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Cell-free DNA Testing Market - Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017-2023

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Cell-free DNA Testing Market-Global Drivers, Restraints, Opportunities, Trends, and Forecasts: 2017-2023

Overview: Cell-free DNA (cfDNA) are non-encapsulated fragments of DNA molecule present in blood and urine that has huge screening and diagnostic applications. CfDNA is used for fetal DNA screening tests to detect chromosomal abnormalities, as a biomarker for specific mutations detection in cancer patients, as a biomarker to detect post transplantation rejection, and other applications. According to the Center of Disease Control and Prevention, around 6,000 babies are born with Down syndrome every year that is nearly 1 in every 700 babies and the disease incidence is increased by about 30% between 1979 and 2003. Further, according to the study by World Health Organization, approximately 14 million new cancer cases were diagnosed and is expected to grow by about 70% over the next 2 decades.

The cfDNA testing market is booming due to advanced maternal age, increasing number of chronic diseases, change in lifestyle that leads to lifestyle diseases like cancer, and unhealthy food habits. The rising disease incidence along with the increasing medical spending and healthcare expenditure provide opportunities for molecular diagnostics company to come up with more number of innovative tests in the market. However, there is a huge market space for molecular diagnostic companies to come up with novel tests directing on transplantation rejection cases like liver, lung, etc, in the near future.

Market Analysis: The Global Cell-free DNA Testing Market is estimated to witness a CAGR of 26.5% during the forecast period 2017-2023. The market is analyzed based on three segments, namely test types, application, and regions.

Regional Analysis: The regions covered in the report are North America, Europe, Asia Pacific, and Rest of the World (RoW). The Americas is set to be the leading region for the cfDNA testing market growth followed by Europe. Asia Pacific and RoW are set to be the emerging regions.

Test Types Analysis: The global cfDNA testing market by test type is segmented into cell-free fetal DNA tests (also called NIPT), circulating tumor DNA tests, and donor-derived cell-free DNA tests. Cell-free fetal DNA tests is the largest segment, as women are more career-oriented, and the trend is seen in western countries to start family at a late age. These lead to an increase in the average maternal age. Donor-derived cfDNA tests are the fastest growing segment. The rising number of organ donors, increasing transplantation procedures, increasing healthcare awareness have made them the fastest growing segment of the market. The market is also witnessing various acquisitions, agreements, and new product launches and collaborations among the top players, which is defining the future of the global cfDNA testing market.

Application Analysis: The global cfDNA testing market by application is segmented into Gynecology, Oncology, and Transplantation. Gynecology occupies the largest market share and transplantation is expected to be the fastest growing segment during the forecasted period.

Key Players: Natera, Inc., Beijing Genomics Institute, F. Hoffmann-La Roche (Roche), Laboratory Corporation of America Holdings, Illumina, Inc., Guardant Health, Trovagene, Inc., Biocept, Inc., and other predominate & niche players.

Competitive Analysis: Currently, the cfDNA tests dominate the global cfDNA testing market. A lot of new players are focusing on this market to provide innovative tests with high accuracy and less turnaround time. Many major players in the market are launching new products to maintain their leadership in the market. Apart from this, the big players are acquiring small companies in the market to enhance their product portfolio and maintain their market leadership. For instance, in September 2016, LabCorp acquired Sequenom to strengthen its non-invasive prenatal testing product portfolio.

Benefits: The report provides complete details about the usage and adoption rate of cfDNA tests in various applications and regions. With that, the key stakeholders can know about the major trends, drivers, investments, vertical player's initiatives, government initiatives toward the test adoption in the upcoming years along with the details of commercial tests available in the market. Moreover, the report provides details about the major challenges that are going to impact the market growth. Additionally, the report gives complete details about the key business opportunities to key stakeholders to expand their business and capture the revenue in the specific verticals to analyze before investing or expanding the business in this market.

Key Stakeholders:

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Table Of Content

Scope

Table of Contents

1 INDUSTRY OUTLOOK 9

1.1 Industry overview 9

1.2 Total addressable market 9

1.3 Industry Trends 10

2 Report Outline 11

2.1 Report Scope 11

2.2 Report Summary 11

2.3 Research Methodology 12

2.4 Report Assumptions 12

3 Market Snapshot 13

3.1 Market Definition-Infoholic Research 13

3.2 Importance of Cell-Free DNA testing 13

3.3 Complications of Cell-Free DNA testing 13

3.4 Segmented Addressable Market (SAM) 14

3.5 Industry Trends 14

3.6 Related Markets 16

3.6.1 Liquid biopsy market 16

3.6.2 Transplantation Diagnostics Market 16

4 Market Outlook 16

4.1 Overview 16

4.2 Regulatory framework 17

4.3 Funding scenario 18

4.4 Market segmentation 19

4.5 PEST Analysis 20

4.6 Porter 5(Five) Forces 21

5 Market Characteristics 22

5.1 DRO-Global Cell-free DNA testing Market Dynamics 22

5.1.1 Drivers 22

5.1.1.1 Rising incidence of babies with chromosomal disorders due to increasing number of late pregnancies 22

5.1.1.2 Rising number of cancers 23

5.1.1.3 Growing demand through non-invasive procedures for early disease diagnosis 23

5.1.2 Opportunities 24

5.1.2.1 Increase healthcare spending and growing healthcare awareness in emerging countries 24

5.1.2.2 Increase in mergers & acquisitions 24

5.1.3 Restraints 24

5.1.3.1 High test cost with less reimbursement facilities 24

5.1.3.2 Ethical issues 25

5.1.3.3 Lack of skilled professionals for performing advanced diagnostic testing 25

6 Test Types: Market Size and Analysis 28

6.1 Overview 28

6.2 Non-invasive prenatal testing (NIPT) 29

6.3 Circulating tumour DNA tests 30

6.4 Donor-derived cell free DNA tests 32

7 Application: Market Size and Analysis 33

7.1 Overview 33

7.2 Prenatal testing 35

7.3 Cancer 35

7.4 Transplantation diagnostics 36

8 Regions: Market Size and Analysis 37

8.1 Overview 37

8.2 North America 38

8.2.1 Overview 38

8.2.2 United states 38

8.2.3 Canada 39

8.3 Europe 39

8.3.1 Overview 39

8.3.2 United Kingdom 40

8.3.3 Germany 41

8.3.4 France 41

8.3.5 Spain 41

8.4 APAC 42

8.4.1 Overview 42

8.4.2 India 42

8.4.3 China 43

8.5 Rest of the World 43

8.5.1 Overview 43

8.5.2 Brazil 44

8.5.3 Middle East 44

9 Competitive Landscape 45

9.1 Overview 45

10 Vendor Profiles 48

10.1 Natera, Inc. 48

10.1.1 Overview 48

10.1.2 Natera Inc.:Product offerings 48

10.1.3 NATERA, INC.: Recent Developments 49

10.1.4 Geographic Presence 52

10.1.5 Business Focus 52

10.1.6 SWOT Analysis 53

10.1.7 Business Strategy 53

10.2 Laboratory Corporation of America Holdings (LABCORP) 54

10.2.1 Overview 54

10.2.2 Laboratory Corporaton Of America Holdings: Product Offerings 55

10.2.3 Laboratory Corporation Of America Holdings: Recent Developments 56

10.2.4 Business Unit 58

10.2.5 Geographic Presence 58

10.2.6 Business Focus 59

10.2.7 SWOT Analysis 59

10.2.8 Business Strategy 60

10.3 Illumina, Inc., 61

10.3.1 Overview 61

10.3.2 Illumina, INC: Product offerings 61

10.3.3 Illumina, INC: Recent Developments 62

10.3.4 Geographic Presence 66

10.3.5 Business Focus 66

10.3.6 SWOT Analysis 67

10.3.7 Business Strategy 67

10.4 BEIJING GENOMICS INSTITUTE 68

10.4.1 Overview 68

10.4.2 Beijing Genomics Institute: Product offerings 68

10.4.3 Beijing Genomics Institute: Recent Developments 69

10.4.4 Business Focus 69

10.4.5 SWOT Analysis 69

10.4.6 Business Strategy 70

10.5 F.Hoffmann-La Roche Ltd 71

10.5.1 Overview 71

10.5.2 F. Hoffmann-la Roche: Product Offerings 71

10.5.3 F. Hoffmann-la roche.: Recent Developments 72

10.5.4 Business Unit 75

10.5.5 Geographic Presence 76

10.5.6 Business Focus 76

10.5.7 SWOT Analysis 77

10.5.8 Business Strategy 77

Companies to Watch For 78

10.6 CareDx, Inc 78

10.6.1 Overview 78

10.6.2 caredx: Recent Developments 79

10.7 LifeCodexx AG 80

10.7.1 Overview 80

10.7.2 LifeCodexx AG: Recent Developments 80

10.8 Biocept, Inc. 81

10.8.1 Overview 81

10.8.2 Biocept, Inc.: Recent Developments 82

10.9 Quest Diagnostics 84

10.9.1 Overview 84

10.9.2 Quest Diagnostics: Recent Developments 85

10.10 Guardant Health 87

10.10.1 Overview 87

10.10.2 Guardant Health: Recent Developments 87

10.11 Inivata Limited 89

10.11.1 Overview 89

10.11.2 Inivata Limited: Recent Developments 89

10.12 Personal Genome Diagnostics 90

10.12.1 Overview 90

10.12.2 Personal Genome Diagnostics: Recent Developments 91

10.13 Trovagene 91

10.13.1 Overview 91

10.13.2 Trovagene, Inc.: Recent Developments 92

Annexure 94

Abbreviations 94


List Of Figure

Charts

CHART 1 RESEARCH METHODOLOGY OF GLOBAL CELL-FREE DNA TESTING MARKET 12

CHART 2 WORLDWIDE CELL-FREE DNA TESTING MARKET REVENUE, 2016-2023 (USD MILLION) 15

CHART 3 PEST ANALYSIS OF GLOBAL CELL-FREE DNA TESTING MARKET 20

CHART 4 PORTER 5 FORCES ON GLOBAL CELL-FREE DNA TESTING MARKET 21

CHART 5 DRO-IMPACT ANALYSIS OF GLOBAL CELL-FREE DNA TESTING MARKET 27

CHART 6 KEY STAKEHOLDERS 27

CHART 7 GLOBAL CELL-FREE DNA TESTING MARKET BY TEST TYPE SEGMENTATION, 2016 (%) 29

CHART 8 GLOBAL CELL-FREE DNA TESTING MARKET BY TEST TYPE SEGMENTATION, 2023 (%) 30

CHART 9 GLOBAL NON-INVASIVE PRENATAL TESTING MARKET REVENUE FORECAST,

2016-2023 (USD MILLION) 31

CHART 10 GLOBAL CIRCULATING TUMOUR DNA MARKET REVENUE FORECAST, 2016-2023 (USD MILLION) 32

CHART 11 GLOBAL DONOR-DERIVED CELL-FREE DNA TESTING MARKET REVENUE FORECAST, 2016-2023 (USD MILLION) 33

CHART 12 GLOBAL CELL-FREE DNA TESTING MARKET BY APPLICATION SEGMENTATION, 2016 (%) 35

CHART 13 GLOBAL CELL-FREE DNA TESTING MARKET BY APPLICATION SEGMENTATION, 2023 (%) 35

CHART 14 GLOBAL CELL-FREE DNA TESTING MARKET BY GEOGRAPHICAL SEGMENTATION, 2016 (%) 38

CHART 15 CELL-FREE DNA TESTING MARKET REVENUE IN NORTH AMERICA, 2016-2023 (USD MILLION) 39

CHART 16 CELL-FREE DNA TESTING MARKET REVENUE IN EUROPE, 2016-2023 (USD MILLION) 41

CHART 17 CELL-FREE DNA TESTING MARKET REVENUE IN ASIA-PACIFIC, 2016-2023 (USD MILLION) 43

CHART 18 CELL-FREE DNA TESTING MARKET REVENUE IN REST OF THE WORLD, 2016-2023 (USD MILLION) 44

CHART 19 NATERA: OVERVIEW SNAPSHOT 52

CHART 20 NATERA: GEOGRAPHIC PRESENCE 53

CHART 21 NATERA: SWOT ANALYSIS 54

CHART 22 LABORATORY CORPORATION OF AMERICA HOLDINGS: OVERVIEW SNAPSHOT 58

CHART 23 LABORATORY CORPORATION OF AMERICA HOLDINGS: BUSINESS UNITS 59

CHART 24 LABORATORY CORPORTATION OF AMERICA HOLDINGS: GEOGRAPHICAL PRESENCE 59

CHART 25 LABORATORY CORPORATION OF AMERICA HOLDINGS: SWOT ANALYSIS 60

CHART 26 ILLUMINA, INC: OVERVIEW SNAPSHOT 65

CHART 27 ILLUMINA, INC: GEOGRAPHIC PRESENCE 67

CHART 28 ILLUMINA, INC: SWOT ANALYSIS 68

CHART 29 BEIJING GENOMICS INSTITUTE: SWOT ANALYSIS 70

CHART 30 F. HOFFMANN-LA ROCHE: OVERVIEW SNAPSHOT 75

CHART 31 F. HOFFMANN.LA ROCHE: BUSINESS UNITS 75

CHART 32 F. HOFFMANN-LA ROCHE: GEOGRAPHICAL PRESENCE 77

CHART 33 F. HOFFMANN-LA ROCHE: SWOT ANALYSIS 78


List Of Table

Tables

TABLE 1 FUNDING SCENARIO 18

TABLE 2 GLOBAL CELL-FREE DNA TESTING MARKET BY TEST TYPES, 2016-2023 (USD MILLION) 30

TABLE 3 GLOBAL CELL-FREE DNA TESTING MARKET BY APPLICATION, 2016-2023 (USD MILLION) 34

TABLE 4 GLOBAL CELL-FREE DNA TESTING MARKET REVENUE BY REGIONS, 2016-2023 (USD MILLION) 38

TABLE 5 GLOBAL NON-INVASIVE PRENATAL TESTING MARKET BY VENDOR RANKING, 2016 47

TABLE 6 OTHER PROMINENT VENDORS OF CELL-FREE DNA TESTING MARKET 48

TABLE 7 CAREDX, INC.: SNAPSHOT 79

TABLE 8 LIFECODEXX AG.: SNAPSHOT 81

TABLE 9 BIOCEPT, INC.: SNAPSHOT 83

TABLE 10 QUEST DIAGNOSTICS: SNAPSHOT 85

TABLE 11 GUARDANT HEALTH INC.: SNAPSHOT 88

TABLE 12 INIVATA LIMITED: SNAPSHOT 90

TABLE 13 PERSONAL GENOME DIAGNOSTICS: SNAPSHOT 91

TABLE 14 TROVAGENE, INC.: SNAPSHOT 93

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Products and Companies


Companies

Natera, Inc., Beijing Genomics Institute, F. Hoffmann-La Roche (Roche), Laboratory Corporation of America Holdings, Illumina, Inc., Guardant Health, Trovagene, Inc., Biocept, Inc., and other predominate & niche players.