![]() |
市場調查報告書
商品編碼
2024464
液態生物檢體市場報告:按產品和服務、循環生物標記、癌症類型、最終用戶、地區分類(2026-2034 年)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2026-2034 |
||||||
2025年全球液態生物檢體市場規模達26億美元。展望未來,IMARC Group預測,到2034年,該市場規模將達到76億美元,2026年至2034年的複合年成長率將達到12.31%。癌症發病率上升、對個人化醫療和治療的需求不斷成長以及自動化液態生物檢體平台的發展是推動市場成長的關鍵因素。
癌症發生率上升
隨著全球癌症發生率的上升,早期發現和後續觀察的重要性日益凸顯。例如,根據世界衛生組織預測,2022年將新增2,000萬例癌症病例,並有970萬人死於癌症。癌症確診五年後的存活人數預計將達5,350萬人。據估計,大約五分之一的人一生中會罹患癌症。到2050年,癌症病例預計將增加3,500多萬例,比2022年估計的2,000萬例增加77%。液態生物檢體提供了一種非侵入性方法,用於檢測循環腫瘤生物標記物,例如血液和尿液等體液中存在的循環性腫瘤細胞(CTC)和遊離DNA(cfDNA)。這些生物標記能夠提供有關癌症的存在、進展和基因特徵的重要訊息,使臨床醫生能夠更早診斷癌症並更有效地監測疾病進展。例如,在2023年美國癌症研究協會(AACR)年會上,研究人員展示了一項利用液態生物檢體技術進行多癌症物種早期檢測的報告,該技術採用創新平台分析DNA甲基化。傳統檢測方法需要在定序前對DNA進行化學處理,而這種新方法無需任何化學或酶處理即可捕獲甲基化的cfDNA分子。研究人員進行了回顧性分析,以驗證平台檢測12種癌症的能力,分析樣本來自約4000人,包括新檢驗的未經治療的癌症患者以及年齡和性別匹配的對照組。約一半的癌症病例處於早期階段。此外,2020年,賓州大學的一個研究團隊在《臨床癌症研究》(Clinical Cancer Research)雜誌上發表了一篇論文,證明他們的液態生物檢體在診斷早期胰腺癌方面具有92%的準確率。這些因素進一步對液態生物檢體市場的前景產生了積極影響。
對非侵入性產前檢測(NIPT)的需求日益成長
傳統的產前篩檢方法,例如羊膜穿刺術和絨毛膜取樣術(CVS),存在一定的併發症風險,包括流產。非侵入性產前檢測(NIPT)透過分析母體血液中循環的遊離胎兒DNA(cffDNA)來檢測胎兒DNA,為產前篩檢提供了一種非侵入性替代方案。例如,根據美國國家醫學圖書館的數據,羊膜穿刺術可在懷孕15週至臨產前進行,即使由經驗豐富的醫師操作,單胎妊娠的流產風險也僅為0.13%。因此,妊娠15週後進行羊膜穿刺術的風險估計為1/100。由於其安全性高且併發症風險低,許多孕婦及其伴侶更傾向於選擇這種非侵入性方法。此外,NIPT在檢測常見的胎兒染色體異常方面展現出很高的準確性,例如21三體症候群(唐氏症)、18三體症(愛德華氏症候群)和13三體症(巴陶氏症)。基於液態生物檢體的NIPT檢測能夠以高靈敏度和特異性檢測胎兒遺傳異常,為準媽媽及其伴侶提供關於胎兒健康的可靠資訊。例如,2023年11月,Novayt旗下子公司Yourgene Health與Laboriad合作,在摩洛哥推出了首個非侵入性產前檢測(NIPT)平台。此外,NIPT最早可在懷孕9-10週進行,因此及早了解胎兒的遺傳健康狀況。早期發現染色體異常有助於準媽媽及其伴侶就懷孕做出明智的決定,並考慮是否需要進行其他診斷測試或為可能需要特殊支持的嬰兒的出生做好準備。例如,根據克利夫蘭診所發表的報導,NIPT檢測可以從懷孕第10週一直進行到產前。這些因素進一步促成了近期液態生物檢體市場價格的上漲。
活性化研發活動和臨床試驗
液態生物檢體技術的進步使其在癌症篩檢、藥物測試最佳化和治療方法選擇中的應用日益廣泛。眾多政府機構及企業正加大對液態生物檢體研發的投入,以進行相關的臨床研究。例如,2023年6月,Anzu Partners主導了Codetta Biosciences的1,500萬美元A輪資金籌措,Genoa Ventures和VC23 LLC也參與了此次融資。 Codetta計劃利用這筆資金籌措迅速擴充其研發、工程、行銷和管理團隊,並加速開發其用於液態生物檢體的多組體學dsPCR平台。此外,臨床試驗也是評估新型液態生物檢體技術和平台性能的重要平台。對研發的投入能夠推動次世代定序(NGS)平台、數位PCR系統以及其他創新技術的開發,從而提高液態生物檢體檢測的敏感度、特異性和擴充性。臨床試驗為在真實臨床環境中檢驗這些技術進步提供了機會,為其商業化和廣泛應用鋪平了道路。例如,2024年4月,專注於解決基因治療生產難題的技術創新公司NewBiologix SA推出了次世代定序(NGS)和光學圖譜平台。這是一套突破性的技術,可為生物製藥產業提供全面的基因組分析服務。這些因素進一步推動了液態切片市場佔有率的擴大。
The global liquid biopsy market size reached USD 2.6 Billion in 2025. Looking forward, IMARC Group expects the market to reach USD 7.6 Billion by 2034, exhibiting a growth rate (CAGR) of 12.31% during 2026-2034. The increasing prevalence of cancer, the rising demand for personalized medicine and treatments, and the development of automated liquid biopsy platforms, represent some of the key factors driving the market growth.
Rising Prevalence of Cancer
With cancer rates on the rise globally, there's a growing emphasis on early detection and monitoring of the disease. For instance, according to WHO, in 2022, there were expected to be 20 million new cancer diagnoses and 9.7 million fatalities. The expected number of people who survived five years after a cancer diagnosis was 53.5 million. Cancer affects around one in every five persons in their lifetime. Over 35 million more cancer cases are expected in 2050, up 77% over the estimated 20 million in 2022. Liquid biopsies offer a non-invasive method to detect circulating tumor biomarkers, such as circulating tumor cells (CTCs) and cell-free DNA (cfDNA), in bodily fluids like blood or urine. These biomarkers can provide valuable insights into the presence, progression, and genetic profile of cancer, enabling clinicians to diagnose cancer at earlier stages and monitor disease progression more effectively. For instance, at the 2023 American Association of Cancer Research Annual Meeting, researchers presented a report on a liquid biopsy multicancer early detection test that analyzes DNA methylation using an innovative platform. While conventional tests need chemical treatment of DNA before sequencing, the novel approach captures methylated cfDNA molecules without any chemical or enzymatic treatment. The scientists conducted a retrospective analysis to examine the ability of the platform to detect 12 cancer types in a sample of around 4,000 people, including recently diagnosed, treatment-naive cancer patients, and age- and gender-matched controls. Approximately half of the cancer cases were in the early stages. In addition, in 2020, a team of researchers from the University of Pennsylvania released a paper in Clinical Cancer Research demonstrating that their liquid biopsy was 92% accurate in diagnosing early pancreatic cancer. These factors are further positively impacting the liquid biopsy market forecast.
Rising Demand for Non-Invasive Pre-Natal Tests (NIPT)
Traditional prenatal testing methods, such as amniocentesis and chorionic villus sampling (CVS), carry a small risk of complications, including miscarriage. NIPT, which involves analyzing cell-free fetal DNA (cffDNA) circulating in the mother's blood, offers a non-invasive alternative for prenatal screening. For instance, according to the National Library of Medicine, amniocentesis can be performed anywhere from 15 weeks of gestation to birth, with a 0.13% chance of loss in singletons in expert hands. In line with this, the risk of getting amniocentesis after 15 weeks of pregnancy is estimated to be 1 in 100. This non-invasive approach is preferred by many expectant parents due to its safety and reduced risk of procedure-related complications. Moreover, NIPT has demonstrated high accuracy in detecting common fetal chromosomal abnormalities, such as trisomy 21 (Down syndrome), trisomy 18 (Edwards syndrome), and trisomy 13 (Patau syndrome). Also, liquid biopsy based NIPT assays can detect fetal genetic abnormalities with high sensitivity and specificity, providing expectant parents with reliable information about their baby's health status. For instance, in November 2023, Yourgene Health, a subsidiary of Novacyt collaborated with Laboriad to introduce the first non-invasive prenatal testing (NIPT) platform in Morocco. Besides this, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. Furthermore, NIPT can be performed as early as 9-10 weeks into pregnancy, providing early insights into fetal genetic health. Early detection of chromosomal abnormalities allows expectant parents to make informed decisions about their pregnancy and consider additional diagnostic testing or preparation for the birth of a child with special needs. For instance, according to an article published by Cleveland Clinic, NIPT testing can be performed from as early as ten weeks of pregnancy until delivery. These factors are further positively influencing the liquid biopsy market's recent prices.
Rising R&D Activities and Clinical Trials
The rising technological advancements in liquid biopsies are escalating the frequency of cancer screening, drug trial optimization, and therapeutic selection. Various government agencies and companies are focusing on investment in research and development to conduct clinical studies on liquid biopsy. For instance, in June 2023, Anzu Partners led a US$15 Million Series A investment round for Codetta Biosciences. Genoa Ventures and VC23 LLC also contributed to the funding. With the funding, Codetta plans to rapidly expand its team in R&D, engineering, marketing, and business administration as well as quicken the development of its multi-omic dsPCR platform for liquid biopsy. Moreover, clinical trials serve as platforms for evaluating the performance of novel liquid biopsy technologies and platforms. Investment in research and development enables the development of next-generation sequencing (NGS) platforms, digital PCR systems, and other innovative technologies that enhance the sensitivity, specificity, and scalability of liquid biopsy assays. Clinical trials provide opportunities to validate these advancements in real-world clinical settings, paving the way for their commercialization and widespread adoption. For instance, in April 2024, NewBiologix SA, a technology innovation company focused on addressing gene therapy manufacturing gaps, launched its next-generation sequencing (NGS) and optical mapping platform, a novel suite of technologies that will provide comprehensive genomic analysis services to the biopharmaceutical industry. These factors are further contributing to the liquid biopsy market share.
Kits and reagents assist dominates the market
According to the liquid biopsy market outlook, the growth of kits and reagents segment is driven by the surging demand for liquid biopsy tests, especially for cancer diagnostics. These kits are used to isolate cell-free DNA from plasma or serum samples. They often utilize methods like spin column-based purification, magnetic bead-based purification, or precipitation-based methods. Moreover, rising research and development activities by the key players for the development of advanced kits are proliferating the segment's growth. For instance, in September 2023, Pillar Biosciences, Inc., Decision Medicine company, launched oncoReveal Core LBx, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories with a solution for liquid biopsy-based pan- cancer tumor profiling .
Circulating tumor cells hold the largest share in the market
According to the liquid biopsy market overview, the surging demand for Circulating Tumor Cells (CTC) is attributed to its wide range of applications in biomarkers such as gene expressions, protein expressions, and DNA mutations. Moreover, the clinical utility of CTC analysis in cancer diagnosis, prognosis, and treatment monitoring is increasingly recognized. As more clinical studies demonstrate the prognostic value of CTC enumeration, characterization, and genomic profiling in various cancer types, there is a growing demand for CTC-based tests in routine clinical practice. For instance, in September 2023, nRichDX introduced a novel RUO-labeled CTC enrichment kit that isolates Circulating Tumor Cells (CTCs) from up to 40mL of whole blood samples, assisting researchers in liquid biopsy assay research and development.
Lung cancer accounts for the majority of the market share
Liquid biopsy offers a non-invasive method for detecting and monitoring lung cancer compared to traditional tissue biopsies. Sampling blood for circulating tumor DNA (ctDNA), circulating tumor cells (CTCs), or exosomes is less invasive and can be performed more frequently, allowing for real-time monitoring of disease progression and treatment response. Moreover, it enables the detection of lung cancer at early stages when tumors are smaller and more amenable to curative treatments. Additionally, it facilitates longitudinal monitoring of treatment response and disease recurrence, leading to timely adjustments in treatment strategies. For instance, in April 2024, researchers at The Royal Marsden and Guardant Health collaborated to develop a new liquid biopsy test that would assist thousands of lung cancer patients. Marsden360, a cutting-edge circulating tumor DNA (ctDNA) test, is expected to accelerate and personalize treatment for this patient population.
Hospitals and laboratories hold the largest share in the market
The growing demand for liquid biopsies in hospitals is mainly driven by the surging adoption of liquid biopsy tests for cancer diagnosis. Additionally, as the clinical utility of liquid biopsy in cancer management becomes increasingly recognized, there is a growing demand from hospitals and laboratories for tests that utilize liquid biopsy techniques. Liquid biopsy offers non-invasive methods for detecting and monitoring cancer, providing valuable information for diagnosis, prognosis, treatment selection, and monitoring of treatment response. For instance, in May 2024, Syndicate Bio, a Nigeria-based biotechnology lab, collaborated with SophiaGenetics, a cloud-native software corporation specialized in data-driven medicine, to provide extensive genomic profiling and liquid biopsy services.
North America exhibits a clear dominance in the market
The report has also provided a comprehensive analysis of all the major regional markets, which include North America (the United States and Canada); Asia Pacific (China, Japan, India, South Korea, Australia, Indonesia and others); Europe (Germany, France, the United Kingdom, Italy, Spain, Russia and others); Latin America (Brazil, Mexico and others) and the Middle East and Africa. According to the report, North America was the largest market for liquid biopsy.
According to the liquid biopsy market statistics, some of the factors driving the North America liquid biopsy market included continual technological advancements, ongoing improvements in the healthcare industry, extensive research and development (R&D) activities conducted by key players, etc. Moreover, cancer remains a major health concern in North America, and the incidence rates continue to rise. Liquid biopsies offer a non-invasive method for detecting and monitoring cancer, which is particularly beneficial for early detection and personalized treatment strategies. Continuous advancements in technologies such as next-generation sequencing (NGS), digital PCR, and microfluidics have enhanced the sensitivity, accuracy, and reliability of liquid biopsy tests. These technological improvements have expanded the applications of liquid biopsies across various cancer types and stages. For instance, in April 2023, Quest Diagnostics, a diagnostic information services provider headquartered in U.S., acquired Haystack Oncology, an early-stage oncology company focused on minimal residual disease (MRD), the fastest-growing category of liquid biopsy testing to aid in the early, accurate detection of residual or recurring cancer and better inform therapy decisions.
(Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.)