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세계의 세포 유리 DNA(cfDNA) 키트 시장 보고서(2025년)
Cell-Free DNA (cfDNA) Kits Global Market Report 2025
상품코드 : 1855818
리서치사 : The Business Research Company
발행일 : On Demand Report
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한글목차

세포 유리 DNA(cfDNA) 키트 시장 규모는 최근 급속도로 확대되고 있습니다. 2024년 16억 달러에서 2025년에는 18억 달러에 달하고, CAGR 12.6%로 확대될 전망입니다. 실적기간 내 성장은 진단 실험실 증가, 종양학 애플리케이션의 채택 확대, 이식 및 부인과 응용 분야에서의 사용 범위의 확대, 진단과 인공지능의 통합 증가로 발생하였습니다.

세포 유리 DNA(cfDNA) 키트 시장 규모는 향후 수년간 급성장할 것으로 전망됩니다. 2029년에는 CAGR 12.3%로 28억 6,000만 달러로 성장할 전망입니다. 예측기간 내 성장은 디지털 중합효소 연쇄반응의 채용 증가, 실시간 중합효소 연쇄반응의 사용 증가, 다른 질병 영역에서의 응용의 확대, 진단 실험실 수 증가, 비침습적 산전 검사 수요 증가로 지원될 것으로 예측됩니다. 예측 기간에 예상되는 주요 동향으로는 단일세포 유전체학의 발전, 자동화된 실험실 워크플로 통합, 단백질체학 기반 진단의 진보, 대사학 분석의 혁신, 효소를 사용하지 않는 핵산 검출법의 개발 등이 있습니다.

유전성 질환의 유병률 증가는 앞으로 수년간 세포 유리 DNA(cfDNA) 키트 시장의 성장을 가속화할 것으로 예측됩니다. 유전자 질환은 하나 이상의 유전자의 돌연변이와 염색체 이상으로 인한 DNA의 변화로 발생하는 병리입니다. 이러한 질병의 발생이 증가하고 있는 것은 라이프 스타일의 변화 또는 공해와 아침식사 등의 환경 요인이 주요인이며 유전자의 돌연변이를 일으키거나 유전성 질환을 악화시킬 가능성이 있습니다. 세포 유리 DNA(cfDNA) 키트는 혈액 및 기타 체액에 존재하는 DNA 단편을 분석하여 유전자 이상을 비침습적으로 조기에 발견할 수 있게 합니다. 이 기술은 신속한 진단을 가능하게 하고 의료 제공업체는 정확한 치료 정책을 결정할 수 있습니다. 예를 들어 미국 정부기관인 질병대책예방센터(CDC)는 2024년 11월 미국에서 신생아의 약 33명 중 1명이 선천성 이상을 갖고 태어났으며, 그 대부분이 유전적 관련을 가지고 있다고 보고했습니다. 그 결과, 유전성 질환의 유병률 증가가 cfDNA 키트 수요에 박차를 가하고 있습니다.

cfDNA 키트 시장의 주요 기업은 cfDNA 분석의 민감도와 정확성을 높이기 위해 디지털 중합효소 연쇄반응(PCR) 기반 절대 정량법을 이용한 혁신적인 제품 개발에 주력하고 있습니다. 디지털 PCR 기반의 절대 정량 기법은 저빈도 유전자 변이를 개선된 일관성으로 정확하게 검출하는 것을 가능하게 하고, 암 진단, 산전 검사, 이식 거부 반응의 모니터링 등의 중요한 용도에 적합합니다. 예를 들어, 2024년 6월, 헝가리에 본사를 두고 있는 분자진단회사인 Omixon은 이식 후 기증자 유래 세포 유리 DNA(dd-cfDNA)를 모니터링하기 위해 설계된 연구 전용 키트 HoloGRAFT ONE을 발표했습니다. 이 키트는 독자적인 유전자 마커와 디지털 PCR을 이용하여 기증자의 DNA와 수혜자의 DNA를 구별하고 복사 수의 돌연변이를 통해 dd-cfDNA의 절대량과 상대량을 측정합니다. 이 혁신적인 검사의 목표는 임상의에게 정확한 cfDNA 데이터를 제공함으로써 이식 거부 반응의 조기 발견을 가능하게 하고, 환자 모니터링을 개선하고, 이식 후 개별 치료를 지원하는 것입니다.

목차

제1장 주요 요약

제2장 시장 특징

제3장 시장 동향과 전략

제4장 시장 : 금리, 인플레이션, 지정학, 무역전쟁과 관세, 그리고 코로나 및 회복이 시장에 미치는 영향을 포함한 거시경제 시나리오

제5장 세계의 성장 분석과 전략 분석 프레임워크

제6장 시장 세분화

제7장 지역별/국가별 분석

제8장 아시아태평양 시장

제9장 중국 시장

제10장 인도 시장

제11장 일본 시장

제12장 호주 시장

제13장 인도네시아 시장

제14장 한국 시장

제15장 서유럽 시장

제16장 영국 시장

제17장 독일 시장

제18장 프랑스 시장

제19장 이탈리아 시장

제20장 스페인 시장

제21장 동유럽 시장

제22장 러시아 시장

제23장 북미 시장

제24장 미국 시장

제25장 캐나다 시장

제26장 남미 시장

제27장 브라질 시장

제28장 중동 시장

제29장 아프리카 시장

제30장 경쟁 구도와 기업 프로파일

제31장 기타 주요 기업 및 혁신 기업

제32장 세계 시장 경쟁 벤치마킹과 대시보드

제33장 주요 인수합병(M&A)

제34장 최근 시장 동향

제35장 시장의 잠재력이 높은 국가, 부문, 전략

제36장 부록

CSM
영문 목차

영문목차

Cell-free DNA (cfDNA) kits are laboratory tools designed to isolate and analyze fragmented DNA circulating in blood or other body fluids. They support non-invasive genetic testing by providing high-quality DNA for applications such as prenatal screening, cancer diagnostics, and transplant monitoring. These kits simplify sample preparation and enhance accuracy in downstream molecular analysis.

The primary product types in the cell-free DNA (cfDNA) kits market include plasma cfDNA kits, serum cfDNA kits, urine cfDNA kits, and others. Plasma cfDNA kits are designed to isolate and analyze DNA fragments circulating in plasma, the liquid component of blood. Key technologies include next-generation sequencing (NGS), polymerase chain reaction (PCR), microarray technology, and digital PCR. Major applications encompass cancer diagnostics, prenatal testing, transplant rejection monitoring, and non-invasive disease detection. Distribution channels consist of direct sales, retail pharmacies, online platforms, and distributors, while end users include hospitals, research laboratories, diagnostic laboratories, and academic institutions.

Note that the outlook for this market is being affected by rapid changes in trade relations and tariffs globally. The report will be updated prior to delivery to reflect the latest status, including revised forecasts and quantified impact analysis. The report's Recommendations and Conclusions sections will be updated to give strategies for entities dealing with the fast-moving international environment.

The fast surge in U.S. tariffs and the trade tensions that followed in spring 2025 are heavily affecting the medical equipment sector, particularly for imported imaging machine components, surgical-grade stainless steel, and plastic disposables. Hospitals and clinics resist price hikes, pressuring manufacturers' margins. Regulatory hurdles compound the problem, as tariff-related supplier changes often require re-certification of devices, delaying time-to-market. Companies are mitigating risks by dual-sourcing critical parts, expanding domestic production of commoditized items, and accelerating R&D in cost-efficient materials.

The cell-free DNA (cfDNA) market research report is one of a series of new reports from The Business Research Company that provides cell-free DNA (cfDNA) market statistics, including cell-free DNA (cfDNA) industry global market size, regional shares, competitors with a cell-free DNA (cfDNA) market share, detailed cell-free DNA (cfDNA) market segments, market trends and opportunities, and any further data you may need to thrive in the cell-free DNA (cfDNA) industry. The cell-free DNA (cfDNA) market research report delivers a complete perspective of everything you need, with an in-depth analysis of the current and future scenario of the industry.

The cell-free DNA (cfDNA) kits market size has grown rapidly in recent years. It will grow from $1.60 billion in 2024 to $1.80 billion in 2025 at a compound annual growth rate (CAGR) of 12.6%. Growth in the historic period was driven by the increasing number of diagnostic laboratories, greater adoption of oncology applications, wider use in transplantation and gynecology applications, and rising integration of artificial intelligence in diagnostics.

The cell-free DNA (cfDNA) kits market size is expected to see rapid growth in the next few years. It will grow to $2.86 billion in 2029 at a compound annual growth rate (CAGR) of 12.3%. Growth in the forecast period is expected to be supported by rising adoption of digital polymerase chain reaction, increased use of real-time polymerase chain reaction, expanding applications in other disease areas, growth in the number of diagnostic laboratories, and higher demand for non-invasive prenatal testing. Key trends anticipated for the forecast period include advancements in single-cell genomics, integration of automated laboratory workflows, progress in proteomics-based diagnostics, innovation in metabolomics analysis, and the development of enzyme-free nucleic acid detection methods.

The increasing prevalence of genetic disorders is expected to drive the growth of the cell-free DNA (cfDNA) kits market in the coming years. Genetic disorders are medical conditions caused by alterations in a person's DNA, which can result from mutations in one or more genes, or chromosomal abnormalities. The rising occurrence of these disorders is largely due to lifestyle changes and environmental factors such as pollution and poor diet, which can either cause genetic mutations or worsen inherited conditions. Cell-free DNA (cfDNA) kits enable early, non-invasive detection of genetic abnormalities by analyzing DNA fragments present in blood or other body fluids. This technology facilitates quicker diagnoses and allows healthcare providers to make accurate treatment decisions. For example, the Centers for Disease Control and Prevention (CDC), a U.S.-based government agency, reported in November 2024 that about 1 in every 33 newborns in the U.S. is born with a birth defect, many of which are genetically related. As a result, the increasing prevalence of genetic disorders is fueling demand for cfDNA kits.

Leading companies in the cfDNA kits market are concentrating on developing innovative products that use digital polymerase chain reaction (PCR)-based absolute quantification to enhance the sensitivity and accuracy of cfDNA analysis. Digital PCR-based absolute quantification allows for the precise detection of low-frequency genetic variants with improved consistency, making it suitable for critical applications such as cancer diagnostics, prenatal testing, and monitoring transplant rejection. For example, in June 2024, Omixon, a molecular diagnostics company based in Hungary, introduced HoloGRAFT ONE, a research-use-only kit designed to monitor donor-derived cell-free DNA (dd-cfDNA) post-transplant. This kit utilizes proprietary genetic markers and digital PCR to differentiate donor DNA from the recipient's DNA, measuring both absolute and relative amounts of dd-cfDNA through copy-number variants. The goal of this innovative test is to enable the early detection of transplant rejection, improve patient monitoring, and support personalized post-transplant care by providing clinicians with precise cfDNA data.

In February 2022, Labcorp Holdings Inc., a U.S.-based life sciences company, acquired Personal Genome Diagnostics Inc. for an undisclosed amount. This acquisition allows Labcorp to integrate Personal Genome Diagnostics' advanced genomic technologies to enhance its cancer diagnostic offerings and bolster its precision medicine capabilities. Personal Genome Diagnostics Inc. is a U.S.-based company specializing in cell-free DNA (cfDNA) kits, with a focus on circulating tumor DNA (ctDNA) for cancer research and diagnostics.

Major players in the cell-free DNA (cfDNA) kits market are F. Hoffmann-La Roche Ltd, Thermo Fisher Scientific Inc., Agilent Technologies Inc., Illumina Inc., Bio-Rad Laboratories Inc., QIAGEN N.V, Natera Inc., Myriad Genetics Inc., Guardant Health Inc., Bioneer Corporation, Streck Inc., Freenome Holdings Inc., GRAIL Inc., Zymo Research Corporation, Geneseeq Technology Inc, Covaris LLC, Active Motif Inc., Norgen Biotek Corp, AMSBIO LLC, EpiGentek Group Inc., Paragon Genomics Inc., Suzhou Beaver Biomedical Engineering.

North America was the largest region in the cell-free DNA (cfDNA) kits market in 2024. Asia-Pacific is expected to be the fastest-growing region in the forecast period. The regions covered in cell-free DNA (cfDNA) kits report are Asia-Pacific, Western Europe, Eastern Europe, North America, South America, Middle East and Africa.

The countries covered in the cell-free DNA (cfDNA) kits market report are Australia, Brazil, China, France, Germany, India, Indonesia, Japan, Russia, South Korea, UK, USA, Canada, Italy, Spain.

The cell-free DNA (cfDNA) kits market consists of revenues earned by entities by providing services such as purification services, bulk services, quality control (QC) services, data integration services, and custom biomarker discovery services. The market value includes the value of related goods sold by the service provider or included within the service offering. The cell-free DNA (cfDNA) kits market also includes sales of plasma separation consumables, liquid biopsy assay kits, serum preparation kits, concentration kits, and bisulfite conversion and methylation kits. Values in this market are 'factory gate' values, that is the value of goods sold by the manufacturers or creators of the goods, whether to other entities (including downstream manufacturers, wholesalers, distributors and retailers) or directly to end customers. The value of goods in this market includes related services sold by the creators of the goods.

The market value is defined as the revenues that enterprises gain from the sale of goods and/or services within the specified market and geography through sales, grants, or donations in terms of the currency (in USD unless otherwise specified).

The revenues for a specified geography are consumption values that are revenues generated by organizations in the specified geography within the market, irrespective of where they are produced. It does not include revenues from resales along the supply chain, either further along the supply chain or as part of other products.

Cell-Free DNA (cfDNA) Kits Global Market Report 2025 from The Business Research Company provides strategists, marketers and senior management with the critical information they need to assess the market.

This report focuses on cell-free dna (cfdna) kits market which is experiencing strong growth. The report gives a guide to the trends which will be shaping the market over the next ten years and beyond.

Reasons to Purchase

Where is the largest and fastest growing market for cell-free dna (cfdna) kits ? How does the market relate to the overall economy, demography and other similar markets? What forces will shape the market going forward, including technological disruption, regulatory shifts, and changing consumer preferences? The cell-free dna (cfdna) kits market global report from the Business Research Company answers all these questions and many more.

The report covers market characteristics, size and growth, segmentation, regional and country breakdowns, competitive landscape, market shares, trends and strategies for this market. It traces the market's historic and forecast market growth by geography.

The forecasts are made after considering the major factors currently impacting the market. These include the technological advancements such as AI and automation, Russia-Ukraine war, trade tariffs (government-imposed import/export duties), elevated inflation and interest rates.

Scope

Table of Contents

1. Executive Summary

2. Cell-Free DNA (cfDNA) Kits Market Characteristics

3. Cell-Free DNA (cfDNA) Kits Market Trends And Strategies

4. Cell-Free DNA (cfDNA) Kits Market - Macro Economic Scenario Including The Impact Of Interest Rates, Inflation, Geopolitics, Trade Wars and Tariffs, And Covid And Recovery On The Market

5. Global Cell-Free DNA (cfDNA) Kits Growth Analysis And Strategic Analysis Framework

6. Cell-Free DNA (cfDNA) Kits Market Segmentation

7. Cell-Free DNA (cfDNA) Kits Market Regional And Country Analysis

8. Asia-Pacific Cell-Free DNA (cfDNA) Kits Market

9. China Cell-Free DNA (cfDNA) Kits Market

10. India Cell-Free DNA (cfDNA) Kits Market

11. Japan Cell-Free DNA (cfDNA) Kits Market

12. Australia Cell-Free DNA (cfDNA) Kits Market

13. Indonesia Cell-Free DNA (cfDNA) Kits Market

14. South Korea Cell-Free DNA (cfDNA) Kits Market

15. Western Europe Cell-Free DNA (cfDNA) Kits Market

16. UK Cell-Free DNA (cfDNA) Kits Market

17. Germany Cell-Free DNA (cfDNA) Kits Market

18. France Cell-Free DNA (cfDNA) Kits Market

19. Italy Cell-Free DNA (cfDNA) Kits Market

20. Spain Cell-Free DNA (cfDNA) Kits Market

21. Eastern Europe Cell-Free DNA (cfDNA) Kits Market

22. Russia Cell-Free DNA (cfDNA) Kits Market

23. North America Cell-Free DNA (cfDNA) Kits Market

24. USA Cell-Free DNA (cfDNA) Kits Market

25. Canada Cell-Free DNA (cfDNA) Kits Market

26. South America Cell-Free DNA (cfDNA) Kits Market

27. Brazil Cell-Free DNA (cfDNA) Kits Market

28. Middle East Cell-Free DNA (cfDNA) Kits Market

29. Africa Cell-Free DNA (cfDNA) Kits Market

30. Cell-Free DNA (cfDNA) Kits Market Competitive Landscape And Company Profiles

31. Cell-Free DNA (cfDNA) Kits Market Other Major And Innovative Companies

32. Global Cell-Free DNA (cfDNA) Kits Market Competitive Benchmarking And Dashboard

33. Key Mergers And Acquisitions In The Cell-Free DNA (cfDNA) Kits Market

34. Recent Developments In The Cell-Free DNA (cfDNA) Kits Market

35. Cell-Free DNA (cfDNA) Kits Market High Potential Countries, Segments and Strategies

36. Appendix

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