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市场调查报告书
商品编码
1722450
2025 年至 2033 年液体活检市场报告(按产品和服务、循环生物标记、癌症类型、最终用户和地区划分)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2025-2033 |
2024 年全球液体切片市场规模达 23 亿美元。展望未来, IMARC Group预计到 2033 年市场规模将达到 72 亿美元,2025-2033 年期间的成长率 (CAGR) 为 12.82%。癌症发病率的上升、个人化医疗和治疗需求的不断增长以及自动化液体活检平台的发展是推动市场成长的一些关键因素。
主要市场驱动因素:由于生活方式的改变,尤其是在工作专业人士中,癌症盛行率的上升,以及下一代定序的引入,推动了市场的成长。液体切片检查能够检测血液或尿液等体液中的癌症相关生物标记物,例如循环肿瘤细胞 (CTC)、游离 DNA (cfDNA) 和外泌体。早期发现对于有效治疗和改善患者预后至关重要,从而推动市场成长。
主要市场趋势:技术进步、扩大临床应用、向多分析物方法的转变、对早期检测和筛检的关注度不断提高以及在临床试验中提高液体活检的采用率是预计将在未来几年刺激市场成长的一些关键因素。此外,定序技术、微流体技术和生物资讯学的不断创新正在提高液体活检检测的敏感性、特异性和可扩展性,从而进一步增加液体活检市场的收入。
地理格局:根据报告,北美占据最大的市场份额。癌症仍然是北美的主要健康问题,每年有相当一部分人口被诊断出患有各种类型的癌症。高发病率推动了对液体活检等创新诊断工具的需求,这些工具为癌症检测和监测提供了非侵入性和准确的方法。这进一步对液体活检市场需求产生了积极影响。
竞争格局:一些领先的液体活检市场公司包括 ANGLE plc、Biocept Inc.、Bio-Rad Laboratories Inc、Epigenomics AG、Exact Sciences Corporation、F. Hoffmann-La Roche AG、Guardant Health Inc.、Illumina Inc.、MDxHealth SA、Menarini Silicon Bioicons、QIAG)、Illumina Inc。
挑战与机会:检测的标准化和验证、临床验证和证据产生以及成本考量和报销是市场目前面临的一些关键挑战。然而,液体活检可以与人工智慧 (AI) 和机器学习等数位健康技术相结合,以增强资料分析、解释和临床决策。这对製造商来说意味着重要的机会。
癌症发生率上升
随着全球癌症发生率的上升,人们越来越重视癌症的早期发现和监测。例如,根据世界卫生组织预测,2022年将有2,000万例新癌症诊断病例和970万例死亡病例。预计癌症确诊后五年内存活的人数为 5,350 万人。大约每五个人中就有一人一生中会罹患癌症。预计 2050 年癌症病例将增加 3,500 多万例,比 2022 年预计的 2,000 万例增加 77%。液体活检提供了一种非侵入性方法来检测血液或尿液等体液中的循环肿瘤生物标记物,例如循环肿瘤细胞 (CTC) 和游离 DNA (cfDNA)。这些生物标记可以为癌症的存在、进展和基因特征提供有价值的见解,使临床医生能够在早期诊断癌症并更有效地监测病情进展。例如,在2023年美国癌症研究协会年会上,研究人员提交了一份关于使用创新平台分析DNA甲基化的液体活检多癌症早期检测测试的报告。传统测试需要在定序前对 DNA 进行化学处理,而新方法无需任何化学或酶处理即可捕获甲基化的 cfDNA 分子。科学家进行了回顾性分析,以检验该平台在约 4,000 人样本中检测 12 种癌症类型的能力,其中包括最近确诊的、未接受治疗的癌症患者以及年龄和性别匹配的对照者。大约一半的癌症病例处于早期阶段。此外,2020年,宾州大学的研究小组在《临床癌症研究》上发表论文,证明他们的液体切片对早期胰臟癌的诊断准确率为92%。这些因素进一步对液体活检市场预测产生了积极影响。
非侵入性产前检测(NIPT)需求不断成长
传统的产前检查方法,例如羊膜穿刺术和绒毛膜绒毛取样(CVS),具有发生併发症(包括流产)的风险。 NIPT 涉及分析母亲血液中循环的无细胞胎儿 DNA(cffDNA),为产前筛检提供了一种非侵入性的替代方法。例如,根据美国国家医学图书馆的资料,羊膜穿刺术可以在怀孕 15 週至分娩期间的任何时间进行,在专业人员手中,单胎流产的几率为 0.13%。据此估计,怀孕 15 週后进行羊膜穿刺术的风险为 1/100。这种非侵入性方法因其安全性和降低手术相关併发症的风险而受到许多准父母的青睐。此外,NIPT 在检测常见的胎儿染色体异常方面表现出很高的准确性,例如 21 三体症候群(唐氏症)、18 三体症(爱德华兹氏症候群)和 13 三体症(帕陶氏症候群)。此外,基于液体活检的 NIPT 检测可以高灵敏度和特异性地检测胎儿基因异常,为准父母提供有关婴儿健康状况的可靠资讯。例如,2023 年 11 月,Novacyt 的子公司 Yourgene Health 与 Laboriad 合作在摩洛哥推出了首个非侵入性产前检测 (NIPT) 平台。除此之外,NIPT 最早可在怀孕 9-10 週时进行,可提前了解胎儿的基因健康状况。早期发现染色体异常可以让准父母对怀孕做出明智的决定,并考虑进行额外的诊断测试或为有特殊需求的孩子的出生做好准备。此外,NIPT 最早可在怀孕 9-10 週时进行,可提前了解胎儿的基因健康状况。早期发现染色体异常可以让准父母对怀孕做出明智的决定,并考虑进行额外的诊断测试或为有特殊需求的孩子的出生做好准备。例如,根据克利夫兰诊所发表的一篇文章,NIPT 测试最早可以在怀孕十週后进行,直到分娩。这些因素进一步对液体活检市场近期的价格产生了积极影响。
研发活动和临床试验不断增加
液体活检技术的不断进步正在提高癌症筛检、药物试验优化和治疗选择的频率。各政府机构及企业均着重投入研发力量,进行液体切片的临床研究。例如,2023 年 6 月,Anzu Partners 领投了 Codetta Biosciences 的 1,500 万美元 A 轮融资。 Genoa Ventures 和 VC23 LLC 也参与了此次融资。利用这笔资金,Codetta 计划迅速扩大其研发、工程、行销和业务管理团队,并加快其用于液体活检的多组学 dsPCR 平台的开发。此外,临床试验可作为评估新型液体活检技术和平台性能的平台。研发投入促进了次世代定序 (NGS) 平台、数位 PCR 系统和其他创新技术的开发,从而提高了液体活检检测的灵敏度、特异性和可扩展性。临床试验提供了在现实临床环境中验证这些进步的机会,为其商业化和广泛应用铺平了道路。例如,2024 年 4 月,专注于解决基因治疗製造差距的技术创新公司 NewBiologix SA 推出了其下一代定序 (NGS) 和光学映射平台,这是一套新颖的技术,将为生物製药行业提供全面的基因组分析服务。这些因素进一步促进了液体活检市场份额的成长。
The global liquid biopsy market size reached USD 2.3 Billion in 2024. Looking forward, IMARC Group expects the market to reach USD 7.2 Billion by 2033, exhibiting a growth rate (CAGR) of 12.82% during 2025-2033. 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.
Major Market Drivers: The rising prevalence of cancer owing to changing lifestyle patterns, especially among working professionals, along with the introduction of next-generation sequencing is propelling the market growth. Liquid biopsies enable the detection of cancer-related biomarkers, such as circulating tumor cells (CTCs), cell-free DNA (cfDNA), and exosomes, in bodily fluids like blood or urine. Early detection is crucial for effective treatment and improved patient outcomes, thereby driving the market growth.
Key Market Trends: Technological advancements, expanding clinical applications, a shift towards multi-analyte approaches, rising focus on early detection and screening, and elevating adoption of liquid biopsies in clinical trials are some of the key factors that are expected to stimulate the market growth in the coming years. Moreover, continuous innovation in sequencing technologies, microfluidics, and bioinformatics is enhancing the sensitivity, specificity, and scalability of liquid biopsy assays, thereby further bolstering the liquid biopsy market revenue.
Geographical Landscape: According to the report, North America accounted for the largest market share. Cancer remains a major health concern in North America, with a significant portion of the population being diagnosed with various types of cancer each year. The high incidence rates drive the demand for innovative diagnostic tools like liquid biopsies that offer non-invasive and accurate methods for cancer detection and monitoring. This is further positively impacting the liquid biopsy market demand.
Competitive Landscape: Some of the leading liquid biopsy market companies are ANGLE plc, Biocept Inc., Bio-Rad Laboratories Inc, Epigenomics AG, Exact Sciences Corporation, F. Hoffmann-La Roche AG, Guardant Health Inc., Illumina Inc., MDxHealth SA, Menarini Silicon Biosystems, QIAGEN N.V., and Thermo Fisher Scientific Inc., among many others.
Challenges and Opportunities: Standardization and validation of assays, clinical validation and evidence generation, and cost consideration and reimbursement are some of the key challenges that the market is currently facing. However, liquid biopsies can be integrated with digital health technologies, such as artificial intelligence (AI) and machine learning, to enhance data analysis, interpretation, and clinical decision-making. This represents key opportunities for the manufacturers.
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.