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

June 2016 | 248 pages | ID: CB716A7F4D3EN
IQ4I Research & Consultancy Pvt. Ltd.

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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)
1 EXECUTIVE SUMMARY

2 INTRODUCTION

2.1 KEY TAKE AWAYS
2.2 REPORT DESCRIPTION
2.3 MARKETS COVERED
2.4 STAKEHOLDERS
2.5 RESEARCH METHODOLOGY
  2.5.1 MARKET SIZE ESTIMATION
  2.5.2 MARKET CRACKDOWN AND DATA TRIANGULATION
  2.5.3 SECONDARY SOURCES
  2.5.4 PRIMARY SOURCES
  2.5.5 KEY DATA POINTS FROM SECONDARY SOURCES
  2.5.6 KEY DATA POINTS FROM PRIMARY SOURCES
  2.5.7 ASSUMPTIONS

3 MARKET ANALYSIS

3.1 INTRODUCTION
3.2 MARKET SEGMENTATION
3.3 FACTORS INFLUENCING MARKET
  3.3.1 DRIVERS AND OPPORTUNITIES
    3.3.1.1 Rising number of late pregnancies leading to high incidence rate of babies with chromosomal disorders
    3.3.1.2 Increasing number of life threatening cancers
    3.3.1.3 Increasing demand for early detection through non-invasive testing procedures
    3.3.1.4 Growing healthcare awareness among people and increasing healthcare expenditure in emerging countries
    3.3.1.5 More number of deals (acquisitions, agreements) for technology sharing
  3.3.2 RESTRAINTS AND THREATS
    3.3.2.1 Expensive cell-free DNA tests with less reimbursement facilities
    3.3.2.2 Ethical issues related to genetic testing
    3.3.2.3 Lack of skilled healthcare professionals
    3.3.2.4 Lack of standardization
    3.3.2.5 Strict legal and regulatory guidelines
    3.3.2.6 Emerging alternative technologies
3.4 REGULATORY AFFAIRS
  3.4.1 U.S.
  3.4.2 EUROPE
  3.4.3 CHINA
  3.4.4 INDIA
  3.4.5 JAPAN
3.5 PORTER’S FIVE FORCE ANALYSIS
  3.5.1 THREAT OF NEW ENTRANTS
  3.5.2 THREAT OF SUBSTITUTES
  3.5.3 COMPETITIVE RIVALRY
  3.5.4 BARGAINING POWER OF SUPPLIERS
  3.5.5 BARGAINING POWER OF BUYERS
3.6 PROCESS FLOW CHART OF CELL-FREE DNA TESTS
3.7 PATENT TRENDS
3.8 MARKET SHARE ANALYSIS (NIPT) BY MAJOR PLAYERS
3.9 FUNDING SCENARIO
3.10 UPCOMING TECHNOLOGIES
3.11 RESEARCH USE ONLY CELL-FREE DNA TESTS

4 CELL-FREE DNA TESTING GLOBAL MARKET, BY TYPE

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

TEST TYPE

  4.4.1 INTRODUCTION
  4.4.2 ALLOSURE

5 CELL-FREE DNA TESTING GLOBAL MARKET, BY APPLICATION

5.1 INTRODUCTION
5.2 GYNECOLOGY
5.3 ONCOLOGY
5.4 TRANSPLANTATION

6 CELL-FREE DNA TESTING GLOBAL MARKET, BY REGION

6.1 INTRODUCTION
6.2 NORTH AMERICA
  6.2.1 U.S.
  6.2.2 CANADA
6.3 EUROPE
6.4 ASIA PACIFIC
  6.4.1 CHINA
  6.4.2 INDIA
6.5 REST OF THE WORLD

7 COMPANY DEVELOPMENTS

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

8 COMPANY PROFILES

8.1 BERRY GENOMICS CO. LTD
  8.1.1 OVERVIEW
  8.1.2 FINANCIALS
  8.1.3 PRODUCT PORFOLIO
    8.1.3.1 BAMBNI TEST
    8.1.3.2 Next SeqCN500
    8.1.3.3 cSMART technology
  8.1.4 KEY DEVELOPMENTS
  8.1.5 BUSINESS STRATEGY
  8.1.6 SWOT ANALYSIS
8.2 BGI (BGI DIAGNOSTICS)
  8.2.1 OVERVIEW
  8.2.2 FINANCIALS
  8.2.3 PRODUCT PORFOLIO
    8.2.3.1 NIFTY Test
  8.2.4 KEY DEVELOPMENTS
  8.2.5 BUSINESS STRATEGY
  8.2.6 SWOT ANALYSIS
8.3 BIOCEPT, INC.
  8.3.1 OVERVIEW
  8.3.2 FINANCIALS
  8.3.3 PRODUCT PORTFOLIO
  8.3.4 KEY DEVELOPMENTS
  8.3.5 BUSINESS STRATEGY
  8.3.6 SWOT ANALYSIS
8.4 CAREDX, INC.
  8.4.1 OVERVIEW
  8.4.2 FINANCIALS
  8.4.3 PRODUCT DESCRIPTION
    8.4.3.1 Allosure
  8.4.4 KEY DEVELOPMENTS
  8.4.5 BUSINESS STRATEGY
  8.4.6 SWOT ANALYSIS
8.5 GUARDANT HEALTH, INC.
  8.5.1 OVERVIEW
  8.5.2 FINANCIALS
  8.5.3 PRODUCT DESCRIPTION
    8.5.3.1 Guardant 360
  8.5.4 KEY DEVELOPMENTS
  8.5.5 BUSINESS STRATEGY
  8.5.6 SWOT ANALYSIS
8.6 ILLUMINA, INC.
  8.6.1 OVERVIEW
  8.6.2 FINANCIALS
  8.6.3 PRODUCT PORTFOLIO
    8.6.3.1 Verifi noninvasive Prenatal Test
  8.6.4 KEY DEVELOPMENTS
  8.6.5 BUSINESS STRATEGY
  8.6.6 SWOT ANALYSIS
8.7 INIVATA LIMITED
  8.7.1 OVERVIEW
  8.7.2 FINANCIALS
  8.7.3 PRODUCT DESCRIPTION
    8.7.3.1 TAm-Seq
  8.7.4 KEY DEVELOPMENTS
  8.7.5 BUSINESS STRATEGY
  8.7.6 SWOT ANALYSIS
8.8 LABORATORY CORP. OF AMERICA HOLDINGS (LABCORP)
  8.8.1 OVERVIEW
  8.8.2 FINANCIALS
  8.8.3 PRODUCT PORTFOLIO
    8.8.3.1 InformaSeq prenatal test
    8.8.3.2 Epi proColon test
  8.8.4 KEY DEVELOPMENTS
  8.8.5 BUSINESS STRATEGY
  8.8.6 SWOT ANALYSIS
8.9 LIFECODEXX AG
  8.9.1 OVERVIEW
  8.9.2 FINANCIALS
  8.9.3 PRODUCT PORFOLIO
    8.9.3.1 Prena Test
  8.9.4 KEY DEVELOPMENTS
  8.9.5 BUSINESS STRATEGY
  8.9.6 SWOT ANALYSIS
8.10 NATERA, INC.
  8.10.1 OVERVIEW
  8.10.2 FINANCIALS
  8.10.3 PRODUCT PORTFOLIO
    8.10.3.1 Panorama
    8.10.3.2 Constellation
  8.10.4 KEY DEVELOPMENTS
  8.10.5 BUSINESS STRATEGY
  8.10.6 SWOT ANALYSIS
8.11 PERSONAL GENOME DIAGNOSTICS
  8.11.1 OVERVIEW
  8.11.2 FINANCIALS
  8.11.3 PRODUCT DESCRIPTION
    8.11.3.1 MetDetect-R
    8.11.3.2 PlasmaSelect-R
  8.11.4 KEY DEVELOPMENTS
  8.11.5 BUSINESS STRATEGY
  8.11.6 SWOT ANALYSIS
8.12 QUEST DIAGNOSTICS
  8.12.1 OVERVIEW
  8.12.2 FINANCIALS
  8.12.3 PRODUCT PORFOLIO
    8.12.3.1 QNatal Advanced
  8.12.4 KEY DEVELOPMENTS
  8.12.5 BUSINESS STRATEGY
  8.12.6 SWOT ANALYSIS
8.13 ROCHE HOLDINGS AG
  8.13.1 OVERVIEW
  8.13.2 FINANCIALS
  8.13.3 PRODUCT PORTFOLIO
    8.13.3.1 Cobas EGFR mutation test V2
    8.13.3.2 HARMONY PRENATAL TEST
  8.13.4 KEY DEVELOPMENTS
  8.13.5 BUSINESS STRATEGY
  8.13.6 SWOT ANALYSIS
8.14 SEQUENOM, INC.
  8.14.1 OVERVIEW
  8.14.2 FINANCIALS
  8.14.3 PRODUCT PORTFOLIO
    8.14.3.1 MaterniT GENOME
    8.14.3.2 MaterniT21 PLUS NIPT
    8.14.3.3 VisibiliT Prenatal Test
    8.14.3.4 Sensigene Fetal Rhd Genotyping
  8.14.4 KEY DEVELOPMENTS
  8.14.5 BUSINESS STRATEGY
  8.14.6 SWOT ANALYSIS
8.15 TROVAGENE, INC.
  8.15.1 OVERVIEW
  8.15.2 FINANCIALS
  8.15.3 PRODUCT PORTFOLIO
  8.15.4 KEY DEVELOPMENTS
  8.15.5 BUSINESS STRATEGY
  8.15.6 SWOT ANALYSIS
LIST OF TABLES

Table 1 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 2 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 3 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 4 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 5 NIPT GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 6 CIRCULATING TUMOR DNA GLOBAL TESTING MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 7 DONOR DERIVED CELL-FREE DNA TESTING MARKET GLOBAL REVENUE, BY REGION, (2017-2022) ($MN)
Table 8 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 9 GLOBAL GYNECOLOGY MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 10 ONCOLOGY GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 11 TRANSPLANTATION GLOBAL MARKET REVENUE, BY REGION, (2017-2022) ($MN)
Table 12 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Table 13 NORTH AMERICAN CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 14 NORTH AMERICAN CELL-FREE DNA TESTING MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 15 EUROPEAN CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 16 EUROPEAN CELL-FREE DNA TESTING MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 17 ASIA-PACIFIC CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 18 ASIA-PACIFIC CELL-FREE DNA TESTING MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 19 ROW CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE, (2014-2022) ($MN)
Table 20 ROW CELL-FREE DNA TESTING MARKET REVENUE, BY APPLICATION, (2014-2022) ($MN)
Table 21 AGREEMENTS, PARTNERSHIPS & COLLABORATIONS (2014-2016)
Table 22 ACQUISITIONS (2014-2016)
Table 23 NEW PRODUCT LAUNCH (2013-2016)
Table 24 OTHER DEVELOPMENTS (2014-2016)
Table 25 APPROVALS (2014-2016)
Table 26 BIOCEPT, INC: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 27 CAREDX, INC.: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 28 ILLUMINA INC: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 29 ILLUMINA INC: TOTAL REVENUE, BY GEOGRAPHY, (2013-2015) ($MN)
Table 30 LABCORP: TOTAL REVENUE AND OPERATING EXPENSES, (2013-2015) ($MN)
Table 31 LABCORP: TOTAL REVENUE, BY SEGMENTS (2013-2015) ($MN)
Table 32 NATERA, INC.: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 33 QUEST DIAGNOSTICS: TOTAL REVENUE AND OPERATING EXPENSES, (2013-2015) ($MN)
Table 34 QUEST DIAGNOSTICS: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN)
Table 35 ROCHE HOLDING AG: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 36 ROCHE HOLDING AG: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN)
Table 37 ROCHE HOLDING AG: TOTAL REVENUE, BY GEOGRAPHY, (2013-2015) ($MN)
Table 38 SEQUENOM, INC.: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)
Table 39 SEQUENOM, INC.: TOTAL REVENUE, BY SEGMENTS, (2013-2015) ($MN)
Table 40 TROVAGENE, INC.: TOTAL REVENUE AND R&D EXPENSES, (2013-2015) ($MN)

LIST OF FIGURES

Figure 1 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY REGION, (2014-2022) ($MN)
Figure 2 CELL-FREE DNA TESTING GLOBAL MARKET:RESEARCH APPROACH
Figure 3 CELL-FREE DNA TESTING GLOBAL MARKET: TOP-DOWN AND BOTTOM-UP APPROACH
Figure 4 CELL-FREE DNA TESTING GLOBAL MARKET: FORECASTING MODEL
Figure 5 CELL-FREE DNA TESTING MARKET: MARKET CRACKDOWN AND DATA TRIANGULATION
Figure 6 CELL-FREE DNA TESTING GLOBAL MARKET: MARKET SEGMENTATION
Figure 7 MARKET DYNAMICS
Figure 8 CELL-FREE DNA TESTING GLOBAL MARKET: PORTER’S ANALYSIS
Figure 9 PROCESS FLOW CHART: CELL-FREE DNA TESTS
Figure 10 CELL-FREE DNA TESTING GLOBAL MARKET:PCT FILING BY MAJOR PLAYERS (2011-2016)
Figure 11 GLOBAL NON-INVASIVE PRENATAL TESTING (NIPT) MARKET SHARE ANALYSIS, BY KEY PLAYERS, 2015 (%)
Figure 12 FUNDING SCENARIO IN CELL-FREE DNA MARKET, (2014-2016) ($MN)
Figure 13 MAJOR TECHNOLOGIES USED IN CELL-FREE DNA TESTING GLOBAL MARKET, (2015) (%)
Figure 14 CELL-FREE DNA TESTING GLOBAL MARKET, BY SAMPLE SOURCE (2015) (%)
Figure 15 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY APPLICATION, (2015 V’S 2022) ($MN)
Figure 16 CELL-FREE DNA TESTING GLOBAL MARKET REVENUE, BY REGION (2014-2022) ($MN)
Figure 17 NORTH AMERICAN CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE AND BY APPLICATION (2015 V’S 2022) ($MN)
Figure 18 EUROPEAN CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE AND BY APPLICATION (2015 V’S 2022) ($MN)
Figure 19 ASIA-PACIFIC CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE AND BY APPLICATION (2015 V’S 2022) ($MN)
Figure 20 REST OF THE WORLD CELL-FREE DNA TESTING MARKET REVENUE, BY TYPE AND BY APPLICATION (2015 V’S 2022) ($MN)
Figure 21 KEY GROWTH STRATEGIES (2013-2016)
Figure 22 AGREEMENTS BY MAJOR PLAYERS: (2014-2016)
Figure 23 COLLOBORATIONS BY MAJOR PLAYERS: (2014-2016)
Figure 24 PRODUCT LAUNCH BY MAJOR PLAYERS: (2014-2016)
Figure 25 SWOT: BERRY GENOMICS
Figure 26 SWOT: BGI.
Figure 27 SWOT: BIOCEPT, INC.
Figure 28 SWOT: CAREDX, INC.
Figure 29 SWOT: GUARDANT HEALTH, INC.
Figure 30 SWOT: ILLUMINA, INC.
Figure 31 SWOT: INIVATA LIMITED
Figure 32 SWOT: LABORATORY CORPORATION OF AMERICA HOLDINGS
Figure 33 SWOT: LIFECODEXX AG
Figure 34 SWOT: NATERA, INC.
Figure 35 SWOT: PERSONAL GENOME DIAGNOSTICS
Figure 36 SWOT: QUEST DIAGNOSTICS
Figure 37 SWOT: ROCHE HOLDINGS AG
Figure 38 SWOT: SEQUENOM, INC.
Figure 39 SWOT: TROVAGENE, INC.


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