Rockville, MD , Dec. 05, 2024 (GLOBE NEWSWIRE) -- According to Fact.MR, a market research and competitive intelligence provider, the global Cell-free DNA Mutation Diagnostics Market is estimated to reach a valuation of US$ 8,830.4 million in 2024 and is expected to grow at a CAGR of 24.9% during the forecast period of (2024 to 2034).
The global cell-free DNA mutation diagnostics market is set to experience exponential growth on the back of increasing demand in prenatal testing, oncology, & organ transplantation. PCR technologies and Next-generation sequencing (NGS) have been in a state of constant development by local players as well as by global manufacturers. The market is poised for a revolution in precision medicine by offering non-invasive solutions for early disease detection and real-time monitoring.
The diagnostics of cfDNA have gained significant momentum as health providers and researchers move towards its non-invasive approach for the detection of mutation used in oncology across the globe, along with early-stage cancer detection, tumor mutational burden assessment, and minimal residual disease measurement, cfDNA diagnostics is seen as a valuable tool for cancer therapy. NIPT also remains popular, standing at a high level of mainstreaming and a growing interest in the test and action from governments in North America, Europe, and Asia-Pacific.
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Key Takeaways from Market Study:
- The global Cell-free DNA mutation diagnostics market is projected to grow at 9% CAGR and reach US$ 81,584.2 million by 2034
- The market created an opportunity of US$ 3,863.0 million growing at a CAGR of 9% between 2019 to 2024
- North America is a prominent region that is estimated to hold a market share of 4% in 2024
- Predominating market players include Illumina, Inc., and Guardant Health, Inc. among Others.
- Polymerase Chain Reaction (PCR) under technology is estimated to grow at a CAGR of 4% creating an absolute $ opportunity of US$ 14,892.3 million between 2024 and 2034
- North America and East Asia are expected to create an absolute $ opportunity of US$ 32,305.5 million and US$ 14,068.7 million consecutively from 2024 – 2034.
"As liquid biopsy technology progresses, cfDNA diagnostics are becoming imperative in various fields of applications ranging from monitoring cancer to transplantation of organs. Demand for precision medicine and advancements in bioinformatics are driving the growth," adds an analyst at Fact.MR.
Leading Players Driving Innovation in the Cell-Free DNA Mutation Diagnostics Market:
Illumina, Inc.; Natera, Inc.; Guardant Health, Inc.; Freenome Holdings, Inc.; GRAIL, Inc.; Exact Sciences Corporation; Foundation Medicine, Inc.; Biocept, Inc.; Thermo Fisher Scientific Inc.; Roche Diagnostics; Agilent Technologies, Inc.; Quest Diagnostics Incorporated; Laboratory Corporation of America Holdings (LabCorp); Myriad Genetics, Inc.; BillionToOne, Inc.; Other Prominent Players
Market Development:
As the World Health Organization (WHO) records 19 million new cases of cancer, it has become every biopharma company's vision to develop innovative Non-invasive tools for instant diagnostics. Continuous improvement in both NGS and PCR platforms has increased the sensitivity and affordability of tests dealing with cfDNA. Emerging techniques, such as CRISPR-based assays and nanopore sequencing, are expected to further expand diagnostic capabilities, catering to diverse clinical needs.
Beyond oncology, cfDNA diagnostics are gaining traction in organ transplantation, enabling the early detection of transplant rejection. Monitoring infectious diseases and experimental applications in neurological disorders are also expected to drive the diversification of the market.
- In January 2023, Foundation Medicine Launched an AI-Powered Bioinformatics Platform which is an artificial intelligence tool to help oncologists interpret large and complex datasets of cfDNA.
- In November 2022, Thermo Fisher acquired Liquid Biopsy Firm NEO New Oncology. This strategic acquisition of NEO New Oncology would help Thermo Fisher to bring more oncology & companion diagnostics to the market to expand and strengthen its cfDNA portfolio.
Cell-Free DNA Mutation Diagnostics Industry News:
- Guardant Health Launches Expanded Liquid Biopsy Platform in June 2023: Guardant Health unveiled its new and broader liquid biopsy and portfolio in what would grant the firm fresh steps toward early diagnosis of cancer with the launch of Guardant360. This is accompanied by Artificial Intelligence to augment the effectiveness of analytical capabilities for the purpose of identifying useful mutations.
- In May 2023, Illumina Partners with AstraZeneca for Companion Diagnostics. This strategic collaboration with AstraZeneca in the cfDNA-based companion diagnostics was aimed to ensure the integration of liquid biopsies to the clinical platforms.
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More Valuable Insights on Offer:
Fact.MR, in its new offering, presents an unbiased analysis of the global Cell-free DNA mutation diagnostics market, presenting historical data for 2019 to 2023 and forecast statistics for 2024 to 2034.
The study reveals essential insights on the basis of the product type (kits and assays {cfDNA isolation kits, and mutation-specific assays}, instruments {sequencers and PCR machines}, bioinformatics tools {mutation detection algorithms, and cloud-based analytics platforms}, service models {diagnostic labs, and outsourced analysis services) technology (next-generation sequencing (NGS), polymerase chain reaction (PCR), and microarrays and hybridization-based assays) application (oncology {cancer screening, therapy monitoring, minimal residual disease (MRD) detection, and tumor mutational burden (TMB)}, prenatal testing {non-invasive prenatal testing (NIPT), and pregnancy complications) organ transplantation, and other applications {infectious disease diagnostics, and neurodegenerative disease research}, end user (diagnostic laboratories {tier 1 global labs, and specialty oncology labs}, hospitals and clinics {academic medical centers, community hospitals with cfDNA as part of routine panels}, Research institutions {cancer genome projects universities with cfDNA innovation centers}, Biopharma {companion diagnostics (CDx), and drug efficacy trials}) across major regions of the world (North America, Latin America, Western Europe, Eastern Europe, East Asia, South Asia, and Pacific, Middle East & Africa).
Segmentation of Cell-free DNA Mutation Diagnostics Industry Research:
- By Product Type :
- Kits and Assays
- cfDNA Isolation Kits
- Mutation-Specific Assays
- Instruments
- Sequencers
- PCR Machines
- Bioinformatics Tools
- Mutation Detection Algorithms
- Cloud-Based Analytics Platforms
- Service Models
- Diagnostic Labs
- Outsourced Analysis Services
- Kits and Assays
- By Technology :
- Next-Generation Sequencing (NGS)
- Polymerase Chain Reaction (PCR)
- Microarrays and Hybridization-Based Assays
- By Application :
- Oncology
- Cancer Screening
- Therapy Monitoring
- Minimal Residual Disease (MRD) Detection
- Tumor Mutational Burden (TMB)
- Prenatal Testing
- Non-Invasive Prenatal Testing (NIPT)
- Pregnancy Complications
- Organ Transplantation
- Other Applications
- Infectious Disease Diagnostics
- Neurodegenerative Disease Research
- Oncology
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