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市场调查报告书
商品编码
1959912
乳癌液态生物检体设备市场 - 全球产业规模、份额、趋势、机会、预测:产品、循环生物标记、应用、区域及竞争格局,2021-2031年Breast Cancer Liquid Biopsy Testing Devices Market - Global Industry Size, Share, Trends, Opportunity, and Forecast, Segmented By Offerings, By Circulating Biomarker, By Application, By Region & Competition, 2021-2031F |
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全球乳癌液态生物检体设备市场预计将从 2025 年的 8.9536 亿美元大幅成长至 2031 年的 23.4546 亿美元,复合年增长率达 17.41%。
这些设备,包括诊断平台和检测试剂盒,旨在从血液样本中分离和分析循环性肿瘤细胞(CTC) 或循环肿瘤 DNA (ctDNA),用于肿瘤学评估。这一增长趋势主要受乳癌发病率上升以及临床上对频繁、非侵入性监测以检测治疗抗药性的需求所驱动。此外,精准医疗的兴起也推动了该行业的发展,精准医疗需要进行详细的基因组分析,但又避免了重复组织切片检查带来的固有风险。美国癌症协会估计,到 2025 年,美国将有约 316,950 名女性被诊断出患有侵袭性乳癌,这凸显了可扩展诊断解决方案的紧迫性。
| 市场概览 | |
|---|---|
| 预测期 | 2027-2031 |
| 市场规模:2025年 | 8.9536亿美元 |
| 市场规模:2031年 | 2,345,460,000 美元 |
| 复合年增长率:2026-2031年 | 17.41% |
| 成长最快的细分市场 | 循环肿瘤DNA |
| 最大的市场 | 北美洲 |
阻碍该市场广泛扩张的主要挑战之一是缺乏标准化的报销政策以及次世代定序检测的高成本。不同医疗体系间保险覆盖范围的不统一,也造成了病人取得这些分子诊断工具经济障碍。此外,检测灵敏度的差异以及获得监管部门核准所需的大量临床检验数据,持续减缓新参与企业进入市场的步伐,阻碍了商业性应用的快速发展。
全球乳癌发生率和盛行率的不断上升是推动可扩展液态生物检体解决方案需求成长的根本原因。随着全球疾病负担的加重,医疗卫生系统正优先考虑能够提供频繁基因组分析的非侵入性工具,以避免组织取样带来的繁琐的后勤和临床操作。不断成长的患者群体需要高通量筛检和监测能力,而分子诊断技术才能在全球范围内有效地实现这一目标。根据世界卫生组织(WHO)于2025年8月发布的乳癌关键数据,2022年全球约有230万女性被诊断出罹患乳癌,显示先进诊断干预措施拥有巨大的市场潜力。
同时,次世代定序(NGS) 和数位 PCR 技术的进步正在消除技术准入壁垒,加速商业性化应用。这些创新显着提高了检测灵敏度,能够精准检测先前无法检测到的低频循环肿瘤 DNA 突变,展现了液态生物检体在治疗方案选择和復发监测方面的临床效用。这种技术成熟度直接体现在临床侦测量的激增上。根据 Natera 公司于 2025 年 2 月发布的《2024 年第四季及全年财务业绩报告》,该公司仅在第四季度就处理了约 15.1 万例肿瘤检测,年增 55%。这种快速普及表明,市场整体趋势是经济效益和临床疗效的双重提升。 Gardant Health 公司报告称,其 2025 年第三季肿瘤相关收入增长至 1.844 亿美元,凸显了基于血液的癌症诊断业务的盈利增长。
缺乏标准化的报销政策以及次世代定序检测的高成本是全球乳癌液态生物检体)检测设备市场扩张的主要障碍。保险公司通常将这些先进的分子检测归类为研究阶段检测而非医疗必要检测,导致不同医疗区域的覆盖范围分散,支付模式也难以预测。这种财务上的不确定性使得临床医生不愿开立液态生物检体处方,因为他们无法保证病人不会承担沉重的经济负担。因此,临床检查室难以证明对这些诊断平台进行必要资本投资的合理性,从而有效地减缓了市场扩张所需的企业发展势头。
这些经济障碍直接限制了患者获得精准医疗的机会,并缩小了医疗器材製造商的潜在市场。当第三方支付方拒绝收费或收取高额自付费用时,患者往往会放弃一些对制定治疗方案或监测復发至关重要的检查。根据美国癌症协会发布的《2025年癌症网路报告》,超过70%的私人保险患者需要自费进行乳癌后续诊断检查。这种经济负担迫使患者选择费用较低的侵入性替代方法,或干脆推迟检查,最终导致该领域商业性成长和技术创新所需的检查数量减少。
微量残存疾病(MRD)监测的广泛应用正在改变临床通讯协定,使医生能够比影像学復发更早检测到微小的肿瘤碎片。这一趋势解决了术后后续观察的一项重大挑战,即传统影像学检查往往无法识别潜在的转移病灶,直到病情发展到临床晚期。透过利用基于肿瘤的检测方法,临床医生可以根据患者的即时復发风险进行分层,从而实现及时的治疗性介入。在2025年12月Exact Sciences、NSABP基金会和德国乳癌研究小组共同发布的新闻稿中,发表了NSABP B-59子研究的结果。研究表明,早期三阴性乳癌患者术后MRD阳性会使远端復发的风险比MRD阴性患者高出约30倍。
同时,人工智慧在生物标记发现领域的应用,正透过解读复杂的基因组资料集来辨识新的治疗靶点,从而重塑竞争格局。市场参与者日益利用机器学习演算法分析大量的临床和分子数据,从而提高液态生物检体检测的灵敏度,并使大规模精准肿瘤学得以实现。随着医疗机构采用这些人工智慧增强型平台进行更精准的分析,这种技术融合正在推动显着的商业性成长。根据Tempus AI于2025年8月发布的报告《Tempus AI:2025年第二季财报》,该公司第二季的肿瘤检测收入达1.332亿美元,较去年同期成长32.9%。这凸显了市场对人工智慧驱动的诊断解决方案日益增长的需求。
The Global Breast Cancer Liquid Biopsy Testing Devices Market is projected to expand significantly, rising from USD 895.36 Million in 2025 to USD 2345.46 Million by 2031, reflecting a CAGR of 17.41%. These devices, which include diagnostic platforms and assay kits, are engineered to isolate and analyze circulating tumor cells or circulating tumor DNA from blood samples for oncological evaluation. This growth trajectory is chiefly propelled by the rising incidence of breast carcinomas combined with the clinical necessity for frequent, non-invasive monitoring to detect treatment resistance. Additionally, the industry is buoyed by the transition toward precision medicine, which demands detailed genomic profiling without the inherent risks of repeated tissue biopsies. Highlighting the urgency for scalable diagnostic solutions, the American Cancer Society estimates that approximately 316,950 women in the United States will be diagnosed with invasive breast cancer in 2025.
| Market Overview | |
|---|---|
| Forecast Period | 2027-2031 |
| Market Size 2025 | USD 895.36 Million |
| Market Size 2031 | USD 2345.46 Million |
| CAGR 2026-2031 | 17.41% |
| Fastest Growing Segment | Circulating Tumor DNA |
| Largest Market | North America |
One significant challenge hampering the widespread expansion of this market is the lack of standardized reimbursement policies and the high cost associated with next-generation sequencing assays. Inconsistent coverage across different healthcare systems creates financial barriers that limit patient access to these molecular diagnostic tools. Furthermore, the variability in assay sensitivity and the requirement for substantial clinical validation data to secure regulatory approval continue to delay market entry for new entrants, thereby impeding rapid commercial adoption.
Market Driver
The Rising Global Incidence and Prevalence of Breast Cancer constitutes the foundational driver propelling the demand for scalable liquid biopsy solutions. As the burden of disease intensifies worldwide, healthcare systems are increasingly prioritizing non-invasive tools that can provide frequent genomic profiling without the logistical and clinical complications of tissue extraction. This escalating patient population necessitates high-throughput screening and monitoring capabilities that only molecular diagnostics can efficiently sustain on a global scale. According to the World Health Organization, August 2025, in the 'Breast cancer' key facts, there were an estimated 2.3 million women diagnosed with breast cancer globally in 2022, highlighting the massive addressable market for advanced diagnostic interventions.
Simultaneously, Advancements in Next-Generation Sequencing (NGS) and Digital PCR Technologies are removing technical barriers to entry and accelerating commercial adoption. These technological innovations have significantly enhanced the sensitivity of assays, allowing for the precise detection of low-frequency circulating tumor DNA mutations that were previously undetectable, thereby validating the clinical utility of liquid biopsies for treatment selection and recurrence monitoring. This technical maturation is directly reflected in the surging volume of clinical testing. According to Natera, Inc., February 2025, in the 'Fourth Quarter and Full Year 2024 Financial Results', the company processed approximately 151,000 oncology tests in the fourth quarter alone, representing a 55% increase year-over-year. This rapid uptake is indicative of a broader market trend where financial viability is improving alongside clinical efficacy; According to Guardant Health, in 2025, the company reported that its oncology revenue grew to $184.4 million in the third quarter, underscoring the lucrative expansion of blood-based cancer diagnostics.
Market Challenge
The lack of standardized reimbursement policies and the high costs associated with next-generation sequencing assays present a formidable barrier to the expansion of the Global Breast Cancer Liquid Biopsy Testing Devices Market. Insurers frequently classify these advanced molecular tests as investigational rather than medically necessary, resulting in fragmented coverage and unpredictable payment models across different healthcare regions. This financial ambiguity discourages clinicians from prescribing liquid biopsies, as they cannot ensure that patients will be insulated from significant expenses. Consequently, clinical laboratories face difficulties in justifying the capital investment required for these diagnostic platforms, effectively slowing the operational momentum needed for market expansion.
These economic hurdles directly restrict patient access to precision medicine, narrowing the addressable market for device manufacturers. When third-party payers deny claims or impose high deductibles, patients often decline testing despite its potential to guide therapy or monitor recurrence. According to the American Cancer Society Cancer Action Network, in 2025, a report indicated that over 70% of commercially-insured patients encountered out-of-pocket expenses for follow-up breast cancer diagnostic tests. This financial toxicity forces patients to opt for less expensive, invasive alternatives or delay testing entirely, thereby reducing the testing volume necessary to drive commercial growth and technological innovation in the sector.
Market Trends
The Rising Adoption of Minimal Residual Disease (MRD) Monitoring is transforming clinical protocols by enabling the detection of microscopic tumor fragments long before radiological recurrence. This trend addresses the critical gap in post-surgical surveillance, where traditional imaging often fails to identify occult metastases until they are clinically advanced. By utilizing tumor-informed assays, clinicians can now stratify patients based on their real-time recurrence risk, allowing for timely therapeutic intervention. According to Exact Sciences, December 2025, in the 'Exact Sciences, the NSABP Foundation, and the German Breast Group Present Results for the Oncodetect(R) MRD Test' press release, results from the NSABP B-59 substudy demonstrated that post-surgery MRD-positive status in early triple-negative breast cancer patients was associated with an approximate 30-fold higher risk of distant recurrence compared to MRD-negative patients.
Concurrently, the Integration of Artificial Intelligence for Enhanced Biomarker Discovery is reshaping the competitive landscape by decoding complex genomic datasets to identify novel therapeutic targets. Market players are increasingly leveraging machine learning algorithms to analyze vast amounts of clinical and molecular data, thereby improving the sensitivity of liquid biopsy panels and operationalizing precision oncology at scale. This technological convergence is driving substantial commercial growth as providers adopt these AI-enhanced platforms for more accurate profiling. According to Tempus AI, August 2025, in the 'Tempus AI: Q2 2025 Earnings' report, the company's oncology testing revenue reached $133.2 million in the second quarter, marking a 32.9% increase year-over-year, which validates the accelerating market demand for AI-driven diagnostic solutions.
Report Scope
In this report, the Global Breast Cancer Liquid Biopsy Testing Devices Market has been segmented into the following categories, in addition to the industry trends which have also been detailed below:
Company Profiles: Detailed analysis of the major companies present in the Global Breast Cancer Liquid Biopsy Testing Devices Market.
Global Breast Cancer Liquid Biopsy Testing Devices Market report with the given market data, TechSci Research offers customizations according to a company's specific needs. The following customization options are available for the report: