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2024-2032 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)Liquid Biopsy Market Report by Product And Service, Circulating Biomarker, Cancer Type, End User, and Region 2024-2032 |
IMARC Group年全球液体切片市场规模达20亿美元。癌症盛行率的不断上升、对个人化医疗和治疗的需求不断增长以及自动化液体活检平台的发展是推动液体活检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,特别是在职业人士中,癌症盛行率不断上升,再加上下一代定序的引入,正在推动市场成长。液体活检能够检测血液或尿液等体液中与癌症相关的生物标记物,例如循环肿瘤细胞 (CTC)、游离 DNA (cfDNA) 和外泌体。早期检测对于有效治疗和改善患者治疗效果至关重要,从而推动市场成长。
主要市场趋势:技术进步、扩大临床应用、向多分析方法的转变、对早期检测和筛检的日益关注以及在临床试验中提高液体活检的采用是预计刺激市场增长的一些关键因素未来几年。此外,定序技术、微流控和生物资讯学的不断创新正在提高液体活检检测的灵敏度、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。癌症仍然是北美的一个主要健康问题,每年有很大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非侵入性且准确的方法。这进一步对液体活检市场需求产生正面影响。
竞争格局:液体切片市场的一些领先公司包括 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 Biosystems、QIAGEN NV 和Thermo Fisher Scientific Inc. 等。
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。这对製造商来说是重要的机会。
癌症盛行率上升
随着全球癌症发生率的上升,人们越来越重视疾病的早期检测和监测。例如,根据世界卫生组织的数据,到 2022 年,预计将有 2,000 万新的癌症诊断和 970 万人死亡。癌症诊断后五年预计存活人数为 5,350 万人。大约五分之一的人一生中都会受到癌症的影响。预计到2050 年,癌症病例将增加超过3500 万例,比2022 年预计的2000 万例增加77%。 ) 和游离DNA。这些生物标记可以为癌症的存在、进展和遗传特征提供有价值的见解,使临床医生能够在早期阶段诊断癌症并更有效地监测疾病进展。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液体活检多癌症早期检测测试的报告,该测试使用创新平台分析 DNA 甲基化。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 cfDNA 分子。科学家进行了一项回顾性分析,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,其中包括最近诊断出的癌症患者、未接受过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,宾州大学的研究团队在《临床癌症研究》上发表了一篇论文,证明他们的液体切片在诊断早期胰臟癌方面的准确率高达92%。这些因素进一步对液体活检市场预测产生正面影响。
对非侵入性产前检查 (NIPT) 的需求不断增长
传统的产前检测方法,例如羊膜穿刺术和绒毛膜绒毛取样(CVS),出现併发症(包括流产)的风险很小。 NIPT 涉及分析母亲血液中循环的胎儿游离 DNA (cffDNA),为产前筛检提供了一种非侵入性替代方案。例如,根据国家医学图书馆的数据,羊膜穿刺术可以在怀孕 15 週至出生期间的任何时间进行,在专家手中,单胎流产的可能性为 0.13%。据此,怀孕 15 週后进行羊膜穿刺术的风险估计为百分之一。此外,NIPT 在检测常见胎儿染色体异常方面表现出很高的准确性,例如 21 三体(唐氏症)、18 三体症(爱德华兹症候群)和 13 三体(帕陶症候群)。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遗传异常,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子公司Yourgene Health与Laboriad合作在摩洛哥推出了第一个非侵入性产前检测(NIPT)平台。除此之外,NIPT 最早可以在怀孕 9-10 週时进行,从而提供对胎儿遗传健康状况的早期了解。及早发现染色体异常可以让准父母就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 最早可以在怀孕 9-10 週时进行,从而儘早了解胎儿遗传健康状况。及早发现染色体异常可以让准父母就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 检测最早可以从怀孕十週一直进行到分娩。这些因素进一步对液体切片市场近期的价格产生正面影响。
不断增加的研发活动和临床试验
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。各政府机构和公司正在专注于投资研发,以进行液体活检的临床研究。例如,2023 年 6 月,Anzu Partners 领投了 Codetta Biosciences 的 1,500 万美元 A 轮投资。 Genoa Ventures 和 VC23 LLC 也参与了此次融资。 Codetta 计划利用这笔资金迅速扩大其在研发、工程、行销和企业管理方面的团队,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。对研发的投资有助于开发下一代定序 (NGS) 平台、数位 PCR 系统和其他创新技术,从而提高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,为其商业化和广泛采用铺平了道路。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 推出了下一代定序(NGS) 和光学图谱平台,这是一套新颖的技术,将为基因治疗提供全面的基因组分析服务。这些因素进一步提高了液体活检的市场份额。
The global liquid biopsy market size reached US$ 2.0 Billion in 2023. Looking forward, IMARC Group expects the market to reach US$ 6.5 Billion by 2032, exhibiting a growth rate (CAGR) of 13.5% during 2024-2032. 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 liquid biopsy 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.
MARC Group provides an analysis of the key trends in each sub-segment of the global liquid biopsy market report, along with forecasts at the global, regional, and country levels from 2024-2032. Our report has categorized the market based on product and service, circulating biomarker, cancer type, and end user.
Kits and Reagents
Platforms and Instruments
Services
Kits and reagents assist dominates the market
The report has provided a detailed breakup and analysis of the liquid biopsy market based on the product and service. This includes kits and reagents, platforms and instruments and services. According to the report, kits and reagents represented the largest segment.
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
Extracellular Vesicles
Circulating Tumor DNA
Others
Circulating tumor cells hold the largest share in the market
A detailed breakup and analysis of the liquid biopsy market based on the circulating biomarker has also been provided in the report. This includes circulating tumor cells, extracellular vesicles, circulating tumor DNA and others. According to the liquid biopsy market report, circulating tumor cells accounted for the largest market share.
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
Breast Cancer
Colorectal Cancer
Prostate Cancer
Liver Cancer
Others
Lung cancer accounts for the majority of the market share
The report has provided a detailed breakup and analysis of the liquid biopsy market based on the cancer type. This includes lung cancer, breast cancer, colorectal cancer, prostate cancer, liver cancer and others. According to the report, lung cancer represented the largest segment.
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
Academic and Research Centers
Others
Hospitals and laboratories hold the largest share in the market
A detailed breakup and analysis of the liquid biopsy market based on the end user has also been provided in the report. This includes hospitals and laboratories, academic and research centers and others. According to the report, hospitals and laboratories accounted for the largest market share.
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
United States
Canada
Asia-Pacific
China
Japan
India
South Korea
Australia
Indonesia
Others
Europe
Germany
France
United Kingdom
Italy
Spain
Russia
Others
Latin America
Brazil
Mexico
Others
Middle East and Africa
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.
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.
Thermo Fisher Scientific Inc.
(Kindly note that this only represents a partial list of companies, and the complete list has been provided in the report.)
May 2024: VESICA HEALTH, INC., a leading multi-omics liquid biopsy company, launched its laboratory developed AssureMDx test to improve the management of hematuria patients and the early detection of bladder cancer.
April 2024: SOPHiA GENETICS, a cloud-native software firm in healthcare and a leader in data-driven medicine, announced that Nigeria-based Syndicate Bio signed on to adopt MSK-ACCESS powered by SOPHiA DDM.
April 2024: City of Hope, one of the largest cancer research and treatment organizations in the United States, collaborated with DELFI Diagnostics, Inc., a developer of accessible blood-based tests that deliver a new way to enhance cancer detection, to utilize DELFI's FirstLook Lung, a blood-based lung cancer liquid biopsy screening test, to improve screening rates in underserved communities in Los Angeles County.