Cell-free Fetal DNA Testing Market Outlook (2023 to 2033)

The cell-free fetal DNA testing market is to capture a CAGR of 10.9% during the forecast period. The market is projected to be valued at US$ 1,466.3 million in 2023 and is likely to be worth US$ 4,124.7 million by 2033.

The adoption of cell-free fetal DNA testing is likely to rise due to an extension of prenatal testing in a safe and non-invasive method during the forecast period. However, prenatal tests are used to find any irregularities in a fetus with screening procedures.

The two predominant prenatal tests are chorionic villus sampling (CVS) and amniocentesis. These both are invasive and could possess harm to the developing fetus. In some cases, it can cause miscarriage. Hence, to detect such problems, the demand for cell-free fetal DNA testing is likely to rise in recent years.

It is possible to do cell-free fetal DNA testing to determine the health of the fetus if the mother has been exposed to teratogens like alcohol, lead, or UV radiation. Growing public awareness of fetal anomalies is projected to be one of the factors driving high revenue share in the cell-free DNA testing market.

Report Attributes Details
Cell-free Fetal DNA Testing Market Value (2023) US$ 1,466.3 million
Cell-free Fetal DNA Testing Market Anticipated Value (2033) US$ 4,124.7 million
Cell-free Fetal DNA Testing Market Projected Growth Rate (2023 to 2033) 10.9%

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Key Safety Measures Driving the Cell-free Fetal DNA Testing Industry

A Significant Shift in Diagnosis

Amniocentesis and chorionic villus sampling prenatal tests are possible within 14-20 weeks and 10-13 weeks of pregnancy respectively. However, cell-free fetal DNA testing is used to detect aneuploidy syndromes and fetal Down syndrome and signals a vital shift in diagnostic practice and prenatal screening. These all factors are flourishing in the market size during the forecast period.

Growing Awareness

The growth of the global cell-free fetal DNA testing market is increasing awareness and the requirement for safe or low-risk obstetric procedures for prenatal testing. Moreover, the technology is used in cell-free DNA analysis and its application to prenatal screening for aneuploidy is rapidly changing in recent years.

Technical Advancements

As technology progresses, improved innovative testing techniques are projected to hit the market and increase competition, which may put pressure on leading players in the cell-free fetal DNA testing industry. It is preferred over karyotyping due to its accurate results and growing demand from end-user segments.

Effective Results

The growth of the cell-free fetal DNA testing market is primarily attributed to accurate and effective results for aneuploidy screening during the forecast period. To detect specific changes, chromosomal abnormalities, and other several conditions of an unborn baby raising the demand for cell-free fetal DNA testing for better results in recent years.

Growth Limiting Factors in the Cell-Free Fetal DNA Testing Market

The high cost of cell-free fetal DNA testing is one of the main reasons limiting the growth of the global market for these tests. Due to patients' limited disposable means, which are unable to adopt cell-free fetal DNA testing, the market's size has recently been constrained.

Cell-free fetal DNA testing is not always accurate in the case of twins, and the market expansion for these tests is expected to be constrained by their high costs, a shortage of qualified physicians, the absence of insurance coverage for these tests, and their poor reimbursement.

Sabyasachi Ghosh
Sabyasachi Ghosh

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Regional Insights

Cell-Free Fetal DNA Testing Industry Outlook in North America

Region North America
Market Share % (2022) 36.5%

The global cell-free fetal DNA testing market is expected to register a healthy CAGR for the forecast period. North America dominates the cell-free fetal DNA testing market as it held more than 36.5% of the share in 2022.

Due to the rising high occurrence of several diseases, rising number of aneuploidies, advancement in the field of aneuploidies, and developed healthcare infrastructure. The market in North America is rising with the adoption of cell-free fetal DNA testing in recent years.

Europe to be the Second Leading Market

Region Europe
Market Share % (2022) 32.2%

The Europe region is followed by North America to hold huge potential for growth in the global cell-free fetal DNA testing market as it held 32.2% of the share in 2022.

The demand for cell-free fetal DNA testing has increased in recent years due to its quick and accurate results, without any risk to developing fetuses. The United Kingdom is a prominent country to lead the market in the region due to several abnormalities and safe detection during the forecast period.

Key Players are Consolidating their Grasp in Countries of Asia for High Revenues

The Asia Pacific cell-free fetal DNA testing industry is projected to expand at a stellar pace through 2033. FMI has projected that India’s market is estimated to witness a 12.4% CAGR, whereas China’s market is estimated to exhibit an 11.6% CAGR. These high-growth countries are pulling up the overall market growth rate.

Genetic diseases impact the fetuses in the mother’s womb. Early detection and diagnosis of these diseases help measure the total risk of these diseases and the chances of their recurrence. Also, parents with a family history or an existing child with a genetic disease bear a high risk of having such a child. All these factors and high fertility rates indicate how important cell-free fetal DNA testing is among expecting parents.

Technological advances and upgradation in the medical infrastructure in the economies of Asia are fueling market expansion further. Surging awareness about the necessity of prenatal testing is emerging as another key propeller for cell-free fetal DNA testing.

The rapidly spreading diagnostic sector in the region is underpinned by robust adoption and surging technological advancements. The booming diagnostic sector is projected to have a positive effect on the application of cell-free fetal DNA testing.

The growth of cell-free fetal DNA testing is running parallel to the increasing fertility rates and genetic diseases among infants. Furthermore, the advancing healthcare scene is expected to have a compounding effect on the growth of cell-free fetal DNA testing in developed and developing countries alike.

The high birth rate, large population, and consanguineous marriage tradition in certain Indian communities are fueling the rate of genetic disorders in India. As a result, the surging prevalence of genetic disorders in infants is catalyzing the demand for cell-free fetal DNA testing.

A couple of factors, including the surging number of pregnant females using prenatal screening and rising mandatory policies for screening tests, are pushing the adoption of cell-free fetal DNA testing.

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Segment Insights

Detection of Abnormal Chromosome Number Segment to Monopolize the Market

The market based on test type is categorized into abnormal chromosome number detection, gender testing, and paternally inherited disorder detection. Among these, the abnormal chromosome number detection type dominates the market during the forecast period.

This segment type locates the additional chromosome in a pregnant woman's blood, as well as the missing chromosome. Furthermore, aberrant chromosome number identification has recently been used to test for Down syndrome and other disorders.

Startups’ Contribution to the Cell-free Fetal DNA Testing Industry

New investors are entering the market as a result of technological advancements and increased income potential. Cell-free fetal DNA testing is becoming more popular as the demand for comprehensive patient care rises. For instance,

  • Sequenom is committed to the creation and marketing of laboratory-developed tests (LDTs) for illnesses and problems affecting fetuses. It is a provider of cell-free, non-invasive fetal nucleic acids for use in prenatal testing.
  • Ariosa Diagnostics is a global molecular diagnostics firm dedicated to enhancing overall patient care by offering testing services through its CLIA laboratory. Ariosa was acquired by Roche in December 2014. To undertake a directed examination of cell-free DNA in blood, Ariosa has created unique technologies.
  • Recombine offers services for clinical genetic testing. The company claims that CarrierMap, its first offering, is a thorough and affordable clinical genetic test. Additionally, it oversees the collection of samples for genetic testing and genetic counseling.
  • ChromoMap is a non-invasive prenatal screening that uses one tube of maternal blood to give information on the health of the fetal chromosomes. It increases patient confidence in their pregnancy while minimizing the risk of miscarriage associated with invasive diagnostic methods.

Influence of Competition on the Cell-free Fetal DNA Testing Market

The market is populated with large as well as medium-sized players vying for a great market share. Manufacturers are taking solid steps like research and development and making efforts in sourcing the latest technology.

The key businesses are developing a variety of remedies to meet patients' expectations for a sickness cure. These players are gaining the lion's share while using different marketing strategies to increase sales. Collaborations, mergers, and acquisitions are a few of these tactics.

Vendors are also strengthening their distribution network in different countries. Moreover, firms are taking strategic initiatives to invigorate their market position.

Recent Developments in the Cell-free Fetal DNA Testing

  • In Aug 2019, the company named Agilent Technologies announced the acquisition of BioTek Instruments, a healthcare equipment manufacturing company, to expand its product portfolio in the coming years.
  • Recently, cell-free DNA testing manufacturers are innovating various solutions to detect cancer & monitor its therapy.

Leading Global Players in the Cell-free Fetal DNA Testing Market

  • Sequenom Laboratories
  • Illumina, Inc.
  • Ariosa Diagnostics
  • Arup Laboratories
  • The Fetal Medicine Center
  • Apollo Path labs

Report Scope

Report Attributes Details
Growth Rate CAGR of 10.9% from 2023 to 2033
Base Year for Estimation 2022
Historical Data 2018 to 2022
Forecast Period 2023 to 2033
Quantitative Units Revenue in US$ million and CAGR from 2023 to 2033
Report Coverage Revenue Forecast, Volume Forecast, Company Ranking, Competitive Landscape, Growth Factors, Trends, and Pricing Analysis
Segments Covered
  • Test Types
  • Region
Regions Covered
  • North America
  • Latin America
  • Europe
  • East Asia
  • South Asia
  • Oceania
  • The Middle East and Africa
Key Countries Profiled
  • The United States
  • Canada
  • Brazil
  • Argentina
  • Germany
  • The United Kingdom
  • France
  • Spain
  • Italy
  • Nordics
  • BENELUX
  • Australia & New Zealand
  • China
  • India
  • ASIAN
  • GCC
  • South Africa
Key Companies Profiled
  • Sequenom Laboratories
  • Illumina, Inc.
  • Ariosa Diagnostics
  • Arup Laboratories
  • The Fetal Medicine Centre
  • Apollo Path labs
Customization Available Upon Request

Key Segmentation

By Test Type:

  • Detection of Abnormal Chromosome Number
  • Gender Testing
  • Paternally Inherited Disorders

By Region:

  • North America
  • Latin America
  • The Asia Pacific
  • The Middle East and Africa
  • Europe

Frequently Asked Questions

What will be the Cell-free Fetal DNA Testing Market Size Value in 2023?

In the current year 2023, the overall market size could be around US$ 1,466.3 million.

What is the Expected CAGR for Global Cell-free Fetal DNA Testing Services?

Until 2033, the overall demand for cell-free fetal DNA testing services could progress at 10.9% CAGR.

How Cell-free Fetal DNA Testing Market Players are Performing in the United States?

The regional market players together contributed for about 36.5% of the global market revenue.

What is the Share of Europe in Adoption of Cell-free Fetal DNA Testing Services?

Adoption of cell-free fetal DNA testing services in Europe held almost 32.2% market share in 2022.

Which Test Type of Cell-free Fetal DNA Testing Mostly Remains in Demand?

The abnormal chromosome number detection segment remains in higher demand.

Table of Content

1. Executive Summary

    1.1. Global Market Outlook

    1.2. Demand-side Trends

    1.3. Supply-side Trends

    1.4. Technology Roadmap Analysis

    1.5. Analysis and Recommendations

2. Market Overview

    2.1. Market Coverage / Taxonomy

    2.2. Market Definition / Scope / Limitations

3. Market Background

    3.1. Market Dynamics

        3.1.1. Drivers

        3.1.2. Restraints

        3.1.3. Opportunity

        3.1.4. Trends

    3.2. Scenario Forecast

        3.2.1. Demand in Optimistic Scenario

        3.2.2. Demand in Likely Scenario

        3.2.3. Demand in Conservative Scenario

    3.3. Opportunity Map Analysis

    3.4. Investment Feasibility Matrix

    3.5. PESTLE and Porter’s Analysis

    3.6. Regulatory Landscape

        3.6.1. By Key Regions

        3.6.2. By Key Countries

    3.7. Regional Parent Market Outlook

4. Global Market Analysis 2018 to 2022 and Forecast, 2023 to 2033

    4.1. Historical Market Size Value (US$ Million) Analysis, 2018 to 2022

    4.2. Current and Future Market Size Value (US$ Million) Projections, 2023 to 2033

        4.2.1. Y-o-Y Growth Trend Analysis

        4.2.2. Absolute $ Opportunity Analysis

5. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Test Type

    5.1. Introduction / Key Findings

    5.2. Historical Market Size Value (US$ Million) Analysis By Test Type, 2018 to 2022

    5.3. Current and Future Market Size Value (US$ Million) Analysis and Forecast By Test Type, 2023 to 2033

        5.3.1. Detection of Abnormal Chromosome Number

        5.3.2. Gender Testing

        5.3.3. Paternally Inherited Disorders

    5.4. Y-o-Y Growth Trend Analysis By Test Type, 2018 to 2022

    5.5. Absolute $ Opportunity Analysis By Test Type, 2023 to 2033

6. Global Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Region

    6.1. Introduction

    6.2. Historical Market Size Value (US$ Million) Analysis By Region, 2018 to 2022

    6.3. Current Market Size Value (US$ Million) Analysis and Forecast By Region, 2023 to 2033

        6.3.1. North America

        6.3.2. Latin America

        6.3.3. Western Europe

        6.3.4. Eastern Europe

        6.3.5. South Asia and Pacific

        6.3.6. East Asia

        6.3.7. Middle East and Africa

    6.4. Market Attractiveness Analysis By Region

7. North America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    7.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    7.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        7.2.1. By Country

            7.2.1.1. USA

            7.2.1.2. Canada

        7.2.2. By Test Type

    7.3. Market Attractiveness Analysis

        7.3.1. By Country

        7.3.2. By Test Type

    7.4. Key Takeaways

8. Latin America Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    8.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    8.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        8.2.1. By Country

            8.2.1.1. Brazil

            8.2.1.2. Mexico

            8.2.1.3. Rest of Latin America

        8.2.2. By Test Type

    8.3. Market Attractiveness Analysis

        8.3.1. By Country

        8.3.2. By Test Type

    8.4. Key Takeaways

9. Western Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    9.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    9.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        9.2.1. By Country

            9.2.1.1. Germany

            9.2.1.2. UK

            9.2.1.3. France

            9.2.1.4. Spain

            9.2.1.5. Italy

            9.2.1.6. Rest of Western Europe

        9.2.2. By Test Type

    9.3. Market Attractiveness Analysis

        9.3.1. By Country

        9.3.2. By Test Type

    9.4. Key Takeaways

10. Eastern Europe Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    10.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    10.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        10.2.1. By Country

            10.2.1.1. Poland

            10.2.1.2. Russia

            10.2.1.3. Czech Republic

            10.2.1.4. Romania

            10.2.1.5. Rest of Eastern Europe

        10.2.2. By Test Type

    10.3. Market Attractiveness Analysis

        10.3.1. By Country

        10.3.2. By Test Type

    10.4. Key Takeaways

11. South Asia and Pacific Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    11.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    11.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        11.2.1. By Country

            11.2.1.1. India

            11.2.1.2. Bangladesh

            11.2.1.3. Australia

            11.2.1.4. New Zealand

            11.2.1.5. Rest of South Asia and Pacific

        11.2.2. By Test Type

    11.3. Market Attractiveness Analysis

        11.3.1. By Country

        11.3.2. By Test Type

    11.4. Key Takeaways

12. East Asia Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    12.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    12.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        12.2.1. By Country

            12.2.1.1. China

            12.2.1.2. Japan

            12.2.1.3. South Korea

        12.2.2. By Test Type

    12.3. Market Attractiveness Analysis

        12.3.1. By Country

        12.3.2. By Test Type

    12.4. Key Takeaways

13. Middle East and Africa Market Analysis 2018 to 2022 and Forecast 2023 to 2033, By Country

    13.1. Historical Market Size Value (US$ Million) Trend Analysis By Market Taxonomy, 2018 to 2022

    13.2. Market Size Value (US$ Million) Forecast By Market Taxonomy, 2023 to 2033

        13.2.1. By Country

            13.2.1.1. GCC Countries

            13.2.1.2. South Africa

            13.2.1.3. Israel

            13.2.1.4. Rest of MEA

        13.2.2. By Test Type

    13.3. Market Attractiveness Analysis

        13.3.1. By Country

        13.3.2. By Test Type

    13.4. Key Takeaways

14. Key Countries Market Analysis

    14.1. USA

        14.1.1. Pricing Analysis

        14.1.2. Market Share Analysis, 2022

            14.1.2.1. By Test Type

    14.2. Canada

        14.2.1. Pricing Analysis

        14.2.2. Market Share Analysis, 2022

            14.2.2.1. By Test Type

    14.3. Brazil

        14.3.1. Pricing Analysis

        14.3.2. Market Share Analysis, 2022

            14.3.2.1. By Test Type

    14.4. Mexico

        14.4.1. Pricing Analysis

        14.4.2. Market Share Analysis, 2022

            14.4.2.1. By Test Type

    14.5. Germany

        14.5.1. Pricing Analysis

        14.5.2. Market Share Analysis, 2022

            14.5.2.1. By Test Type

    14.6. UK

        14.6.1. Pricing Analysis

        14.6.2. Market Share Analysis, 2022

            14.6.2.1. By Test Type

    14.7. France

        14.7.1. Pricing Analysis

        14.7.2. Market Share Analysis, 2022

            14.7.2.1. By Test Type

    14.8. Spain

        14.8.1. Pricing Analysis

        14.8.2. Market Share Analysis, 2022

            14.8.2.1. By Test Type

    14.9. Italy

        14.9.1. Pricing Analysis

        14.9.2. Market Share Analysis, 2022

            14.9.2.1. By Test Type

    14.10. Poland

        14.10.1. Pricing Analysis

        14.10.2. Market Share Analysis, 2022

            14.10.2.1. By Test Type

    14.11. Russia

        14.11.1. Pricing Analysis

        14.11.2. Market Share Analysis, 2022

            14.11.2.1. By Test Type

    14.12. Czech Republic

        14.12.1. Pricing Analysis

        14.12.2. Market Share Analysis, 2022

            14.12.2.1. By Test Type

    14.13. Romania

        14.13.1. Pricing Analysis

        14.13.2. Market Share Analysis, 2022

            14.13.2.1. By Test Type

    14.14. India

        14.14.1. Pricing Analysis

        14.14.2. Market Share Analysis, 2022

            14.14.2.1. By Test Type

    14.15. Bangladesh

        14.15.1. Pricing Analysis

        14.15.2. Market Share Analysis, 2022

            14.15.2.1. By Test Type

    14.16. Australia

        14.16.1. Pricing Analysis

        14.16.2. Market Share Analysis, 2022

            14.16.2.1. By Test Type

    14.17. New Zealand

        14.17.1. Pricing Analysis

        14.17.2. Market Share Analysis, 2022

            14.17.2.1. By Test Type

    14.18. China

        14.18.1. Pricing Analysis

        14.18.2. Market Share Analysis, 2022

            14.18.2.1. By Test Type

    14.19. Japan

        14.19.1. Pricing Analysis

        14.19.2. Market Share Analysis, 2022

            14.19.2.1. By Test Type

    14.20. South Korea

        14.20.1. Pricing Analysis

        14.20.2. Market Share Analysis, 2022

            14.20.2.1. By Test Type

    14.21. GCC Countries

        14.21.1. Pricing Analysis

        14.21.2. Market Share Analysis, 2022

            14.21.2.1. By Test Type

    14.22. South Africa

        14.22.1. Pricing Analysis

        14.22.2. Market Share Analysis, 2022

            14.22.2.1. By Test Type

    14.23. Israel

        14.23.1. Pricing Analysis

        14.23.2. Market Share Analysis, 2022

            14.23.2.1. By Test Type

15. Market Structure Analysis

    15.1. Competition Dashboard

    15.2. Competition Benchmarking

    15.3. Market Share Analysis of Top Players

        15.3.1. By Regional

        15.3.2. By Test Type

16. Competition Analysis

    16.1. Competition Deep Dive

        16.1.1. Sequenom Laboratories

            16.1.1.1. Overview

            16.1.1.2. Product Portfolio

            16.1.1.3. Profitability by Market Segments

            16.1.1.4. Sales Footprint

            16.1.1.5. Strategy Overview

                16.1.1.5.1. Marketing Strategy

        16.1.2. Illumina, Inc.

            16.1.2.1. Overview

            16.1.2.2. Product Portfolio

            16.1.2.3. Profitability by Market Segments

            16.1.2.4. Sales Footprint

            16.1.2.5. Strategy Overview

                16.1.2.5.1. Marketing Strategy

        16.1.3. Ariosa Diagnostics

            16.1.3.1. Overview

            16.1.3.2. Product Portfolio

            16.1.3.3. Profitability by Market Segments

            16.1.3.4. Sales Footprint

            16.1.3.5. Strategy Overview

                16.1.3.5.1. Marketing Strategy

        16.1.4. Arup Laboratories

            16.1.4.1. Overview

            16.1.4.2. Product Portfolio

            16.1.4.3. Profitability by Market Segments

            16.1.4.4. Sales Footprint

            16.1.4.5. Strategy Overview

                16.1.4.5.1. Marketing Strategy

        16.1.5. The Fetal Medicine Centre

            16.1.5.1. Overview

            16.1.5.2. Product Portfolio

            16.1.5.3. Profitability by Market Segments

            16.1.5.4. Sales Footprint

            16.1.5.5. Strategy Overview

                16.1.5.5.1. Marketing Strategy

        16.1.6. Apollo Path labs

            16.1.6.1. Overview

            16.1.6.2. Product Portfolio

            16.1.6.3. Profitability by Market Segments

            16.1.6.4. Sales Footprint

            16.1.6.5. Strategy Overview

                16.1.6.5.1. Marketing Strategy

        16.1.7. Trovagene, Inc

            16.1.7.1. Overview

            16.1.7.2. Product Portfolio

            16.1.7.3. Profitability by Market Segments

            16.1.7.4. Sales Footprint

            16.1.7.5. Strategy Overview

                16.1.7.5.1. Marketing Strategy

        16.1.8. Roche Holdings AG

            16.1.8.1. Overview

            16.1.8.2. Product Portfolio

            16.1.8.3. Profitability by Market Segments

            16.1.8.4. Sales Footprint

            16.1.8.5. Strategy Overview

                16.1.8.5.1. Marketing Strategy

        16.1.9. Berry Genomics Co. Ltd

            16.1.9.1. Overview

            16.1.9.2. Product Portfolio

            16.1.9.3. Profitability by Market Segments

            16.1.9.4. Sales Footprint

            16.1.9.5. Strategy Overview

                16.1.9.5.1. Marketing Strategy

        16.1.10. Premaitha Health

            16.1.10.1. Overview

            16.1.10.2. Product Portfolio

            16.1.10.3. Profitability by Market Segments

            16.1.10.4. Sales Footprint

            16.1.10.5. Strategy Overview

                16.1.10.5.1. Marketing Strategy

17. Assumptions & Acronyms Used

18. Research Methodology

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