The cell-free DNA testing is a non-invasive screening test that is widely applied in the field of gynecology, oncology and transplantation. It enables detection of chromosomal abnormalities in the fetus, specific mutations in cancer patients and helps to detect graft rejection. The initial steps involves the collection of patient’s sample with cell-free DNA in different forms, as required, such as fetal DNA, circulating tumor DNA and donor derived cell-free DNA based on the tests to be performed. This is followed by sequencing using various modern sequencing techniques and employing software algorithms to analyse the data to give rapid and accurate results for early disease diagnosis.

Lifestyle and environmental changes followed by unhealthy food habits ultimately leads to incidence of cancer and other related diseases that is likely to drive the growth of the market. Advanced maternal age is one of the major causes behind increasing occurrence of genetic abnormalities among infants, across the world, with several other factors in consideration. Therefore, growing economy in developing countries and increasing demand for effective and safer diagnostic methods are pushing the molecular diagnostic companies to develop advanced diagnostic tests. On the other hand, high cost, lack of skilled labor, and various ethical issues regarding genetic tests are restraining the growth of cfDNA market. However, molecular diagnostics companies have immense scope to expand their product portfolio for cfDNA based solutions, by offering efficient diagnostic tests to enable detection of post-transplantation rejection, such as lung and liver transplantation, among others.

The use of cell-free DNA isolation and extraction kits, tubes, and other consumables has increased due to the rising prevalence of cancer, the increasing key player initiatives, and the rising government initiatives in the cell-free DNA isolation and extraction market. The constant significant investments by healthcare companies to meet industry demand and the growing adoption of cell-free DNA isolation and extraction kits, tubes, and reagents among major end users are the major factors propelling the growth of the global cell-free DNA isolation and extraction market. The global cell-free DNA isolation and extraction market was valued at $169.9 million in 2020 and is expected to reach $735.1 million by 2031, witnessing a CAGR of 14.19% during the forecast period 2021-2031.

Market Segmentation

• Consumable - Cell-Free DNA Isolation and Extraction Kits, ell-Free DNA Isolation and Extraction Tubes, and Other Consumables

• Platform - Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), and Other Platforms

• Technique - Magnetic Beads-Based, Spin Column-Based, and Other Techniques

• Application - Non-Invasive Prenatal Testing (NIPT), Oncology, Transplant Rejection, and Other Applications

• End-User - Academic Research Institutes and Laboratories, Pharmaceutical and Biotechnology Companies, Contract Research Organizations (CROs), Clinical Diagnostic Centers, and Other End Users

Regional Segmentation

• North America - U.S., Canada

• Europe - Germany, U.K., France, Italy, Spain, Denmark, and Rest-of-Europe

• Asia-Pacific - China, India, Japan, Singapore, South Korea, Australia, and Rest-of-Asia-Pacific

• Rest-of-the-World

Market Growth Drivers

• Cell-Free DNA Isolation and Extraction Inclined by Rising Prevalence of Cancer

• Strategic Initiatives by Key Market Players

• Rise in the Field of Microbial Sequencing

Market Challenges

• High Cost of Automated Instruments

• Genomic Data Protection

• Rigid Regulatory Standards

Market Opportunities

• Technological Advancement Toward Innovation in Cell-Free DNA Isolation and Extraction

• Massive Scope for Adoption of NGS-based Genetic Tests in Emerging Markets

Key Companies Profiled

Thermo Fisher Scientific Inc., QIAGEN, Danaher, PerkinElmer, Inc., Endress+Hauser AG, Agilent Technologies, Inc., F. Hoffmann-La Roche Ltd., Merck KGaA, Illumina, Inc., Takara Bio Inc., Aline Biosciences, EpiGentek Group, Inc., Omega Bio-tek, Inc., Promega Corporation, Streck, Inc., AccuBioMed Co., Ltd., AMSBIO, Covaris, Inc., EntroGen, Inc., NeoGeneStar LLC, Norgen Biotek Corp., STRATEC SE, System Biosciences, LLC, Vela Diagnostics

Competitive Landscape

The global cell-free DNA isolation and extraction market comprise well-established and newly emerging companies. Several companies are attempting to sustain their position in the market by launching new products and raising funds to develop new products for the isolation and extraction of cell-free DNA from different sample types. Key market players of the global cell-free DNA isolation and extraction market witnessed product launch, product approval and business funding, and synergistic activities majorly during the period January 2018-November 2021. The inclination of companies toward product launches suggests that the companies are involved in continuously bringing new products to the market to isolate cell-free DNA, which is primarily attributed to an increase in liquid biopsy studies and approval of several liquid biopsy assays by the regulatory agencies.

Key Questions Answered in this Report:

• How is cell-free DNA isolation and extraction revolutionizing oncology?
• What are the major market drivers, challenges, and opportunities in the global cell-free DNA isolation and extraction market?
• What are the underlying structures resulting in the emerging trends within the global cell-free DNA isolation and extraction market?
• How is the COVID-19 pandemic impacting the global cell-free DNA isolation and extraction ecosystem?
• What are the key development strategies that the major players are implementing in order to sustain themselves in the competitive market?
• What are the key regulatory implications in developed and developing regions pertaining to the use of cell-free DNA isolation and extraction-targeted therapies?
• What are the potential entry barriers expected to be faced by the companies willing to enter a particular region?
• How is each market segment expected to grow during the forecast period 2021-2031, and what is the anticipated revenue to be generated by each segment? Following are the segments:
o Consumable (Cell-Free DNA Isolation and Extraction Kits, Cell-Free DNA Isolation and Extraction Tubes, and Other Consumables)
o Platform (Next-Generation Sequencing (NGS), Polymerase Chain Reaction (PCR), and Other Platforms)
o Technique (Magnetic Beads-Based, Spin Column-Based, and Other Techniques)
o Application (Non-Invasive Prenatal Testing (NIPT), Oncology, Transplant Rejection, and Other Applications)
o End User (Pharmaceutical and Biotechnology Companies, Academic and Research Institutions, Contract Research Organizations (CROs), and Other End Users)
o Region (North America, Europe, Asia-Pacific, and Rest-of-the-World)
• What are the growth opportunities for the cell-free DNA isolation and extraction companies in the region of their operation?
• Who are the leading players with significant offerings in the global cell-free DNA isolation and extraction market?
• Which companies are anticipated to be highly disruptive in the future, and why?

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