (cfDNA) Testing Global Market - Forecast to 2022

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Table of Content

1 EXECUTIVE SUMMARY 20

2 INTRODUCTION 28

2.1 KEY TAKE AWAYS 28
2.2 REPORT DESCRIPTION 28
2.3 MARKETS COVERED 30
2.4 STAKEHOLDERS 31
2.5 RESEARCH METHODOLOGY 31
- 2.5.1 MARKET SIZE ESTIMATION 32
- 2.5.2 MARKET CRACKDOWN AND DATA TRIANGULATION 35
- 2.5.3 SECONDARY SOURCES 36
- 2.5.4 PRIMARY SOURCES 36
- 2.5.5 KEY DATA POINTS FROM SECONDARY SOURCES 37
- 2.5.6 KEY DATA POINTS FROM PRIMARY SOURCES 37
- 2.5.7 ASSUMPTIONS 38

3 MARKET ANALYSIS 40

3.1 INTRODUCTION 40
3.2 MARKET SEGMENTATION 41
3.3 FACTORS INFLUENCING MARKET 42
- 3.3.1 DRIVERS AND OPPORTUNITIES 42
  - 3.3.1.1 Rising number of late pregnancies leading to high incidence rate of
babies with chromosomal disorders 42
- 3.3.1.2 Increasing number of life threatening cancers 43
- 3.3.1.3 Increasing demand for early detection through non-invasive testing procedures 44
- 3.3.1.4 Growing healthcare awareness among people and increasing

healthcare expenditure in emerging countries 45

3.3.1.5 More number of deals (acquisitions, agreements) for technology

sharing 46

3.3.2 RESTRAINTS AND THREATS 46
- 3.3.2.1 Expensive cell-free DNA tests with less reimbursement facilities 46
- 3.3.2.2 Ethical issues related to genetic testing 47
- 3.3.2.3 Lack of skilled healthcare professionals 47
- 3.3.2.4 Lack of standardization 48
- 3.3.2.5 Strict legal and regulatory guidelines 49
- 3.3.2.6 Emerging alternative technologies 49

3.4 REGULATORY AFFAIRS 50

3.4.1 U.S. 50
3.4.2 EUROPE 51
3.4.3 CHINA 52
3.4.4 INDIA 52
3.4.5 JAPAN 52

3.5 PORTER’S FIVE FORCE ANALYSIS 53

3.5.1 THREAT OF NEW ENTRANTS 54
3.5.2 THREAT OF SUBSTITUTES 55
3.5.3 COMPETITIVE RIVALRY 55
3.5.4 BARGAINING POWER OF SUPPLIERS 56
3.5.5 BARGAINING POWER OF BUYERS 57

3.6 PROCESS FLOW CHART OF CELL-FREE DNA TESTS 58

3.7 PATENT TRENDS 59

3.8 MARKET SHARE ANALYSIS (NIPT) BY MAJOR PLAYERS 61

3.9 FUNDING SCENARIO 64

3.10 UPCOMING TECHNOLOGIES 70

3.11 RESEARCH USE ONLY CELL-FREE DNA TESTS 71

4 CELL-FREE DNA TESTING GLOBAL MARKET, BY TYPE 73

4.1 INTRODUCTION 73
4.2 CELL-FREE DNA PRENATAL TESTING GLOBAL MARKET, BY TEST TYPE 77
- 4.2.1 INTRODUCTION 77
- 4.2.2 CELL-FREE FETAL DNA TESTS 79
  - 4.2.2.1 Bambni test 86
  - 4.2.2.2 Clarigo 86
  - 4.2.2.3 Harmony test 86
  - 4.2.2.4 Informaseq test 87
  - 4.2.2.5 Informed pregnancy screening 87
  - 4.2.2.6 Iona test 88
  - 4.2.2.7 MaterniT GENOME 88
  - 4.2.2.8 MaterniT21 Plus test 89
  - 4.2.2.9 Nifty test 89
  - 4.2.2.10 Panorama test 90
  - 4.2.2.11 Prena test 91
  - 4.2.2.12 Prenatalis 91
  - 4.2.2.13 QNatal Advanced test 92
  - 4.2.2.14 SafeT21 Express test 92
  - 4.2.2.15 Verifi test 93
  - 4.2.2.16 VisibiliT test 93
4.3 CELL-FREE TUMOUR DNA GLOBAL TESTING MARKET, BY TEST TYPE 94
- 4.3.1 INTORDUCTION 94
- 4.3.2 CIRCULATING TUMOR DNA TESTS 96
  - 4.3.2.1 CancerIntercept 100
  - 4.3.2.2 Circulogene’s finger stick monitoring technology 100
  - 4.3.2.3 Cologuard test 101
  - 4.3.2.4 EGFR mutation test v2 101
  - 4.3.2.5 Enchanced TAm-Seq 102
  - 4.3.2.6 Epi procolon test 102
  - 4.3.2.7 FoundationACT 102
  - 4.3.2.8 Guardant360 103
  - 4.3.2.9 ICEme 103
  - 4.3.2.10 LBx HCP 50 105
  - 4.3.2.11 METDetect 105
  - 4.3.2.12 NeoLAB liquid biopsy 106
  - 4.3.2.13 OnTarget Enrichment 106
  - 4.3.2.14 PCM BRAF V600F mutation detection test 107
  - 4.3.2.15 PCM EGFR mutation detection test 107
  - 4.3.2.16 PCM KRAS mutation detection test 108
  - 4.3.2.17 Others 109
4.4 DONOR DERIVED CELL-FREE DNA TESTING GLOBAL MARKET, BY

TEST TYPE 110

4.4.1 INTRODUCTION 110
4.4.2 ALLOSURE 112

5 CELL-FREE DNA TESTING GLOBAL MARKET, BY APPLICATION 113

5.1 INTRODUCTION 113
5.2 GYNECOLOGY 115
5.3 ONCOLOGY 117
5.4 TRANSPLANTATION 120

6 CELL-FREE DNA TESTING GLOBAL MARKET, BY REGION 122

6.1 INTRODUCTION 122
6.2 NORTH AMERICA 124
- 6.2.1 U.S. 125
- 6.2.2 CANADA 126
6.3 EUROPE 129
6.4 ASIA PACIFIC 133
- 6.4.1 CHINA 134
- 6.4.2 INDIA 134
6.5 REST OF THE WORLD 139

7 COMPANY DEVELOPMENTS 143

7.1 INTRODUCTION 143
- 7.1.1 AGREEMENTS,PARTNERSHIP & COLLABORATION AS A MAJOR GROWTH STRATEGY OF CELL-FREE DNA MARKET PLAYERS 143
7.2 AGREEMENTS, PARTNERSHIPS & COLLABORATIONS 145
7.3 ACQUISITIONS 157
7.4 NEW PRODUCT LAUNCH 162
7.5 OTHER DEVELOPMENTS 167
7.6 APPROVALS 170

8 COMPANY PROFILES 173

Description

Cell-free DNA are small fragments of DNA circulating freely in the blood and body fluids which are utilized as a valuable biomarker to advance personalized medicine, and improve the quality of life. The groundbreaking discovery of cfDNA in 1948 has opened up to new possibilities in the field of gynecology, oncology, transplantation and infectious diseases. The cell-free DNA testing global market is segmented based on the type, applications and geography. By type the market is divided into cell-free fetal DNA, circulating tumour DNA, Donor derived cell-free DNA. By application, the Cell-free DNA testing market is divided into gynecology, oncology, and transplantation. `
Among the Cell-free DNA testing market by test type, the cell-free fetal DNA testing market is dominating the market by occupying a largest share of XX%. The donor DNA product is expected to launch in 2017 hence CAGR is calculated from 2017-20122 which makes it the fastest growing segment with CAGR XX%. In applications, the gynecology holds the largest segment with XX% share and transplantation is the fastest growing segment with a CAGR of XX% from 2017 to 2022. Geographical wise, North America holds the largest market, with a share of XX% followed by Europe and Asia. The APAC region is the fastest growing region with a CAGR of XX% from 2015 to 2022 suggesting an array of opportunities for growth and likely to be getting into the eyes of new investors in the cell-free DNA testing market. Growth in the Asian market is attributed to rising prevalence of diseases related to lifestyle change and government initiatives in establishing innovative technologies and demand for sophisticated medical services.
The cell-free DNA testing market is expected to grow steadily at a CAGR of XX% during 2015 to 2022. The factors driving the growth of this market are raising number of late pregnancies leading to high incidence rates of babies with chromosomal disorders, increasing number of life threatening cancer and infectious diseases are likely to propel the market. In addition, increasing demand for early detection through non-invasive testing procedures, healthy growth with increase in the number of deals by collaborations and acquisitions to open an array of opportunities for the market to flourish are some of the opportunities that are propelling the growth of the market. However, lack of trained health care professionals, ethical issues related to genetic testing, lack of standardization, high cost and non affordability in low- and middle-income countries, unfavourable reimbursement policies and strict legal and regulatory guidelines are hampering the growth of the market. The threats for the Cell-free DNA testing market include the availability of alternative screening methods which will impact the existing market.
The cell-free DNA testing global market is a highly competitive market and all the existing players in this market are involved in developing new and advanced assays to maintain their market shares. The major players in the cell-free DNA testing market include Berry Genomics Co. Ltd (China), BGI (China), Boreal Genomics (U.S), Guardant health, Inc(U.S), Inivata Limited (U.K), Illumina, Inc.(U.S.), Laboratory Corp. of America Holdings (U.S.), Lifecodexx AG (Germany), Natera, Inc. (U.S.), Personal Genome Diagnostics (U.S), Premaitha Health (U.K.), Quest Diagnostics (U.S.), Roche Holdings AG (Switzerland), Sequenom, Inc. (U.S.), Trovagene, Inc (U.S) etc.
The report provides an in depth market analysis of the above mentioned segments across the following regions:
• North America
• Europe
• Asia-Pacific
• Rest of the World (RoW)