Global Cell Free DNA Isolation and Extraction Market

Biomarker play an important role in development of translational medicine, which facilitates translation of basic research into medical advances. In line with this, most pharmaceutical and biotechnology companies are committing to associate their therapeutic drugs with diagnostic assays to monitor the drug response as number of biomarkers are directly associated with drugs. For instance, Thermo Fisher Scientific in collaboration with Novartis AG, Pfizer Inc. and GlaxoSmithKline Plc. is developing multi-market universal next-generation sequencing for multiple companion diagnostic programs, which will help pharma companies to match cancer patients with specific drug candidate

Early detection of cancer requires suitable diagnostic procedures to screen asymptomatic population which is on average risk of cancer, particularly for breast cancer, cervical cancers, colon cancers and melanoma. Increasing awareness of early signs and symptoms of cancer among physicians and other healthcare professionals as well as among general population. Governments in developed countries such as the U.S. raise funds for cancer research to aid in the diagnosis and treatment. Clinical trials are also funded by governments to support companies in developing effective diagnostic tests for cancer. The cell-free DNA isolation and extraction market drivers includes inclusion of cancer screening tests in national cancer screening programs, increasing discretionary funding for cancer research, associating drugs with diagnostic assays, constantly growing list of cancer biomarkers, exploring next-generation sequencing techniques for cancer diagnostics and others. Market restrains includes lack of standardization and appropriate controls of cell free DNA kits, insurance coverage and reimbursement issues and enormous R&D investment with no therapeutic result.

The global cell free DNA isolation and extraction market is anticipated to grow over $442.8 Million with 14,638.3 Thousand units by 2026, aided by the rising demand for non-invasive prenatal testing among high risk pregnant women and increased demand for liquid biopsy. North America is the leading contributor to the global cell free DNA isolation and extraction market, in terms of both, volume and revenue. The contribution of North America to the global cell free DNA isolation and extraction market was volume and valued to be approximately 59% and 61% in 2016, respectively. However, Asia Pacific is expected to grow, by volume, at an impressive 21.15% CAGR during the forecast period. The extraction kits hold the largest share of the total cfDNA extraction/isolation market and growing at a double digit CAGR. Furthermore, with magnetic bead-based kits, proteinase and heat treatment are unnecessary, enabling all the processes to be conducted at room temperature. As compared to traditional cfDNA extraction methods, there is also a significant reduction in processing and hands-on time.

Among the applications, non-invasive prenatal testing (NIPT) leads the cfDNA extraction/isolation market share. In 2016, the NIPT segment accounted for 72% of the total market. However, the market share of NIPT segment is expected to decrease substantially during the forecast period owing high market penetration rate of cfDNA technology in the cancer diagnostic and screening application. In 2016, next generation sequencing was the most used downstream quantification technique for cfDNA and accounted for 71% of the total sample processing share and is expected to remain the leading quantification technique in 2026.

This market intelligence report provides a multidimensional view of the global cell free DNA isolation and extraction market in terms of market size and growth potential. This research report aims at answering various aspects of the global cell free DNA isolation and extraction market with the help of the key factors driving the market, threats that can possibly inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion.

Furthermore, the competitive landscape chapter in the report explicates the competitive nature of the global market and enables the reader to get acquainted with the recent market activities, such as product launches, regulatory clearance, and certifications, partnerships, collaborations, business expansions as well as mergers and acquisitions, among others. The research report provides a comprehensive analysis of the product sales, and manufacturers, and trend analysis by segments and demand analysis by geographical regions.

The report also profiles  companies including several key players, such as Agilent Technologies, Inc., Berry Genomics, BGI Diagnostics, BioCAT GmbH, F. Hoffmann-La Roche AG, GATC Biotech AG., Illumina, Inc., Laboratory Corporation of America, LifeCodexx AG, Merck KGaA, Natera Inc., NIPD Genetics, Norgen Biotek Corp., PreAnalytiX GmbH, Premaitha Health Plc, QIAGEN, Quest Diagnostics, SeraCare Life Sciences, Inc., STRATEC Biomedical AG, Thermo Fisher Scientific, AccuBioMed, Aline Biosciences, BioChain, Bioo Scientific Corporation, COVARIS, INC., Epigentek Group Inc., NeoGenStar LLC, Omega Bio-tek, Inc, Promega Corporation, System Biosciences, LLC., and STRECK, INC.,  among others.

Cell-free DNA are non-encapsulated DNA that enters the bloodstream during apoptosis or necrosis. This cell-free DNA is cleared by macrophages during normal body functioning, but overproduction of cells during cancer produces extra cfDNA in the blood. The CfDNA are found in blood, plasma, serum, or other body fluids and holds clinical significance in diagnosis, monitoring, and detection of various non-invasive diseases. The cfDNA is a screening method for tumors and other fetal DNA studies, they are challenging to extract as they are found in small quantities, and so reliable and consistent methods are required to isolate the less abundant cell-free DNA with higher sensitivity as they have a half-life of about two hours. The global cfDNA extraction and isolation industry is a multi-billion-dollar market which consists of multitudinous companies involved in the development of cfDNA extraction/isolation kits and automated instruments based on various sequencing platforms such as NGS and PCR to bolster the increasing demand for non-invasive screening tests and procedures.

cfDNA extraction and isolation products include extraction/isolation kit, automated instruments, and other consumables to improve the overall non-invasive screening process efficiency. Cell-free DNA testing is a new and efficient technology in which free-flowing DNA fragments from a liquid sample such as saliva, urine, and blood from patients are analyzed to screen a condition or disease. Cell-free DNA testing is essential solutions for the medical diagnostic companies that are facing increasing level of demand for high productivity and cost reduction. The recent advances in Cell-free DNA testing have paved the way for the development of multiple advanced technologies to aid in the battle against cancer and various other diseases including genetic and infectious diseases. The advent of screening procedures such as NIPT and liquid biopsy with improved efficiency of screening results are the most prominent factors facilitating the growth of Cell-free DNA testing in the medical diagnostic industry. Furthermore, these advanced testing procedures have also enabled the companies in the medical diagnostic industry to meet the regulatory compliance as well as manage their profit margins and remain competitive in the market.

The purpose of this study is to gain a holistic view of the Cell-free DNA testing market in terms of various influencing factors, such as recent trends and technological advancements. The scope of this report constitutes an in-depth study of the global Cell-free DNA testing market, including a thorough analysis of the products across different regions. The market has been segmented into ‘product’, ‘platform’, ‘application ‘and ‘regions’. The report presents the reader with an opportunity to unlock comprehensive insights concerning the market and helps in forming well informed strategic decisions. The research uncovers some of the substantial parameters that must be taken into consideration before entering the market.

This research report aims at answering various aspects of the global Cell-free DNA testing market with the help of the key factors driving the market, restraints that can inhibit the overall market growth, and the current growth opportunities that are going to shape the future trajectory of the market expansion. The report includes an in-depth examination of the key ecosystem players and key strategies and developments taking place in this market. Moreover, the report includes chapters on market dynamics (market drivers, opportunities and challenges) and industry analysis as well.

The research study considers the market share analysis for a comprehensive understanding of the global Cell-free DNA testing market and assesses the factors governing the same. Growth share matrix and detailed pricing analysis have been included in the report. The market by region has been further sub-segmented into various countries, and in each sub-segment, the key market trends, list of the key players, and the recent developments that have taken place have been discussed.

The key players who have been contributing significantly to the Cell-free DNA testing market include Agilent Technologies, Inc., Berry Genomics, BGI Diagnostics, BioCAT GmbH, F. Hoffmann-La Roche AG, GATC Biotech AG., Illumina, Inc., Laboratory Corporation of America, LifeCodexx AG, Merck KGaA, Natera Inc., NIPD Genetics, Norgen Biotek Corp., PreAnalytiX GmbH, Premaitha Health Plc, QIAGEN, Quest Diagnostics, SeraCare Life Sciences, Inc., STRATEC Biomedical AG, Thermo Fisher Scientific, AccuBioMed, Aline Biosciences, BioChain, Bioo Scientific Corporation, COVARIS, INC., Epigentek Group Inc., NeoGenStar LLC, Omega Bio-tek, Inc, Promega Corporation, System Biosciences, LLC., and STRECK, INC.,  among others.