Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Size is valued at 7.50 Billion in 2024 and is predicted to reach 17.19 Billion by the year 2034 at an 8.8% CAGR during the forecast period for 2025-2034.
Circulating cell-free DNA is defined as DNA fragments released in the bloodstream for essential and chronic disorders. ccfDNA, also known as circulating DNA (ctDNA), has recently gained popularity as a non-invasive illness biomarker. The scientific community's interest in therapeutic applications of ctDNA continues to grow at an exponential rate, fueling its attractiveness as a viable target in a wide range of study domains. One of the primary drivers of the Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market is the growing concern for early cancer detection. Other drivers include the success of NIPTs, increased cancer prevalence, and an increase in research and development initiatives to investigate the usefulness of circulating biomarkers in disease diagnosis. Furthermore, advances in molecular technology are promoting the exploration of cfDNA as a possible tool for the creation of minimally invasive diagnostics. The use of cfDNA-based diagnostics enhances both informed clinical decision-making and patient outcomes.
However, lack of standardization, poor reimbursement policies, and legal and regulatory restrictions are among the factors impeding market expansion. The dearth of awareness among people in underdeveloped nations is also hindering market expansion.
The circulating cell-free dna (ccfDNA) diagnostics market is segmented on the basis of application, technology, products and end-users. by application segment, the market is further segmented into cancer diagnostics, non-invasive prenatal testing (NIPT), transplant monitoring, infectious disease detection, other (e.g., metabolic disorders). whereas, by technology, the market comprises next-generation sequencing (NGS), digital PCR (dPCR), quantitative real-time PCR (qPCR), and others (e.g., mass spectrometry). as per the end-user category, the market includes hospitals & clinics, diagnostic laboratories, research institutions, consumers (home testing). the product segment consists of assays/tests, kits, instruments, software/analytics, and services.
The market for circulating cell-free DNA (ccfDNA) diagnostics is expected to be dominated by non-invasive prenatal testing in terms of revenue. The dominance of this market has been aided by the popularity of non-invasive tests based on cfDNA. Furthermore, the segment is being driven by increased medical coverage for NIPTs. A non-invasive DNA testing process without the hazards associated with amniocentesis or CVS (chorionic villus sample). One of the major aspects driving this segment's revenue growth is increasing knowledge of the procedure's benefits. On the other hand, the category for cancer diagnostics is anticipated to develop the fastest. The main engine of segment expansion is rising investment in the creation of liquid biopsies.
The hospitals & prenatal clinics segment is anticipated to gain the major share of the global circulating cell-free DNA (ccfDNA) diagnostics market in the forecast period. The public's understanding and acceptance of non-invasive prenatal DNA screening is growing, which has boosted this sector's income flow. Hospitals & prenatal clinics remain the leading end-users of the market due to the benefits of NIPTs, such as early risk diagnosis of chromosomal defects like down syndrome and trisomy utilizing NIPTs. However, the fastest expanding end-user of this industry is emerging to be the biotechnology and pharmaceutical industries. The primary driver of this category is the recent approval of companion diagnostics.
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Report Attribute |
Specifications |
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Market size value in 2024 |
USD 7.50 Billion |
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Revenue forecast in 2034 |
USD 17.19 Billion |
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Growth rate CAGR |
CAGR of 8.8% from 2025 to 2034 |
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Quantitative units |
Representation of revenue in US$ Million and CAGR from 2025 to 2034 |
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Historic Year |
2021 to 2024 |
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Forecast Year |
2025-2034 |
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Report coverage |
The forecast of revenue, the position of the company, the competitive market structure, growth prospects, and trends |
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Segments covered |
By Application, Technology, Product and End-Use |
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Regional scope |
North America; Europe; Asia Pacific; Latin America; Middle East & Africa |
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Country scope |
U.S.; Canada; U.K.; Germany; China; India; Japan; Brazil; Mexico ; France; Italy; Spain; South Korea; South East Asia |
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Competitive Landscape |
Hoffmann-La Roche, Natera Inc., Illumina Inc., Agena Bioscience, Paragon Genomics, Thermo Fisher Scientific, Bio-Rad Laboratories, Lucence Health, and Eurofins. |
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Customization scope |
Free customization report with the procurement of the report, Modifications to the regional and segment scope. Particular Geographic competitive landscape. |
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Pricing and available payment methods |
Explore pricing alternatives that are customized to your particular study requirements. |
Chapter 1. Methodology and Scope
1.1. Research Methodology
1.2. Research Scope & Assumptions
Chapter 2. Executive Summary
Chapter 3. Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Snapshot
Chapter 4. Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Variables, Trends & Scope
4.1. Market Segmentation & Scope
4.2. Drivers
4.3. Challenges
4.4. Trends
4.5. Investment and Funding Analysis
4.6. Porter's Five Forces Analysis
4.7. Incremental Opportunity Analysis (US$ MN), 2025-2034
4.8. Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Penetration & Growth Prospect Mapping (US$ Mn), 2024-2034
4.9. Competitive Landscape & Market Share Analysis, By Key Player (2024)
4.10. Use/impact of AI on CIRCULATING CELL-FREE DNA (CCFDNA) DIAGNOSTICS MARKET Industry Trends
Chapter 5. Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Segmentation 1: By Technology, Estimates & Trend Analysis
5.1. Market Share by Technology, 2024 & 2034
5.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Technology:
5.2.1. Next-Generation Sequencing (NGS)
5.2.2. Digital PCR (dPCR)
5.2.3. Quantitative Real-Time PCR (qPCR)
5.2.4. Others (e.g., Mass Spectrometry)
Chapter 6. Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Segmentation 2: By Application, Estimates & Trend Analysis
6.1. Market Share by Application, 2024 & 2034
6.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Application:
6.2.1. Cancer Diagnostics
6.2.2. Non-Invasive Prenatal Testing (NIPT)
6.2.3. Transplant Monitoring
6.2.4. Infectious Disease Detection
6.2.5. Other (e.g., Metabolic Disorders)
Chapter 7. Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Segmentation 3: By Product, Estimates & Trend Analysis
7.1. Market Share by Product, 2024 & 2034
7.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following Product:
7.2.1. Assays/Tests
7.2.2. Kits
7.2.3. Instruments
7.2.4. Software/Analytics
7.2.5. Services
Chapter 8. Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Segmentation 4: By End User, Estimates & Trend Analysis
8.1. Market Share by End User, 2024 & 2034
8.2. Market Size (Value US$ Mn) & Forecasts and Trend Analyses, 2021 to 2034 for the following End User:
8.2.1. Hospitals & Clinics
8.2.2. Diagnostic Laboratories
8.2.3. Research Institutions
8.2.4. Consumers (Home Testing)
Chapter 9. Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Segmentation 5: Regional Estimates & Trend Analysis
9.1. Global Circulating Cell-Free DNA (ccfDNA) Diagnostics Market, Regional Snapshot 2024 & 2034
9.2. North America
9.2.1. North America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.2.1.1. US
9.2.1.2. Canada
9.2.2. North America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
9.2.3. North America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.2.4. North America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Product, 2021-2034
9.2.5. North America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.3. Europe
9.3.1. Europe Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.3.1.1. Germany
9.3.1.2. U.K.
9.3.1.3. France
9.3.1.4. Italy
9.3.1.5. Spain
9.3.1.6. Rest of Europe
9.3.2. Europe Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
9.3.3. Europe Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.3.4. Europe Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Product, 2021-2034
9.3.5. Europe Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.4. Asia Pacific
9.4.1. Asia Pacific Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.4.1.1. India
9.4.1.2. China
9.4.1.3. Japan
9.4.1.4. South Korea
9.4.1.5. Southeast Asia
9.4.1.6. Rest of Asia Pacific
9.4.2. Asia Pacific Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
9.4.3. Asia Pacific Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.4.4. Asia Pacific Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts By Product, 2021-2034
9.4.5. Asia Pacific Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.5. Latin America
9.5.1. Latin America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Country, 2021-2034
9.5.1.1. Brazil
9.5.1.2. Mexico
9.5.1.3. Argentina
9.5.1.4. Rest of Latin America
9.5.2. Latin America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
9.5.3. Latin America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.5.4. Latin America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Product, 2021-2034
9.5.5. Latin America Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
9.6. Middle East & Africa
9.6.1. Middle East & Africa Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by country, 2021-2034
9.6.1.1. GCC Countries
9.6.1.2. South Africa
9.6.1.3. Rest of Middle East and Africa
9.6.2. Middle East & Africa Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Technology, 2021-2034
9.6.3. Middle East & Africa Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Application, 2021-2034
9.6.4. Middle East & Africa Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by Product, 2021-2034
9.6.5. Middle East & Africa Circulating Cell-Free DNA (ccfDNA) Diagnostics Market Revenue (US$ Million) Estimates and Forecasts by End User, 2021-2034
Chapter 10. Competitive Landscape
10.1. Major Mergers and Acquisitions/Strategic Alliances
10.2. Company Profiles
10.2.1. Hoffmann-La Roche
10.2.1.1. Business Overview
10.2.1.2. Key Product/Service
10.2.1.3. Financial Performance
10.2.1.4. Geographical Presence
10.2.1.5. Recent Developments with Business Strategy
10.2.2. Natera Inc.
10.2.3. Illumina Inc.
10.2.4. Agena Bioscience
10.2.5. Paragon Genomics
10.2.6. Thermo Fisher Scientific
10.2.7. Bio-Rad Laboratories
10.2.8. Lucence Health
10.2.9. Eurofins
By Application
By Technology
By Product
By End-User
By Region-
North America-
Europe-
Asia-Pacific-
Latin America-
Middle East & Africa-
InsightAce Analytic follows a standard and comprehensive market research methodology focused on offering the most accurate and precise market insights. The methods followed for all our market research studies include three significant steps – primary research, secondary research, and data modeling and analysis - to derive the current market size and forecast it over the forecast period. In this study, these three steps were used iteratively to generate valid data points (minimum deviation), which were cross-validated through multiple approaches mentioned below in the data modeling section.
Through secondary research methods, information on the market under study, its peer, and the parent market was collected. This information was then entered into data models. The resulted data points and insights were then validated by primary participants.
Based on additional insights from these primary participants, more directional efforts were put into doing secondary research and optimize data models. This process was repeated till all data models used in the study produced similar results (with minimum deviation). This way, this iterative process was able to generate the most accurate market numbers and qualitative insights.
Secondary research
The secondary research sources that are typically mentioned to include, but are not limited to:
The paid sources for secondary research like Factiva, OneSource, Hoovers, and Statista
Primary Research:
Primary research involves telephonic interviews, e-mail interactions, as well as face-to-face interviews for each market, category, segment, and subsegment across geographies
The contributors who typically take part in such a course include, but are not limited to:
Data Modeling and Analysis:
In the iterative process (mentioned above), data models received inputs from primary as well as secondary sources. But analysts working on these models were the key. They used their extensive knowledge and experience about industry and topic to make changes and fine-tuning these models as per the product/service under study.
The standard data models used while studying this market were the top-down and bottom-up approaches and the company shares analysis model. However, other methods were also used along with these – which were specific to the industry and product/service under study.
To know more about the research methodology used for this study, kindly contact us/click here.
