![]() |
市场调查报告书
商品编码
1776752
2032 年液态切片市场预测:按产品类型、生物标记类型、样本类型、技术、应用、最终用户和地区进行的全球分析Liquid Biopsy Market Forecasts to 2032 - Global Analysis By Product Type (Assay Kits & Reagents, Instruments, Services, and Other Product Types), Biomarker Type, Sample Type, Technology, Application, End User and By Geography |
根据 Stratistics MRC 的数据,全球液态切片市场预计在 2025 年达到 134.4702 亿美元,预计到 2032 年将达到 326.2851 亿美元,预测期内的复合年增长率为 13.5%。
液态切片是一种非侵入性诊断技术,透过分析血液和尿液等体液中存在的生物标记(例如循环肿瘤DNA (ctDNA)、RNA和外泌体)来检测癌症和其他疾病。液态切片可以即时洞察疾病进展,从而实现早期发现、监测治疗效果和检测復发。液态切片提供了一种比传统组织切片检查更安全、更快捷的替代方案,可增强患者照护并制定个人化治疗策略。
根据国际癌症研究机构(IARC)的数据,预计2023年全球新增癌症病例将超过2,070万例。
个人化医疗日益受到偏好
个人化医疗的日益兴起是液态切片市场扩张的主要催化剂。随着肿瘤治疗日益个人化,临床医生越来越依赖液体切片检查等微创工具来指南治疗决策。这些检测能够即时监测肿瘤动态,帮助医师根据个别分子谱制定个人化治疗方法。透过循环生物标记检测可操作突变的能力,支持标靶治疗的应用,并改善患者预后。精准诊断需求的不断增长,正在加速液态切片在研究和临床领域的应用。
有限的临床检验
许多液态切片检测,尤其是那些用于检测早期癌症或罕见突变的检测,缺乏全面、大规模的临床试验来确认其敏感性、特异性和整体可靠性。如果没有强有力的检验,医疗保健提供者可能会犹豫是否将这些检测用于诊断、治疗计划和监测等重要决策。这种不确定性也会影响监理机关的核准和报销,进一步延缓市场渗透。为了获得更广泛的认可,需要进行更多纵向研究和同侪审查证据,以确立其在不同患者群体中的临床效用。
基因组学和次世代定序仪(NGS)的进展
NGS技术能够高通量、高精度且经济高效地分析血液检体中的循环肿瘤DNA (ctDNA)、外泌体和其他生物标记。这些技术进步使得能够以前所未有的灵敏度和特异性检测基因突变、拷贝数变异和表观遗传变异。随着NGS越来越普及并逐渐融入临床工作流程,其早期诊断癌症、监测病情进展和指南个人化治疗的能力将会增强。定序速度、数据分析和生物资讯学的持续改进正在进一步加速液态切片在临床上的应用。
数据解释的复杂性
液态切片产生的基因组数据日益复杂,带来了巨大的挑战。解读多个基因组合併区分临床相关突变和良性突变需要高级生物资讯学专业知识。不一致的报告标准和对突变分类缺乏共识可能会给临床医生带来困惑。这种复杂性可能会延迟治疗决策或导致治疗方法方案不理想。小型实验室和医疗保健机构可能缺乏有效管理和分析此类数据的基础设施。如果没有精简的解读工具和标准化的指南,液态切片的潜力可能无法充分利用。
新冠疫情对液态切片市场产生了双重影响。起初,诊断延迟和就诊次数减少导致癌症筛检和监测业务暂时下滑。然而,对非侵入性、远端检测解决方案的需求使液体切片检查重新成为人们关注的焦点。随着医疗体系的调整,液体切片检查已成为比组织切片检查更安全的替代方案,尤其对于免疫力缺乏的患者。疫情过后,人们对早期检测和即时监测的认识不断提高,加速了市场应用。
预计设备部分将成为预测期内最大的部分
预计仪器仪表领域将在预测期内占据最大的市场占有率,因为NGS系统、数位PCR和微流体设备等平台在实现精准的生物标记检测方面发挥关键作用。这些仪器仪表构成了液态切片工作流程的支柱,支持研究和临床应用。定序速度、通量和自动化的持续创新正在提高检测的效率和扩充性。随着对高灵敏度诊断的需求不断增长,对先进设备的投资预计也将增加。
专科诊所部门预计在预测期内实现最高复合年增长率
预计专科诊所细分市场将在预测期内实现最高成长率。这些诊所越来越多地采用液态切片进行癌症筛检、治疗方法选择和復发监测。其集中的专业知识和精简的工作流程使其成为高级诊断的理想环境。个人化医疗意识的不断增强,促使患者前往专科中心寻求客製化治疗。此外,诊断公司与专科诊所之间的合作也扩大了尖端侦测的可近性。
由于癌症发病率上升、医疗基础设施扩张以及政府加大对精准医疗的投资,预计亚太地区将在预测期内占据最大市场占有率。中国、印度和日本等国家正迅速普及包括液态切片在内的先进诊断技术。本土企业也纷纷进入市场,提供符合当地需求的经济高效的解决方案。官民合作关係和有利的监管改革正在进一步加速市场渗透。
北美受惠于成熟的医疗保健体系、强大的研发生态系统以及基因组技术的早期应用。基于液态切片的伴随诊断的监管核准不断增加,提升了临床可靠性。此外,对非侵入性癌症筛检和监测的需求不断增长,刺激了检测量的增加。生物技术公司、学术机构和医疗保健提供者之间的策略联盟正在推动创新。
According to Stratistics MRC, the Global Liquid Biopsy Market is accounted for $13447.02 million in 2025 and is expected to reach $32628.51 million by 2032 growing at a CAGR of 13.5% during the forecast period. Liquid biopsy is a non-invasive diagnostic technique that detects cancer and other diseases by analyzing biomarkers such as circulating tumor DNA (ctDNA), RNA, or exosomes present in body fluids like blood or urine. It offers a real-time snapshot of disease progression, enabling early detection, monitoring of treatment response, and detection of recurrence. Liquid biopsy provides a safer, quicker alternative to traditional tissue biopsies, enhancing patient care and personalized treatment strategies.
According to the International Agency for Research on Cancer (IARC), over 20.7 million new cancer cases are expected in 2023.
Increased preference for personalized medicine
The growing shift toward personalized medicine is a major catalyst for the expansion of the liquid biopsy market. As oncology care becomes more tailored, clinicians increasingly rely on minimally invasive tools like liquid biopsy to guide treatment decisions. These tests enable real-time monitoring of tumor dynamics, helping physicians adjust therapies based on individual molecular profiles. The ability to detect actionable mutations through circulating biomarkers supports the use of targeted therapies, improving patient outcomes. This rising demand for precision diagnostics is accelerating the adoption of liquid biopsy across research and clinical settings.
Limited clinical validation
Many liquid biopsy tests, particularly those detecting early-stage cancers or rare mutations, lack comprehensive, large-scale clinical trials to confirm their sensitivity, specificity, and overall reliability. Without robust validation, healthcare providers may hesitate to trust these tests for critical decisions such as diagnosis, treatment planning, or monitoring. This uncertainty also impacts regulatory approvals and insurance reimbursements, further delaying market penetration. To gain broader acceptance, more longitudinal studies and peer-reviewed evidence are essential to establish clinical utility across diverse patient populations.
Advancements in genomics and next-generation sequencing (NGS)
NGS technologies enable high-throughput, accurate, and cost-effective analysis of circulating tumor DNA (ctDNA), exosomes, and other biomarkers from blood samples. These innovations allow for the detection of genetic mutations, copy number variations, and epigenetic changes with unprecedented sensitivity and specificity. As NGS becomes more accessible and integrated into clinical workflows, it enhances the ability to diagnose cancer early, monitor disease progression, and guide personalized treatment. Continuous improvements in sequencing speed, data analytics, and bioinformatics are further accelerating the clinical adoption of liquid biopsy.
Complexity in data interpretation
The increasing complexity of genomic data generated by liquid biopsy tests poses a significant challenge. Interpreting multi-gene panels and distinguishing clinically relevant mutations from benign variants requires advanced bioinformatics expertise. Inconsistent reporting standards and lack of consensus on variant classification can lead to confusion among clinicians. This complexity may delay treatment decisions or result in suboptimal therapy selection. Smaller labs and healthcare providers may lack the infrastructure to manage and analyze such data effectively. Without streamlined interpretation tools and standardized guidelines, the full potential of liquid biopsy may remain underutilized.
The COVID-19 pandemic had a dual impact on the liquid biopsy market. Initially, diagnostic delays and reduced hospital visits led to a temporary decline in cancer screening and monitoring procedures. However, the need for non-invasive, remote-friendly testing solutions brought renewed attention to liquid biopsy. As healthcare systems adapted, liquid biopsy emerged as a safer alternative to tissue biopsies, especially for immunocompromised patients. Post-pandemic, the market witnessed accelerated adoption driven by increased awareness of early detection and real-time monitoring.
The instruments segment is expected to be the largest during the forecast period
The instruments segment is expected to account for the largest market share during the forecast period, due to the critical role of platforms such as NGS systems, digital PCR, and microfluidic devices in enabling accurate biomarker detection. These instruments form the backbone of liquid biopsy workflows, supporting both research and clinical applications. Continuous innovation in sequencing speed, throughput, and automation is enhancing test efficiency and scalability. As demand for high-sensitivity diagnostics grows, investment in advanced instrumentation is expected to rise.
The specialty clinics segment is expected to have the highest CAGR during the forecast period
Over the forecast period, the specialty clinics segment is predicted to witness the highest growth rate. These clinics are increasingly adopting liquid biopsy for cancer screening, therapy selection, and recurrence monitoring. Their focused expertise and streamlined workflows make them ideal settings for implementing advanced diagnostics. As awareness of personalized medicine grows, patients are turning to specialty centers for tailored care. Additionally, partnerships between diagnostic companies and specialty clinics are expanding access to cutting-edge tests.
During the forecast period, the Asia Pacific region is expected to hold the largest market share, driven by rising cancer incidence, expanding healthcare infrastructure, and increasing government investment in precision medicine. Countries like China, India, and Japan are witnessing rapid adoption of advanced diagnostics, including liquid biopsy. Local players are also entering the market with cost-effective solutions tailored to regional needs. Public-private partnerships and favorable regulatory reforms are further accelerating market penetration.
Over the forecast period, the North America region is anticipated to exhibit the highest CAGR, owing to the region benefits from a well-established healthcare system, strong R&D ecosystem, and early adoption of genomic technologies. Regulatory approvals for liquid biopsy-based companion diagnostics are increasing, boosting clinical confidence. Additionally, rising demand for non-invasive cancer screening and monitoring is fueling test volumes. Strategic collaborations between biotech firms, academic institutions, and healthcare providers are driving innovation.
Key players in the market
Some of the key players in Liquid Biopsy Market include F. Hoffmann-La Roche Ltd., Menarini Silicon Biosystems, Guardant Health Inc., Freenome Holdings, Inc., Illumina Inc., Biocept, Inc., Thermo Fisher Scientific Inc., ANGLE plc, Exact Sciences Corporation, Caris Life Sciences, Natera Inc., NeoGenomics Laboratories, QIAGEN N.V., Lucence Health Inc., Bio-Rad Laboratories Inc., Foundation Medicine, Inc., Epigenomics AG, Johnson & Johnson Services Inc., Myriad Genetics, Inc., and Sysmex Corporation.
In May 2025, Roche announced a strategic collaboration with Broad Clinical Labs to develop and pilot groundbreaking applications using Roche's recently unveiled next-generation sequencing (NGS) Sequencing By Expansion (SBX) technology. This collaboration will focus on harnessing the power of the SBX technology to transform clinical genomics and biomedical discovery. It will also aim to establish the SBX technology as a routine offering for fast, scalable sequencing for Broad Clinical Lab's research community.
In July 2022, Menarini Silicon Biosystems Inc, announced at the American Association for Clinical Chemistry (AACC) Annual Scientific Meeting & Clinical Lab Expo that they have entered into a commercial agreement for the exclusive distribution of the CHORUS TRIO immunometric assay system in the United States of America.
Note: Tables for North America, Europe, APAC, South America, and Middle East & Africa Regions are also represented in the same manner as above.